The Company

 

Investors

New Haven Pharmaceuticals is privately held.

New Haven Pharmaceuticals, Inc. (NHP) develops proprietary, controlled release specialty pharmaceuticals based on approved or GRAS (“Generally Recognized as Safe”) active pharmaceutical ingredients for use in new therapeutic indications. NHP’s novel product pipeline is built on three licenses from Yale University and Micropump® Aspirin, the world’s only 24-hour controlled-release aspirin, licensed from Flamel Technologies.

An NDA filing on the Company's lead product, NHP-554C, is expected in 2013 followed by a US launch in 2014, and an EU launch is being planned for 2014 based upon an approved Marketing Authorization Application ("MAA") covering nine EU countries.

Micropump® Aspirin Products

  • NHP-554C - a novel anti-platelet therapy comprised of Micropump® Aspirin designed for those patients at higher risk for a secondary stroke or cardiac event. NHP-554C was designed to provide important benefits relative to all other aspirin products: true 24 hour anti-platelet activity, an improved GI side effect profile, the preservation of prostacyclin, and lower hepatic saturation. Approved in nine EU countries.
  • NHP-554P - a proprietary and potentially safer aspirin treatment for arthritis combining Micropump® Aspirin with proprietary technology from Yale University.
  • NHP-554L - a proprietary therapy for liver injury or inflammation based upon proprietary technology from Yale University.
  • NHP-554B – a proprietary therapy for the treatment of foreign body reaction to implanted biomaterials such as silicone implants based up proprietary technology from Yale University.
  • NHP-554CZ – an even safer second generation antiplatelet therapy (successor to NHP-554C) incorporating proprietary Yale University technology. An NDA filing is planned in 2014.

NHP-229 Technology

NHP is developing a controlled-release formulation of zinc salts for breakthrough GERD (Gastro Esophageal Reflux Disease) based on proprietary technology from Yale University. NHP-229 is being developed as adjunct therapy to proton pump inhibitors (e.g., Nexium) and as a stand-alone GERD therapy for adults and children. NHP-229 technology is also incorporated into other NHP products to enhance their GI safety.

Senior Management

Patrick Fourteau
Chief Executive Officer

Patrick Fourteau served as President and Chief Executive Officer of Shionogi from 2008 until 2010. Prior to the acquisition of Sciele by Shionogi and Co. Ltd., Mr. Fourteau served as President and CEO of Sciele Pharma from 2003 until 2008 and served on the board of directors of Sciele from 2004 until 2008. He is a seasoned pharmaceutical industry executive having over 30 years of healthcare industry experience, with particular expertise in executing sales strategies for pharmaceutical products. Mr. Fourteau served as President of Worldwide Sales of inVentiv Health, Inc. from 2000 to 2002, President of various divisions of St. Jude Medical, Inc. from 1995 to 2000 and as an Executive of Eli Lilly and Company. He serves on the Board of Insys Therapeutics. Mr. Fourteau earned his B.A. and M.A. in Mathematics from the University of California, Berkeley and an MBA from Harvard University.

Harry H. Penner, Jr.
Executive Chairman

Mr. Penner is co-founder, Chairman and CEO of the company.  He has 30 years of management experience in the pharmaceutical and biotechnology sectors.  He previously founded and co-founded six other biotechnology companies, including Rib-X Pharmaceuticals, Inc., Marinus Pharmaceuticals, Inc., RxGen, Inc., MAKScientific, LLC, RHEI Pharmaceuticals, Inc. and Affinimark Technologies, Inc.  He has served as Chairman and Chief Executive Officer of Nascent BioScience, Inc. since September 2001 and most recently served as the Chairman and Chief Executive Officer of Marinus Pharmaceuticals.  From 1993 to 2001, he was President, Chief Executive Officer and Vice Chairman of Neurogen Corporation, a publicly-traded biotechnology company.  Previously, he served as Executive Vice President of Novo Nordisk A/S and President of Novo Nordisk of North America, Inc. from 1988 to 1993.  From 1985 to 1988, he was Executive Vice President and General Counsel of Novo Nordisk A/S.  Mr. Penner received a B.A. from the University of Virginia, a J.D. from Fordham University, and an L.L.M. from New York University and has completed senior management programs at Stanford.

Scott B. Kozak
Chief Business Officer

Mr. Kozak is co-founder, Vice Chairman and Chief Business Officer of the company and has more than 20 years of experience in the pharmaceutical industry.  Since January 2006, he served as Senior Vice President of Commercial Operations at RHEI Pharmaceuticals, Inc., where he licensed the company’s entire seven product portfolio.  Prior to joining RHEI, Mr. Kozak was Vice President of Business Development at EpiCept Corp. from April 2002 to December 2005.  At Epicept, he partnered programs with Endo Pharmaceuticals, Inc. and Adolor Corp.  Prior to joining EpiCept, Mr. Kozak was the Director of Licensing and Corporate Development at Forest Laboratories, Inc.  Before joining Forest Laboratories in September 1999, Mr. Kozak was Assistant Director, Global Licensing and Corporate Development at Hoffmann-La Roche, Inc., where he was responsible for the licensing efforts in the Metabolic and Drug Delivery areas and was a member of the Metabolic Therapeutic Area Strategy Team responsible for global planning.  From 1989 to 1997, Mr. Kozak held various sales, marketing and licensing and acquisition positions at Solvay Pharmaceuticals.  While at Solvay, Mr. Kozak was responsible for the marketing of their lithium line of products and was a member of the launch team for Luvox, an SSRI marketed for OCD.  Mr. Kozak received his B.S. in Marketing from the University of Connecticut and his M.B.A. in marketing and international business from Kennesaw State University's Michael J. Coles College of Business.

