Today - Thursday, December 18, 2014
- The FDA approves Lannett Company's (LCI +0.3%) Abbreviated New Drug Application (ANDA) for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, the therapeutic equivalent to the reference listed drug, Cosopt Ophthalmic Solution of Oak Pharmaceuticals (AKRX +0.4%). The U.S. wholesale market is ~$123M.
- The product is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
- The FDA's PDUFA date for its review of BioCryst Pharmaceuticals' (BCRX +0.6%) New Drug Application (NDA) for peramivir for the treatment of adult patients with acute uncomplicated influenza is December 23.
- Previously: BioCryst Pharma +12% after FDA accepts NDA for peramivir (Feb. 25, 2014)
- The FDA's PDUFA date for its Priority Review of AbbVie's (ABBV +1.2%) three-pronged combination HCV regimen is December 21. Since the date is Sunday, the agency may issue its decision tomorrow. One of the anti-virals, ABT-450 (ritonavir), was co-developed with Enanta Pharmaceuticals (ENTA +5%).
- Previously: AbbVie HCV regimen gets priority review (June 13, 2014)
- The FDA's PDUFA date for its Fast Track/Priority Review of Cubist Pharmaceuticals' (CBST) New Drug Application (NDA) for its combination drug, ceftolozane/tazobactam, for the treatment of complicated urinary tract infections is December 21. Since this is Sunday, the agency may issue its decision tomorrow.
- Ceftolozane/tazobactam is designated a Qualified Infectious Disease Product (QIDP). If approved, it will have a five-year period of market exclusivity.
- Previously: Cubist NDA gets Priority Review (June 20, 2014)
- Thinly-traded nano cap Aveo Pharmaceuticals (AVEO +18.6%) jumps on a massive 10x surge in volume in apparent response to the news that superstar investor Seth Klarman (Baupost) has established a position in the penny stock which has lost 96% of its value since mid-2011. Baupost established its position in February, however.
- The company has four cancer therapeutic candidates in development that have been vetted through its Human Response Platform.
- In November, the company extended an exclusive license to Ophthotech (OPHT +0.4%) for tivozanib for the potential treatment of non-cancer diseases of the eye.
- Previously: Aveo licenses tivozanib to Ophthotech (Nov. 12, 2014)
- Thinly-traded nano cap Agenus (AGEN +11.3%) jumps on triple normal volume in response to the successful outcome of the Phase 3 clinical trial of GlaxoSmithKline's (GSK +2.4%) shingles vaccine candidate, HZ/su. One of the key components of the vaccine's adjuvant system, AS01B, is Agenus' QS-21 Stimulon adjuvant.
- Previously: Glaxo shingles vaccine candidate successful in Phase 3 study (Dec. 18, 2014)
- StemCells (STEM +5.2%) reports that the first patient has been transplanted with the company's proprietary HuCNS-SC (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury (SCI). The procedure was performed at the University of Miami as part of the Phase 2 Pathway Study, the first clinical trial designed to assess the safety and efficacy of transplanting human neural stem cells into patients with SCI. The trial will enroll up to 52 patients and follow participants for one year.
- The primary efficacy endpoint is the change in upper extremity strength (hands, arms, shoulders) measured according to the International Standards for Neurological Classification of Spinal Cord Injury.
- In May, the company completed enrollment and dosing in a Phase 1/2 trial in thoracic spinal cord injury. Post-transplant gains in sensory function below the level of injury were demonstrated in 6 of 12 patients. Two converted from a complete injury (AIS A) to an incomplete injury (AIS B).
- Amedica (AMDA +5.8%) provides an update on its operations. Management expects sales for the year to come in at $22M - 24M.
- In Q4, there is strong demand for its core silicon nitride material but not so for its metals products.
- The company has received compiled data from its CASCADE study comparing cervical fusion clinical and radiographic outcomes of its proprietary porous silicon nitride to plastic interbody spacers made of polyether ether ketone (PEEK) filled with bone autograft. It plans to announce the results in January.
- Chimerix (CMRX +5%) and ContraVir (OTCQB:CTRV +14.5%) enter into a strategic collaboration to develop and commercialize CMX157, a potent analog of the antiviral drug tenofovir DF (Gilead Sciences' (GILD +2.4%) Viread).
- Under the terms of the agreement, Chimerix licenses CMX157 to ContraVir in exchange for an upfront payment of 120K shares of ContraVir preferred stock with a stated value of $1.2M and up to ~$20M in clinical, regulatory and initial commercial milestones for the U.S. and Europe. Chimerix will also receive royalties on commercial sales as well as additional milestones in these territories.
