Fri, Mar. 27, 9:19 AM
- The experimental Ebola vaccines from GlaxoSmithKline (NYSE:GSK) and NewLink Genetics (NASDAQ:NLNK) (NYSE:MRK) appear to be safe, based on interim results in a mid-stage trial in Liberia. The vaccines, administered as a single injection, are being evaluated for safety and efficacy on more than 600 people there. Based on the positive results, the study will now progress to the next phase of efficacy testing where additional volunteers will be injected with one of the vaccines or placebo to see if their immune systems produce anti-Ebola antibodies.
- The Ebola epidemic, its course winding down, has claimed more than 10,000 lives.
Tue, Mar. 24, 5:15 PM
- Merck (NYSE:MRK) has upped its buyback authorization by $10B to $11.7B. That's good for repurchasing 7% of shares at current levels.
- The drug giant still expects its 2015 average diluted share count to be around 2.86B, down from 2014's 2.93B and Q4's 2.88B. It spent $13B returning cash last year via buybacks and dividends.
- MRK +1.2% AH to $59.32.
Tue, Mar. 24, 9:08 AM
- A Phase 3 study (KEYNOTE-006) comparing Merck's (NYSE:MRK) Keytruda (pembrolizumab) to Bristol-Myers Squibb's (NYSE:BMY) Yervoy (ipilimumab) in the first-line treatment of patients with advanced melanoma met its two primary endpoints of statistically significant improvements in progression-free survival (PFS) and overall survival (OS). Based on the recommendation of the independent Data Monitoring Committee, the trial will be stopped early. The results will be presented at the American Association of Cancer Research Annual Meeting in Philadelphia, April 18 - 22.
- The trial randomized 834 patients to receive Keytruda 10 mg/kg every three weeks, Keytruda 10 mg/kg every two weeks or four cycles of Yervoy 3 mg/kg every three weeks. Secondary endpoints were overall response rate, duration of response and safety.
- An earlier Phase 2 comparing the two in advanced melanoma also favored Keytruda. Yervoy is big seller for BMY, generating almost $1B in sales the past four quarters.
- Previously: Merck PD-1 inhibitor extends PFS in melanoma (Nov. 17, 2014)
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Fri, Mar. 13, 4:56 PM
- The FDA cancels its March 18 meeting of the Anesthetic and Analgesic Advisory Committee where it planned to review Merck's (NYSE:MRK) resubmitted New Drug Application (NDA) for sugammadex, a reversal agent for the muscle relaxants rocuronium or vecuronium, used in surgical procedures to facilitate endotracheal intubation and to relax the skeletal muscles during surgery or mechanical ventilation. The agency said that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101) and that it wants to complete the inspections prior to an Ad Comm meeting and the completion of its review. Merck expects to receive a Complete Response Letter (CRL) by April 22.
- Merck also received a CRL for its resubmitted NDA for sugammadex in September 2013. In that CRL, the FDA stated that had concerns about operational aspects of a hypersensitivity study that it requested in 2008.
- The FDA issued a CRL in August 2008 to then-owner Schering-Plough stating that it had concerns over hypersensitivity or allergic reactions. The agency's action was unexpected considering an earlier Ad Comm vote unanimously recommending approval.
- Sugammadex was discovered by Organon, which was acquired by Schering-Plough in 2007, which was acquired by Merck in 2009.
Thu, Mar. 12, 3:49 PM
- The FDA accepts for review Bristol-Myers Squibb's (BMY +1.6%) resubmitted New Drug Application (NDA) for daclatasvir in combination with Gilead's (GILD +0.8%) sofosbuvir (Sovaldi) for the treatment of chronic hepatitis C (HCV) genotype 3. BMY amended the original NDA to include data from the Phase 3 ALLY-3 study which showed high cure rates for the regimen, with sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naive and 86% of treatment-experienced HCV-3 patients. The FDA will review the submission within a six-month time frame.
- HCV-3 is the second most common HCV genotype after HCV-1, affecting over 54M people worldwide compared to over 83M for HCV-1. HCV-3 is generally more aggressive and carries a higher risk of hepatocellular carcinoma (liver cancer).
- Daclatasvir is an nonstructural protein 5A (NS5A) replication complex inhibitor. The precise mechanism of action is unknown, but it is suspected that it deregulates the relationship between NS5A and intracellular HCV replication sites.
- Related tickers: (ABBV +2.4%)(MRK +0.1%)(ACHN +0.8%)(RGLS -3%)
Wed, Mar. 11, 10:56 AM
- Biotech investors, giddy over the robust demand for hepatitis C drugs like Gilead's (GILD +0.4%) Sovaldi and Harvoni, are eagerly anticipating the next wave of new therapies for non-alcoholic steatohepatitis (NASH) or "fatty liver disease." It resembles the alcoholic variety but affects people who drink little or no alcohol. According to the NIH, it affects 2 - 5% of Americans.
