Yesterday, 12:42 PM
Thu, Nov. 19, 7:04 AM
- Eli Lilly (NYSE:LLY) and Merck (NYSE:MRK) extend their immuno-oncology collaboration with a new Phase 3 clinical trial assessing Lilly's ALIMTA (pemetrexed) and Merck's KEYTRUDA (pembrolizumab) as first-line treatment of non-small cell lung cancer (NSCLC). The study will be sponsored by Merck and will be open to treatment-naive NSCLC patients regardless of PD-L1 status. A Phase 2 study was initiated earlier this year.
- Financial terms are not disclosed.
- ALIMTA is Lilly's number two seller, booking $2.6B in sales over the past four quarters. It is a folate analog metabolic inhibitor indicated for the treatment of NSCLC, in combination with chemo.
- KEYTRUDA , Merck's fastest growing drug (Q3 sales = $352M), is a humanized monoclonal antibody that increases the ability of the body's immune system to fight tumor cells by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2.
- Previously: Lilly and Merck team up in cancer trials (Jan. 13)
Mon, Nov. 16, 10:30 AM
- Results from two Phase 2 clinical trials, C-CREST 1 and 2, show Merck's (MRK +0.3%) investigational all-oral, triple-combination HCV regimens produced cure rates as high as 100% in treatment-naive HCV-1,-2 or -3 patients. The data will be presented today at The Liver Meeting in San Francisco.
- The two regimens are grazoprevir, MK-3682 and elbasvir and grazoprevir, MK-3682 and MK-8408. C-CREST 1 assessed the regimens in treatment-naive, non-cirrhotic HCV-1 and -2 patients while C-CREST 2 assessed them in treatment-naive, non-cirrhotic HCV-3 patients. All 240 patients completed eight weeks of therapy and reached follow-up 12 weeks after the end of treatment.
- The cure rates for HCV-1 were 91 - 100%; HCV-2: 60 - 94% and HCV-3: 86 - 95%.
- Grazoprevir is an NS3/4A inhibitor, MK-3682 is an NS5B polymerase inhibitor and elbasvir and MK-8408 are NS5A inhibitors.
Mon, Nov. 16, 10:07 AM
- Data from two mid-stage clinical trials, SURVEYOR-I and SURVEYOR-II, show AbbVie's (ABBV +1.3%) investigational HCV regimen, ABT-493 and ABT-530, produced cure rates as high as 100% after 12 weeks of treatment. The results are being presented at The Liver Meeting in San Francisco.
- Results from the two ongoing studies include genotypes 1, 2 and 3. Data from genotypes 4 - 6 will be presented at future meetings.
- SURVEYOR-I is assessing ABT-493 and ABT-530, with and without ribavirin, in cirrhotic and non-cirrhotic adult HCV-1 patients and non-cirrhotic HCV-4,-5 and -6 treatment-naive or treatment-resistant adults. The cure rates range from 97 - 100% in HCV-1.
- SURVEYOR-II is assessing ABT-493 and ABT-530, with and without ribavirin, in cirrhotic and non-cirrhotic adults with HCV-2 or -3 who were new to therapy or had failed earlier treatment with interferon/ribavirin. The cure rates range from 96 - 100% in HCV-2 and 83 - 94% in HCV-3.
- ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, are being developed for the pan-genotypic (genotypes 1-6) treatment of HCV infection. ABT-493 was discovered under the company's collaboration with Enanta Pharmaceuticals (ENTA -1.2%). A Phase 3 trial in genotypes 1-6 was initiated this month.
- Related tickers: (MRK +0.4%)(GILD +0.1%)(BMY +0.2%)(JNJ +0.8%)
Mon, Nov. 16, 8:21 AM
- The design of a pivotal Phase 3 clinical trial assessing GENFIT's (OTCPK:GNFTF) lead product candidate, Fast Track-tagged Elafibranor (GFT505), for the treatment of non-alcoholic steatohepatitis (NASH) has been finalized. The study is set to commence this quarter.
