Friday, January 4, 2019
Akari Therapeutics resumed with a Buy from Neutral at B. Riley FBR
https://thefly.com/landingPageNews.php?id=2843885
Momenta downgraded to Neutral from Overweight at JPMorgan
https://thefly.com/landingPageNews.php?id=2843887
ImaginAb in Immuno-Oncology License, Trial Collaboration with Nektar
ImaginAb Inc., an immuno-oncology imaging company, today announced that it has entered into a non-exclusive license and clinical trial collaboration with Nektar Therapeutics (Nasdaq: NKTR). Under the terms of the agreement, Nektar will use ImaginAb`s CD8 ImmunoPET technology to measure whole body and tumor CD8+ T cells` density and distribution in cancer patients. The collaboration will provide important mechanistic insight into various candidates in Nektar`s immuno-oncology portfolio.
“Our goal is to help companies accelerate the research and development of next-generation cancer immunotherapies, so clinicians can treat cancer patients more effectively,” said Martyn Coombs, Chief Executive Officer of ImaginAb. “Working with Nektar, one of the world`s leading biotechnology companies, will help us further develop CD8 ImmunoPET as an imaging agent and platform.”
Financial terms of the agreement were not disclosed.
“Novel PET biomarkers are essential to better understand and rationally develop next-generation immunotherapies, and ImaginAb`s CD8 ImmunoPET technology is designed to give us a non-invasive whole-body view of immune system activity,” said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Scientific Officer of Nektar. “Through this partnership with ImaginAb, we now have access to a novel and important technology that can simultaneously measure CD8+ T cells in multiple tissues, including all target and non-target tumor lesions. Since the proliferation and tumor-infiltration of CD8+ T cells is a key mechanistic feature of our pipeline candidates, including NKTR-214, we have the potential to use this technology in future clinical trials to potentially expedite the development of our immuno-oncology pipeline therapies.”
GENFIT, LabCorp to Expand Access to Innovative NASH Diagnostic Assay
LabCorp (NYSE: LH), a leading global life sciences company, and GENFIT (Euronext: GNFT), a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, have announced the signing of a licensing agreement between GENFIT and Covance, LabCorps drug development business. The agreement will expand access to an innovative non-alcoholic steatohepatitis (NASH) liver diagnostic test for the clinical research market.
NASH is a silent, asymptomatic disease that often progresses to more serious and life-threatening stages before a clinical diagnosis is made. Liver biopsy, a highly invasive procedure, is currently the clinical standard to formally diagnose NASH and stage fibrosis. Furthermore, there are currently no extensively validated non-invasive diagnostic tests in NASH to address evolving disease and therapeutic implications, providing clinical and market opportunities for new product innovations.
To address this pressing need, GENFIT has developed a novel, non-invasive test created specifically for NASH. This multi-parametric blood-based biomarker test, named NIS4, leveraged a rich biobank of samples from roughly 700 well-characterized patients to establish a novel combination of biomarkers to identify and monitor patients with NASH and significant fibrosis. The primary focus of the licensing agreement will be to deploy NIS4 in the clinical research space through Covances central laboratories to further validate the tests use for better identification and characterization of patients, and to generate new biological insights on NASH disease pathogenesis.
We are very enthusiastic to announce this agreement, which represents a major step in GENFITs commercial strategy in NASH. The expertise that LabCorp and Covance have in this field will add tremendous value to GENFITs pioneering work in developing this innovative technology. Im excited to see collaborations like this, which will help move the test toward the goal of being an in vitro diagnostic (IVD) to identify NASH patients who should be considered for therapeutic intervention, said Jean-Franois Mouney, chairman & CEO of GENFIT.
LabCorp and Covance will be able to leverage our experience in clinical trial biomarkers and diagnostics development to validate the NIS4 algorithm, said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. We are well-positioned to expand access to NIS4 to the global clinical research community through this agreement. Forward-thinking collaborations like this one enable early and efficient validation of diagnostics that have the potential to significantly impact patients with serious, life-changing unmet medical needs, including NASH.
GENFIT is a pioneer in NASH therapeutics and diagnostics development. Both LabCorp Diagnostics and Covance have been involved in the development of drugs and diagnostics for more than 20 years, and Covance is a recognized global leader in NASH clinical trials.
