BioWorld International Correspondent
LONDON - GeneMedix plc is to list on Nasdaq, giving it access to U.S. capital markets as it draws up plans to expand its biogenerics development and manufacturing capabilities into the U.S.
The company also confirmed it is in merger talks with an international pharmaceutical company, as part of its strategy of building a global biogenerics company and accessing U.S. markets.
Paul Edwards, CEO, told BioWorld International that GeneMedix is making the move against the backdrop of changing attitudes toward generics among U.S. regulators, coupled with growing enthusiasm from U.S. investors.
"There have been positive statements from Sen. [Orrin] Hatch and [FDA Commissioner] Mark McClellan indicating [biogenerics] will be allowed at some point, and we are also seeing a lot of interest from investors," he said.
Edwards, who spoke to investors at a conference in Washington at the end of last year and who will be attending two U.S. biogenerics conferences in the next month, said, "There is suddenly a very big recognition of the market potential of biogenerics, and U.S. investors don't want to get left behind by European competition."
Biopharmaceuticals with global sales of $10 billion will lose patent protection by 2007, and 60 percent of that market is in the U.S. However, the regulatory processes for biogenerics are not clear because they are not covered by the abridged procedures for traditional generics set out in the Hatch-Waxman Act of 1984.
GeneMedix, based in Newmarket, UK, has manufacturing plants in Shanghai, China and Tullamore, Ireland. It has one marketed product, Neustim (GM-CSF), for the treatment of neutropenia caused by chemotherapy, which is approved in China. The company is listed in London and Singapore.
Products in development include a version of Thousand Oaks, Calif-based Amgen Inc.'s erythropoietin (EPO), which comes off patent in Europe at the end of 2004; interferon-alfa; interferon-beta; human growth hormone; and insulin.
While recognizing that it might be some time before the U.S. market for biogenerics opens, Edwards believes the spread of GeneMedix's activities will make it attractive to U.S. investors because the company is "well positioned in Europe and in Asia" and has a lower risk profile.