Merck Talks About Its Pipeline Post-Singulair

With its blockbuster asthma drug Singulair going off-patent at the end of the year, Merck is looking to a few key drugs to fill the revenue gap in the coming years, said the company at a recent Deutsche Bank Healthcare conference.

Merck & Co. Inc. isn’t holding its breath for the patent loss of its blockbuster asthma drug Singulair (montelukast); instead, the big pharma is shifting its focus to products that could have a major impact on large markets like diabetes and hepatitis C. At the Deutsche Bank Healthcare Conference in Boston on May 9, Merck CFO Peter Kellogg and the head of the company’s diabetes and endocrinology franchise, Nancy Thornberry, spoke about the drugs expected to sustain the company through Singulair’s loss of exclusivity.

“As we look at 2012, we do recognize we are working against certain headwinds, and we're trying to make sure our growth-drivers are sufficient to offset those headwinds,” said Kellogg.

Singulair, by a wide margin, remained Merck’s top-seller in 2011. It posted full-year sales of $5.5 billion, up 10%, from the year prior. With the August patent expiry in the U.S., however, Merck is resigned to “a significant decline in sales,” Executive VP and President, Global Human Health, Adam Schechter, said during the company’s year-end call on Feb. 2, despite the fact that the asthma and allergy drug retains exclusivity in the EU until next February and in Japan until 2016.

Merck has been doing all it can to retain Singulair revenues for as long as possible. The company was able to hold off generic competition, particularly from Teva Pharmaceutical Industries Ltd., through a series of court battles, ending with a decision in its favor in August 2009 (Also see "Merck Wins Singulair Patent Battle With Teva" - Pink Sheet, 19 Aug, 2009.).

Now, Merck is looking to the products that potentially could fill that $5 billion hole. The company will target a few key markets, including a follow-on product to its diabetes drug Januvia (sitagliptin) that will target diabetics with cholesterol problems, as well as drugs for the hot hepatitis C space.

Expanding On The Januvia Franchise

Merck’s oral DPP-4 inhibitor for type 2 diabetes, Januvia, is its second-largest-selling drug with $3.3 billion in sales in 2011. That, with Janumet – a drug that combines the active ingredient of Januvia with metformin, makes up 76% of the DPP-4 market. Janumet tallied sales of $1.4 billion last year. Now, Merck is rolling out another Januvia combo drug that combines its active ingredient with the cholesterol drug Zocor (simvastatin), called Juvisync, which was approved in October 2011 (Also see "Diabetes Franchise May Help Merck Offset Loss Of Singulair" - Pink Sheet, 2 Feb, 2012.).

“We think there's a real opportunity for the product, because Type 2 diabetics are at increased risk of cardiovascular disease by two- to fourfold. And statin therapy is recommended in those patients, but the majority of them don't take a statin,” said Thornberry. “So, we think having the combination of sitagliptin and simvastatin in a single pill with one co-pay offers a substantial opportunity for patients to control both their glucose and their cholesterol.”

Moving beyond Januvia, Merck is working on a once-weekly DPP-4 inhibitor, MK-3102, which is expected to enter Phase III trials this year. “Our research tells us that Type 2 diabetics [who] have a very large pill burden really welcome anything that simplifies their treatment regimen,” said Thornberry. “This particular molecule just completed Phase IIb, and we believe will have an efficacy and safety and tolerability profile that will be very similar to sitagliptin, with a dose that'll be 25 mg or less.”

Merck has taken a three-pronged approach to treating diabetes: “One is new oral agents, but obviously the bar is high,” said Thornberry. “And we're not just looking for oral agents that are only incrementally better than standard of care, but really have a substantial benefit.”

“The other is in the area of GLP-1 analogs, and there we think there is still opportunity. I think it's actually going to take a while for our GLP-1 analog to emerge, and we're particularly interested in the analogs that may have the potential for greater body weight loss,” she added.

“And then, in the insulin area, we believe that for sustained leadership in diabetes we really should be in the insulin area. So we have made a commitment to get into insulin.”

HCV Heats Up

In hepatitis C, where it inherited an industry-leading position from its 2009 merger with Schering-Plough Corp., Merck retains high hopes for slow-selling protease inhibitor Victrelis (boceprevir) (Also see "Merck Makes Hepatitis C A Priority" - Pink Sheet, 11 Nov, 2011.).

“We really have to look at it in a couple stages. The first part is we have Victrelis on the market right now, and that's very important to us. There are a number of new patients coming into the therapy,” said Kellogg at the conference. “There's a number of patients that have fairly acute conditions and they need to get going, and so we're making sure that we're rolling that out worldwide and really making sure we're well-positioned in the market and driving awareness and supporting the physician community to make sure that they can handle that load.”

The second wave of Merck’s HCV strategy hinges on the development of another PI, MK-5172. Data from a study presented 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, and there is other evidence to show that the drug has antiviral activity against a wide range of resistant mutant HCV types.

“MK-5172 is involved in a Phase II trial right now,” said Kellogg. “We have completed the first 12 weeks of dosing in that trial, but the ribavirin and peg-interferon component is continuing for another 12 to 24 weeks. That data could be available later this year. It's not yet complete.”

Opportunity In Biosimilars

One the areas that Merck has recently shifted resources to is its biosimilar business under Merck Bioventures. Kellogg said that biosimilars are now “a part of our overall biologics portfolio, and we’re thinking about biologics as a whole in terms of novels and biosimilars.” The company has four of the copycat biologics in development currently, including a biosimilar of the rheumatoid arthritis drug Enbrel (etanercept).

“We're now looking at prioritization decisions. And so we looked at what is the best opportunity for our R&D investments, whether they're biosimilars or they're novel biologics,” said Kellogg. “As these biosimilars move forward, it's becoming more and more of an R&D, clinical development story. So we're actually putting more of our focus on the clinical development side for the biosimilars as well as the novel biologics.”