Like many other pharma transactions, Sandoz's $1 billion U.S. oral solids and dermatology selloff to India's Aurobindo has been delayed by U.S. antitrust review. Novartis' Zolgensma faces delayed EU and Japan decisions, though CEO Vas Narasimhan said they had nothing to do with the recent data manipulation scandal. AstraZeneca dialed back its China growth to a mid-teens percentage increase as a bulk procurement scheme rolls out across the country. And more.
Over a year has passed since the $1 billion acquisition deal for Novartis’ Sandoz U.S. oral solids and dermatology business, by India’s Aurobindo Pharma, was made public. And still, because of some “elements” the U.S. Federal Trade Commission (FTC) has requested, the two firms are expecting it’ll be months before they complete the transaction, Novartis CEO Vas Narasimhan said.
EU and Japanese regulators are raising some additional “manufacturing questions” that will delay Zolgensma’s approval in the territories into 2020. Narasimhan said the requests were not related to the company's recent data manipulation scandal. An inspection of Zolgensma’s manufacturing facility is scheduled for December, a company spokesperson said.
AstraZeneca previously said it had expected China growth to slow in the second half of the year. But in Q3, the country still turned up a whopping 40% increase at constant exchange rates. That’s because the national rollout of a bulk procurement program was slower than expected, CEO Pascal Soriot said. Moving forward, the company still expects growth in the mid-teens from China as it launches new products, such as blockbuster anti-EGFR lung cancer drug Tagrisso.
Cour Pharma’s celiac disease candidate, CNP-101, previously showed it could cut levels of inflammation-promoting cytokines in a small phase 2a study. Now, Takeda has acquired an exclusive global license to the medicine with a payment of up to $420 million. Cour’s treatment is a nanoparticle loaded with gliadin—a component of gluten—to reprogram the immune system so it doesn’t attack the intestines when a person with celiac disease is exposed to gluten.
Samsung Bioepis’ biosimilars sales seemed stagnant in the EU in the third quarter. According to Biogen, the Samsung BioLogics joint venture partner, its three biosimilars—to Humira, Enbrel and Remicade—raked in $184 million in Q3, flat against Q2, and came 7.5% below the Street’s consensus. Enbrel copy Benepali, the company’s flagship product, dropped 6% over the same period last year to $116 million.
Shionogi and Johnson & Johnson's Janssen are offering up access to data and samples from a discontinued Alzheimer’s disease clinical development program through a collaboration with the Alzheimer’s Drug Discovery Foundation (ADDF). The information will be available though the ADDF Diagnostics Accelerator initiative, which funds R&D projects that identify and characterize biomarkers for Alzheimer’s.