Tuesday, September 25, 2018
MorphoSys says licensee Janssen began Phase 3 study
MorphoSys announced that its licensee Janssen Research has initiated a phase 3 clinical trial of guselkumab in pediatric patients suffering from chronic plaque psoriasis. According to clinicaltrials.gov, the trial, PROTOSTAR, is expected to enroll approximately 125 children between 6 and 18 years of age with plaque psoriasis and will evaluate the efficacy, safety and pharmacokinetics of guselkumab against etanercept and placebo. Guselkumab is a fully human anti-IL-23 monoclonal antibody developed by Janssen, and was generated utilizing MorphoSys’s proprietary HuCAL antibody technology. Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG, said: “We are very pleased that our licensee Janssen has started phase 3 development for the treatment of chronic plaque psoriasis in children. If successful, we hope that this study will contribute to providing more therapeutic options to this patient group.”
https://thefly.com/landingPageNews.php?id=2795435
Abbott 1-Year Results Show Portico Valve Safely Cut Severe Aortic Stenosis
One-Year Results from Real-World Study Showed Abbott’s Portico™ Transcatheter Aortic Valve Safely and Successfully Reduced Severe Aortic Stenosis
– Late-breaking data from real-world experience with the first fully repositionable and retrievable valve were consistent with previous results, and support that Portico can be successfully used in various anatomies in a real-world setting
– Patients who received a Portico aortic heart valve had low rates of stroke, death and valve leak; and improved heart failure symptoms, quality of life and functional capacity
– The minimally invasive Portico procedure allows doctors to replace a diseased or damaged aortic heart valve without major surgery
Abbott (NYSE: ABT) today announced one-year results from a real-world, international, multicenter, 941-patient study of the company’s Portico™ transcatheter aortic valve replacement (TAVR) system in patients with symptomatic, severe aortic stenosis – a life-threatening narrowing of the heart’s aortic valve. At one year, implantation with the Portico valve was safe and associated with low rates of stroke, death and leaks between patients’ natural heart tissue and the Portico valve.
The one-year results from the PORTICO I study were presented during a late-breaking session at the 30th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation in San Diego, and simultaneously published in the Journal of the American College of Cardiology. Results at one year were consistent with 30-day results reported earlier this year; with data used to support CE Mark; and with data and results from other commercially available TAVR valves. Portico is under investigation in the United States.
The Portico transcatheter valve is a minimally invasive alternative to surgical aortic valve replacement for patients diagnosed with severe aortic stenosis who are high-risk candidates for open-heart surgery. Aortic stenosis is a common and life-threatening valve disease in which the aortic valve opening in the heart narrows and restricts blood flow from the left ventricle to the aorta. More than one in eight people aged 75 and older have moderate or severe aortic stenosis,[1] which reduces the heart’s pumping ability. Most patients don’t have symptoms for decades, but once symptoms appear, the prognosis is poor without surgical treatment,[2] manifesting in shortness of breath, fatigue, and ultimately heart failure.[3]
‘Portico offers physicians the ability to safely and successfully treat patients suffering from symptomatic, severe aortic stenosis with a high level of confidence,’ said Lars Sondergaard, M.D., DMSc, Rigshospitalet, Copenhagen, Denmarkand principal investigator of the study. ‘These one-year results in a real-world setting give us assurance that Portico is an excellent and important treatment option for patients with severe aortic stenosis who are at increased risk for open-heart surgery.’
NY agency expresses concerns about proposed Aetna, CVS Health deal
In a letter dated September 17 that was made public on September 24, New York Department of Financial Services Superintendent Maria Vullo told Connecticut Insurance Department Commissioner Katharine Wade that NYDFS has “identified several key issues” with the proposed acquisition of Aetna (AET) by CVS Health (CVS) “that may be harmful to both New York and Connecticut consumers and markets.” The proposed acquisition of health insurer by a PBM “raises significant market competition concerns” regarding Aetna having an unfair competitive advantage, Vullo’s letter states. In afternoon trading, shares of Aetna are down 1.3% to $200.69. Shares of Express Scripts (ESRX), which is waiting for regulatory approval of its agreement to be acquired by Cigna (CI), is down about 1% as well.
https://thefly.com/landingPageNews.php?id=2795371
Knight Therapeutics and Jaguar Health Announce Strategic Partnership
Knight Therapeutics Inc. (GUD.TO) (“Knight”), a Canadian-based specialty pharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative prescription and over-the-counter pharmaceutical products, and Jaguar Health, Inc. (JAGX) (“Jaguar” or the “Company”), a commercial stage pharmaceutical company focused on developing novel, sustainably derived gastrointestinal products on a global basis, today announced that they have entered into a Distribution, License and Supply Agreement (the Agreement) that grants Knight the exclusive right to commercialize Mytesi® (crofelemer 125 mg delayed-release tablets) and related products in Canada and Israel and a right of first negotiation to commercialize Mytesi and related products in specified Latin American countries.
Mytesi is an FDA-approved product in the U.S. indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Jaguar is also pursuing possible follow-on indications for Mytesi in cancer therapy-related diarrhea (CTD), an important supportive care indication for patients undergoing cancer treatment; for rare disease indications for infants and children with congenital diarrheal disorders and short bowel syndrome (SBS); for irritable bowel syndrome (IBS); for supportive care for inflammatory bowel disease (IBD); and as a second-generation anti-secretory agent for use in cholera patients.
