Wednesday, April 16, 2014
- Shares of Advanced Cannabis Solutions (CANN +44.5%) are up big today in apparent sympathy with CannaVest (CANV +43.7%) after CO cleared the way for the latter's hemp production.
- Today's turnover is 83K shares versus its daily average of 84K. Retail investors need to be careful here. A large up move without a commensurate rise in volume undermines its validity.
- GlaxoSmitKline (GSK +0.9%) investigates its sales operations in Lebanon and Jordan over alleged free samples and travel benefits to doctors in exchange for prescribing its products.
- The situation follows bribery allegations in China, Poland and Iraq.
- The company issues a statement stating its policy of zero tolerance for unethical or illegal behavior. Last year, there were 161 violations of corporate sales and marketing policies resulting in 48 dismissals and 113 written warnings. It says that these numbers are in line with its competitors.
- The firm denies it has a systemic problem.
- The Colorado Department of Agriculture extends a Commercial Industrial Hemp Registration to CannaVest (CANV). This permits the company to grow and process industrial hemp.
- The first harvest may happen as early as September.
- Share are up 48% to $25 on 96K shares in today's trading.
- Average daily turnover is only 21K shares so retail investors should tread carefully.
- (HEMP) (MWIP)
- Vials from nine batches of Roche's (RHHBY) top-selling drug allegedly stolen in Italy have been tampered with and reintroduced into the European market. Adulterated vials have turned up in Germany, Finland and the U.K. Some do not contain any trastuzumab at all while others have been diluted.
- There are no reports of harm to patients from the fakes. The company is recalling the suspect vials as a precaution.
- Herceptin sales last year were $6.9B.
- Television producer Verde Media Group (VMGI +38.5%) creates a Biotech Division to capitalize on the legalized cannabis movement. The division will develop platform technologies for extracting highly purified THC and cannabidiol (CBD) and their use in various delivery systems such as sublingual, inhaled and blended with food products.
- The Biotech Division subsidiary Butazyme LLC signs an agreement with Asia-based Phoenix Energy to produce omega-3 oils.
- (CBIS) (ENDO) (HEMP) (LATF) (MWIP) (VAPE)
- The Troy and Alana Pack Patient Safety Act is on the November ballot in California. If voters approve the measure the state will institute random drug tests on physicians with hospital privileges and testing after an adverse event such as a preventable death.
- A USA Today report finds that over 100K doctors abuse prescription drugs every year yet few are ever caught despite the risk to patients.
- The California Medical Board estimates that 18% of physicians will have a substance abuse problem at some point in their careers and 1% - 2% abuse drugs and/or alcohol at any given time.
- In 2008 the state scrubbed a failed substance abuse treatment program because it did not have a mechanism to detect doctors who continued to take drugs nor did it provide for disclosure to patients.
- Healthcare ETFs: IYH, XLV, VHT, CURE, FXH, RXL, IHF, FHLC, XHS, PSCH, RYH, PTH, RXD
- Apricus Biosciences' (APRI +18.9%) U.K. distribution partner Takeda Pharmaceuticals accepts the first shipment of the company's topical treatment for erectile dysfunction as it prepares to launch the product there.
- European regulators approved Vitaros in June followed by national phase approval by the U.K. in August.
- The $225M ED market is the largest in Europe.
- Consensus revenue estimates for Apricus are $8M this year and $10.8M in 2015.
- 18 mutual funds have positions, the same number as a year ago.
- Harvard Apparatus Regenerative Technology (HART -1.1%) hires Saverio La Francesca, M.D. as Chief Medical Officer.
- Dr. Francesca joins the firm from the DeBakey Heart and Vascular Center in Houston. Prior to that he was an attending surgeon at the Department of Cardiopulmonary Transplantation at the Texas Heart Institute. He has direct experience in more than 1,000 organ transplants including 200+ heart and lung transplant procedures.
- HART's lead product is a bioreactor/synthetic scaffold system for trachea transplants. Limited Phase 1 clinical trials have begun in Sweden and Russia.
- Move over Medbox (MDBX) because the ZaZZZ American Green Machine is in town in Colorado.
- Tranzbyte (ERBB) COO Stephen Shearin reports that the Doctors Orders pot dispensary in Denver will soon take delivery of the company's automated weed dispensing machine that the firm unveiled on April 12.
