Biotech Digest – JAZZ Reports Positive Results, CTSO Inks New Contract, AMGN Forges Collaboration

Top Pick of the Day: CAPR

Capricor Therapeutics (CAPR) announced encouraging six-month results in a Phase 1/2 clinical trial, HOPE, evaluating lead product candidate CAP-1002 in Duchenne muscular dystrophy (DMD) patients at least 12 years old with heart disease secondary to DMD. HOPE randomized 25 subjects to receive either a single dose of CAP-1002 (n=13) or usual care (n=12). Patients in the test group experienced a statistically significant improvement in systolic thickening of the inferior wall of the heart (p=0.030) and in the function of the middle and distal upper limb (p=0.045). Differences in several other cardiac and skeletal muscle metrics that support a treatment effect were also observed. CAP-1002 was generally well-tolerated.
Capricor Therapeutics jumped over 16 percent in the pre-market session. Its Year to Date gain stands at 16 percent while it lost 23 percent of its value in the past 12 months.

Focus Ticker: CANF

Can-Fite BioPharma (CANF) stock shot up as the company announced approval of its  Phase 3 ACRobat clinical trial protocol evaluating piclidenoson for the first-line treatment of rheumatoid arthritis by the Institutional Review Board at Ashkelon, Israel's Barzilai Medical Center. This is the first trial site to OK the study. ACRobat's primary endpoint is low disease activity after 12 weeks of treatment compared to methotrexate. The 500-subject study's duration will be 24 weeks and will be conducted at sites in Israel, Europe and Canada.
Can-Fite BioPharma stock gained over 28 percent in the pre-market session. The firm is an Israel-based biopharmaceutical company.

Sector News

Jazz Pharmaceuticals (JAZZ) reported results from its Phase 2/3 clinical trial, EXPRESS, evaluating Xyrem (sodium oxybate) for the treatment of cataplexyin pediatric patients with narcolepsy. The study met its primary and key secondary endpoints. The preliminary data are consistent with the results from adult studies and real-world post-marketing experience. The company plans to submit its supplemental NDA in the U.S. seeking a pediatric claim for Xyrem in the fourth quarter.
Achillion Pharmaceuticals (ACHN) announced mid-stage data for triple combo of simeprevir, odalasvir and AL-335 for HCV-3. The data showed a 100% cure rate at weeks 6 and 8 for HCV genotype 1. However, it did not show enough of an efficacy signal for HCV genotype 3 to warrant continued development. Odalasvir, an NS5A inhibitor, is being developed by J&J's Janssen Pharmaceuticals under a May 2015 global agreement.


PhaseRx announced that the European Medicines Agency has granted its lead product candidate PRX-OTC an Orphan Drug for the treatment of ornithine transcarbamylase deficiency, a rare inherited disorder that causes ammonia to accumulate in the blood. Among the benefits of Orphan Drug status in the EU is a 10-year period of market exclusivity for the indication, if approved.

CytoSorbents (CTSO) announced that it has been awarded a two-year contract by the U.S. Department of Defense chemical and biological defense research unit. The contract is estimated to be worth nearly $1 million. The agreement involves the support of continued development of CytoSorb for fungal mycotoxin blood purification. The aim of the Phase 2 Small Business Innovation Research (SBIR) program is to demonstrate the ability of CytoSorb to absorb mycotoxins in vivo and improve survival in animals.

Deals and Collaborations 

Amgen (AMGN) announced its new collaboration with Novartis (NVS). The deal calls for co-promotion of erenumab in the US. Novartis will be responsible for exclusive marketing of the drug in Canada. Amgen retains exclusive rights in Japan and Novartis in the rest of the world. Under the terms of the agreement, Amgen will receive milestone payments from Novartis starting this year and will share U.S. commercialization costs. 
Eaton Pharmaceuticals (EAPH) reported signing a non-disclosure agreement with an  Israel-based agricultural products developer ahead of negotiations over deal with the company.Potential alternatives are  an acquisition, joint venture or a distribution agreement. The Israeli firm produces crop protection products that are based on extracts from local plants in the Judean Desert.

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