Merck Suffers Blow Developing New Migraine Drug

Merck, maker of the Maxalt migraine drug, has been betting heavily on adding a new medicine to its lineup aimed at the multibillion-dollar migraine market. The company has been planning to ask the FDA this year to approve the medicine, telcagepant, and analysts predicted the drug could have $800 million or more in sales in 2015. Analysts considered telcagepant one of Merck’s key new products.

But the drug maker announced this morning that it would delay taking telcagepant to the FDA, and one analyst wondered whether the drug would ever make it. “It is fully conceivable that this product will be terminated,” Sanford Bernstein’s Tim Anderson wrote in a note to investors.

The problem: some patients participating in an exploratory study gauging whether the drug could be taken daily to prevent migraines developed high levels of liver enzymes. The company stopped the study and is reviewing data from another study, said Peter Kim, Merck’s research chief. Meantime, it is moving ahead with studies of the drug’s intermittent use to treat migraine attacks.

Merck disclosed the telcagepant news in announcing disappointing financial results for the first quarter.

The struggles are another reminder of the unpredictability of drug research and development, and the difficulties that Merck and other big pharmaceutical companies have had finding lucrative new drugs to replace the blockbusters losing patent protection over the next several years.

More than a third of Merck’s revenues come from drugs whose patents run out through 2013, according to Edward Jones’ Linda Bannister. The depth of its “patent cliff” is so steep that Merck, which had prided itself on its homegrown research, is now inking drug development deals with outside firms. More telling, it agreed to buy Schering-Plough for $41.1 billion.

Seamus Fernandez, a Leerink Swann analyst, told the Healh Blog that the telcagepant news — combined with its poor first-quarter performance — “increases the importance of a successful merger outcome.” In a conference call with analysts, Merck officials said the merger, slated for completion in the fourth quarter, was on track.

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