Reducing the side effects and improving compliance of the millions of people who take aspirin regularly is the goal of a pharmaceutical company raising up to $7.7 million in anticipation of a 2013 NDA filing.
Company name: New Haven Pharmaceuticals.
Industry: pharmaceuticals.
Location: New Haven, Connecticut.
Solution/product: Using technology licensed from Yale University and Flamel Technologies, New Haven Pharmaceuticals develops controlled-release specialty pharmaceuticals. Its lead candidate, a once-daily, 24-hour antiplatelet drug, is being developing as four programs, the first of which is for the secondary prevention of stroke and cardiovascular events. Follow-on applications include arthritis, foreign body reaction and liver injury in patients with hepatitis C. The company says the drug’s micro-pump technology licensed from Flamel (the same technology used in GSK’s Coreg CR) allows for a longer transit time in the small intestine, so the aspirin’s effects could last up to 24 hours. New Haven is also developing a controlled-release formulation of zinc salts to treat breakthrough GERD.
Money raised: $6.5 million of a targeted $7.7 million round, according to a recent Securities and Exchange Commission filing. So far, 17 investors have participated.
How it will be used: The company couldn’t be reached, but according to its website, it’s anticipating filing an NDA for the first product next year, followed by a U.S. and European launch in 2014.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Investors: unknown. Known existing investors include Enhanced Capital.
Management team: CEO Patrick Fourteau is the former president and CEO of Shionogi, the U.S.-based company of Japanese pharmaceutical company Shionogi & Co. Ltd., and Sciele Pharma, with additional experience in leadership positions at inVentive Health, St. Jude Medical and Eli Lilly. Harry Penner, a co-founder and the executive chairman, has founded six other biotech companies and is also a director of Celldex Therapeutics.
Market opportunity: Around 33 million Americans take aspirin regularly to prevent stroke and heart attack. New Haven’s formulation is intended to extend the therapeutic effect of the drug, reduce toxicity and GI side effects, and improve compliance. PLx Pharma is testing a candidate that addresses one of those areas — GI toxicity. Pozen is also developing a delayed-release aspirin combined with omeprazole to cut down on stomach irritation, but delayed its NDA filing likely until next year.
