Vorapaxar (SCH 530348) is an investigational protease activated receptor-1 (PAR-1) antagonist for the treatment of thrombosis. Phase III studies for acute coronary syndrome (TRA CER) and the secondary prevention of thrombosis (TRA 2P) are ongoing. Merck anticipates filing an NDA in the U.S. in 2011. Anacetrapib (MK-0859) is an investigational cholesteryl ester transfer protein inhibitor. It is currently being evaluated in a Phase III study (DEFINE study). Merck anticipates starting enrollment in a cardiovascular outcomes trial in 2011. TREDAPTIVE (ER niacin/laropiprant, MK-0524A) is an investigational fixed-dose combination of nicotinic acid (niacin) and laropiprant, a selective prostanoid DP1 inhibitor, designed to selectively block the binding of prostaglandin, PGD(2), to its receptor, DP1. Enrollment in HPS2-THRIVE, a Phase III cardiovascular outcomes study, has been completed and Merck anticipates filing an NDA in 2012.

Diabetes and Obesity

Following initial approval of JANUVIA (sitagliptin), Merck's first in-class DPP-4 inhibitor, the company is pursuing new indications and evaluating combinations with other diabetes therapies. Ongoing Phase III trials of sitagliptin in fixed-dose combinations include MK-431C (sitagliptin and pioglitazone) and MK-431D (sitagliptin and simvastatin).

Infectious Disease

Boceprevir (SCH 503034) is a potent oral protease inhibitor candidate for the treatment of hepatitis C. Ongoing Phase III studies (SPRINT-2 and RESPOND-2) are designed to evaluate boceprevir as an addition to current therapy and its impact on treatment duration. Merck anticipates filing an NDA for boceprevir in the U.S. in 2010. MK-3415A is two monoclonal antibodies targeting Clostridium difficile toxins A and B. The company is currently in the process of designing the Phase III program to evaluate MK-3415 for the treatment of Clostridium difficile infection.

Neuroscience and Ophthalmology

Preladenant (SCH 420814) is a novel adenosine A-2 receptor antagonist being evaluated for the treatment of Parkinson's disease. Phase III clinical trials are scheduled to start in 2010. MK-4305 is a novel orexin receptor antagonist being evaluated in Phase III studies for the treatment of insomnia. Phase IIb data are scheduled to be presented in June 2010.

Oncology

Ridaforolimus (MK-8669) is an oral mTOR inhibitor to which Merck recently announced it had acquired a full exclusive license. The SUCCEED trial evaluating ridaforolimus in soft tissue sarcoma is fully enrolled. Merck anticipates filing for the sarcoma indication in the U.S. in 2010. Further studies are ongoing evaluating ridaforolimus alone and in combination for multiple other cancer types. Dalotuzumab (MK-0646) is an antibody targeting the insulin-like growth factor receptor-1 (IGF-1r). Interim analysis of the ongoing Phase II study for colorectal cancer and the decision to proceed into Phase III are scheduled for 2010.

Women's Health and Endocrinology

Corifollitropin alfa (SCH 900962) is a novel biologic being evaluated for controlled ovarian stimulation in women undergoing assisted reproductive treatment. Merck anticipates filing in the U.S. in 2012.

Vaccines

V503 is a 9-valent HPV vaccine designed to target HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58. The Phase III trial is ongoing and Merck anticipates filing a Biologics License Application (BLA) in 2012.

Pipeline Chart

A new interactive pipeline chart lists investigational candidates in Phase II and Phase III of clinical development as well as four compounds currently under regulatory review. The interactive chart also details mechanism of action, partners and marketing rights in specific geographic regions for Phase III candidates. The chart may be accessed at: www.merck.

Merck 2010 Financial Targets

On May 4, Merck provided financial targets for 2010. The company anticipates its full-year 2010 non-GAAP (generally accepted accounting principles) earnings per share (EPS) to be in the range of $3.27 to $3.41, excluding certain items, and a 2010 GAAP EPS range of $1.15 to $1.50. The 2010 non-GAAP guidance excludes purchase accounting adjustments, restructuring and merger-related costs, a pretax gain from AstraZeneca's asset option exercise, and the first-quarter tax charge related to the recently enacted health care reform legislation. EPS and other financial targets assume for 2010 that Merck retains full rights to REMICADE (infliximab) and SIMPONI (golimumab) in the applicable markets.

Merck continues to target a high single-digit non-GAAP EPS compound annual growth rate for the combined company from 2009 to 2013 when compared to Merck 2009 non-GAAP EPS. As the company has previously said, the longer-term targets are applicable regardless of the assumptions made for the REMICADE and SIMPONI business.

SOURCE Merck & Co., Inc.