1. -- NUZYRA Generated Net U.S. Sales of $12.4 Million in the Fourth Quarter 2020; a 14% Increase Over the Third Quarter 2020

    -- NUZYRA Expansion into the Primary Care Setting in 2021

    -- Paratek Expects Full Year 2021 Total Revenue Between $166 and $177 Million

    BOSTON, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the quarter and year ended December 31, 2020.

    "The launch of NUZYRA continued to demonstrate…

    -- NUZYRA Generated Net U.S. Sales of $12.4 Million in the Fourth Quarter 2020; a 14% Increase Over the Third Quarter 2020



    -- NUZYRA Expansion into the Primary Care Setting in 2021

    -- Paratek Expects Full Year 2021 Total Revenue Between $166 and $177 Million

    BOSTON, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the quarter and year ended December 31, 2020.



    "The launch of NUZYRA continued to demonstrate consistent quarter-over-quarter growth through 2020 in a challenging environment created by the ongoing COVID-19 pandemic," said Evan Loh, M.D., Chief Executive Officer at Paratek. "The full year commercial net U.S. sales of NUZYRA, which landed at the high end of our guidance range, reflects the strong health of the underlying core commercial business. With two Biomedical Advanced Research and Development Authority (BARDA) Project BioShield procurements for the Strategic National Stockpile (SNS) now anticipated in 2021 plus the expected continued commercial growth of NUZYRA, we are anticipating a significant ramp up in total revenue for 2021. We believe prescribers recognize NUZYRA as an important life-saving antibiotic that addresses patient needs in the face of the growing global threat from antibiotic resistance."



    "In our conversations with clinicians over the past several years, it is clear there is a tremendous unmet need for a well-tolerated, once daily oral broad-spectrum antibiotic that includes coverage against MRSA for skin infections. Current generic antibiotic options are universally challenged by either significant bacterial resistance or serious safety concerns that limit their clinical utility," said Adam Woodrow, Paratek's President and Chief Commercial Officer. "NUZYRA's product profile makes it a very attractive treatment option for community use. With access now solidly established with the payers and significant support from infectious disease specialists, we believe our primary care expansion will accelerate and strengthen our sales trajectory, especially as we enter the second half of 2021."



    Key 2021 Priorities

    • Expansion of NUZYRA into Primary Care Setting: Paratek completed the hiring of approximately 40 U.S. sales representatives in February 2021 to enable the expansion of the NUZRYA launch into the primary care setting. The Company expects to execute this expansion within its previously communicated cash runway guidance.
    • NTM Rare Disease Opportunity: The Company plans to initiate a Phase 2b study, as early as mid-2021, to explore the potential utility of omadacycline as a treatment for non-tuberculous mycobacteria (NTM) infections due to Mycobacterium abscessus (M. abscessus), a rare disease with currently no approved therapies. M. abscessus and based on Company estimates represents a potential $1.0 billion addressable market opportunity in the U.S.
    • Continued Progress of the BARDA Project BioShield Anthrax Program: The Company expects to continue to execute and deliver on its contract with BARDA to develop NUZYRA for the treatment of pulmonary anthrax, a critical bioterrorism threat deemed important to national security by BARDA. These activities include advancing the U.S. onshoring of NUZYRA manufacturing and the continued execution of certain preclinical research activities supporting the pulmonary anthrax development program. Under Paratek's five-year agreement with BARDA, the Company also anticipates two procurements of 2,500 treatment courses of NUZYRA each in 2021 for addition to the SNS.

    Other Recent Highlights

    • In December 2020, Paratek entered into a $60 million non-recourse loan agreement with an affiliate of R-Bridge Healthcare Investment Advisory (the R-Bridge Loan) that will be repaid using (i) all proceeds of royalties from the Company's License and Collaboration Agreement with Zai Lab and (ii) an initial 2.5% revenue interest from the Company's U.S. net sales of NUZYRA (initial annual cap of $10 million).
      • The net proceeds of the R-Bridge Loan, together with cash on hand, was used to prepay in full all obligations outstanding under the Company's Amended and Restated Loan and Security Agreement with Hercules Capital on December 31, 2020.

    Fourth Quarter and Full Year 2020 Financial Results

    • Fourth quarter 2020 revenue
      • Total revenue was $16.0 million for the fourth quarter of 2020, an increase of 17% over the third quarter of 2020 and an increase of 78% over the fourth quarter of 2019.   
      • NUZYRA generated $12.4 million in net U.S. sales during the fourth quarter of 2020, an increase of 14% over the third quarter of 2020 and an increase of 130% over the fourth quarter of 2019.   
      • Government contract service and grant revenue was $2.8 million for the fourth quarter of 2020 versus $2.7 million in the third quarter of 2020.  No revenue was generated from the BARDA contract in 2019 as it was executed in December of that year. 
    • Full year 2020 total revenue 
      • Full year 2020 total revenue was $46.9 million, an increase of 184% over full year 2019 total revenue.   
      • NUZYRA generated $38.8 million in net U.S. sales for the full year 2020, an increase of 237% over the full year 2019.
        • The growth in NUZYRA sales in 2020 reflects the Company's continued commitment to strong execution and NUZYRA's attributes that address unmet needs in the marketplace despite the significant disruptions of patient traffic to physician offices and institutions throughout the ongoing COVID-19 pandemic.
        • In today's COVID-19 environment, NUZYRA's ability to minimize hospital stays with the oral formulation is especially relevant for many prescribers and a meaningful benefit for patients.
      • Government contract service and grant revenue was $6.7 million in 2020.  No revenue was generated from the BARDA contract in 2019 as it was executed in December of that year. 
      • Collaboration and royalty revenue of $1.5 million in 2020 is primarily comprised of royalties earned from SEYSARA® sales in the U.S. Collaboration and royalty revenue of $5.0 million in 2019 included a $3.0 million milestone earned from Zai Lab in addition to royalties earned from SEYSARA sales in the U.S.

    Research and development (R&D) expenses were $6.3 million for the fourth quarter of 2020, compared to $9.1 million for same period in the prior year. R&D expenses were $23.9 million for the full year 2020, compared to $39.6 million in the prior year. The decrease in both periods is primarily the result of lower clinical study costs associated with completion of the Phase 2 UTI program in 2019, partially offset by an increase in expenses incurred under the BARDA contract and third-party manufacturing process scale-up to meet expected future demand for NUZYRA. 



    Selling, general and administrative (SG&A) expenses were $24.3 million for the fourth quarter of 2020, compared to $21.3 million for the same period in the prior year.  The $3.0 million increase is primarily due to costs incurred to realign our hospital territories and our community expansion. 



    SG&A expenses were $89.9 million for the full year 2020, compared to $89.1 million in the prior year.  The $0.8 million increase is primarily the result of costs for the Company's contract sales organization and higher product distribution fees, partially offset by lower marketing and promotional program expenses, personnel-related costs and travel due to the COVID-19 pandemic.



    Paratek reported a net loss of $25.0 million, or ($0.54) per share, for the fourth quarter of 2020, compared to a net loss of $27.4 million, or ($0.81) per share, for the same period in 2019. 



    Paratek reported a net loss of $96.5 million, or ($2.19) per share, for the full year 2020 compared to a net loss of $128.8 million, or ($3.93) per share, for the same period in 2019. 



    Financial Guidance 

    Paratek also announced its full year 2021 financial guidance.

    • Paratek estimates 2021 total revenue in the range of $166 to $177 million. This range includes the following components:
      • 2021 NUZYRA net U.S. product sales are expected to be approximately $138 to $144 million, which includes:
        • U.S. net product sales between $62 to $68 million from the core commercial business
        • Two SNS procurements by BARDA valued at approximately $76 million
      • Royalty and collaboration revenue of approximately $8 million
      • BARDA government contract service and grant revenue between $20 to $25 million
        • BARDA contract service and grant revenue consists of reimbursement of NUZYRA post-marketing requirements, the anthrax development program and the U.S. onshoring of NUZYRA manufacturing
    • Paratek estimates 2021 R&D and SG&A expense to be approximately $150 to $155 million. This range includes the following components:
      • Core business R&D and SG&A expense of $130 million, an increase of 20% over 2020 but consistent with 2019 pre-pandemic levels
        • The expected increase in R&D and SG&A expense in 2021 when compared to 2020 will be driven by costs associated with the primary care expansion and the initiation of the phase 2b study in NTM
      • BARDA R&D and U.S. onshoring cost reimbursements between $20 to $25 million
    • Based upon the Company's current operating plan as described above, Paratek anticipates its existing cash, cash equivalents and marketable securities of $125.2 million as of December 31, 2020, provide for a cash runway through the end of 2023 with a pathway to cash flow break even.

    Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance. 



    Call and Webcast

    Paratek's earnings conference call for the quarter and year ended December 31, 2020 will be broadcast at 4:30 p.m. EST on February 24, 2021. The live audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek's website at www.ParatekPharma.com.



    Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13716761. Investors can also access the call at http://public.viavid.com/index.php?id=143647.



    Website Information

    Paratek routinely posts important information for investors on the Investor Relations section of its website at www.ParatekPharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek's website, in addition to following its press releases, U.S. Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek's website is not incorporated by reference into, and is not a part of, this document.



    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.



    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.



    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.



    In 2019, Paratek was awarded a contract from BARDA, valued at ~$285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.



    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.



    About NUZYRA®

    NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.



    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.



    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the impact of the COVID-19 pandemic on our revenue projections, access to hospital institutions, supply chain and clinical trials, projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including the status of the FDA review of the pre-EUA submission, the exercise and timing of BARDA's procurement of NUZYRA for the SNS, BARDA exercising full contract line items, including for U.S. onshoring and PMR reimbursement, our anticipated cash runway, our operating expenses, our R-Bridge loan secured by our Zai Labs royalties and a NUZYRA synthetic royalty, our SEYSARA royalties and SEYSARA-backed loan, the strategy, execution and progression of our commercial launch of NUZYRA, our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, our plans to evaluate additional indications for NUZYRA, including NTM, and to work toward an oral-only indication in CABP, future governmental stockpiling opportunities, and our potential to further drive long-term value for all of our shareholders.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.



    PARATEK PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (unaudited)

    (in thousands)

      As of December 31,
       2020   2019 
    Cash, cash equivalents and marketable securities $125,162  $215,379 
    Total assets  176,853   251,079 
    Working capital  140,164   219,154 
    Total current liabilities  23,953   24,200 
    Long-term debt  250,474   260,728 
    Common stock and additional paid-in capital  705,535   671,537 
    Accumulated deficit  (807,799)  (711,258)
    Total stockholders' deficit  (102,260)  (39,647)





    Condensed Consolidated Statements of Operations


    (unaudited)

    (in thousands, except loss per share data)

      Three Months Ended December 31,  Year Ended December 31, 
      2020  2019  2020  2019 
    Product revenue, net $12,422  $5,415  $38,753  $11,517 
    Government contract service revenue  1,739      3,299    
    Government contract grant revenue  1,103      3,407    
    Collaboration and royalty revenue  755   3,552   1,465   5,027 
    Net revenue  16,019   8,967   46,924   16,544 
    Expenses:                
    Cost of product revenue  2,925   1,755   8,651   3,484 
    Research and development  6,286   9,133   23,922   39,554 
    Selling, general and administrative  24,341   21,261   89,855   89,135 
    Total operating expenses  33,552   32,149   122,428   132,173 
    Loss from operations  (17,533)  (23,182)  (75,504)  (115,629)
    Other income and expenses:                
    Interest income  167   739   1,515   3,574 
    Interest expense  (5,265)  (4,626)  (20,240)  (16,403)
    Loss on extinguishment of debt  (2,368)     (2,368)   
    Other gains (losses), net  (11)  5   56   (31)
    Net loss before provision for income taxes  (25,010)  (27,064)  (96,541)  (128,489)
    Provision for income taxes     301      301 
    Net loss attributable to common stockholders $(25,010) $(27,365) $(96,541) $(128,790)
    Net loss per share attributable to common stockholders:                
    Basic and diluted net loss per common share $(0.54) $(0.81) $(2.19) $(3.93)
    Weighted average common shares outstanding                
    Basic and diluted  45,911,211   33,789,704   44,174,765   32,791,934 

    CONTACT:

       
    Investor and Media Relations:   
    Ben Strain   
    617-807-6688   
       





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  2. BOSTON, Feb. 18, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at the 10th Annual SVB Leerink Global Healthcare Conference which will be held Thursday, February 25, 2021 at 11:20 a.m. ET.

    To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/svbleerink47/prtk/2689024.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software…

    BOSTON, Feb. 18, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at the 10th Annual SVB Leerink Global Healthcare Conference which will be held Thursday, February 25, 2021 at 11:20 a.m. ET.

    To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/svbleerink47/prtk/2689024.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.



    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.



    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.



    In 2019, Paratek was awarded a contract from BARDA, valued at ~$285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.



    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.



    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:

    Ben Strain

    617-807-6688

     



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  3. BOSTON, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced the Company will host a conference call and live audio webcast on Wednesday, February 24, 2021 at 4:30 p.m. EST to report its financial results for the quarter and full year ended December 31, 2020 and provide a corporate update.

    The audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of the Company's website at www.ParatekPharma.com.

    Domestic investors wishing to participate…

    BOSTON, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced the Company will host a conference call and live audio webcast on Wednesday, February 24, 2021 at 4:30 p.m. EST to report its financial results for the quarter and full year ended December 31, 2020 and provide a corporate update.



    The audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of the Company's website at www.ParatekPharma.com.



    Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13716761. Investors can also access the call at http://public.viavid.com/index.php?id=143647.



    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.



    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.



    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.



    In 2019, Paratek was awarded a contract from BARDA, valued at ~$285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.



    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.



    About NUZYRA®

    NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.



    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.



    Forward Looking Statements

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:

    Ben Strain

    617-807-6688

     



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  4. BOSTON, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a biopharmaceutical company that develops and commercializes life-saving therapies for public health threats in the community, hospital, and military settings, today announced the expansion of the Company's commercial promotion of NUZYRA® (omadacycline) into the community setting, building on the successful launch of NUZYRA in the hospital environment.

    The revenue trajectory of the ongoing NUZYRA commercial launch has exceeded that of other antibiotics launched in the last five years. Based on NUZYRA's product attributes, including its once-daily oral formulation, and broad reimbursement coverage secured to date, Paratek has initiated efforts to expand…

    BOSTON, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a biopharmaceutical company that develops and commercializes life-saving therapies for public health threats in the community, hospital, and military settings, today announced the expansion of the Company's commercial promotion of NUZYRA® (omadacycline) into the community setting, building on the successful launch of NUZYRA in the hospital environment.

    The revenue trajectory of the ongoing NUZYRA commercial launch has exceeded that of other antibiotics launched in the last five years. Based on NUZYRA's product attributes, including its once-daily oral formulation, and broad reimbursement coverage secured to date, Paratek has initiated efforts to expand NUZYRA's commercial promotion into the community setting. NUZYRA's once-daily IV and oral treatment option, which is approved for both community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), fills a critical gap today at a time when it is essential to keep patients out of the hospital during the ongoing COVID-19 pandemic. The Company's expansion of commercial promotion in the community setting will focus on ABSSSI, with a plan to broaden to include CABP after the anticipated approval of the oral-only loading-dose regimen for CABP, which is expected during the second quarter of 2021.

