VM BioPharma Announces FDA Fast Track Designation Granted for Investigational Gene Therapy VM202 for Patients with Amyotrophic Lateral Sclerosis (ALS)

TLANTA, May 17, 2016 /PRNewswire/ — VM BioPharma, the United States division of ViroMed Co., Ltd. in Seoul, South Korea(KOSDAQ:084990), today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for the Company’s lead investigational drug, VM202, a Phase 2 novel gene therapy for the potential treatment of Amyotrophic Lateral Sclerosis (ALS). ViroMed is anticipating the publication of data from the Phase 1/2 trial of VM202 in ALS in the second half of the year. The primary endpoint of the trial was the safety and tolerability of VM202, and measures of the ALS Functional Rating Scale (ALSFRS-r) and other efficacy parameters were studied as secondary endpoints.

“We are very pleased to announce that the FDA has granted Fast Track designation for VM202 in the potential treatment of ALS. This status underscores the need to expedite potentially new and important treatment options for the ALS community,” said Dr. Seungshin Yu, head of new business development of ViroMed Co., Ltd. “The Fast Track designation, coupled with the recent Orphan Drug designation from the FDA, provides even more momentum in our work to address the urgent and significant unmet medical need that remains in the treatment of people with ALS.”

The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Through the Fast Track program, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may also be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted. These expedited processes can significantly cut down the development time and cost associated with bringing a drug to market, and the orphan-drug designation also allows for 7 years of market exclusivity even after expiration of related patents.

About Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a rare neurodegenerative disease of unknown causes where the motor neurons necessary to move muscles in the body are destroyed, leading to paralyzation of all muscles, such as those in the tongue, neck, and the limbs. The disease occurs mostly in adults and average life expectancy is 2-5 years of symptoms onset. According to the National Institutes of Health (NIH), prevalence of ALS in the U.S. is 3.9 cases per 100,000 persons, and there are currently an estimated of 450,000 patients around the worldi. With roughly 20,000-30,000 patients in the U.S currently, there are an estimated 6,400 new patients are diagnosed with the diseased every year. (ref: ALS TDI, ALS Association).

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