Friday, December 19, 2014
- The FDA has approved the use of Cubist's (NASDAQ:CBST) Zerbaxa (ceftolozane/tazobactam) for "the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria."
- Cubist adds the FDA's decision was "supported by positive data from two pivotal Phase 3 clinical trials - one in patients with cUTI and the other in patients with cIAI."
- Cubist, still set to be acquired by Merck (NYSE:MRK) for $9.5B, is up 2% AH.
- Previous: PDUFA date approaches for Zerbaxa
- Once Walgreens (NYSE:WAG) finishes acquiring the 55% of Alliance Boots it doesn't yet own, the company will move to the Nasdaq and change its symbol to WBA. The company will delist from both the NYSE and the Chicago Stock Exchange.
- On Dec. 10, Walgreens announced (to investor approval) CEO Greg Wasson will retire once the Alliance merger is finished. Shareholders vote on the deal on Dec. 29.
- The FDA approves AbbVie's (ABBV) Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) for the treatment of HCV genotype 1 infection, including those with cirrhosis.
- Related tickers: (GILD +3.2%) (ENTA +3.9%)
- Previously: PDUFA date approaches for AbbVie HCV combo therapy (Dec. 18, 2014)
- The FDA and European Medicines Agency (EMA) designate PTC Therapeutics' (PTCT +2.2%) Translarna (ataluren) an Orphan Drug for the treatment of mucopolysaccharidosis I (MPS 1).
- MPS 1 is an inherited genetic disorder caused by a deficiency in lysosomal enzymes responsible for the breakdown of by-products in the body's cells.
- Translarna is a protein restoration therapy designed to designed to enable the formation of a functioning protein in patients with genetic disorders caused by nonsense mutation. It is also an Orphan Drug for Duchenne muscular dystrophy and cystic fibrosis.
- Soligenix (OTCQB:SNGX -19.3%) prices its public offering of 1,886,530 units at $1.21 per unit. Each unit consists of one share of common stock and 0.6 of a warrant to purchase one share of common stock at $1.48 per share. Closing date is December 24.
- Net proceeds will fund R&D activities and general corporate purposes.
- Thinly-traded small cap Flamel Technologies (FLML +12%) heads north in response to its announcement that it achieved its objective of a single before-bedtime dose of sodium oxybate using its proprietary Micropump technology. A single dose option for sufferers of narcolepsy would eliminate a second dose 2.5 to 4 hours later that is necessary with the current standard of care, Jazz Pharmaceuticals' (JAZZ -0.9%) Xyrem (sodium oxybate). This would be more convenient and would eliminate the disruption in sleep.
- Flamel plans to meet with the FDA before mid-2015 to clarify a regulatory path.
- Pfizer's (PFE +0.2%) receipt of the European Commission's marketing authorization for Duavive (conjugated estrogens/bazedoxifene) triggers a milestone payment for an undisclosed amount to development partner Ligand Pharmaceuticals (LGND +1.4%).
- Duavive is indicated for the treatment of estrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom progestin-containing therapy is not appropriate. It pairs conjugated estrogens with an estrogen agonist/antagonist, known as a selective estrogen receptor modulator. Bazedoxifene is used instead of progestin in order to protect the uterine lining against hyperplasia that may result from estrogen alone therapy.
12:22 PM| Comment!
- The FDA approves the use of Cerus' (CERS +7.6%) Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets. Three days ago, the agency approved the system for plasma.
- Previously: Cerus +20.3% AH; FDA approves Intercept for plasma (Dec. 16, 2014)
- FDA Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor sends Herbalife (HLF +1.1%) CEO Michael O. Johnson a letter requesting the company remove a broadcast advertisement on YouTube that mischaracterizes the regulator's role pertaining to dietary supplements. In the video, former FDA director Vasilios H. Frankos, Ph.D., states that during his time at the agency he made sure that nutritional supplements were safe and effective for use. This is surprising since the FDA does not regulate dietary supplements.
- The FDA's request is far from urgent. The video was published on April 12, 2011.
- Thinly-traded 2014 IPO Immune Design (IMDZ +14.7%) moves up on average volume albeit on turnover of only 29K. Shares are up 56% since the intermediate low of $20.02 on December 12.
- After building a two-month base following its July 24 debut, shares more than tripled before correcting in late November.
- The clinical-stage company develops cancer immunotherapies identified through its two discovery platforms, IMDZVex and GLAAS.