    "In our conversations with clinicians over the past several years, it is clear there is a tremendous unmet need for a new, safe, well-tolerated and effective broad-spectrum once-daily oral antibiotic in the community setting. The existing older-generation agents are universally challenged by either significant resistance concerns that limit their utility or serious safety concerns," said Adam Woodrow, President and Chief Commercial Officer at Paratek. "NUZYRA's product profile makes it a very attractive option for community use, and with reimbursement access now solidly established, combined with significant support from infectious disease specialists who have been using NUZYRA successfully since its launch in early 2019, we believe we can successfully continue to strengthen our launch trajectory, especially as we enter the second half of 2021."

    To support the launch of NUZRYA into the community setting, Paratek has initiated the hiring of approximately 40 U.S. community-based sales representatives, which will complement its established and successful hospital-based sales organization. Upon completion of the current community-based expansion, Paratek anticipates having a sales force to address both the community and hospital settings of approximately 90-100 customer facing representatives. The Company expects to execute this expansion within its previously communicated cash runway guidance. The expansion of the sales organization builds upon a focused and targeted community sales pilot program conducted in the second half of 2020. The data provided by the pilot suggest NUZYRA has an opportunity to address significant unmet needs in the community setting through building awareness among primary care physicians, leading to meaningful trial and adoption with positive patient outcomes. Paratek expects to accomplish this initial phase of the community expansion within the first quarter of 2021.

    "Every other sector of the pharmaceutical armamentarium has added new, more effective and better tolerated treatment options over the past 20 years while the community antibiotic segment has gone in the other direction, where our choice of treatments has become ever more limited because of a lack of innovation and overwhelming resistance. This shift significantly increases risks to patients," said Dr. Susan Butler-Sumner, a family medicine physician practicing in the community setting for more than 40 years. "Universally, community-based clinicians in the U.S. are looking for new antibiotic treatment options, particularly safe, well-tolerated and effective once-daily oral options with an accompanying IV formulation if needed. I believe NUZYRA will be able to significantly help address this clinically important treatment gap."

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from BARDA, valued at ~$285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    About NUZYRA

    NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

    Indications and Usage

    NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:

    Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

    Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae. 

    Usage

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    Important Safety Information

    Contraindications

    NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.

    Warnings and Precautions

    Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.

    The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

    Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

    NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.

    Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

    Adverse Reactions

    The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

    Drug Interactions

    Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.

    Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.

    Use in Specific Populations

    Lactation: Breastfeeding is not recommended during treatment with NUZYRA.

    To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the timing, size and scope of our Community based product launch and community and hospital-based field forces, cash runway expectations and the impact of the COVID-19 pandemic on our business. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:
    Ben Strain
    617-807-6688



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  5. BOSTON, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at the 2021 H.C. Wainwright BIOCONNECT Virtual Conference which will be broadcast starting on Monday, January 11, 2021 at 6:00 a.m. ET.

    To access the live webcast of Paratek's presentation, please visit https://journey.ct.events/view/f3b52f49-bcd0-4072-bdc0-942d1d5937d0.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any…

    BOSTON, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at the 2021 H.C. Wainwright BIOCONNECT Virtual Conference which will be broadcast starting on Monday, January 11, 2021 at 6:00 a.m. ET.

    To access the live webcast of Paratek's presentation, please visit https://journey.ct.events/view/f3b52f49-bcd0-4072-bdc0-942d1d5937d0.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a five-year contract from the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $285 million, with an option to extend to ten years, to support the development of NUZYRA for the treatment of pulmonary anthrax, FDA post-marketing requirements (PMR) associated with the initial NUZYRA approval, and the option to procure up to 10,000 treatment courses of NUZYRA for the Strategic National Stockpile (SNS) for use against potential biothreats.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:
    Ben Strain
    617-807-6688


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  6. BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced the Company entered into a $60 million non-recourse loan agreement with an affiliate of R-Bridge Healthcare Investment Advisory (the R-Bridge Loan) that will be repaid using all proceeds of royalties from the Company's License and Collaboration Agreement with Zai Lab (Shanghai) Co., Ltd. (Zai Lab) and a 2.5% revenue interest from the Company's U.S. net sales of NUZYRA with an annual cap of $10 million. The R-Bridge…

    BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced the Company entered into a $60 million non-recourse loan agreement with an affiliate of R-Bridge Healthcare Investment Advisory (the R-Bridge Loan) that will be repaid using all proceeds of royalties from the Company's License and Collaboration Agreement with Zai Lab (Shanghai) Co., Ltd. (Zai Lab) and a 2.5% revenue interest from the Company's U.S. net sales of NUZYRA with an annual cap of $10 million. The R-Bridge Loan has a maturity date of 12 years from the date of execution.

    The net proceeds of the loan, together with cash on hand, was used to prepay in full all obligations outstanding under the Company's Amended and Restated Loan and Security Agreement with Hercules Capital, Inc. (the Hercules Senior Secured Debt).

    In May 2020, Zai Lab, announced its New Drug Application (NDA) for omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) had been accepted with priority review in China. Upon Zai Lab's regulatory approval, anticipated in the first half of 2021, Paratek will receive a $6.0 million milestone payment. All milestone payments under the Zai Lab License and Collaboration Agreement are excluded from the R-Bridge Loan and are retained by the Company.

    Key Highlights

    • The R-Bridge Loan is non-recourse to the Company other than the Zai Lab royalties and the U.S. NUZYRA revenue interest.

           - The maturity date extends the repayment and amortization period up to nine years beyond that of the now-retired Hercules Senior Secured Debt, providing greater financial flexibility for the Company.

           - Under certain circumstances, the revenue interest rate payable on the U.S. NUZYRA net sales may increase up to either 3.5% or 5% and the annual cap may increase from $10 million to $12 million.

           - All milestone payments under the License and Collaboration Agreement with Zai Lab are retained by the Company.

           - The loan may be prepaid in whole or in part at any time without premium or penalty.
    • The Hercules Senior Secured Debt has been retired.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a License and Collaboration Agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    About R-Bridge (CBC Group)

    R-Bridge is a member of CBC Group (formerly known as C-Bridge Capital), one of the largest and most active healthcare-dedicated investment firms in Asia focused on platform-building, buyout opportunities, and alternative financing across three core areas: pharmaceutical & biotech, medtech, and healthcare services. CBC's investment strategies empower healthcare sector champions to make transformative changes that enable sustainable long-term growth, fulfil unmet medical needs and continuously push the boundaries of innovation. Within CBC, R-Bridge is dedicated in providing alternative, non-dilutive financing backed by royalties, revenue interest and other cash flows generated by the sale of healthcare products and services in Greater China, the first of its kind for the asset class and the region. R-Bridge provides additional sources of capital to healthcare companies operating in China to continue their extraordinary growth trajectories, commercializing their products and services in China and on a global scale. Founded in 2014, CBC has a strong team of investment, healthcare and portfolio management professionals based across Singapore, Shanghai, Beijing, Hong Kong and New York. Currently, CBC manages over $2.7 billion of committed capital, including $300M managed by R-Bridge, and has a team of over 60 distinguished medical, investment and operations professionals focused on building the most trusted partner in China healthcare.

    Forward Looking Statements

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements regarding the Company's financial condition, borrowing terms, including recourse to the Company, expected regulatory approval of NUZYRA in China, anticipated milestone payments from Zai Lab, and royalties payable on the Company's NUZYRA product. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:   
    Ben Strain   
    617-807-6688   
       


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  7. BOSTON, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at the 2020 Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 11:25 a.m. ET or 4:25 p.m. GMT.

    To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/jeff141/paratek/2291400.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be…

    BOSTON, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at the 2020 Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 11:25 a.m. ET or 4:25 p.m. GMT.

    To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/jeff141/paratek/2291400.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.



    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.



    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.



    In 2019, Paratek was awarded a five-year contract from the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $285 million, with an option to extend to ten years, to support the development of NUZYRA for the treatment of pulmonary anthrax, FDA post-marketing requirements (PMR) associated with the initial NUZYRA approval, and the option to procure up to 10,000 treatment courses of NUZYRA for the Strategic National Stockpile (SNS) for use against potential biothreats.



    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.



    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:
    Ben Strain
    617-807-6688

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  8. -- NUZYRA® (omadacycline) Generated Net Product Revenue of $10.9 Million in the Third Quarter 2020; a 35% Increase Over the Prior Quarter

    -- Paratek now Anticipates Full Year 2020 Total Revenue to be at the Higher End of the Previously Communicated Range of $78 to $83 Million

    -- Company Lowering 2020 R&D and SG&A Expense Guidance to Approximately $120 million

    -- Omadacycline Added to the FDA's Essential Medicines List as a Medical Counter Measure Against Biological Threats 

    BOSTON, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats…

    -- NUZYRA® (omadacycline) Generated Net Product Revenue of $10.9 Million in the Third Quarter 2020; a 35% Increase Over the Prior Quarter



    -- Paratek now Anticipates Full Year 2020 Total Revenue to be at the Higher End of the Previously Communicated Range of $78 to $83 Million



    -- Company Lowering 2020 R&D and SG&A Expense Guidance to Approximately $120 million



    -- Omadacycline Added to the FDA's Essential Medicines List as a Medical Counter Measure Against Biological Threats 

    BOSTON, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the quarter ended September 30, 2020.



    "We continue to execute against our plan for NUZYRA, which is reflected in the third quarter net revenue growth of 35% over the prior quarter," said Evan Loh, M.D., Chief Executive Officer. "Our launch trajectory continues to show NUZYRA is meaningfully outperforming other recent antibiotic launches, which we believe reflects the clinical importance of NUZYRA's oral dosing flexibility. We are particularly pleased with this revenue growth despite an environment that saw a continued downturn in overall broad-spectrum antibiotic utilization of approximately 18% versus the same period in the prior year. NUZYRA is making a real difference in the lives of patients, and prescribers recognize that NUZYRA is an important life-saving antibiotic that addresses current and future needs in the face of the growing global threat from antibiotic resistance."



    Third Quarter 2020 NUZYRA Commercial Highlights and Update

    • NUZYRA generated $10.9 million in net revenue in the third quarter of 2020, a 35% increase over the prior quarter and a 252% increase over the third quarter of 2019.
    • NUZYRA revenue growth reflects continued commitment to strong execution and NUZYRA's attributes that address unmet needs in the marketplace despite the reductions in patient traffic to physician offices and institutions of approximately 25% compared to pre-COVID-19 levels. In today's COVID-19 environment, NUZYRA's ability to minimize hospital stays with the oral formulation is especially relevant for many prescribers and a potentially meaningful benefit for patients.

    Other Recent Highlights

    • The Food and Drug Administration (FDA) review of the pre-Emergency Use Authorization (pre-EUA) application, which was submitted in February, remains ongoing. As part of the ongoing review, the supplemental mouse pharmacokinetic data requested by FDA are in the final stages of publishing at BARDA and will be submitted to FDA imminently. Based on agency discussions, we believe FDA will complete their review in a timely fashion.
    • Seven posters from the NUZYRA clinical and microbiology programs were presented at the IDWeek 2020 virtual meeting in October 2020.

    ° In a multicenter real-world study evaluating NUZYRA, the authors concluded that NUZYRA was effective and well-tolerated in this small sample for a variety of infections, including pulmonary M. abscessus (11 patients; average treatment duration 6.4 months) and MDR/XDR A. baumannii and Enterobacteriaceae (7 patients; average duration 14 days). These data continue to reinforce the importance of additional studies to expand these encouraging clinical findings.

    ° Additional data presented also highlighted that the substitution of NUZYRA in place of standard of care, such as quinolones, for the treatment of patients with Community-Acquired Bacterial Pneumonia (CABP), has the potential to reduce Clostridioides difficile infection and deliver cost savings in the acute care setting.

    Third Quarter 2020 Financial Results



    Total revenue was $13.7 million for the third quarter of 2020, an increase of 47% versus the prior quarter and 251% versus the same quarter in the prior year.

    • U.S. NUZYRA net revenue of $10.9 million for the third quarter of 2020 grew 35% versus the prior quarter and 252% versus the same quarter in the prior year.
    • Government contract service and grant revenue was $2.7 million for the third quarter of 2020 versus $0.9 million in the prior quarter. No revenue was generated from the BARDA contract in 2019.

    Research and development (R&D) expenses were $6.7 million for the third quarter of 2020, compared to $8.4 million for same period in the prior year. The $1.7 million decrease is primarily the result of lower clinical study costs associated with completion of the Phase 2 UTI program in 2019, partially offset by an increase in costs incurred under the BARDA contract and third-party manufacturing scale-up costs.



    Selling, general and administrative (SG&A) expenses were $20.9 million for the third quarter of 2020, compared to $23.6 million for the same period in the prior year.  The $2.7 million decrease is primarily the result of lower personnel-related costs and a reduction in sales and marketing costs due to COVID-19.



    Paratek reported a net loss of $20.9 million, or ($0.46) per share, for the third quarter of 2020, compared to a net loss of $32.6 million, or ($1.00) per share, for the same period in 2019.



    Financial Guidance 

    Paratek now anticipates its full year 2020 total revenue to be at the higher end of the previously communicated range of $78 to $83 million driven by strong NUZYRA net revenue trends.

    • This revenue guidance assumes that the initial BARDA procurement of NUZYRA, valued at approximately $38 million, will occur by the end of 2020. The FDA review could be completed as early as the end of this year but may slip into the first quarter of 2021. The first procurement is expected soon after completion of the FDA review. Accordingly, revenue from the first procurement will be recognized as early as late 2020 or in the first quarter of 2021.
    • 2020 R&D and SG&A expenses are now expected to be approximately $120 million compared to the prior guidance of $135 million, driven by a continued focus on operational efficiencies, and the timing of certain expenses driven by the COVID-19 pandemic, some of which will now occur in 2021.  
    • Based upon our current operating plan, which includes estimated NUZYRA U.S. product revenue, BARDA procurements of NUZYRA for the SNS, and cost reimbursement under the BARDA contract, we anticipate that our existing cash, cash equivalents and marketable securities of $149.5 million, as of September 30, 2020, will provide for a cash runway through the end of 2023 with a pathway to cash flow break even.   This anticipated pathway assumes the Company will be able to fund all company operating expenses, anticipated capital expenditures, and debt service, including repayment in full of the Hercules Loan and Security Agreement.

    Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance. 



    Call and Webcast

    Paratek's earnings conference call for the quarter ended September 30, 2020 will be broadcast at 4:30 p.m. EST on November 5, 2020. The live audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek's website at www.ParatekPharma.com.



    Domestic investors wishing to participate in the call should dial: 888-204-4368 and international investors should dial: 323-994-2093. The conference ID is 9510788. Investors can also access the call at http://public.viavid.com/index.php?id=142174.



    Website Information

    Paratek routinely posts important information for investors on the Investor Relations section of its website at www.ParatekPharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek's website, in addition to following its press releases, U.S. Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek's website is not incorporated by reference into, and is not a part of, this document.



    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.



    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.



    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.



    In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.



    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.



