Search This Blog

Tuesday, September 3, 2019

J&J RSV vaccine nabs accelerated review status in U.S.

The FDA designates Johnson & Johnson (JNJ -0.2%) unit Janssen Pharmaceutical’s prophylactic respiratory syncytial virus (RSV) senior vaccine a Breakthrough Therapy for the prevention of RSV-mediated lower respiratory tract disease in adults at least 60 years old.
The candidate is currently in Phase 2b development in people at least 65 years old.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

Sanofi started at Outperform by Bernstein

Target $52

Cidara, Mundipharma in Partnership to Develop and Commercialize Rezafungin

Collaboration combines strengths to develop and commercialize life-saving antifungal treatment and prophylaxis, an area of high unmet medical need
Mundipharma acquires exclusive rights to develop and commercialize rezafungin in all markets outside of the United States and Japan, which will be retained by Cidara
Cidara to receive upfront payment of $30 million and equity investment of $9 million, co-development funding, development milestones and tiered royalty stream
Total transaction value could exceed $568 million
Cidara to host conference call today at 8:00 a.m. ET/5:00 a.m. PT

Novartis: Sandoz to Commercialize Polpharma Planned Biosim Natalizumab

Novartis AG’s (NOVN.EB) biosimilars division Sandoz has signed a global agreement with Polpharma SA for the commercialization of a proposed natalizumab biosimilar, the company said Tuesday.
The medicine is in phase 3 clinical development for the treatment of relapsing-remitting multiple sclerosis, Novartis said.
Under the deal, Polpharma will maintain responsibilities for development, manufacturing and supply of proposed biosimilar natalizumab. Sandoz will commercialize and distribute the medicine in all markets upon approval, through an exclusive global license, the company said.
Other terms of the agreement are confidential, it said.

Novartis, Lonza deepen biosimilars push with MS, arthritis drug deals

Swiss drugmakers Novartisand Lonza separately deepened their push into so-called biosimilars, betting cheaper copies of name-brand drugs will make headway among cost-conscious insurers and governments.

Novartis’s Sandoz generics unit, among the biggest biosimilars makers, on Tuesday agreed to license from Poland’s Polpharma Biologics a version of Biogen’s decade-old Tysabri for multiple sclerosis. This is the fifth proposed biosimilar licensed by Sandoz in nine months.
Meanwhile, Lonza announced it had contracted drug substance production for South Korean drugmaker Celltrion’s Remsima, a copy of Johnson & Johnson’s Remicade against autoimmune diseases like rheumatoid arthritis.
Biosimilar versions of patent-expired blockbusters such as Remicade and Tysabri have advanced in Europe, although U.S. adoption has lagged as drugmakers fiercely defend original versions. Novartis has lost its share of fights, including a recent court setback over Amgen’s Enbrel.
Rebates offered to U.S. insurers by drugmakers have also erected barriers, although with markets like MS and immunology each in the tens of billions of dollars the allure remains great. This year, Canada’s British Columbia province began switching patients to biosimilars in a bid to save tens of millions of dollars.
Lonza Chief Executive Marc Funk said his Basel-based company, which helps other drug firms outsource their production, would give Celltrion “the flexible capacity and agile teams it needs to respond to evolving market demand”.
With their deal, Novartis and Sandoz add to a growing stable of MS drugs, including older Gilenya and newly approved Mayzent, as well as a late-stage biological hopeful, ofatumumab, in its pipeline.
“Biosimilars create competition and cost savings, which are proven to make room in healthcare systems to treat more patients,” said Pierre Bourdage, Sandoz’s interim biopharmaceuticals head, without giving financial details of the deal for the Polpharma molecule now in late-stage trials.
Novartis could have decent luck with MS biosimilars, analysts said, given the high costs of the debilitating disease for health systems. “The acceptance for cheaper MS medicines will be great, because around half of all patients cannot afford them,” ZKB analyst Michael Nawrath wrote in a note.
Copies of biological drugs are called biosimilars because, unlike small-molecule chemicals, they cannot be exactly replicated in the factory. Still, studies show they carry the same potential benefits for patients.

Bayer Approaches Glyphosate Critics

Bayer respects that politicians in some European countries want to reduce the use of glyphosate, said the company’s crop-science division president Liam Condon in an interview with German newspaper Tagesspiegel. Mr. Condon said the company will work with institutions and interest groups to develop alternative solutions.
–However, Mr. Condon said glyphosate-based products continue to play an important role in weed-killing worldwide and Bayer remains convinced of the “safety and effectiveness of these products,” reports Tagesspiegel.
Full story (in German): https://bit.ly/2kcyvrj

Another extension for Roche-Spark takeover offer

Roche (OTCQX:RHHBY) and Spark Therapeutics (NASDAQ:ONCE) have announced yet another extension of the Swiss drugmaker’s $4.3B takeover offer for the U.S. gene therapy specialist as regulatory reviews in the U.S. and Britain continue.
The offer for Spark shares now runs to Oct. 1, Roche said, adding that around 24.1% of Spark’s outstanding shares had been tendered as of the end of August.