Business And Legal News In Brief

Positive top-line results for Roche's CellCept: Roche and Vifor Pharma announced June 3 that CellCept (mycophenolate mofetil) demonstrated superiority to azathioprine (AZA) in delaying treatment failure in patients with lupus nephritis during the maintenance phase of the Aspreva Lupus Management Study, one of the largest ever conducted in lupis nephritis. Vifor Pharma will report full results at the International Congress on Systemic Lupus Erythematosus June 24-27. Late last year, positive data from a second Phase III trial of Human Genome Sciences/GlaxoSmithKline's lupus candidate Benlysta generated attention, but FDA has not approved a new treatment for the disease in more than 50 years, leaving stakeholders awaiting the next market entrant (1"The Pink Sheet" DAILY, Nov. 2, 2009)

Positive top-line results for Roche's CellCept: Roche and Vifor Pharma announced June 3 that CellCept (mycophenolate mofetil) demonstrated superiority to azathioprine (AZA) in delaying treatment failure in patients with lupus nephritis during the maintenance phase of the Aspreva Lupus Management Study, one of the largest ever conducted in lupis nephritis. Vifor Pharma will report full results at the International Congress on Systemic Lupus Erythematosus June 24-27. Late last year, positive data from a second Phase III trial of Human Genome Sciences/GlaxoSmithKline's lupus candidate Benlysta generated attention, but FDA has not approved a new treatment for the disease in more than 50 years, leaving stakeholders awaiting the next market entrant (¹ (Also see "Benlysta Back In The Spotlight With BLISS-76, But Second Phase III Still May Not Be Enough To Support Some Claims" - Pink Sheet, 2 Nov, 2009.)).

Biovail licenses fourth Parkinson's Disease program: Biovail's subsidiary, Biovail Laboratories, acquired U.S. and Canadian rights to sell products containing istradefylline - a new chemical entity targeted for the treatment of Parkinson's disease - from Japanese pharma Kyowa Hakko Kirin. Under the deal, which also includes a supply agreement for istradefylline, Biovail paid $10 million upfront and agreed to pay up to $20 million in potential milestones through an FDA approval. After that, Kyowa Hakko Kirin also could earn an additional $35 million in sales milestones. Biovail also will make tiered royalty payments on sales of products containing istradefylline of up to 30 percent. In 2008, Kyowa Hakko Kirin received an FDA action letter citing efficacy concerns after submitting a new drug application for istradefylline (² (Also see "Kyowa Hakko’s Parkinson’s Drug Is Not Approvable – U.S. FDA" - Scrip, 28 Feb, 2008.)).

Trubion wins patent case against Genentech; Biogen: Seattle-based Trubion Pharmaceuticals won a dispute to revoke Genentech and Biogen Idec's European patent 1176981 for the use of an anti-CD20 antibody for rheumatoid arthritis, announced June 3. Trubion filed an opposition to the patent in 2006, objecting to its validity. Shortly after that, MedImmune, Genmab A/S, Centocor, Glaxo Group, Merck Serono and (at that time) Wyeth filed oppositions to Genentech's patent. After a series of appeals, on June 1 the Opposition Division of the European Patent Office upheld its decision that Genentech (now Roche) and Biogen's patent should be revoked since it did not meet the so-called requirements for patentability. Genentech and Biogen can pursue a claim limited to the use of rituximab in combination with methotrexate to treat RA, however. The implications of the suit are not immediately clear for the companies involved.

Javelin files suit against Hospira: Javelin Pharmaceuticals filed a breached agreement suit against Hospira after Hospira extended its tender offer for the second time to buy the pharma for $145 million in cash. The companies reached their initial agreement in April, then in mid-May Hospira extended its tender offer until June 2, only to extend it further to June 16. Hospira says the most recent extension is linked to issues related to the recall in Europe of certain batches of Javelin's post-operative pain drug, Dyloject (diclofenac sodium). Therabel Pharma UK Limited, which sells the drug in the UK, reported a white particulate matter in some vials of Dyloject in its supply chain, which led to a Drug Alert Class 2 Medicines recall in the UK. "Hospira has delivered notice of the extension of the tender offer to Javelin based on its determination that all of the conditions to the offer had not been satisfied as of the expiration date of the offer," the pharma said, though it intends to complete the offer when these concerns are resolved.

Purdue Pharma's Ultram ER patent ruled invalid: The U.S. Court of Appeals for the Federal Circuit upheld a district court decision that Purdue's Ultram ER (tramadol) patent claims are invalid for obviousness. In a June 3 ruling, the court agreed that the claims would be obvious in light of another patent that describes formulations of opioid analgesics, including tramadol, for once-daily dosing and given what is known in prior art. Ortho-McNeil sells Ultram ER under a license from Purdue. Purdue and Ortho-McNeil had sued Par for infringement.

Patent office proposes three-track patent examination process: The U.S. Patent and Trademark Office is proposing an initiative to give applicants a choice of three tracks for review of patent applications that are filed first in the U.S. Track I applicants would receive priority examination, Track II would receive traditional examination and under Track III, applicants could delay review of non-continuing applications for up to 30 months. For applications based on a prior foreign-filed application, PTO would not act until it receives a copy of the search report, if any, on the first office action from the foreign office and a reply to that action. A public meeting on the proposal will be held at PTO July 20. The patent office recently launched another program allowing applicants to expedite review of one application in exchange for dropping another (³ (Also see "Patent Office Would Get Ability To Set Fees Under House Bill; PTO To Allow Applicants To Fast Track One Application By Dropping Another" - Pink Sheet, 24 May, 2010.)). The PTO expects the three-track process to cut the pendency, currently almost three years.