    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the impact of the COVID-19 pandemic on our revenue projections, access to hospital institutions, supply chain and clinical trials, projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including the status of the FDA review of the pre-EUA application, the status of our supplemental mouse pharmacokinetic data to support the human dose recommendation, the timing and exercise of BARDA's procurement of NUZYRA for the SNS, BARDA exercising full contract line items, including for U.S. onshoring and PMR reimbursement, our anticipated cash runway, our operating expenses, our SEYSARA royalties and SEYSARA -backed loan funded on May 1, 2019, the strategy, execution and progression of our commercial launch of NUZYRA, our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, our plans to evaluate additional indications for NUZYRA, including NTM, and to work toward an oral-only indication in CABP, future governmental stockpiling opportunities, and our potential to further drive long-term value for all of our shareholders.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.



    PARATEK PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (unaudited)

    (in thousands)

      September 30,

    2020
      December 31,

    2019
     
    Cash, cash equivalents and marketable securities $149,498  $215,379 
    Total assets  198,686   251,079 
    Working capital  172,103   219,154 
    Total current liabilities  22,899   24,200 
    Long-term debt, less current portion  250,631   260,728 
    Common stock and additional paid-in capital  702,805   671,537 
    Accumulated deficit  (782,789)  (711,258)
    Total stockholders' deficit  (79,884)  (39,647)
             

    Condensed Consolidated Statements of Operations

    (unaudited)

    (in thousands, except loss per share data)

      Three Months Ended

    September 30,
      Nine Months Ended

    September 30,
     
      2020  2019  2020  2019 
    Product revenue, net $10,895  $3,053  $26,330  $6,102 
    Government contract service revenue  785      1,560    
    Government contract grant revenue  1,866      2,303    
    Collaboration and royalty revenue  113   881   710   1,475 
    Net revenue $13,659  $3,934  $30,903  $7,577 
    Expenses:                
    Cost of product revenue  2,017   958   5,724   1,731 
    Research and development  6,687   8,350   17,636   30,421 
    Selling, general and administrative  20,902   23,636   65,514   67,874 
    Total operating expenses  29,606   32,944   88,874   100,026 
    Loss from operations  (15,947)  (29,010)  (57,971)  (92,449)
    Other income and expenses:                
    Interest income  280   992   1,347   2,873 
    Interest expense  (5,178)  (4,560)  (14,974)  (11,777)
    Other gains (losses), net  (10)  (36)  67   (72)
    Net loss $(20,855) $(32,614) $(71,531) $(101,425)
    Other comprehensive loss                
    Unrealized gain (loss) on available-for-sale securities, net of tax  (154)  (68)  26   276 
    Comprehensive loss $(21,009) $(32,682) $(71,505) $(101,149)
    Basic and diluted net loss per common share $(0.46) $(1.00) $(1.64) $(3.12)
    Weighted average common stock outstanding                
    Basic and diluted  45,483,346   32,590,454   43,591,724   32,458,010 
                     

    CONTACT:

       
    Investor and Media Relations:   
    Ben Strain   
    617-807-6688   
       

    Primary Logo

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  9. BOSTON, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, announced today that data from its NUZYRA (omadacycline) clinical and microbiology programs are being presented at the IDWeek 2020 virtual meeting.

    NUZYRA is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. 

    Poster presentations are available beginning on Wednesday, October 21 in the…

    BOSTON, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, announced today that data from its NUZYRA (omadacycline) clinical and microbiology programs are being presented at the IDWeek 2020 virtual meeting.

    NUZYRA is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. 

    Poster presentations are available beginning on Wednesday, October 21 in the IDWeek ePoster Gallery.

    Presentation Title: Subinhibitory Concentrations of Omadacycline Inhibit Staphylococcus aureus Hemolytic Activity In Vitro

    Poster #: 1202

    Presenter: A. Serio

    Presentation Title: In Vitro Activity of Omadacycline Against 7000 Bacterial Pathogens from the United States Stratified by Infection Type (2019)

    Poster #: 1253

    Presenter: M. Huband

    Presentation Title: Comparative Activity of Omadacycline Against Extended-spectrum Beta-lactamase Positive and Negative Escherichia coli and Klebsiella pneumoniae Strains Recovered from Urine Specimens

    Poster #: 1267

    Presenter: T. Stone

    Presentation Title: Real-World Experience with Omadacycline for Nontuberculous Mycobacterial and Gram-Negative Infections: A Multicenter Evaluation

    Poster #: 1290

    Presenter: T. Morrisette

    Presentation Title: Targeted Substitution of Omadacycline in Place of Standard of Care for CABP Treatment is Associated with a Risk Reduction of Clostridioides difficile Infection and Financial Cost Savings in the Acute Care Setting

    Poster #: 1492

    Presenter: M. Rodriguez

    Presentation Title: Omadacycline in Female Adults with Acute Pyelonephritis: Results from a Randomized, Double-Blind, Adaptive Phase 2 Study

    Poster #: 1687

    Presenter: K. Wright

    Presentation Title: Omadacycline in Female Adults with Cystitis: Results from a Randomized, Double-Blinded, Adaptive Phase 2 Study

    Poster #: 1688

    Presenter: K. Wright

    "These poster presentations continue our commitment to share new data about the clinical safety and efficacy of NUZYRA and ensure clinicians have comprehensive information available to them as they make treatment decisions for their patients with community-acquired infections," said Randy Brenner, Chief Development & Regulatory Officer of Paratek. "To that end, Paratek supports analysis of real-world use of NUZYRA, including the potential utility of NUZYRA in nontuberculous mycobacterium abscessus lung infections, a rare, chronic and difficult-to-treat lung infection for which there are currently no FDA approved therapies."

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    About NUZYRA

    NUZYRA® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

     

    Indications and Usage

    NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:

     

    Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

    Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae. 

    Usage

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    Important Safety Information

    Contraindications

    NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.

    Warnings and Precautions

    Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.



    The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.



    The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

    Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

    NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.



    Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.



    Adverse Reactions

    The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.



    Drug Interactions

    Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.



    Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.



    Use in Specific Populations

    Lactation: Breastfeeding is not recommended during treatment with NUZYRA.



    To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.



    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACTS:

    Investor and Media Relations:

    Ben Strain

    617-807-6688

    Primary Logo

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  10. BOSTON, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at H.C. Wainwright 22nd Annual Global Investment Conference, Monday, September 14, 2020 at 5:00 p.m. ET.

    To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/hcw7/prtk/1629433.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen…

    BOSTON, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at H.C. Wainwright 22nd Annual Global Investment Conference, Monday, September 14, 2020 at 5:00 p.m. ET.

    To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/hcw7/prtk/1629433.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

       
    Investor and Media Relations:   
    Ben Strain   
    617-807-6688   
       

    Primary Logo

    View Full Article Hide Full Article
  11. -- Paratek Raises Full Year 2020 Revenue Guidance; Total Revenue guidance expected to be Between $78 and $83 Million Driven by Strong NUZYRA Net Revenue

    -- Company Lowering 2020 R&D and SG&A Expense Guidance to approximately $135 million Driven by Continued Focus on Operational Efficiencies

    -- FDA Pre-EUA Review Remains Ongoing; NUZYRA Procurement by BARDA for the Strategic National Stockpile Anticipated by year-end 2020

    -- Company Strengthens Long-term Cash Position through Amendment to Hercules Loan Agreement

    BOSTON, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening…

    -- Paratek Raises Full Year 2020 Revenue Guidance; Total Revenue guidance expected to be Between $78 and $83 Million Driven by Strong NUZYRA Net Revenue

    -- Company Lowering 2020 R&D and SG&A Expense Guidance to approximately $135 million Driven by Continued Focus on Operational Efficiencies

    -- FDA Pre-EUA Review Remains Ongoing; NUZYRA Procurement by BARDA for the Strategic National Stockpile Anticipated by year-end 2020

    -- Company Strengthens Long-term Cash Position through Amendment to Hercules Loan Agreement

    BOSTON, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the quarter ended June 30, 2020.

    "Demand for NUZYRA was strong in the first half of 2020 with the momentum continuing into the third quarter," said Evan Loh, M.D., Chief Executive Officer. "I am particularly pleased that these results were achieved despite a healthcare environment where the unprecedented global pandemic temporarily closed many healthcare practices and eliminated essentially all face to face access for our sales representatives. Our results reinforce our continued belief and confidence that NUZYRA is well-positioned to help address current and future unmet medical needs at a time when antibiotic resistance is a growing global threat."

    "BARDA and Paratek continue to effectively execute on the anthrax development program and U.S. onshoring activities for NUZYRA," Dr. Loh continued.  "The FDA review of the pre-EUA application remains ongoing and BARDA continues to be fully committed to procuring NUZYRA for the Strategic National Stockpile once the FDA review process is completed.  We appreciate BARDA's confidence in Paratek and their significant investment in this innovative, long-term public-private partnership for the development of NUZYRA in the fight against bioterrorism and antimicrobial resistance in order to save lives and protect Americans."

    Recent NUZYRA Commercial Highlights

    • NUZYRA generated $8.1 million in net revenue in the second quarter of 2020, an 11% increase over the prior quarter and 378% increase over the second quarter of 2019. NUZYRA revenue growth continues to validate the Company's initial launch strategy with 90% of demand being generated from hospitals and adjacent sites of care.

    Other Highlights

    • The initial NUZYRA procurement by Biomedical Advanced Research and Development Authority (BARDA) for the Strategic National Stockpile (SNS) valued at approximately $38 million is now anticipated to be secured by year end 2020.

    ° The Food and Drug Administration (FDA) review of the pre-Emergency Use Authorization (pre-EUA) application, which was submitted in February, remains ongoing. The Company believes the review was delayed due to internal resourcing at FDA caused by the COVID-19 pandemic and other review priorities at FDA unrelated to NUZYRA.  As part of the ongoing review, FDA has requested supplemental mouse pharmacokinetic data to support the human dose recommendation in case of an immediate anthrax outbreak. This work has been initiated and expected to be completed in 8 to 10 weeks.

    • In July 2020, the supplemental NDA to support an oral-only dosing label for Community-Acquired Bacterial Pneumonia (CABP) was submitted to FDA with an approval expected during the 2020-2021 pneumonia season.   
    • In August 2020, Paratek modified its outstanding loan agreement with Hercules Capital. 

    ° Under the terms of the agreement, Paratek repaid $10 million of the principal $70 million loan balance reducing the outstanding loan to $60 million. 

    ° The interest-only period under the new loan agreement is now extended through December 2021, with further extension of the interest-only period of up to an additional 12 months, contingent on Paratek achieving certain performance-based milestones.

    Second Quarter 2020 Financial Results

    Paratek reported a net loss of $23.1 million, or ($0.53) per share, for the second quarter of 2020, compared to a net loss of $33.2 million, or ($1.02) per share, for the same period in 2019.

    Total revenue was $9.3 million for the second quarter of 2020, an increase of 18% versus the prior quarter and 356% versus the same quarter in the prior year. 

    • U.S. NUZYRA net revenue of $8.1 million for the second quarter of 2020 grew 11% versus the prior quarter and 378% versus the same quarter in the prior year.
    • Government contract service and grant revenue was $0.9 million for the second quarter of 2020 versus $0.3 million in the prior quarter.  No revenue was generated from the BARDA contract in 2019.
    • Second quarter 2020 collaboration and royalty revenue was $0.3 million, which is consistent with both the prior quarter and the same quarter in prior year. 

    Research and development (R&D) expenses were $4.6 million for the second quarter of 2020, compared to $10.7 million for the second quarter of 2019. The $6.1 million decrease is primarily the result of lower personnel-related costs, lower clinical study costs associated with our Phase 2 UTI program and other operational efficiencies.

    Selling, general and administrative (SG&A) expenses were $21.0 million for the second quarter of 2020, compared to $20.9 million for the second quarter of 2019. 

    As of June 30, 2020, Paratek had $186.8 million in cash, cash equivalents and marketable securities. 

    Financial Guidance

    Paratek is raising its full year 2020 revenue guidance primarily based on the stronger than anticipated U.S. NUZYRA net product revenue modestly offset by lower than anticipated royalty revenue from SEYSARA.

    • Paratek now estimates 2020 total revenue to be between $78 and $83 million, an increase from our prior guidance of $75 and $80 million. 

    ° The Company now anticipates the initial BARDA procurement of 2,500 anthrax treatment courses valued at approximately $38 million to occur by the end of 2020 contingent on the completion of the pre-EUA application review by FDA.

    • 2020 R&D and SG&A expense is now expected to be approximately $135 million compared to the prior guidance of $140 million, driven by an increased focus on operational efficiencies and other favorability driven by the COVID-19 pandemic.  Excluding the BARDA R&D and onshoring cost reimbursement, R&D and SG&A expense is expected to be modestly lower when compared to 2019.

    ° Based upon our current operating plan, which includes estimated NUZYRA U.S. product revenue and cost reimbursement under the BARDA contract, we anticipate that our existing cash, cash equivalents and marketable securities of $186.8 million, as of June 30, 2020, provide for a cash runway through the end of 2023 with a pathway to cash flow break even. This anticipated pathway assumes the Company will be able to fund all company operating expenses, anticipated capital expenditures, and debt service, including repayment in full of the Hercules Loan and Security Agreement.

    Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance. 

    Call and Webcast

    Paratek's earnings conference call for the quarter ended June 30, 2020 will be broadcast at 8:30 a.m. EDT on August 10, 2020. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek's website at www.ParatekPharma.com.  

    Domestic investors wishing to participate in the call should dial: 888-256-1007 and international investors should dial: 323-994-2093. The conference ID is 8856661. Investors can also access the call at http://public.viavid.com/index.php?id=141013.

    Website Information

    Paratek routinely posts important information for investors on the Investor Relations section of its website at www.ParatekPharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek's website, in addition to following its press releases, U.S. Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek's website is not incorporated by reference into, and is not a part of, this document.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the impact of the COVID-19 pandemic on our revenue projections, supply chain and clinical trials, projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including the status of the FDA review of the pre-EUA application, the status of our supplemental mouse pharmacokinetic data to support the human dose recommendation, the timing and exercise of BARDA's procurement of NUZYRA for the SNS, BARDA exercising full contract line items, including  for U.S. onshoring and PMR reimbursement, our anticipated cash runway, our operating expenses, our SEYSARA royalties and SEYSARA -backed loan funded on May 1, 2019, the strategy, execution and progression of our commercial launch of NUZYRA,  our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, our plans to evaluate additional indications for NUZYRA, including NTM, and to work toward an oral-only indication in CABP, future governmental stockpiling opportunities, and our potential to further drive long-term value for all of our shareholders.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.





