Dec. 5, 2014, 12:48 PM
- At the Melanoma Bridge conference in Italy, OncoSec Medical (OTCQB:ONCS -1.8%) Chief Scientific Officer Dr. Robert Pierce presented six-month data from the first Phase 2 clinical trial of the company's investigational intratumoral plasmid IL-12 IL-12 electroporation (pIL-12 EP) monotherapy (ImmunoPulse IL-12) in patients with Stage III and IV metastatic melanoma.
- Tumor response were evaluated using modified RECIST criteria for cutaneous lesions. The primary endpoint was best overall response rate (bORR) by modified RECIST. In the 29 response-evaluable patients, bORR was 31% (9/29) while 14% (4/29) achieved a complete response.
- Based on these data, the company plans to initiate a Phase 2b trial to evaluate ImmunoPulse IL-12 with Merck's (MRK +1.4%) Keytruda (pembrolizumab).
Dec. 5, 2014, 7:19 AM
- Doctors say that simple intravenous fluid drips could save the lives of many Ebola patients, but they are not being deployed due to a perception that no treatment will work. Many patients are succumbing to extreme dehydration and electrolyte depletion caused by vomiting and diarrhea, according to Ian Roberts of the London School of Hygiene and Tropical Medicine and Anders Perner of Copenhagen University. "Ebola treatment must be more that just a setting for quarantine. Patients will be reluctant to attend treatment centers unless the care they receive...is superior to the care provided by family members."
- The epidemic in West Africa has claimed more than 6,000 lives out of ~17,000 that have been infected. All but 15 of the deaths have occurred in Sierra Leone, Guinea and Liberia.
- ETFs: IRY, IXJ
- Ebola-related tickers: (NYSE:GSK) (NYSE:JNJ) (NYSE:MRK) (NASDAQ:NLNK) (OTCQB:AEMD) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:SRPT) (NASDAQ:BCRX)
Dec. 4, 2014, 8:23 AM
- In a Phase 1 trial sponsored by the University of Oxford, 30 healthy volunteers will receive Bavarian Nordic's MVA-BN Filo booster vaccine in combination with the monovalent cAd3-EBO Z Ebola vaccine co-developed by GlaxoSmithKline (NYSE:GSK) and the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). Recent preclinical research suggests that employing an MVA-based booster dose may deliver a more robust and durable immune response to the primary vaccine.
- The study involves 60 healthy adults divided into three cohorts each receiving different doses of the cAd3-EBO Z vaccine. Half of each cohort will also receive the booster dose of MVA-BN Filo.
- The primary endpoint is safety and tolerability. The secondary endpoint is the cellular and humoral immune response. Preliminary results should be available in 1H 2015.
- Both cAd3-EBO Z and MVA-BN Filo have been developed in collaboration with NIAID, which also investigated the prime boost regimen of MVA-BN Filo and Crucell Holland B.V.'s AdVac technology. Crucell is part of J & J (NYSE:JNJ) unit Janssen Pharmaceuticals. Bavarian Nordic and Janssen are collaborating on the development and manufacture of large quantities of their vaccine regimen and intend to start clinical trials shortly.
- Related tickers: (NYSE:MRK) (NASDAQ:NLNK)
Nov. 28, 2014, 9:23 AM
- The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
- Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
- Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
- Previously: BI begins enrollment in Phase 3 CRC trial
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Lung cancer-related tickers: (NYSE:BMY) (NYSE:MRK) (NASDAQ:CLVS) (NASDAQ:FPRX) (NASDAQ:BIND) (NYSE:GSK) (NASDAQ:ARIA) (NASDAQ:ECYT) (NYSE:AZN) (OTC:MKGAF) (OTCPK:MKGAY) (NASDAQ:ONTY) (NYSE:PFE) (NASDAQ:HTBX) (OTCQX:RHHBY) (NASDAQ:INCY)
Nov. 25, 2014, 1:42 PM
- OncoSec Medical (OTCQB:ONCS +13.5%) and the University of California, San Francisco enter into a clinical collaboration to evaluate the safety, tolerability and efficacy of the combination of Merck's (MRK +0.6%) Keytruda (pembrolizumab) and OncoSec's ImmunoPulse (intratumoral IL-12) in metastatic melanoma.
