Friday, March 14, 2014
6:50 PM| 15 Comments
- The FDA approves Bristol-Myers Squibb (BMY) and Pfizer's (PFE) sNDA for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis for patients who have undergone knee or hip replacement surgery.
- In the U.S., 719,000 knee replacement and 332,000 hip replacement surgeries are performed each year.
- The product is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
- Senators Barbara Boxer (D-CA) and Mark Kirk (R-IL) introduce legislation that will establish a national strategy to support regenerative medicine (RM) research.
- Among the requirements of the Regenerative Medicine Promotion Act are: a report by the GAO identifying all ongoing federal programs and activities pertaining to RM, the establishment of a Regenerative Medicine Coordinating Council and the maintenance of a national strategy for the promotion of RM R&D.
- Companies involved in the space include ONVO, HART, CUR, CYTX, STEM, ATHX.
12:27 PM| Comment!
- Citron Research reports on analysis of Questcor's (QCOR -0.8%) Acthar.
- It alleges the product is not porcine deamidated corticotrophin, the amino acid sequence is different than the sequence described in the product's package insert and the actual concentration of deamidated corticotrophin is much lower than the claimed 80IU/ml.
- The FDA is reviewing the lab tests.
- InterMune (ITMN) prices its offering of 7.5M shares of common stock at $32.75/share netting $233M to the company.
- Overallotment is 1.125M shares.
- Proceeds will be used to fund Esbriet commercialization.
- Omeros Corp (OMER) prices its offering of 3.043,479 shares of common stock at $11.50/share yielding net proceeds of ~$32.8M.
- If the underwriters purchase 100% of the overallotment of 456,521 shares, the gross proceeds will be an additional $5.2M.
- Funds will be used for general corporate purposes including the potential commercialization of OMS302 and R&D.
- Consensus revenue estimates for 2014 and 2015 are $29.1M and $71.1M, respectively.
- 103 mutual funds have positions, up from 93 a year earlier.
- Hologix (HOLX) appoints Eric Compton Chief Operating Officer.
- Claus Egstrand named Senior Vice President and General Manager of the company's ex-US business.
- David Harding named Senior Vice President of Corporate Strategy.
- All will assume their new roles on April 14 and report to Steve MacMillan, President and CEO.
- Nano cap regenerative medicine firm Harvard Apparatus Regenerative Technology (HART) is poised for an opening gap up.
- The stock broke out on March 4 on heavy volume. It peaked at $10.98 on March 11, a 100% gain from its previous high of $5.47.
- The firm posted an updated investor presentation on its website this morning.
- Financial results were disclosed on March 7.
- 71 mutual funds have positions.
- (BDSI) files its 10-K and provides an update on its key initiatives.
- BUNAVAIL PDUFA date is June 7, 2014.
- Positive Phase III top-line results reported for BEMA Buprenorphine.
- 2013 R&D expense was $53.3M ($41.8M for BEMA).
- Net loss was $57.4M (-$1.51/share) due to higher R&D costs.
- Cash balance as of February 28 was $89.8M.
- Preparations being made for the Q3 launch of BUNAVAIL.
- Second database lock for BEMA Phase III clinical trial to occur at mid-year triggering a $10M milestone payment from Endo International (ENDP). NDA to be filed in late 2014 or early 2015.
- Phase III trial for Clonidine Topical Gel commences by end of March. Interim data may be available by year end.
- Consensus revenue estimates for 2014 and 2015 are $13.5M and $31.5M, respectively.
- 112 mutual funds have positions, up from 99 a year earlier.
- Johnson and Johnson (JNJ) faces 20,000 product liability lawsuits relating to Ethicon's transvaginal mesh. The product was used to treat pelvic organ prolapse. It withdrew the product from the market in 2012 citing business reasons, but some recipients of the device complained of pain due to its shrinkage or erosion from its original placement.
- Documents provided by J&J in the discovery process suggest that a company-paid physician consultant sought to change the language of the treatment guidelines published by a medical society in 2007.
- The company also attempted to change the language of a research paper published in the New England Journal of Medicine in 2011. The journal's editors are currently fighting a subpoena to testify in the case.
- The firm engaged the MD as a consultant for 10 years paying him ~$800,000.
7:43 AM| Comment!
- Idenix Pharmaceuticals (IDIX) files patent infringement lawsuit against Gilead Sciences (GILD) in France, Germany and the UK.
- The suit pertains to European patent EP 1 523 489 that covers 2-methyl-2-fluoro nucleosides for the treatment of Hep C.
- The company seeks remedies regarding Gilead's commercial activities with its drugs containing sofosbuvir.
- Cantor Fitzgerald downgrades Oncothyreon (ONTY) from Buy to Hold citing valuation. Yesterday's close of $3.89 near its price target of $4.
- Stifel maintains its Buy rating and raises its price target from $3 to $6 citing the potential long-term label expansion of ARRY-380.
- The company expects to burn $30M - $33M next year. It has enough cash to fund operations for the next 12 months.
- 48 mutual funds have positions, down from 102 last year.
Thursday, March 13, 2014