Isotechnika shares in meltdown on FDA response; Amplimmune forges $508M development pact with GSK; Five Prime inks $139M deal;

 @FierceBiotech: Shire forges $565M buyout deal for Movetis. Story | Follow @FierceBiotech

 @JohnCFierce: BrainCells gets a depression drug from Proximagen for up to $51M, no breakout on the upfront (which is weak). News | Follow @JohnCFierce

> Isotechnika Pharma (ISA) announced that the FDA is demanding that its development partner, Lux Biosciences, undertake a new clinical trial of voclosporin before it is approved. The news caused Isotechnika's shares to plunge by 50 percent. Lux received a Complete Response letter from the FDA on voclosporin for non-infectious uveitis that "requested additional information and recommended that an additional clinical trial be conducted in order to consider a future approval" of voclosporin for this indication. "We will continue to work closely with the FDA to gain US regulatory approval for voclosporin, which we believe could offer an important new treatment option for patients with this serious disease," stated Dean Mitchell, the CEO of Lux Biosciences. Report | Release

> Amplimmune has forged a $508 million pact with GlaxoSmithKline to further develop PD-1 targeting therapies for cancer and other diseases. GSK will obtain exclusive worldwide rights to AMP-224 as well as other potential next generation fusion proteins that target PD-1. Under the terms of the deal, GSK will pay Amplimmune an upfront payment of $23 million. Amplimmune is also eligible for up to $485 million in regulatory, development and sales milestone payments - including milestones associated with IND filing and conducting a Phase 1 trial of AMP-224. Amplimmune may also receive up to double digit royalties on global sales. The collaboration will focus primarily on development of AMP-224, Amplimmune's Fc-fusion protein of the B7-DC ligand (also known as PD-L2), which targets PD-1. Release

> Five Prime has inked a development deal with GlaxoSmithKline which is worth up to $139 million. The developer will get $15 million from GSK this year under the pact, in which Five Prime will seek out new drugs for skeletal muscular disorders. Story

> After seeing its lead therapy naproxcinod rebuffed at the FDA, France's NicOx says it will shutter its U.S. headquarters office in Warren, NJ. As we seek to work out possible next steps for naproxcinod in the US and to pursue the approval process in Europe, it is essential that we manage our resources in the most effective manner," said CEO Michele Garufi. NicOx release

> PPD is suing the former managers of Magen BioSciences, saying they misled the clinical research organization about the potency of its lead drug when they sold the company. PPD claims it incurred damages of $24.3 million. Story

> Pine Brook, NJ-based Elusys Therapeutics says it has won a second contract year of funding valued at $40.6 million for the advanced development of Anthim, a treatment of anthrax infection following a biowarfare attack. This new funding is in addition to $16.8 million already received under their contract and is part of a potential five-year contract award totaling up to $143 million. Elusys release

> Germany's Merck KGaA is reportedly trying to sell its infertility-treatment business in an effort to get out of the women's health arena, Bloomberg is saying, citing two people with knowledge of the plan. And one name being bandied about as a potential purchaser is generics giant Teva Pharmaceutical Industries. Story

> ArQule and Daiichi Sankyo are laying the groundwork for a Phase III study of their experimental therapy for non small-cell lung cancer. Report

> Cambridge, MA-based Acceleron Pharma has won fast track status for ACE-031, which is being developed for Duchenne muscular dystrophy. Story

> Germany's Evotec has won a EUR 2.5 million from Boehringer Ingelheim. Evotec release

And Finally... In the animal world, orangutans rate as one of the worst couch potatoes. Release

Suggested Articles

The deal comes almost two years after Roche dropped the tumor microenvironment modulator after putting it through a clutch of early-phase studies.

The buzzy life sciences company Verily is looking to speed up COVID testing with a new lab based at its native South San Francisco.

Although Genfit canned its NASH program last month, it has been plugging away at a blood-based diagnostic for the liver disease.