Edwards Lifesciences Corp. (NYSE: EW) continues pushing the envelope on cutting-edge transcatheter cardiovascular therapies, recently receiving European CE Mark approval for the Cardioband Tricuspid Valve Reconstruction System for the treatment of tricuspid regurgitation.
Georg Nickenig, professor and chief of the cardiology department of the University Hospital Bonn, a research hospital in Germany, said the approval makes the device “the first transcatheter tricuspid therapy” commercially available.
The Irvine-based structural heart disease and critical care-monitoring device maker acquired the Cardioband technology when it bought Israeli device maker Valtech Cardio Ltd. in January 2017 for $690 million. Valtech develops transcatheter repair technology of mitral and tricuspid heart valves; it received CE Mark approval for its Cardioband mitral valve repair device in 2015. The deal excluded Valtech’s mitral valve replacement program.
The Valtech purchase price was comprised of an upfront cash payment of $340 million and an additional $350 million in milestones over 10 years. The recent approval is one of the prespecified milestones that prompts a distribution of cash and stock totaling $50 million to the former investors of Valtech.
“We are very pleased to be developing the most comprehensive product portfolio to address both mitral and tricuspid valve disease,” said Bernard Zovighian, Edwards corporate vice president of transcatheter mitral and tricuspid therapies.
The system isn’t approved for commercial sale in the U.S.
Company shares trade at $135 for an approximate $28.3 billion market cap. It announced this month that it entered an accelerated share agreement to repurchase an aggregate of $400 million of Edwards common stock. As of March 31, the company had approximately $1.3 billion remaining on its share repurchase program approved by directors.
Drug Launch
Aerie Pharmaceuticals Inc. (Nasdaq: AERI) has launched Rhopressa in the U.S. after the glaucoma eye drug won Food and Drug Administration approval in December.
Chief Executive Vicente Anido said it’s “the first new drug class in more than two decades for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension.”
The eye drop has formulary, or outcome-based, contracts for commercial insurance coverage this year, and the company said it’s likely to secure Medicare Part D program coverage next year.
Rhopressa is made by Aerie’s contract manufacturer in Florida, according to a company spokesperson. Its manufacturing facility in Athlone, Ireland, is under construction and will come on line in 2020 for manufacture of all Aerie products.
The ophthalmic company has another late clinical-stage glaucoma drug, Roclatan, for which it plans to file for FDA approval this quarter.
Shares of the company traded at $48 each for a $1.9 billion market cap.
It moved its headquarters to Durham, N.C., in March, occupying 32,586 square feet of lab and office space at Research Triangle Park, which is home to over 260 companies, including IBM Corp., Cisco Systems Inc., pharmaceutical company GlaxoSmithKline PLC and biotech company Biogen.
Aerie maintains a significant presence in Irvine, its former headquarters; it said regulatory, commercial support and other administrative activities are here. Chief Operating Officer Thomas Mitro and Chief Commercial Officer Judith Robertson and “a lot of key functions are here and staying here,” the spokesperson confirmed.
Precision Medicine
The National Institutes of Health is expanding an effort to grow precision medicine research, opening national enrollment in the All of Us Research Program. All of Us will gather genetic, biological, environmental, health and lifestyle data from a million or more volunteer participants living in the U.S. to study how the factors affect individual health.
Congress has authorized $1.5 billion over 10 years to fund the program.
“The diversity expected among California’s participants in the All of Us Research Program will be an important part of the scientific journey,” said Hoda Anton-Culver, co-leader of the California Precision Medicine Consortium and principal investigator of the All of Us Research Program at the University of California-Irvine medical school.
The California Precision Medicine Consortium is co-led by Anton-Culver and Lucila Ohno-Machado at UC San Diego Health and also includes UC Davis, UC San Francisco, the Keck School of Medicine at the University of Southern California, Cedars Sinai Medical Center and the San Diego Blood Bank.
To learn more about the program and how to join, visit JoinAllofUs.org.