- Publicly-traded companies with NASH-related development programs include: Tobira Therapeutics (RGDO +2.3%), Islet Sciences (OTCQB:ISLT), Merck (MRK -0.5%), Intercept Pharmaceuticals (ICPT +3.4%), Gilead Sciences, Shire plc (SHPG -0.6%), Galectin Therapeutics (GALT), La Jolla Pharmaceutical (LJPC -1.5%), Conatus Pharmaceuticals (CNAT -1.2%), Raptor Pharmaceutical (RPTP -1.3%), Galmed Pharmaceuticals (GLMD +1.9%) and Genfit (OTCPK:GNFTF).
- TheStreet's Adam Feuerstein says that comparing clinical trial results between firms will require scrutiny because of differences in the designs of the studies, including efficacy criteria and treatment duration. In an article published today, he compares the ongoing trials of Genfit and Intercept. Genfit's efficacy endpoint of its mid-stage study is less stringent than Intercept's but it may make it more difficult to demonstrate a statistically significant benefit versus placebo. Results from Genfit's trial are expected later this month. If positive, it should rally NASH-related stocks.
Wed, Mar. 11, 7:28 AM
- Merck's (NYSE:MRK) PD-1 inhibitor Keytruda (pembrolizumab) is now available in the U.K. despite not having an approved Marketing Authorization Application (MAA) by the European Medicines Agency (EMA). The cancer immunotherapeutic is the first treatment to be accepted under the U.K.'s new Early Access to Medicines Scheme (EAMS) for the treatment of advanced melanoma based on the significance of early study results and unmet medical need. Pembrolizumab received the Promising Innovative Medicine (PIM) designation in the U.K. in October 2014.
- Last year, the U.K. Medicines and Healthcare Products Regulatory Authority (MHRA) introduced EAMS to order to provide patients access to promising, innovative treatments before an MAA has been granted. Under the voluntary program, the MHRA gives a scientific opinion of the benefit/risk profile of the treatment, based on the data submitted to EAMS. The opinion is valid for one year and can be renewed.
- Pembrolizumab's MAA is currently under review by the EMA.
Thu, Mar. 5, 10:47 AM
- Phase 3 trials to assess the safety and efficacy of the experimental Ebola vaccine co-developed by Merck (MRK +0.2%) and NewLink Genetics (NLNK +0.8%) will commence in two days in Guinea according to a statement by the World Health Organization (WHO). The trials will be conducted in the Basse Guinee region which dealt with the most Ebola cases.
- A "ring vaccination" strategy will be employed whereby everyone who has been in contact with a newly diagnosed Ebola patient will be vaccinated, an approach used to eradicate smallpox in the 1970s.
- Trials of two vaccine candidates, Merck/NewLink and GlaxoSmithKline (GSK +0.1%), in Liberia appear to be working. No new cases have been reported for 13 days.
- Trials for Glaxo's offering will begin in Guinea when supplies are available.
Thu, Mar. 5, 7:51 AM
- Merck (NYSE:MRK) and Eisai (OTC:ESALF) (OTCPK:ESALY) establish a clinical trial collaboration to evaluate the safety, tolerability and efficacy of Merck's PD-1 inhibitor pembrolizumab (Keytruda) in combination with Eisai's RTK inhibitor lenvatinib mesylate (Lenvima) and its microtubule dynamics inhibitor eribulin mesylate (Halaven).
- The planned trials include a multicenter, open-label Phase 1b/2 study of lenvatinib plus pembrolizumab in select solid tumors and an open-label, single-arm, multicenter Phase 1b/2 study of eribulin in combination with pembrolizumab in metastatic triple-negative breast cancer. The trials are expected to commence in H2.
- Financial terms are not disclosed.
Fri, Feb. 27, 12:20 PM
- According the the World Health Organization (WHO), a recommendation from the Strategy Advisory Group of Experts (SAGE), an independent advisory body, to commence the widespread introduction of an Ebola vaccine won't happen until at least August due to the timing of results from clinical trials.
- Liberia is currently testing vaccine candidates from GlaxoSmithKline and Merck-NewLink. Sierra Leone and Guinea will announce their plans soon.
- The steep decline in Ebola cases will make it more difficult to prove the efficacy of the experimental vaccines so some of the testing may have to be moved to Sierra Leone, according to the U.S. National Institutes of Health.
