Global Insight Perspective | |
Significance | Of the 48 drugs undergoing various phases of clinical development, 19 have progressed, and of the seven drugs in late-stage development, three hold good potential for future franchises. Merck will seek approval for obesity drug taranabant and a cholesterol combination drug in 2008. |
Implications | The update provides a fillip for the company, restoring some confidence in the pharma major's pipeline for the next five years. Additionally, Merck's plans for approval of expanded use of Gardasil and Isentress will also add to revenues. |
Outlook | Merck's drug discovery pipeline looks robust in the short term. The similarity between some of the drugs in the late-stage pipeline to Pfizer's (U.S.) failed cholesterol drug, torcetrapib, and Sanofi-Aventis's (France) obesity product, Acomplia/Zimultin, will lead to some doubt over approval. |
R&D Pipeline
Merck has unveiled a new group of late-stage drugs in its R&D pipeline, which are expected to face regulatory scrutiny in the next five years. According to the company, New Drug Applications (NDAs) for two drugs—MK-0542B and MK-0364—will be filed next year, with the same number anticipated until 2010, providing a potential revenue stream. More importantly, regulatory action is expected on two drugs—Cordaptive (MK-0542A) and Emend injection. Furthermore, Merck will also pursue expanded-use approvals for its cervical vaccine, Gardasil, for adult women aged under 45 years and AIDS treatment Isentress for the treatment of naive HIV-1 patients. Off the 48 drugs in Merck's clinical development programme, 19 have registered progress, including cardiovascular drug MK 8141, diabetes drug MK 0893, ophthalmic SIRNA -027, and sarcopenia drug MK-2866, each entering Phase II development.
Merck: Key Drugs in R&D Pipeline (Phase III) | ||
Drug Candidate | Indication | Anticipated Regulatory Filing |
MK-0524B | Athero | 2008 |
MK-0364 (taranabant) | Obesity | 2008 |
MK-0974 | Migraine | 2009 |
MK-7418 (rolofylline) | Acute heart failure | 2009 |
MK-8669 (deforolimus) | Cancer | 2010 |
Heplisav | Hepatitis B vaccine | 2010 (for adult dosages) |
MK-0822 (odanacatib) | Osteoporosis | 2012 |
Source: Merck & Co. | ||
Goals for 2010
The company has reaffirmed its financial performance guidance forecasts for 2007 and 2008, which reflect some of the targets set for 2010. The emphasis is clearly on mitigating some of the losses brought about by Fosamax generic competition, as well as looking to boost revenue levels before the expiry of its blockbuster drug, Zocor:
- Compound annual revenue growth of 4-6% from 2005-10. Fifty per cent of revenues to gain from joint-venture (JV) efforts.
- Plan to return product gross margin to pre-Zocor levels in 2008.
- Reduce clinical development cycle times compared with the pharmaceutical sector.
- Mid-single-digit compound annual growth in R&D funding during the period.
Mevacor OTC Attempts
Merck is also pursuing the over-the-counter (OTC) approval for its cholesterol lowering drug, Mevacor (lovastatin); the U.S. FDA is currently reviewing the request from the U.S. pharma major. The Wall Street Journal notes that there is not much clarity on safety and effective use of the drug, which could potentially act as an obstacle to the drug gaining OTC status as a medical reviewer. Merck is seeking approval for a 20-mg dose of Mevacor to be marketed OTC. The source notes that an advisory panel will discuss the issue and recommend to the FDA this week.
Outlook and Implications
The R&D pipeline unveiled by Merck shows good progress, and there is potential for a sustained revenue franchise from some of the late-stage pipeline products. Prominent among the potentials are MK-0542B and the migraine drug MK-0974. However, the inclusion of some candidates will worry analysts given the prior experience of similar drugs; Phase II drug MK-0859 (anacetrapib) is one such example. The candidate is similar to Pfizer's torceptrapib, which was withdrawn after studies indicated an imbalance of "mortality and cardiovascular events" (see United States: 4 December 2006: Increased Mortality Rate Kills Pfizer's Tortured Torceptrapib). The company has said it plans to move the CETB inhibitor into Phase III in 2008. Given the nature of the prior incidents, Merck's candidate will be closely followed. Another candidate that requires mention is obesity drug taranabant. Sanofi-Aventis's Acomplia (rimonabant) ran into rough weather earlier this year after clinical regulatory review of clinical trial data regarding weight-loss drug Acomplia (rimonabant) linked a high dose of the drug with suicidal thoughts and behaviour. Merck has responded by stating it will pursue lower dosage, evaluating doses up to 2 mg.
On the issue of Mevacor, this would be Merck's third attempt to gain an OTC approval for the drug. The initial comments from the medical reviewer do not seem encouraging, and the company will have its work cut out to demonstrate that the drug will be safely and effectively used. Merck has submitted new clinical data to the review committee on the drug in the hope of driving its case home.