MARTIN PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR LIVANTRA™
NEW YORK, March 29, 2018 — Martin Pharmaceuticals, a clinical stage pharmaceutical company focused on repurposing already-approved drugs to offer life-changing advances to patients afflicted with rare (orphan) diseases or challenging medical conditions, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for LIVANTRA™ in the treatment of Acute on Chronic Liver Failure.
Orphan drug designation is granted to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs.
ABOUT ACUTE ON CHRONIC LIVER FAILURE AND LIVANTRA
Acute-on-chronic liver failure (ACLF) is a syndrome characterized by acute decompensation of chronic liver disease associated with organ failures and high short- term mortality. The greater the number of organ systems involved, the higher the mortality rate. Despite current aggressive medical management, mortality at 30 and 90 days in ACLF remains high, ranging from about 50% in milder cases to nearly 80% in patients with 3 or more organ system failures.
Each year in the U.S. approximately 41,000 people are rushed to hospital with ACLF. Costs of ACLF patient care can range from $116,000 to $180,000 per episode.
Medical management is often viewed as a bridge to transplantation, but many patients don’t qualify for transplantation (age, co-morbidities, etc.) and demand greatly exceeds the supply (50% die before getting a transplant and only 25% of patients are successfully transplanted).
LIVANTRA is a potential game changer as it may help patients to survive ACLF without transplantation, or allow patients to live long enough to receive a new liver.
ABOUT MARTIN PHARMACEUTICALS
Martin Pharmaceuticals, Inc. is a privately held pharmaceutical company headquartered in the historic Woolworth building in New York City. We concentrate on uncovering already-approved drugs and repurposing them to benefit patients facing a different need than originally intended for those medications. We also focus our discovery efforts on “orphan” indications. On March 15, 2018, the Company announced it had completed a seed round of financing.
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Healthcare Veterans Launch Martin Pharmaceuticals To Repurpose Drugsfor Orphan Indications; Seed Round Oversubscribed
Healthcare Veterans Launch Martin Pharmaceuticals To Repurpose Drugs
for Orphan Indications; Seed Round Oversubscribed
NEW YORK, New York, March 15, 2018 — Two accomplished healthcare executives,
David Martin Geliebter and Sven Martin Jacobson, founders of Remedy
Pharmaceuticals, announced the launch of Martin Pharmaceuticals, with the mission of
repurposing already-approved drugs in order to offer life-changing advances to patients
afflicted with rare (orphan) diseases or challenging medical conditions. Martin is the
sixth healthcare company the pair has started since 2001.
In May 2017, Remedy Pharmaceuticals sold its repurposed, orphan-designated CNS drug
program, CIRARA® to Biogen (NASDAQ:BIIB) for a $120 million upfront payment plus
future potential milestones and royalties.
Martin also revealed that it completed a seed round of financing from a group of
outside investors to advance a clinical-stage, repurposed drug program. The offering
was oversubscribed. No other details were provided other than the Company is planning
to start recruiting patients into a phase 1/2 trial for an unspecified life-threatening acute
ABOUT MARTIN PHARMACEUTICALS
Martin Pharmaceuticals, Inc. is a privately held pharmaceutical company headquartered
in the historic Woolworth building in New York City. We concentrate on uncovering
already-approved drugs and repurposing them to benefit patients facing a different
need than originally intended for those medications.
We also focus our discovery efforts on “orphan” indications. In the U.S. the Orphan Drug
Designation program provides orphan status to drugs and biologics which affect fewer
than 200,000 people. Orphan Drug Designation provides companies with, among other
benefits, tax incentives and the exclusive right to commercialize the cure for a specific
condition for a period of seven years without interference from potential competitors.
Europe, Japan, and Australia have similar programs.
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