    PARATEK PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (unaudited)

    (in thousands)

      June 30,

    2020
      December 31,

     2019
     
    Cash, cash equivalents and marketable securities $186,818  $215,379 
    Total assets  227,126   251,079 
    Working capital  188,278   219,154 
    Total current liabilities  33,925   24,200 
    Long-term debt, less current portion  251,586   260,728 
    Common stock and additional paid-in capital  698,222   671,537 
    Accumulated deficit  (761,934)  (711,258)
    Total stockholders' deficit  (63,458)  (39,647)





    Condensed Consolidated Statements of Operations

    (unaudited)

    (in thousands, except loss per share data)

      Three Months Ended  Six Months Ended 
    June 30,June 30,
      2020  2019  2020  2019 
    Product revenue, net $8,133  $1,702  $15,436  $3,049 
    Government contract service revenue  439      775    
    Government contract grant revenue  437      437    
    Collaboration and royalty revenue  317   343   597   594 
    Net revenue $9,326  $2,045  $17,245  $3,643 
    Expenses:                
    Cost of product revenue  2,236   567   3,707   773 
    Research and development  4,561   10,679   10,949   22,071 
    Selling, general and administrative  20,975   20,920   44,613   44,238 
    Total operating expenses  27,772   32,166   59,269   67,082 
    Loss from operations  (18,446)  (30,121)  (42,024)  (63,439)
    Other income and expenses:                
    Interest income  363   935   1,067   1,881 
    Interest expense  (4,971)  (3,991)  (9,797)  (7,217)
    Other gains (losses), net  (5)  (24)  78   (36)
    Net loss $(23,059) $(33,201) $(50,676) $(68,811)
    Other comprehensive loss                
    Unrealized gain (loss) on available-for-sale securities, net of tax  (217)  144   180   344 
    Comprehensive loss $(23,276) $(33,057) $(50,496) $(68,467)
    Basic and diluted net loss per common share $(0.53) $(1.02) $(1.19) $(2.12)
    Weighted average common stock outstanding                
    Basic and diluted  43,629,836   32,446,202   42,635,520   32,390,691 





    Investor and Media Relations:

    Ben Strain

    617-807-6688

    Primary Logo

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  12. BOSTON, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at two upcoming healthcare conferences. 

    The BTIG Biotechnology Conference 2020
    Tuesday, August 11, 2020 at 11:30 a.m. ET.
    To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/btig/prtk/

    2020 Wedbush PacGrow Healthcare Virtual Conference
    Wednesday, August 12, 2020 at 2:55 p.m. ET.
    To access the live webcast of Paratek's presentation, please…

    BOSTON, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at two upcoming healthcare conferences. 

    The BTIG Biotechnology Conference 2020

    Tuesday, August 11, 2020 at 11:30 a.m. ET.

    To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/btig/prtk/

    2020 Wedbush PacGrow Healthcare Virtual Conference

    Wednesday, August 12, 2020 at 2:55 p.m. ET.

    To access the live webcast of Paratek's presentation, please visit https://wsw.com/webcast/wedbush36/prtk/2262299.

    Please connect to the sites at least 15 minutes prior to the live presentations to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:



    Investor and Media Relations:

    Ben Strain

    617-807-6688

     

    Primary Logo

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  13. BOSTON, July 28, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced the Company will host a conference call and live audio webcast on Monday, August 10, 2020 at 8:30 a.m. EDT to report its financial results for the quarter ended June 30, 2020 and provide a corporate update.

    The audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of the Company's website at www.ParatekPharma.com.

    Domestic investors wishing to participate in the call…

    BOSTON, July 28, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced the Company will host a conference call and live audio webcast on Monday, August 10, 2020 at 8:30 a.m. EDT to report its financial results for the quarter ended June 30, 2020 and provide a corporate update.

    The audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of the Company's website at www.ParatekPharma.com.

    Domestic investors wishing to participate in the call should dial: 888-256-1007 and international investors should dial: 323-994-2093. The conference ID is 8856661. Investors can also access the call at http://public.viavid.com/index.php?id=141013.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use.

    The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    About NUZYRA®

    NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

    Forward Looking Statements

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:

    Ben Strain

    617-807-6688



    Primary Logo

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    • Experienced healthcare industry executive with 35 years of experience
    • Additions to the board of directors to support the company's advancing its lead program, NTX-001, along with its pipeline products

    Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for the treatment of peripheral nerve injuries (PNI), today announced the hiring of Robert (Bob) S. Radie as Chief Executive Officer. Mr. Radie also will serve as Chairman of Neuraptive's Board of Directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200623005779/en/

    Robert Radie joins Neuraptive Therapeutics, Inc. as Chairman and CEO. (Photo: Business Wire)

    Robert Radie joins Neuraptive Therapeutics, Inc. as Chairman and…

    • Experienced healthcare industry executive with 35 years of experience
    • Additions to the board of directors to support the company's advancing its lead program, NTX-001, along with its pipeline products

    Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for the treatment of peripheral nerve injuries (PNI), today announced the hiring of Robert (Bob) S. Radie as Chief Executive Officer. Mr. Radie also will serve as Chairman of Neuraptive's Board of Directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200623005779/en/

    Robert Radie joins Neuraptive Therapeutics, Inc. as Chairman and CEO. (Photo: Business Wire)

    Robert Radie joins Neuraptive Therapeutics, Inc. as Chairman and CEO. (Photo: Business Wire)

    "We are very pleased to have attracted an experienced and accomplished industry executive to lead Neuraptive," said Ivan Gergel, MD, a partner at New Rhein Healthcare Investors and a member of Neuraptive's Board of Directors. "Having led numerous companies from their development stage through acquisition or commercialization, Bob brings deep knowledge from the pharmaceutical and biotech industries, with significant executive, development, commercial, and deal-making capabilities."

    Mr. Radie brings more than three decades of industry experience, working in both public and private pharmaceutical and biotech companies, and across a range of therapeutic areas. He has held senior executive positions in six companies, including serving as Chief Executive Officer of Zyla Life Sciences, Inc. Transmolecular Inc, and Topaz Pharmaceuticals, Inc., which was acquired by Sanofi Pasteur. Mr. Radie also served as Chief Business Officer at Prestwick Pharmaceuticals, Inc., which was sold to Biovail Pharmaceutics, Morphotek, Inc., which was sold to Eisai Co., Ltd., and Senior Vice President of Strategy and Planning at Vicuron Pharmaceuticals, Inc., which was sold to Pfizer.

    Mr. Radie currently serves on the board of directors of several companies, including Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), and Rockwell Medical Technologies Inc. (NASDAQ:RMTI). He also serves as a member of the board of directors of Life Sciences Pennsylvania (LSPA), the Pennsylvania industry advocacy group.

    "I am eager to get started with Neuraptive as the company transitions into a clinical-stage organization on the verge of enrolling the first patients in an important Phase 2 trial and having recently received Fast Track designation from the FDA," said Bob Radie. "I look forward to working with the board of directors and the experienced team of executives and employees to bring potentially game-changing technologies to patients who have experienced nerve injuries and to the surgeons who treat them."

    The following changes are being made to the board of directors as the company progresses to a clinical-stage organization. Gino DiSciullo, Ph.D., a co-founder of Neuraptive, has stepped down as a director. "We want to thank Gino for his contributions to the company over the last two years," said Ivan Gergel. In the coming months, an additional independent director will be added.

    In addition, the New Rhein Investors collectively have indicated their intention to invest at least $3,000,000 in the next Qualified Financing, provided that the terms and conditions of such financing are acceptable to the New Rhein Investors, New Rhein previously invested $7.5M in the company's Series A Financing.

    About Neuraptive Therapeutics

    Neuraptive is creating innovative novel therapies for nerve repairs to improve clinical outcomes for patients and surgeons who care for them. The company's franchise therapeutic product, NTX-001, has the potential to improve the quality and speed of recovery of nerve sensation and function for eligible patients who have sustained traumatic injuries or who are undergoing reconstructive surgical procedures. Neuraptive is rapidly advancing its pipeline and will leverage its capabilities to transition into a clinical-stage company. Investors include New Rhein Healthcare Investors through its Fund 18 and Ben Franklin Technology Partners. The company is headquartered in Philadelphia, PA, and has offices near Boulder, CO, as well as surgical translational medical facilities at the Colorado University Anschutz Medical Center in Aurora, CO. For more information, see www.neuraptive.com.

    About New Rhein Healthcare Investors

    New Rhein is a venture capital/early growth stage fund manager whose investment strategy focuses on proven molecules used in new ways, such as new delivery forms and potential new uses and indications. In this way, New Rhein limits science-based risk and concentrates on development and execution. Prior investments have included medicines for Alzheimer's disease, ophthalmic disorders, respiratory disease, and molecular oncology diagnostics. New Rhein's partners, associates, and advisors are knowledgeable former industry executives with solid track records of operational, investment, and transactional experience. New Rhein combines significant deal-making expertise with deep operating experience, allowing it to tailor the right deal for the right situation and work with its portfolio companies to achieve maximum value for their products. For more information, see www.newrhein.com.

    Cautionary Note on Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. including, among others, statements we make regarding the time for the commencement of clinical trials. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.

    View Full Article Hide Full Article
  14. BOSTON, May 29, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced its virtual 2020 Annual Meeting of Stockholders (the "Annual Meeting") will now be held at 9:00 a.m. Eastern Time.

    The previously announced date of the Annual Meeting, June 10, 2020, will not change. As described in the proxy materials previously distributed for the Annual Meeting, stockholders as of the close of business on April 13, 2020, the record date, may attend the meeting virtually via the Internet at www.virtualshareholdermeeting.com/PRTK2020

    BOSTON, May 29, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced its virtual 2020 Annual Meeting of Stockholders (the "Annual Meeting") will now be held at 9:00 a.m. Eastern Time.

    The previously announced date of the Annual Meeting, June 10, 2020, will not change. As described in the proxy materials previously distributed for the Annual Meeting, stockholders as of the close of business on April 13, 2020, the record date, may attend the meeting virtually via the Internet at www.virtualshareholdermeeting.com/PRTK2020 by entering the 16-digit control number found in such proxy materials or, for stockholders that hold their shares in "street name," by following the instructions provided by each such stockholder's bank or brokerage firm. Online check-in will begin at 8:45 a.m. Eastern Time, and stockholders should allow ample time for the check-in procedures.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements 
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:    
         
    Investor and Media Relations:    
    Ben Strain    
    617-807-6688    
       

    Primary Logo

    View Full Article Hide Full Article
  15. BOSTON, May 28, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at the Jefferies 2020 Virtual Healthcare Conference, Wednesday, June 3, 2020 at 8:00 a.m. ET.

    To access the live webcast of Paratek's presentation, please visit http://wsw.com/webcast/jeff126/prtk/.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay…

    BOSTON, May 28, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at the Jefferies 2020 Virtual Healthcare Conference, Wednesday, June 3, 2020 at 8:00 a.m. ET.

    To access the live webcast of Paratek's presentation, please visit http://wsw.com/webcast/jeff126/prtk/.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements 
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:    
         
    Investor and Media Relations:    
    Ben Strain    
    617-807-6688    
       

    Primary Logo

    View Full Article Hide Full Article
  16. BOSTON, May 11, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at Bank of America Securities 2020 Health Care Conference, Wednesday, May 13, 2020 at 11:40 a.m. ET.

    To access the live webcast of Paratek's presentation, please visit http://www.veracast.com/webcasts/bofa/healthcare2020/id57206441686.cfm.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary…

    BOSTON, May 11, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at Bank of America Securities 2020 Health Care Conference, Wednesday, May 13, 2020 at 11:40 a.m. ET.

    To access the live webcast of Paratek's presentation, please visit http://www.veracast.com/webcasts/bofa/healthcare2020/id57206441686.cfm.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements 
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:
    Ben Strain
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  17.             -- Announced Initiation of Funding from BARDA for All FDA Required Post-Marketing Studies and Security Requirements and U.S. Onshoring of an Additional Manufacturing Supply Chain for NUZYRA

    BOSTON, May 11, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the quarter ended March 31, 2020. 

    "Demand for NUZYRA continued to increase in the first quarter of 2020 with net revenue growing 35% versus the fourth…

                -- Announced Initiation of Funding from BARDA for All FDA Required Post-Marketing Studies and Security Requirements and U.S. Onshoring of an Additional Manufacturing Supply Chain for NUZYRA

    BOSTON, May 11, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the quarter ended March 31, 2020. 

    "Demand for NUZYRA continued to increase in the first quarter of 2020 with net revenue growing 35% versus the fourth quarter of 2019, with particular strength seen with the oral formulation.  NUZYRA is well-positioned to help address current and future public health emergencies at a time when antibiotic resistance is a growing global threat," said Evan Loh, M.D., Chief Executive Officer.  "I would like to thank the entire Paratek team for their dedication and efforts during the COVID-19 pandemic and continuing to drive the business forward, ensuring patients continue to have access to NUZYRA, with its once-daily oral and intravenous formulations, approved for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections." 

    Recent NUZYRA Commercial Highlights

    • NUZYRA generated $7.3 million in net revenue in the first quarter of 2020.
    • The Company transitioned efficiently to a fully virtual model including the sales and marketing organization.
    • Over 80% of commercial lives, greater than 50% of Medicaid lives and over one third of Medicare lives in the U.S. now have access to NUZYRA with limited or no restrictions.
      • Secured multi-year agreement with Humana Medicare Part D and Commercial lines of business to place NUZYRA on their formulary with no restrictions.

    Other Highlights

    • Biomedical Advanced Research and Development Authority (BARDA) has initiated funding to support all of the U.S. Food and Drug Administration (FDA) post-marketing requirements associated with the approval of NUZYRA including pneumonia and pediatric studies as well as the five-year post-marketing bacterial surveillance study.
      • The cost reimbursement for these post-marketing commitments is projected to total approximately $77 million.
    • BARDA initiated funding to support the onshoring of Paratek manufacturing activities for NUZYRA.
      • The cost reimbursement for the onshoring and security requirement activities is projected to total approximately $20 million over the next couple of years.
      • Helps to further secure NUZYRA's overall supply chain, adding a comprehensive additional supply chain to our existing infrastructure, and over the projected collaboration timeframe, will provide for a secure, United States based manufacturing supply chain.
    • The Company's partner for the greater China region, Zai Lab Limited (Zai Lab), announced its New Drug Application (NDA) for omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) has been accepted with priority review in China. 
      • Paratek earned $3.0 million upon this regulatory submission in the fourth quarter of 2019. 
      • Paratek is eligible to receive $6.0 million upon regulatory approval and royalties on net sales.
    • Data from the NUZYRA clinical and microbiology programs were made available through the 30th European Congress of Clinical Microbiology & Infectious Diseases, ECCMID 2020.  Four abstracts from the congresses abstract book released last week continued to highlight the efficacy and safety profile of NUZYRA, highlighting omadacycline's in vitro activity for a number of key pathogens, quality of life outcomes in the Phase 3 program and the epidemiology and potential advantages omadacycline with regards to Clostridioides difficile infections.
    Session Title: Skin and soft tissue infections
    Poster Title: Self-reported health status in ambulatory acute bacterial skin and skin structure infection patients who inject drugs, who received oral therapy with omadacycline or linezolid
    Session Title: Update on Clostridioides difficile infection
    Poster Title: Predicted risk and observed occurrence of Clostridioides difficile infection in patients with community-acquired bacterial pneumonia treated with omadacycline or moxifloxacin
    Session Title: Challenges in the management of community-acquired pneumonia
    Poster Title: Epidemiology of Clostridioides difficile infections among hospitalized community-acquired pneumonia patients who received empiric treatment with ceftriaxone plus a macrolide
    Session Title: Antimicrobials against Gram-positive bacteria
    Poster Title: Activity of Omadacycline and Comparator Agents against Bacterial Pathogens from the United States by Infection Type (2019)
    • Paratek granted a license to Almirall, S.A. ((Almirall, TSX:ALM) for SEYSARA® (sarecycline) in the greater China region, which includes the Peoples Republic of China, Hong Kong, and Macau.  Almirall plans to develop sarecycline for acne in China, with a submission to the China National Medical Products Administration expected in 2023.  Under the terms of the agreement, Paratek will earn high single-digit royalties on net sales.   