- The 1,800-subject, randomized, double-blind, placebo-controlled trial will be conducted across 200 centers worldwide. The study population will include NASH patients who have a NAFLD Activity Score (NAS) of at least 4, with F2 (light) or F3 (severe) fibrosis. Participants will receive 120 mg of Elafibranor or placebo once daily. An interim analysis will be performed on the first 900 patients after 72 weeks that will support initial regulatory approval. To support full approval, the trial will continue to conclusion to show the impact of Elafibranor on the prevention of cirrhosis and other liver-related outcomes on the full study population. A group of F1 fibrotic patients who have cardiometabolic co-morbidities will be enrolled as well. The study will continue post-marketing and will remain blinded after the interim analysis. All patients will be followed until the occurrence of a pre-defined number of progressions to cirrhosis or other liver-related events.
- The primary endpoint is the resolution of NASH without worsening of fibrosis.
- NASH-related tickers: (NASDAQ:TBRA)(NASDAQ:ICPT)(NASDAQ:DRRX)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:CNAT)(NASDAQ:VBLT)(NASDAQ:RPTP)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)
Mon, Nov. 16, 7:42 AM
- Preliminary results from a Phase 2a clinical trial, OSIRIS, showed HCV-4 patients treated with Janssen's (NYSE:JNJ) OLYSIO (simeprevir) and Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir) for 12 weeks achieved cure rates as high as 100%. The data were presented at The Liver Meeting in San Francisco.
- OSIRIS assessed the regimen of simeprevir 150 mg and sofosbuvir 400 mg in 63 HCV-4 patients, both treatment-naive and treatment-experienced, with and without cirrhosis. Patients without cirrhosis were randomized to receive either eight or 12 weeks of therapy while patients with cirrhosis received 12 weeks of treatment.
- Results showed a 100% cure rate (SVR12) in patients treated for 12 weeks (n=43) and 75% (n=20) in patients treated for eight weeks. Five patients in the eight-week group relapsed, all were genotype IL28B non-CC and non-responders to other therapies.
- HCV-4 is the most common type of HCV infection in the Middle East. As many as 10% of Egyptians are HCV-positive, almost all genotype 4.
- Related tickers: (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:MRK)
Mon, Nov. 16, 7:05 AM
- Pharco Pharmaceuticals, Egypt's largest drug firm, announces results from a Phase 3 clinical trial assessing the combination of Gilead Sciences' (NASDAQ:GILD) sofosbuvir (different formulation than Sovaldi) plus privately held Presidio Pharmaceuticals' pan-genotypic NS5A inhibitor ravidasvir in patients with HCV genotype 4 infection. The data will presented today at The Liver Meeting in San Francisco.
- Results from the 300-subject study showed that treating HCV-4 patients with sofosbuvir 400 mg and ravidasvir 200 mg once daily for 12 weeks resulted in cure rates (SVR12) of 98% overall (n=255/261) and 100% (n=163/163) in non-cirrhotic patients, suggesting that ribavirin in unnecessary for these patients even if they failed to respond to treatment with interferon. No relapses were observed.
- According to Sovaldi's package insert, its HCV-4 cure rate is 96% (n=27/28) when combined with interferon and ribavirin per results from the NEUTRINO study.
- HCV-4 is the most common type of HCV infection in the Middle East.
- Pharco licensed ravidasvir hydrochloride in Egypt from Presidio Pharma in August 2014.
- Related tickers: (NYSE:ABBV) (NYSE:MRK) (NASDAQ:ENTA)
Sat, Nov. 14, 9:35 PM
- Results from a Phase 3 clinical trial, C-EDGE CO-STAR, show a 95% (n=189/198) cure rate in HCV-1, -4 or -6-positive patients who inject drugs and are receiving opioid agonist therapy for their addiction who were treated with Merck's (NYSE:MRK) once-daily tablet of elbasvir/grazoprevir for 12 weeks. The data were presented at The Liver Meeting 2015 in San Francisco.