- Gilead Sciences (GILD +1.1%) and Osaka, Japan-based Ono Pharmaceutical Company (OTC:OPHLF) (OTCPK:OPHLY) enter into an exclusive license agreement to develop and commercialize ONO-4059, Ono's oral Brutons tyrosine kinase (BTK) inhibitor, for the treatment of B-cell malignancies and other diseases.
- Under the terms of the agreement, Gilead will pay Ono an upfront fee plus development, regulatory and commercial milestones.
- Gilead will have exclusive rights to develop and commercialize ONO-4059 worldwide except Japan, South Korea, Taiwan, China and the ASEAN countries, where Ono retains development and commercialization rights.
- Eli Lilly (LLY -0.2%) and Lyon, France-based Adocia enter into a worldwide licensing collaboration to develop an ultra-rapid insulin, known as BioChaperone Lispro, for the treatment of type 1 and 2 diabetes. The product, currently in Phase 1b, utilizes Adocia's proprietary BioChaperone technology.
- Under the terms of the agreement, Adocia will receive an upfront payment of $50M, up to $280M in potential development and regulatory milestones and up to $240M in sales milestones. Lilly is responsible for the future development, manufacturing and commercialization of BioChaperone Lispro and will reimburse Adocia for certain R&D expenses during the term of the contract.
- The French firm retains the right to develop and license its insulin programs unrelated to prandial ultra-rapid insulin.
- The European Commission designates Halozyme Therapeutics' (HALO +9.1%) PEGylated recombinant human hyaluronidase, PEGPH20, an Orphan Medicinal Product for the treatment of pancreatic cancer. Among the benefits of EMA Orphan status is a 10-year period of market exclusivity if approved.
- The FDA designated PEGPH20 an Orphan Drug for the same indication in October. If approved, it will have a seven-year period of market exclusivity in the U.S.
- PEGPH20 is currently in Phase 2 development.
- Previously: Halozyme +4.2% AH; cancer drug gets orphan designation (Oct. 2, 2014)
- Previously: Halozyme pancreatic cancer drug candidate Fast Track'd (Sept. 3, 2014)
- OncoGenex Pharmaceuticals (OGXI -3.5%) announces the results of a Phase 2 study assessing the efficacy of low (600 mg) and high (1000 mg) dose apatorsen in combination with gemcitabine/cisplatin chemotherapy compared to chemotherapy alone in patients with metastatic bladder cancer.
- The 600 mg dose showed a 14% reduction in risk of death and a 17% reduction in progressive disease compared to chemo alone. In a subgroup of patients with lower performance status (Karnofsky score <=80%), low dose apatorsen plus chemo reduced the risk of death 50%.
- Less benefit was observed with the high dose due to a high incidence of adverse events and discontinuation of both apatorsen and chemo. The low dose was well tolerated.
- The company will work with investigators and regulatory authorities to clarify a development path forward.
- Thinly-traded nano cap TransEnterix (TRXC +35.3%) builds on yesterday's high volume 57% move. This morning, the company announced the successful completion of four general surgery and urology procedures using its SurgiBot patient-side robotic surgery system.
- Management says that the preparation of a 510(k) filing with the FDA is on track with a targeted submission date of mid-2015.
- It value proposition is ease of use and lower cost compared to currently available systems.
- Related ticker: (NASDAQ:ISRG)
- The FDA approves Teva Pharmaceutical Industries' (NYSE:TEVA) QNASL (beclomethasone dipropionate) 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis in children 4 - 11 years of age. It will be commercially available in February.
- The product's 80 mcg formulation is cleared for use in patients at least 12 years old.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting the approval of Celgene's (NASDAQ:CELG) Revlimid (lenalidomide) for the continuous oral treatment on adult patients with previously untreated multiple myeloma who are not eligible for stem cell transplantation.
- In the EU, Revlimid is currently approved in combination with dexamethasone as a second-line treatment for multiple myeloma.
- A final decision by the European Commission usually takes about 60 days.
- Aratana Therapeutics (NASDAQ:PETX) is up 38% premarket on moderately-high volume. After yesterday's close, the company announced positive results from a pivotal field study evaluating AT-001 (grapiprant) for the treatment of osteoarthritis in dogs. Canines receiving AT-001 demonstrated statistically significant improvements in pain assessment scores compared to placebo (p<0.05).
- Grapiprant offers targeted pain relief by blocking the EP4 receptor, which plays a key role in pain and inflammation.
- The company will provide more details on the results after further analysis of the data.