Dec. 22, 2014, 8:44 AM
- The U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) awards a $30M contract to NewLink Genetics (NASDAQ:NLNK) subsidiary BioProtection Systems as the prime contractor to support the development and manufacturing of its rVSV-EBOV (Ebola) vaccine candidate, including a new 330-subject Phase 1b study.
- The investigational vaccine was initially developed by the Public Health Agency of Canada. It is now being advanced by NewLink and Merck (NYSE:MRK).
Dec. 19, 2014, 6:35 PM
- 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
Dec. 18, 2014, 12:29 PM
- 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)
Dec. 18, 2014, 8:31 AM
- 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.
Dec. 18, 2014, 8:23 AM
- Merck (NYSE:MRK) acquires privately-held Lausanne, Switzerland-based Oncoethix for an upfront payment of $110M and up to an additional $265M in clinical and regulatory milestones.
- Oncoethix's lead product is OTX015, a BET bromodomain inhibitor (2,3,4) currently in Phase 1b development for the treatment of hematological malignancies and advanced solid tumors.
- Bromodomain proteins 2,3 and 4 are considered potential cancer targets because of their pivotal role in regulating the transcription of growth-promoting genes and cell cycle regulators. In experimental models, the inhibition of BRD2/3/4 produced a potent antiproliferative effect associated with cell cycle arrest and cellular senescence.
Dec. 17, 2014, 2:06 PM
- 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)
Dec. 16, 2014, 1:55 AM| 3 Comments
Dec. 11, 2014, 11:58 AM
- The Global Alliance for Vaccines and Immunisation, Gavi, plans to spend as much as $300M for up to 12 million doses of an Ebola vaccine as soon as the World Health Organization (WHO) recommends one for use. An additional $90M could be used to support countries that introduce the vaccine and to rebuild devastated health systems and restore immunisation services in Ebola-stricken countries.
- Gavi is funded by governments and the Bill & Melinda Gates Foundation.
- Two vaccine candidates are currently being tested in humans in Phase 1 trials. The first trial, assessing Merck (MRK +0.8%) and NewLink Genetics' (NLNK -0.8%) candidate, experienced a hiccup recently when four volunteers complained of joint pain in their hands and feet. The trial is on hold as a precaution, but will restart on January 15 contingent on no further adverse events. The second trial, assessing the combination of GlaxoSmithKline's (GSK +0.4%) monovalent cAd3-EBO Z Ebola vaccine candidate with Bavarian Nordic's MVA-BN Filo booster vaccine, has experienced no adverse events to date.
- Johnson & Johnson (JNJ +0.8%) will begin testing its Ebola vaccine candidate in January and says it will have 250K doses for clinical study by May.
- Previously: Merck-NewLink Ebola vaccine trial interrupted (Dec. 11, 2014)
- Previously: Phase 1 underway for Ebola booster vaccine regimen (Dec. 4, 2014)
- Previously: J&J to begin testing Ebola vaccine in January; expects 250K doses ready by May (Oct. 22, 2014)
Dec. 11, 2014, 8:08 AM
- The Phase 1 study assessing the safety of the Ebola vaccine candidate from Merck (NYSE:MRK) and NewLink Genetics (NASDAQ:NLNK) has been stopped a week early as a precaution after four volunteers (out of a total of 59) complained of joint pain in their hands and feet. All are being monitored by the medical team. The trial is due to resume on January 5 in as many as 15 volunteers after investigators confirm that the pain symptoms are benign and temporary.
Dec. 10, 2014, 2:15 PM
- The FDA approves Merck's (MRK +0.4%) Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV), five more than previously-approved Gardasil.
- Gardasil 9 is a vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. It is indicated for the prevention of cervical, vulvar, vaginal and anal cancers caused by seven types of HPV and for the prevention of genital warts caused by HPV types 6 or 11. The additional HPV types - 31, 33, 45, 52 and 58 - cause ~20% of cervical cancers and are not covered by previously FDA-approved HPV vaccines.
- Gardasil generated ~$1.8B in sales over the past four quarters.
Dec. 10, 2014, 9:14 AM
- In a presentation at the San Antonio Breast Cancer Symposium, Merck's (NYSE:MRK) PD-1 inhibitor Keytruda (pembrolizumab) shows an overall response rate of 18.5% in patients with PD-L1 positive, advanced triple-negative breast cancer, one of the most aggressive forms of breast cancer, in a Phase 1b trial. Most of the patients in the study had received two or more prior chemotherapies for metastatic disease and 87.5% had received prior neo-adjuvant or adjuvant therapy.
