Merck & Co., Inc. (NYSE: MRK) today announced its updated, newly integrated, late-stage pipeline following its recent merger with Schering-Plough. The new pipeline features a broad and diversified portfolio of investigational medicines and vaccines, including more than 20 candidates in Phase III or under regulatory review, and more than 20 candidates in Phase II of development.
“Since the announcement of the merger in March 2009, we have received regulatory approvals for SIMPONI™ (golimumab), SAPHRIS® (asenapine) and ELONVA®, (corifollitropin alfa injection). In addition, following the closing of the merger, we have made important progress in defining our new pipeline and advancing new projects”
"The combination of two complementary pipelines has yielded a robust and diversified portfolio to fuel Merck's future growth," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "Many of the more than 40 Phase II and Phase III investigational medicines and vaccines have the potential to have a major impact on human health."
Merck's newly integrated pipeline follows a comprehensive prioritization process that closely examined all compounds in development at both companies prior to the merger. Candidates were prioritized based on a series of criteria, including potential for impact on human health, molecular characteristics, stage of development, probability of success and commercial potential.
The new combined pipeline is composed of small molecules, vaccines and biologics targeting a broad range of unmet medical needs including: atherosclerosis and thrombosis, cancer, diabetes, hepatitis C infection, insomnia, and schizophrenia. Merck's pipeline is particularly strong in therapeutic areas in which both companies have long-established research programs, such as cardiovascular disease and infectious diseases; Merck has eight investigational medicines in each of these two categories:
Cardiovascular: anacetrapib (atherosclerosis); acadesine (ischemia reperfusion injury); betrixaban (thrombosis); MK-524A (atherosclerosis); MK 524B (atherosclerosis); MK-0736 (hypertension); vernakalant (atrial fibrillation) and vorapaxar (thrombosis).
Infectious Disease: boceprevir (hepatitis C); MK-3009 (Staphylococcus); MK 3415A (Clostridium difficile); vicriviroc (HIV); vaniprevir (hepatitis C); V419 (pediatric vaccine); V503 (Human Papilloma Virus vaccine) and V710 (Staphylococcus aureus vaccine).
"Since the announcement of the merger in March 2009, we have received regulatory approvals for SIMPONI™ (golimumab), SAPHRIS® (asenapine) and ELONVA®, (corifollitropin alfa injection). In addition, following the closing of the merger, we have made important progress in defining our new pipeline and advancing new projects," said Dr Kim. "Merck is poised to continue to build on our current portfolio and deliver even more on our commitment to improve human health."
The complementary nature of the two pipelines is underscored by the fact that only two programs, hepatitis C and cancer, needed to prioritize a lead molecule for continued development. Vaniprevir (MK-7009), a second-generation hepatitis C protease inhibitor candidate and dalotuzumab (MK-0646), an IGF-1R inhibitor, both currently in Phase II clinical trials, were selected to continue development.
Notable recent pipeline progress includes the initiation of Phase III trials for MK-4305, the company's novel orexin antagonist being evaluated for insomnia, and an allergy immunotherapy tablet for ragweed allergies (SCH 39641). In addition, a Phase II study evaluating MK-6913 for the treatment of hot flashes in postmenopausal women has been initiated.
The new pipeline lists investigational candidates in Phase II and Phase III of clinical development as well as four compounds currently under regulatory review. In addition, marketing rights in specific geographic regions are detailed.