|Healthcare Review: Prima Biomed, Repros Therapeutics, Spectrum Pharmaceuticals, Teva, Aetna|
|By Staff and Wire Reports|
|Thursday, 06 February 2014 16:05|
Prima Biomed ($PBMD +29.9%) says multiple jurisdictions have approved its amended CAN-004 protocol including regulators in Latvia, Lithuania, Bulgaria, Ukraine and Belarus. As previously announced, the CAN-004 trial was approved by the Belgian regulators in January. PBMD says the CAN-004 amendment also has been approved by ethics committees and institutional review boards in the U.S., Australia, Belgium, Bulgaria, Latvia and Lithuania.
After meeting with the FDA to discuss Phase 3 trial data requirements for the use of its Androxal drug to treat secondary hypogonadism, Repros Therapeutics ($RPRX +12.9%) says it "expects to maintain its timeline for submitting an NDA prior to the end of 2014."Repros adds it "understands that the safety of Androxal will stand on its own merits during NDA review and no additional safety assessments are currently planned prior to NDA submission."
The FDA has given a priority review designation to Spectrum Pharmaceuticals' ($SPPI +3.5%) filing of a New Drug Application (NDA) for its Beleodaq blood-cancer treatment .The FDA has set a deadline of August 9 for deciding whether or not to authorize Beleodaq. Spectrum has requested that the FDA approve Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
Teva ($TEVA) net profit rises to $380M from $320M.The 4.8% increase in revenue was primarily attributable to higher sales of generic medicines in the U.S., specialty medicines globally and OTC products. The rise was partially offset by a decrease in generics sales outside the U.S., mostly in Japan due to the weaker yen, and API sales to third parties. Revenue breakdown: total generics +1% to $2.7B; specialty medicines +5% to $2.2B.
Aetna ($AET) net profit almost doubles to $369M from $190M a year earlier, boosted by the acquisition of Coventry Healthcare. Aetna's total medical benefit ratio edged down to 83.9% from 84.1%.Membership rose to 22.19M at the end of 2013 from 18.24M a year earlier. Aetna expects to add 110,000 new private Medicare customers in Q1.Reiterates 2014 operating EPS guidance of at least $6.25 a share.