- Five patients (18.5%) responded to pembrolizumab out of the 27 who were evaluable. One (3.7%) had a complete response and four (14.8%) showed a partial response. Seven patients (25.9%) showed stable disease. 33% of patients achieved tumor shrinkage. At six months, progression-free survival (PFS) was 23.3%.
- At the time of analysis, the median duration of response had not been reached in three of five responders on therapy for 11 months or longer. The mean time to response was 18 weeks.
- Merck intends to start a Phase 2 trial in 1H 2015.
- PD-1 inhibitors are considered by many observers to be the most promising immunotherapeutic weapons in the fight against cancer.
- Previously: Merck PD-1 inhibitor extends PFS in melanoma (Nov. 17, 2014)
Dec. 9, 2014, 7:14 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Moventig (naloxegol) for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxatives. It is the first once-daily oral peripherally -acting mu-opioid receptor agonist (PAMORA) approved in the EU.
- Moventig is part of an exclusive worldwide license agreement initiated in 2009 with Nektar Therapeutics (NASDAQ:NKTR). The product utilizes Nektar's oral small molecule polymer conjugate technology.
- Previously: Ad Comm supports approval of Moventig for OIC (Sept. 26, 2014)
- Previously: FDA clears OIC drug (Sept. 16, 2014)
- OIC-related tickers: (NASDAQ:PGNX) (NASDAQ:CBST) (NASDAQ:SLXP) (NASDAQ:SGYP)
Dec. 8, 2014, 6:11 PM
- The judge handling Cubist's (NASDAQ:CBST) infringement suit against Hospira (NYSE:HSP) over a generic version of Cubist's Cubicin has ruled several of Cubist's patent claims are invalid.
- Commenting on the ruling, Evercore ISI thinks Hospira will be able to launch a generic version of the drug by June 2016 in a "worst-case scenario." Cubist received a favorable ruling regarding its patent claims last year.
- Merck (NYSE:MRK), which announced this morning it's buying Cubist for $9.5B, is down 1.4% AH. Cubist is down 2.1%, and Hospira is up 2.3%.
Dec. 8, 2014, 5:04 PM
- Amgen (NASDAQ:AMGN) and Merck (NYSE:MRK) initiate a collaborative study to evaluate the safety and efficacy of the former's talimogene laherparepvec and the latter's Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma.
- The study will have two phases: Phase 1 will determine the safety and tolerability of talimogene laherparepvec in combination with Keytruda in patients with previously untreated, unresected stage IIIB to IVM1c melanoma. The second phase will be randomized to evaluate the safety and efficacy of the two drugs. Approximately 110 patients will be enrolled across 35 sites in the U.S., Europe and Australia.
- Pembrolizumab is a PD-1 inhibitor. Talimogene laherparepvec is designed to promote tumor antigen release to initiate an anti-tumor immune response which may be complimentary to pembrolizumab's role in releasing PD-1 pathway-mediated inhibition of anti-tumor immune responses.
- The FDA recently accepted for review Amgen's BLA for talimogene laherparepvec for the treatment of regionally or distantly metastatic melanoma. The PDUFA date is July 28, 2015. An MAA has also been submitted in Europe.
- Previously: Amgen submits MAA for cancer immunotherapeutic (Sept. 2, 2014)
Dec. 8, 2014, 1:23 PM
- Micro cap Cellceutix (OTCPK:CTIX +22.1%) jumps on a 5x surge in volume after the FDA grants Qualified Infectious Disease Product (QIDP) status to Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The company is scheduled to meet with the FDA later this month on a planned Phase 3 trial evaluating the safety and efficacy of Brilacidin for ABSSSI.
- Brilacidin is a member of a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the "front line" of defense in the human immune system.
- In a Phase 2b clinical trial, a single dose of Brilacidin demonstrated equivalent effectiveness as a seven-day regimen of daptomycin (CBST +35.4%) for the treatment of ABSSSI.
- Among the benefits of QIDP is Fast Track and Priority Review status and a five-year period of market exclusivity if approved.
Dec. 8, 2014, 12:45 PM
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