Cephalon Inc. celebrates its 20-year anniversary today with a new approved product for promotion by its sales reps, who shouldn't expect any shortage of call opportunities with three more new drug applications expected soon from the company.
Cephalon is paying ECR Pharmaceuticals $100 million in cash for North American rights to Amrix (cyclobenzaprine hydrochloride extended-release capsules), a muscle relaxant product approved by the FDA in February for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Frazer, Pa.-based Cephalon expects to launch the product early in the fourth quarter.
Cephalon Chairman and CEO Frank Baldino, who founded the now-$4.8 billion company in 1987, said he believes Cephalon can get "significant penetration" into the muscle relaxant market, since its new product has advantages vs. existing drugs such as once-a-day dosing and reduced side effects in areas such as sedation and drowsiness.
Cyclobenzaprine hydrochloride is the active ingredient in Johnson & Johnson's Flexeril, a class from which 37 percent of the 45 million prescriptions for muscle relaxants were written in 2006, Cephalon said.
Privately held ECR, of Richmond, Va., is eligible to receive undisclosed milestone payments from Cephalon if Amrix sales reach certain levels. ECR got rights to the product from Eurand NV, of Milan, Italy, which applied its Diffucaps extended-release technology to Amrix. Eurand remains entitled to royalty payments from Cephalon.
Amrix will be sold by both the pain and central nervous system sales forces at Cephalon, whose approved products include the sleepiness drugs Provigil and Nuvigil and the pain drugs Actiq and Fentora. The company is planning separate new drug application filings this year seeking approval of Treanda (bendamustine) for treating chronic lymphocytic leukemia and indolent non-Hodgkin's lymphoma, and a supplemental NDA filing for Fentora in treating non-cancer breakthrough pain. Cephalon's product sales were $859 million for the first six months of the year, with total revenues of $884 million.
"This looks like a nice overlap of our [sales] call universe," Baldino told BioWorld Today, adding that Amrix will be sold to both pain specialists and neurologists. "It a great product with great qualities, and it's approved, which makes it even better.
"We're pretty happy about this," Baldino said of the Amrix acquisition. "We believe this will be an important player in the space," while also helping drive sales growth at Cephalon.
Baldino pointed to Skelaxin (metaxalone), a King Pharmaceuticals Inc. product that, like Amrix, is a muscle relaxant indicated as an adjunct to rest, physical therapy and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. He said that product has achieved about 10 percent market penetration, translating into about $480 million in U.S. sales.
Cephalon said it anticipates the Amrix acquisition will be modestly dilutive in the fourth quarter due to product launch costs, and to be accretive in 2008 and thereafter. The company, however, reaffirmed its existing guidance on 2007 sales and adjusted income per share.
Twenty years on, Baldino continues to stress increasing sales and making money for shareholders. "It's a good company with good growth and tremendous products, and here's another one today we're adding to the list," he said.
"If you look back when you start these things, to end up 20 years later as one of the top biotech companies we're very pleased to be among them. You never expect to do this when you started. It's very nice it turned out the way it did. It's been a great 20 years."
Cephalon's stock (NASDAQ:CEPH) gained 90 cents Thursday to close at $72.14.