Merck & Co has been extolling the virtues of its pipeline to analysts, claiming it to be the best in the industry, and outlined plans to grow in the emerging markets.
The company has hosted its first R&D and business briefing since the completion of its $41 billion merger with Schering-Plough and says that four drugs are currently under regulatory review, with another five likely to filed this year. The already-filed four treatments are a fixed-dose combination of Asmanex (mometasone) and Foradil (formoterol) for the maintenance treatment of asthma (USA and Europe), and Brinavess (vernakalant) for atrial fibrillation, the contraceptive NOMAC/E2 (nomegestrol acetate/17 beta-estradiol) and asenapine for schizophrenia and bipolar I disorder (all EU).
In 2010, the company anticipates “five new major market filings” – boceprevir,for hepatitis C, a new diabetes combo Janumet XR (sitagliptin/metformin) and NOMAC/E2 (all USA), MK-0431D (sitagliptin and simvastatin) and the sarcoma drug ridaforolimus (worldwide). In addition, Merck plans to file for marketing approval for the injectable antibiotic daptomycin and the lymphoma drug Zolinza (vorinostat) in Japan.
Research head Peter Kim said “I believe Merck has the best pipeline in the industry”, noting that there are more than 20 ongoing Phase III candidates. The company expects to have five biosimilars in late-stage development by 2012, spurred by the passage of US health care reform legislation which should create a pathway for such drugs.
However Merck noted that it has discontinued development of MK-2578, a PEGylated version of Amgen’s aneamia drug Aranesp (darbepoetin alfa). The company said it had received feedback from regulators that an assessment of the drug’s effects on cardiovascular health would be required for approval, and Dr Kim said “this additional requirement would entail substantial commitment of resources and, most importantly, result in significant delay”.
As for emerging markets, Merck president Kenneth Frazier said they will be “a key contributor to our long-term performance”. The company is the second leading pharmaceutical company in Latin America, where it markets six of the 20 most widely sold medicines in the region and since 2007, it has increased the number of sales representatives in China by 90% to about 3,000 today.
Merck believes sales from emerging markets will grow to represent more than 25% of pharmaceutical and vaccine sales by 2013. It also plans to actively seek public-private partnerships as well as “local low-cost manufacturing, licensing, co-marketing networks and projects to leverage its global capabilities”.
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