- Immunopulse is an investigational intratumoral therapy that uses plasmid DNA that encodes for Interleukin-12 and delivers it directly into the tumor via a proprietary electroporation device.
- The collaboration will be a Phase 2 trial that will commence in Q1 2015. Merck will supply pembrolizumab and OncoSec will supply the electroporation devices and plasmid IL-12.
Nov. 25, 2014, 1:07 PM
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 24, 2014, 9:59 AM
- Merck (MRK -0.5%) submits a new drug application to the Japanese Pharmaceuticals and Medicinal Devices Agency for omarigliptin for the treatment of type 2 diabetes. Japan is the first country with a regulatory filing for the drug candidate.
- Omarigliptin is a once-weekly DPP-4 inhibitor. Merck's Januvia (sitagliptin), approved by the FDA in 2006, was the first agent in the class to achieve regulatory clearance.
Nov. 24, 2014, 9:48 AM
- Merck (MRK -0.7%) enters into an exclusive worldwide license agreement with NewLink Genetics (NLNK +0.5%) to develop and commercialize the latter's investigational rVSV-EBOV (Ebola) vaccine candidate.
- Phase 1 trials are currently underway at Walter Reed Army Institute of Research and the NIAID at the NIH. If successful, the NIH will commence a large, randomized Phase 3 study to evaluate the safety and efficacy of rVSV-EBOV and another investigational Ebola vaccine candidate co-developed by the National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline (GSK -0.3%).
- The rVSV-EBOV vaccine was created by scientists at the Public Health Agency of Canada's National Microbiology Laboratory.
Nov. 24, 2014, 8:40 AM
- Tetraphase Pharmaceuticals (NASDAQ:TTPH) is reportedly considering selling itself after being approached by interested suitors. Sources say the acquirer could be Acetelion (OTCPK:ALIOF) (OTC:ALIOY) or Roche (OTCQX:RHHBY).
- The attraction is Tetraphase's antibiotic eravacycline, currently in Phase 3 development. Both oral and IV formulations of the drug have demonstrated higher dose response rates than Johnson & Johnson's (NYSE:JNJ) Levaquin (levofloxacin) for the treatment of complicated urinary tract infections. In the Ignite-2 study, patients receiving 200 mg eravacycline IV-to-oral doses achieved a response rate of 70.8% while patients receiving 250 mg IV-to-oral doses achieved 64.3%, both significantly ahead of Levaquin's 52.2% response rate.
- A trial comparing eravacycline to Merck's (NYSE:MRK) Invanz (ertapenem) for the treatment of complicated intra-abdominal infections is underway.
- TTPH is up 18% premarket on light volume.
- Previously: Tetraphase completes eravacycline Phase 3 enrollment
Nov. 21, 2014, 8:48 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of AbbVie's (NYSE:ABBV) Viekirax (a combination of ombitasvir, paritaprevir and ritonavir) plus Exviera (dasabuvir), with or without ribavirin, for patients with chronic HCV genotype 1 infection and Viekirax only, with ribavirin, for patients with HCV genotype 4 infection. A final decision by the European Commission usually takes about 60 days.
- The FDA tagged Viekirax a Breakthrough Therapy and granted priority review of AbbVie's NDA in June.
- Related tickers: (NASDAQ:ENTA) (NASDAQ:GILD) (NYSE:MRK) (NYSE:BMY) (NASDAQ:RGLS) (NASDAQ:CNAT) (NASDAQ:ACHN)
- Previously: Enanta declines HCV drug co-development option with AbbVie
- Previously: AbbVie presents HCV/HIV and liver transplant HCV data
Nov. 17, 2014, 3:59 PM
- In a Phase 2 clinical trial, Merck's (MRK +0.7%) anti-PD-1 therapy, Keytruda (pembrolizumab), improved progression-free survival (PFS) versus chemotherapy in patients with ipilimumab-refractory advanced melanoma. At six months, PFS for the 2 mg/kg and 10 mg/kg doses was 34% and 38%, respectively, compared to 16% for chemo (p<0.0001).
