Merck & Co Reasserts R&D Pipeline, Will File Five More NDAs in 2010

Merck & Co provided the latest update on its research and development (R&D) pipeline, noting 20 experimental candidates in its Phase III clinical pipeline. Following the acquisition of Schering-Plough (U.S.), the Phase III line-up now reflects 55% of molecules from Merck, and 45% from legacy Schering-Plough. The following provides the main highlights of Merck's research strengths:

• Four new molecular entities are currently under regulatory review: mometasone + formoterol combination for asthma, Brinavess (vernakalant IV) for atrial fibrillation, Nomac + E2 (nomegestrol acetate + 17 beta-estradiol) for contraception, and asenapine for schizophrenia and bipolar disorder.
• In 2010, five new major market filings for new molecular entities and combination products are set. This includes boceprevir, Janumet XR (sitagliptin + metformin HCL; U.S.), Nomac + E2 (U.S.), MK-0431D (sitagliptin and simvastatin; worldwide), ridaforolimus (worldwide), and five additional major market filings for new indications or new formulations.
• Merck also plans to file for marketing approval of daptomycin, for injection, and Zolinza (vorinostat) in Japan.
• The therapeutic areas in Merck's main focus are as follows: cardiovascular, diabetes and obesity, infectious diseases, oncology, neuroscience and ophthalmology, vaccines, bone, respiratory, immunology, and dermatology.
• The firm also reaffirmed its commitment to novel biologics, as well as biosimilars (also described as follow-on biologics) with five innovative and two biosimilar candidates in clinical development. The company continues to anticipate having five biosimilar programmes in Phase III development by 2012.

Emerging Markets Focus

Merck also indicated its sustained push into expanding its operations in emerging-market economies, indicating that its research pipeline is expected to support commercialisation prospects. The firm said it anticipates that sales from emerging markets will grow to represent more than 25% of the company's total pharmaceutical and vaccine sales by 2013, spurred by implementation of the company's emerging-market strategy. This strategy incorporates intensifying the marketing of new products, optimising Merck's in-line portfolio of medicines, vaccines, and consumer-care products, and fully leveraging the market for branded generics. The firm also claimed to be the second leading pharmaceutical company in Latin America, where the company markets 6 of the 20 most widely sold medicines in the region.

Outlook and Implications

Merck's enhanced late-stage pipeline reflects a rise in not only traditional therapeutic areas such as cardiovascular and infectious diseases, but also in asthma, anaesthetics, and women's health. The combined portfolio increases the potential of its Phase III clinical development, and also provides focus on combination-product research. The immediate-term prospects of Merck & Co's marketed portfolio have been significantly bolstered, with five new drug applications planned in addition to the drugs already under review in the United States and European Union. Merck's capabilities in areas such as biosimilars were also highlighted, indicating that the firm is pursuing expanding its pipeline despite withdrawing from researching one of the candidates—pegylated erythropoietin. The integration of Schering-Plough's pipeline is to provide a balance between lifecycle management of marketed drugs, biologics—including entry into biosimilars—and investments into disease areas.