Search This Blog

Tuesday, September 4, 2018

Janssen Submits Nasal Spray Application for Treatment-Resistant Depression


The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen)today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray. Janssen is seeking FDA approval of esketamine for treatment-resistant depression in adults.
Esketamine is an investigational, rapidly acting antidepressant that works differently than currently available therapies for major depressive disorder. Through glutamate receptor modulation, esketamine is thought to help restore connections between brain cells in people with treatment-resistant depression.
‘Of the nearly 300 million people who suffer from major depressive disorder worldwide, about one-third do not respond to currently available treatments.3,4 This represents a major unmet public health need,’ said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. ‘We are committed to working with the FDA to bring this new treatment option to U.S. patients with treatment-resistant depression and to the medical community.’
The NDA is based on five pivotal Phase 3 studies of esketamine nasal spray in patients with treatment-resistant depression: three short-term studies, one withdrawal maintenance of effect study, and one long-term safety study. Data from these studies demonstrate that treatment with esketamine nasal spray plus a newly initiated oral antidepressant compared to placebo nasal spray plus a newly initiated antidepressant was associated with rapid reduction of depressive symptoms and delayed time to relapse of symptoms of depression.5,6 The long-term safety study showed that the esketamine doses studied were generally tolerated, with no new safety signals with dosing up to 52 weeks, compared to data from the short-term esketamine studies.7 The short-term esketamine Phase 3 study in adults with treatment-resistant depression included a newly initiated oral antidepressant in both the control and placebo groups.5
‘Esketamine has been shown to target critical aspects of glutamate-mediated synaptic plasticity, thereby bringing about rapid and sustained improvement in people with treatment-resistant depression,’ said Husseini K. Manji, MD, Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC.
Synaptic plasticity refers to the strength of information that flows through synapses, the spaces where neurons, cells in the brain, are connected.
Esketamine nasal spray will be self-administered by patients under the supervision of health care professionals.
The U.S. FDA granted Breakthrough Therapy Designations for esketamine nasal spray for treatment-resistant depression and for a second indication, major depressive disorder with imminent risk for suicide.8 Janssen is currently conducting Phase 3 clinical studies for the second indication.
Janssen plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the esketamine treatment-resistant depression indication later in 2018.
Posted by at No comments:

As Brexit costs mount, Pfizer estimates $100M to adapt its supply chain


n yet another indication of what the burden of Brexit will be for drug manufacturers, Pfizer has said that it has tallied its costs to revise its manufacturing and supply chain at about $100 million.
In a quarterly filing, the New York-based Big Pharma player said that its “preparations are well advanced to make the changes necessary to meet EU legal requirements after the U.K. is no longer a member state, especially in the regulatory, manufacturing and supply chain areas,” so that it can ensure a continuity of supply in the U.K. and Europe.
“The one-time costs of making these adaptations are currently estimated at approximately $100 million,” Pfizer said.
According to Bloomberg, which first reported the Pfizer figure, GlaxoSmithKline has also estimated its Brexit costs at about $100 million. Smaller company AstraZeneca has pegged its costs at about $40 million.
With a deal between the U.K. and the EU on how to have an orderly separation nowhere in sight, drugmakers have been mapping out their own plans on how to avoid backups and shortages in supplying drugs from one market to the other after the divorce in March of next year.
Anticipating delays at border crossings, French drugmaker Sanofi is considering flying vaccines, which have a short shelf life, to a predetermined spot in the U.K. where the government would release the delivery instantly. Another option, if the two sides could agree, would be to mark trucks so that they can pass customs without the usual checks.
Sanofi has already said it was increasing its inventory of drugs for the U.K. from the usual 10 weeks to 14. AstraZeneca has also said it is stockpiling drugs supplied by the U.K. and EU for each other. Merck & Co. is making its own plans, including reserving as much as six months’ worth of product in the face of a possible “temporary supply blackout” next March.
But the U.K.’s National Health Service wants to ensure that all drugmakers are prepared for the worst. Last week, it ordered drugmakers to report by Sept. 10 how they will stockpile in the U.K. those medications currently made in Europe but sold to the National Health Service. It wants at least six weeks’ worth of supplies above their regular buffers.
“While we recognise that many companies will already have made their own arrangements we are keen to receive a response from all companies to ensure we have a comprehensive picture. … We are asking suppliers to confirm their plans on a product-by-product basis,” the report says.
Posted by at No comments:

