Cubist Pharmaceuticals: An Extraordinary Arbitrage Opportunity
Cubist And The Threat Of Antibiotic Resistance
Cubist Pharmaceuticals: Doomsday Preparation Update
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
Dec. 10, 2015, 8:46 AM
- Eli Lilly (NYSE:LLY) and Merck (NYSE:MRK) plan to commence a Phase 1 clinical trial in early 2016 to evaluate the combination of Lilly's cyclin-dependent kinase (CDK) 4 and 6 inhibitor, abemaciclib (LY2835219), and Merck's KEYTRUDA (pembrolizumab) across multiple tumor types. Based on the results in the Lilly-sponsored study, the collaboration may progress to a Phase 2 trial in patients with metastatic breast cancer or non-small cell lung cancer, which Lilly will also sponsor.
- Abemaciclib is a cell cycle inhibitor that is designed to block the growth of cancer cells by inhibiting the enzymes CDK4 and CDK6. 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.
- The companies established a clinical trial collaboration in January to evaluate the combination of KEYTRUDA and various Lilly compounds across a range of cancers.
- Previously: Lilly and Merck team up in cancer trials (Jan. 13)
Dec. 8, 2015, 3:18 PM
- It's been a rough run for value stocks over the past few years, but the metric used to determine value - price/book - may not be the right one, says Citi's Robert Buckland. Free-cash-flow yield is better, he argues. noting this metric tracked traditional value in the 1990s and 2000s, but has easily outperformed over the past decade.
- It's a sign of the times, he says, as FCF is a "capex-suspicious metric," and investors are concerned about the economic outlook, and cynical about capital allocation decisions of managements.
- The list of 28 U.S. value (as defined by FCF yield) plays: BHI, VIAB, WFM, ANTM, HPQ, ABC, LBTYA, M, AAPL, CTL, XRX, LYB, CMI, ETN, MRK, VLO, CSCO, WRK, IBM, LVS, ESRX, IP, CAH, ADM, INTC, CAT, ABBV, EMN
Dec. 4, 2015, 12:01 PM
- Relypsa (RLYP +16.6%) jumps on increased volume in response to rumors that Merck (MRK +0.5%) may be eyeing the company. Actelion Pharmaceuticals (OTCPK:ALIOY -0.4%) is another rumored suitor considering AstraZeneca's (AZN +0.4%) recent takeover of ZS Pharma (ZSPH -0.1%).
- Relypsa's sole product is Veltassa (patiromer for oral suspension) for the treatment of hyperkalemia (abnormally high levels of serum potassium), cleared by the FDA on October 21.
- Previously: Good news is bad news for Relypsa; shares down 26% premarket after approval of Veltassa (Oct. 22)
- Previously: ZS Pharma take out by AstraZeneca puts the spotlight on Relypsa; shares rise 17% premarket (Nov. 6)
Dec. 4, 2015, 9:06 AM
- Amgen (NASDAQ:AMGN) and Merck (NYSE:MRK) announce a cancer immunotherapy collaboration to support an open-label Phase 1b/3 clinical trial assessing the combination of BLINCYTO (blinatumomab) and KEYTRUDA (pembrolizumab) in patients with diffuse large B-cell lymphoma (DLBCL).
- Amgen's BLINCYTO is a CD19 bispecific T cell engager (BiTE) that helps the body's immune system to detect and attack malignant cancer cells. The modified antibodies are designed to engage two different targets simultaneously thereby juxtaposing T cells to cancer cells and triggering apoptosis (cell death). Merck's 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.
- The companies will also collaborate to support an open-label Phase 1/2 study of the combination of KEYTRUDA and Amgen's AMG 820, an anti-colony-stimulating factor 1 receptor (CSF1R) antibody, in patients with select advanced solid tumors. AMG 820 is a fully human antagonistic IgG2 monoclonal antibody that binds to CSF1R. It helps the body's immune system fight cancer by decreasing the function of tumor-associated white blood cells called macrophages.
Nov. 24, 2015, 12:42 PM
- Merck (NYSE:MRK) declares $0.46/share quarterly dividend, 2.2% increase from prior dividend of $0.45.
- Forward yield 3.46%
- Payable Jan. 8; for shareholders of record Dec. 15; ex-div Dec. 11.
Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products worldwide. It is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets vaccines and... More
Industry: Drug Manufacturers - Major
Country: United States
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