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February 10, 2016 6:05 PM ET

Pharmaceuticals

Company Overview of New Haven Pharmaceuticals, Inc.

Company Overview

New Haven Pharmaceuticals, Inc. develops prescription pharmaceuticals that utilize currently marketed drugs or generally recognized as safe active pharmaceutical ingredients for therapeutic applications. It offers NHP-554C, an anti-platelet aspirin product for patients at higher risk for a secondary stroke/acute cardiac event that slowly releases into the bloodstream over 24 hours; NHP-554CZ, an anti-platelet aspirin product incorporating Yale University technology utilizing zinc salts; and NHP-229 for the purpose of lowering stomach acid alone or in combination with other drugs. The company was founded in 2008 and is based in New Haven, Connecticut.

142 Temple Street

Suite 205

New Haven, CT 06510

United States

Founded in 2008

Key Executives for New Haven Pharmaceuticals, Inc.

Chief Executive Officer, President and Director
Age: 67
Co-Founder and Executive Chairman
Age: 70
Executive Vice President of Operations and Director
Age: 51
Chief Business Officer
Vice President of Regulatory Affairs
Age: 62
Compensation as of Fiscal Year 2015.

New Haven Pharmaceuticals, Inc. Key Developments

New Haven Pharmaceuticals, Inc. Announces Availability of DURLAZA™

New Haven Pharmaceuticals, Inc. announced the availability by prescription of DURLAZA™, 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. 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.

New Haven Pharmaceuticals, Inc. Shows DURLAZA™ (Aspirin) Extended-Release Capsules Delivers Sustained Antiplatelet Effects for Full 24 Hours

New Haven Pharmaceuticals, Inc. announced new study data that shows the company's FDA-approved drug DURLAZA™ delivers sustained antiplatelet control for a full 24-hour period in high-risk patients. DURLAZA™ is the first prescription, low dose, extended-release aspirin, (162.5mg), for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack). The data was released during a poster presentation at the American Heart Association's Scientific Sessions event in Orlando, Fla. Low-dose aspirin has been proven to reduce the risk of secondary cardiovascular events and mortality in high-risk patients with stable cardiovascular (CV) disease. This result is primarily due to aspirin's ability to inhibit platelet aggregation (blood clotting). DURLAZA™ utilizes extended-release, microcapsule technology to prolong aspirin release. In an open-label, single-center study, high-risk patients with type II diabetes (T2DM) with a history of CV 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. The company expects market availability in early 2016. Indication and Important Limitations of Use: DURLAZA (aspirin) Extended Release Capsules 162.5 mg is indicated: to reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable angina; to reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack. Limitation of use: Use immediate-release aspirin, not DURLAZA in situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention). 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: DURLAZA increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk for bleeding; Aspirin may cause gastric ulceration and bleeding. Avoid use of aspirin in patients with active peptic ulcer disease; DURLAZA can cause fetal harm when administered to a pregnant woman, including low birth weight, increased incidence for intracranial hemorrhage in premature infants, stillbirths and neonatal deaths. Avoid DURLAZA in the third trimester of pregnancy.

New Haven Pharmaceuticals Receives FDA Approval for DURLAZA Extended Release Capsules for Secondary Prevention of Stroke and Acute Cardiac Events

New Haven Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved DURLAZA (aspirin), the first and only 24-hour, Extended Release Capsules, (162.5mg) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack). 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). 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. DURLAZA, like immediate-release aspirin, increases the risk of bleeding and gastric ulceration, and may cause fetal harm when administered to a pregnant woman.

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