Cipla, Zydus Cadila and more eye $1B deal for Bharat Serums


Several Indian biopharma companies are eyeing a potential buy of Bharat Serums and Vaccines in a deal that could be worth $1 billion, according to The Economic Times, which cites two sources familiar with the talks. Price remains a key stumbling block.
Among potential buyers are Cipla, Zydus Cadila and Dr. Reddy’s Laboratories, plus private equity fund Baring Asia, according to the publication.
Two private equity funds—Kotak Private Equity and Orbimed Asia—hold 23% of the biologics company, while the Daftary family owns the rest. The owners have hired Jefferies to manage the sale, but the discussions are in early stages. Price is considered a hurdle to the deal, according to industry experts cited by TET.
Bharat Serums and Vaccines has more than 900 employees worldwide and operates in more than 45 countries. Founded in 1971, the company sells meds in gynecology, assistive reproductive technology, critical care, neurology, nephrology and more. The drugmaker owns two subsidiaries: BSV BioSciences, a California R&D outfit working on early-stage development of recombinant molecules, and a German branch that manufactures and markets biological APIs.
Last year Mylan entered talks for a potential purchase of Bharat Serums, but the deal didn’t materialize.
Posted by at No comments:

Merck gets partial refusal on Keytruda in lymphoma from NICE cost watchdogs


Just one week after England’s National Institute for Health and Care Excellence (NICE) said no to Gilead’s CAR-T treatment Yescarta in non-Hodgkin lymphoma, it has decided that Merck’s blockbuster checkpoint inhibitor, Keytruda, is not a good treatment choice in Hodgkin lymphoma—at least not for all patients.
NICE published a guidance document on Monday suggesting that Keytruda should not be used in patients with relapsed or refractory Hodgkin lymphoma who have already been treated with both the chemotherapy drug Adcetris and an autologous stem cell transplant. It did recommend the drug for use on its Cancer Drugs Fund in patients who are not eligible for stem cell transplant.
The reason for the split decision? NICE said it currently recommends Bristol-Myers Squibb’s rival checkpoint inhibitor, Opdivo, for treating relapsed or refractory Hodgkin lymphoma after Adcetris and stem cell transplant. Physicians suggested to NICE that the cost-effectiveness of Keytruda (pembrolizumab) would likely be similar to that of Opdivo (nivolumab), but Merck did not provide head-to-head data in patients who had received stem cell transplants, according to the decision.
“The committee noted that the company had not provided evidence to demonstrate different clinical efficacy between nivolumab and pembrolizumab, or provided a convincing explanation as to why the treatment effects would be likely to differ,” the agency wrote.
Merck did not immediately respond to a request for comment from FiercePharma. Keytruda is approved in the U.K. as a solo therapy in patients with Hodgkin lymphoma who have either failed stem cell transplant or are ineligible for it.
The company provided economic models for Keytruda in Hodgkin lymphoma patients who had failed stem cell transplants, but NICE found them to be faulty. Merck’s package for NICE included data from a trial showing an improvement in progression-free survival and objective response rate in both subsets of patients, but it wasn’t clear how big an effect it was. The company also initially forecast that stem cell transplants would happen 12 weeks after patients started their treatments—an inappropriate assumption, NICE said, because the effort to find stem cell donors almost always causes a delay in the procedure.
So Merck revised the model, assuming that all transplants would happen 24 weeks after treatment. NICE quibbled with the company’s methodology, though, ultimately deciding that conclusions about overall survival benefits from Keytruda in patients undergoing stem cell transplants were “likely to have been overestimated in the model,” the guidance document said.

