AMAG AMAG Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
AMAG-423 / Digoxin immune fab (DIF)
Severe preeclampsia in pregnant women
|
Phase 2/3
Phase 2/3
|
Phase 2/3 trial stopped due to low likelihood of efficacy - August 6, 2020.
|
|
Ciraparantag
Anticoagulated reversal agent / Healthy volunteers
|
Phase 2
Phase 2
|
Phase 2b trial planned.
|
|
Makena
Preterm birth
|
Phase 3
Phase 3
|
Advisory Committee voted 9-7 recommending withdrawal from market - October 29, 2019.
|
|
Feraheme
Adults with iron deficiency anemia (IDA)
|
Approved
Approved
|
Approval for sNDA filing announced February 5, 2018.
|
|
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
|
Approved
Approved
|
FDA approval announced June 21, 2019.
|
|
Makena - auto injector
Reduce the risk of preterm birth in women with a singleton pregnancy
|
Approved
Approved
|
Approval announced February 14, 2018.
|
Latest News
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WALTHAM, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. has submitted its response to the FDA's Notice of Opportunity for a Hearing ("NOOH") regarding the Agency's proposal to withdraw approval for Makena—also referred to as 17-OHPC—the only FDA-approved treatment, along with five generic versions, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
The submission of supporting documentation follows upon AMAG's October 14, 2020 request for a hearing and provides detail on the company's position in requesting a hearing, recognizing clinicians' decade-long use of this treatment and the public health implications of withdrawing approval. The response sets out data, analyses, and information demonstrating why Makena should remain available as the only FDA-approved option for women in the U.S. who are at risk for preterm birth, including clinical study results that highlights the evidence of effectiveness of Makena among Black and other minority women.
AMAG—and its new owner, Covis Pharma Group, a leading pharmaceutical company that has a track record of working collaboratively with FDA and is focused on providing therapeutic solutions for patients with life-threatening conditions and chronic illnesses—stand ready to discuss data-driven next steps to maintain Makena as an option for physicians and patients, including developing a new randomized, controlled trial and further evaluating real-world data.
"We seek a hearing to ensure that higher risk women and their doctors retain access to the only safe and effective, FDA-approved treatment for preterm birth and remain committed to the science and clinical experience supporting the value of Makena for appropriate U.S. patients," said Covis CEO Michael Porter. "We stand ready to work collaboratively with the Agency to address methods of more fully understanding and maintaining this important treatment option for this high-risk underrepresented, principally minority patient population. Preterm birth is an increasing health issue in the U.S., with preterm birth rates significantly higher than in other developed countries. We believe that a thorough review of the benefits of Makena, particularly among at-risk, disadvantaged communities, is required."
Nearly a year after the divided Advisory Committee meeting and without an opportunity to discuss options for further data generation, FDA sent a NOOH to AMAG and generic manufacturers of 17-OHPC. At the Advisory Committee meeting, experts agreed that additional data would be useful in clarifying benefit or defining the population in whom the drug may provide the most benefit. AMAG agrees that additional data would be helpful and had hoped to discuss several possible avenues with FDA.
AMAG, and its new owner Covis, remain committed to conducting a further study of 17-OHPC. As described in the submission response, possible additional studies include: (1) a retrospective study using secondary real-world data sources, including electronic health record databases and claims databases; and (2) a prospective, primary data collection study with selected hospitals and healthcare networks, such as the Maternal-Fetal Medicine Units Network as well as non-academic sites. AMAG is also open to discussing another randomized clinical trial, better focused on the most at-risk, principally minority patient populations.
A summary of key arguments that warrant discussion at a public forum can be found in the full copy of the submission available here. While the FDA reviews the submission of supporting documentation, Makena remains approved and available and the product label remains unchanged.
About AMAG
AMAG is a commercial-stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.About Covis
Covis is headquartered in Luxembourg with operations in Zug, Switzerland and is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.Media Contact
Jill Courtney Kornmayer
[email protected]
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LUXEMBOURG and ZUG, Switzerland, Nov. 16, 2020 /PRNewswire/ -- Covis Group S.à r.l. ("Covis") today announced the completion of its acquisition of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) through the successful tender offer for all of the outstanding shares of common stock of AMAG at $13.75 per share in cash and subsequent merger. The combined organization will operate as part of the Covis Pharma Group and will be led by Covis CEO Michael Porter.
