Global Briefs: J&J, Alkermes, Astellas & Amgen

A roundup of news from Johnson & Johnson, Alkermes, Astellas, Taysha Gene Therapies, and Amgen. Highlights below.

* J&J To Acquire Abiomed for $16.6 Bn
* Alkermes To Explore Spinning Off Oncology Biz into Separate Company
* Astellas Takes $50-M Stake in Taysha Gene Therapies
* Amgen Opens R&D Facility

J&J To Acquire Abiomed for $16.6 Bn
Johnson & Johnson has agreed to acquire Abiomed, a Danvers, Massachusetts-based medical device company focused on cardiovascular disease, for $16.6 billion.

The transaction is expected to be completed prior to the end of the first quarter of 2023 and is conditioned on the tender of a majority of the outstanding shares of Abiomed’s common stock, as well as the receipt of applicable regulatory approvals and other customary closing conditions.

Source: Johnson & Johnson

Alkermes To Explore Spinning Off Oncology Biz into Separate Company
Alkermes, a Dublin, Ireland-based bio/pharmaceutical company, reports that it will explore spinning off its oncology business into an independent, publicly traded company. The company’s Board of Directors approved exploring separating its commercial-stage neuroscience business and development-stage oncology business.

The oncology business would continue to focus on the discovery and development of cancer therapies, including the continued development of nemvaleukin alfa, an immunotherapy currently in potential registration-enabling studies to treat platinum-resistant ovarian cancer and mucosal melanoma. The assets subject to a separation are also expected to include a portfolio of preclinical, engineered cytokines, including tumor-targeted split interleukin-12 and interleukin-18.

The company says that additional details regarding a separation, including the name of the contemplated Oncology Company, its executive management team, and its Board of Directors, as well as financial details for the two contemplated companies, would be provided at a later date. The separation, if consummated, is expected to be completed in the second half of 2023. Alkermes anticipates the Oncology Company would be located within the company’s existing Waltham, Massachusetts, campus. The facilities and research and manufacturing operations in Wilmington, Ohio, and Athlone, Ireland, = will remain with Alkermes. Separation of the two businesses would be subject to customary closing conditions and final approval by Alkermes’ Board of Directors.

Source: Alkermes

Astellas Takes $50-M Stake in Taysha Gene Therapies
Astellas Pharma has agreed to take a $50-million stake in Taysha Gene Therapies, a Dallas, Texas-based gene-therapy company, to support the advancement of Taysha’s adeno-associated virus (AAV) gene-therapy development programs for the treatment of Rett syndrome, a rare genetic neurological disorder, and giant axonal neuropathy (GAN), a rare inherited genetic disorder that affects both the central and peripheral nervous systems.

Taysha Gene Therapies was founded in partnership with The University of Texas Southwestern Medical Center to develop and commercialize gene therapies, and with UT Southwestern, is advancing a product portfolio of 26 gene-therapy product candidates.

Under the agreement, Astellas will invest a total of $50 million to acquire 15% of the outstanding common stock of Taysha and to receive an exclusive option to license two of Taysha’s clinical stage programs: TSHA-102, an intrathecally delivered AAV9 gene-replacement therapy, and TSHA-120, an intrathecally dosed AAV9 gene-replacement therapy that delivers the gene, gigaxonin. Both therapies have received orphan drug and rare pediatric disease designations from the US Food and Drug Administration and orphan drug designation from the European Commission.

Additionally, Taysha has granted Astellas certain rights related to any potential change of control of Taysha. Definitive agreements would be executed upon Astellas’ exercise of any such option, and any change of control transaction would require approval by Taysha’s stockholders.

Astellas has made several recent moves to build its capabilities in gene therapies. In 2020, it acquired Audentes (now Astellas Gene Therapies, California) and opened a  commercial GMP gene-therapy manufacturing facility in North Carolina in June (June 2022).

Source: Astellas Pharma

Amgen Opens New R&D Facility
Amgen has opened a new research and development site in San Francisco, California. The new 245,000-square-foot research facility, which is the company’s second largest R&D facility, will focus on developing therapeutics for cancer, inflammatory disease, and cardiometabolic disorders and will provide a workplace for 650 staff.

Source: Amgen