CHMA Chiasma Inc.

4
-0.04  -1%
Previous Close 4.04
Open 4.01
52 Week Low 2.77
52 Week High 5.74
Market Cap $252,989,592
Shares 63,247,398
Float 43,099,317
Enterprise Value $174,062,592
Volume 1,112,776
Av. Daily Volume 844,626
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Drug Pipeline

Drug Stage Notes
MYCAPSSA (octreotide)
Maintenance treatment of adult acromegaly
Phase 3
Phase 3
Phase 3 trial met primary non-inferiority endpoint - November 18, 2020.
MYCAPSSA (octreotide)
Acromegaly
CRL
CRL
CRL April 15 2016
MYCAPSSA (octreotide)
Acromegaly
Approved
Approved
FDA approval announced June 26, 2020.

Latest News

  1. LEXINGTON, Mass., July 27, 2021 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology, today announced the appointment of Anand Varadan to its Board of Directors, effective July 26, 2021. Mr. Varadan brings expertise in commercialization and successful product launches. In addition, Mark Iwicki stepped down from his role on the Board of Directors effective July 23, 2021.

    "We are delighted to welcome Anand to the Pulmatrix Board," said Ted Raad, Chief Executive Officer of Pulmatrix. "Anand is a recognized leader in the biotech industry and his extensive experience in corporate strategy and commercialization will be invaluable to Pulmatrix's future growth and success. I look forward to Anand's guidance as we execute on our vision to bring iSPERSE enabled inhaled therapies to patients with a broad range of large market indications. I'd also like to thank Mark for his invaluable contributions to Pulmatrix during his time on the Board."

    Mr. Varadan currently serves as an Executive Vice President, Chief Commercial Officer at Chiasma (NYSE:CHMA), a clinical, late-stage biopharmaceutical company, where he leads commercial strategy and operations. Mr. Varadan previously served as Chiasma's strategic advisors, and earlier as Chiasma's Chief Commercial Officer. Before joining Chiasma, Mr. Varadan served as Executive Vice President, Chief Commercial Officer of Karyopharm Therapeutics, Inc, an oncology-focused pharmaceutical company, where he led a successful launch of Xpovio for multiple myeloma. Mr. Varadan also provides commercial and strategic consultancy services through his consulting firm, Ignition Insights, LLC. Earlier in his career, Mr. Varadan held management and commercial leadership roles at Amgen Inc., a biopharmaceutical company, in the U.S., E.U., and Canada including Vice President, Inflammation and Nephrology Business Unit. Prior to Amgen, Mr. Varadan was a brand manager at Procter and Gamble Company.

    Mr. Vardan added, "I am excited about joining the Pulmatrix Board at such an exciting time in the Company's evolution as they expand to non-respiratory indications. I look forward to contributing to Pulmatrix's mission to advance and commercialize their differentiated iSPERSE pipeline, collaborating with management and fellow Board members." 

    About Pulmatrix 

    Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for serious lung diseases such as allergic bronchopulmonary aspergillosis ("ABPA"), COPD, and neurologic disorders such as acute migraine. Pulmatrix's product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

    FORWARD-LOOKING STATEMENTS

    Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements of historical fact, and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that", "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the impact of the novel coronavirus (COVID-19) on the Company's ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on the Company's ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company's products, including patent protection; and the outcome of the Company's dispute with Cipla regarding the continued development of Pulmazole. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC, including its most recent annual report on Form 10-K, as amended, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact

    Timothy McCarthy, CFA

    212.915.2564

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/pulmatrix-appoints-director-anand-varadan-301342205.html

    SOURCE Pulmatrix, Inc.

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  2. NEEDHAM, Mass., June 28, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of MYCAPSSA® (oral octreotide capsules) as a maintenance therapy for adults with acromegaly.

    The MAA is supported by positive results from Chiasma's global Phase 3 MPOWERED™ non-inferiority clinical trial comparing MYCAPSSA to long-acting injectable somatostatin…

    NEEDHAM, Mass., June 28, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of MYCAPSSA® (oral octreotide capsules) as a maintenance therapy for adults with acromegaly.