U.K.'s NICE Approves Astra's Asthma Medication After Striking Pricing Deal
The U.K. regulator tasked with advising the country's health service on what drugs to use said Friday that it will recommend AstraZeneca PLC's (AZN.LN) asthma medication Fasenra, reversing an earlier negative decision.
The National Institute for Health and Care Excellence said the judgment comes after it struck a deal over pricing with the Anglo-Swedish pharmaceutical company. Fasenra has a list price of 1,955 pounds ($2,475) per dose, but NICE said it was able to negotiate this down, though the final price remains confidential.
Fasenra is a monthly shot for the treatment of severe eosinophilic asthma, a type of asthma in which the body produces an excessive amount of white blood cells called eosinophils. It is Astra's first respiratory drug in a class of medicines called biologics, which are derived from living organisms.
The drugmaker has previously told Dow Jones that it hopes Fasenra can eventually replace the use of steroids, which have extensive side-effects, as a treatment.
Biologic medicines can transform the lives of patients suffering from severe eosinophilic asthma, which can otherwise hold them back from doing daily tasks, said Meindert Boysen, director of NICE's Centre for Health Technology Evaluation.
"This recommendation of a further biological option demonstrates how a competitive pharmaceuticals market combined with NICE's appraisal process provides the NHS and patients with value-for-money and choice," Mr. Boysen said.
https://www.marketscreener.com/ASTRAZENECA-4000930/news/AstraZeneca-U-K-s-NICE-Approves-Astra-s-Asthma-Medication-After-Striking-Pricing-Deal-27820678/
The National Institute for Health and Care Excellence said the judgment comes after it struck a deal over pricing with the Anglo-Swedish pharmaceutical company. Fasenra has a list price of 1,955 pounds ($2,475) per dose, but NICE said it was able to negotiate this down, though the final price remains confidential.
Fasenra is a monthly shot for the treatment of severe eosinophilic asthma, a type of asthma in which the body produces an excessive amount of white blood cells called eosinophils. It is Astra's first respiratory drug in a class of medicines called biologics, which are derived from living organisms.
The drugmaker has previously told Dow Jones that it hopes Fasenra can eventually replace the use of steroids, which have extensive side-effects, as a treatment.
Biologic medicines can transform the lives of patients suffering from severe eosinophilic asthma, which can otherwise hold them back from doing daily tasks, said Meindert Boysen, director of NICE's Centre for Health Technology Evaluation.
"This recommendation of a further biological option demonstrates how a competitive pharmaceuticals market combined with NICE's appraisal process provides the NHS and patients with value-for-money and choice," Mr. Boysen said.
https://www.marketscreener.com/ASTRAZENECA-4000930/news/AstraZeneca-U-K-s-NICE-Approves-Astra-s-Asthma-Medication-After-Striking-Pricing-Deal-27820678/
Bayer: U.S. judge limits evidence in trial over Roundup cancer claims
A federal judge overseeing lawsuits alleging Bayer glyphosate-based weed killer causes cancer has issued a ruling that could severely restrict evidence that the plaintiffs consider crucial to their cases.
U.S. District Judge Vince Chhabria in San Francisco in an order on Thursday granted Bayer unit Monsanto’s request to split an upcoming trial into two phases. The order initially bars lawyers for plaintiff Edwin Hardeman from introducing evidence that the company allegedly attempted to influence regulators and manipulate public opinion.
Thursday’s order applies to Hardeman’s case, which is scheduled to go to trial on Feb. 25, and two other so-called bellwether trials which will help determine the range of damages and define settlement options for the rest of the 620 Roundup cases before Chhabria.
But Hardeman’s lawyers contended that such evidence, including internal Monsanto documents, showed the company’s misconduct and were critical to California state court jury’s August 2018 decision to award $289 million in a similar case. The verdict sent Bayer shares tumbling though the award was later reduced to $78 million (61.7 million pounds) and is under appeal.
Under Chhabria’s order, evidence of Monsanto’s alleged misconduct would be allowed only if glyphosate was found to have caused Hardeman’s cancer and the trial proceeded to a second phase to determine Bayer’s liability.
Bayer denies allegations that glyphosate causes cancer, saying decades of independent studies have shown the world’s most widely used weed killer to be safe for human use.