The addition of AMAG's category leading treatments and development-stage assets in women's health and hematology/oncology supports the execution of Covis' strategic vision to enhance the company's ability to impact the lives of patients by expanding its portfolio of 'best in class' products in attractive new therapeutic areas. In addition, Covis will be positioned to further support patients, building on its track record of efficient and effective management of therapeutic solutions.
"The acquisition of AMAG represents a key milestone in Covis' efforts to fulfill our strategic vision to become a leading global specialty pharma company for life threatening and chronic illnesses for both commercial and development stage assets," said Michael Porter, CEO of Covis. "AMAG's expertise and key products—Feraheme®, Makena® and Ciraparantag—add tremendous value to Covis as we execute our mandate of expanding patient access to much needed therapies. We will continue to put patients' interests first and look forward to collaborating with the FDA to ensure that Makena continues to be available as an option for appropriate patients. More than ever, we are positioned to continue growth of our therapeutic portfolio globally and look forward to further enhancing our capabilities and offerings. We're excited to work with our designated transition teams to execute on our integration plans and move forward as a stronger, unified organization."
The tender offer expired at 12:00 a.m., Eastern Time, on November 12, 2020 (one minute after 11:59 p.m., Eastern Time, on November 12, 2020). The condition to the tender offer that a majority of the outstanding shares of AMAG's common stock be validly tendered and not withdrawn was satisfied and, accordingly, all such validly tendered shares were accepted for payment. Following the consummation of the tender offer, Covis Mergerco Inc. merged with and into AMAG pursuant to Section 251(h) of the General Corporation Law of the State of Delaware. As a result of the merger, each share of AMAG that was not validly tendered in the tender offer (other than shares held by any stockholder of AMAG who properly demanded appraisal of such shares under the applicable provisions of Delaware law) was cancelled and converted into the right to receive $13.75 per share in cash, and AMAG became an indirect wholly owned subsidiary of Covis. Shares of AMAG will cease to be traded on NASDAQ.
Goldman Sachs & Co. LLC acted as exclusive financial advisor, and Goodwin Procter LLP acted as legal advisor to AMAG. Paul, Weiss, Rifkind, Wharton and Garrison LLP acted as legal advisor to Covis. Financing for this transaction has been provided by Capital One, N.A. and investment funds and accounts managed by HPS Investment Partners, LLC.
About Covis
Covis is headquartered in Luxembourg with operations in Zug, Switzerland and is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.
Cautionary Statement Regarding Forward-Looking Statements
This communication contains forward-looking statements. Forward-looking statements relate to future events or Covis' future financial performance. Covis generally identifies forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar words. These statements are only predictions. Covis has based these forward-looking statements largely on its then-current expectations and projections about future events and financial trends as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Covis' control. Covis' actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: risks associated with the combined organization following completion of the merger transaction including difficulties in executing Covis' strategic vision, continuing to grow Covis' therapeutic portfolio and enhancing Covis' capabilities and offerings; the outcome of any legal proceedings that may be instituted against the parties and others related to the merger transaction; the inability of Covis' to impact the lives of patients by expanding its portfolio of 'best in class' products in attractive new therapeutic areas; Covis not being positioned to further support patients, and failing to efficiently and effectively manage therapeutic solutions; Covis not being able to fulfill its strategic vision of becoming a leading specialty pharma company globally for life threatening and chronic illnesses for both commercial and development stage assets, which could have a material adverse impact on Covis' business, financial results and operations; Covis failing to collaborate with the FDA to ensure that Makena continues to be available as an option for appropriate patients; risks associated with Makena's withdrawal, including the impacts on Covis' financial results; Covis failing to grow its therapeutic portfolio globally and enhancing its capabilities and offerings; Covis not being able to execute on its integration plans, resulting in a failure to achieve synergies or a more unified, stronger organization; and unanticipated difficulties or expenditures relating to the merger transaction, the response of business partners and competitors to the completion of the merger transaction, and/or potential difficulties in employee retention as a result of the completion of the merger transaction. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Covis cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Covis undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.
