The FDA posted its draft guidance for developing drugs to treat noncirrhotic nonalcoholic steatohepatitis with liver fibrosis. Companies developing NASH treatments include Intercept Pharmaceuticals (ICPT), Genfit (GNFTF), Madrigal Pharmaceuticals (MDGL), CymaBay Therapeutics (CBAY) and Viking Therapeutics (VKTX). The patient inclusion criteria sponsors should consider for clinical trials in drug development for treatment of noncirrhotic NASH with liver fibrosis include: “Patients should have a histological diagnosis of NASH with liver fibrosis made close to the time of trial enrollment (i.e., no more than 6 months before enrollment). Because baseline histology is critical for efficacy evaluation, liver biopsies obtained more than 6 months before enrollment may not represent an accurate status of the disease at the 210 beginning of the trial,” the FDA said. It adds, “Because some NASH patients are treated with vitamin E or pioglitazone, enrollment of such patients in clinical trials may confound treatment effects. Therefore, such NASH patients should either discontinue vitamin E or pioglitazone or be on stable doses for 6-12 months before enrollment. Stratified randomization may be necessary to avoid imbalances between treatment arms for concurrent treatment with vitamin E or pioglitazone.”
Monday, December 3, 2018
Aquestive Therapeutics says studies show DBF successfully administered
Aquestive Therapeutics announced findings from two clinical studies, including the Adult Epilepsy Monitoring Unit study, showing that its investigational diazepam buccal film, or DBF, was successfully used and had similar bioavailability whether administered between seizures or during or shortly after seizures in adults with poorly controlled tonic-clonic seizures or focal seizures with impaired awareness. The findings are detailed in two presentations at the annual meeting of the American Epilepsy Society. “Currently, the only formulations of diazepam approved by the U.S. Food and Drug Administration for acute treatment of seizures are injected or rectally administered, which can be cumbersome and uncomfortable for patients who suffer from repetitive seizures. These findings, showing consistent usability and bioavailability, demonstrate Libervant’s potential to address patient needs for an orally administered treatment alternative that is efficacious, easy to use and portable anywhere. We are excited to add this to our growing epilepsy franchise,” said Keith Kendall, CEO of Aquestive Therapeutics.
Genentech’s Hemlibra provided sustained bleed control in pivotal study
Genentech, a member of the Roche Group, announced data from the primary analysis of the Phase III HAVEN 2 study evaluating Hemlibra prophylaxis in children younger than 12 years of age with hemophilia A with factor VIII inhibitors, including longer follow-up for once-weekly dosing and new data for less frequent dosing schedules. These data from the largest pivotal study in children with hemophilia A with factor VIII inhibitors were presented at the 60th American Society of Hematology Annual Meeting. In updated results from the HAVEN 2 study with a median of 11 additional months of data, 76.9 percent of children with hemophilia A with factor VIII inhibitors treated with Hemlibra once weeklyexperienced zero treated bleeds. Importantly, once-weekly Hemlibra showed a 99 percent reduction in treated bleeds compared to prior treatment with bypassing agents as prophylaxis or on-demand in a prospective intra-patient comparison. New data also showed that 90 percent of children with factor VIII inhibitors receiving Hemlibra every two weeks and 60 percent of children receiving Hemlibra every four weeks experienced zero treated bleeds, demonstrating clinically meaningful bleed control at both dosing schedules. No cases of thrombotic microangiopathy or thrombotic events occurred. The most common adverse events in the HAVEN 2 study primary analysis were consistent with those previously observed in the interim analyses. Hemlibra is approved in over 50 countries worldwide, including the U.S., EU member states and Japan, to treat people of all ages with hemophilia A with factor VIII inhibitors based on pivotal data that included interim results from the HAVEN 2 study.
