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Merck HCV FDA Submission in 1st Half 2015
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Merck to Continue Focus on Cancer Drug Keytruda
Company Will Also Seek Approval for Hepatitis C Treatment
WSJ Jan 12 2015. Ahead of its presentation at the J.P. Morgan Healthcare Conference, Merck outlined goals for the year and said its redesigned operating model helped the company remain on track to save $2.5 billion in annual net cost by the end of 2015. The restructuring, begun in October 2013, is intended to create international research hubs in areas such as Boston and Shanghai, as well as prune the research pipeline. In October, Merck sold its consumer-care business to Bayer AG , and has unloaded other products in smaller deals. Instead, Merck, which had an aging drug portfolio, has been prioritizing the areas of immuno-oncology, hepatitis C, cardiometabolic disease, antimicrobial resistance and Alzheimer's disease. Merck's leaders have made clear they aren't interested in pursuing large-scale acquisitions, but rather more modest-size, "bolt-on" deals that bolster the company's research-and-development pipeline and its product lineup.
Merck Accelerates Drug-Submission Plans
Mid-Year Applications Are Goal for Keytruda for Lung Cancer, New Hep C Treatment
Merck hopes that an overhaul of its research-and-development engine in the past 18 months has positioned it to introduce two new drugs at least several months earlier than expected.
By
Peter Loftus
Jan. 11, 2015
Merck & Co. has accelerated its plans to submit new drugs for hepatitis C and lung cancer for regulatory approval, in a bid to close the gap with competitors in two lucrative segments.
The Kenilworth, N.J., drug maker hopes that an overhaul of its research-and-development engine in the past 18 months has positioned it to introduce the new drugs at least several months earlier than expected. It is possible the drugs could hit the market later this year if government regulators approve them.
Merck has made speed an important focus of its R&D overhaul, in an effort to get to market as fast as possible with new drugs. The company has cut spending on many of its research programs and shifted resources to more promising projects including cancer immunotherapy and hepatitis C. One tack to speed development: enrolling patients in clinical trials of its experimental hepatitis C treatment more quickly than originally planned.
"The tempo has changed," said Roger Perlmutter, who took over as president of Merck Research Laboratories in 2013. "What we are doing is focusing our efforts more profoundly, increasing the speed at which we complete things."
Recent changes include the acquisitions of Cubist Pharmaceuticals, which works on the relatively understudied area of antibiotic resistance, and Idenix Pharmaceuticals, which develops hepatitis C treatments.
The company said Sunday it will file an application around midyear for U.S. regulatory approval to expand the use of its new cancer immunotherapy Keytruda to include the treatment of non-small-cell lung cancer, the most common form of the deadliest cancer.
Keytruda is known as a PD-1 inhibitor and is designed to work by stimulating the body's immune system to fight tumors. Keytruda and other new cancer immunotherapies are expected to form a multi-billion-dollar market in coming years, especially if they are shown to be effective for multiple cancer types.
The Food and Drug Administration first approved Keytruda in September to treat the skin cancer melanoma. Use of the drug to treat lung cancer would represent a far bigger commercial opportunity because there are more patients. More than 220,000 new cases of lung cancer are diagnosed in the U.S. each year, versus about 76,000 for melanoma, according to the American Cancer Society. Keytruda costs about $12,500 a month.
Late-stage clinical trials of Keytruda in lung-cancer patients aren't scheduled to be completed until at least 2018. But Merck has reported early-stage trials showing Keytruda shrank tumors in at least 20% of lung-cancer patients, and has conducted interim analyses of the ongoing studies, which could support a regulatory application.
In October, the FDA designated Keytruda as a "breakthrough therapy" for lung cancer, a status that confers closer communications between agency officials and Merck, which could facilitate an early agency decision.
Bernstein analyst Tim Anderson said in a research note last week that an FDA approval of Keytruda's use in lung cancer in the second half of 2015 would be about six to 12 months earlier than many analysts have been expecting.
He expects such an approval to bump Keytruda's 2015 sales to about $900 million, versus Wall Street consensus estimates closer to $400 million.
Merck's main competitor in cancer immunotherapy, Bristol-Myers Squibb Co. , initiated an application last year for FDA approval of its own PD-1 inhibitor, Opdivo, as a treatment for lung cancer. The agency hasn't issued a decision. The FDA approved Opdivo to treat melanoma in December.
Merck also plans to file an application in the first half of this year for FDA approval to market a new two-drug, single-pill combination to treat the liver disease hepatitis C. The drugs, grazoprevir and elbasvir, cured at least 90% of infected patients in a mid-stage clinical trial and Merck is testing them in late-stage studies.
The company previously said it expected to file for regulatory approval of the hepatitis C regimen sometime during 2015.
In hepatitis C, Merck is trying to catch up to market leader Gilead Sciences Inc., which analysts estimate raked in at least $12 billion in combined sales in 2014 from the blockbuster drug Sovaldi and the first all-oral combination drug, Harvoni. AbbVie Inc. recently introduced the second all-oral regimen, Viekira Pak.
Merck isn't expected to overtake Gilead, but could grab a significant portion of a large market.
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