Under the terms of the Agreement, Knight will be responsible for all regulatory and commercial activities for Mytesi and related products in the licensed territories. Upon achievement of certain regulatory and sales milestones defined in the Agreement, Jaguar may receive payments from Knight Therapeutics in an aggregate amount of up to USD $18,019,743 (based on September 23, 2018 USD-CAD exchange rates) payable throughout the initial 15-year term of the Agreement.
“We are pleased to enter into this strategic transaction with Jaguar for Mytesi,” said Jonathan Ross Goodman, Chief Executive Officer of Knight.” Mytesi will strengthen Knight’s portfolio of GI products and will be an important treatment option for Canadian and Israeli patients, if Mytesi is approved in these markets. We are excited to support Jaguar as they seek to develop Mytesi for follow-on indications such as cancer therapy-related diarrhea.”
“Our collaboration with Knight is an important step towards unlocking value and making our products available in global markets,” said Lisa Conte, president and chief executive officer of Jaguar. “The Knight team is highly experienced and has a strong track record of successful partnerships.”
Elanco expands commitment to fight antimicrobial resistance
Elanco Animal Health updated its commitment to fighting antimicrobial resistance, which includes promoting responsible antibiotic use practices and policies while developing alternatives to medically important antibiotics. This latest move further refines Elanco’s aggressive, multifaceted 8-point plan announced in 2015 at the White House Stewardship Forum. Today’s commitments focus on three key areas of stewardship, including combating antimicrobial resistance through responsible antibiotic use, reducing the need for medically important antibiotics in livestock, and significantly investing in researching new alternatives. New commitments include: Investing at least half of Elanco’s food animal research and development budget in projects dedicated to developing alternatives to shared-class antibiotics; Increasing veterinary and professional oversight access in countries with limited resources through new partnerships; Expanding data collection and analytics to inform animal health professionals on best practices; Encouraging vaccination and nutrition programs that reduce the need for medically important antibiotics by preventing disease.
https://thefly.com/landingPageNews.php?id=2795327
Coherus Biosciences receives European Commission approval for UDENYCA
Coherus BioSciences announced the European Commission has granted marketing authorization to UDENYCA, a pegfilgrastim biosimilar. UDENYCA is one of the first pegfilgrastim biosimilars to gain marketing authorization in Europe. UDENYCA is currently under evaluation by the U.S. Federal Drug Administration with an action date of November 3, 2018.
https://thefly.com/landingPageNews.php?id=2795347
Glaxo vax helps prevent TB in HIV negative adults in phase 2
GSK and Aeras reported that GSK’s M72/AS01E[1] candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection[2] in an ongoing phase IIb clinical trial testing. These primary results published in the New England Journal of Medicine after two years of trial demonstrate an overall vaccine efficacy of 54%, with varied response rates observed in different demographic sub-groups. The candidate vaccine had an acceptable safety and reactogenicity profile.
Tuberculosis is the leading cause of death through infectious disease worldwide and represents a significant public health threat with 1.6 million attributed deaths in 2017. It is estimated that one-quarter of the global population has latent tuberculosis infection, of whom approximately 10% will develop active pulmonary tuberculosis disease. Currently, multi-drug resistant strains of tuberculosis are emerging globally, and the only currently available vaccine against tuberculosis, BCG, does not provide proven and consistent protection in adults in tuberculosis endemic countries. Without a more effective vaccine, it will not be possible to achieve the WHO target of decreasing the number of new cases by 90% and the number of tuberculosis deaths by 95% between 2015 and 2035.
Dr Emmanuel Hanon, Senior Vice-President and Head of R&D, Global Vaccines GSK, said: ‘These initial findings represent a significant innovation in the development of a new and much-needed vaccine and advance the scientific understanding of tuberculosis. This scientific breakthrough – one of the very few in tuberculosis vaccine development for almost 100 years – has been made possible by our strategic partnership with Aeras, in which GSK is providing the innovation expertise and technology platforms, such as the proprietary AS01 adjuvant.’
The study assesses the safety and efficacy of M72/AS01E protecting adults with latent tuberculosis infection against developing pulmonary tuberculosis disease. The ongoing trial is conducted in tuberculosis endemic regions (Kenya, South Africa and Zambia) and involves 3,573 HIV-negative adults. For this analysis, participants who received two doses of either M72/AS01E or placebo 30 days apart have been followed up for at least 2 years to detect evidence of pulmonary tuberculosis disease. In the vaccine group, 10 participants developed active pulmonary tuberculosis compared to 22 participants in the placebo group.
Jacqui Shea, Chief Executive Officer of Aeras, which contributed to the partnership their decades long experience in tuberculosis vaccine clinical development, clinical operations capabilities and strong links with African clinical sites and patient communities, said: ‘This ground-breaking study shows – for the first time – that a subunit vaccine can significantly reduce the incidence of pulmonary tuberculosis in healthy, HIV-negative adults with latent tuberculosis infection, and that more effective vaccines against tuberculosis are achievable. Given the overwhelming public health need, the importance of these promising results, which need to be confirmed through additional clinical research, cannot be overstated. An effective vaccine, able to reduce transmission, would be by far the most impactful new intervention to end the global tuberculosis epidemic’.
The study is still ongoing and a final analysis including all efficacy, safety, reactogenicity and immunogenicity data will be performed in 2019 after all participants have completed three years of follow up.
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