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)
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Thu, Feb. 19, 9:25 AM
- The initiation of a clinical trial evaluating the rVSV-EBOV (Ebola) vaccine triggers a $20M milestone payment from Merck (NYSE:MRK) to NewLink Genetics (NASDAQ:NLNK).
- The rVSV-EBOV vaccine candidate, originally developed by the Public Health Agency of Canada, was licensed by NewLInk subsidiary BioProtection Systems. It was exclusively licensed to Merck on November 24, 2014.
Thu, Feb. 12, 1:18 PM
- Novavax (NVAX +1.7%) commences patient enrollment in a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M. The study, being conducted in Australia, involves 230 healthy subjects between the ages of 18 and 50. Each person will receive two intramuscular injections, one on Day 0 and one on Day 21.
- The trial will also evaluate immunogenicity as measured by serum concentrations of IgG antibodies to the Ebola Makona strain glycoprotein.
- According to CEO Stanley C. Erck, the company now has the capability to rapidly scale up manufacturing to produce millions of doses of Ebola vaccine.
- Related tickers: (GSK -1%)(JNJ -1.8%)(OTCPK:BVNRY)(MRK +0.1%)(NLNK +5.3%)
- Previously: Johnson & Johnson announces Ebola vaccine development consortia (Jan. 16)
- Previously: First Glaxo Ebola vaccine to arrive in Liberia (Jan. 23)
Thu, Feb. 12, 11:25 AM
- AbbVie (ABBV -0.5%) submits a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare seeking approval for its all-oral, ribavirin-free, interferon-free, 12-week antiviral treatment of ombitasvir/paritaprevir/ritonavir, dosed once daily, for the treatment of patients with chronic hepatitis C genotype 1 infection.
- The Phase 3 trial data supporting the application demonstrated an SVR12 of 95% (106 of 112 subjects) in a subgroup of treatment-naive, non-cirrhotic adult genotype 1b-infected Japanese patients with a high viral load (at least 100K IU/mL).
- 1.5M - 2M Japanese are infected with HCV, with HCV-1 being the most common genotype affecting 60 - 70% of infected people. Of this group, ~95% are infected with the sub-type 1b.
- Previously: AbbVie 2-DAA HCV treatment successful in Japan Phase 3 (Feb. 2)
- Related tickers: (GILD -0.3%)(MRK -0.2%)(ENTA -3.7%)
Fri, Feb. 6, 7:04 AM
- Merck (NYSE:MRK) prices a $8B debt offering that it will use to repay the commercial paper that financed its acquisition of Cubist Pharmaceuticals. The tranches are as follows:
- $300M floating rate notes due February 2017; $700M floating rate notes due February 2020; $1,250M of 1.85% notes due February 2020; $1,250M of 2.35% notes due February 2022; $2,500M of 2.75% notes due 2025 and $2,000M of 3.70% notes due February 2045.
- Closing date is February 10.
Wed, Feb. 4, 9:52 AM
- In an unprecedented move, the FDA rescinds its Breakthrough Therapy designation for Merck's (MRK -2.4%) investigational HCV combo treatment, grazoprevir/elbasvir. The agency declined to comment on its action, but it means that the review period for the company's New Drug Application (NDA), expected to be filed by mid-year, will now be the standard ten months instead of six.
- The FDA grants Breakthrough Therapy status to a drug candidate that treats a serious medical condition and preliminary clinical evidence shows that it may demonstrate a significant improvement on a clinically significant endpoint compared to available therapies. Considering the high level of efficacy of Gilead's (GILD -9.4%) Sovaldi and Harvoni, the potential advantages of Merck's offering are apparently no longer evident.
- Related ticker: (ABBV -6.1%)
Wed, Feb. 4, 7:46 AM
- Merck (NYSE:MRK) Q4 results ($M): Total Revenues: 10,482 (-7.4%); Pharmaceutical: 9,370 (-4.0%); Animal Health: 885 (+1.6%); Consumer Care: 16 (-95.9%); Other: 211 (-29.2%).
- Sales By Product: Januvia/Janumet: 1,652 (+1.7%); Zetia/Vytorin: 1,032 (-10.4%); Remicade: 557 (-10.2%); Isentress: 418 (-5.4%); Gardasil: 356: (-9.6%); Nasomex: 268 (-18.0%); Proquad, MMRII & Varivax: 366 (+34.1%); Singulair: 319 (+7.0%).
- COGS: 3,749 (-18.6%); R&D Expense: 2,283 (+24.3%); SG&A Expense: 2,924 (-1.9%); Net Income: 7,316 (+797.7%); EPS: 2.54 (+876.9%).
- Gross Profit: 6,733 (+0.3%); COGS: 35.8% (-12.1%); Gross Margin: 64.2% (+8.3%); Operating Earnings: 1,526 (-19.4%); Operating Earnings Yield: 14.6% (-13.0%); Net Earnings Yield: 69.8% (+869.3%).
- 2015 Guidance: Revenues: $38.3B - 39.8B; EPS: $1.62 - 1.91; Non-GAAP EPS: $3.32 - 3.47.
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