Global Pharma Briefs: News from Europe and the USBy
A roundup of developments from the UK (AstraZeneca) and the US (Amgen, Fresenius Kabi).
AstraZeneca Gains Global Rights to Allergan’s Autoimmune Disease Drug
AstraZeneca has completed its previously communicated agreement with Allergan to recover the global rights to brazikumab, an investigational drug to treat autoimmune diseases. AstraZeneca and Allergan have terminated their previous license agreement and all rights to brazikumab have returned to AstraZeneca. Allergan agreed to return the rights back to AstraZeneca to satisfy a condition by regulatory authorities to divest the product for approval of AbbVie’s $63-billion acquisition of Allergan.
Earlier this year (January 2020), AstraZeneca and Allergan agreed to terminate their existing license agreement, and to revert all rights to brazikumab to AstraZeneca.
Under the termination agreement, Allergan will fund an agreed amount, estimated to be the total costs expected to be incurred by AstraZeneca for completing development of brazikumab for treating Crohn’s disease and ulcerative colitis, including the development of a companion diagnostic.
As part of a 2012 collaboration between Amgen and AstraZeneca to jointly develop and commercialize a clinical-stage inflammation portfolio, Amgen is entitled to receive a high single-digit to low double-digit royalty on sales of brazikumab if approved and launched. This includes the original inventor royalty. Other than this, AstraZeneca will own all rights and benefits arising from the product with no other payments due to Amgen or Allergan.
Court Rules in Favor of Amgen in Patent Lawsuit for Kyprolis
A federal district court has ruled in favor of Amgen by upholding the validity of patent claims from three patents that protect Amgen’s multiple myeloma therapy, Kyprolis (carfilzomib), from certain generic-drug competition.
The ruling prevents Cipla, a Mumbai, India-based pharmaceutical company, from making, using, selling, offering to sell, or importing its generic version of Kyprolis until expiration of the three US patents examined in the case. The latest patent expiry is in December 2027.
Onyx Therapeutics, an indirect, wholly owned subsidiary of Amgen, brought a patent infringement suit against Cipla in 2016. The decision by the US District Court in Delaware earlier this month (May 2020) followed an earlier bench trial in May 2019. Prior to the trial, Cipla acknowledged that its generic product would infringe all of the asserted claims, which left the only the issue of validity of the asserted patents to be addressed by the court.
Fresenius Kabi Recalls 13 Lots of NSAID due to Particulate Matter
Fresenius Kabi USA, a Lake Zurich, Illinois-based healthcare company, is voluntarily recalling 13 lots of ketorolac tromethamine injection, a nonsteroidal anti-inflammatory drug (NSAID), due to the presence of particulate matter in eight reserve samples vials. The particular matter was composed of carbon, silicon, oxygen and polyamides.
The recalled lots were distributed nationwide in the US to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019.