Target $10
Tuesday, June 18, 2019
ContraVir Moves Higher After NASH Drug Shows 100% Fibrosis Prevention Efficacy
ContraVir Pharmaceuticals Inc CTRV 0.11% shares were rallying Monday on positive news related to its non-alcoholic steatohepatitis, or NASH, drug.
ContraVir, which came under pressure Friday following news of an erroneous SEC filing, said Monday ahead of the market open that findings from its first study with human, precision-cut liver slice cultures showed that potent, profibrotic molecules that were co-administered with its NASH candidate CRV431 were 100% effective in preventing fibrosis induction beyond baseline levels.
“CRV431 at clinically relevant concentrations also partially or completely blocked several genetic and protein biomarkers of inflammation and fibrosis,” the company said.
CRV431 was simultaneously tested with Phase 3 candidates GENFIT S A/ADR GNFT 0.1%‘s elafibranor and Intercept Pharmaceuticals Inc ICPT 0.18%‘s obeticholic acid, and was found to be more effective in preventing fibrosis than the latter two.
Elafibranor was found to be 62% effective and OCA 9% effective in preventing fibrosis, as measured by Picrosirius Red staining.
In early June, ContraVir said a Phase 1 single ascending dose study of CRV431 was safe and well-tolerated in humans.
Alexion ULTOMIRIS Gets Marketing Authorization from Japan
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved ULTOMIRIS® (ravulizumab), the first and only long-acting C5 complement inhibitor administered every eight weeks, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
PNH is an ultra-rare and severe disease that, when left untreated, may cause a wide range of debilitating symptoms and complications, including thrombosis. Thrombosis occurs when a blood clot presents inside a blood vessel, and slows or blocks the flow of blood through the circulatory system. Serious cases of thrombosis can occur throughout the body and result in organ damage, stroke, heart attack, and potentially premature death.
FDA OKs Merck KEYTRUDA Monotherapy for Metastatic Small Cell Lung Cancer
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This accelerated approval is based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This marks the first indication for KEYTRUDA in SCLC.
“KEYTRUDA is already an established treatment option for non-small cell lung cancer, and today’s approval in small cell lung cancer demonstrates our commitment to bringing forward new treatment options for patients with advanced, difficult-to-treat cancers,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “We look forward to continuing to advance important clinical research in small cell lung cancer.”
Astellas hypercholesterolemia drug Repatha gets supplemental indication OK
Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, ‘Amgen Astellas’) and Astellas Pharma Inc. (Headquarters, Tokyo; President and CEO: Kenji Yasukawa, Ph.D., ‘Astellas’) today announced that Amgen Astellas has received approval in Japan for a supplemental indication for the hypercholesterolemia drug Repatha® SC Injection (evolocumab (Genetical Recombination), ‘Repatha®‘). The supplemental indication is for treating hypercholesterolemia patients who are not suitable for HMG-CoA reductase inhibitor (‘statin’) therapy.
As defined in Precautions Related to Dosage and Administration section of the previous prescribing information, Repatha® was originally approved for use in combination with statins only. The approval for the supplemental indication will make it possible for Repatha® to be used alone in familial hypercholesterolemia or hypercholesterolemia patients for whom statin therapy is not suitable, due to a history of side effects or contraindication.
Shizuya Yamashita, M.D., Ph.D., Vice Chairman/Director of Rinku General Medical Center says, ‘The management of low-density lipoprotein (LDL) cholesterol (LDL-C) is key to the prevention of coronary artery disease such as angina pectoris and myocardial infarction. In regards to secondary prevention, patients with acute coronary syndrome, high-risk type 2 diabetes, or familial hypercholesterolemia, should target LDL-C
Jointly developed by Amgen Astellas and Astellas in Japan, Repatha® is a human IgG2 monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the ability of hepatic LDL receptors to remove LDL-C, or ‘bad’ cholesterol, from the blood.
Roche wins Japan approval for personalised cancer drug Rozlytrek
Swiss drugmaker Roche’s push into personalised cancer medicines hit a milestone on Tuesday with Japanese approval of a new drug, Rozlytrek, that targets patients who must be identified via genetic profiling.
Japan is the first country to give its blessing to Rozlytrek, also known as entrectinib, targeting people with NTRK fusion-positive solid tumours, across 10 different tumour types including breast, colorectal, neuroendocrine, lung and pancreatic cancers.
Rozlytrek aims to treat people with a rare genetic anomaly, called NTRK fusions, that drive growth in a range of tumours found throughout the body. This approach, where prospective patients must be identified via a biomarker test, is a departure from an era when doctors treated patients based on where the tumour occurred in the body.
While positive news for Roche, the Basel-based company has been beaten to the regulatory finish line in this emerging area: German drugmaker Bayer’s Vitrakvi has already won U.S. backing for solid tumours that test positive for NTRK genes. Roche has yet to get U.S. and European approvals.
“Today’s approval of Rozlytrek represents a new chapter in personalised healthcare, applying advanced diagnostics to deliver precision medicines,” said Sandra Horning, Roche’s chief medical officer, adding she hopes for approval elsewhere “as soon as possible”.
On their own, NTRK fusions are so rare that doctors are not likely to run dedicated tests for each. But since they occur in a multitude of tumours, Roche sees potentially broad application for Rozlytrek, in conjunction with companion diagnostic tests from its Foundation Medicine unit.
Roche is also testing Rozlytrek in cancers with additional genetic anomalies.
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