|Healthcare Review: Biogen Idec, Inovio Pharmaceuticals, Intuitive Surgical, Puma Biotechnology, Gilead Sciences|
|By Staff and Wire Reports|
|Wednesday, 23 July 2014 13:28|
The European Commission approves Biogen Idec's ($BIIB) Plegridy (peginterferon beta-1a) as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS). It is the only pegylated interferon approved for RRMS. Patients dose themselves every two weeks with a subcutaneous injection using a prefilled syringe.
In a Phase 2 clinical trial evaluating Inovio Pharmaceuticals' VGX-3100 as a treatment for biopsy-proven cervical intraepithelial neoplasia 2/3 (CIN2/3), the cancer immunotherapy candidate achieved its primary endpoint of histopathological regression of CIN2/3 to CIN1 or no disease. It also demonstrated clearance of HPV in conjunction with regression of cervical lesions. Robust T-cell activity was detected compared to placebo.
Shares of Intuitive Surgical (NASDAQ:ISRG) are up 13% on modest volume. The company announced Q2 earnings yesterday. Consensus views for Q3 and Q4 are EPS of $2.86 on revenues of $505M and EPS of $3.51 on revenues of $571M, respectively.
Shares of Puma Biotechnology (NYSE:PBYI) skyrocket 186% on massive volume after the company reported top-line results from its Phase 3 clinical trial evaluating PB272 (neratinib) as a treatment for HER2-positive breast cancer. The study, called ExteNET, enrolled 2,821 patients in 41 countries who had undergone surgery and adjuvant treatment with Herceptin (trastuzumab) (OTCQX:RHHBY). After treatment with trastuzumab, patients were randomized to receive adjuvant treatment with neratinib or placebo for one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS) or death for a period of two years after randomization.
The U.S. regulator grants traditional approval for Gilead Sciences' ($GILD) Zydelig (idelalisib) as a treatment for chronic lymphocytic leukemia (CLL) that has relapsed. Zydelig is to used with Rituxan (rituximab) (OTCQX:RHHBY) (BIIB) in cases where Rituxan alone is appropriate therapy. In a Phase 3 clinical trial, patients treated with Zydelig + Rituxan demonstrated mean progression-free survival of 10.7 months compared to 5.5 months for the Rituxan + placebo cohort.