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Thursday, June 7, 2018

Senseonics, Beta Bionics Partner to Develop Bionic Pancreas System


 Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on the development and commercialization of transformative glucose monitoring products, and Beta Bionics, a medical technology company leveraging machine learning artificial intelligence to develop and commercialize the world’s first autonomous bionic pancreas, today announced that they have entered into a development agreement to integrate glucose data from the Eversense® Continuous Glucose Monitoring (CGM) system into the iLet Bionic Pancreas system.
The Eversense CGM system is a long-term, implantable continuous glucose monitoring system that continually measures interstitial fluid glucose levels and wirelessly sends the readings to a smartphone application. The iLet Bionic Pancreas system is a dual-chamber, autonomous, infusion pump that mimics a biological pancreas by automatically and autonomously adapting insulin and glucagon dosing to meet the individual needs of a person with diabetes.
“We are very excited to partner with Beta Bionics to integrate our long-term glucose sensor with the bionic pancreas system,” said Tim Goodnow, President and CEO of Senseonics. “The combination of these two technologies could create a unique option for increased simplicity, convenience and confidence in diabetes management. We are pleased to be working with the Beta Bionics team as they advance a real breakthrough for people with diabetes.”
“Senseonics has generated impressive clinical data demonstrating the remarkable accuracy of their Eversense CGM system and providing a categorically different CGM alternative for people with diabetes,” said Ed Damiano, President and CEO of Beta Bionics. “We believe that only highly accurate, reliable and safe sensors are suitable for driving automated insulin delivery systems. Based on clinical data from multiple clinical studies, the Eversense CGM system appears to meet these high standards. We are excited to partner with Senseonics to help make the iLet Bionic Pancreas system a platform of choice for people with diabetes – one that will ultimately allow people to choose between multiple CGMs, to choose between multiple insulin types, and to choose glucagon.”
Under this development agreement, Beta Bionics will work with Senseonics to integrate the Eversense CGM system with the iLet, so that real-time Eversense data may serve as one CGM option to drive the fully autonomous iLet Bionic Pancreas system.

Buffett, Dimon, Bezos have unnamed CEO for health care venture


Warren Buffett, Jeff Bezos and Jamie Dimon have picked a leader for their health care venture.

Buffett told CNBC on Thursday that the CEO will probably be announced within two weeks.
“We have an outstanding individual,” Dimon said. “Character, culture, capability, heart, mind, the whole thing.”
The three corporate leaders said in January that their companies — Berkshire Hathaway (BRKB), Amazon (AMZN) and JPMorgan Chase (JPM) — would work together to give their combined 840,000 employees better health care choices. The CEOs hope to bring down costs, both for their workers and their companies.

They have not provided much detail on the venture, but the announcement alone was enough to spook health care and drug stocks.
Buffett cautioned on Thursday that solutions won’t be easy. He called health care “a very, very tough nut to crack, and it’s going to take significant time.”
“There are a lot of things that can be done better,” Dimon added. He mentioned fraud, administrative costs and overuse of certain drugs.

Joint Corp. target upped by Roth


Joint Corp. price target raised to $12 from $7.75 at Roth Capital. Roth Capital analyst David Bain raised his price target for Joint Corp. to $12 from $7.75, saying he is incrementally bullish after meeting with management given continued strong same store sale momentum, unit reduction time to breakeven and management’s strategic approach to corporate store ownership. The analyst reiterates a Buy rating on the shares.