AstraZeneca data from ACE-LY-004 trial showed sustained response to Calquence
AstraZeneca and Acerta Pharma, its hematology research and development center of excellence, have presented new, long-term follow-up results for CALQUENCE in patients with relapsed or refractory mantle cell lymphoma and updated results of an ongoing clinical trial assessing acalabrutinib monotherapy in treatment-naive patients with chronic lymphocytic leukemia at the 60th American Society of Hematology Annual Meeting & Exposition in San Diego, CA. Long-term follow-up data presented from the Phase II ACE-LY-004 trial in relapsed or refractory MCL showed sustained and clinically meaningful responses to CALQUENCE with a median follow-up of more than two years, confirming its efficacy and safety profile in this patient population. Initial data from this trial served as the basis for the accelerated approval of CALQUENCE for the treatment of adult patients with MCL who have received at least one prior therapy by the US Food and Drug Administration in October 2017. The ORR in the trial was 81%.
Altria, Cronos in talks
Altria Group is in early talks to acquire Cronos Group as it looks to diversify business beyond traditional smokers, Reuters reported Monday. The talks between Cronos and Altria are expected to last for several weeks and there is no certainty that the Canadian company will agree to a deal. A transaction would mark one of the biggest combinations between mainstream tobacco and the booming marijuana sector and would come after Altria’s shares have dropped by more than 20% over the year as cigarette smoking continues to decrease in the U.S.
CRONOS DECLINES TO COMMENT: Contacted by The Fly after the report, a Cronos Group spokesperson said the company does “not comment on market rumors.”
WHAT’S NOTABLE: Last Wednesday, The Wall Street Journal reported that Altria is in talks to take a “significant” minority interest in Juul Labs, a controversial e-cigarette startup that was last valued at $16B in a private fundraising round this summer. Altria has an agreement with Philip Morris (PM) to market IQOS, subject to regulatory approval. Philip Morris is already selling it in 43 countries and has said it could get approved for the U.S. by the end of the year. Juul has drawn criticism over its products’ popularity with teens and the U.S. Food and Drug Administration previously announced plans to place restrictions on sales of flavored e-cigarettes. Juul also said it would restrict sales of nearly all its flavored pods to the internet, and stop most social media promotion to combat youth vaping. Following the FDA statement on the agency’s proposed steps against underage smoking, Altria General Counsel Murray Garnick said it “welcomed” the FDA’s efforts to address the underage use of e-vapor products and said it believes Congress should raise the legal age of purchase for all tobacco products to 21. Altria previously said it would pull its pod-based e-vapor products from the market until approved by FDA. Following the WSJ report, Morgan Stanley analyst Pamela Kaufman said she had no knowledge of a potential deal between Altria and Juul but that taking such a stake could make strategic sense for Altria to gain exposure to a fast growing product that poses a threat to its cigarette business. Altria does not have a robust reduced risk product portfolio and Juul’s e-cigs could significantly enhance its competitive position, stated Kaufman, who also believes Altria would likely be buying in at a lower valuation than the previously reported $15B given the FDA recently prohibited flavored pods sales in convenience stores. Additionally in October, Altria was said to be in talks to acquire an equity stake in Canadian cannabis grower Aphria (APHQF). Further, the report said Altria executives had met with Aphria’s management on several occasions, but it could take time for the two companies to strike a deal. Following the report, Aphria said in a statement, “While Aphria engages in discussions with potential strategic partners and/or investors from time to time, the company notes that there is no agreement, understanding or arrangement in place with a potential investor at this time. Aphria will advise the investment community of any material changes, if and when they occur, in accordance with applicable disclosure requirements.” On Monday, The Financial Times said Altria has held discussions with Aphria and Tilray (TLRY).
COMPANIES EYE CANNABIS: In September, Coca-Cola (KO) was reportedly monitoring the nascent cannabis drinks industry and in talks with Canadian marijuana producer Aurora Cannabis (ACB) to develop the drinks. Constellation Brands (STZ, STZ.B) previously announced it will spend $3.8B to increase its stake in Canadian marijuana producer Canopy Growth (CGC) and Molson Coors Brewing (TAP) is starting a joint venture with Quebec’s Hydropothecary to develop cannabis drinks. In addition, Diageo (DEO) had been holding talks with at least three Canadian cannabis producers regarding a potential deal and Heineken’s (HEINY) Lagunitas label has launched a brand focused on non-alcoholic drinks infused with THC.
