* Sigma Pharmaceuticals (SIP) - SIP enjoyed a strong run since its August low, posting a 12-month high of 67c in mid September. The price is overbought and diverging with the RSI indicator on a daily and weekly basis, suggesting that a pull back is on the cards. Given the overbought momentum conditions and the proximity to important resistance of 71c, we believe that the upside from here (if any) would be limited. Therefore, we recommend investors take profits and re-invest in other companies within the sector, which offer better returns in the near-term. Approaching Resistance.
* Tissue Therapies (TIS, Buy, Price Target 96c) - announced today that commercial negotiations are proceeding well. The company is confident that an announcement will be made during November and sales of VitroGro to treat chronic wounds are expected to start in the UK and Europe during the second quarter of calendar 2012, as planned. Our comment: Yeah, Yeah!
* QRX Pharma (QRX, Buy, Price Target $2.95) Following QRX's recent $26.5 million capital raising, we have updated our forecasts and valuation, noting minimal underlying changes. Key upcoming milestones include: 1) FDA feedback on NDA submission expected 2HCY11; 2) partnering deal expected 2HCY11; and 3) product approval in 2HCY12.
Key Stories
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* After the markets closed yesterday BioDelivery Sciences in Raleigh, NC put out a release detailing the late-stage failure of its pain drug, BEMA Buprenorphine. And despite the best efforts of the CEO and R&D chief to make it sound like nothing more than a bump in the road to final success, its shares (BDSI) went into a nosedive, losing more than half their value. The drug failed a simple standard in pain studies - significantly beating out a placebo for pain relief. But CEO Mark Sigo focused on the positive findings, including a near-miss in the opioid experienced arm of the study. Now the biotech is planning a second late-stage study while continuing a hunt for a partner. The R&D chief put the trial failure down to an unusually high placebo response. Our comment - Go QRX.
(Source: FierceBiotech)
* Merck (MRK) is stepping away from a consumer-drugs partnership with Johnson & Johnson (JNJ). After quality issues at one of the 50-50 joint venture's plants spurred recalls of Pepcid and Mylanta products, Merck sold its interest to J&J for $175 million, giving up the rights to market Pepcid, Mylanta, Mylicon and other common over-the-counter drug brands in the US and Canada. Merck says it's selling out of the 22-year-old JV so it can focus more tightly on its own wholly owned consumer drugs operation, which it acquired along with Schering-Plough in 2009. "Termination of the JJMCP venture ... gives Merck greater freedom to operate in the OTC consumer sector," the company said in a statement, adding that it aims to "fully exploit" its pipeline of prescription-to-OTC conversions and "actively pursue" OTC licensing.
(Source: FiercePharma)
* GlaxoSmithKline (GSK) can thank Greece and Angela Merkel if its attempt to sell an OTC drug portfolio stalls. Europe's inability to get its act together is frustrating some M&A, as satisfactory financing is tough to nail down, Reuters reports. So, roiled debt markets are slowing down GSK's sale process, sources tell the news service.
(Source: FiercePharma)
Most recent FDA drug approvals
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* September 26 - Soliris (eculizumab). For the treatment of Atypical Hemolytic Uremic Syndrome in pediatrics and adult patients. Alexion Pharmaceuticals Inc.
* September 23 - Remicade (infliximab). For the treatment of moderate to severe active Ulcerative Colitis (UC) in pediatric patients. Janssen Biotech Inc (formerly Centocor Ortho Biotech Inc).
* September 19 - Prolia (denosumab) For the treatment of bone loss induced by Hormone Ablation Therapy. Amgen Inc.