Soligenix (OTCQB:SNGX) says that its OrbeShield radiation drug has received fast track designation from the U.S. FDA after a series of advances in the development program.
The news comes after the FDA granted orphan drug designation for OrbeShield, which Soligenix said gives the company a seven year term of market exclusivity for the drug upon final approval, and leverage to a wide range of financial and regulatory benefits.
OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.
The main ingredient in OrbeShield is oral BDP - a topically active corticosteroid that has a local effect on inflamed tissue. Aside from acute radiation syndrome, the company is also developing oral BDP for pediatric Crohn's disease.
The fast track status announced today is one the FDA reserves for a drug intended to treat a serious or life-threatening condition, and one that shows the potential to address an unmet medical need.
The designation is designed to fast track the development of the drug, and expedite its review. For example, Soligenix will be eligible to submit a new drug application for OrbeShield on a rolling basis, meaning the FDA can review sections of the application prior to receiving complete submission.
New drug applications for fast track development programs are ordinarily eligible for priority review, which gives an abbreviated review time of six months.
"There are no FDA approved therapies for the treatment of GI ARS," said president and CEO, Christopher J. Schaber.
"The FDA's action in granting fast track designation is a validation of BDP's potential to address this life-threatening, unmet medical need.
"We look forward to working closely with the FDA, as well as with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to potentially expedite the OrbeShieldTM development program."
Earlier this month, the development stage biopharmaceutical company announced that BARDA had called on Soligenix to submit a potential multi-year, multi-million dollar contract proposal to develop OrbeShield.
In pre-clinical studies, the company said that OrbeShield showed a “statistically significant survival advantage” in animals that received the therapy up to 24 hours following exposure to lethal doses of total body irradiation, when compared with placebo control animals. Median survival post exposure in the control group was eight days, compared to 87 days in the OrbeShield treated group.
Based on this development program and others, Soligenix's stock has been gaining significantly of late. In the last year, its stock more than doubled, and just yesterday, rose nearly 9% to $1.46 on the back of an article in the influential financial markets blog Seeking Alpha, which outlined the "reintroduction" of the company after a "devastating setback" in 2011.
The article focused on Soligenix as an example of small biotech companies that get defined by lead product candidates, where "a setback or outright failure of the lead program can be catastrophic to the company's share price", with no residual value given to the rest of the pipeline.
"I believe investments in forgotten gems like these can be profitable as the valuations can become very attractive due to the over-reaction of the marketplace. The downside risk could be minimal and the upside gains could be substantial as the company's developments finally begin attracting investor attention once again," the writer noted.
In 2011, Soligenix's share price suffered due to its phase III clinical trial failure of orBec - an oral formulation of beclomethasone dipropionate (BDP) - for Graft-versus-Host disease. But the company's leaders pushed forward developing the remainder of its platform, to the benefit of its share price.
Its stock was inactive in premarket trading on Tuesday, but opened up by more than 7.5% to $1.57 in early deals.
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