Merck held a briefing to outline its R&D strategy following the completion of the Schering-Plough merger. The company provided a review of its late-stage pipeline, commercial strategy, as well as its growth strategy.

“This merger was about creating a new global health care leader, and we are well on our way,” said chairman and chief executive officer, Richard T. Clark. “Today’s Merck has excellent capabilities across pharmaceuticals, vaccines and biologics; a robust late-stage pipeline with the potential to sustain near- and long-term growth; a broader product portfolio and an expanded global footprint. The combination of these capabilities with our strategic vision and our people will enable us to achieve our goals. We also have made considerable progress in executing our integration plans while continuing to drive revenue growth, maintain our business momentum and reduce our cost structure.

During the R&D briefing, Peter S. Kim, executive vice president and president, Merck Research Laboratories (MRL), described the company’s newly integrated pipeline, which includes several candidates targeting atherosclerosis, thrombosis, hepatitis C, insomnia, migraine, osteoporosis and Parkinson’s disease.

Four new molecular entities are currently under regulatory review, including the mometasone/formoterol combination for asthma in the U.S. and EU, Brinavess (vernakalant IV) for atrial fibrillation in the EU, Nomac/E2 (nomegestrol acetate/17 beta-estradiol) for contraception in the EU, and asenapine for schizophrenia and bipolar I disorder in the EU. In 2010, the company anticipates five new filings for new molecular entities and combination products: boceprevir, Janumet XR (sitagliptin/metformin HCL) (U.S.), Nomac/E2 (U.S.), MK-0431D (sitagliptin and simvastatin) (Worldwide) and ridaforolimus (Worldwide). In addition, Merck plans to file for marketing approval for daptomycin (for injection) and Zolinza (vorinostat) in Japan.

During the past 16 months, as part of the company’s life-cycle management strategy, Merck has received approvals for additional indications for Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], an expansion for Isentress (raltegravir tablets) to support use in treatment-naïve HIV patients, new uses for Januvia and Janumet in diabetes, as well as an expanded indication for Pegintron (peginterferon alfa-2b) and a new formulation for Temodar (temozolomide). Additionally new indications or new formulations are under review for Gardasil, Implanon NXT (etonogestrel implant) and Nasonex (mometasone furoate monohydrate).

Dr. Kim also addressed the company’s biologics strategy aimed at creating a balanced biologics portfolio made up of both biosimilars, which will be the focus of Merck BioVentures, as well as novel biologics. Merck has five novel biologics and two biosimilar candidates in clinical development and the company anticipates having five biosimilar programs in Phase III development by 2012. As part of its prioritization process, Merck has discontinued development of its PEGylated erythropoietin candidate.

Merck’s late-stage pipeline has more than 20 ongoing Phase III candidates including new molecular entities and combination programs. The company also has eight ongoing programs for new indications or formulations for marketed products. According to the company, approximatley 55% of the molecules originated from legacy Merck and 45% came from legacy Schering-Plough.

Drug candidates highlighted include: Allergen Immunotherapy (SCH 697243, SCH 039641), fast-dissolving tablets being investigated for the treatment of grass pollen and ragweed allergies; Odanacatib (MK-0822), a novel candidate cathepsin K inhibitor being evaluated for the treatment of osteoporosis; Vorapaxar (SCH 530348), an investigational protease activated receptor-1 (PAR-1) antagonist for the treatment of thrombosis and acute coronary syndrome; Anacetrapib (MK-0859), an investigational cholesteryl ester transfer protein inhibitor; Tredaptive (ER niacin/laropiprant, MK-0524A), an investigational fixed-dose combination of nicotinic acid (niacin) and laropiprant, in cardiovascular disease; new indications for Januvia evaluating combinations with other diabetes therapies; Boceprevir (SCH 503034), a potent oral protease inhibitor for the treatment of hepatitis; MK-3415A, two monoclonal antibodies targeting Clostridium difficile toxins A and B; Preladenant (SCH 420814), a novel adenosine A-2 receptor antagonist being evaluated for the treatment of Parkinson’s disease; MK-4305, a novel orexin receptor antagonist being evaluated for insomnia; Ridaforolimus (MK-8669), an oral mTOR inhibitor being evaluated in soft tissue sarcoma and other cancers; Dalotuzumab (MK-0646), an antibody targeting the insulin-like growth factor receptor-1 (IGF-1r) for colorectal cancer; Corifollitropin alfa (SCH 900962), a novel biologic being evaluated for controlled ovarian stimulation in assisted reproductive treatment; and V503, a 9-valent HPV vaccine designed to target HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.