Array Expects To Have Phase III MEK Inhibitor All To Itself, Without Partner Novartis

Following Novartis’ oncology deal with GSK, which included another MEK inhibitor, Array anticipates getting the asset back for itself. Novartis would be obliged to continue supporting Phase III studies, Array says, as part of a pipeline update in second-quarter earnings call.

Array BioPharma Inc. is gearing up to get the Phase III MEK inhibitor binimetinib all to itself, following development partner Novartis AG’s acquisition of a competing drug in the same class through a broader deal this spring with GlaxoSmithKline PLC.

One of Array’s two Phase III assets, binimetinib, was partnered with Novartis in a co-development and commercialization deal in 2010 [See Deal] worth $45 million upfront plus another...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By 

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By 

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

More from R&D

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.