Positive European opinion announced for OvaRex as orphan drug.(Brief Article)

2002 SEP 5 - (NewsRx.com & NewsRx.net) -- AltaRex Corp. announced that the Committee for Orphan Medical Products (COMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has adopted a positive opinion recommending the granting of orphan medicinal product designation for OvaRex MAb (Oregovomab) for the treatment of ovarian cancer.

The COMP has forwarded its opinion of June 27, 2002, to the European Commission for final decision expected within 45 days. European orphan drug designation enables recipient companies to receive regulatory guidance in the drug development process as well as reduced filing fees and allows for up to 10 years of European market exclusivity upon approval of the market application.

OvaRex was granted orphan drug status by the U.S. Food and Drug Administration (FDA) in the United States in 1996 and received FDA Fast Track designation in 1998.

AltaRex has advanced OvaRex MAb through phase II studies in North America and has recently entered into collaboration for further development with a wholly owned subsidiary of United Therapeutics Corporation under which AltaRex licensed OvaRex (and other products) for North America and other regions worldwide excluding the European Union and certain other countries.

United Therapeutics has disclosed its intention, subject to a program review with the U.S. Food and Drug Administration, to initiate a phase III randomized pivotal trial of OvaRex ...