GlaxoSmithKline plc (NYSE:GSK): Closing price $50.11
On Friday, GlaxoSmithKline and Genmab A/S announced the submission of a variation to the marketing authorization to the European Medicines Agency for the use of Arzerra (ofatumumab) in combo with an alkylator-based therapy, to be employed for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. The submission is based mainly on results from an international, multi-center, randomized Phase III evaluation of ofatumumab in combination with chlorambucil versus chlorambucil alone in over 400 patients with previously untreated CLL.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA): Closing price $38.45
Teva announced Friday that the District Court of the Hague has released a favorable ruling in a patent revocation action brought by Mylan B.V., which is a subsidiary of Mylan Laboratories Inc., seeking a court judgment that Teva’s European Patent NL 762,888 expiring in May of 2015 for its relapsing-remitting multiple sclerosis product, Copaxone (glatiramer acetate injection) is invalid. The court turned aside each one of the grounds of invalidity that Mylan had raised against the claims of Teva’s ’888 patent. The favorable decision follows a similar result in the English Court of Appeal in July 2013, which also affirmed that the claims of Teva’s patent are valid.
Isis Pharmaceuticals, Inc. (NASDAQ:ISIS): Closing price $36.07
On Friday, Isis reported that it dosed the first infant in the 12 mg dose group in the Phase 2 study evaluating ISIS-SMN in infants with Type I spinal muscular atrophy. The Phase 2 study was created to permit Isis to define the optimal dose for the larger Phase 2/3 study in infants, and to provide safety and tolerability data. Isis intends to finalize this study and commence the larger Phase 2/3 pivotal study early in 2014. The firm earned a $2 million milestone payment from Biogen IDEC linked with the advancement of this study.
Tekmira Pharmaceuticals Corp. (NASDAQ:TKMR): Closing price $8.9107
The developer of RNA interference therapeutics, announced Friday that it is presenting additional TKM-PLK1 data at the 6th Annual NET Conference hosted by the North American Neuroendocrine Tumor Society to be held in Charleston, South Carolina from October 4 and 5. Forty percent (6 out of 15) of patients evaluable for response, treated at a dose equal to or greater than 0.6 mg/kg, exhibited clinical benefit. Of the 36 patients enrolled, three out of the four ACC patients treated with TKM-PLK1 achieved stable disease, including one patient who saw a 19.3-percent reduction in tumor size and remains on study receiving TKM-PLK1.