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Fri, Jan. 15, 7:47 AM
- Merck (NYSE:MRK) settles a multi-district class action lawsuit in New Jersey federal court involving persons who purchased Merck stock between May 21, 1999 and October 29, 2004, who sought damages related to losses precipitated by the company's statements regarding Vioxx.
- Under the terms of the agreement, Merck will pay $830M to settle all claims plus an additional amount for approved attorneys' fees and expenses. Net of insurance coverage, the company will pay ~$680M, for which it will take the charge in Q4 2015.
- The company still faces individual suits related to Vioxx, a non-steroidal anti-inflammatory drug approved in 1999 but withdrawn from the market in 2004 due to an increase risk in cardiovascular events.
Tue, Jan. 12, 7:41 AM
- BioLineRx (NASDAQ:BLRX) and Merck (NYSE:MRK) collaborate in a Phase 2 clinical trial assessing the combination of BioLineRx's BL-8040 and Merck's KEYTRUDA (pembrolizumab) in patients with metastatic pancreatic adenocarcinoma.
- The trial, expected to commence by mid-year, will be sponsored and conducted by BioLineRx. Both companies have the option to expand the collaboration into a pivotal late-stage trial. Additional details are not disclosed.
- BL-8040 is a synthetic peptide that binds to a protein found on the surface of cancer cells called CXCR4, a chemokine receptor that that plays a key role in tumor growth and survival. CXCR4 is overexpressed in more than 70% of human cancers and is associated with a poor prognosis.
- KEYTRUDA helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells.
Mon, Jan. 11, 4:27 PM
Mon, Jan. 11, 9:28 AM
- AbbVie (NYSE:ABBV) commences enrollment in six global Phase 3 clinical trials assessing the safety and efficacy of its all-oral, once-daily, ribavirin-free hepatitis C regimen, ABT-493 (NS3/4A inhibitor) and ABT-530 (NS5A inhibitor), in patients with genotypes 1-6 chronic HCV infection.
- Four studies, ENDURANCE 1,2,3,4, will evaluate the regimen for up to 12 weeks in patients without cirrhosis. The two EXPEDITION studies will assess the regimen for 12 weeks in difficult-to-treat patients, those with compensated cirrhosis (EXPEDITION 1) and those with severe renal impairment and end-stage renal disease with or without compensated cirrhosis (EXPEDITION 4).
- Related ticker: (NASDAQ:GILD)(NYSE:MRK)
Wed, Jan. 6, 7:47 AM
- Hasselt, Belgium-based Complix and Merck (NYSE:MRK) enter into strategic drug discovery collaboration to develop Cell-Penetrating Alphabodies (CPABs) for the treatment of cancer. Under the terms of the agreement, Complix will use its proprietary Alphabody platform to deliver CPABs against two intracellular cancer targets. Merck will fund the research and has the option to exclusively develop the compounds on a global basis. Complix will receive an undisclosed upfront payment, milestones up to $280M and tiered royalties.
- CPABs are a class of small proteins engineered to bind to a range of antigens, including intracellular targets that are difficult for current drugs to reach. They have the ability to enter tumor cells and effectively and selectively modulate intracellular protein-to-protein interactions that play key roles in the initiation and progression of many cancers. Their potential efficacy is enhanced by virtue of remaining stable within tumor cells for up to 24 hours after administration.
Tue, Jan. 5, 10:44 AM
- With the aim of grabbing some of Mallinckrodt's (MNK +1.9%) Acthar business, ANI Pharmaceuticals (ANIP +2.7%) buys two New Drug Applications (NDAs) from a Dutch subsidiary of Merck (MRK +1.2%) for purified corticotropin gel and corticotropin zinc hydroxide for $75M in cash plus a percentage of future sales.
- H.P. Acthar Gel (repository corticotropin injection) accounted for $274.2M of Mallinckrodt's fiscal Q4 revenues of $882.4M (31%). It is indicated for the treatment of infantile spasms, multiple sclerosis, systemic lupus erythematosus, allergic and inflammatory ophthalmic processes and other conditions.
Dec. 21, 2015, 11:35 AM
- Medivation (MDVN +4%) commences a Phase 2 clinical trial evaluating MDV9300 in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The international, open-label study will enroll ~180 subjects who will be divided into two cohorts: those with an incomplete response following salvage therapy and are ineligible for an autologous stem cell transplant (ASCT) and those who have received an ASCT. Each group will receive 200 mg of MDV9300 via IV infusion. The primary endpoint is best overall response rate.
- MDV9300 (pidilizumab) is a humanized monoclonal antibody that binds to a receptor on T cells and pro-B cells called Programmed Cell Death 1 (PD-1) like Merck's (MRK -0.7%) KEYTRUDA (pembrolizumab). Blocking the interaction between PD-1 and and its ligands PD-L1 and PD-L2 activates the immune system to attack and kill cancer cells.
- Medivation secured an exclusive global license to pidilizumab from Israel-based CureTech in October 2014.
- Previously: Medivation exercises option for PD-1 inhibitor (Dec. 22, 2014)
Dec. 18, 2015, 4:22 PM
- The FDA approves the use of Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) as first-line therapy in patients with unresectable or metastatic melanoma, the second melanoma-related indication for the PD-1 inhibitor.
- Previously: PDUFA date tomorrow for Merck's sBLA for KEYTRUDA as first-line therapy for melanoma (Dec. 18)
Dec. 18, 2015, 10:31 AM
- M&A rumors are active this morning with the latest being Stryker (SYK -1%) eyeing Smith & Nephew (SNN +3.5%).
