|Healthcare Review: NeuroMetrix, Inovio Pharmaceuticals, Endocan, BioLineRx, Orexigen Therapeutics|
|By Staff and Wire Reports|
|Wednesday, 11 June 2014 13:41|
NeuroMetrix ($NURO) applies for marketing clearance in China for its NC-stat DPNCheck peripheral neuropathy detection device. Once cleared, it will be marketed by the company's partner for Asian markets Omron Healthcare. Approximately 100M Chinese have diabetes which comprises almost one quarter of the world total, making it the largest peripheral neuropathy diagnostic market by volume.
In a regulatory filing, cannabinoid-based cosmeceutical maker Endocan ($ENDO) discloses that its original accountant Scott W. Hatfield, CPA had his registration revoked by the PCAOB as of July 11, 2013. Since then, the company has been unable to communicate with Mr. Hatfield to find out why this happened. On June 5, 2014 the firm engaged Turner, Stone & Co. as its certifying accountant who will re-audit fiscal years 2012 and 2011 in addition to 2013.
Inovio Pharmaceuticals ($INO) takes umbrage over yesterday's bearish article published by TheStreet's Adam Feuerstein. In today's press release, the company says it intends to report VGX-3100's Phase 2 data at the end of July. At present, it remains blinded. Pertaining to efficacy, the study measures regression of disease from late-stage cervical pre-cancer (CIN 2/3) to early stage pre-cancer (CIN 1) or elimination of disease. The study is 80% powered to achieve a 52% response rate in vaccinated subjects compared to a hypothetical 25% in the control group. The 25% figure is based on natural regression response rates that have ranged from 4% - 40% in other studies.
The USPTO issues a Notice of Allowance to BioLineRx ($BLRX) for the composition of BL-7010, a novel polymer for the treatment of celiac disease. The patent, when issued, will be valid until at least 2026. BL-7010 has a high affinity for gliadins, the immunogenic proteins in gluten that cause celiac disease. By sequestering gliadins, BL-7010 masks them from enzyme degradation and prevents the formation of immunogenic peptides that trigger the immune system. It is excreted with gliadin from the digestive tract and not absorbed by the blood.
The FDA extends its review of Orexigen Therapeutics' ($OREX) resubmitted NDA for NB32, the company's weight loss drug candidate. The new PDUFA date is September 11, 2014. The regulator says that it needs the extension to reach agreement on the post-marketing obligation to evaluate NB32's cardiovascular outcomes. CEO Michael Narachi says, "We are working expeditiously with the FDA to finalize the review. We are encouraged by the high level of engagement with the FDA and are confident that we can reach agreement on the remaining post-marketing obligation."