- No financial terms are disclosed.
- The University of California, San Diego approves a Phase 1 clinical trial to assess the safety of Neuralstem's (CUR) NSI-566 stem cells for the treatment of thoracic spinal cord injuries (T2 - T12). The study targets patients with AIS A level impairment (complete paralysis).
- The trial has a one-year completion date.
- There are 10K new spinal cord injuries in the U.S. each year.
- The company is currently conducting a Phase 2 trial for the use of NSI-566 in ALS.
- Zalicus (ZLCS) has agreed to sell itself to Boston-based Epirus Biopharmaceuticals, a developer of biosimilar monoclonal antibodies, in an all-stock deal.
- The combined company will trade on Nasdaq and will be led by Epirus' management team, with Amit Munshi as CEO.
- The deal comes after Zalicus' Z160 therapy for pain treatment failed in two Phase 2 trials.
- Epirus has also just closed a $36M Series B financing round. The company's pipeline includes biosimilars to Merck's Remicade (inflammatory diseases), AbbVie's Humira (anti-inflammatory, such as for rheumatoid arthritis) and Roche's Avastin (cancer).
- Zalicus' stockholders will own approximately 14-19% of the combined company at the closing of the deal and Epirus' shareholders 81-86%, based on the amount of cash that Zalicus will hold. If closing were today, Zalicus shareholders would get 14%.
- Notwithstanding, Zalicus' shares are +44%. (PR)
- Impax Laboratories' (IPXL) +1.8%) Global Pharamaeuticals division launches its generic version of Genzyme's (SNY +0.2%) Renvela (sevelamer carbonate).
- The company will sell a specific allotment of bottles granted under a license from Genzyme. Impax's aNDA for the product is currently under regulatory review.
- The U.S. Renvela market is ~$900M.
- Baxter International's (BAX) BAX 111 treatment met the primary endpoint in a Phase III trial of patients with von Willebrand disease, the most common type of inherited bleeding disorder.
- BAX 111 successfully treated 22 patients who experienced bleeding episodes during the trial.
- Secondary endpoints included those related to additional efficacy and safety measures, pharmacokinetics and health-related quality of life.
- Shares are +1.55% premarket. (PR)
- Overall operational sales for Q1 grew 0.5% for Abbott Laboratories (ABT) to ~$5.2B. Diagnostics and Medical Devices grew 5.1% and 0.3%, respectively, while Nutrition fell 1.7% and Pharmaceuticals fell 0.7%.
- International operations continue to deliver higher growth rates than domestic ops.
- Ex-U.S. business delivered ~72% of global sales.
- In the Nutrition segment, Adult International grew 12.4% versus growth in the U.S. of 5.2%. Pediatric fell in both markets.
- Diagnostics grew in all segments and markets led by Molecular's 12.6% and POC's 10% increase internationally.
- Pharmaceutical sales in key emerging markets (led by BRIC) were almost flat with a slight 0.2% gain.
- International Device sales grew 4.7%.
- Management confirms its 2014 EPS guidance range of $2.16 - $2.26 ex items.
- GAAP EPS range for the fiscal year is $1.13 - $1.23.
- Press release
- Reckitt Benckiser (RBGLY) could spin off its declining pharmaceuticals operations, saying that the idea is "emerging as a strong option." However, selling the business or even keeping it are still possible.
- The division's net sales dropped 15% in Q1 to £170M.
- Total net revenues declined 6% to £2.37B.
- Shares are +0.3% in London. (PR)
- Cardica (CRDC) offers 32.5M shares of common stock for public sale at $0.85/share plus 191,474 shares of Series A convertible preferred stock at $85/share (each share converts into 100 shares of common).
- Underwriters over-allotment is 4.875M shares of common.
- Gross proceeds expected to be ~$44M.
- Closing date April 22.
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- Researchers in Boston find that casual pot use (one - seven joints a week) changes the size, shape and density of the nucleus accumbens and the nucleus amygdala, regions of the brain that regulate emotion and motivation.
- More study is needed to determine the specific effects of the changes which appear different than the effects of consuming alcohol.
- The National Institute on Drug Abuse and the White House Office of National Drug Control Policy partially funded the work.
- Healthcare ETFs: IYH, XLV, VHT, CURE, FXH, RXL, IRY, IXJ, FHLC, PSCH, RYH, PTH, RXD