Cephalon Inc. reacquired rights to its cancer pain product, Actiq, in 12 countries from Elan Pharma Ltd., a subsidiary of Elan Corp. plc, to the tune of $50 million in cash.
Actiq is one of three drugs already marketed by West Chester, Pa.-based Cephalon in the U.S., where Actiq had sales of $47.8 million in the first half of 2002.
The deal marked the second in as many days for Elan, which is divesting assets in a restructuring move away from oncology and hospital and primary care products to focus on only neurology, pain management and autoimmune diseases.
"This is consistent with our aspirations to continue to profitably grow and not take on additional pipeline risk, so here we are buying a product we know very well, we manufacture and we sell in the U.S.," Cephalon Senior Director of Investor Relations Robert Merritt told BioWorld Today. "And now, we'll be able to sell it in Europe."
Andrew Gitkin, senior biotechnology analyst with UBS Warburg in New York, said: "[Cephalon] has over the past year purchased all the rights to their marketed drugs. By doing so, they have centralized the marketing strategy, as well as the entire product development strategy within the company. In a sense, they're more in control of their own destiny, and I view that as a positive."
It was the second time this week that Elan, of Dublin, Ireland, disposed of assets.
On Wednesday, Elan and Enzon Inc., of Bridgewater, N.J., reported that Enzon would buy the North American and Japanese rights to Abelcet, Elan's drug for severe fungal infections, for $370 million. And there should be more ahead, said Sunny Uberoi, spokesman for Elan. (See BioWorld Today, Oct. 3, 2002.)
"You can certainly expect more in terms of asset disposal by the end of the year," he said, calling this week's deals "important steps" toward the company's goal of raising $1 billion by December 2003.
Elan gained the rights to Actiq (oral transmucosal fentanyl citrate) in 12 countries, including the UK and Germany, in December 1999 from Anesta Corp., of Salt Lake City. Cephalon acquired Anesta in a stock deal valued at $444 million in July 2000. (See BioWorld Today, July 18, 2002.)
The other countries are Austria, Belgium, Greece, Ireland, Italy, Luxembourg, the Netherlands, Switzerland, the Philippines and Taiwan.
Actiq had been marketed by Elan in the UK since January 2001 and in Germany and Ireland since early 2002, the company said. U.S. sales of Actiq by Cephalon were about $15 million in 2000, $51 million in 2001 and are expected to be between $100 million and $110 million for 2002, Merritt said. The company will be offering guidance on 2003 when it issues its third-quarter earnings Nov. 6, Merritt said.
"This is a rapidly growing product, and I think it has an attractive opportunity to grow nicely in Europe, as well," he said.
Actiq will be launched in 2003 in Austria, Belgium, Greece, Italy, Luxembourg, the Netherlands and Switzerland, Merritt said.
"Separate from this particular deal, we will also be launching in France," he said, noting that Cephalon already had the rights to Actiq in that country prior to the deal with Elan.
Cephalon has a sales force of about 150 in France, due to its acquisition of Laboratoire L. Lafon, of Maisons-Alfort, France, for $450 million in cash in December, he said. Cephalon also has "a small presence" in Germany, the UK and Switzerland. (See BioWorld Today, Dec. 4, 2001.)
Cephalon also markets Provigil (modafinil), a tablet for excessive daytime sleepiness associated with narcolepsy, and Gabitril (tiagabine hydrochloride), its anti-epileptic drug. Cephalon acquired control of worldwide rights to Provigil when it acquired Laboratoire L. Lafon. The company acquired Gabitril from Abbott Laboratories, of Abbott Park, Ill., in November 2000, for $100 million to be paid over four years. (See BioWorld Today, Nov. 2, 2000.)
Internationally, Cephalon markets about 22 products outside the U.S.
Cephalon is pursuing additional indications for drugs it markets in the U.S. For example, in September, Cephalon reported results from an investigational, multi-center study in 248 children between the ages of 6 and 13 showing that Provigil significantly improves symptoms of attention deficit hyperactivity disorder (ADHD) in children.
"The FDA requires two controlled studies for registration," Merritt said. "This may or may not qualify depending on what the FDA says, but it was a well-controlled study and had a very nice response. We will certainly be pursuing a label in ADHD that will require an additional trial or trials."
Cephalon also is pursuing "a broad label" for excessive sleepiness for those with clinical disorders, such as obstructive sleep apnea, depression, restless leg syndrome and insomnia. The company plans to file a supplemental new drug application for Provigil around the end of the year, Merritt said.
The company has other ongoing small trials that Merritt said the company hopes will point it in the appropriate direction for pursuing larger trials.
"We're looking for a signal in three areas: generalized anxiety, neuropathic pain and insomnia," he said.
Cephalon's stock (NASDAQ:CEPH) rose 29 cents Thursday to close at $41.58. Elan's stock (NYSE:ELN) rose 14 cents Thursday to close at $1.53.