Global Briefs: Gilead, Bayer, AbbVie & More
A roundup of news from Gilead Sciences, Daiichi Sankyo, Seagen (formerly Seattle Genetics), Bayer, AbbVie, and Novartis.
FDA Lifts Clinical Hold on Gilead Cancer Drug Combo
The US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on studies evaluating Gilead’s investigational agent, magrolimab, in combination with azacitidine. The FDA removed the partial clinical hold after a review of safety data.
Gilead acquired magrolimab, a monoclonal antibody for treating several cancers, including myelodysplastic syndrome, acute myeloid leukemia, and diffuse large B-cell lymphoma, as part of its $4.9-billion acquisition of Forty Seven Inc., a Menlo Park, California-based immuno-oncology company.
With this decision from the FDA, enrollment in the US can resume for the studies investigating magrolimab in combination with azacitidine in myelodysplastic syndrome and acute myeloid leukemia. Gilead, in close coordination with regulatory authorities, says it is planning to re-open enrollment in the magrolimab studies that were placed on a voluntary hold outside of the US. The company says it is also working with the FDA regarding the remaining partial clinical hold affecting studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma. The ongoing clinical studies evaluating magrolimab in solid tumors were not subject to the clinical hold.
During the partial clinical hold, patients already enrolled in the affected Gilead magrolimab studies, including a Phase III study, continued receiving treatment. Prior to the trial hold, Gilead already met the pre-specified enrollment threshold required for the first interim analysis of the Phase III study. Based on this, Gilead says the readout for the first interim analysis remains on schedule for 2023.
Source: Gilead Sciences
Seagen Awarded $41.82 M in ADC Patent-Litigation Case
Seagen (formerly Seattle Genetics) has been awarded $41.82 million in an antibody drug conjugate (ADC) patent-litigation case.
The US District Court of Eastern District of Texas ruled that Daiichi Sankyo infringed Seagen’s US patent (US Patent Number 10,808,039) by selling its ADC, Enhertu (trastuzumab deruxtecan), in the US. Seagen was awarded damages of $41.82 million for past infringement of the patent. In addition, Seagen says it will request additional royalty payments for future sales of Enhertu in the US through the life of the patent through 2024. Enhertu was co-developed and co-commercialized by Daiichi Sankyo and AstraZeneca.
In a related matter, on April 7, 2022, the Patent Trial and Appeal Board of the US Patent and Trademark Office granted a request on rehearing and instituted two post-grant review (PGR) proceedings brought against certain claims of the Seagen patent.
Separately, Seagen is engaged in an arbitration it brought against Daiichi Sankyo over ownership of certain technology used by Daiichi Sankyo in trastuzumab deruxtecan and several other drug candidates. In the arbitration, which remains ongoing, Seagen contends that the linker and other ADC technology used in these compounds are improvements to Seagen’s ADC technology, the ownership of which is automatically assigned to Seagen under a 2008 collaboration agreement between Daiichi Sankyo and Seagen. A decision in the arbitration case is expected by mid-2022.
Bayer Names New Head of Oncology Development
Bayer has named Tara Frenkl, MD, MPH, formerly the Senior Vice President, Head of Medicine Development Leaders in Oncology at GlaxoSmithKline (GSK), as Bayer’s new Head of Oncology Development in its Oncology Strategic Business Unit, effective April 25, 2022.
Ms. Frenkl will report to Christine Roth, Head of the Oncology Strategic Business Unit in the company’s Pharmaceuticals Division. Prior to joining Bayer, she held the role of Senior Vice President, Head of Medicine Development Leaders in Oncology at GSK. Prior to joining GSK, Ms. Frenkl was at Merck & Co. for 13 years in roles of increasing responsibility.
AbbVie, Novartis To Provide Assistance to Ukraine
AbbVie has pledged to provide assistance to Ukraine. AbbVie has pledged to: (1) donate a total of $1 million to nonprofit partners for medical care and supplies for Ukraine and Ukrainian refugees; (2) donate essential medicines to the Ukrainian government and disaster relief partners; (3) provide relief and additional financial support as needed to Ukrainian employees and their immediate families; and (4) double the AbbVie Foundation’s employee donation match for select disaster relief partners with active humanitarian relief efforts in Ukraine and surrounding countries.
AbbVie’s assistance coincides with Novartis’ pledge for an additional donation of $25 million in medical aid to Ukraine and bordering countries. Novartis also made an initial $3-million donation to charities supporting refugees and displaced people in Ukraine and bordering countries.