New Haven Pharmaceuticals Announces Availability of DURLAZA™, First and Only Once-Daily 24-Hour Aspirin

NEWHAVEN, Conn., Jan. 7, 2016 New Haven Pharmaceuticals, Inc. today announced the availability by prescription of DURLAZA™, the first and only 24-hour, extended-release aspirin capsules (162.5mg) approved by the U.S. Food and Drug Administration (FDA) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack) in high-risk cardiovascular patients. DURLAZA is now commercially available for physicians and their patients.

"We are very pleased to announce the national availability of DURLAZA as a new, novel alternative option for high-risk cardiovascular patients who would benefit from increased all-day protection from clotting risks," said Patrick Fourteau, CEO of New Haven Pharmaceuticals. "We are confident of the positive effects that DURLAZA has on stabilizing and maintaining platelet inhibition for a full 24-hours – no other single, low-dose aspirin can offer this level of coverage to these patients. We believe that DURLAZA offers a significant benefit by reducing the risk of secondary strokes and heart attacks."

DURLAZA received FDA approval in September 2015. In an open-label, single-center study, high-risk patients with Type II Diabetes (T2DM) with a history of Cardiovascular Disease (or multiple CV risk factors) were treated daily with DURLAZA for 14 days +/- 4 days. The assessment concluded that the new, extended-release orally administered aspirin formulation provided sustained antiplatelet effects over 24 hours in patients with a favorable safety profile.

Low-dose aspirin has been proven to reduce the risk of secondary cardiovascular events and mortality in high-risk patients with stable cardiovascular disease. This is primarily due to aspirin's ability to inhibit platelet aggregation (blood clotting). DURLAZA's 24-hour extended delivery helps maximize the benefit of aspirin by providing consistent platelet inhibition around the clock and the potential for improved patient compliance and adherence to aspirin therapy.

While the body is making platelets 24-hours a day, current immediate-release traditional aspirin only stays in the blood for about a mean duration of four to six hours, with peak plasma concentrations peaking after just 30 minutes. DURLAZA utilizes extended-release, microcapsule technology to prolong aspirin release. DURLAZA offers the only once-daily, 24-hour antiplatelet therapy through the extended release of its 162.5mg dose, resulting in prolonged absorption and sustained platelet exposure to aspirin.

Interested patients should consult with a physician regarding which prescription options are most suitable for their specific needs.

About DURLAZA™

Indicationand Important Limitations of Use
DURLAZA (aspirin) Extended Release Capsules 162.5 mg is indicated:

Limitation of use: Use immediate-release aspirin, not DURLAZA in situations where a rapid onset of action of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).

Important Safety Information
Contraindications
DURLAZA is contraindicated in patients with a hypersensitivity to nonsteroidal anti- inflammatory drugs (NSAIDs) and in patients with the syndrome of asthma, rhinitis, and nasal polyps. DURLAZA may cause severe urticaria, angioedema, or bronchospasm

Warnings and precautions

Adverse reactions
The following adverse reactions have been reported for products containing low dose aspirin:

Selected Drug interactions
Do not take DURLAZA 2 hours before or 1 hour after consuming alcohol. Alcohol can interfere with the controlled release properties of DURLAZA

Please click here for full Prescribing Information for DURLAZA.

About New Haven Pharmaceuticals, Inc.

New Haven Pharmaceuticals Inc. (www.newhavenpharma.com) 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 attractive market opportunities. In addition to FDA- approved DURLAZA™, New Haven Pharmaceuticals is developing products incorporating proprietary Yale University technology utilizing zinc salts, including both a proprietary zinc salts product designed to lower stomach acid in patients suffering from gastro-esophageal reflux disease (or GERD) and a combination product with DURLAZA.