    The MAA is supported by positive results from Chiasma's global Phase 3 MPOWERED™ non-inferiority clinical trial comparing MYCAPSSA to long-acting injectable somatostatin analogs (iSSAs) for maintenance of biochemical response in patients with acromegaly who previously responded to both therapies. MYCAPSSA, the first and only oral somatostatin analog for the treatment of acromegaly approved by the Food and Drug Administration (FDA), is available in the U.S. for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

    "We are pleased to submit our marketing authorization application to the EMA as planned, as this marks an important step forward in our mission to expand the availability of MYCAPSSA to patients outside the U.S. suffering from acromegaly," said Raj Kannan, chief executive officer of Chiasma.  

    About the CHIASMA MPOWERED™ Trial 

    The MPOWERED™ trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCAPSSA® (oral octreotide capsules) in the European Union. This non-inferiority clinical trial was designed to compare MYCAPSSA to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly. The trial enrolled 146 adult acromegaly patients of which 92 patients who were responders to MYCAPSSA after a six-month run-in phase were then randomized to a nine-month controlled (RCT) phase to either receive continued treatment on MYCAPSSA (n=55) or their prior injectable therapy (octreotide long-acting release or lanreotide autogel) (n=37). The primary endpoint of the trial was time-weighted average of IGF-1 <1.3 x upper limit of normal during the nine-month RCT phase. As previously announced, MPOWERED met its primary endpoint of non-inferiority compared to long-acting SSA injectables.

    About MYCAPSSA

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION AND USAGE

    MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

    CONTRAINDICATIONS

    Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

    Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.

    Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

    ADVERSE REACTIONS

    The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

    DRUG INTERACTIONS

    The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.

    Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

    PREGNANCY

    Advise premenopausal females of the potential for an unintended pregnancy.

    To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.

    About Acromegaly

    Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in the United States.

    About Chiasma

    Chiasma is a commercial stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In June 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale in the United States. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company's development of MYCAPSSA for the treatment of acromegaly, statements regarding the regulatory review of MYCAPSSA, statements regarding the data from the MPOWERED trial and whether the data will support the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA in the European Union and ultimately regulatory approval, statements regarding the company's expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, and statements concerning the commercial or therapeutic potential of MYCAPSSA. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the EMA, the sufficiency of the data collected from the company's clinical trials to obtain regulatory approval in the European Union or elsewhere, the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



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  3. Amryt Pharma Announces Filing of Preliminary Registration Statement on Form F-4 in Connection with Its Proposed Acquisition of Chiasma, Inc.

    DUBLIN, Ireland, and Boston MA, June 15, 2021, Amryt (NASDAQ:AMYT, AIM: AMYT))), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces it has filed a registration statement on Form F-4 (the "Registration Statement"), which contains a preliminary proxy statement/prospectus, with the US Securities and Exchange Commission ("SEC"), in connection with its previously announced proposed acquisition of Chiasma, Inc. (NASDAQ:CHMA) in an all-stock combination (the "proposed transaction").

    The Registration Statement…

    Amryt Pharma Announces Filing of Preliminary Registration Statement on Form F-4 in Connection with Its Proposed Acquisition of Chiasma, Inc.

    DUBLIN, Ireland, and Boston MA, June 15, 2021, Amryt (NASDAQ:AMYT, AIM: AMYT))), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces it has filed a registration statement on Form F-4 (the "Registration Statement"), which contains a preliminary proxy statement/prospectus, with the US Securities and Exchange Commission ("SEC"), in connection with its previously announced proposed acquisition of Chiasma, Inc. (NASDAQ:CHMA) in an all-stock combination (the "proposed transaction").

