Rehovot, Israel May 3rd 2011 -- D-Pharm Ltd., (DPRM: TASE) has received Fast Track designation by the U.S. Food and Drug Administration (FDA) for its DP-b99 development program for treatment of moderately severe stroke
patients. DP-b99 is currently being tested in a pivotal international phase 3 trial, MACSI.
The FDA Fast Track development program is a designation that accelerates the approval in the U.S. of
investigational new drugs undergoing clinical trials. It is specifically designed to facilitate the development,
and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The Fast Track
will allow D-Pharm to submit parts of its request for a new drug approval (NDA) as these parts become
available, without having to wait and submit all parts of the application together, as usually required by the
FDA. Alex Kozak, D-Pharm’s CEO commented, “This Fast Track designation to expedite the progress of
DP-b99 to market is an important vote of confidence in D-Pharm and we look forward to the frequent and
fruitful interactions with the agency encouraged by this designation.”
The Membrane Activated Chelator Stroke Intervention (MACSI) Phase III trial is a randomized, double
blind, placebo-controlled study. It is designed to compare the effect on ischemic stroke outcome between
a placebo group and a group of patients treated with 1 mg/kg/day of DP-b99 for 4 consecutive days. The
MACSI study is enrolling 770 patients, with recruitment ongoing at over 100 clinical sites in North
America, Europe, South America, South Africa and Israel. In April 2010 the protocol for the trial was
agreed with the U.S. FDA under the Special Protocol Assessment (SPA) procedure.
DP-b99 is a unique broad-spectrum neuroprotective drug that addresses an array of brain damaging
processes occurring in stroke patients. Both preclinical and clinical Phase I and II studies indicate a
favorable efficacy and safety profile for DP-b99. In the Phase IIb trial in 150 ischemic stroke patients, DP-
b99 increased by two-fold the percentage of patients that recovered from ischemic stroke. DP-b99 may
be administered within a nine hour therapeutic window.
Every year around 1.5 million people in the U.S., Western Europe and Japan suffer an acute stroke.
Stroke is a leading cause of death in the western world and around 50% of stroke survivors suffer from
some form of severe disability. According to the American Heart Association (AHA) the annual economic
burden of stroke in the U.S. was around $70B in 2009. Currently, between 2-5% of stroke patients receive
tissue plasminogen activator (tPA), the only drug currently approved for treatment of acute stroke in the
D-Pharm (www.dpharm.com) is a clinical stage, biopharmaceutical company pioneering the development
of lipid-like therapeutics, and has generated a rich pipeline of patent protected proprietary products. D-
Pharm’s pipeline includes advanced clinical stage products, DP-b99 for treatment of ischemic stroke
patients and DP-VPA, a novel drug for treatment of epilepsy, bipolar disorder and prophylaxis of migraine.
DP-VPA, a prodrug of valproic acid, is in Phase II clinical development. DP-460 is in preclinical
development intended as an oral, disease-modifying therapy for Alzheimer's disease. Other mimics of
bioactive lipids, LipidoMimetix, are at an earlier developmental stage for cancer.
D-Pharm was established in 1993 at the initiative of Dr. Alex Kozak, President and CEO. In August 2009
the Company completed the first offering of its shares on the Tel Aviv stock exchange. The largest
shareholder in the company is Clal Biotechnology Industries (46%).
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Statements in this press release that are not historical facts are forward-looking information, as defined in
the Securities Law, based on information available to D-Pharm at the time of this press release. The
estimations could, some or all, be unrealized, or could be realized in significantly different ways than