Sanofi under formal investigation for Depakine allegations; Beam licenses CAR-T tech from Oxford Biomedica
Sanofi is facing a formal investigation on manslaughter charges, due to accusations that its epilepsy drug Depakine caused birth malfunctions and slow neurological development when taken during pregnancy.
The French pharma was formally charged in February, years after evidence surfaced that the drug, sodium valproate, posed neurodevelopmental risks. Sodium valproate first hit the market in 1967 for the treatment of epilepsy and bipolar disorder, and is currently prescribed in more than 100 countries.
Between 2006 and 2014, France’s social affairs inspection agency IGAF believes that 425 to 450 babies exposed to the drug suffered congenital birth defects or were stillborn, according to a Reuters report. The EMA re-evaluated the drug in 2014, and the following year recommendations were enforced that practitioners not prescribe the treatment for women of childbearing age.
Sanofi denied the allegations. “All these elements do not in any way prejudge the responsibility of the company,” the company wrote in a statement to Reuters.
The Association for the assistance of parents of children suffering from anti-convulsant syndrome (APESAC) initiated the criminal investigation. To begin a formal investigation, an investigative judge had to deem the case serious enough to warrant a further look, according to Reuters. — Nicole DeFeudis
Beam inks CAR-T deal with Oxford Biomedica
The gene editing experts at Beam Therapeutics have added Oxford Biomedica’s LentiVector platform to its CART- repertoire. The license gives Beam access to the same technology Novartis and Juno have leveraged to manufacture their cell therapies.
By carrying out targeted base changes, Beam promises to knock out the expression of multiple cell surface targets on T cells at once.
Under the new deal, Oxford Biomedica was paid an undisclosed upfront sum to kick off development and manufacturing for one preclinical program. More payments and milestones are to come. — Amber Tong
RedHill grabs full commercialization rights to ex-AstraZeneca drug
When RedHill Biopharma bought Movantik, a treatment for opioid induced constipation, from AstraZeneca in April, it also inherited a co-commercialization alliance with Daiichi Sankyo. It’s now revised the deal to grab exclusive responsibility to market the drug and pay royalties to the Japanese pharma instead.
“The closing of this new agreement with Daiichi Sankyo will allow us to have full control over brand strategy and commercialization activities for Movantik in the U.S. while also increasing our margins,” Rick Scruggs, RedHill’s chief commercial officer and head of US operations, said in a statement.
In addition to a mid-teen royalty rate on net sales, Daiichi is entitled to three lump sums payments from 2021 to 2023. They also received 283,387 American Depositary Shares of RedHill’s stock $RDHL as part of a subscription agreement.
Movantik, a peripherally acting μ-opioid receptor antagonist, generated $96 million in the US last year. RedHill acquired global rights to the drug excluding Europe, Canada and Israel. — Amber Tong
PPD enters three-year agreement with Pfizer
Wilmington, NC-based contract research organization PPD has inked a three-year agreement to help grow Pfizer’s portfolio in “multiple therapeutic areas.” The deal builds on the companies’ current relationship, in which PPD offers lab services and clinical development expertise to facilitate drug development. PPD and Pfizer are currently keeping the financial terms under wraps.
Pfizer has 23 drugs in Phase III development, ranging from vaccines to oncology. It’s currently working with BioNTech on four Covid-19 vaccine programs, two of which are being fast tracked by the FDA. Their candidate BNT162b2 just enrolled in a Phase II/III study, setting it up for regulatory review as soon as October. — Nicole DeFeudis