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PRESS RELEASE
Roger Ulrich Joins Board of Remedy Pharmaceuticals Founder of Calistoga Pharmaceuticals, board member and former Chief Scientific Officer of Acerta Pharma to help guide future of company focused on ground-breaking therapy for CNS-related edema NEW YORK, New York, June 21, 2016 — Remedy Pharmaceuticals, a privately-held pharmaceutical company focused on bringing life-saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced that Roger Ulrich has joined the company’s board of directors. In 2006 Dr. Ulrich co-founded Calistoga Pharmaceuticals, which was acquired by Gilead Sciences (NASDAQ:GILD) in 2011 in a transaction valued at up to $600 million. Dr. Ulrich left Gilead in 2012 to help build Acerta Pharma as a member of the Board and as acting Chief Scientific Officer. In February of this year, AstraZeneca (NYSE:AZN) acquired a 55% share of Acerta Pharma for $4 billion with an option to purchase the remainder of the company for $3 billion. Dr. Ulrich has many years of successful drug discovery and development experience. Prior to Acerta and Calistoga, Dr. Ulrich was senior scientific director with Merck Research Laboratories-Rosetta Inpharmatics (NYSE:MRK). Prior to Merck, Dr. Ulrich held various scientific and leadership positions within the pharmaceutical industry including Abbott Laboratories (now AbbVie, NYSE:ABBV), Pharmacia-Upjohn and The Upjohn Company, now part of Pfizer (NYSE:PFE). Prior to his pharmaceutical industry career, he worked at West Virginia and Michigan State Universities, and at Argonne National Laboratories. Dr. Ulrich has authored more than 125 publications and continues to serve on scientific and clinical advisory boards for industry, academia and government. Dr. Ulrich received his B.A. in biology/chemistry and his M.A. in biomedical sciences from Western Michigan University. He received a Ph.D. in cellular and molecular biology from West Virginia University, and is a fellow of the Academy of Toxicological Sciences. “We are honored to have Roger join our Board,” said David Geliebter, Executive Chairman of Remedy Pharmaceuticals. “He has achieved extraordinary success helping advance medicine, and is sure to be a tremendous asset as we move forward in achieving our mission of helping people afflicted with CNS-related edema to not only survive, but live life to the fullest.” “I am very excited to join the Board of Remedy, said Roger Ulrich. “The company’s underlying science is transformative and I look forward to working with the board and the team to help shape what I’m certain to be its bright future.” ABOUT CIRARA CIRARA is a patented, high affinity inhibitor of Sur1-Trpm4 channels, which are upregulated following ischemia and trauma. Opening of these channels can lead to edema, midline shift, increased intracranial pressure and brain herniation, culminating in permanent disability or death. Sur1-Trpm4 channels were discovered by University of Maryland neurosurgeon Dr. J. Marc Simard, scientific founder and board member of Remedy Pharmaceuticals. CIRARA is suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses our proprietary, patented MPD™ technology. CIRARA is an investigational drug and is not approved by FDA. ABOUT REMEDY PHARMACEUTICALS Remedy Pharmaceuticals, Inc. is a privately-held, clinical stage pharmaceutical company focused on developing and bringing lifesaving treatment to people affected by acute central nervous system (CNS) edema – including large hemispheric infarction, subarachnoid hemorrhage, and contusional traumatic brain injury, as well as other ischemic injuries and neurological disorders. Contact: Remedy Pharmaceuticals Sven Jacobson 212-586-2226 x 225 sven@remedypharmaceuticals.com
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PRESS RELEASE
Remedy Pharmaceuticals Receives FDA Fast Track Designation for CIRARA™ NEW YORK, New York, June 8, 2016 — Remedy Pharmaceuticals, a privately-held pharmaceutical company focused on bringing life-saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug, CIRARA, for the treatment of Large Hemispheric Infarctions (LHI). The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. FDA may consider a "rolling review" of completed sections of the New Drug Application (NDA) before the complete application is submitted. Fast Track designation drugs ordinarily qualify for priority review, thereby expediting the FDA review process. “We are very pleased to achieve this additional important milestone for our LHI program, following the FDA’s