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Soligenix Announces Expansion of Partnership With Sigma-Tau Pharmaceuticals for orBec® in Europe
Date:7/28/2011

issued patents and pending worldwide patent applications, orBec® benefits from orphan drug designations in the US and in Europe for the treatment of GI GVHD, as well as an orphan drug designation in the US for the prevention of acute GVHD and the treatment of chronic GI GVHD.  Orphan drug designations provide for 7 and 10 years of market exclusivity upon approval in the US and Europe, respectively.  orBec® has also received Fast Track designation from the FDA for the treatment of GI GVHD.

About GVHD

GVHD is a painful, debilitating and sometimes fatal disease.  It is a common disorder among immunocompromised cancer patients after receiving allogeneic stem cell or bone marrow transplants.  Unlike organ transplants where the patient's body may reject the organ, in GVHD it is the donor cells that begin to attack the patient's body – most frequently the gut, liver and skin.  Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea.  If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal.

Systemic immunosuppressive agents such as prednisone, which are the current standard treatments for GVHD, are associated with high mortality rates due to infection and debility.  Further, these drugs have not been approved for treating GVHD in the US or European Union, but rather are used off-label for this indication.

About the Sigma-Tau Group

The Sigma-Tau Group is a leading international pharmaceutical group with wholly Italian-owned capital that invests in the research, development and marketing of innovative and effective treatments to improve patient well-being and quality of life. Sigma-Tau was founded in Italy in 1957 and achieved global revenues of euro 673 million in 2010.  Sigma-Tau Group has headquarters in Pomezia (Rome, Italy), and subsidiaries
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