- C-EDGE CO-STAR is a double-blind, placebo-controlled study that randomized 301 participants into two arms: an immediate treatment group (ITG) (n=201) that received elbasvir/grazoprevir (blinded) for 12 weeks and a deferred treatment group (DTG) (n=100) that received placebo for 12 weeks, followed for four weeks and then received elbasvir/grazoprevir (open label) for 12 weeks. Of the 301 subjects, 76% had genotype 1a infection, 21% had cirrhosis and 7% were co-infected with HIV. According to clinicaltrials.gov, the estimated study completion date is December 2018.
- 96% (n=147/153) of HCV-1a, 97% (n=28.29) of HCV-1b; 100% (n=11/11) of HCV-4 and 60% (n=3/5) of HCV-6 patients achieved virologic cure after receiving elbasvir/grazoprevir for 12 weeks.
- Virologic failures occurred in nine (4.5%) ITG patients, seven relapses and two discontinuations for study drug-related issues.
- The company's NDA is currently under FDA review. The PDUFA date is January 28.
- Previously: FDA accepts Merck's NDA for HCV combo grazoprevir/elbasvir (July 28)
Fri, Nov. 13, 8:33 AM
- Based on its analysis of unblinded trial data, the independent Data Monitoring Committee (DMC) recommends Merck's (NYSE:MRK) REVEAL outcomes study of anacetrapib continue with no changes. According to clinicaltrials.gov, the estimated completion date for the 30,000-subject trial is January 2017.
- Anacetrapib inhibits a protein called cholesterol ester transfer protein (CETP), which is designed to elevate HDL cholesterol (the "good" cholesterol). CETP inhibitors were all the rage a few years ago over their potential to provide more cardioprotective benefits than lowering LDL cholesterol (the "bad" cholesterol). Big Pharma's efforts to push CETP inhibitors over the finish line hit fell flat due to toxicity and less-than-expected efficacy. Eli Lilly (NYSE:LLY), Roche (OTCQX:RHHBY), and Pfizer (NYSE:PFE) all abandoned their programs.
- Merck has not given up, however. It ran a 1,623-subject study, DEFINE, which showed that anacetrapib was both safe and effective and raised HDL by 150%. REVEAL, initiated in 2011, is designed to settle the issue once and for all. The trial will cost upwards of $500M to complete so the company is banking on a positive outcome.
Fri, Nov. 13, 6:52 AM
- Merck's (NYSE:MRK) Animal Health unit acquires privately held Harrisvaccines for an undisclosed sum. The Ames, IA-based firm develops and commercializes vaccines for food production and companion animals based on its proprietary RNA Particle technology and its versatile production platform that enables it to target a wide range of viruses and bacteria.
Thu, Nov. 12, 12:21 PM
- The U.S. Court of Appeals for the Federal Circuit validates the patent covering Merck's (MRK -0.9%) Cubicin (daptomycin for injection) that expires on June 15, 2016 but invalidates four additional patents that expire in 2019 and 2020. Its ruling affirms a lower court's decision made in December 2014 in a patent litigation suit between Cubist Pharmaceuticals, acquired by Merck in December 2014 and Hospira, acquired by Pfizer (PFE -0.7%) in September 2015.
- Merck is currently considering its options. The decision by the appeals court clears the way for generic competition next year. Cubicin is Merck's fastest growing drug, generating $187M, $293M and $325M in sales in Q1, Q2 and Q3, respectively.
Fri, Nov. 6, 3:38 PM
- The FDA's Anesthetic and Analgesic Drug Products Advisory Committee votes in favor of approval of Merck's (MRK -0.8%) sugammadex, branded as BRIDION. The reversal agent for muscle relaxants used in surgery was developed by Schering Plough, acquired by Merck in 2009. It is currently cleared for sale in over 75 countries but the FDA rejected the company's NDA twice before. The PDUFA date is December 19.