OTHER CANNABIS STOCKS: Other publicly traded companies in the space include Aurora Cannabis, CV Sciences (CVSI), CannTrust Holdings (CNTTF), Canopy Growth, Cronos Group, General Cannabis (CANN), India Globalization Capital (IGC), Tilray (TLRY), ICC International Cannabis (KNHBF), MedMen Enterprises (MMNFF), Biome Grow (ORTFD), MediPharm Labs (MLCPF) and Indiva (NDVAF).
PRICE ACTION: Shares of Cronos are up 11.8% to $10.23, while Altria rose 1.2% to $55.46 in afternoon trading.
BeiGene presents data on tislelizumab in Chinese patients with R/R cHL
BeiGene announced the presentation of clinical data from the pivotal Phase 2 trial of its investigational anti-PD-1 antibody, tislelizumab, in Chinese patients with relapsed/refractory, R/R, classical Hodgkin’s lymphoma, cHL. These data were presented in an oral session at the 60th Annual Meeting of the American Society of Hematology, taking place December 1-4, in San Diego, CA, and are included in BeiGene’s new drug application in China for tislelizumab for the treatment of patients with R/R cHL. “We set out to address the needs of patients with R/R cHL who have failed to achieve a response or progressed after autologous stem cell transplant. ASCT, or who are not candidates for ASCT, as these patients, unfortunately, have very poor outcomes,” said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. “We are excited to report strong results including high complete response rates from the first registration study for this potentially differentiated anti-PD-1 agent.” Tislelizumab was discovered by BeiGene scientists, and is being developed globally and in China as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid and hematologic cancers with 11 Phase 3 or potentially registration-enabling studies ongoing or planned to initiate in the near term. The NDA for tislelizumab in China in patients with R/R cHL has been accepted by the China National Medical Products Administration and granted priority review status. “In this study, tislelizumab demonstrated an overall response rate, ORR, of 86%, including a CR rate of 61 %. Tislelizumab was also generally well-tolerated by patients with R/R cHL. We are excited by its clinical activity and believe that tislelizumab represents a potential new immunotherapy option for patients in China and elsewhere in the world,” said Yuqin Song, M.D., Ph.D., Associate Professor of Medical Oncology, Deputy Director of the Lymphoma Department at Peking University Cancer Hospital in China, and the presenting author of the study.
https://thefly.com/landingPageNews.php?id=2831485
U.S. judge says may order halt to integration of CVS-Aetna
A federal judge who has been asked to sign off on the government’s decision to approve CVS Health Corp’s (CVS.N) acquisition of insurer Aetna Inc indicated on Monday he may ask the companies to halt integration pending his decision.
Judge Richard Leon of the U.S. District Court for the District of Columbia complained at a hearing last week that the two sides had treated him as a “rubber stamp” for the deal. CVS closed the $69 billion transaction last week and began the integration process.
Leon said at a hearing on Monday that he would issue an order asking the two sides to argue why he should not require CVS and Aetna to be held separate until he decides whether he will approve the consent agreement reached in October between the companies and the U.S. Justice Department.
Makan Delrahim, the assistant attorney general for antitrust, declined comment after the hearing.
A CVS spokesman said in an email after the hearing: “CVS Health and Aetna are one company, and our focus is on transforming the consumer health experience.”
Leon said during the brief hearing that he was “concerned” the Justice Department’s filing with the court pointed to antitrust issues. In October, the Justice Department approved the merger of CVS, a pharmacy chain and benefits manager, and Aetna on condition that the health insurer sell its Medicare Part D drug plan business to WellCare Health Plans Inc (WCG.N).
Most deals struck between the government and companies to resolve antitrust concerns are approved by federal courts with little fuss under the 1974 Tunney Act, which requires courts to ensure the agreement is in the public interest.
Companies generally do not wait for final court approval before closing their transactions.
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