The exclusion of Keytruda after stem cell transplant from the NHS’ list of covered drugs could dampen what has been an impressive run from Merck in the ongoing rivalry with BMS. In the second quarter, Keytruda hauled in $1.67 billion in total sales, surpassing Opdivo’s $1.63 billion in sales in the same period. It was the first time Keytruda beat Opdivo in the market for PD-1/L1 inhibitors.
Merck has scored some key wins for Keytruda that are helping fuel its strong run. In August, for example, the FDA expanded the drug’s label to say that when it is combined with Eli Lilly’s Alimta and platinum chemo in patients with treatment-naïve non-small cell lung cancer, it cuts the risk of death by 50% over chemo alone. Merck has the distinction of having the only checkpoint inhibitor that’s approved in the U.S. in the first-line lung cancer setting. And in July, the European Medicines Agency’s (EMA) recommended the combo, too.
Just how big an effect the NICE rejection in Hodgkin’s lymphoma will have on Keytruda remains to be seen. But one thing can be said for certain: England’s cost-effectiveness watchdogs are clearly not welcoming the pricey new generation of immuno-oncology treatments with open arms. That was evident in NICE’s rejection of Yescarta, which came immediately after the personalized cell therapy was approved in Europe to treat relapsing diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma.
NICE didn’t disclose Gilead’s planned price of Yescarta in the U.K., saying only that the product lacks “plausible potential to be cost-effective.” Gilead is in discussions with the agency and hopes to reach an agreement that will reverse the decision.
Posted by at No comments:

UnitedHealth price target raised to $304 from $270 at Credit Suisse


Credit Suisse analyst A.J. Rice raised his price target for UnitedHealth to $304 from $270 after surveying 737 health benefit managers across the country to gain insight into market perceptions regarding national health insurers, cost trends, premium expectations, and employer priorities heading into 2019. The analyst notes that the survey bodes well for his MCOs coverage. He reiterates an Outperform rating on the shares.
Posted by at No comments:

DelMar Pharmaceuticals Appoints Oppenheimer as Strategic Advisor


DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) (“DelMar” or the “Company”), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced the appointment of Oppenheimer & Co. Inc. to serve as its strategic advisor. In this capacity, the firm will work on behalf of DelMar to manage the exploration and evaluation of a wide range of strategic opportunities with the goal of facilitating shareholder value generation.
“We believe that seeking a strategic transaction gives us the best opportunity to maximize shareholder value,” said Robert E. Hoffman, Chairman of the Board of Directors. “In addition, we continue to be dedicated to executing our ongoing Phase 2 trials for MGMT-unmethylated GBM patients at MD Anderson Cancer Center in Houston, Texas, and at Sun Yat-Sen University Cancer Center in Guangzhou, China.”
While the Company is evaluating strategic opportunities, there can be no assurance that this strategic review will result in a transaction.
Posted by at No comments:

Merck gets priority review for Keytruda for rare skin 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 accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking accelerated approval for KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This sBLA is based on data from the Phase 2 KEYNOTE-017 trial including overall response rate (ORR) and duration of response (DOR); these data were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. In July 2017, KEYTRUDA was granted Breakthrough Therapy Designation by the FDA for this indication. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Dec. 28, 2018.
“Merkel cell carcinoma, a rare type of skin cancer, is an aggressive and fast-growing disease that has been associated with mortality rates higher than other types of skin cancer, including melanoma,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “KEYNOTE-017 represents the longest observation to date of patients with advanced Merkel cell carcinoma receiving anti-PD-1 therapy in the first-line setting, and demonstrated durable tumor control in these patients. We look forward to working closely with the FDA throughout the review process and to bringing KEYTRUDA to patients with Merkel cell carcinoma.”
Posted by at No comments:
Subscribe to: Comments (Atom)