Merck & Co has formed a new division called Merck BioVentures MBV, which will employ its own proprietary glyco-engineering technology to develop follow-on biologics.
Unveiling the new division at an analysts meeting at its headquarters, company executives also disclosed plans to file for US regulatory approval of three new drugs in 2009, including a single-pill combination of the cholesterol drug Zetia and a generic version of Pfizer Inc's Lipitor.
''Follow-on biologics represent a significant market opportunity due to the extensive patent expiries of leading biologics scheduled to occur through 2017,'' Merck said.
The company's first follow-on biologic programme, MK-2578 for anemia, is in clinical development and is planned for launch in 2012. Merck anticipates to have at least five follow-on biologic candidates in late-stage development by 2012.
''Merck BioVentures was enabled by our acquisition of GlycoFi in 2006,'' Peter Kim, head of Merck's research arm, said, adding, ''Merck BioVentures is uniquely positioned for success as a result of the humanised GlycoFi yeast platform which has the potential to provide us with a competitive advantage at a time when the patents on many marketed biologic therapeutics are set to expire.''
Merck said it aims to file for regulatory approval of Rolofylline, a treatment for heart failure, and Telcagepant, a treatment for migraines in 2009. Merck also disclosed earlier-stage research programmes to develop new drugs for respiratory disease and insomnia, as well as a vaccine for staph infections. In addition, it said, it was developing a follow-up to cervical cancer vaccine Gardasil that could offer broader protection against the virus that causes the disease.
Merck BioVentures is developing "follow-on biologics," or generic versions of biotech-style drugs. The drugs under development include an anti-anemia drug that would compete with Amgen's Aranesp. Merck expects to launch this drug in 2012.
Merck expects to have at least five follow-on biologic drugs in late-stage development by 2012. It expects to launch six drugs from the BioVentures unit between 2012 and 2017. The unit also will explore innovative new biologics, not just new versions of existing drugs.
Follow-on biologics are different from traditional generic versions of so-called small-molecule drugs, such as those now available for Merck's Zocor cholesterol drug.
There is currently no clear regulations in the US for companies that wish to sell their own versions of other companies' biotech drugs and Merck expects to conduct clinical trials for the follow-on biologics.
Merck plans to spend $1.5 billion in research and development for the BioVentures unit by 2015. The new division is likely to be located at a site in Elkton, Va., and is likely to have external partners for the process.
Merck's biotech division would be competing with industry leaders such as Amgen, Novartis and Teva Pharmaceutical Industries Ltd, which are looking to enter the follow-on biologics field.