WALTHAM, Mass., Sept. 16, 2014 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that Judith Johnson, M.D., has rejoined the company as vice president of pharmacovigilance and pharmacoepidemiology. Dr. Johnson will have responsibility for all pharmacovigilance functions at AMAG, including product safety surveillance, aggregate safety reporting, pharmacoepidemiology and risk management. She will also oversee the company’s compliance with U.S. Food and Drug Administration (FDA) and regulatory requirements for Feraheme® (ferumoxytol) Injection and MuGard® Mucoadhesive Oral Wound Rinse.
“Judy brings with her a wealth of experience and ability in the areas of drug safety and risk management, which will be critical for the future success of AMAG as we work to build a diversified, multi-product pharmaceutical company,” said Steven Caffé, M.D., Senior Vice President, Chief Development & Regulatory Officer at AMAG.
Over the past ten years, Dr. Johnson has held leadership roles in pharmacovigilance and drug safety at such biopharmaceutical companies as EMD Serono, Inc., AMAG, Genzyme and Parexel. Dr. Johnson received her bachelor’s degree from Mount Holyoke College and her medical degree from the University of Pennsylvania School of Medicine. She completed her Ophthalmology, Anesthesia, and General Surgery Residency at George Washington University Medical Center and was a practicing ophthalmologist from 1985 until 2002.
Inducement Equity Awards
In connection with Dr. Johnson’s entering into employment with AMAG, Dr. Johnson will be granted (i) an option to purchase 20,000 shares of common stock and (ii) 5,300 restricted stock units. The option will have an exercise price equal to the closing price of AMAG’s common stock on the grant date and will be exercisable in four equal annual installments beginning on the first anniversary of the grant date. The option will have a ten-year term and be subject to the terms and conditions of the stock option agreement pursuant to which the option will be granted. The restricted stock units will vest in four equal annual installments beginning on the first anniversary of the grant date and will be subject to the restricted stock unit agreement pursuant to which the restricted stock units will be granted. These equity awards will be granted without stockholder approval as inducements material to Dr. Johnson entering into employment with AMAG in accordance with NASDAQ Listing Rule 5635(c)(4).
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that markets Feraheme® (ferumoxytol) Injection and MuGard® Mucoadhesive Oral Wound Rinse in the United States. Along with driving continued growth of its products, AMAG intends to continue to expand its portfolio through the in-license or purchase of additional pharmaceutical products or companies, including revenue-generating commercial products and late-stage development assets that leverage its corporate infrastructure and commercial expertise. Our primary goal is to bring to market therapies that provide clear benefits and improve patients’ lives. For additional company information, please visit www.amagpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding: Dr. Johnson’s contributions are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, among others: (1) uncertainties regarding the likelihood and timing of potential approval of Feraheme in the U.S. in the broader IDA indication in light of the complete response letter (CRL) we received from the U.S. Food and Drug Administration (FDA) informing us that our supplemental new drug application (sNDA) for the broader indication could not be approved in its present form and stating that we had not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed broader indication, (2) the possibility that following FDA review of post-marketing safety data, including reports of serious anaphylaxis, cardiovascular events, and death, the FDA will request additional technical or scientific information, new studies or reanalysis of existing data, on-label warnings, post-marketing requirements/commitments or risk evaluation and mitigation strategies (REMS) in the current CKD indication for Feraheme, (3) uncertainties regarding our and Takeda’s ability to successfully compete in the IV iron replacement market both in the US and outside the US, including the EU, as a result of limitations, restrictions or warnings in Feraheme’s/Rienso’s current or future label that put Feraheme/Rienso at a competitive disadvantage, (4) uncertainties regarding Takeda’s ability to obtain regulatory approval for Rienso in the EU and Feraheme in Canada, in the broader IDA patient population, (5) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso and in turn affect sales, or the company’s ability to market the product both in the US and outside of the US, including the EU, (6) uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (7) uncertainties relating to our patents and proprietary rights, both in the US and outside of the US, (8) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDA’s recently published draft bioequivalence recommendation for ferumoxytol, (9) uncertainties regarding our ability to compete in the oral mucositis market in the U.S. and (10) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2014 and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc. MuGard is a registered trademark of Access Pharmaceuticals, Inc. Rienso is a trademark of Takeda Pharmaceutical Company Limited.
CONTACT: AMAG Pharmaceuticals, Inc. Contact:
Katie Payne, 617-498-3303
AMAG Pharmaceuticals, Inc.