    The Registration Statement provides important information about Amryt, Chiasma and the proposed transaction, but has not yet been declared effective by the SEC and is subject to change.  Completion of the proposed transaction, which is expected in the third quarter of 2021, is subject to the receipt of approvals from the shareholders and stockholders of Amryt and Chiasma, respectively, the Registration Statement being declared effective by the SEC, the receipt of regulatory clearance and other customary closing conditions.  The proposed transaction has been approved and recommended by the boards of directors of both Amryt and Chiasma and is endorsed and supported by voting agreements with lead security holders of both businesses – Athyrium Capital Management, LP, Highbridge Capital Management and MPM Capital.

    Under the terms of the proposed transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the proposed transaction will be exchanged for 0.396 Amryt American Depositary Shares ("Amryt ADSs"), each representing the right to receive five Amryt ordinary shares.  Based on the reference price of Amryt ADSs as of the time of final determination of the exchange ratio of $12.95 on Nasdaq on May 4, 2021, the last full trading day before the public announcement of the proposed transaction, the implied per share value of Chiasma common stock was approximately $5.13 per share or $339.2 million in total equity value, assuming the treasury stock method.  The enterprise value as of May 4, 2021, the last full trading day before the public announcement of the proposed transaction, implied by the proposed transaction was approximately $268.9 million.  The enterprise value implied by the proposed transaction is calculated incorporating Chiasma's publicly stated debt and debt like items and less Chiasma's cash, in each case as of the last publicly reported March 31, 2021 balance sheet date.  

    Because the exchange ratio is fixed, the market value of the merger consideration to Chiasma stockholders will fluctuate with the market price of the Amryt ADSs and will not be known at the time that Chiasma stockholders vote on the proposed transaction.   

    Using the treasury stock method for share options, warrants and restricted stock units, Amryt holders prior to the close of the proposed transaction will own approximately 60% of the combined company post-closing and Chiasma holders prior to the close of the proposed transaction will own approximately 40% of the combined company post-closing, assuming Amryt's outstanding convertible debentures are not converted. 

    The proposed transaction leverages Amryt's proven commercial execution ability, global infrastructure and successful integration capabilities to accelerate MYCAPSSA® launch in the US and international markets, maximize value from MYCAPSSA® and further develop life-cycle management opportunities.  Amryt expects the proposed transaction to accelerate and diversify Amryt's growing revenues and deliver estimated annual cost synergies of approximately $50 million. The proposed transaction will create a leading rare and orphan disease company with significant scale, an attractive mix of established cash-flow generating and long-term growth products and a diversified development pipeline.  

    Neither this announcement nor any copy of it may be taken or transmitted directly or indirectly into or from any jurisdiction where to do so would constitute a violation of the relevant laws or regulations of such jurisdiction. Any failure to comply with this restriction may constitute a violation of such laws or regulations. Persons in possession of this announcement or other information referred to herein should inform themselves about, and observe, any restrictions in such laws or regulations.

    This announcement has been prepared for the purpose of complying with the applicable law and regulation of the United Kingdom and the United States and information disclosed may not be the same as that which would have been disclosed if this announcement had been prepared in accordance with the laws and regulations of jurisdictions outside the United Kingdom or the United States. In the United Kingdom, this announcement is directed only at (i) persons who have professional experience in matters relating to investments who fall within the definition of "investment professionals" in Article 19(5) of The Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 ("Order"), (ii) persons who are high net worth entities falling within Article 49(2)(a) to (d) of the Order, or (iii) other persons to whom this announcement may otherwise lawfully be communicated (all such persons referred to in (i), (ii) and (iii) together being referred to as "relevant persons"). This document must not be acted or relied on in the United Kingdom by persons who are not relevant persons. In the United Kingdom, any investment or investment activity to which this document relates is available only to relevant persons and will be engaged in only with such persons.

    About Amryt

    Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases.  Amryt comprises a strong and growing portfolio of commercial and development assets.  

    Amryt's commercial business comprises two orphan disease products – metreleptin (Myalept®/ Myalepta®) and lomitapide (Juxtapid®/ Lojuxta®).

    Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.  For additional information, please follow this link

    Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel and Brazil (under the trade name Lojuxta®). For additional information, please follow this link.