- More than 23,500 cases of Ebola have been reported in the three African countries, with more than 9,500 fatalities. Only 99 new confirmed cases were reported for last week.
- (GSK -0.6%)(MRK -0.5%)(NLNK +1.2%)(GILD -0.8%)
Thu, Feb. 26, 7:30 AM
- The FDA approves Sanofi's (NYSE:SNY) Toujeo (insulin glargine [rDNA origin] injection, 300 U/ml), a once-daily long-acting basal insulin, to improve glycemic control in adults with type 1 and type 2 diabetes. The company expects Toujeo to be available in the U.S. at the beginning of Q2.
- Sanofi's intent is to transition patients from its current once-daily basal insulin, Lantus (insulin glargine [rDNA origin] injection, 100 U/ml), which faces competition from generics, to the premium-priced Toujeo, although the company has yet to disclose the specific price.
- Toujeo will be available in a disposable prefilled pen that contains 450 units of insulin and requires only one third of the injection volume to deliver the same number of insulin units as Lantus. The maximum single injection of 80 IU meets the needs to the vast majority of diabetics on basal insulin.
- Lantus is the top-selling insulin in the world, pulling in $7.2B for Sanofi last year. Analysts say the conversion to Toujeo is far from certain, however. Payers may lack enthusiasm for paying more for the new product which is not that differentiated from the old.
- Toujeo's approval in Europe is pending.
- Related tickers: (NYSE:LLY) (NYSE:MRK)
Tue, Feb. 24, 2:05 PM
Tue, Feb. 24, 8:14 AM
- Merck (NYSE:MRK) extends a royalty-free license to the Medicines Patent Pool (MPP) for its pediatric formulations of raltegravir (marketed as Isentress in the U.S.) for the treatment of HIV-1 infection in infants and children from four weeks to under 12 years of age in developing countries. This is the MPP's first agreement that provides access to an HIV integrase inhibitor for use in combination HIV therapy for patients in this age range.
- Raltegravir is the only integrase inhibitor cleared for use in infants and children as young as four weeks in the U.S. and European Union. Pediatric formulations are available as chewable tablets (25 mg and 100 mg) and granules for oral suspension (single-use 100 mg packets).
- There are ~3.2M children infected with HIV worldwide.
- The MPP, founded in 2010, is a United Nations-backed organization that aims to increase access to HIV medicines and technologies to people in developing countries. It has agreements with AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY), Gilead Sciences (NASDAQ:GILD), Roche (OTCQX:RHHBY), NIH and ViiV Healthcare (NYSE:PFE) (NYSE:GSK).
Mon, Feb. 23, 7:42 AM
- Merck (NYSE:MRK) enters into a multi-year collaboration agreement with South San Francisco, CA-based NGM Biopharmaceuticals to discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. The deal includes multiple NGM drug candidates currently in preclinical development such as NP201 for the potential treatment of diabetes, obesity and nonalcoholic steatohepatitis (NASH).
- NGM's lead product candidate is NGM282, an Orphan Drug- and Fast Track-designated optimized form of fibroblast growth factor 19 (FGF19). In preclinical animal models, it significantly reduced blood glucose and body weight and improved insulin sensitivity.
- NGM will lead the research and development of the existing preclinical candidates and will have the autonomy to pursue other discovery-stage programs at its discretion. Merck will have the option to license all resulting NGM programs following human proof-of-concept trials. If it exercises its option, Merck will lead global product development and commercialization for product(s), if approved.
- Under the terms of the agreement, Merck will pay NGM an upfront payment of $94M and purchase a 15% equity stake in NGM for $106M. It also commits up to $250M to fund all of NGM's efforts under the initial five-year term of the partnership. Prior to Merck initiating a Phase 3 trial for a licensed candidate, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund the development and share in global cost and revenues up to 50%.
- NGM will host a conference call this morning at 9:30 am ET to discuss the deal.
Fri, Feb. 20, 7:15 AM
- The World Health Organization (WHO) approves the use of a 15-minute point-of-care test developed by Corgenix Medical (OTCQB:CONX) to detect the presence of the Ebola virus. The company developed the assay with funding assistance of the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.
- Procurement and roll-out in Africa will begin in a few weeks pending the completion of administrative procedures with the U.S. FDA.
- Ebola-related tickers: (NYSE:MRK) (NASDAQ:NLNK) (NYSEMKT:IBIO) (NASDAQ:NVAX) (NYSE:GSK) (NYSE:JNJ) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:BCRX) (NASDAQ:SRPT) (NASDAQ:CMRX) (NASDAQ:ABIO) (OTCQB:AEMD) (OTCPK:BVNRY) (NASDAQ:INO) (OTCQX:RHHBY)
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