- Study results, including secondary endpoints, were presented today by Dr. Antoni Ribas, professor, Hematology/Oncology and Surgery, UCLA at the Society of Melanoma Research 2014 Congress in Zurich, Switzerland.
- The study's co-primary endpoints are PFS and overall survival (OS). Investigators will evaluate OS in 2015.
- Keytruda is approved in the U.S. at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Nov. 17, 2014, 1:02 PM
- In a Phase 3 trial, patients receiving Merck's (MRK +0.9%) Vytorin (ezetimibe/simvastatin) experienced fewer major cardiovascular events than those receiving simvastatin alone. In the study, called Improve-It, at seven years, 32.7% of patients taking Vytorin experienced a primary endpoint event compared to 34.7% of patients taking simvastatin alone (p=0.016) (hazard ratio: 0.936).
- Based on the LDL-cholesterol range in the study's treatment arms, the 6.4% relative risk reduction observed in the Vytorin arm was consistent with the treatment effect that had been projected based on prior studies of statins.
- The company intends to submit the data to the FDA to support a new indication for the reduction on major cardiovascular events for Vytorin and Zetia (ezetimibe).
Nov. 13, 2014, 11:56 AM
- The FDA's Anesthetic and Analgesic Drug Products Advisory Committee meets on November 24, 25 to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also review the efficacy of ESI and the overall risk benefit profile of injecting steroids in the epidural space to treat pain. Regulatory options will also be discussed which could include changes to product labeling.
- Briefing doc
- Related tickers: (MRK +0.7%)(PFE +0.2%)(BMY -1.3%)(NVS +2%)
Nov. 13, 2014, 9:01 AMGene mutation targeted by Merck's Zetia leads to lower cholesterol levels and reduced heart disease risk
- Researchers from the Broad Institute and Massachusetts General Hospital identify rare mutations that inactivate a gene the body uses to take cholesterol in food and move it into the bloodstream. The mutations, found in 1 in 650 people, lead to lower cholesterol levels and a reduction in heart disease risk of as much as 50%.
- One of the mutations is the same one targeted by Merck's (NYSE:MRK) Zetia (ezetimibe). The drug works by blocking the absorption of cholesterol in the stomach. Whether the drug can prevent heart attacks and death over and above the use of statins is unclear. A definitive study on the issue, called Improve-It, will be presented at next week's American Heart Association meeting in Chicago. It compares the combination (Merck's Vytorin) of Zetia and the generic cholesterol-lowering drug simvastatin to simvastatin alone.
- There is a high degree of interest in the study results since the failure to prove that Vytorin (and, therefore, Zetia) contributes to a decrease in heart disease and death over and above simvastatin could have a devastating impact on Merck's $4B franchise. FDA guidelines issued last year recommend only those drugs shown to reduce heart attack, stroke and death should be prescribed.
Nov. 11, 2014, 4:52 PM
- A Phase 3 study evaluating Amgen's (NASDAQ:AMGN) brodalumab versus Janssen's (NYSE:JNJ) Stelara (ustekinumab) and placebo at week 12 in patients with moderate-to-severe plaque psoriasis met its primary endpoints. Brodalumab was superior to ustekinumab in achieving total clearance of skin disease as measured by PASI-100. Compared to placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12 (measured by PASI-75). All key secondary endpoints were also met.
- Proportion of patients achieving total clearance of disease: brodalumab-210 mg: 36.7%; brodalumab-140 mg: 27.0%; Stelara: 18.5%; placebo: 0.3%.
- Proportion of patients achieving PASI-75: brodalumab-210 mg: 85.1%; brodalumab-140 mg: 69.2%; Stelara: 69.3%; placebo: 6.0%.
- Amgen plans to present the complete results at a future medical conference.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NASDAQ:CELG) (NYSE:NVS) (NASDAQ:DERM) (NASDAQ:IDRA) (NYSE:HSP) (NYSE:PFE) (NYSEMKT:CANF) (NYSE:MRK)
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