    Amryt's lead development candidate, Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.  Filsuvez® has been selected as the brand name for Oleogel-S10.  The product does not currently have regulatory approval to treat EB.  In June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. 

    Amryt's pre-clinical gene therapy platform, AP103, offers a potential treatment for patients with Dystrophic EB, and is also potentially relevant to other genetic disorders. 

    About Chiasma

    Chiasma is a commercial stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In June 2020, Chiasma received FDA approval of MYCAPSSA® for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA®, the first and only oral SSA approved by the FDA, is available for commercial sale.  Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA®, TPE® and Chiasma® are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com

    For more information on Amryt, including products, please visit www.amrytpharma.com.

    Financial Advisors

    Shore Capital (Edward Mansfield, Daniel Bush, John More) is NOMAD and Joint Broker to Amryt in the UK.  Stifel (Ben Maddison) is Joint Broker to Amryt in the UK.

    Forward-Looking Statements

    This announcement relates to the proposed transaction between Amryt and Chiasma and includes forward-looking statements, which are typically identified by words such as "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative). Forward-looking statements relate to future events and anticipated results of operations, business strategies, the anticipated benefits of the proposed transaction, the anticipated impact of the proposed transaction on the combined company's business and future financial and operating results, the expected amount and timing of synergies from the proposed transaction, the plans, objectives, expectations and intentions of Amryt, Chiasma or the combined company, the anticipated closing date for the proposed transaction and other aspects of our operations or operating results. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's and Chiasma's present and future business strategies and the environment in which Amryt and Chiasma expect to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements, and actual results could differ materially from those currently anticipated due to a number of risks and uncertainties. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond each of Amryt's and Chiasma's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Risks and uncertainties that could cause results to differ from expectations include: uncertainties as to the timing of the contemplated proposed transaction; uncertainties as to the approvals by Amryt's shareholders and Chiasma's stockholders required in connection with the contemplated proposed transaction; the possibility that a competing proposal will be made; the possibility that the closing conditions to the contemplated proposed transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant a necessary regulatory approval; the effects of disruption caused by the announcement of the contemplated proposed transaction making it more difficult to maintain relationships with employees, customers, vendors and other business partners; the risk that stockholder litigation in connection with the contemplated proposed transaction may affect the timing or occurrence of the contemplated proposed transaction or result in significant costs of defense, indemnification and liability; other business effects, including the effects of industry, economic or political conditions outside of the control of the parties to the contemplated proposed transaction; proposed transaction costs; actual or contingent liabilities; disruptions to the financial or capital markets; and other risks and uncertainties discussed in Amryt's and Chiasma's respective filings with the SEC. You can obtain copies of Amryt's and Chiasma's respective filings with the SEC for free at the SEC's website (www.sec.gov).  Past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company's current beliefs and assumptions and are based on information currently available to management.

    Important Additional Information and Where to Find It

    The Registration Statement will include a document that serves as a prospectus of Amryt and a proxy statement of Chiasma (the "proxy statement/prospectus"), Chiasma intends to file a proxy statement with the SEC (the "proxy statement"), and each party will file other documents regarding the proposed transaction with the SEC. Investors and security holders are urged to carefully read the entire Registration Statement and proxy statement/prospectus or proxy statement and other relevant documents filed with the SEC when they become available because they will contain important information. A proxy statement/prospectus or a proxy statement will be sent to Chiasma's stockholders once the Registration Statement is declared effective. Investors and security holders will be able to obtain the Registration Statement and the proxy statement/prospectus or the proxy statement free of charge from the SEC's website.

    For the avoidance of doubt, the Registration Statement does not constitute a "prospectus" in the UK or in any member state of the EEA for the purposes of the Prospectus Regulation (Regulation (EU) 2017/1129) and has not been reviewed by any competent authority in the UK or in any member state of the EEA.  No offer of securities to the public is being made in the UK or in any member state of the EEA.