- CMX157 is a novel lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the antiviral agent tenofovir diphosphate. In in vitro studies, CMX157 was 200-fold more potent than tenofovir against all major HIV subtypes resistant to current therapies. The structure of CMX157 results in lower circulating levels of tenofovir which lowers its systemic exposure and reduces the potential for renal side effects.
- The next step in the development of CMX157 is a Phase 2 trial.
- The Medicines Company (MDCO -0.3%) and SciClone Pharmaceuticals (SCLN +2.3%) establish a strategic partnership that extends a license and exclusive rights to SciClone for two of MDCO's cardiovascular products in China.
- The two products are Angiomax (bivalirudin), an anticoagulant indicated for patients undergoing coronary intervention that is currently under regulatory review by the China Food and Drug Administration, and the clinical-stage (in China) Cleviprex (clevidipine), a third-generation dihydropyridine calcium channel blocker indicated for the reduction of blood pressure.
- Under the terms of the agreement, SciClone will be responsible for all aspects of commercialization for both products in China. The Medicines Company will be receive an upfront fee, a prodcut support services fee and various milestones up to an aggregate of $50.5M plus royalties on commercial sales.
- Thinly-traded nano cap AxoGen (NASDAQ:AXGN) is up 16% premaket on light turnover. The stock looks like it will build on yesterday's 8% up move on a massive 17x surge in volume.
- There is no particular news driving the positive money flow although there has been steady insider buying over the last half of the year. CEO Robert Johnston bought 10K shares earlier this month at $3.06.
- AxoGen provides off-the-shelf nerve allografts for the surgical repair of peripheral nerve discontinuties.
- OvaScience (NASDAQ:OVAS) is up 20% premarket on higher-than-normal volume. Shares are poised to continue their surge from yesterday's 19% move after the company announced that it had advanced three fertility treatments, including successfully maturing human egg precursor cells into eggs in vitro. This is a major milestone for its hormone-free OvaTure treatment.
- OVAS has been on a tear this year. Shares are up over seven-fold from the low of $5.51 on May 9.
- Neogen (NEOG) FQ2 results: Revenues: $68.5M (+14.9%), Food Safety: $33M (+16.2%), Animal Safety: $35.5M (+13.8%); COGS: $34.2M (+13.6%); Operating Expenses: $21.3M (+7.6%); Operating Income: $12.9M (+33.0%); Net Income: $7.8M (+25.8%); EPS: $0.21 (+23.5%); Quick Assets: $94.3M (+23.3%).
- No guidance given.
- BioReference Laboratories (BRLI +0.2%) FQ4 results: Revenues: $227.6M (+18.4%); COGS: $120.7M (+12.9%); G&A: $76.1M (+17.4%); Operating Income: $30.8M (+51.0%); Net Income: $18.3M (+64.9%); EPS: $0.66 (+65.0%); CF Ops: $9.1M.
- FY2014 results: Revenues: $832.3M (+16.3%); COGS: $462.3M (+17.7%); G&A: $286.6M (+19.1%); Operating Income: $83.4M (+1.7%); Net Income: $46.8M (+2.2%); EPS: $1.68 (+1.8%); Quick Assets: $17.5M (-2.8%); CF Ops: $16.6M.
- No guidance given.
- A Phase 3 clinical trial assessing a controlled-release (CR) formulation of Pfizer's (NYSE:PFE) Lyrica (pregabalin) for the treatment of postherpetic neuralgia (pain after shingles or PHN) met its primary efficacy endpoint of time to loss of therapeutic response (LTR), or durability of effect, in pain reduction compared to placebo. The time to LTR in the double blind phase (<30% pain response relative to baseline mean pain) occurred in 13.9% of the patients in the test group versus 30.7% of patients in the control group. The results were statistically significant.
- The company plans to submit the final results from the study for publication after analyses are done.
- The value proposition of a CR formulation is once-daily dosing. Currently, Lyrica is dosed 2-3 times per day depending on the indication.
8:33 AM| Comment!
- Chinese authorities approve the start of clinical trials for an experimental Ebola vaccine developed by the Academy of Military Medical Sciences and Chinese biotech outfit Tianjin CanSino Biotechnology. The trials are supposedly going to commence this month. No other details are available.
- Glaxo (NYSE:GSK) and Merck (NYSE:MRK) remain the front runners.