Plans eight U.S. filings in 2012-2013 and profiles innovative candidates in Alzheimer's disease, diabetes, hepatitis C and psoriasis
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known outside the United States and Canada as MSD, today is hosting a R&D and Business Briefing.
"Innovation is the centerpiece of our growth strategy at Merck," said Kenneth C. Frazier, president and chief executive officer. "We continue to make significant progress on our strategy to drive growth from our existing portfolio and to bring forward breakthrough medicines and vaccines that address unmet medical needs and return significant value to our shareholders."
At the meeting, Peter S. Kim, president of Merck Research Laboratories, four of the company's therapeutic area research franchise heads, and the president of Merck BioVentures provided an overview of candidates in development and progress in advancing the company's pipeline. Merck has 19 candidates in Phase III clinical trials targeting a broad range of diseases. The company plans to submit eight new U.S. filings in 2012-2013, including five new candidates: TREDAPTIVE [ER niacin/laropiprant] (atherosclerosis), suvorexant (insomnia), odanacatib (osteoporosis), V503 (cervical cancer vaccine) and BRIDION [sugammadex] (reversal of neuromuscular blockade).
"Merck's strong late-stage pipeline has considerable potential," said Kim. "We continue to advance important, novel candidates both in our late-stage pipeline and in our earlier pipeline to deliver on our goals to provide patients with meaningful improvements over today's treatments and to help advance global health care."
In addition, the company highlighted six novel candidates in various stages of development being evaluated for the treatment of atherosclerosis (anacetrapib), type 2 diabetes (MK-3102), prevention of herpes zoster (V212), psoriasis (MK-3222), hepatitis C infection (MK-5172), Alzheimer's disease (MK-8931), several of which have the potential to transform medical care.
- Anacetrapib is a novel reversible and selective cholesteryl ester transfer protein (CETP) inhibitor being investigated in a large Phase III outcomes study, the REVEAL study, for the treatment of atherosclerosis. This candidate is anticipated to be filed after the results of the study become available; results from REVEAL are expected after 2015.
- MK-3102 is a novel, once-weekly oral dipeptidyl peptidase-4 (DPP-4) inhibitor candidate for the treatment of type 2 diabetes. In research presented, MK-3102 administered once-weekly showed greater than 80 percent inhibition of DPP-4 for seven days. MK-3102 is anticipated to enter Phase III clinical trials in 2012.
- V212 is an inactivated varicella-zoster virus (VZV) vaccine in Phase III development for the prevention of herpes zoster (shingles) in immunocompromised individuals.
- MK-3222 is an anti-interleukin-23 (IL-23) monoclonal antibody candidate being investigated for the treatment of psoriasis. MK-3222 is anticipated to enter Phase III clinical trials in 2012.
- MK-5172 is a potent, oral pan-genotypic NS3/4a protease inhibitor. Data from a study presented last week at the 2011 American Association for the Study of Liver Diseases meeting showed MK-5172 suppressed HCV in patients infected with HCV genotypes 1 and 3. In addition, new in vitro data shows antiviral activity against a wide range of resistant mutant HCV types. Phase II clinical trials evaluating MK-5172 in combination with pegylated interferon/ribavirin were initiated earlier this year. The company is actively pursuing the use of MK-5172 in an interferon-free regimen for HCV.
- MK-8931 is a novel, potentially first-in-class, potent β-site amyloid precursor protein cleaving enzyme (BACE1) inhibitor being investigated for the treatment of Alzheimer's disease. Initiation of a Phase II clinical trial is anticipated in 2012.
Biosimilars continue to represent an important component of Merck's balanced pipeline portfolio. Merck BioVentures has established strong development and manufacturing collaborations and continues to make good progress in advancing its biosimilars portfolio. Merck will strategically advance into Phase III for specific opportunities where the company can be a first mover upon patent expiry of the originator product.
Pipeline Progress Throughout Integration
Merck underscored the strong progress that the company has made in the integration of the two legacy research organizations since the completion of the merger on November 4, 2009. During the integration period, the company continued to advance its strong pipeline of candidates, with eight new molecular entity and combination products receiving regulatory approval: BRINAVESS (vernakalant) (EU), DULERA (formoterol/mometasone) (U.S.), ELONVA (corifollitropin-α) (EU), JUVISYNC (sitagliptin/simvastatin) (U.S.), SYCREST (asenapine) (EU), VICTRELIS (boceprevir) (EU & U.S.), ZOELY (nomegestrol acetate/ 17β-estradiol) (EU) and CUBICIN (daptomycin for injection) (Japan).
Merck's Strong Pipeline
Merck's late-stage pipeline consists of 32 Phase II and Phase III candidates including new molecular entities and combination programs. Recent notable progress includes two cancer candidates, MK-1775 and MK-2206 that have moved into Phase II trials. In addition, Phase III studies have been initiated for MK-3415A, a candidate for the treatment of C. difficile infection and MK-0431E, a novel investigational combination of sitagliptin and atorvastatin being evaluated for the treatment of type 2 diabetes and atherosclerosis.
An interactive pipeline chart that lists investigational candidates in Phase II and Phase III of clinical development as well as candidates currently under regulatory review can be accessed at: http://www.merck.com/research/pipeline/home.html.
The archived presentations from the R&D and Business Briefing will be available for viewing for 12 months following the event at www.merck.com/investors/home.html.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health 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 healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
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; the impact of pharmaceutical industry regulation and health care legislation; 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 United States and internationally and the exposure to litigation and/or regulatory actions.
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Ian McConnell, 908-423-3046
Alex Kelly, 908-423-5185
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