Merck & Co., Inc. (NYSE: MRK) today outlined its drug pipeline and has reaffirmed its guidance given last week. Merck plans to emerge next year and into the next decade leaner and more responsive to customer needs and with a strong drug candidate pipeline.
Some of the initiatives are as follows:
- It intends to derive additional growth from emerging markets and follow-on biologics;
- Merck is on track to achieve its goal of $2 billion in emerging market sales by 2010;.
- It is making significant investments in key emerging markets in Chinaand India, with the goal of attaining a leadership position in thosemarkets over the long term;
- It is moving to diversify its portfolio by creating a new division,Merck BioVentures, which leverages a unique platform for both follow-onand novel biologics;
Merck’s Late-Stage pipeline advances will anticipate submitting New Drug Application filings with the U.S. FDA:
- MK-0974, telcagepant, an investigational compound for the treatment ofmigraines; MK-7418, rolofylline, an investigational compound for thetreatment of acute heart failure;
- MK-0653C, ezetimibe combined with atorvastatin, an investigationalmedication for the treatment of dyslipidemia being developed by theMerck-Schering Plough joint venture.
Merck anticipates in 2009 three supplemental filings that have been orwill be submitted to the FDA and other regulatory agencies:
- two for GARDASIL, Merck’s HPV vaccine;
- and one for ISENTRESS, a first-in-class integrase inhibitor for thetreatment of HIV-1 infection, for an expanded indication for use intreatment-naïve patients. In the U.S. alone, if approved, thetreatment-naïve indication would triple the number of patients for whomISENTRESS would be indicated.
Research and development efforts that include 47 active clinicalprograms across the Company’s major research franchises: bone,respiratory, immunology and endocrine; cardiovascular; diabetes andobesity; infectious diseases; neuroscience; oncology and vaccines. Asof Dec. 9, 2008, Merck’s pipeline includes nine candidates in PhaseIII, 15 in Phase II and 23 in Phase I.
Here are details of seven of the drug candidates currently in Phase III clinical development:
- MK-7418, rolofylline, a potential first-in-class selective adenosine A1antagonist, is a Phase III investigational drug being evaluated for thetreatment of acute heart failure. An NDA filing with the FDA continuesto be anticipated in 2009.
- MK-0974, telcagepant, an investigational oral calcitonin gene-relatedpeptide receptor antagonist for the treatment of migraine. The Companycontinues to anticipate filing an NDA with the FDA in 2009.
- MK-8669, deforolimus, is a novel mTor inhibitor being evaluated for thetreatment of cancer. The drug candidate is being jointly developed andcommercialized with ARIAD Pharmaceuticals, Inc., under an agreementreached in 2007. A Phase III study (SUCCEED) in patients withmetastatic soft-tissue or bone sarcomas is under way. The Companycontinues to anticipate filing an NDA with the FDA in 2010.
- V503, a nine-valent HPV vaccine in development to provide broadercoverage against HPV. The Phase III clinical program is underway andMerck anticipates a filing with the FDA in 2012.
- MK-0822, odanacatib, is a highly selective inhibitor of the cathepsin Kenzyme for the treatment of osteoporosis. The Phase III program isongoing. Merck said that it continues to anticipate filing an NDA withthe FDA in 2012.
- MK-0524A combines extended-release niacin and a novel flushinginhibitor, laropiprant. MK-0524A has demonstrated the ability to lowerLDL-cholesterol (LDL-C), raise HDL-cholesterol (HDL-C) and lowertriglycerides with significantly less flushing than traditionalextended release niacin alone. The cardiovascular outcomes trial,HPS2-THRIVE, is ongoing and expected to complete in 2012. Merckanticipates filing an NDA with the FDA for MK-0524A in 2012.
- MK-0859, anacetrapib, is an inhibitor of the cholesteryl ester transferprotein that has shown promise in lipid management by raising HDL-C andreducing LDL-C without raising blood pressure. A Phase III study wasinitiated in April 2008 and enrollment in a cardiovascular outcomesstudy is expected to begin in 2010. The Company anticipates filing anNDA with the FDA beyond 2014.
Merck reaffirmed its 2008 financial guidance just on December 4,and gave its outlook for 2009. Full-year 2008 non-GAAP earnings areexpected to be $3.28 to $3.32 EPS. Merck also gaveguidance for its Fiscal 2009 of $3.15 to $3.30 non-GAAP EPS.
Shares are currently up about 2% pre-market at $27.60, but we wouldnote that shares were briefly indicated up 4%. As a reminder, somedrug company pipeline presentations can go either way regardless of thedata presented.
Jon C. Ogg
December 9, 2008