- Unsurprisingly, Merck (MRK -1.1%) continues to eye Relypsa (RLYP +0.9%).
- Previously: Relypsa up 17% on rumored Merck interest (Dec. 4)
- Update: Sources say the Stryker will pay ~$18B for SNN. A deal could be announced as early as next week.
Dec. 18, 2015, 8:44 AM
- Tomorrow is the FDA's action date (PDUFA) for its review of Merck's (NYSE:MRK) supplemental Biologics License Application (sBLA) seeking clearance of KEYTRUDA (pembrolizumab) as first-line treatment of unresectable or metastatic melanoma. Since tomorrow is, of course, Saturday the agency should issue its decision today.
- KEYTRUDA is currently approved for the treatment of unresectable/metastatic melanoma following treatment with ipilimumab (Bristol-Myers Squibb's Yervoy) and, if BRAF V600-positive, a BRAF inhibitor.
- The FDA's action date for its review of Merck's sBLA for the use of KEYTRUDA in ipilimumab-refractory melanoma is December 24.
- Previously: FDA accepts Merck's sBLA for expanded use of Keytruda, PDUFA date December 19 (Aug. 18)
Dec. 18, 2015, 8:27 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) announces that it will review Merck's (NYSE:MRK) Marketing Authorization Application (MAA) for elbasvir 50 mg/grazoprevir 100 mg for the treatment of adults with hepatitis C genotype 1,3,4 or 6 infection under its standard timetable rather than accelerated assessment as previously stated. The action date will be in mid-2016.
- The FDA's PDUFA date for its review of Merck's NDA is January 28.
- Previously: Merck's marketing app for HCV combo pill accepted for review in Europe (July 23)
Dec. 18, 2015, 8:10 AM
- AbbVie (NYSE:ABBV) enters into a licensing agreement with The Medicines Patent Pool (MPP), a United Nations-sponsored public health organization, that will allow generic antiretroviral therapy (ARV) firms to manufacture and sell generic versions of Lopinavir/Ritonavir (LPV/r) across Africa.
- Once generic ARV firms obtain a sublicense from MPP, they will also be able to commercialize combinations of ritonavir with other ARVs, such as atazanavir and darunavir, as alternative second-line therapies.
- The license is royalty-free and non-exclusive. In December 2014, AbbVie extended a license to MPP for pediatric formulations of LPV/r.
- Bristol-Myers Squibb (NYSE:BMY) and Merck (NYSE:MRK) have also signed licensing deals with MPP.
- Africa accounts for ~90% of the total usage of LPV/r in donor-funded developing countries, according to MPP Executive Director Greg Perry.
Dec. 15, 2015, 7:00 PM
- The FDA has signed off on an expanded age indication for Merck's (MRK +1.4%) Gardasil 9 HPV medication, to include use in males ages 16-26.
- The drug -- a 9-valent vaccine form of its quadrivalent Gardasil -- was already approved for use in boys 9-15, and for girls and young women ages 9-26.
- The drug addresses the greatest number of HPV types among available vaccines.
- With both Gardasil and Gardasil 9 approved for the same populations among males and females, the company says it's reached a milestone in transitioning to the 9-valent drug.
Dec. 15, 2015, 4:19 PM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 against backing Merck's (NYSE:MRK) ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin) for the claim of reducing the risk of cardiovascular events in patients with coronary heart disease.
- Results from the company's Phase 3 study, IMPROVE-IT, showed a modest 6.4% risk reduction in patients receiving ezetimibe compared to simvastatin alone.
- Previously: Ad Comm tomorrow for cardiovascular indication for Merck's cholesterol meds (Dec. 13)
Dec. 15, 2015, 3:42 PM
- The long bumpy road to U.S. approval is officially over for Merck (MRK +1.2%). The FDA finally approves sugammadex, branded as Bridion, to reverse the effects of neuromuscular blockade induced by the muscle relaxants rocuronium bromide and vecuronium bromide, commonly used in long surgical procedures. The PDUFA date was December 19.
- This was the fourth NDA submission for company. The FDA issued Complete Response Letters in response to the first three: July 2008, September 2013 and April 2015, citing the need to see more data on potential allergic reactions to the product despite the fact that it has been commercially available in over 60 countries for a number of years.
- Previously: Merck still on the sideline in the U.S. with sugammadex (April 28)
- Previously: Merck strikes out again with sugammadex (March 13)
Dec. 13, 2015, 6:37 PM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets tomorrow to discuss Merck (NYSE:MRK) subsidiary MSD International GmbH's supplemental New Drug Applications seeking approval for expanded labels for cholesterol fighters ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin). The proposed indication is to reduce the risk of cardiovascular events in patients with coronary heart disease.
- The committee will be reviewing the results from the 18,144-subject Phase 3 IMPROVE-IT study which assessed the efficacy of ezetimibe/simvastatin compared to simvastatin alone in reducing the risk of cardiovascular events in patients who had experienced a previous cardiovascular event within 10 days prior to enrollment (subjects were stable at time of randomization). The primary endpoint was time to first occurrence of cardiovascular death, major coronary event or non-fatal stroke over a period as long as nine years.
- Results showed a 6.4% relative risk reduction in the ezetimibe/simvastatin arm compared to the simvastatin arm (p=0.016). In a subgroup analysis, the treatment effect of the combo was most significant in diabetics (p=0.001) and patients at least 75 years old (p=0.0003).
- FDA briefing doc
- Merck GmbH briefing doc
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