Global Pharma Briefs: News from AstraZeneca, Pfizer, Gilead, AbbVie

By Miranda Greenberg -

February 11, 2021

A roundup of news from Japan (Bristol-Myers Squibb), the UK (AstraZeneca), and the US (Pfizer, Apotex, AbbVie, Gilead, Caribou Biosciences, and Jubilant).

Japan

BMS Donates $52 M for Cancer Research in Japan
Bristol-Myers Squibb has donated JPY 5.5 billion ($52 million) to Kyoto University, a research university in Japan, to support immuno-oncology research.

The funds will be used to finance the construction of the main building of the Center for Cancer Immunotherapy and Immunobiology, a newly established immuno-oncology research institute headed by Tasuku Honjo, a Nobel laureate and professor of the university. Construction of the building, which will be named the Bristol-Myers Squibb Building at the Center for Cancer Immunotherapy and Immunobiology, is scheduled to begin in 2021.

The Center for Cancer Immunotherapy and Immunobiology was established in April 2020 as a research institute within Kyoto University's Graduate School of Medicine. The center serves as a hub for scholars from Japan and overseas pursuing scientific advancement of immuno-oncology in search of next-generation cancer treatments.

Source: Bristol-Myers Squibb


UK

AstraZeneca To Divest 26.7% Ownership in Viela Bio for $760-M Plus
AstraZeneca has agreed to divest its 26.7% ownership in Viela Bio, a Gaithersburg, Maryland-based biotechnology company, as part of the proposed acquisition of Viela by Horizon Therapeutics.

Viela Bio received approval by the US Food and Drug Administration’s Center for Drug Evaluation and Research in 2020 for Uplizna (inebilizumab-cdon) for the treatment of neuromyelitis optica spectrum disorder.

AstraZeneca is anticipating to receive cash proceeds and profit of $760 million to $780 million upon closing of the sale of the holding. The divestment is expected to be completed by the end of the first quarter of 2021, subject to certain limited exceptions.

Source: AstraZeneca


AstraZeneca Divests European Rights of Crestor in $350-M Deal
AstraZeneca has completed the sale of its European commercial rights (except in the UK and Spain) for its anti-cholesterol drug, Crestor (rosuvastatin), and associated brands to Grünenthal, an Aachen, Germany-based pharmaceutical company, in a deal worth up to $350 million.

Under the agreement, AstraZeneca received a payment of $320 million from Grünenthal and may also be eligible for future milestone payments of up to $30 million.

In 2019, Crestor generated sales of $136 million and profit before tax of $98 million in the countries covered by the agreement.

Source: AstraZeneca and Grünenthal


US

Pfizer Extends US Patent for Ibrance Until 2027
Pfizer has extended its US patent for Ibrance (palbociclib), a drug to treat advanced (metastatic) breast cancer, by more than four years until March 5, 2027.

Ibrance is currently approved in more than 100 countries and has been prescribed to more than 350,000 patients globally. Ibrance had 2020 revenues of $5.4 billion. 

The US Patent Term Extension (PTE) certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations, published by the US Food and Drug Administration. This extension does not include potential pediatric exclusivity.

Source: Pfizer


Apotex Issues Recall of Anticoagulant Due to Syringe Mislabeling 
Apotex is voluntarily recalling two batches of enoxaparin sodium injection, USP, an anticoagulant, to the consumer level in the US due to mislabeling of syringe-barrel measurement markings.

The recall is due to a packaging error resulting in some syringes barrels containing 150-mg/mL markings (corresponding to 120-mg/0.8-mL strength) instead of 100-mg/mL markings (corresponding to 100-mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date (as reported on February 2, 2021), Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma Limited, a Hyderabad, India-based generic injectable pharmaceutical products company.

The two affected batches of enoxaparin sodium injection, USP were distributed by Apotex nationwide in the US to wholesalers and warehousing chains.

Source: US Food and Drug Administration and Apotex


AbbVie, Caribou Biosciences in $340-M Pact for CAR-T Cell Products
AbbVie and Caribou Biosciences, a Berkeley, California-based clinical-stage CRISPR genome-editing biotechnology company, have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics in a $340-million deal.

Under the multi-year agreement, AbbVie will use Caribou’s Cas12a CRISPR hybrid RNA-DNA (chRDNA) genome-editing and cell-therapy technologies to research and develop two new CAR-T cell therapies directed to targets specified by AbbVie. AbbVie will have exclusive rights to Caribou’s Cas12a chRDNA genome-editing and cell therapy technologies for the selected targets. Caribou will conduct certain preclinical research, development, and manufacturing activities for the collaboration programs, and AbbVie will reimburse Caribou for all such activities pursuant to the collaboration. AbbVie is responsible for all clinical development, commercialization, and manufacturing efforts. 

AbbVie has the option to pay a fee to expand the collaboration to include up to an additional two CAR-T cell therapies. Caribou will receive $40 million in an upfront cash payment and equity investment, along with up to $300 million in future development, regulatory, and launch milestones. Caribou may also receive additional payments for commercial milestones as well as global tiered royalties.

Source: Abbvie and Caribou Biosciences


Gilead To Open New Business Services Center in North Carolina
Gilead Sciences has announced plans to open a new Business Services Center in the Research Triangle region in North Carolina.

When it is operational later this year (2021), the Gilead Business Services Center will be the new home for a number of the company’s functions, including human resources operations for its sites in North America, as well as specific finance and information technology teams.

The center is expected to be fully operational, and employees will begin to move on site in the third quarter of 2021, pending ongoing restrictions from COVID-19. Gilead will begin recruiting for dozens of open roles. The majority of the site will be staffed by new employees.

When the center is running at full capacity, which Gilead anticipates will take up to two years, it will include 275 employees. Gilead will continue to grow its business in Foster City, California and its headquarters will remain in Foster City. Gilead has more than 13,000 employees globally, with more than half located at its sites in California.

Source: Gilead Sciences


Jubilant Biosys, Yale Form Small-Molecule Research Pact
Jubilant Biosys, a subsidiary of Jubilant Life Sciences, and Yale University have announced a research collaboration for multiple small-molecule research programs.

Under the partnership, Jubilant Biosys will provide research services to investigators at Yale University working on novel therapeutic targets. Areas of collaboration include medicinal chemistry, structural biology, and in vitro and in vivo pharmacology.

Source: Jubilant Biosys