Gazette.Net: Stem cell biotech Osiris Therapeutics wins overseas

Osiris Therapeutics announced a couple of legal and regulatory victories this week.

The Columbia biotech, which develops stem cell treatments for a variety of conditions, won a challenge to its Australian patent.

The patent, filed in 2009, covers the use of mesenchymal stem cells, including the companys intravenous Prochymal product, to treat inflammatory conditions in the gastrointestinal tract, including Crohns disease and ulcerative colitis.

Under Australian law, the opponents identity was not disclosed, Osiris said in a news release.

Actually, the challenge was filed in November by a patent attorney, Gavin Recchia. But under Australian law, such challenges may be filed by anyone, including those without a commercial interest, Victor Portelli of the Australian patent agency said. However, the client of the filer need not be disclosed, at least initially.

The challenge was withdrawn this month before any supporting evidence was filed.

Last year, Prochymal became the worlds first stem cell drug approved by an internationally recognized regulatory authority. Its also approved to treat acute graft versus host disease, a serious complication of bone marrow transplantation that kills up to 80 percent of children affected, many soon after diagnosis, according to Osiris. Canada and New Zealand have approved it, and its also available in the U.S. and six other nations under an expanded access program.

Osiris also reported the European Medicines Agency has designated it as the orphan drug title holder for Prochymal for treating graft versus host disease. The designation provides incentives, such as market exclusivity for up to 10 years following approval.

Osiris stock rose 9 percent on the news Tuesday, before falling back Wednesday and Thursday.

In other Maryland bioscience industry news:

More here:
Gazette.Net: Stem cell biotech Osiris Therapeutics wins overseas

Related Post