Friday, August 22, 2014
- Durata Therapeutics (NASDAQ:DRTX) exercised its right to defer the $25M milestone payment due Pfizer (NYSE:PFE) that was triggered by the first commercial sale of Dalvance (dalbavancin). The milestone was established in 2009 as part of Durata's acquisition of Vicuron Pharmaceuticals from Pfizer.
- In lieu of the cash payment, Durata delivered a $25M promissory note to Pfizer that bears 10% interest compounded annually and matures on July 7, 2019.
- The FDA clears ViiV Healthcare's Triumeq (abacavir 600 mg, dolutegravir 50 mg, lamivudine 300 mg) for the treatment of HIV-1 infection. The single-pill regimen combines the integrase strand transfer inhibitor dolutegravir with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine.
- ViiV Healthcare is an HIV-focused company established in 2009 by GlaxoSmithKline (GSK) and Pfizer (PFE +0.5%). Shionogi joined the venture in October 2012.
- Accuray (ARAY +4.1%) fiscal Q4 and full year results:
- Q4: Revenues: $102.0M (+20.1%); Gross Profit: $38.4M (+40.7%); Operating Expenses: $43.1M (+7.8%); Operating Loss: ($4.7M) (+63.0%); Net Loss: ($9.8M) (+47.6%); Loss Per Share: ($0.13) (+48.0%); Quick Assets: $171.9M (-1.4%).
- Fiscal 2014: Revenues: $369.4M (+16.9%); Gross Profit: $142.8M (+46.3%); Operating Loss: ($18.1M) (+77.6%); Net Loss: ($35.4M) (+65.7%); Loss Per Share: ($0.47) (+64.7%).
- Fiscal 2015 Guidance: Revenues: $390M - 410M; non-GAAP EBITDA: $18M - 27M.
11:31 AM| Comment!
- Johnson & Johnson (JNJ -0.7%) invests $20M in the form of a convertible note in regenerative medicine company ViaCyte in exchange for a future equity stake and the rights to its type 1 diabetes combination product candidate VC-01.
- VC-01 works by loading pancreatic progenitor cells into a proprietary device that is implanted under the skin. The progenitor cells then mature into insulin-producing cells that assist the under-producing pancreas.
- The peer-reviewed journal Circulation Research publishes Aastrom Biosciences' (ASTM +9.1%) Phase 2a clinical trial results for its heart failure therapy candidate ixmyelocel-T as a treatment for advanced heart failure due to ischemic dilated cardiomyopathy (DCM). The study entitled "Safety and Efficacy of Ixmyelocel-T: An Expanded, Autologous Multi-Cellular Therapy, in Dilated Cardiomyopathy" showed that treatment with ixmyelocel-T reduced the incidence of major adverse cardiovascular events (MACE) in patients with ischemic DCM.
- In two open-label studies, a total of 61 patients were randomized. Fifty-nine were treated with ixmyelocel-T or standard-of-care (SOC). The ixmyelocel-T group experienced fewer MACE events than the SOC group, although the results do not appear to be statistically significant.
- A poster on an ixmyelocel-T study involving 39 patients disclosed that certain characteristics in the study design made it difficult (translation: impossible) to draw conclusions about efficacy. The only conclusion was the noting of some consistent trends. The published study only involves 20 additional subjects so the "conclusions" are most assuredly the same.
- In his order denying Allergan's (AGN -1%) motion to expedite its lawsuit against Valeant Pharmaceuticals (VRX +0.3%) and Pershing Square, Judge David Carter mentioned that Pershing Square has the votes to call a special meeting of shareholders. Allergan must call the meeting within 120 days after at least 25% of its shareholders request it in a Delaware court.
- The company's pursuers intend to use the meeting to oust six of the firm's directors and replace them with people favoring their proposed acquisition.
9:42 AM| Comment!
- Mallinckrodt (NYSE:MNK) announces the following executive changes pursuant to the Questcor (NASDAQ:QCOR) acquisition:
- SVP and Chief Strategy Officer Gary Phillips, M.D. appointed as SVP and President of Autoimmune and Rare Disease business (includes the commercial organization supporting H.P. Acthar Gel).
- Questcor SVP and Chief Compliance Officer Ray Furey appointed as SVP and Chief Compliance Officer at Mallinckrodt.
- Both executives will report to CEO Mark Trudeau. A search is underway for a Chief Strategy Officer.
- Mylan (NASDAQ:MYL) begins shipping its potassium chloride extended release tablets (8 mEq (600 mg) and 10 mEq (750 mg)), generic versions of Upsher-Smith's Klor-Con, for the treatment of patients with hypokalemia, with or without metabolic alkalosis, digitalis intoxication and hypokalemic familial periodic paralysis.
- According to IMS Health, the U.S. market is ~$135M.
- The European Medicines Agency accepts Cubist Pharmaceuticals' (NASDAQ:CBST) Marketing Authorization Application for ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. The European Commission should announce its decision by 2H 2015.
- NeoGenomics (NASDAQ:NEO) announces that the underwriters of its recent stock offering have exercised their option for an additional 1.05M shares of common stock at $4.60 per share. Net proceeds of the offering now total ~$34.6M which will be used for working capital, capex and general corporate purposes.
- The DEA has reclassified hydrocodone combination drugs to stem a rise in their abuse, and will now label them in a category reserved for medical substances with the highest potential for harm.
- The move has been resisted by many drug makers and wholesalers, but others like Mallinckrodt (NYSE:MNK) support it and say it will have no significant impact on their business.
- Major makers of hydrocodone combination drugs include Actavis (NYSE:ACT), Teva (NYSE:TEVA), AbbVie (NYSE:ABBV), Zogenix (NASDAQ:ZGNX), Lannett (NYSE:LCI), and Alkermes (NASDAQ:ALKS).
- Allergan's (NYSE:AGN) request to advance its lawsuit against Valeant Pharmaceuticals (NYSE:VRX) and Pershing Square has been denied by a California federal judge.
- Allergan claims the two engaged in insider trading ahead of their takeover bid, saying their unusual partnership violated securities regulations.
- Pershing Square's Bill Ackman began acquiring a stake in Allergan in February in partnership with Valeant after the two had begun discussing offering a bid for the company. Ackman only disclosed his ~10% stake the day before they made the offer.
- Previously:The rhubarb continues as Allergan pursuers file countersuit
Thursday, August 21, 2014
- In a regulatory filing, Isis Pharmaceuticals (ISIS -3.1%) discloses that it earned an $18M milestone payment from development partner Biogen Idec (BIIB -1.1%) by virtue of dosing the first infant in the ENDEAR Phase 3 clinical trial evaluating ISIS-SMNrx as a treatment for spinal muscular dystrophy.
- Ampliphi Biosciences (OTCQB:APHB +11.4%) restates its financial statements for the quarters ended September 30, 2013, December 31, 2013 and March 31, 2014 and for the year ended December 31, 3013 due to non-cash adjustments related to its Series B Preferred Stock dividend clause to reflect its treatment as a compound derivative.
- It will restate its financials for the year ended December 31, 2013 due to a reclassification of in-process R&D related to its acquisition of Biocontrol Ltd.
- The financials for the years ended December 31, 2011, 2012 and 2013 will be revised to recognize amortization of certain patents.
- The FDA clears Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the reduction in the risk of recurrent DVT and PE following initial therapy.
- This expands its label beyond its initial indication as a treatment to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
- In 2007, Bristol-Myers Squibb (BMY) and Pfizer (PFE -0.3%) entered into a global collaboration to develop and commercialize apixaban, an oral anticoagulant discovered by BMY.