Generic version of Abbott's urokinase drug Abbokinase, for the treatment of pulmonary embolism or lung blood clots, to be developed in agreement with secretive partner
Microbix Biosystems has signed a major new agreement with a leading multinational pharmaceutical company for the worldwide rights to its lead biotherapeutic drug ThromboClear, a generic version of Abbott Laboratories's urokinase product, Abbokinase.
Under the terms of the agreement, Microbix is to receive a royalty equal to 35% of the gross margin with its partner assuming overall responsibility and all costs for commercialising ThromboClear, estimated to be in excess of $12 million.
The market for Abbokinase is forecast to reach US$360 million by 2005 according to a report published by JP Morgan. Abbott Laboratories today is the sole source for the drug. "Capturing one third of this lucrative market should be achievable given the general demand in the US for lower-cost generic versions of brand name drugs," said William Gastle, president and CEO of Microbix.
In a 1998 report forecasting results for that fiscal year, Merrill Lynch estimated that Abbokinase (urokinase) would account for US$115 million in earnings for Abbott on sales of nearly US$250 million.
As part of the agreement, Microbix declined to name its partner.
"Our partner prefers that its name not be disclosed at present for competitive reasons," said Mr Gastle.
"We can report that we have its commitment to fully support this product and in particular to finance the significant regulatory, production and marketing costs remaining." According to Mr Gastle, Microbix's partner is a large, well- respected global pharmaceutical company.
"It has all the capabilities we were looking for in a partner including a significant position in the generics market, strong presence in the US market and a specific interest in generic biologics.
Microbix's knowledge of biologics development and manufacturing scale-up complements our partner's knowledge of manufacturing, regulatory procedures, sales and marketing," he said.
"Microbix is already in late stage development of its next product and in this partnership we've found a natural fit between our two companies in terms of our combined knowledge which we expect will naturally lead to new development and more joint efforts in the field of generic biologics," he continued.
Today's announcement adds to the news last month that Abbott Laboratories received approval by the FDA to reintroduce urokinase after being required to take it off the market in 1999 when the FDA found significant manufacturing deficiencies in its production plant in Chicago.
Physicians are expected to welcome the return of urokinase for the treatment of pulmonary embolism or lung blood clots that affect an estimated 500,000 patients in the US annually, according to Dow Jones reporter Daniel Rosenberg. "Abbott's own significant investment and recent approval confirms a healthy urokinase market," Mr Gastle said, "and one we will be sharing." Microbix's shareholders have had a "long wait for this news," he added "so they should be very pleased to hear of our agreement with a strong partner which now undertakes to finance the project.
It's a very good arrangement for both companies." Microbix specialises in developing and manufacturing cell culture-derived biologics for an emerging world market of biotherapeutic drugs and vaccines.
It makes reagents for building diagnostic products and tools used in biotechnology research.