Nancy C. Motola, Ph.D., R.A.C.
Vice President of Regulatory Affairs

Dr. Motola is the Regulatory Vice President of New Haven. She is also Senior Vice President, Regulatory Affairs, at Rib-X Pharmaceuticals and is co-founder of Pharmaceutical Strategic Regulatory Consulting, LLC, a full service regulatory affairs consultancy firm to the pharmaceutical industry.  From 1998 until 2008 she was Vice President and Senior Vice President, Regulatory Affairs and Quality, at Alexion Pharmaceuticals, Inc., where she was responsible for the approval of Soliris (eculizumab).  Prior to Alexion, she spent 11 years in Regulatory Affairs positions of increasing responsibility at Bayer Corp., where she obtained NDA approvals of Baycol, Adalat CC and Nisocor; Abbott Laboratories, where she had regulatory responsibility for the Depakote franchise; and E.R. Squibb and Sons, Inc., where she also spent five years as a Research Investigator in Chemical Development.  She is a founder and past Chairperson of the Regulatory Sciences Section of the American Association of Pharmaceuticals Scientists, a member of the Dean’s Advisory Board of the College of Pharmacy, University of Rhode Island, and a frequent contributor to industry-sponsored program committees, panel discussions and symposia.  Dr. Motola received a Ph.D. in medicinal chemistry from the University of Rhode Island, College of Pharmacy, and is Regulatory Affairs Certified.

 

Board of Directors

  • Harry Penner
    Executive Chairman (Founder)
  • Patrick Fourteau
    President & Chief Executive Officer
  • William Sessa
    Yale University (Professor of Pharmacology)
  • Per Lindberg
    Inventor of Nexium (formerly VP, AstraZeneca)
  • Larry Dillaha, MD
    Chief Medical Officer, Insys (Former Chief Medical Officer at Sciele)
  • Scott Kozak
    Chief Business Officer (Co-founder)

Pipeline

 


Micropump® Aspirin, or NHP-554, consists of a Micropump® formulation of acetylsalicylic acid (“ASA”) or aspirin, and represents the world’s only proprietary, once-daily oral 24-hour controlled-release aspirin.  Micropump® Aspirin exhibits an extended release profile specifically conducive to the chronic medical conditions for which it is being developed, while also possessing a more favorable safety profile compared to currently available aspirin products.  New Haven is developing NHP-554 as four programs: NHP-554C for the secondary prevention of stroke and cardiovascular events, NHP-554P for arthritis, NHP-554B for the treatment of foreign body reaction, and NHP-554L for the treatment of liver injury in patients with hepatitis C virus, or HCV.

The design of the Micropump® microparticles allows a prolonged transit time in the small intestine with a plasma mean residence time extended up to 24 hours, rendering it ideal for drugs which require frequent dosing due to short half-lives. Over-the-counter (“OTC”) aspirin is only available in immediate and delayed release (enteric coated) formulations. Furthermore, Micropump® formulations are intended to extend therapeutic coverage, reduce toxicity and/or side effects and improve patient compliance. New Haven has an exclusive worldwide license, excluding China, to Micropump® Aspirin from Flamel.  Micropump® technology is also currently utilized in Coreg CR, a drug marketed by GlaxoSmithKline for cardiovascular indications.

NHP-554C – Anti-platelet Therapy – Secondary Prevention of Stroke + Cardiac Events
NHP-554C, the Company’s most advanced product candidate, is being developed as an anti-platelet therapy for the secondary prevention of stroke and cardiovascular events. An NDA filing is expected in 2011 and a US commercial launch in 2012.

EU Approval and Launch - NHP-554C was approved in Europe under a Marketing Authorization Application (“MAA”). The Company is pursuing a launch in 2011 and 2012 in the 9 EU countries where it is approved and an extension of MAA approval to other EU countries.

Market Opportunity - Over 100 million people globally currently take aspirin daily to prevent heart attack and stroke. Aspirin prevents clot formation through the inhibition of thromboxane, a prostaglandin derivative that induces platelet aggregation. Unfortunately, currently available aspirins (both immediate release and enteric coated) cause gastrointestinal (GI) side effects and inhibit vascular prostacyclin, a prostaglandin derivative that acts to prevent platelet activation and serves as a vasodilator.

