Healthcare Industry News: intravenous iron replacement
News Release - June 24, 2013
AMAG Pharmaceuticals Appoints Steven Caffe, M.D. as Chief Development and Regulatory OfficerLEXINGTON, Mass., June 24, 2013 -- (Healthcare Sales & Marketing Network) -- AMAG Pharmaceuticals, Inc. (AMAG) today announced the appointment of Steven Caffe, M.D. as senior vice president and chief development and regulatory officer. Dr. Caffe brings 20 years of experience in global biopharmaceuticals development and regulatory approvals to AMAG. He joins AMAG from MedImmune, AstraZeneca's global biologics research and development arm, where he most recently served as senior vice president of global regulatory affairs and patient safety.
"Steve brings a wealth of relevant development and regulatory experience to AMAG, gained through a distinguished 20-year career in pharmaceutical companies ranging from Merck & Co. to MedImmune," said William Heiden, president and chief executive officer of AMAG. "His experience in global product development and life-cycle management strategies and execution will be invaluable to us near-term as we work towards the potential regulatory approval of Feraheme(R) for the treatment of iron deficiency anemia in a broader patient population, and longer-term as our product portfolio expands through our on-going business development activities. We are pleased to welcome Steve to AMAG."
Dr. Caffe commented, "AMAG is undergoing a significant turnaround, with the continued growth of Feraheme and the addition of MuGard(TM) forming a solid foundation on which we can build a premier specialty pharmaceutical company. I am energized to join the company at this time and look forward to sharing the journey with the talented team at AMAG."
Dr. Caffe has broad-based industry experience across several therapeutic areas, and in the development of biopharmaceuticals and medical devices. Early in his career, Dr. Caffe served as a medical director for Parke-Davis, before its acquisition by Pfizer, and has since had roles of increasing responsibility at major pharmaceutical companies. Through his experience at Merck & Co., Sanofi, Baxter and most recently MedImmune, Dr. Caffe has assembled and led high-performing teams through many development and regulatory programs, successfully achieving key new product approvals and extending the life cycle of several commercial products. Dr. Caffe received his medical degree from the Faculte de Medecine Saint-Antoine, Universite Pierre et Marie Curie (Paris 6), completed his internship and residency, and practiced medicine at the academic hospitals of the Assistance Publique de Paris with a focus on emergency and intensive care.
Inducement Equity Awards
In connection with Dr. Caffe's entry into his employment agreement, effective on the first day of employment, Dr. Caffe will be granted (i) an option to purchase 60,000 shares of common stock and (ii) 35,000 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. Caffe's 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(R) (ferumoxytol) Injection and MuGard(TM) Mucoadhesive Oral Wound Rinse in the United States. Along with driving organic growth of its products, AMAG intends to expand its portfolio with additional commercial-stage specialty products. The company is seeking complementary products that leverage the company's commercial footprint and focus on hematology and oncology centers and hospital infusion centers. 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: the approval of the supplemental new drug application Feraheme for a broader patient population; Dr. Caffe's contributions to AMAG and the intended expansion and focus of AMAG's product portfolio; the company's intent to drive organic growth of Feraheme; and the company's plans to seek complementary commercial products to add to its portfolio 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: (1) uncertainties regarding our and Takeda's ability to successfully compete in the intravenous iron replacement market both in the US and outside the US, including the EU, (2) uncertainties regarding our ability to compete in the oral mucositis market in the US, (3) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader IDA indication both in the US and outside of the US, including the EU, (4) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (5) uncertainties regarding the manufacture of Feraheme/Rienso or Mugard, (6) uncertainties relating to our patents and proprietary rights both in the US and outside the US, (7) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDA's recently published draft bioequivalence recommendation for ferumoxytol, and (8) other risks identified in our Securities and Exchange Commission (SEC) filings, including our Quarterly Report on Form 10-Q for the year ended March 31, 2013 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.
Rienso is a registered trademark of Takeda Pharmaceutical Company Limited. MuGard is a trademark of Access Pharmaceuticals, Inc.
Source: AMAG Pharmaceuticals
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