    Amryt will also publish a shareholder circular in connection with the shareholder approvals required in connection with the proposed transaction which will be made available to Amryt shareholders and on its website.  

    No Offer or Solicitation

    This announcement shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. For the avoidance of doubt, the Registration Statement does not constitute a "prospectus" in the UK or in any member state of the European Economic Area ("EEA") for the purposes of the Prospectus Regulation (Regulation (EU) 2017/1129) and has not been reviewed by any competent authority in the UK or in any member state of the EEA.  No offer of securities to the public is being made in the UK or in any member state of the EEA.

    Participants in the Solicitation

    Amryt, Chiasma and certain of their respective directors, executive officers and employees may be deemed participants in the solicitation of proxies from Chiasma stockholders in connection with the proposed Transaction. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the stockholders of Chiasma in connection with the proposed Transaction, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the definitive proxy statement/prospectus or proxy statement when it is filed with the SEC. Information about the directors and executive officers of Chiasma and their ownership of Chiasma shares is set forth in the definitive proxy statement for Chiasma's 2021 annual meeting of stockholders, as previously filed with the SEC on April 26, 2021. Free copies of these documents may be obtained as described in the paragraphs above.

    Contacts

    Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, 

    Edward Mansfield, Shore Capital, NOMAD, +44 (0) 207 468 7906,

    Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564,

    Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700







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  4. NEEDHAM, Mass., May 27, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company") today presented patient-reported outcomes (PROs) data from its MPOWERED™ Phase 3 trial demonstrating that study patients with acromegaly reported significantly improved quality of life and work productivity after transitioning from long-acting injectable somatostatin analogs (iSSAs) to MYCAPSSA®. The data were shared as an oral presentation at the 30th Annual American Association of Clinical Endocrinology (AACE) Meeting being held virtually from May 26-29, 2021.

    "The encouraging PROs data from the MPOWERED study further our understanding of the potential positive clinical impact that MYCAPSSA has for patients with acromegaly," said Nienke…

    NEEDHAM, Mass., May 27, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company") today presented patient-reported outcomes (PROs) data from its MPOWERED™ Phase 3 trial demonstrating that study patients with acromegaly reported significantly improved quality of life and work productivity after transitioning from long-acting injectable somatostatin analogs (iSSAs) to MYCAPSSA®. The data were shared as an oral presentation at the 30th Annual American Association of Clinical Endocrinology (AACE) Meeting being held virtually from May 26-29, 2021.

    "The encouraging PROs data from the MPOWERED study further our understanding of the potential positive clinical impact that MYCAPSSA has for patients with acromegaly," said Nienke Biermasz, M.D., Ph.D., Presenting Author. "These PROs provide important information to help physicians assess disease and treatment burden for patients treated with iSSAs and may provide the confidence in MYCAPSSA as a treatment option that can be taken at home and also avoid some of the injection-related issues impacting quality of life and work productivity."

    In the MPOWERED study, 146 patients entered the 6-month run-in phase in which all patients received MYCAPSSA. Ninety-two patients who were responders to MYCAPSSA at end of run-in were then randomized into the 9-month randomized controlled treatment (RCT) phase to receive MYCAPSSA or iSSAs. Among the 92 randomized patients, results showed that several PROs, including quality of life and work productivity, were significantly improved at the end of the run-in phase (reflecting outcomes on MYCAPSSA) compared to their results at the baseline of run-in (reflecting outcomes on iSSAs). Significant improvements were observed in the index scores of the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), a PRO developed to measure quality of life over five domains (mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression; mean change from baseline of run-in to end of run-in, 0.053; 95% CI, 0.0130–0.0922). Significant improvements were also seen in comparing baseline of run-in to end of run-in on the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), a PRO developed to measure work and social activity in clinical trials, for presenteeism (impairment at work/reduced on-the-job effectiveness; least squares mean [LSM], –6.65; 95% CI,–12.39 to –0.90; P=0.024), work productivity loss (LSM, –6.92; 95% CI, –12.83 to –1.02; P=0.022) and activity impairment (LSM, –4.94; 95% CI, –9.17 to –0.71; P=0.022).