- Previously: FDA Ad Comm review tomorrow for Merck's sugammadex; third time a charm? (Nov. 5)
Fri, Nov. 6, 11:25 AM
- Although not in Valeant's (VRX +1.5%) class, Eli Lilly (LLY -1.4%) and Merck (MRK -1.3%) disclose in their Q3 10-Qs that they have received inquiries over certain aspects of their drug pricing.
- Lilly's 10-Q (p. 48): "In September 2015, we were advised that the U.S. Attorney's office for the Eastern District of Pennsylvania and the Civil Division of the Western U.S. Department of Justice are conducting an inquiry concerning our treatment of certain distribution service agreements with wholesalers when calculating and reporting Average Manufacturer Prices in connection with the Medicaid drug rebate program. We are voluntarily responding to this request."
- Merck's 10-Q (p. 22): "The Company has received a civil investigative demand from the U.S. Attorney's Office, Eastern District of Pennsylvania which requests information relating to the Company's contracting and pricing of Dulera Inhalation Aerosol with certain pharmacy benefit managers and Medicare Part D plans. The Company is cooperating with the investigation."
Thu, Nov. 5, 4:04 PM
- The FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet tomorrow to review Merck's (MRK -0.9%) New Drug Application for sugammadex sodium injection, a reversal agent of the muscle relaxants rocuronium or vecuronium used in surgery.
- This is the third application from Merck unit Organon. It received its first CRL in July 2008 and the second CRL in April of this year. The agency wanted to see more data on potential allergic reactions to the product.
- FDA briefing doc
- Merck briefing doc
- Draft Questions
- Previously: Merck still on the sideline in the U.S. with sugammadex (April 28)
- Previously: Merck surprises some with its plan to seek marketing approval for two drugs despite safety concerns (May 6, 2014)
Wed, Nov. 4, 12:48 PM
- Johnson & Johnson (JNJ) acquires privately held Novira Therapeutics, a clinical stage biopharmaceutical firm developing therapies to cure chronic hepatitis B infection within one year of treatment, for an undisclosed sum. The transaction should close this quarter.
- Novira's lead product candidate is NVR 3-778, a orally available, small molecule, direct-acting antiviral that inhibits the HBV core or capsid protein. HBV core is an attractive drug target since it is plays a key role in viral replication and survival. NVR 3-778 disrupts the HBV life cycle by inducing the assembly of defective capsids. According to the company, its inhibitors, when used in combination with current standard-of-care drugs (nucleosides and interferon), should deliver greater and faster suppression of viral DNA and new virus production.
- Selected HBV-related tickers: (ARWR +2.1%)(GILD -1%)(CTRV -3.2%)(ABUS +2.6%)(DVAX -1.8%)(MRK +0.7%)(SNY -0.8%)(GSK +0.1%)(ISIS +2.1%)(ALNY +3.1%)(BMY -0.6%)
Tue, Nov. 3, 7:24 AM
- GlaxoSmithKline (NYSE:GSK) and Merck (NYSE:MRK) announce the initiation of a Phase 1 clinical trial assessing Glaxo's investigational GSK3174998 as monotherapy and in combination with Merck's KEYTRUDA (pembrolizumab) in patients with locally advanced, recurrent or metastatic solid tumors that have progressed after standard treatment. The primary endpoints are adverse events and dose-limiting toxicities. According to clinicaltrials.gov, the estimated study completion date is January 2020.
- GSKJ3174998 is a humanized IgG1 anti-OX40 monoclonal antibody that was discovered via a collaboration with MD Anderson Cancer Center. OX40 is a tumor necrosis factor receptor found on the surface of activated CD4+ and CD8+ T cells. OX40 agonism stimulates the immune system while reducing the immunosuppressive effects of regulatory T cells sometimes found in tumors.
- KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body's immune system to fight tumor cells by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2.
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