GlaxoSmithKline Biologicals (a GSK unit) and AFFiRiS GmbH have entered a collaboration agreement granting GSK exclusive rights to AFFiRiS's Alzheimer's disease vaccine programs that target beta-amyloid. GSK is acquiring exclusive rights to develop and commercialize two vaccine candidates currently in Phase I development that are based on AFFiRiS AFFiTOPE technology. GSK also has an exclusive option to develop and commercialize alternative Alzheimer's vaccine candidates in preclinical development.
   
Under the terms of the agreement, AFFiRiS will receive an up-front payment of $28.8 million and is eligible for future milestone payments and royalties. The total potential value of the agreement could reach $551.3 million in the event of full commercial success of the candidate vaccines. This agreement is subject to government approval.
   
AFFiRiS AFFiTOPE technology allows the design of proteins with very specific binding characteristics that are ideally suited for the development of vaccines against disease-causing "rogue" human proteins such as beta-amyloid, which is central to the pathology of Alzheimer's disease.
   
Walter Schmidt, co-founder and chief executive officer of AFFiRiS, said, "We are pleased that we could secure GSK Biologicals, one of the world's leading vaccine companies, in collaborating on the development our Alzheimer's disease vaccine programs. This deal brings together two companies with strong innovation, vaccine development and commercialization capabilities and experience."

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted a NDA to the FDA for carisbamate, an investigational compound for the adjunctive treatment of partial onset seizures in patients 16 years of age and older.
   
The filing is supported by data from three placebo-controlled trials in patients with epilepsy. Results from the first study were presented at the Ninth EILAT Conference on Antiepileptic Drugs in June and results from two additional studies will be presented at the annual meeting of the American Epilepsy Society later this year.
   
In 1999, J&JPRD and SK Holdings Co. entered into a license agreement to develop and commercialize carisbamate under which J&JPRD received global marketing rights. If approved, carisbamate will be marketed by Ortho-McNeil Neurologics under the brand name Comfyde.

Elan

3Q Revenues: $270.1 million (+53%) 

3Q Loss: $83.5 million  (loss of $87.4 million in 3Q07) 

YTD Revenues: $730.4 million (+35%)

YTD Loss: $240.5 million (loss of $321.5 million in YTD07)

Comments: Biopharmaceuticals business grew by 85% driven by a strong performance from Tysabri, with Elan’s recorded sales up 159% to $164.5 million. Total in-market sales of Tysabri were $237.0 million in the quarter (+154%). Azactam sales were $24.2 million (+17%). Maxipime sales were $5.7 million down from $19.2 million in 3Q07. R&D expenses were $90.0 million in the quarter (+53%) primarily related to the advancement of the company’s Alzheimer’s disease programs in the clinic. Revenue from the Elan Drug Technologies (EDT) business was up 3% to $71.2 million. Manufacturing revenue and royalties totaled $67.5 million and total contract revenue was  $3.7 million in the quarter. Due to uncertainty in the financial and credit markets, Elan has decided to hold onto the EDT business and allow it to develop and grow as an independent, wholly-owned subsidiary. Potential generic competition looms for several of the products from which Elan earns manufacturing revenue and royalties.

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