recent acceptance of our investigational new drug (IND) application,” said Sven Jacobson, CEO of Remedy Pharmaceuticals. “This latest development provides further momentum as we advance CIRARA, with the near-term goal to initiate our phase 3 clinical trial by the end of this year.” ABOUT THE CHARM TRIAL AND LHI CHARM (Cirara in large Hemispheric infarction Analyzing modified Rankin & Mortality) is a phase 3 trial in patients with large hemispheric infarction (LHI). LHI is a devastating disease associated with significant disability and mortality. Brain swelling (often termed “malignant edema”) frequently occurs following LHI as a result of the opening of Sur1-Trpm4 channels in the capillary endothelium, which leads to dysfunction of the blood brain barrier. Such swelling can compromise arterial inflow to surrounding tissues, causing further ischemic damage and enlargement of the infarct, and frequently results in brain herniation and death. The risk of neurological deterioration and death is high, 40% to 80%. For a White Paper on LHI, please go to: http://www.remedypharmaceuticals.com/uploads/7/1/7/3/71731607/lhi.whitepaper.3jun16.pdf ABOUT CIRARA CIRARA is a patented, high affinity inhibitor of Sur1-Trpm4 channels, which are upregulated following ischemia and trauma. Opening of these channels can lead to edema, midline shift, increased intracranial pressure and brain herniation, culminating in permanent disability or death. Sur1-Trpm4 channels were discovered by University of Maryland neurosurgeon Dr. J. Marc Simard, scientific founder and board member of Remedy Pharmaceuticals. CIRARA is suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses our proprietary, patented MPD™ technology. CIRARA is an investigational drug and is not approved by FDA. ABOUT REMEDY PHARMACEUTICALS Remedy Pharmaceuticals, Inc. is a privately-held, clinical stage pharmaceutical company focused on developing and bringing lifesaving treatment to people affected by acute central nervous system (CNS) edema – including large hemispheric infarction, subarachnoid hemorrhage, and contusional traumatic brain injury, as well as other ischemic injuries and neurological disorders. Contact: Remedy Pharmaceuticals Sven Jacobson 212-586-2226 x 225 sven@remedypharmaceuticals.com Remedy Pharmaceuticals Announces Contest to Name its Subarachnoid Hemorrhage Clinical Trial6/7/2016 PRESS RELEASE
Remedy Pharmaceuticals Announces Contest to Name its Subarachnoid Hemorrhage Clinical Trial NEW YORK, New York, June 7, 2016 — Remedy Pharmaceuticals, a privately-held pharmaceutical company focused on bringing life-saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced a contest to name its upcoming clinical trial in Subarachnoid Hemorrhage (SAH). SAH is a serious, life-threatening condition. Each year some 30,000 to 35,000 people in the U.S. are afflicted by SAH, a type of stroke caused by bleeding into the space between the brain and the skull. Remedy Pharmaceuticals is planning to begin a Phase 2a clinical study of its drug CIRARA in patients with SAH. “We’re looking for an acronym that conveys the meaning of this trial,” notes, David Geliebter, Remedy’s Executive Chairman. “SAH is a serious subject, but it doesn’t mean we can’t have a little fun with our name contest.” Rules and entry instructions can be found at: www.remedypharmaceuticals.com/name-that-trial.html ABOUT CIRARA CIRARA is a patented, high affinity inhibitor of Sur1-Trpm4 channels, which are upregulated following ischemia and trauma. Opening of these channels can lead to edema, midline shift, increased intracranial pressure and brain herniation, culminating in permanent disability or death. Sur1-Trpm4 channels were discovered by University of Maryland neurosurgeon Dr. J. Marc Simard, scientific founder and board member of Remedy Pharmaceuticals. CIRARA is suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses our proprietary, patented MPD™ technology. CIRARA is an investigational drug and is not approved by FDA. ABOUT REMEDY PHARMACEUTICALS Remedy Pharmaceuticals, Inc. is a privately-held, clinical stage pharmaceutical company focused on developing and bringing lifesaving treatment to people affected by acute central nervous system (CNS) edema – including large hemispheric infarction, subarachnoid hemorrhage, and contusional traumatic brain injury, as well as other ischemic injuries and neurological disorders. Contact: Remedy Pharmaceuticals Sven Jacobson 212-586-2226 x 225 sven@remedypharmaceuticals.com |
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