    Anticipated Near-Term 2020 Milestones

    • The initial NUZYRA procurement by BARDA for the Strategic National Stockpile (SNS) valued at approximately $38 million remains on track and is anticipated to be secured in the second quarter of 2020.
    • The supplemental NDA to support an oral-only dosing label for CABP is anticipated to be filed with the FDA mid-year with potential approval during the 2020-2021 pneumonia season.   

    First Quarter 2020 Financial Results
    Paratek reported a net loss of $27.6 million, or ($0.66) per share, for the first quarter of 2020, compared to a net loss of $35.6 million, or ($1.10) per share, for the same period in 2019.    

    Revenue earned during the first quarter of 2020 of $7.9 million was attributable to U.S. NUZYRA net sales of $7.3 million, government contract service revenue of $0.3 million and collaboration and royalty revenue of $0.3 million.  Revenue earned during the first quarter of 2019 was attributable to net U.S. NUZYRA product revenue of $1.3 million and royalty and collaboration revenue of $0.3 million. 

    Research and development (R&D) expenses were $6.4 million for the first quarter of 2020, compared to $11.4 million for the first quarter of 2019. The $5.0 million decrease is primarily the result of lower clinical study costs associated with our Phase 2 UTI program completed in 2019 and other operational efficiencies as Paratek continues to focus on streamlining operations. 

    Selling, general and administrative (SG&A) expenses were $23.6 million for the first quarter of 2020, compared to $23.3 million for the first quarter of 2019.  The modest increase is primarily the result of personnel-related costs in support of the commercialization of NUZYRA, additional contract sales force costs, and higher trade and distribution fees, partially offset by lower sales and marketing costs due to COVID-19-related travel restrictions that prohibited in-person training events and sales meetings from taking place during a portion of the first quarter. 

    As of March 31, 2020, Paratek had $194.8 million in cash, cash equivalents and marketable securities.   

    Financial Guidance 
    In evaluating the 2020 financial guidance, the Company balanced its strong first quarter results against the forecasting challenges related to the COVID-19 pandemic.  As a result, Paratek is currently maintaining its full year 2020 financial guidance and will not be making any adjustments at this time. 

    The 2020 financial guidance issued in conjunction with the 2019 fourth quarter earnings call consisted of the following components:

    • Paratek estimates 2020 total revenues to be between $75 and $80 million.  This revenue consists of the following elements:
      • 2020 NUZYRA U.S. net product sales is expected to be approximately $66 million with approximately $38 million of these sales coming from the initial BARDA procurement of 2,500 anthrax treatment courses.
        • The initial NUZYRA BARDA procurement is anticipated to be secured in the second quarter of 2020.
      • Royalty and collaboration revenue combined with government contract service revenue earned under the BARDA contract are expected to be approximately $9 to $14 million.
        • Of note, government contract service revenue consists of cost reimbursement by BARDA for 2020 spend on the Company's post-marketing requirement clinical development activities, anthrax development program and onshoring of U.S. NUZYRA manufacturing.
    • 2020 R&D and SG&A expense is expected to be approximately $140 million.
      • R&D expense includes approximately $5 million earmarked for start-up activities in preparation for potential nontuberculous mycobacteria (NTM) studies.
      • Excluding the BARDA R&D and onshoring cost reimbursement, R&D and SG&A expense is expected to remain relatively flat when compared to 2019.
    • Based upon the Company's current operating plan, which includes estimated NUZYRA product sales, and the BARDA cost reimbursement of activities related to the Project BioShield contract, the Company anticipates that its existing cash, cash equivalents and marketable securities of $194.8 million as of March 31, 2020, provide for a cash runway through the end of 2023 with a pathway to cash flow break even. 
      • This anticipated pathway assumes the Company will be able to fund all company operating expenses, anticipated capital expenditures, and debt service, including repayment in full of the Hercules Loan and Security Agreement under its existing terms.   

    Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance.  

    Call and Webcast
    Paratek's earnings conference call for the quarter ended March 31, 2020 will be broadcast at 8:30 a.m. EDT on May 11, 2020. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek's website at www.ParatekPharma.com.   

    Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13703077. Investors can also access the call at http://public.viavid.com/index.php?id=139619 

    Website Information
    Paratek routinely posts important information for investors on the Investor Relations section of its website at www.ParatekPharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek's website, in addition to following its press releases, U.S. Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek's website is not incorporated by reference into, and is not a part of, this document. 

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.  

    The Company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. 

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world. 

    In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax. 

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter. 

    Forward Looking Statements 
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the impact of the COVID-19 pandemic on our revenue projections, supply chain and clinical trials, projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including BARDA exercising full contract line items for procurement and PMR reimbursement, our anticipated cash runway, our operating expenses, our SEYSARA royalty-backed loan funded on May 1, 2019, the progression of our commercial roll out for NUZYRA,  our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, our plans to evaluate additional indications for NUZYRA, including NTM, and to work toward an oral-only indication in CABP, future governmental stockpiling opportunities, and our potential to further drive long-term value for all of our shareholders.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.  


    PARATEK PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets
    (unaudited)
    (in thousands)

        March 31,
    2020
        December 31,
     2019
     
    Cash, cash equivalents and marketable securities   $ 194,790     $ 215,379  
    Total assets     233,660       251,079  
    Working capital     183,897       219,154  
    Total current liabilities     43,109       24,200  
    Long-term debt, less current portion     240,299       260,728  
    Common stock and additional paid-in capital     683,166       671,537  
    Accumulated deficit     (738,875 )     (711,258 )
    Total stockholders' deficit     (55,238 )     (39,647 )








    Condensed Consolidated Statements of Operations
    (unaudited)
    (in thousands, except loss per share data)

        Three Months Ended
    March 31,
          2020       2019  
    Product revenue, net   $   7,303     $   1,347  
    Government contract service revenue       337         —   
    Collaboration and royalty revenue       280         251  
    Net revenue   $   7,920     $   1,598  
    Expenses:        
      Cost of product revenue       1,471         206  
      Research and development       6,389         11,392  
      Selling, general and administrative     23,638         23,316  
    Total operating expenses       31,498         34,914  
    Loss from operations       (23,578 )       (33,316 )
    Other income and expenses:        
    Interest income       705         946  
    Interest expense       (4,826 )       (3,226 )
    Other gains (losses), net       82         (14 )
    Net loss   $   (27,617 )   $   (35,610 )
    Other comprehensive loss        
    Unrealized gain on available-for-sale securities, net of tax     397         200  
    Comprehensive loss   $   (27,220 )   $   (35,410 )
    Basic and diluted net loss per common share $   (0.66 )   $   (1.10 )
    Weighted average common stock outstanding    
    Basic and diluted       41,641,203         32,334,563  

















    CONTACT:

         
    Investor and Media Relations:    
    Ben Strain    
    617-807-6688    
       



     


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  18. BOSTON, April 30, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced the Company will host a conference call and live audio webcast on Monday, May 11, 2020 at 8:30 a.m. EDT to report its financial results for the quarter ended March 31, 2020 and provide a corporate update. 

    The audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of the Company's website at www.ParatekPharma.com

    Domestic investors wishing to participate in the call should…

    BOSTON, April 30, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced the Company will host a conference call and live audio webcast on Monday, May 11, 2020 at 8:30 a.m. EDT to report its financial results for the quarter ended March 31, 2020 and provide a corporate update. 

    The audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of the Company's website at www.ParatekPharma.com

    Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13703077. Investors can also access the call at http://public.viavid.com/index.php?id=139619.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use. 

    The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    About NUZYRA®
    NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

    Forward Looking Statements
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:
    Investor and Media Relations:
    Ben Strain
    617-807-6688

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  19. BOSTON, April 02, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Biomedical Advanced Research and Development Authority (BARDA) has initiated funding to support all of the U.S. Food and Drug Administration (FDA) post-marketing requirements associated with the approval of NUZYRA including pneumonia and pediatric studies as well as the five-year post-marketing bacterial surveillance study. The reimbursement cost for these post-marketing commitments is projected to total…

    BOSTON, April 02, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Biomedical Advanced Research and Development Authority (BARDA) has initiated funding to support all of the U.S. Food and Drug Administration (FDA) post-marketing requirements associated with the approval of NUZYRA including pneumonia and pediatric studies as well as the five-year post-marketing bacterial surveillance study. The reimbursement cost for these post-marketing commitments is projected to total approximately $77 million.

    In connection with the FDA approval of NUZYRA in October 2018, the FDA required that Paratek complete post-marketing pediatric studies examining the safety and efficacy of NUZYRA in children ages eight to 17 years.  This includes a pharmacokinetic study as well as safety studies in children with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).  The FDA also required Paratek conduct an additional safety and efficacy study in adults with CABP. Finally, the FDA required a five‑year post‑marketing bacterial surveillance study, which is mandatory for all newly approved antibiotics.

    "We are eager and well-prepared to conduct these studies, which will now be funded entirely through the BARDA Project BioShield public-private partnership award.  The clinical and microbiologic data from these studies will augment the wealth of existing data examining the safety and efficacy of once-daily, oral and intravenous NUZYRA in life-threatening community acquired infections," said Evan Loh, M.D., CEO, Paratek. "We are grateful for BARDA's significant investment and their shared commitment to fighting antimicrobial resistance and ensuring that life-saving antibiotics are available to the patients who need them."

    In December 2019, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, awarded Paratek a five-year contract, valued at up to $285 million, to support:  1) the development of NUZYRA for the treatment of pulmonary anthrax; 2) all of the U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval; 3) U.S. onshoring and manufacturing security requirements and 4) the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.

    Under the terms of the contract that are now initiated, reimbursement has begun for all of the U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval.

    Paratek Statement on COVID-19
    We applaud the heroic efforts of medical professionals around the world who are working to protect public health and combat the COVID-19 pandemic. Whether directly treating patients impacted by the virus or implementing containment measures to constrain its transmission, you selflessly put the needs and journey of your patients first. 

    We at Paratek will strive to do our part during this crisis. The safety of or employees, the healthcare community and payers is paramount. We are taking appropriate steps to protect our employees, healthcare community and payers, following all local and federal requirements, and continually monitoring the situation to provide the appropriate guidance.  Paratek has embraced the public health guidance regarding social distancing with all employees now working from home, utilizing a virtual model for meetings and interactions with the healthcare community and payers.

    As the global COVID-19 pandemic continues to evolve, to date we have been able to provide an uninterrupted supply of our commercially available antibiotic, NUZYRA®. Based on current inventory levels and expected demand, we do not currently anticipate a shortage of NUZYRA. 

    Due to the demands on the healthcare system during this unprecedented crisis with COVID-19, the recruitment of our ongoing clinical studies has been paused. At the current time, the only study currently recruiting is our oral only pharmacokinetic study in patients with pneumonia.  As the study has not yet completed recruitment, the study will take longer than anticipated.  As the situation evolves, we intend to provide future updates on timing of the initiation of recruitment and completion of the study.

    About NUZYRA
    NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.
     
    Indications and Usage
    NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
     
    Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

    Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae. 

    Usage
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    Important Safety Information

    Contraindications
    NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.

    Warnings and Precautions
    Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.

    The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

    Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

    NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.

    Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

    Adverse Reactions
    The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

    Drug Interactions
    Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.
    Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.

    Use in Specific Populations
    Lactation: Breastfeeding is not recommended during treatment with NUZYRA.

    To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, funding status of post-marketing studies for NUZYRA, potential success for treating anthrax, timing and value of the BARDA award and contract, Covid-19 impact on the timing  of our clinical trials, and potential of the business. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:    
    Ben Strain    
    617-807-6688    
       

    Primary Logo

    View Full Article Hide Full Article
  20. BOSTON, April 01, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, today announced that the Biomedical Advanced Research and Development Authority (BARDA) has initiated funding to support the onshoring of Paratek manufacturing activities for NUZYRA. The reimbursement cost for the onshoring and security requirement activities is projected to total approximately $20 million.

    In December 2019, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant…

    BOSTON, April 01, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, today announced that the Biomedical Advanced Research and Development Authority (BARDA) has initiated funding to support the onshoring of Paratek manufacturing activities for NUZYRA. The reimbursement cost for the onshoring and security requirement activities is projected to total approximately $20 million.

    In December 2019, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, awarded Paratek a five-year contract, valued at up to $285 million, to support: 1) the development of NUZYRA for the treatment of pulmonary anthrax; 2) all of the U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval; 3) U.S. onshoring and manufacturing security requirements and 4) the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.

    "We are committed to studying NUZYRA in the fight against antimicrobial resistance and the treatment and prophylaxis of anthrax and believe that NUZYRA will play an important role in supporting the biodefense preparedness of our country," said Evan Loh, MD, CEO, Paratek. "Establishing our entire manufacturing process in the United States and ensuring that these facilities are secure is an important step for protecting Americans and for pandemic preparedness. This initiative helps to further secure NUZYRA's overall supply chain, adding a comprehensive secondary supply chain to our existing infrastructure, and over the projected collaboration timeframe, will provide for a secure, United States based manufacturing supply chain. We look forward to working with BARDA to meet all of these goals."

    Under the terms of the contract that has now been initiated, Paratek will commit to ensure that all current suppliers meet BARDA security requirements and to onshore a secondary supply chain in the United States for NUZYRA.

    About NUZYRA
    NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

    Indications and Usage
    NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:

    Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

    Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by
    the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae. 

    Usage
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    Important Safety Information

    Contraindications
    NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.

    Warnings and Precautions
    Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.

    The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

    Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

    NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.

    Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

    Adverse Reactions
    The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

    Drug Interactions
    Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.
    Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.

    Use in Specific Populations
    Lactation: Breastfeeding is not recommended during treatment with NUZYRA.

    To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential success for treating anthrax, timing and value of the BARDA award and contract, strength of our supply chain and potential of the business. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:
    Investor and Media Relations:
    Ben Strain
    617-807-6688

    Primary Logo

    View Full Article Hide Full Article
  21. BOSTON, March 10, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that a pre-emergency use authorization (EUA) application for NUZYRA (omadacycline) has been submitted to the U.S. Food and Drug Administration (FDA). With a pre-EUA, FDA could allow for the potential use of NUZYRA during a declared emergency under emergency use authorization for the treatment and prophylaxis of pulmonary anthrax in a public health emergency. 

    The pre-EUA application was submitted by the Biomedical…

    BOSTON, March 10, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that a pre-emergency use authorization (EUA) application for NUZYRA (omadacycline) has been submitted to the U.S. Food and Drug Administration (FDA). With a pre-EUA, FDA could allow for the potential use of NUZYRA during a declared emergency under emergency use authorization for the treatment and prophylaxis of pulmonary anthrax in a public health emergency. 

    The pre-EUA application was submitted by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, as part of the public-private partnership between Paratek and BARDA to develop the drug. A pre-EUA allows BARDA to procure NUZYRA to potentially be used during a public health emergency including the treatment and prophylaxis of pulmonary anthrax.  

    The purchase of the first 2,500 treatment courses of NUZYRA, valued at approximately $38 million, will take place upon the acceptance of the pre-EUA, which is expected in the first half of 2020.

    "At a time when current antibiotic treatment options against anthrax are limited, we are pleased that in partnership with BARDA, the pre-EUA application for NUZYRA has been completed and filed with the FDA," said Evan Loh, M.D. CEO, Paratek. "We have been studying the potential utility of antibiotics against bioterrorism threats for over a decade and have evaluated the in vitro activity and in vivo efficacy of NUZYRA against Bacillus anthracis, the causative pathogen of anthrax. We believe these promising in vitro and in vivo data combined with the well-characterized oral and intravenous pharmacokinetics, safety, and tolerability of NUZYRA provide confidence in the potential utility of NUZYRA against anthrax."    

