BioWorld International Correspondent

An FDA extension of the deadline for completing its review of a new drug application submitted by MediGene AG forced the company to revise its financial forecast for the year and prompted a share price fall of almost 9 percent on the Frankfurt Stock Exchange.

MediGene's shares closed Friday at €5.75 (US$7.32), down from the previous day's close of €6.31.

Georg Dönges, spokesman for Martinsried, Germany-based MediGene, said the 90-day extension was routine and was not linked to any concerns about the dossier the company had submitted for its Polyphenon E ointment, which is in development for genital warts. "There is no hint whatsoever that there is a problem," he told BioWorld International. "It was just some statistical data they already had, but they said they wanted it in another form."

The original Prescription Drug User Fee Act (PDUFA) date was July 28, but the FDA classified the additional documentation MediGene submitted at its request as a major amendment. Accordingly, the deadline for the completion of the review has now been pushed to Oct. 31. MediGene expects that the drug, the active ingredient of which is an anti-inflammatory substance purified from green tea leaves, will not launch in 2006.

"It's still possible, but it's unlikely," Dönges said.

The company had originally included in its 2006 forecast a milestone payment of €10 million, which its U.S. marketing partner, Fairfield, N.J.-based Bradley Pharmaceuticals Inc., is due to pay once Polyphenon E is approved. MediGene had forecast that it would break even this year and log revenues of €30 million. According to its revised guidance, it expects to post a loss of between €10 million and €15 million and revenues of €20 million to €25 million.

Discussions on filing for approval in the European Union are under way with regulatory authorities in several European countries, Dönges said. "We plan to file this year." The company will submit Polyphenon E for approval under the European Union's mutual recognition procedure, rather than through the centralized procedure administered by the London-based European Medicines Agency. Discussions with prospective marketing partners are under way also, but the company has not yet finalized its commercialization strategy for Europe. "It's an option for us to market it by ourselves," Dönges said.

Its revised guidance also is due to the company's decision to devote additional resources to what it described as its "main value driving project" - EndoTag, an anti-angiogenesis platform technology based on the use of a liposome carrier to deliver cytotoxic drugs. EndoTag-1 is undergoing a Phase II trial in pancreatic cancer. A Phase II trial in breast cancer will commence later this year, Dönges said. n

Evotec To Earn Up To €100M From Roche CNS Drug Pact

By Cormac Sheridan

BioWorld International Correspondent

Evotec AG could earn upward of €€100 million (US$127.9 million) in milestone payments from an alliance with F. Hoffmann-La Roche Ltd. therapies against a particular ion channel target associated with CNS diseases and other indications.

The company had started the program in-house, but it attracted the attention of Basel, Switzerland-based Roche, which also has two medicinal chemistry collaborations ongoing with Evotec. It remains at an early discovery stage, several years from the clinic, Joern Aldag, president and CEO of Hamburg, Germany-based Evotec, told BioWorld International.

"It's a known target, and we have found some initial chemical matter," he said. "Finding good chemistry on it is simply very valuable."

Neither company has disclosed the identity of the target involved, but Evotec said both companies believe it is "of high priority." Evotec does not have a proprietary position with respect to the target but it has IP on the chemistry it is developing and on its "know-how," Aldag said.

The companies will share costs up to clinical development, at which point Roche will have exclusive rights to take on any drugs identified by the partners. Evotec would receive milestone payments plus royalties on eventual product sales. The first milestone would fall due, Aldag said, on identification of the first clinical candidate, in advance of an investigational new drug filing. If Roche fails to exercise its opt-in rights, Evotec would be entitled to continue development of the program, but it would be required to make certain payments to Roche.

Bringing in a partner at this early stage enables Evotec to reduce the risk attached to the project and to devote resources to other programs that are running in parallel, Aldag said. Evotec's strengths, he said, are in vitro chemistry, assay development and screening.

"When it gets to more of the biology-chemistry integration work, that's where Roche comes in," he said.