    William Ludlam, M.D., Ph.D., Sr. Vice President, Clinical Development and Medical Affairs of Chiasma, added, "We are pleased to report data showing that MYCAPSSA represents a treatment option for acromegaly with the potential to positively impact patients whose lives may otherwise be significantly disrupted by injectable therapies. Taken together with the rest of the clinical data set we have generated for MYCAPSSA, these results further support our belief in MYCAPSSA's potential to become the new standard of pharmacological care for the maintenance treatment of acromegaly patients."  

    MPOWERED™ MYCAPSSA® Safety: 

    The safety profile of MYCAPSSA capsules in the MPOWERED trial was consistent with the known safety profile of octreotide but without adverse injection site reactions. No new or unexpected safety signals were detected during the study among MYCAPSSA subjects. See Important Safety Information below for contraindications, warnings, precautions and adverse reactions associated with MYCAPSSA based in the current approved labeling in the United States.

    About the CHIASMA MPOWERED™ Trial 

    The MPOWERED™ trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCPASSA® (oral octreotide capsules) in the European Union. This non-inferiority clinical trial was designed to compare MYCAPSSA to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly. The trial enrolled 146 adult acromegaly patients of which 92 patients who were responders to MYCAPSSA after a six-month run-in phase were then randomized to a nine-month controlled (RCT) phase to either receive continued treatment on MYCAPSSA (n=55) or their prior injectable therapy (octreotide long-acting release or lanreotide autogel) (n=37). The primary endpoint of the trial was time-weighted average of IGF-1 <1.3 x upper limit of normal during the nine-month RCT phase. As previously announced, MPOWERED met its primary endpoint of non-inferiority compared to long-acting SSA injectables.

    About MYCAPSSA

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION AND USAGE

    MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

    CONTRAINDICATIONS

    Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

    Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.

    Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

    ADVERSE REACTIONS

    The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

    DRUG INTERACTIONS

    The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.

    Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

    PREGNANCY

    Advise premenopausal females of the potential for an unintended pregnancy.

    To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.

    About Acromegaly

    Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in the United States.

    About Chiasma

    Chiasma is a commercial stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In June 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the data from the MPOWERED trial, including, but not limited to, the patient reported outcomes data, statements regarding the company's expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, and statements concerning the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



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  5. -- New clinical data accepted for oral and e-Poster presentation at AACE --

    -- e-ECE clinical data previously presented at Endocrine Society's 2021 annual meeting --

    NEEDHAM, Mass., May 20, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, today announced that it will virtually present encore data from its MPOWERED™ Phase 3 clinical trial at the 23rd European Congress of Endocrinology (e-ECE) (May 22-26, 2021) and new data from the MPOWERED trial at the 30th

    -- New clinical data accepted for oral and e-Poster presentation at AACE --

    -- e-ECE clinical data previously presented at Endocrine Society's 2021 annual meeting --

    NEEDHAM, Mass., May 20, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, today announced that it will virtually present encore data from its MPOWERED™ Phase 3 clinical trial at the 23rd European Congress of Endocrinology (e-ECE) (May 22-26, 2021) and new data from the MPOWERED trial at the 30th Annual American Association of Clinical Endocrinology (AACE) Meeting (May 26-29, 2021).

    Oral presentations and posters for display are summarized below:

    e-ECE 2021 Oral Presentation

    Title: A Phase 3 Large International Noninferiority Trial (MPOWERED): Assessing Maintenance of Response to Oral Octreotide Capsules in Comparison to Injectable Somatostatin Receptor Ligands

    Presenter: Maria Fleseriu, M.D., FACE, Professor, Medicine and Neurological Surgery, Director OHSU Northwest Pituitary Center

    Session Date/Time: Wednesday, May 26, 2021, 8:30 a.m. – 9:30 a.m. EDT

    e-ECE 2021 e-Poster Presentations

    Title: Safety Results from MPOWERED, a Phase 3 Trial of Oral Octreotide Capsules in Adults with Acromegaly

