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.
Wed, Feb. 4, 7:11 AM
Tue, Feb. 3, 5:30 PM
Tue, Feb. 3, 8:41 AM
- Merck (NYSE:MRK) announces that Belsomra (suvorexant), for the treatment of adult patients with insomnia or who have difficulty falling asleep or staying asleep, is now available in pharmacies in the U.S. It is the only orexin receptor antagonist approved for this indication in the United States.
- Belsomra suppresses the wake drive in the brain by blocking orexin receptors. Orexin is a neurotransmitter involved in promoting wakefulness. ~30M Americans suffer from insomnia.
Mon, Jan. 26, 10:29 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Merck's (MRK +0.2%) Sivextro (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Merck acquired the rights to Sivextro via its acquisition of Cubist Pharmaceuticals.
- A final decision from the European Commission usually takes ~60 days.
- The FDA approved Sivextro in June.
- Previously: FDA give thumbs up to Cubist antibiotic (June 21, 2014)
Wed, Jan. 21, 11:41 AM
- Merck (MRK) plans to withdraw its hepatitis C medicine, Victrelis (boceprevir), from the U.S. market by the end of this year due to declining demand in the wake of the Gilead Sciences (GILD +1.1%) juggernaut. Victrelis will remain available internationally.
- Vertex Pharmaceuticals (VRTX +0.4%) pulled its offering, Incivek (telaprevir) in August for the same reason and exited the hepatitis arena.
- Merck is not giving up yet. It plans to file an NDA by mid-year for an all-oral ribavirin-free hep C regimen, grazoprevir/elbasvir.
Wed, Jan. 21, 8:53 AM
Mon, Jan. 19, 5:11 PM
- As expected, the European Commission approves Novartis' (NYSE:NVS) Cosentyx (secukinumab) as a first-line systemic treatment for adult patients with moderate-to-severe psoriasis. It is the first interleukin-17A inhibitor cleared in Europe.
- Cosentyx is also cleared for sale in Australia and Japan. FDA approval is imminent considering the unanimous positive vote by the Dermatologic and Ophthalmic Drugs Advisory Committee in October.
- Previously: Europe Ad Comm gives thumbs up to Novartis psoriasis drug (Nov. 21, 2014)
- Previously: Ad Comm backs approval of secukinumab (Oct. 21, 2014)
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Fri, Jan. 16, 8:54 AM
- A consortia of global research institutions and non-government organizations has been formed to work with Janssen Pharmaceuticals (NYSE:JNJ) to accelerate the development of its Ebola vaccine. The Innovative Medicines Initiative intends to grant more than €100M to fund the development work. The project is delineated into three areas or topics:
- Topic 1: Vaccine development, Phases 1, 2 and 3. Consortia members: Janssen, London School of Hygiene and Tropical Medicine, Oxford University, Insititut National de la Sante et de la Recherche Medicale (INSERM), La Centre Muraz.
- Topic 2: Manufacturing capability: Janssen, Bavarian Nordic A/S, Vibalogics.
- Topic 3: Deployment and compliance of vaccination regimens: Janssen, London School of Hygiene and Tropical Medicine, Grameen Foundation, World Vision of Ireland.
- A recently-started Phase 1 trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics. Janssen, in partnership with Bavarian Nordic A/S (OTCPK:BVNRY), has produced more than 400K regimens of the prime-boost vaccine for use in large-scale trials that could begin as early as April.
- Ebola vaccine-related tickers: (NASDAQ:NLNK) (NYSE:MRK) (NYSE:GSK)
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Tue, Jan. 13, 8:44 AM
- Eli Lilly (NYSE:LLY) and Merck (NYSE:MRK) establish a clinical trial collaboration through a subsidiary to evaluate the safety, tolerability and efficacy of Merck's PD-1 inhibitor Keytruda (pembrolizumab) in combination with Lilly's compounds in multiple studies.
- Merck will conduct a Phase 2 trial assessing the combination of pembrolizumab and pemetrexed as a first-line treatment of non-small cell lung cancer (NSCLC).
- Lilly will conduct a multiple-arm Phase 1/2 trial assessing the combination of pembrolizumab and ramucirumab in multiple tumors and another Phase 1/2 assessing pembrolizumab and necitumumab in NSCLC.
- Additional details about the partnership are undisclosed.
Mon, Jan. 12, 7:13 AM
- Acknowledging that it needs to speed up its development efforts, Merck (NYSE:MRK) plans to file for another indication for Keytruda (pembrolizumab) by midyear, for the treatment of non-small cell lung cancer, the most common form of the disease.
- It also plans to submit its NDA for grazoprevir/elbasvir for the treatment of HCV infection in H1.
- Merck Research Laboratories President Roger Perlmutter says, "The tempo has changed. What we are doing is focusing our efforts more profoundly, increasing the speed at which we complete things."
Sun, Jan. 11, 10:29 PM
- Based on an assessment by the independent Data Monitoring Committee, Bristol-Myers Squibb (NYSE:BMY) stops its Phase 3 trial, CheckMate-017, evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced squamous cell non-small cell lung cancer (NSCLC). The committee concluded that the study met its primary endpoint of demonstrating superior overall survival (OS) compared to docetaxel. This is the first time a PD-1 inhibitor has shown a survival advantage in lung cancer.
- Eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension.
- The company will complete a full analysis of the data and work with investigators on the future presentation and publication of the results.
- PD-1-related tickers: (NASDAQ:MDVN) (NYSE:MRK) (NASDAQ:FPRX) (NASDAQ:CELG) (OTCQX:RHHBY) (NYSE:AZN)
Thu, Jan. 8, 7:55 PM
- The FDA approves Daiichi-Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
- Edoxaban is an anticoagulant that inhibits factor Xa. It was approved in Japan in 2011 for the prevention of venous thromboembolism in patients undergoing total knee replacement surgery, total hip replacement surgery and hip fracture surgery.
- Anticoagulant-related tickers: (NASDAQ:ISIS) (NYSE:BAX) (NASDAQ:PTLA) (NASDAQ:MSLI) (NYSE:MRK) (NYSE:JNJ) (NASDAQ:MDCO) (NASDAQ:SCLN) (NYSE:PFE) (NYSE:BMY) (NYSE:AZN) (OTCPK:BAYRY)
Mon, Jan. 5, 9:24 AM
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