Company expects to launch first biogeneric, which will compete with Amgen’s Aranesp, in 2012.
While most of the bigger pharmaceutical firms have steered clear of investing in biogenerics, Merck & Co. reported plans to set up a new division to focus solely on developing such follow-ons. The segment will be called Merck BioVentures MBV and will concentrate on developing follow-on treatments for patients in primary care, specialty care, and hospital settings.
Merck BioVentures will untilize the glyco-engineering technology, gained through the acquisition of GlycoFi. The first follow-on biologic program is MK-2578 for anemia, which will compete with Amgen’s Aranesp. Merck believes that it will be able to launch MK-2578 in 2012 and will have at least five candidates in late-stage development by that year.
“Merck BioVentures is uniquely positioned for success as a result of the humanized 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,” said Peter S. Kim, Ph.D., EVP and president, Merck Research Laboratories.
It is important to note that there is as yet no regulatory pathway in place for biogenerics, which is under much scrutinity from big pharma. Many view the new political regime as more receptive to the idea of follow-ons, though, and expect legislature to move quicker than was previously anticipated.
As part of its plans for the future, Merck also outlined a number of other initiatives: continued focus on advancing its current pipeline and on innovation; optimizing life-cycle management programs; and enhancing growth in emerging markets like India and China,
“Next year will continue to be a period of fundamental transformation that establishes Merck as a different competitor for the next decade,” noted Merck chairman, president, and CEO, Richard T. Clark. “We look to emerge leaner and more responsive to our customers’ needs and with a pipeline that offers significant potential, thanks to the scientific innovation that will continue to be the hallmark of our company. This new Merck will be built for the new era that our industry has entered—and it will be built for long-term success.”
