BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 01/21/16 --
Amarin Corporation plc (NASDAQ: AMRN) has appointed Craig B. Granowitz, M.D., Ph.D. to the position of chief medical officer. In this role, Dr. Granowitz will provide strategic and operational leadership across multiple functions including medical affairs, drug safety and medical communications. In addition, the title and role of Steven Ketchum, Ph.D., Amarin's president of research and development and senior vice president, has been expanded to include the responsibility of chief scientific officer.
"These additions serve to strengthen Amarin's leadership team and add valuable expertise at a time of great promise and progress for Amarin as it continues to grow its existing commercial business and work toward the completion of its cardiovascular outcomes study," commented John F. Thero, president and chief executive officer of Amarin. "I am confident that Craig and Steve will deliver on Amarin's vision of improving patient care and becoming a leader in cardiovascular health."
Dr. Granowitz has a strong leadership background in medical affairs, with extensive experience managing a multi-national medical affairs organization for a portfolio of leading cardiovascular products. Prior to joining Amarin, Dr. Granowitz was senior vice president and head of global medical affairs, global human health at Merck, where he developed and implemented an entirely new global medical affairs organization following Merck's merger with Schering-Plough. In this capacity, among his numerous achievements, he provided critical medical affairs support in the run-up to and read-out of Merck's cardiovascular outcomes study, IMPROVE-IT. From 2003 to 2008, he was group vice president, head of global medical affairs for Schering-Plough. His work at Schering-Plough and, later, Merck, was critical to the growth and success of a global medical affairs organization that spans multiple therapeutic areas and now operates in more than 80 countries worldwide. Prior to joining Schering-Plough, Dr. Granowitz co-founded Proliance Pharmaceuticals, a venture-capital backed pharmaceutical development and finance management start-up company.
"Craig's experience leading impactful scientific exchange and outreach together with his extensive network and influence with physicians will be valuable as we work to further educate healthcare professionals regarding the efficacy and safety of Vascepa today and the future," continued Mr. Thero. "He brings a wealth of experience leading cross-functional teams to effectively engage external audiences and align scientific objectives with commercial goals. His commitment to medical excellence, integrity and compliance coupled with a keen appreciation for market needs and strong sense of urgency makes him an excellent fit for Amarin."
In his newly expanded role of chief scientific officer, Dr. Ketchum will lead Amarin's clinical development and regulatory strategy for Vascepa, with particular emphasis on continuing to advance the REDUCE-IT cardiovascular outcomes study and ensure its positioning for success.
Mr. Thero said, "Steve has helped transform our business since joining Amarin in February 2012. Among his many contributions, he has been instrumental in the implementation, refinement and timely execution of REDUCE-IT, our cardiovascular outcomes study, which we believe is the cornerstone of Amarin's future and positioned for success. As a result of Steve's efforts, we now have a clear clinical and regulatory strategy for the expanded use of Vascepa. I am confident that with his visionary leadership, Amarin will continue to be a leader in the research and development of the omega-3 acid, EPA, and through clinical study of its highly pure pharmaceutical grade lead product, Vascepa,
clarify pathways to cardiovascular health and improve patient care."
Dr. Ketchum has a significant record of achievement in the life sciences industry, with 20 years of experience in late-stage product development and clinical regulatory strategy, having led the filings of multiple successful new drug applications (NDAs) and supplemental NDAs. Prior to joining Amarin, Dr. Ketchum served as senior vice president, research and development for Sunesis Pharmaceuticals where, as a member of the Executive Committee, he provided strategic direction for all facets of research and development, including clinical strategy and operations, regulatory affairs, and pharmaceutical development. Prior to Sunesis, Dr. Ketchum was senior vice president, research and development and medical affairs at Reliant Pharmaceuticals with responsibilities for
leading the strategic direction and day-to-day operations of Reliant's clinical research, product development, and medical affairs departments, including responsibilities for Lovaza, an earlier generation prescription omega-3 drug. Dr. Ketchum has also served as senior vice president, operations and regulatory affairs for IntraBiotics Pharmaceuticals, Inc., where he was responsible for regulatory affairs, project management, quality assurance, and supply chain management in support of late-stage clinical research.
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin's clinical program includes commitment to an ongoing outcomes study. Amarin's first product, Vascepa® (icosapent ethyl) capsules, is a highly pure EPA omega-3 prescription product. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com
(icosapent ethyl) capsules
VASCEPA® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly pure-EPA omega-3 prescription product in a 1 gram capsule.
Indications and Usage
- VASCEPA (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of VASCEPA on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for VASCEPA
- VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
This press release contains forward-looking statements, including statements about the future of drug development programs at Amarin and the contribution of executives to Amarin's drug development and commercialization plans and corporate progress. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In particular, as disclosed in its previous filings with the U.S. Securities and Exchange Commission, Amarin's ability to effectively commercialize Vascepa will depend in part on its ability to continue to effectively finance its development programs, create market demand for Vascepa through education, marketing and sales activities, to develop and
maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of Vascepa and to maintain patent protection for Vascepa. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: individual contributions to Amarin from the named executives, uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that related cost may increase beyond expectations; the risk that future litigation, court decisions and interpretation and interactions with regulatory authorities may impact Vascepa marketing and sales rights and efforts; the risk that Vascepa may not show clinically meaningful effects in REDUCE-IT
or support regulatory approvals for cardiovascular risk reduction; and the risk that patents may not be upheld in patent litigation and applications may not result in issued patents. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new
information, future events or circumstances or otherwise.
Availability of other information about Amarin
Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com /investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to
review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin contact information:
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315
In U.S.: +1 (646) 378-2954
In U.S.: +1 (212) 583-2791
Source: Amarin Corp. plc
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