Wednesday, December 17, 2014
- In a Phase 3 clinical trial, Tetraphase Pharmaceuticals' (NASDAQ:TTPH) investigational antibiotic, eravacycline, was found to be non-inferior (no worse than) compared to ertapenem (Merck's Invanz) for the treatment of complicated intra-abdominal infection. The study's primary endpoint was the clinical response at the test-of-cure visit in the two treatment arms.
- The company is developing eravacycline as a broad spectrum intravenous and oral antibiotic. It expects to submit its regulatory applications by the end of 2015.
- The U.S. Court of Appeals for the Federal Circuit finds that three of the patents covering DNA-based BRC1 and BRCA2 tests asserted by Myriad Genetics (NASDAQ:MYGN) against privately-held reference laboratory Ambry Genetics do not contain subject matter eligible for patent protection. In an opinion posted today on its docket, the court says, "Myriad did not create or alter any of the genetic information encoded in the BRCA1 or BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them."
- Myriad sued Ambry in 2013 soon after Ambry began offering the tests subsequent to the decision by the U.S. Supreme Court stating that genomic sequences cannot be patented.
- MYGN is unchanged in after hours trading.
- The FDA approves Alcon Laboratories' (NVS +0.6%) Xtoro (finafloxacin otic suspension) for the treatment of acute otitis externa, an infection known as swimmer's ear.
- Acute otitis externa is an infection of the outer ear and ear canal, typically caused by bacteria in the ear canal. The infection causes inflammation that can lead to pain, swelling, redness and discharge from the ear.
- Xtoro is an ear drop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus.
2:27 PM| Comment!
- In an interview on Bloomberg Television, Pershing Square's Bill Ackman said that former top distributors for Herbalife (HLF +2.1%) have gone to investigators to substantiate his claims that the company operates an illegal pyramid scheme. During the interview, Mr. Ackman also provided a video from 2005 that shows a top distributor acknowledging that Herbalife operates a pyramid scheme.
- An investigation into the company's practices by the Federal Trade Commission is ongoing.
- HLF shares are down over 50% this year.
- According to Bloomberg, Amgen (AMGN +1%) intends to charge $178,000 per standard course of treatment for its blood cancer therapy, Blincyto (blinatumomab). The price assumes two cycles of treatment at $89,000 per cycle, the median duration of treatment for patients who responded to therapy in clinical trials.
- For comparison purposes, Merck's (MRK +0.7%) Keytruda (pembrolizumab) costs $150,000 per year and Bristol-Myers Squibb's (BMY +2.2%) Yervoy (ipilimumab) costs $120,000 per course.
- Previously: FDA clears Amgen blood cancer immunotherapy (Dec. 3, 2014)
- Recent IPO Calithera Biosciences (CALA -7.5%) drops again on moderately-higher volume as profit takers continue to take money off the table after the stock's 217% run-up. Shares are off 31% from the peak of $33.48 on December 15.
- Previously: Calithera up again after ASH presentation (Dec. 10, 2014)
- Previously: Calithera up after ASH presentation (Dec. 8, 2014)
11:14 AM| Comment!
- Piper Jaffray likes Becton, Dickinson and Company (BDX +1.1%) as its top large cap pick for 2015. It raises its price target to $160 from $141 citing the upside potential of the CareFusion acquisition. Shares currently exchange hands at $135.
- Its top small cap pick is Idera Pharmaceuticals (IDRA +4.5%) with a price target of $7. Shares are currently at $3.70.
- SA Contributors Samreen Agha and EXPstocktrader are bullish on Idera as well.
- Previously: Idera +6.3% AH after presenting IMO-8400 data (Dec. 8, 2014)
- Previously: Idera up on preclinical data (Dec. 3, 2014)
- Pfizer (PFE +0.2%) initiates a Phase 2 clinical trial assessing its investigational compound, PF-06252616, in boys with Duchenne Muscular Dystrophy (DMD), a genetic disorder characterized by progressive muscle degeneration and weakness. It occurs in ~1 in 3,500 male births worldwide.
- The study will evaluate the safety, tolerability and efficacy of PF-06252616 in boys aged 6 to <10 years old diagnosed with DMD regardless of genotype.
- The FDA designated PF-06252616 an Orphan Drug in July 2012 and Fast Track in November 2012.
- DMD-related tickers: (SRPT +4.1%)(RNA +0.1%)(PTCT +1.6%)(OTCQB:MRNA +5.8%)(ROSG +0.4%)
- Previously: Catabasis Pharmaceuticals' CAT-1004 tagged an Orphan Drug for DMD (Nov. 24, 2014)
- Catalyst Pharmaceutical Partners (CPRX +1.4%) Co-Founder and Director Hubert E. Huckel, M.D., passed away on December 13.
- CEO Patrick J. McEnany says, "We are profoundly saddened by the passing of Hubert. Dr. Huckel was a valued friend and a member of our Board, providing great support over the years. His contributions to Catalyst were invaluable. He will be greatly missed. We mourn his loss and extend our deepest sympathies to his family."