Merck Announces Robust Integrated Pipeline With More Than 20 Medicines and Vaccines in Late-Stage Development
Integrated pipeline includes potential first-in-class candidates in therapeutic areas including cardiology, diabetes and infectious diseases
WHITEHOUSE STATION, N.J., March 1, 2010 â”€ 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.
"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 SIMPONITM (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.
The new pipeline chart may be viewed at: http://www.merck.com/research/pipeline/home.html?WT.svl=content.
Further detailed information regarding Merck's research strategy and selected pipeline candidates will be presented during Merck's R&D and Business Briefing to be held on May 11, 2010 in Whitehouse Station, N.J.
Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. Merck. Be Well. For more information, visit www.merck.com.
Forward Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2009 Annual Report on Form 10-K, Schering-Plough's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site: www.sec.gov.