    In December 2019, BARDA awarded Paratek a 5-year contract, valued at up to $285 million, to support: 1) the development of NUZYRA for the treatment of pulmonary anthrax; 2) all of the U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval; and 3) the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. 

    About NUZYRA
    NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains. 

    Indications and Usage
    NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms: 

    Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. 

    Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.  

    Usage
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 

    Important Safety Information 

    Contraindications
    NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients. 

    Warnings and Precautions
    Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. 

    The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. 

    The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. 

    Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. 

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. 

    NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. 

    Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. 

    Adverse Reactions
    The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. 

    Drug Interactions
    Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.

    Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. 

    Use in Specific Populations
    Lactation: Breastfeeding is not recommended during treatment with NUZYRA. 

    To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use. 

    The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. 

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world. 

    In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax. 

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter. 

    Forward Looking Statements
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential success for treating anthrax, timing and value of the BARDA award and contract, and potential of the business. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:     
    Ben Strain     
    617-807-6688     
       

    Primary Logo

    View Full Article Hide Full Article
  22. BOSTON, March 02, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that on February 28, 2020, the Company granted stock options and restricted stock units to two new employees of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning…

    BOSTON, March 02, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that on February 28, 2020, the Company granted stock options and restricted stock units to two new employees of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.

    The stock options are to acquire, in the aggregate, 21,100 shares of the Company's common stock at a per share exercise price of $4.78, the closing sales price on February 28, 2020, and shall vest over a four-year vesting period, under which 25% of the shares will vest after 12 months of employment, with the remaining shares vesting monthly thereafter over the remaining 36-month period, subject to the employee's continuous service. The restricted stock units are to acquire, in the aggregate, 17,600 shares of the Company's common stock and shall vest upon the conclusion of a 36-month vesting period, under which 100% of the restricted stock units will vest after 36 months of employment, subject to the employee's continuous service. The stock options and restricted stock units are subject to the terms and conditions of the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, and the terms and conditions of the stock option agreement and restricted stock unit award agreement covering each grant.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use. 

    The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    CONTACT:
    Investor and Media Relations:     
    Ben Strain     
    617-807-6688     

    Primary Logo

    View Full Article Hide Full Article
  23. BOSTON, Feb. 26, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at SVB Leerink 9th Annual Global Healthcare Conference today, Wednesday, February 26, 2020 at 3:00 p.m. ET at the Lotte New York Palace Hotel in New York.

    To access the live webcast of Paratek's presentation, please visit http://wsw.com/webcast/svbleerink34/prtk/.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software…

    BOSTON, Feb. 26, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at SVB Leerink 9th Annual Global Healthcare Conference today, Wednesday, February 26, 2020 at 3:00 p.m. ET at the Lotte New York Palace Hotel in New York.

    To access the live webcast of Paratek's presentation, please visit http://wsw.com/webcast/svbleerink34/prtk/.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements 
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:
    Ben Strain
    617-807-6688

     

    Primary Logo

    View Full Article Hide Full Article
  24. -- Paratek Expects Full Year 2020 Total Revenues to be Between $75 and $80 Million including NUZYRA Net Sales of Approximately $66 Million  

    -- Paratek Now Anticipates its Cash Runway Will Extend Through the End of 2023 with a Pathway to Cash Flow Break Even

    BOSTON, Feb. 25, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the fourth quarter and year-ended December 31, 2019.

    "2019 was a transformative year for Paratek…

    -- Paratek Expects Full Year 2020 Total Revenues to be Between $75 and $80 Million including NUZYRA Net Sales of Approximately $66 Million  

    -- Paratek Now Anticipates its Cash Runway Will Extend Through the End of 2023 with a Pathway to Cash Flow Break Even

    BOSTON, Feb. 25, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the fourth quarter and year-ended December 31, 2019.

    "2019 was a transformative year for Paratek.  Demand for NUZYRA continued to increase in the fourth quarter with net sales growing a robust 74% versus the prior quarter," said Evan Loh, M.D., Chief Executive Officer.  "With particular strength seen with the oral formulation, NUZYRA is on track to have one of the most successful antibiotics launches in the last decade."

    Dr. Loh continued, "In December, we announced that we entered into a 5-year contract valued up to $285 million with Biomedical Advanced Research and Development Authority, or BARDA, to support the development of NUZYRA for the treatment of pulmonary anthrax.  We believe that this long-term Project BioShield agreement with BARDA, along with the approved indications for NUZYRA in CABP and ABSSSI, solidify Paratek's position as a leader in the anti-infective space.  The magnitude of the projected funding through this BARDA agreement and the expected continued strong launch trajectory of NUZYRA will significantly strengthen Paratek's balance sheet."

    "The recent news with coronavirus only further highlights the urgent need for innovative therapeutics to fight this devastating disease," said Randy Brenner, Chief Development & Regulatory Officer.  "As with influenza, many of the coronavirus fatalities are unfortunately associated with secondary bacterial pneumonia infections, further highlighting the importance of a novel once daily well-tolerated oral and IV antibiotic in the treatment paradigm for pandemic preparedness.  With a broad-based public-private partnership established by our recently announced BARDA contract, anchored by a therapy that is approved for pneumonia, we are aggressively pursuing other opportunities within the government to support national pandemic preparedness."

    NUZYRA Commercial Highlights

    • NUZYRA generated $11.5 million in net sales in the 11 months since its February 2019 launch.
    • NUZYRA generated $5.4 million in net sales in the fourth quarter of 2019, an increase of 74% versus prior quarter, driven by increases in demand.
    • Over 80% of commercial lives and greater than 50% of Medicaid lives in the U.S. now have access to NUZYRA.

    Recent Highlights

    • BARDA awarded Paratek a 5-year contract valued at up to $285 million, with an option to extend to 10-years, to support:  1) the development of NUZYRA for the treatment of pulmonary anthrax; 2) all of the U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval; and 3) the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax to be secured in the Strategic National Stockpile.
      • The pre-Emergency Use Authorization (EUA) for NUZYRA is targeted for submission to the FDA in the first quarter of 2020.  The purchase of the first 2,500 treatment courses will be initiated once FDA agrees the application is sufficient which is expected in the second quarter of 2020. 
    • Zai Lab Limited announced its New Drug Application for omadacycline for the treatment of CABP and ABSSSI infections has been accepted in China.
      • Paratek earned $3.0 million upon this regulatory submission in the fourth quarter of 2019. 
      • Paratek is eligible to receive $6.0 million upon regulatory approval and royalties on net sales.
    • Paratek entered into a license grant with Almirall (ALM) for SEYSARA® (sarecycline) for the greater China region, which includes the Peoples Republic of China, Hong Kong, and Macau.  Almirall plans to develop sarecycline for acne in China, with a submission to the China National Medical Products Administration expected in 2023.  Under the terms of the agreement, Paratek will earn high single-digit royalties on net sales. 

    Fourth Quarter and Full Year 2019 Financial Results
    Paratek reported a net loss of $27.4 million, or ($0.81) per share, for the fourth quarter of 2019, compared to a net loss of $22.8 million, or ($0.71) per share, for the same period in 2018.

    For the year ended December 31, 2019, Paratek reported a net loss of $128.8 million, or ($3.93) per share, compared to a net loss of $112.4 million, or ($3.57) per share, for the same period in 2018.

    Revenue earned during the fourth quarter of 2019 of $9.0 million was attributable to U.S. NUZYRA net sales of $5.4 million and collaboration and royalty revenue of $3.6 million, which included a $3.0 million milestone earned from Zai Lab and royalties earned from SEYSARA sales in the U.S.  Revenue earned during the fourth quarter of 2018 was primarily attributable to a $12.0 million milestone earned from Almirall, LLC upon FDA approval of SEYSARA and a $5.0 million milestone earned from Zai Lab upon FDA approval of NUZYRA.

    Revenue earned during the year ended December 31, 2019 of $16.5 million was attributable to U.S. NUZYRA net sales of $11.5 million and royalty and collaboration revenues of $5.0 million, consisting primarily of a $3.0 million milestone payment earned in December 2019 upon submission of the first regulatory approval application for a licensed product in the People's Republic of China and royalties earned from SEYSARA sales in the United States.  Revenue earned during the year ended December 31, 2018 of $17.0 million was primarily attributable to a $12.0 million milestone earned from Almirall, LLC upon FDA approval of SEYSARA and a $5.0 million milestone earned from Zai Lab upon FDA approval of NUZYRA.

    Research and development expenses were $9.1 million in the fourth quarter of 2019 compared to $11.8 million for the same period in 2018.

    Research and development expenses were $39.6 million for the year ended December 31, 2019, compared to $57.5 million for the year ended December 31, 2018. The $17.9 million decrease is primarily the result of the capitalization of NUZYRA commercial supply costs, which were classified as research and development expense until FDA approval of NUZYRA on October 2, 2018, partially offset by higher clinical study costs associated with our Phase 2 UTI program.

    Selling, general and administrative expenses were $21.3 million in fourth quarter of 2019, compared to $25.3 million for the same period in 2018.

    Selling, general and administrative expenses were $89.1 million for the year ended December 31, 2019, compared to $63.7 million for the year ended December 31, 2018.  The $25.4 million increase is primarily the result of the cost of our contract sales force, higher marketing, trade and distribution fees, and increased salaries, benefits and other personnel-related costs in support of the commercialization of NUZYRA.

    As of December 31, 2019, Paratek had $215.4 million in cash, cash equivalents and marketable securities.

    Financial Guidance 
    Paratek also announced its full year 2020 financial guidance. This financial guidance consists of the following components:

    • Paratek estimates 2020 total revenues to be between $75 and $80 million.  This revenue consists of the following elements:
      • 2020 NUZYRA U.S. net product sales is expected to be approximately $66 million with approximately $38 million of these sales coming from the initial BARDA procurement of 2,500 anthrax treatment courses.
        • The initial NUZYRA BARDA procurement is anticipated to be secured in the first half of 2020.
      • Royalty and collaboration revenue and BARDA grant revenue are expected to be approximately $9 to $14 million.
        • Of note, BARDA grant revenue consists of reimbursement associated with the post-marketing requirement clinical development activities, the anthrax development program and the onshoring of U.S. NUZYRA manufacturing.
    • 2020 R&D and SG&A expense is expected to be approximately $140 million.
      • R&D expense includes approximately $5 million earmarked for start-up activities in preparation for a potential NTM registrational study.
      • Excluding the BARDA R&D and onshoring cost reimbursement, R&D and SG&A expense is expected to remain relatively flat when compared to 2019.
    • Based upon our current operating plan which includes estimated NUZYRA product sales, and the BARDA expense reimbursement of activities related to the Project BioShield contract, we anticipate that our existing cash, cash equivalents and marketable securities of $215.4 million as of December 31, 2019, extend our cash runway through the end of 2023 with a pathway to cash flow break even. 
      • This anticipated pathway assumes the Company will be able to fund all company operating expenses, anticipated capital expenditures, and debt service, including repayment in full of the Hercules Loan and Security Agreement under its existing terms. 

    Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance.

    Call and Webcast
    Paratek's earnings conference call for the quarter ended December 31, 2019 will be broadcast today at 4:30 p.m. EST on February 25, 2019. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek's website at www.ParatekPharma.com.

    Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13699046. Investors can also access the call at http://public.viavid.com/index.php?id=138081.

    Website Information
    Paratek routinely posts important information for investors on the Investor Relations section of its website at www.ParatekPharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek's website, in addition to following its press releases, U.S. Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek's website is not incorporated by reference into, and is not a part of, this document.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements 
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including BARDA exercising full contract line items for procurement and PMR reimbursement, our anticipated cash runway, our operating expenses, our SEYSARA royalty-backed loan funded on May 1, 2019, the progression of our commercial roll out for NUZYRA,  our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, our plans to evaluate additional indications for NUZYRA, including NTM, and to work toward an oral-only indication in CABP, future governmental stockpiling opportunities, and our potential to further drive long-term value for all of our shareholders.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

     
    PARATEK PHARMACEUTICALS, INC.
     
    Condensed Consolidated Balance Sheets
    (unaudited)
    (in thousands)
           
        As of December 31,  
        2019     2018  
    Cash, cash equivalents and marketable securities   $ 215,379     $ 292,838  
    Total assets     251,079       300,192  
    Working capital     219,154       237,534  
    Total current liabilities     24,200       17,709  
    Long-term debt     260,728       228,959  
    Common stock and additional paid-in capital     671,537       630,174  
    Accumulated deficit     (711,258 )     (582,468 )
    Total stockholders' equity (deficit)     (39,647 )     47,578  
                     


     
    Condensed Consolidated Statements of Operations
    (unaudited)
    (in thousands, except loss per share data)
                   
        Three Months Ended December 31,
        Year Ended December 31,  
        2019      2018     2019     2018  
    Product revenue, net   $ 5,415     $     $ 11,517     $  
    Collaboration and royalty revenue     3,552       17,017       5,027       17,117  
    Net revenue     8,967       17,017       16,544       17,117  
    Expenses:                                
    Cost of product revenue     1,755             3,484        
    Research and development     9,133       11,802       39,554       57,508  
    Selling, general and administrative     21,261       25,263       89,135       63,658  
    Impairment of intangible assets                       107  
    Changes in fair value of contingent consideration           (14 )           (71 )
    Total operating expenses     32,149       37,051       132,173       121,202  
    Loss from operations     (23,182 )     (20,034 )     (115,629 )     (104,085 )
    Other income and expenses:                                
    Interest income     739       968       3,574       3,260  
    Interest expense     (4,626 )     (3,191 )     (16,403 )     (10,985 )
    Other losses, net     5       (30 )     (31 )     (44 )
    Net loss before provision for income taxes     (27,064 )     (22,287 )     (128,489 )     (111,854 )
    Provision for income taxes     301       502       301       502  
    Net loss attributable to common stockholders   $ (27,365 )   $ (22,789 )   $ (128,790 )   $ (112,356 )
    Net loss per share attributable to common stockholders:                                
    Basic and diluted net loss per common share   $ (0.81 )   $ (0.71 )   $ (3.93 )   $ (3.57 )
    Weighted average common shares outstanding                                
    Basic and diluted     33,789,704       32,143,147       32,791,934       31,513,454  
                                     

    CONTACT:

    Investor and Media Relations:
    Ben Strain
    617-807-6688

     

     

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  25. BOSTON, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced the Company has entered into a license grant with Almirall (ALM) for SEYSARA® (sarecycline) for the greater China region, which includes the Peoples Republic of China, Hong Kong, and Macau.  Under the terms of the agreement, Paratek will earn high single-digit royalties on net sales in the greater China region.  Almirall plans to develop sarecycline for acne in China, with a potential submission to the China National…

    BOSTON, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced the Company has entered into a license grant with Almirall (ALM) for SEYSARA® (sarecycline) for the greater China region, which includes the Peoples Republic of China, Hong Kong, and Macau.  Under the terms of the agreement, Paratek will earn high single-digit royalties on net sales in the greater China region.  Almirall plans to develop sarecycline for acne in China, with a potential submission to the China National Medical Products Administration in 2023.  Almirall also has rights to SEYSARA for acne in the U.S. and has successfully commercialized the product since its launch in January 2019.  