Contact
Arik Ben-Zvi
Breakwater Strategy
(202) 270-1848
[email protected]
View original content:http://www.prnewswire.com/news-releases/covis-group-completes-acquisition-of-amag-pharmaceuticals-301173667.htmlSOURCE Covis Pharma
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NEW YORK, Nov. 5, 2020 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P MidCap 400 and SmallCap 600 effective prior to the opening of trading on Friday, November 13:
- First Bancorp (NASD:FBNC) will replace AMAG Pharmaceuticals Inc. (NASD:AMAG) in the S&P SmallCap 600. Covis Group is acquiring AMAG Pharmaceuticals in a deal expected to be completed soon pending final conditions.
- MGIC Investment Corp. (NYSE:MTG) will replace The Geo Group Inc. (NYSE:GEO) in the S&P MidCap 400, and The Geo Group will replace Gulfport Energy Corp. (NASD:GPOR) in the S&P SmallCap 600. Halozyme Therapeutics Inc.(NASD:HALO) will replace Mednax Inc. (NYSE:MD) in the S&P MidCap 400, and Mednax will replace Washington Prime Group Inc. (NYSE:WPG) in the S&P SmallCap 600. The GEO Group and Mednax are more representative of the small-cap market space. Gulfport Energy and Washington Prime Group are no longer representative of the small-cap market space.
Following is a summary of the changes that will take place prior to the open of trading on the effective date:
Effective Date
Index Name
Action
Company Name
Ticker
GICS Sector
November 13, 2020
S&P MidCap 400
Addition
MGIC Investment
MTG
Financials
S&P MidCap 400
Addition
Halozyme Therapeutics
HALO
Health Care
S&P MidCap 400
Deletion
Geo Group
GEO
Real Estate
S&P MidCap 400
Deletion
Mednax
MD
Health Care
S&P SmallCap 600
Addition
First Bancorp
FBNC
Financials
S&P SmallCap 600
Addition
Geo Group
GEO
Real Estate
S&P SmallCap 600
Addition
Mednax
MD
Health Care
S&P SmallCap 600
Deletion
AMAG Pharmaceuticals
AMAG
Health Care
S&P SmallCap 600
Deletion
Gulfport Energy
GPOR
Energy
S&P SmallCap 600
Deletion
Washington Prime Group
WPG
Real Estate
For more information about S&P Dow Jones Indices, please visit www.spdji.com
ABOUT S&P DOW JONES INDICES
S&P Dow Jones Indices is the largest global resource for essential index-based concepts, data and research, and home to iconic financial market indicators, such as the S&P 500® and the Dow Jones Industrial Average®. More assets are invested in products based on our indices than products based on indices from any other provider in the world. Since Charles Dow invented the first index in 1884, S&P DJI has been innovating and developing indices across the spectrum of asset classes helping to define the way investors measure and trade the markets.
S&P Dow Jones Indices is a division of S&P Global (NYSE:SPGI), which provides essential intelligence for individuals, companies, and governments to make decisions with confidence. For more information, visit www.spdji.com.
FOR MORE INFORMATION:
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View original content:http://www.prnewswire.com/news-releases/mgic-investment--halozyme-therapeutics-set-to-join-sp-midcap-400-first-bancorp-the-geo-group--mednax-to-join-sp-smallcap-600-301167618.htmlSOURCE S&P Dow Jones Indices
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NEW YORK, Oct. 31, 2020 /PRNewswire/ -- Halper Sadeh LLP, a global investor rights law firm, announces it is investigating:
Virtusa Corporation (NASDAQ:VRTU) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to funds affiliated with Baring Private Equity Asia for $51.35 per share. If you are a Virtusa shareholder, click on this link to learn more about your rights and options: https://halpersadeh.com/actions/virtusa-corporation-vrtu-stock-merger-baring-asia/.
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to Covis Group S.à r.l. for $13.75 per share in cash. If you are an AMAG shareholder, click on this link to learn more about your rights and options: https://halpersadeh.com/actions/amag-pharmaceuticals-inc-stock-merger-covis/.
