Washington Editor

In a three-year collaboration entered Tuesday with Cephalon Inc., Novuspharma SpA will use its preclinical research technology to screen a number of cancer compounds provided by Cephalon.

Cephalon’s proteasome inhibitors that demonstrate anticancer activity will be screened by Novuspharma, of Bresso, Italy.

Though neither company would discuss the financial terms of the agreement, Novuspharma released a prepared statement saying any new compounds resulting from the research would be jointly owned by the companies. Furthermore, clinical candidates would be initially developed by Novuspharma until proof of concept is achieved in patients, and subsequent development would be jointly supported by the companies.

Cephalon will retain marketing rights in the Americas and Japan, while Novuspharma gets them in Europe.

In a conference call with reporters and investors Tuesday, Silvano Spinelli, Novuspharma’s CEO, said the companies are not releasing much on the financial terms, because “there’s nothing to tell.”

Robert Grupp, vice president of corporate communications for West Chester, Pa.-based Cephalon, told BioWorld Today that the deal is fairly standard. “This is a pretty classic R&D collaboration where Novuspharma is using its capabilities to screen our rather extensive library of compounds looking for molecules that we might jointly carry forward, so it’s really no more complicated than that. Proteasome inhibitors are the platform technology that defines Cephalon’s research and development initiative.”

The proteasome is a naturally occurring cellular protease complex that works by regulating the expression and activity of proteins involved in cell cycle progression, cell survival and tumor growth, Cephalon said.

For Novuspharma, the opportunity to work with Cephalon is important in two ways. “The first reason is for purely scientific reasons,” Spinelli said. “We think that the proteasome is an ideal target for anticancer activity. The second reason is, it gives us the opportunity to cooperate with an outstanding partner that already has a record in terms of development and commercialization of pharmaceutical products.”

Meanwhile, Frank Baldino, Cephalon’s chairman and CEO, released a statement saying, “By combining Cephalon’s lead proteasome inhibitor compound technology with Novuspharma’s preclinical and technical capabilities, we will maximize the potential of our oncology drug discovery efforts.”

The collaboration comes on the heels of Cephalon’s release of first-quarter product sales of $95.8 million and diluted earnings per share of 25 cents (before certain charges and extraordinary items). That compares to product sales of $40.8 million and a loss per share of 28 cents in the first quarter of 2001.

Cephalon’s stock (NASDAQ:CEPH) closed Tuesday at $54.13, down 82 cents.

In early April, Cephalon spent $55 million to buy back the interest of two unaffiliated investors in a joint venture formed in December for U.S. commercial effort on behalf of Provigil and Gabitril. The buyback meant a $7.1 million extraordinary charge during the first quarter, including the write-off of $4.6 million of costs capitalized in connection with formation of the venture. (See BioWorld Today, April 2, 2002.)

“We had a terrific start to the year with strong sales in all of our three lead products as well as a great first quarter in France at our new acquisition,” Grupp said. “We are very excited with the results, particularly in this gloomy market.”

For the three months ended March 31, sales of Provigil (modafinil) tablets were $44.2 million, a 64 percent increase over sales of $27 million in the 2001 quarter. Sales of Actiq (oral transmucosal fentanyl citrate) were $19.3 million, a 192 percent increase over sales of $6.6 million in the first quarter of 2001. Sales of Gabitril (tiagabine hydrochloride) were $10.2 million, or 41 percent over sales of $7.2 million last year.

Laboratoire L. Lafon, Cephalon’s French subsidiary, reported sales of $22.1 million, which were included in company results for the first time since it was acquired in December.

Cephalon spent $450 million in cash in December to purchase Lafon, of Maisons Alfort, France. Via the deal, Cephalon gained worldwide rights to its flagship product, Provigil, a sleep disorder therapy. (See BioWorld Today, Dec. 4, 2001.)

Currently, Cephalon is assembling a supplemental new drug application for use of Provigil for any clinical disorder in which excessive sleepiness is a major symptom. (Provigil is on the market for excessive daytime sleepiness resulting from narcolepsy.)

Grupp said the company expects to submit the supplement by the end of the year and anticipates a 12-month review cycle.

Novuspharma was formed in 1998 as a spin-off from Boehringer Mannheim and Hoffmann-La Roche.