Novartis: New NIBR director named. Entresto closer to be available EU

Switzerland-based Novartis has today appointed Dr. James E. Bradner, physician-scientist from Dana-Farber Cancer Institute and Harvard Medical School, as President of the Novartis Institutes for BioMedical Research (NIBR) and a member of the Executive Committee of Novartis, effective March 1, 2016. The company also shared news about Entresto being a step closer to becoming available in EU.

Dr. James E. Bradner will succeed Mark C. Fishman, M.D., who will reach his contractual retirement age in March 2016 after a distinguished 13-year career at Novartis as the leader of the company’s drug discovery and early clinical development efforts.

Regarding the new appointment, Joseph Jimenez, CEO of Novartis said

“Mark has done an outstanding job leading NIBR, and he will be missed. He redefined research at Novartis – recruiting top scientists and clinicians from around the world, putting patient need and disciplined science at the center of our strategy,  which has  filled our pipeline with new medicines.”

“I am confident that Jay will continue this track record of success. He is an accomplished scientist whose discoveries in the area of chemical biology have revealed novel approaches for treating cancer and other illnesses.  He is also an entrepreneur who has been the driving scientific force behind several biotech start-ups. His experience and perspectives make him a great fit to further develop our internal research capabilities, as well as expand our external collaboration efforts with biotech companies and academic institutions.”

Novartis adds that Dr. Bradner will be based at NIBR’s global headquarters in Cambridge, Massachusetts and report to Joseph Jimenez, Chief Executive Officer of Novartis. He will join Novartis on January 1, 2016 to work alongside Dr. Fishman and the NIBR leadership team to ensure a smooth transition.

Dr. Bradner is on the faculty of Harvard Medical School in the Department of Medical Oncology at the Dana-Farber Cancer Institute.

Entresto closer to become available in EU

Entresto tablet. Image: Novartis

In addition, Novartis has today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Entresto (sacubitril/valsartan), marking an important milestone towards becoming available in the EU. Pending final approval by the European Commission (EC) Entresto, previously known as LCZ696, will be available for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF).

“With the poor prognosis heart failure patients face – only half will be alive 5 years from diagnosis – the CHMP’s endorsement of Entresto brings hope for HFrEF patients in Europe,” said David Epstein, Division Head, Novartis Pharmaceuticals.

“Already we’re hearing about the benefits US doctors and HFrEF patients are experiencing with Entresto and hope to receive a final green-light from the EC soon.”

The CHMP’s decision, which follows previous US and Swiss approvals, is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril.

“The striking results in the PARADIGM-HF trial led me to believe that once approved LCZ696 could quickly replace what has been the bedrock treatment for more than 20 years, ACE-inhibitors” said Professor John McMurray of the University of Glasgow and one of two Principal Investigators.

“Thousands of lives could be extended and hospital admissions prevented with LCZ696’s unique ability to boost natriuretic peptides, heart-helpful hormones, while simultaneously inhibiting the RAAS system.”