Eaton Vance Corp. (NYSE:EV) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to Morgan Stanley. If you are an Eaton Vance shareholder, click on this link to learn more about your rights and options: https://halpersadeh.com/actions/eaton-vance-corp-ev-stock-merger-morgan-stanley/.
Cellular Biomedicine Group, Inc. (NASDAQ:CBMG) concerning potential violations of the federal securities laws and/or breaches of fiduciary duties relating to its sale to a consortium that includes members of Cellular Biomedicine management and several entities. If you are a Cellular Biomedicine shareholder, click on this link to learn more about your rights and options: https://halpersadeh.com/actions/cellular-biomedicine-group-inc-cbmg-stock-merger/.
Halper Sadeh LLP may seek increased consideration, additional disclosures and information concerning the proposed transaction, or other relief and benefits on behalf of shareholders.
Shareholders are encouraged to contact the firm free of charge to discuss their legal rights and options. Please call Daniel Sadeh or Zachary Halper at (212) 763-0060 or email [email protected] or [email protected].
Halper Sadeh LLP represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Halper Sadeh LLP
Daniel Sadeh, Esq.
Zachary Halper, Esq.
(212) 763-0060
[email protected]
[email protected]
https://www.halpersadeh.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/alert-halper-sadeh-llp-reminds-shareholders-about-its-ongoing-merger-investigations-investors-are-encouraged-to-contact-the-firm--vrtu-amag-ev-cbmg-301164336.htmlSOURCE Halper Sadeh LLP
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NEW YORK, Oct. 21, 2020 /PRNewswire/ -- Moore Kuehn, PLLC, a law firm focusing in securities litigation located on Wall Street in downtown New York City, is investigating potential claims concerning whether the following proposed mergers are fair to shareholders. Moore Kuehn may seek increased consideration, additional disclosures, or other relief on behalf of the shareholders of these companies:
- NTN Buzztime, Inc. (NYSE:NTN)
A registration statement was recently filed with the SEC regarding Brooklyn ImmunoTherapeutics' acquisition of NTN. Upon completion of the merger, shareholders of NTN will own between approximately 5.92% and 3.26% of the combined company. The investigation concerns whether NTN's board oversaw an unfair process and agreed to an inadequate deal price.
- Concho Resources Inc. (NYSE: CXO)
Concho Resource has agreed to be acquired by ConocoPhillips. Under the proposed transaction, shareholders of Concho will receive 1.46 shares of ConocoPhillips per share.
- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG)
A solicitation statement was recently filed with the SEC regarding Covis Group's acquisition of AMAG, which may omit material information used to evaluate the merger. Under the proposed transaction, shareholders of AMAG will receive $13.75 per share.
- Front Yard Residential Corporation (NYSE: RESI)
Front Yard Residential has agreed to be acquired by Pretium and a group of its investors and funds. Under the proposed transaction, shareholders of Front Yard will receive $13.50 per share.
Moore Kuehn is investigating whether the Boards of the above companies 1) acted to maximize shareholder value, 2) failed to disclose material information, and 3) conducted a fair process.
Moore Kuehn encourages shareholders who would like to discuss their rights to contact Justin Kuehn, Esq. by email at [email protected] or telephone at (212) 709-8245. The consultation and case are free with no obligation to you. Moore Kuehn pays all case costs and does not charge its investor clients. Shareholders should contact the firm immediately as there may be limited time to enforce your rights.
Moore Kuehn is a 5-star Google rated New York City law firm with attorneys representing investors and consumers in litigation involving securities laws, fraud, breaches of fiduciary duties, and other claims. For additional information about Moore Kuehn, please visit http://www.moorekuehn.com/practice/new-york-securities-litigation/.
Attorney advertising. Prior results do not guarantee similar outcomes.
Contacts:
Moore Kuehn, PLLC
Justin Kuehn, Esq.
30 Wall Street, 8th Floor
New York, New York 10005
[email protected]
(212) 709-8245
View original content to download multimedia:http://www.prnewswire.com/news-releases/moore-kuehn-encourages-ntn-cxo-amag-and-resi-investors-to-contact-law-firm-301157155.htmlSOURCE Moore Kuehn, PLLC