    Presenter: Pamela Freda, M.D., Columbia University

    Session Date/Time: Monday, May 24, 2021, 8:00 a.m. – 8:30 a.m. EDT

    Title: Oral Octreotide Capsules Lowered Incidence and Improved Severity of Acromegaly Symptoms Compared to Injectable Somatostatin Receptor Ligands—Results from the MPOWERED Trial

    Presenter: Nienke Biermasz, M.D., Ph.D., Leiden University Medical Center

    Session Date/Time: Tuesday, May 25, 2021, 8:00 a.m. – 8:30 a.m. EDT

    Title: Addition of Cabergoline to Oral Octreotide Capsules May Improve Biochemical Control in Patients with Acromegaly Who Are Inadequately Controlled with Monotherapy

    Presenter: Maria Fleseriu, M.D., FACE, Professor, Medicine and Neurological Surgery, Director OHSU Northwest Pituitary Center

    Session Date/Time: Tuesday, May 25, 2021, 8:00 a.m. – 8:30 a.m. EDT

    Title: Improved Acromegaly Patient Satisfaction with Oral Octreotide Capsules Compared with Injectable Somatostatin Receptor Ligands in the MPOWERED Trial

    Presenter: Murray B. Gordon, M.D., Allegheny General Hospital

    Session Date/Time: Wednesday, May 26, 2021, 8:00 a.m. – 8:30 a.m. EDT

    AACE 2021 Oral Presentation

    Title: Improved Quality of Life and Work Productivity in Patients with Acromegaly Receiving Oral Octreotide Capsules in the Phase 3 MPOWERED Trial

    Presenter: Nienke Biermasz, M.D., Ph.D., Leiden University Medical Center

    Session Date/Time: Thursday, May 27, 2021, 1:30 p.m. – 1:45 p.m. EDT

    AACE 2021 Late-Breaker e-Posters - Available online via the virtual e-Poster Gallery beginning May 26

    Title: Effects of Prior Injectable Somatostatin Receptor Ligand Type and Dose in Patients with Acromegaly Receiving Oral Octreotide Capsules in the Phase 3 MPOWERED Trial

    Lead Author: Murray B. Gordon, M.D., Allegheny General Hospital

    Title: Injection Site Reactions and Their Impact in Patients with Acromegaly Receiving Injectable Somatostatin Receptor Ligands in the Phase 3 MPOWERED Trial

    Lead Author: Murray B. Gordon, M.D., Allegheny General Hospital

    To register and view the full schedules as well as abstracts, visit e-ECE's website here and AACE's website here.

    Chiasma will sponsor a product theatre presentation at the AACE annual meeting titled "Understanding the Management of Acromegaly with MYCAPSSA® (octreotide) Delayed-Release Oral Capsules" on Wednesday, May 26 at 2:45 p.m. EDT. Anthony P. Heaney, M.D., Ph.D., Professor, UCLA, will lead the presentation and a live Q&A session.

    About the MPOWERED™ Trial

    The MPOWERED trial was a global, non-inferiority, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCAPSSA in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019, of which 92 patients were deemed responders to octreotide capsules per the protocol following a six-month run-in were randomized to either octreotide capsules (n=55) or injectable somatostatin receptor ligands (octreotide LAR or lanreotide autogel) (n=37), and then followed for an additional nine months. The trial was designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with leading injectable somatostatin analogs.

    About MYCAPSSA

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION AND USAGE

    MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

    CONTRAINDICATIONS

    Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

    Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.

    Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

    ADVERSE REACTIONS

    The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

    DRUG INTERACTIONS

    The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.

    Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

    PREGNANCY

    Advise premenopausal females of the potential for an unintended pregnancy.

    To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.

    About Acromegaly

    Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in the United States.

    About Chiasma

    Chiasma is a commercial-stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In June 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the data from the MPOWERED trial and the therapeutic potential of MYCAPSSA. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



    Primary Logo

    View Full Article Hide Full Article
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