But the company faces more than 9,300 U.S. lawsuits over Roundup’s safety in state and federal courts across the country.
Bayer in a statement welcomed Chhabria’s decision.
“The court’s decision to keep the focus of the trial on the extensive science relevant to human health is encouraging,” the company said.
Aimee Wagstaff, one of Hardeman’s lawyers, in a statement said she was confident the jurors will find Roundup caused the man’s cancer and proceed to the second phase.
Hardeman’s attorneys had opposed proposals to split up the trial on the grounds that their scientific evidence allegedly showing glyphosate causes cancer was inextricably linked to Monsanto’s alleged wrongful conduct.
Bayer has also asked that some of the plaintiffs’ evidence on causation, specifically a finding by the World Health Organisation’s cancer unit that glyphosate is “probably carcinogenic,” be excluded in the first phase because it has no basis in science.
Chhabria, who has previously expressed scepticism of that finding, on Thursday said he would soon decide to which degree he would allow it to be introduced at trial.
The assessment is central to the plaintiffs’ claims, as other regulatory agencies, including the U.S. Environmental Protection Agency, have determined glyphosate likely does not cause cancer.
Zealand Pharma completes investment in strategic partner Beta Bionics
- Zealand Pharma invests USD 3.5 million in the final close of strategic partner Beta Bionics’ series B financing round
- Beta Bionics is the developer of the iLet™ bionic pancreas – an autonomous dual hormone artificial pancreas, using Zealand’s dasiglucagon for automated glucose regulation in type 1 diabetes
- Dasiglucagon is a potential first-in-class glucagon analogue for use together with insulin in dual-hormone infusion therapy with potential to transform diabetes management
Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced the completion of a USD 5 million strategic equity investment in Beta Bionics, a medical technology company developing the iLet™ bionic pancreas system. The iLet is a pocket-sized, dual-chamber, autonomous, glycemic control system that mimics a biological pancreas by calculating and dosing insulin and/or glucagon as needed based on data from the diabetic patient’s continuous glucose monitor. The iLet will utilize Zealand’s proprietary first-in-class stable glucagon analogue, dasiglucagon, in combination with insulin. This dual hormone therapy has the potential to significantly improve diabetes management for people who today are on insulin therapy.
In 2017, Zealand made an initial USD 1.5 million equity investment in Beta Bionics with an option to invest a further USD 3.5 million pending the achievement of specific development milestones. Zealand has now exercised this option based on the significant regulatory and clinical progress seen throughout 2018. This strategic equity investment, as part of the Series B financing, further strengthens the collaboration between Zealand Pharma and Beta Bionics in moving forward with the Phase 3 program for iLet in 2019.
Prior clinical studies have demonstrated that patients with type 1 diabetes using the autonomous dual hormone system spend significantly more time in the normal glucose range, had significantly fewer dangerous hypoglycemic events (low blood sugar), and reduced need for correcting the low blood glucose with excessive food intake (source: data on file).
“We are truly impressed with the clinical data generated so far with the iLet™ and excited by the progress in our collaboration with Beta Bionics. We look forward to starting the pivotal phase 3 development program in the second half of 2019,” said Adam Steensberg, Chief Medical and Development Officer at Zealand. “Zealand’s proprietary stable glucagon analogue, dasiglucagon, has great potential to dramatically improve Type 1 diabetes patient care and outcomes when used in cutting edge dual-hormone artificial pancreas pumps like the iLet.”
Zealand Pharma has demonstrated in multiple clinical trials that dasiglucagon is effective in preventing and correcting insulin-induced low plasma glucose events (hypoglycemia). With its unique stability profile in liquid formulations, dasiglucagon is strongly suited for use in dual-hormone artificial pancreas pump systems as already demonstrated with Beta Bionics’ iLet.
“Our enduring commitment at Beta Bionics is to bring the dual-hormone iLet to market to improve the lives of as many people with type 1 diabetes as possible,” said Ed Damiano, President and Chief Executive Officer at Beta Bionics. “We are very excited by the impressive results achieved with dasiglucagon in pre-clinical studies and clinical trials. We look forward to beginning our phase 3 pivotal trial program with the talented team at Zealand Pharma.”
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