    As part of this agreement, Paratek and Almirall also finalized a license granting Paratek exclusive rights to develop, manufacture and commercialize sarecycline outside of the U.S.  Under the terms of the agreement, Paratek will share with Almirall any potential revenues of SEYSARA (sarecycline) outside of the U.S. and greater China region.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

    The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    In 2019, Paratek was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of NUZYRA for the treatment of pulmonary anthrax.

    Paratek exclusively licensed certain U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC, or Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements
    This press release contains forward-looking statements including statements related to our sarecycline overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:
    Ben Strain
    617-807-6688

     

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  26. - Total award valued at up to $285 million 

    - Paratek to host a conference call today, December 18, 2019 at 5:30 p.m. EST

    BOSTON, Dec. 18, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, announced today that the Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), and Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company a 5-year contract, with an option to extend to 10-years, to support the development of Paratek's NUZYRA® (omadacycline) for the treatment of pulmonary anthrax, FDA post-marketing requirements…

    - Total award valued at up to $285 million 

    - Paratek to host a conference call today, December 18, 2019 at 5:30 p.m. EST

    BOSTON, Dec. 18, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, announced today that the Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), and Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company a 5-year contract, with an option to extend to 10-years, to support the development of Paratek's NUZYRA® (omadacycline) for the treatment of pulmonary anthrax, FDA post-marketing requirements (PMR) associated with the initial NUZYRA approval, and the option to procure up to 10,000 treatment courses of NUZYRA for the Strategic National Stockpile (SNS) for use against potential biothreats.

    BARDA's Project BioShield program was created to accelerate the research, development, purchase, and availability of effective medical products against chemical, biological, radiological, or nuclear agents. Project BioShield provides the government with the authority and funding to develop, acquire, stockpile, and distribute the medical products needed to protect the United States against biothreats.

    "BARDA is encouraged by the opportunity to partner with Paratek Pharmaceuticals to further develop this critical antibiotic that will help us to combat antimicrobial resistance and treat anthrax infections," said Dr. Rick Bright, BARDA Director and Deputy Assistant Secretary for Preparedness and Response. "This award is an important step in BARDA's efforts to enhance our national health security preparedness."

    Under the terms of the agreement, BARDA will award initial funding of approximately $59 million for the development of NUZYRA for the treatment of pulmonary anthrax and the purchase of an initial 2,500 treatment courses of NUZYRA to add to the current SNS. The contract provides for additional potential time-based funding including: approximately $77 million for existing FDA PMR commitments scheduled to begin in April 2020 and approximately $20 million for manufacturing-related requirements scheduled to begin in June 2020. The remaining staged, milestone-based funding includes the potential for approximately $13 million to support the development of NUZYRA for the prophylaxis of anthrax and a maximum of approximately $115 million to provide for three additional purchases of NUZYRA for the SNS, each of which will be triggered upon development milestones related to the anthrax treatment development program.

    NUZYRA is a broad spectrum, once-daily oral and intravenous (IV) modernized tetracycline that was approved in October 2018 to treat community-acquired pneumonia and skin infections. 

    "We would like to thank BARDA, ASPR, and HHS for their commitment to this innovative and long-term private-public partnership recognizing Paratek's commitment to studying NUZYRA in the treatment and prophylaxis of anthrax. Through Project BioShield, BARDA has identified and validated the important role that Paratek and NUZYRA will play in helping to enhance the biodefense preparedness of our country, saving lives and protecting Americans," said Evan Loh, M.D., CEO of Paratek. "Paratek has been studying the potential utility of antibiotics against bioterrorism threats for over a decade. Through these activities, we have generated promising in vitro and in vivo animal data with NUZYRA against select biothreat pathogens. For these reasons, we believe that NUZYRA is well-positioned to help address potential public health emergencies at a time when antibiotic resistance is a growing global threat."

    BARDA is part of the Health and Human Services Office of the Assistant Secretary for Preparedness and Response and is charged with preparing the nation for public health emergencies by directly supporting the development of new antibacterial products. This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00001.

    Conference Call and Webcast

    Paratek's conference call for the BARDA Project BioShield Contract will be broadcast today, December 18, 2019 at 5:30 p.m. EST. The webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek's website at www.ParatekPharma.com.

    Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13697620. Investors can also access the call at http://public.viavid.com/index.php?id=137408.

    About NUZYRA

    NUZYRA (omadacycline) is a novel antibiotic with both once-daily intravenous (IV) and oral formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

    Indications and Usage

    NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:

    Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

    Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae. 

    Usage
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    Important Safety Information

    Contraindications
    NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.

    Warnings and Precautions
    Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.

    The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

    Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

    NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.

    Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

    Adverse Reactions

    The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

    Drug Interactions

    Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.

    Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.

    Use in Specific Populations

    Lactation: Breastfeeding is not recommended during treatment with NUZYRA.

    To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company's lead commercial product, NUZYRA® (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

    Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    SEYSARA® (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.

    Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to the Company's award and agreement with the Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), our future anticipated funding and activities and commitments under the award, the study of NUZYRA in new indications, our overall strategy, products, prospects and potential. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the new indications, plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    PARATEK® and the Hexagon Logo are registered trademarks of Paratek Pharmaceuticals, Inc. NUZYRA® and its design logo are registered trademarks of Paratek Pharmaceuticals, Inc.

    CONTACT:

    Investor and Media Relations:
    Ben Strain
    617-807-6688

    Primary Logo

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  27. BOSTON, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that on November 29, 2019, the Company granted stock options and restricted stock units to one new employee of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material…

    BOSTON, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that on November 29, 2019, the Company granted stock options and restricted stock units to one new employee of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.

    The stock options are to acquire, in the aggregate, 3,550 shares of the Company's common stock at a per share exercise price of $2.93, the closing sales price on November 29, 2019, and shall vest over a four-year vesting period, under which 25% of the shares will vest after 12 months of employment, with the remaining shares vesting monthly thereafter over the remaining 36-month period, subject to the employee's continuous service. The restricted stock units are to acquire, in the aggregate, 3,000 shares of the Company's common stock and shall vest upon the conclusion of a 36-month vesting period, under which one hundred percent 100% of the restricted stock units will vest after 36 months of employment, subject to the employee's continuous service. The stock options and restricted stock units are subject to the terms and conditions of the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, and the terms and conditions of the stock option agreement and restricted stock unit award agreement covering each grant.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company's lead commercial product, NUZYRA® (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

    Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

    SEYSARA™ (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.

    Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories. For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    About NUZYRA
    NUZYRA (omadacycline) is a novel antibiotic with both once-daily intravenous (IV) and oral formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

    CONTACT:
    Investor and Media Relations:     
    Ben Strain     
    617-807-6688     

    Primary Logo

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  28. -- Third Quarter 2019 NUZYRA® (omadacycline) Net Sales increased 82% versus the Prior Quarter to $3.1 Million --

    -- Oral-only CABP Pharmacokinetics Study Initiated--

    BOSTON, Nov. 12, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today reported financial results and provided an update on corporate activities for the third quarter ended September 30, 2019.

    "It has been a productive period for Paratek.  We saw a significant increase in demand for NUZYRA with third quarter net sales growing 82% versus the prior quarter." said Evan Loh, M.D., Chief Executive Officer.  "We are encouraged by the performance…

    -- Third Quarter 2019 NUZYRA® (omadacycline) Net Sales increased 82% versus the Prior Quarter to $3.1 Million --

    -- Oral-only CABP Pharmacokinetics Study Initiated--

    BOSTON, Nov. 12, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today reported financial results and provided an update on corporate activities for the third quarter ended September 30, 2019.

    "It has been a productive period for Paratek.  We saw a significant increase in demand for NUZYRA with third quarter net sales growing 82% versus the prior quarter." said Evan Loh, M.D., Chief Executive Officer.  "We are encouraged by the performance of NUZYRA so far this year as we saw a significant increase in demand, particularly driven by the oral formulation and continued progress in securing institutional and payer access.  We also initiated sites for the pharmacokinetics study with the goal of obtaining an oral-only indication in CABP in time for the 2020 pneumonia season.  We believe this value driver has the potential to further drive increased utilization of the oral formulation and offer additional treatment options to an even broader universe of patients-in-need."

    Third Quarter 2019 NUZYRA Commercial Highlights

    • NUZYRA generated $3.1 million in net sales in the U.S. in the third quarter of 2019.
      -- Accounting for inventory, NUZYRA gross demand increased from approximately $1.7 million in the second quarter of 2019 to approximately $3.3 million in the third quarter of 2019.
    • Expanded the sales force size in time for the 2019 pneumonia season.
    • Over 75% of commercial lives in U.S. now have access to NUZYRA.

    Other Recent Highlights

    • Paratek initiated sites for a pharmacokinetics study intended to obtain oral-only indication in CABP with potential approval of the indication in time for the 2020 pneumonia season.  
    • Paratek announced topline data from its two exploratory Phase 2 clinical studies evaluating the efficacy and safety of omadacycline in patients with two common forms of urinary tract infections.
    • Paratek withdrew European Marketing Authorization application (MAA) for oral and intravenous NUZYRA in skin infections and pneumonia.  The EMA deemed the MAA approvable for skin infections but requested a second pneumonia study in order to approve the pneumonia indication.
    • Paratek presented new data from NUZYRA development program at IDWeek 2019; highlighting Paratek's commitment to further understanding safety and efficacy of NUZYRA in unique population subsets.

    Third Quarter 2019 Financial Results
    Paratek reported a net loss of $32.6 million, or ($1.00) per share, for the third quarter of 2019, compared to a net loss of $32.1 million, or ($1.01) per share, for the same period in 2018.

    Revenue earned during the third quarter of 2019 was attributable to net U.S. NUZYRA product sales of $3.1 million and collaboration and royalty revenue of $0.9 million, consisting primarily of royalties earned from SEYSARA sales in the U.S.

    Research and development expenses were $8.4 million in the third quarter of 2019 compared to $16.0 million for the same period in 2018. The decrease was primarily the result of the capitalization of NUZYRA commercial supply costs, which were classified as research and development expense until FDA approval of NUZYRA on October 2, 2018, partially offset by higher clinical study costs associated with our Phase 2 UTI program. 

    Selling, general and administrative expenses were $23.6 million in third quarter of 2019, compared to $13.6 million for the same period in 2018.  The increase was primarily the result of the cost of our contract sales force, higher marketing, trade and distribution fees, and costs in support of the commercialization of NUZYRA.

    Based upon our current operating plan, we anticipate that our existing cash, cash equivalents and marketable securities of $225.6 million as of September 30, 2019, and estimated NUZYRA product sales, will fund company operating expenses, capital expenditures, and debt service beyond the first quarter of 2021.  

    Financial Guidance 
    The company now anticipates 2019 NUZYRA U.S. net product sales will come in within the previously communicated range of $10.0 to $13.0 million; likely at the lower end of the range.

    We anticipate that continued revenue growth in the fourth quarter will be partially driven by recent initiatives that include the increase in the size of the field force in time for the fall pneumonia season and further expansion of institutional access within the group of approximately 600 targeted hospitals.

    Call and Webcast
    Paratek's earnings conference call for the quarter ended September 30, 2019 will be broadcast today at 4:30 p.m. EST on November 12, 2019. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek's website at www.ParatekPharma.com.

    Domestic investors wishing to participate in the call should dial: 855-327-6838 and international investors should dial: 604-235-2082. The conference ID is 10008072. Investors can also access the call at http://public.viavid.com/index.php?id=136394.

    Website Information
    Paratek routinely posts important information for investors on the Investor Relations section of its website at www.ParatekPharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek's website, in addition to following its press releases, U.S. Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek's website is not incorporated by reference into, and is not a part of, this document.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company's lead commercial product, NUZYRA® (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

    Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

    SEYSARA® (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.

    Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements 
    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the projected net product revenues including assumptions related to our financial guidance, our anticipated cash runway, our SEYSARA royalty-backed loan funded on May 1, 2019, the progression of our commercial roll out for NUZYRA,  our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, the results of our Phase 2 studies of omadacycline in UTI, our plans to evaluate additional indications for NUZYRA, and to work toward an oral-only indication in CABP, and our potential to further drive long-term value for all of our shareholders.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.


    PARATEK PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets
    (unaudited)
    (in thousands)

        September 30,
    2019
      December 31,
    2018
        (unaudited)    
    Cash, cash equivalents and marketable securities   $ 225,637     $ 292,838  
    Total assets     252,774       300,192  
    Working capital     220,158       237,534  
    Total current liabilities     25,018       17,709  
    Long-term debt     260,410       228,959  
    Common stock and additional paid-in-capital     643,139       630,174  
    Accumulated deficit     (683,893 )     (582,468 )
    Total stockholders' equity     (40,606 )     47,578  
                     

    Condensed Consolidated Statements of Operations
    (unaudited)
    (in thousands, except loss per share data)

        Three Months Ended
    September 30,
        Nine Months Ended
    September 30,
     
        2019     2018     2019     2018  
    Product revenues, net   $ 3,053     $     $ 6,102     $  
    Collaboration and royalty revenue     881       50       1,475       101  
    Total revenue   $ 3,934     $ 50     $ 7,577     $ 101  
    Expenses:                                
    Cost of revenue     958             1,731        
    Research and development     8,350       16,040       30,421       45,706  
    General and administrative     23,636       13,610       67,874       38,395  
    Impairment of intangibles           21             107  
    Changes in fair value of contingent consideration           (11 )           (57 )
    Total operating expenses     32,944       29,660       100,026       84,151  
    Loss from operations     (29,010 )     (29,610 )     (92,449 )     (84,050 )
    Other income and expenses:                                
    Interest income     992       922       2,873       2,292  
    Interest expense     (4,560 )     (3,383 )     (11,777 )     (7,793 )
    Other loss, net     (36 )     (12 )     (72 )     (14 )
    Loss before income taxes   $ (32,614 )   $ (32,083 )   $ (101,425 )   $ (89,565 )
    Provision for income taxes                        
    Net loss     (32,614 )     (32,083 )     (101,425 )     (89,565 )
    Net loss per share - basic and diluted   $ (1.00 )   $ (1.01 )   $ (3.12 )   $ (2.86 )
    Weighted average common stock outstanding                                
    Basic and diluted     32,590,454       31,742,854       32,458,010       31,301,249  

     

    CONTACT:

    Investor and Media Relations:
    Ben Strain
    617-807-6688

    Primary Logo

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  29. BOSTON, Nov. 01, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that on October 31, 2019, the Company granted stock options and restricted stock units to three new employees of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material…

    BOSTON, Nov. 01, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that on October 31, 2019, the Company granted stock options and restricted stock units to three new employees of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.

    The stock options are to acquire, in the aggregate, 6,300 shares of the Company's common stock at a per share exercise price of $3.08, the closing sales price on October 31, 2019, and shall vest over a four-year vesting period, under which 25% of the shares will vest after 12 months of employment, with the remaining shares vesting monthly thereafter over the remaining 36-month period, subject to the employee's continuous service. The restricted stock units are to acquire, in the aggregate, 3,000 shares of the Company's common stock and shall vest upon the conclusion of a 36-month vesting period, under which one hundred percent 100% of the restricted stock units will vest after 36 months of employment, subject to the employee's continuous service. The stock options and restricted stock units are subject to the terms and conditions of the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, and the terms and conditions of the stock option agreement and restricted stock unit award agreement covering each grant.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company's lead commercial product, NUZYRA® (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

    Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

    SEYSARA™ (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.

    Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories. For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    About NUZYRA
    NUZYRA (omadacycline) is a novel antibiotic with both once-daily intravenous (IV) and oral formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

    CONTACT:
    Investor and Media Relations:     
    Ben Strain     
    617-807-6688
     

    Primary Logo

    View Full Article Hide Full Article
  30. BOSTON, Oct. 31, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, announced the outcome of its two exploratory Phase 2 clinical studies evaluating the efficacy and safety of its once-daily oral and intravenous (IV) modernized tetracycline omadacycline in patients with two common forms of urinary tract infections (UTI).

    Both studies were adaptive studies which included multiple dosage regimens of omadacycline with the objective to identify a dose regimen for further investigation that would be clinically and microbiologically effective in each of the UTI indications to be studied.

    The first Phase 2 study…

    BOSTON, Oct. 31, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, announced the outcome of its two exploratory Phase 2 clinical studies evaluating the efficacy and safety of its once-daily oral and intravenous (IV) modernized tetracycline omadacycline in patients with two common forms of urinary tract infections (UTI).

    Both studies were adaptive studies which included multiple dosage regimens of omadacycline with the objective to identify a dose regimen for further investigation that would be clinically and microbiologically effective in each of the UTI indications to be studied.

    The first Phase 2 study, conducted in the U.S., was designed to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral-only omadacycline compared to an oral-only regimen of nitrofurantoin in female patients with cystitis, or uncomplicated urinary tract infections (uUTI). In the study, 225 subjects were randomized to receive one of four omadacycline dosing regimens or nitrofurantoin.

    The second Phase 2 study, conducted globally, was designed to evaluate the efficacy, safety, tolerability and pharmacokinetics of once-daily IV or IV-to-oral omadacycline compared to a once-daily regimen of IV-to-oral levofloxacin, in patients with acute pyelonephritis, a common clinical subset of complicated UTI (cUTI).  In the study, 201 patients were randomized into four omadacycline dosing regimens or levofloxacin. 

    In both studies, omadacycline showed generally comparable levels of clinical success to either nitrofurantoin or levofloxacin, as determined by the investigator's assessment of clinical response at the post-treatment evaluation. However, the microbiological responses were generally lower than the comparators.  Consistent with safety results from previously completed pivotal Phase 3 clinical trials, omadacycline was generally safe and well-tolerated in both studies. 

    Due to the exploratory intent and small numbers of subjects enrolled in each dose in these phase 2 studies, the Company has identified dose regimens that require additional investigation before determining any future development plans for these indications.  Additional analyses are ongoing including pathogen-specific level efficacy and relationships of both clinical and microbiological responses to urinary pharmacokinetic data. The Company plans on presenting data from both studies at a future medical conference.

    "We are pleased with the innovative design and high-quality conduct of these exploratory Phase 2 adaptive studies, providing data that has both identified potential dose regimens for future investigation and ruled out ineffective ones." said Evan Loh, M.D., CEO of Paratek. "Beyond these top-line data, we have more data to evaluate from these studies in order to determine the best path forward for omadacycline in UTI. We are grateful to the patients, principal investigators, clinical site staffs, our CRO and vendor partners, and the Paratek clinical development team who participated in and enabled these studies to be executed in a timely and professional manner."

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company's lead commercial product, NUZYRA® (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

    Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

    SEYSARA® (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.

    Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories. For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    Forward Looking Statements

    This press release contains forward-looking statements including statements related to our clinical development program, UTI clinical trials, future UTI development, overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACTS:

    Investor and Media Relations:
    Ben Strain
    617-807-6688

    Primary Logo

    View Full Article Hide Full Article
  31. BOSTON, Oct. 01, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that on September 30, 2019, the Company granted stock options and restricted stock units to two new employees of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material…

    BOSTON, Oct. 01, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that on September 30, 2019, the Company granted stock options and restricted stock units to two new employees of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.

    The stock options are to acquire, in the aggregate, 4,800 shares of the Company's common stock at a per share exercise price of $4.32, the closing sales price on September 30, 2019, and shall vest over a four-year vesting period, under which 25% of the shares will vest after 12 months of employment, with the remaining shares vesting monthly thereafter over the remaining 36-month period, subject to the employee's continuous service. The restricted stock units are to acquire, in the aggregate, 3,950 shares of the Company's common stock and shall vest upon the conclusion of a 36-month vesting period, under which one hundred percent 100% of the restricted stock units will vest after 36 months of employment, subject to the employee's continuous service. The stock options and restricted stock units are subject to the terms and conditions of the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, and the terms and conditions of the stock option agreement and restricted stock unit award agreement covering each grant.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company's lead commercial product, NUZYRA® (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek is also studying NUZYRA for the treatment of urinary tract infections (UTI).

    Paratek has submitted a marketing authorization application of omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

    SEYSARA™ (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.

    Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories. For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    About NUZYRA
    NUZYRA (omadacycline) is a novel antibiotic with both once-daily intravenous (IV) and oral formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com

    CONTACT:
    Investor and Media Relations:
    Ben Strain
    617-807-6688
     

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  32. WASHINGTON, Oct. 1, 2019 /PRNewswire/ -- The Antimicrobials Working Group (AWG), a coalition of companies with the mission to combat drug-resistant infections and spur life-saving innovations, today announced that eleven of its member companies will present data from their clinical and research programs at IDWeek 2019 to be held October 2-6, 2019 in Washington D.C.

    IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS) that brings together infectious disease professionals to present and discuss the latest approaches in prevention, diagnosis, treatment, and epidemiology…

    WASHINGTON, Oct. 1, 2019 /PRNewswire/ -- The Antimicrobials Working Group (AWG), a coalition of companies with the mission to combat drug-resistant infections and spur life-saving innovations, today announced that eleven of its member companies will present data from their clinical and research programs at IDWeek 2019 to be held October 2-6, 2019 in Washington D.C.

    IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS) that brings together infectious disease professionals to present and discuss the latest approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases.

    "AWG members look forward to joining their peers in the scientific community, from around the world, to present and discuss the newest innovations to combat drug-resistant infections," said Evan Loh, M.D., Chief Executive Officer of Paratek Pharmaceuticals and Chairman of the AWG. "AWG companies will highlight progress in their clinical and research programs in antifungal, antibacterial, and non-traditional therapies in 52 presentations during the conference. These efforts underscore the coalition's commitment to developing new antimicrobial medicines for serious and life-threatening infectious diseases."

    The following AWG member companies will be presenting at IDWeek 2019: Amplyx Pharmaceuticals, Aridis Pharmaceuticals, Cidara Therapeutics Inc., Entasis Therapeutics Inc., Melinta Therapeutics Inc., Nabriva Therapeutics US Inc., Paratek Pharmaceuticals Inc., Qpex Biopharma, Inc., SCYNEXIS Inc., Summit Therapeutics plc, and VenatoRx Pharmaceuticals, Inc.

    For more information on AWG member company presentations and access to specific abstracts, please visit: https://www.antimicrobialsworkinggroup.org/idweek-2019/

    About The Antimicrobials Working Group

    AWG was founded in 2012 with the vision of utilizing collective power to improve the regulatory, investment, and commercial environment for emerging infectious disease companies. Today, AWG is comprised of thirteen antimicrobials companies: Amplyx Pharmaceuticals, Aridis Pharmaceuticals, Cidara Therapeutics Inc. (NASDAQ:CDTX), Entasis Therapeutics Inc. (NASDAQ:ETTX), Iterum Therapeutics Ltd. (NASDAQ:ITRM), Melinta Therapeutics Inc. (NASDAQ:MLNT), Nabriva Therapeutics US Inc. (NASDAQ:NBRV), Paratek Pharmaceuticals Inc. (NASDAQ:PRTK), Qpex Biopharma, Inc., SCYNEXIS Inc. (NASDAQ:SCYX), Summit Therapeutics plc (NASDAQ:SMMT, AIM: SUMM)), VenatoRx Pharmaceuticals, Inc., and X-Biotix Therapeutics, Inc.

    For more information, visit: www.antimicrobialsworkinggroup.org

    About The Conafay Group

    The Conafay Group, led by Stephen R. Conafay, Principal, is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for AWG.

    For more information, visit: www.conafaygroup.com

    Cision View original content:http://www.prnewswire.com/news-releases/antimicrobials-working-group-highlights-member-company-participation-at-idweek-2019-300927885.html

    SOURCE Antimicrobials Working Group (AWG)

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  33. BOSTON, Sept. 09, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) mourns the loss of Stuart Levy, M.D., who passed way last week. Dr. Levy co-founded the company more than two decades ago along with Dr. Walter Gilbert and was instrumental in the development of Paratek's lead antibiotic, NUZYRA® and SEYSARA®.

    "Stuart was a distinguished physician who was the forefront of antibiotic development and a dedicated champion for the prudent use of antibiotics," said Evan Loh, M.D., Paratek CEO. "More importantly, he was a dear friend and mentor to so many and his passion lives on in each of us as we work to continue his mission of combating the daily threat of life-threatening infections. We will greatly miss him."

    Dr. Levy discovered…

    BOSTON, Sept. 09, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) mourns the loss of Stuart Levy, M.D., who passed way last week. Dr. Levy co-founded the company more than two decades ago along with Dr. Walter Gilbert and was instrumental in the development of Paratek's lead antibiotic, NUZYRA® and SEYSARA®.

    "Stuart was a distinguished physician who was the forefront of antibiotic development and a dedicated champion for the prudent use of antibiotics," said Evan Loh, M.D., Paratek CEO. "More importantly, he was a dear friend and mentor to so many and his passion lives on in each of us as we work to continue his mission of combating the daily threat of life-threatening infections. We will greatly miss him."

    Dr. Levy discovered the efflux mechanism for drug (tetracycline) resistance and was among the first scientists to document the transfer of resistant bacteria from animals to farm workers. Dr. Levy published more than 250 papers, as well as four edited books and two special journal editions about antibiotic use and resistance. His 1992 book, The Antibiotic Paradox: How Miracle Drugs Are Destroying the Miracle, has been cited widely and translated into four languages. 

    Dr. Levy graduated magna cum laude from Williams College and received his medical degree from the University of Pennsylvania. He completed his residency at Mt. Sinai Hospital in New York and performed postdoctoral research at the National Institutes of Health. He received honorary degrees in biology from Wesleyan University and Des Moines University, and was awarded ASM's 1995 Hoechst-Roussel Award for esteemed research in antimicrobial chemotherapy, the 2011 Hamao Umezawa Memorial Award by the International Society of Chemotherapy and the 2012 Abbott- ASM Lifetime Achievement Award. 

    Dr. Levy is survived by his wife, Cecile Pastel Levy, and his three children, Suzanne Levy Friedman, Arthur Levy, and Walter Levy. He is also survived by his twin brother Jay Levy of San Francisco and his sister Ellen Koenig of the Dominican Republic.  

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company's lead commercial product, NUZYRA® (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek is also studying NUZYRA for the treatment of urinary tract infections (UTI).

    Paratek has submitted a marketing authorization application of omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

    SEYSARA ® (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.

    Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    CONTACT:

    Investor and Media Relations:
    Ben Strain
    617-807-6688
     

    Primary Logo

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  34. BOSTON, Sept. 04, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that the Company will present at 21st Annual H.C. Wainwright Global Investment Conference on Monday, September 9 at 11:15 a.m. ET at the Lotte New York Palace Hotel in New York.

    To access the live webcast of Paratek's presentation, please visit http://wsw.com/webcast/hcw5/prtk/.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following…

    BOSTON, Sept. 04, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that the Company will present at 21st Annual H.C. Wainwright Global Investment Conference on Monday, September 9 at 11:15 a.m. ET at the Lotte New York Palace Hotel in New York.

    To access the live webcast of Paratek's presentation, please visit http://wsw.com/webcast/hcw5/prtk/.

    Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company's lead commercial product, NUZYRA™ (omadacycline), which has launched and is available in the U.S., is a once-daily intravenous and oral antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek is also studying NUZYRA for the treatment of urinary tract infections (UTI). 

    Paratek has submitted a marketing authorization application of omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.  

    Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax. 

    SEYSARA™ (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.  

    Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.  

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter. 

    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein

    CONTACT:

    Investor and Media Relations:    
    Ben Strain    
    617-807-6688    
       

    Primary Logo

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  35. BOSTON, Sept. 03, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that on August 30, 2019, the Company granted stock options and restricted stock units to six new employees of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material…

    BOSTON, Sept. 03, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that on August 30, 2019, the Company granted stock options and restricted stock units to six new employees of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.

    The stock options are to acquire, in the aggregate, 20,550 shares of the Company's common stock at a per share exercise price of $3.74, the closing sales price on August 30, 2019, and shall vest over a four-year vesting period, under which 25% of the shares will vest after 12 months of employment, with the remaining shares vesting monthly thereafter over the remaining 36-month period, subject to the employee's continuous service. The restricted stock units are to acquire, in the aggregate, 17,350 shares of the Company's common stock and shall vest upon the conclusion of a 36-month vesting period, under which one hundred percent 100% of the restricted stock units will vest after 36 months of employment, subject to the employee's continuous service. The stock options and restricted stock units are subject to the terms and conditions of the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, and the terms and conditions of the stock option agreement and restricted stock unit award agreement covering each grant.

    About Paratek Pharmaceuticals, Inc.
    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company's lead commercial product, NUZYRA® (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek is also studying NUZYRA for the treatment of urinary tract infections (UTI).

    Paratek has submitted a marketing authorization application of omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

    Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

    SEYSARA™ (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.

    Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories. For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

    About NUZYRA
    NUZYRA (omadacycline) is a novel antibiotic with both once-daily intravenous (IV) and oral formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

    Please see full Prescribing Information for NUZYRA at www.NUZYRA.com

    CONTACT:
    Investor and Media Relations:     
    Ben Strain     
    617-807-6688     
     

    Primary Logo

    View Full Article Hide Full Article
  36. BOSTON, Aug. 26, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that the Company will present at Baird's 2019 Global Healthcare Conference on Wednesday, September 4 at 3:10 p.m. ET at the InterContinental New York Barclay in New York.

    To access the live webcast of Paratek's presentation, please visit http://wsw.com/webcast/baird56/prtk/.  Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following…

    BOSTON, Aug. 26, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today announced that the Company will present at Baird's 2019 Global Healthcare Conference on Wednesday, September 4 at 3:10 p.m. ET at the InterContinental New York Barclay in New York.

    To access the live webcast of Paratek's presentation, please visit http://wsw.com/webcast/baird56/prtk/.  Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

    About Paratek Pharmaceuticals, Inc.

    Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company's lead commercial product, NUZYRATM (omadacycline), which has launched and is available in the U.S., is a once-daily intravenous and oral antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek is also studying NUZYRA for the treatment of urinary tract infections (UTI). 

    Paratek has submitted a marketing authorization application of omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.  

    Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax. 

    SEYSARA™ (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.  

    Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.  

    For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.  

    Forward Looking Statements 

    This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2018 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

    CONTACT:

    Investor and Media Relations:
    Ben Strain
    617-807-6688

    Primary Logo

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