Ophthotech in gene therapy pact with U.s of Florida, Pennsylvania


Ophthotech Corporation (OPHT) announced today that it has entered into an exclusive global license agreement with the University of Florida Research Foundation and the University of Pennsylvania (Penn) to develop and commercialize a novel adeno-associated virus (AAV) gene therapy product for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP), an orphan monogenic disease that is characterized by progressive and severe loss of vision leading to blindness. Preclinical anatomical and functional proof-of-concept studies have demonstrated promising results in a canine disease model. In addition to the exclusive license agreement, Ophthotech and Penn have also entered into a master sponsored research agreement, facilitated by the Penn Center for Innovation (PCI), pursuant to which Ophthotech and Penn plan to conduct preclinical and natural history studies. In parallel with the sponsored research, Ophthotech plans to commence IND-enabling activities. Based on current timelines, Ophthotech expects to initiate a Phase 1/2 clinical trial in early 2020.
“The scientific elegance of this novel gene therapy product is its design to knock down the expression of the mutant rhodopsin while delivering the replacement functional rhodopsin with a single AAV vector, restoring normal protein expression in preclinical studies” stated Kourous A. Rezaei, M.D., Chief Medical Officer of Ophthotech. “Collaborating with the eminent scientists at the University of Florida and the University of Pennsylvania reinforces Ophthotech’s commitment to build a gene therapy pipeline for treatment of retinal diseases based on cutting edge technology.”
As part of this collaboration, Ophthotech will work in partnership with internationally renowned scientists in gene therapy for orphan retinal diseases.
  • Investigators at the University of Florida include Professor Alfred S. Lewin, PhD, Program Director, Molecular Genetics and Microbiology and Professor William W. Hauswirth, PhD, Maida and Morris Rybaczki Eminent Scholar Chair in Ophthalmic Sciences.
  • Investigators at the University of Pennsylvania include Professor William A. Beltran, DVM, PhD, Director of the Division of Experimental Retinal Therapies, Department of Clinical Sciences and Advanced Medicine, School of Veterinary Medicine, and Professor Gustavo D. Aguirre, School of Veterinary Medicine, and from Penn’s Perelman School of Medicine and Scheie Eye Institute, Professor Samuel G. Jacobson, MD, PhD, Director of the Center for Hereditary Retinal Degenerations, and Professor Artur V. Cideciyan, PhD.
“The results of our gene therapy experiments in the canine model of RHO-adRP whose disease closely mimics that in humans have been encouraging,” stated Professor Beltran.
“Orphan retinal degenerative diseases are potentially devastating to patients, who do not have any treatment options available to them,” stated Professor Lewin. “Gene therapy presents a compelling scientific approach for treating and potentially curing a wide range of retinal diseases.”
“This agreement highlights another step in our deep commitment to build a promising gene therapy portfolio through collaborations with leading academic institutions and innovative biotech companies to create value for our shareholders,” stated Glenn P. Sblendorio, Chief Executive Officer and President of Ophthotech. “We continue to focus our efforts on developing treatment options for patients with retinal diseases.”
It is estimated that there are approximately 11,000 RHO-adRP individuals in the United States and the five major European markets. There is currently no U.S. FDA or European Medicines Agency approved therapy to treat this orphan inherited retinal disease.

Argenx target upped by Piper


Argenx price target raised to $130 from $100 at Piper Jaffray. Piper Jaffray analyst Edward Tenthoff raised his price target for Argenx to $130 after the company reached an agreement with FDA to initiate a single Phase III trial of efgartigimod in generalized myasthenia gravis this year. Full Phase II data presented at the American Academy of Neurology conference showed “rapid and durable clinical benefit,” Tenthoff tells investors in a research note. The analyst reiterates an Overweight rating on Argenx shares.

Proteostasis data ‘confusing’ but Wainwright keeps buy


Proteostasis data bring more questions than answers, says H.C. Wainwrigh. H.C. Wainwright analyst Andrew Fein sees more questions than answers after Proteostasis Therapeutics (PTI) reported the initial outcome of its 801-01 clinical trial comprising 14 day dosing of PTI-801, a second generator corrector on top of Vertex’s (VRTX) Orkambi. In the analyst’s opinion, the trial met its primary objective of demonstrating safety and tolerability for three different doses of PTI-801. However, Proteostasis reported on a series of outcome measurements that “generated some positive data, some negative data and some somewhat confusing data,” the analyst adds. In the end, he feels the data set is “somewhat incompletely baked and provides more questions than answers.” Fein has a Buy rating on Proteostasis with a $15 price target.

Mesoblast started at buy by Wainwright


Mesoblast initiated with a Buy at H.C. Wainwright. H.C. Wainwright analyst Jason Kolbert started Mesoblast with a Buy rating and $17 price target. The analyst sees Mesoblast as having the strongest pipeline in the regenerative medicine space.