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Friday, 11 January 2013
Soligenix gets FDA orphan designation for radiation drug OrbeShield
Development stage biopharmaceutical company Soligenix(OTCQB:SNGX) Wednesday said that the FDA has granted orphan drug designation to its radiation therapy, OrbeShield.
The company said in addition to a seven year term of market exclusivity for OrbeShield upon final approval, the FDA’s orphan drug designation also provides leverage to a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive user fees and certain tax credits.
"The FDA's decision to grant oral BDP orphan drug designation signifies an important step for Soligenix as we continue to expand our oral BDP pipeline," said president and CEO Christopher J. Schaber, PhD.
"The marketing exclusivity that orphan drug designation imparts adds significantly to the existing patent estate surrounding OrbeShield."
The main ingredient in OrbeShield is oral BDP - a topically active corticosteroid that has a local effect on inflamed tissue.
OrbeShield is being developed for the treatment of gastrointestinal acute radiation syndrome, which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.
There is no established treatment or preventive measure for the gastrointestinal damage that occurs after high-dose radiation, andSoligenix has said there is an “urgent need” to develop specific medical countermeasures against the effects of radiation-induced gastrointestinal injury.
The company noted that BDP has been marketed in the U.S. and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma.
Soligenix said that oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation such as Crohn's disease and radiation enteritis.
The company last week announced it had regained the North American and European commercial rights to its oral BDP.
Soligenix is currently developing oral formulations of the drug, including its two-tablet system specifically designed for delivery of BDP throughout the small bowel and the colon.
Last month, it also acquired SGX94 - a drug technology that regulates the immune system.
Soligenix is planning to develop the drug technology in both of its key units, namely cancer supportive care in its biotherapeutics segment, and infectious diseases under its vaccines/biodefense division.
Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.