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New Haven Pharmaceuticals Appoints Larry Dillaha, M.D. As Executive Vice President Operations



4/2/2014 6:36:01 AM

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BRANFORD, Conn., April 2, 2014 /PRNewswire/ -- New Haven Pharmaceuticals, Inc. (the "Company"), a privately held specialty pharmaceuticals company, today announced the appointment of Larry Dillaha, M.D., to the newly-created position of Executive Vice President Operations. Dr. Dillaha joins the Company from Insys Therapeutics, Inc. (Nasdaq: INSY) where he served as Chief Medical Officer since April 2010.

"We are delighted to welcome Larry, who will provide significant insight and direction as we finalize the NDA submission for DURLAZA, our unique controlled-release aspirin product, and prepare for its launch," said Patrick Fourteau, Chief Executive Officer. "He joins our company at an exciting time, as we develop additional products in our pipeline, which are focused on antiplatelet aspirin therapy as well as relief from gastro-esophageal reflux disease."

"I am looking forward to moving New Haven Pharmaceuticals' novel products through development to commercialization, starting with DURLAZA," said Dr. Dillaha. "I firmly believe that this product, if approved, will provide a significant benefit to many among the growing number of patients who currently take aspirin daily to prevent heart attack and stroke. Naturally, the opportunity to work with Patrick again and others on the talented New Haven team was a great attraction."

While Dr. Dillaha's primary operational focus will be on clinical, medical, and product development matters, he is expected to contribute broadly to the Company's growth and development.

Prior to joining New Haven Pharmaceuticals, Dr. Dillaha served as Chief Medical Officer of Insys Therapeutics. Previously, he served as Executive Vice-President and Chief Medical Officer for Shionogi and Co., Ltd. (formerly Sciele Pharma, Inc. and First Horizon Pharmaceutical Corp.), where he oversaw the development of and successful FDA filings for numerous compounds integral to that company's success. Prior to Shionogi/Sciele, Dr. Dillaha served as Medical Director for Sanofi-Aventis, a multinational pharmaceutical company, where he was involved in several major clinical studies for the company's lead compounds, including Plavix® (clopidogrel). A member of New Haven Pharmaceuticals' board of directors since 2012, Dr. Dillaha also serves as a member of the board of directors of InVasc Therapeutics, Inc., a pharmaceutical company. Dr. Dillaha earned his M.D. degree and his B.A. in Biology from the University of Tennessee.

About DURLAZA
DURLAZA is an investigational novel aspirin product designed to be slowly released into the bloodstream over 24 hours. Currently available aspirin products are released over a shorter period of time into the bloodstream. Aspirin, or acetylsalicylic acid, prevents clot formation through the inhibition of thromboxane, a naturally-occurring prostaglandin derivative in the body that induces platelet aggregation.

DURLAZA is being developed for the secondary prevention of stroke and acute cardiovascular events/to reduce the risk of stroke or acute cardiac events in patients who have suffered a prior stroke or acute cardiac event. The Company plans to submit a New Drug Application ("NDA") for DURLAZA to the U.S. Food and Drug Administration ("FDA") in the third quarter of 2014; assuming timely review under the Prescription Drug User Fee Act ("PDUFA") and FDA approval of the NDA, the Company expects to launch DURLAZA in the United States in the third quarter of 2015.

About New Haven Pharmaceuticals, Inc.
New Haven Pharmaceuticals Inc. (NHP) is a specialty pharmaceuticals company developing new prescription drug products that utilize currently marketed drugs or generally recognized as safe (GRAS) active pharmaceutical ingredients (APIs) for use in therapeutic applications representing market opportunities. NHP is currently developing controlled-release aspirin products including DURLAZA, a proprietary, once-daily oral 24-hour controlled-release aspirin product, a second-generation combination product incorporating proprietary Yale University technology utilizing zinc salts, and a proprietary zinc salts product designed to lower stomach acid in patients suffering from gastro-esophageal reflux disease (or GERD).

For more information on NHP, please visit www.newhavenpharma.com.

DURLAZA is a trademark of New Haven Pharmaceuticals Inc.

Contacts:
Harry H. Penner, Jr.
Executive Chairman
(203) 676-3676
hpenner@newhavenpharma.com

Lisa Wilson
President
In-Site Communications, Inc.
(917) 543-9932
lwilson@insitecony.com

SOURCE New Haven Pharmaceuticals, Inc.



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