BMY's Opdivo Scores Another FDA Nod, INO To Take A Shot At Zika, OMED On Watch

(RTTNews) - Amgen's (AMGN) Repatha has been approved in Japan for the treatment of patients with familial hypercholesterolemia or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins).

Repatha was developed in Japan by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc.

The drug is already approved in the European Union, United States and Canada. Priced at $14,100 a year, Repatha is seen by analysts as a potential blockbuster.

AMGN closed Friday's trading at $156.08, up 2.16%.

Bristol-Myers Squibb Co.'s (BMY) cancer drug Opdivo has scored another FDA nod - this time in combination with Yervoy for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval. This is the seventh approval for Opdivo in just over a year, and the fourth for late-stage melanoma.

Global sales of Opdivo in the nine months ended September 30, 2015 were $467 million.

BMY closed Friday's trading at $64.40, up 2.01%.

A collaborative research program has been initiated by Inovio Pharmaceuticals (INO) and Korea-based GeneOne Life Science to test and advance a DNA-based vaccine for preventing and treating the emerging and virulent Zika virus infection. The Zika virus vaccine candidate is currently undergoing preclinical animal studies to evaluate its immunogenicity.

The two companies are already collaborating on two phase I stage vaccine candidates namely, INO-4212, a vaccine for Ebola infection, and GLS-5300, a vaccine for MERS infection.

INO closed Friday's trading at $5.07, up 0.20%.

OncoMed Pharmaceuticals Inc.'s (OMED) phase Ib trial of Demcizumab in pancreatic cancer has demonstrated safety and yielded early efficacy results.

In the trial, which had enrolled a total of 56 subjects, the first 24 subjects were treated with Demcizumab and Gemcitabine and after a protocol amendment, 32 subjects received Demcizumab (in a truncated fashion) with the new standard of care of Gemcitabine plus Abraxane.

According to OncoMed, Demcizumab in combination with chemotherapy had an acceptable safety profile, and the updated Kaplan-Meier estimated median progression-free survival was 7.1 months and median overall survival was 12.7 months for the patients who received the Demcizumab-Gemcitabine-Abraxane combination.

The current standard-of-care treatment for advanced pancreatic cancer with Gemcitabine and Abraxane, based on phase III data, has median progression-free survival of 5.5 months and median overall survival of 8.5 months, the company added.

A phase II study of Demcizumab in first-line pancreatic cancer patients with metastatic disease, dubbed YOSEMITE, is underway. Enrollment in this trial is expected to be completed in 2016 - with data anticipated in early 2017.

OMED closed Friday's trading at $17.57, up 3.78%.