NHP-554C Advantages – NHP-554C represents a unique product opportunity that was developed in consultation with a Nobel laureate to address the shortcomings of conventional aspirin products. NHP-554C inhibits thromboxane (which induces platelet aggregation) like other aspirin products, but NHP-554C also reduces insult to the gastrointestinal (“GI”) tract, preserves vascular prostacyclin (which inhibits clot formation), and provides continuous platelet turnover protection, all as a result of its specially designed 24 hour controlled-release profile. These significant advantages position NHP-554C as a substantially more efficacious and safer version of aspirin, which the Company believes supports the product’s viability as a commercially attractive prescription product.

NDA Filing - Based on a pre-NDA meeting with the FDA in December, 2009 the Company plans to file an NDA for NHP-554C in mid 2011 for the secondary prevention of stroke and cardiovascular events (consistent with the current FDA professional labeling for aspirin).

NHP-554CZ – Antiplatelet Therapy

NHP-554CZ, a proprietary form of NHP-554C (utilizing Yale IP) potentially represents an even safer second generation antiplatelet therapy. Development is expected to begin in 2011 with plans to file an NDA in 2014.

NHP-554P for Arthritis

The Company plans to develop NHP-554P as a proprietary and potentially safer aspirin treatment for arthritis (utilizing Yale IP).  An NDA is expected to be filed in 2014.

New Haven Pharmaceuticals is developing NHP-554B as a proprietary, once-daily treatment for the therapeutic regulation of the host response to biomaterials by inhibition of the inflammasome pathway.  NHP- 554B is a Micropump® formulation of ASA, or aspirin, and represents the world’s only proprietary, once-daily oral 24-hour controlled-release aspirin. Micropump® aspirin exhibits an extended release profile specifically conducive to the prevention and treatment of Foreign Body Reaction, while also possessing a more favorable safety profile compared to currently available aspirin products.

NHP-554L is a proprietary, once-daily treatment for HCV hepatoprotection. HCV infection is the main cause of chronic liver disease throughout the world and may progress to cirrhosis and hepatocellular carcinoma.  Approximately 170 million people, or 3% of the world’s population, are chronic carriers of HCV and at risk of developing cirrhosis and/or liver cancer. At Yale University, aspirin’s hepatoprotective, anti-inflammatory effects have been shown to significantly reduce mortality in mice with acetaminophen-induced hepatotoxicity, a model for liver injury.  The Company believes this observed hepatoprotective property of aspirin derives from the down regulation of the proinflammatory cytokines, IL-18 and IL-1β, both of which have been shown to be elevated in HCV-induced liver disease.

The Company plans to file an IND in 2011 and initiate Phase IIa clinical trials in HCV hepatoprotection in 2011, as well. The Company also believes that NHP-554L can potentially be developed to treat drug-induced liver injury (“DILI”), non-alcoholic steatohepatitis (“NASH”), non-alcoholic fatty liver disease (“NAFLD”), and to extend the therapeutic index of drugs whose dosing is limited by elevated liver enzymes as determined by liver function tests (“LFTs”). The Company’s related patent application asserts broad claims for the use of salicylates, including NHP-554L, for hepatoprotection, the treatment of liver diseases, and the reduction of liver toxicity in connection with a variety of drug candidates and marketed drugs. 

NHP-229 is being developed as a proprietary, once-daily oral adjunct therapy to proton pump inhibitors, or PPIs, for the treatment of patients with gastroesophageal reflux disease, or GERD, who experience breakthrough symptoms, including nocturnal reflux, while taking PPIs or who do not have adequate response to PPIs.  PPIs are currently the second leading therapeutic class of drugs with $13 billion of sales in 2009 according to IMS Health.  Despite this, approximately 40% of PPI patients suffer breakthrough GERD two to four times a week, and 65% of GERD sufferers experience breakthrough at night.  Additionally, approximately 20% to 25% of GERD patients taking PPIs do not respond to treatment in the U.S. 

Researchers at Yale have demonstrated that the API in NHP-229 exhibits a dose-dependent ability to increase gastric pH and a sustained systemic acid suppression effect when taken up into the parietal cells of the stomach tissue of animals and humans.  Additionally, they have shown that the API demonstrates fast action in reducing gastric acid secretion, raising the pH of the stomach to at least 4.0 in less than 20 to 30 minutes.  Following formulation work, the Company plans to file an IND and commence Phase I studies 2011.  The Company believes NHP-229 can also potentially be developed for standalone use, for pediatric use, and as adjunct therapy in the treatment of a number of other significant indications, including pediatric GERD, Zollinger-Ellison syndrome, ulcer disease and gastric cancer.

 

Partnering


New Haven Pharmaceuticals intends to establish commercial partnerships with pharmaceutical companies and/or contract sales organizations to market and sell its products once regulatory approvals are obtained.  The company’s products will be marketed to primary care physicians, psychiatrists, cardiologists and gastroenterologists.

For further information, please contact:

Scott B. Kozak
Chief Business Officer
(203) 809-4286
scott.kozak@newhavenpharma.com

Contact Us


New Haven Pharmaceuticals, Inc.
142 Temple Street
Suite 205
New Haven, CT 06510

Patrick Fourteau, CEO
(770) 329-0074
info@newhavenpharma.com