Mfg News: Merck & Co., Novartis, Viatris & More

A roundup of manufacturing news from Merck & Co., Novartis, Viatris, and Alnylam Pharmaceuticals.

Merck & Co. Expands Mfg Facility for HPV Vaccines
Merck & Co. has expanded its vaccines-manufacturing facility in Elkton, Virginia, by completing the construction of 120,000 square feet to increase capacity and supply of its human papillomavirus (HPV) vaccines, following regulatory reviews and approvals. The company expects to add 150 jobs at the site.

In 2019, Merck committed more than $1 billion to expand production capacity at existing manufacturing facilities and build new facilities to address global demand for its HPV vaccines. The company has expanded and maximized its existing facilities and nearly doubled supply of its HPV vaccines from 2017-2020. Merck expects supply of its HPV vaccines to double again between 2020-2023 as the company continues to expand capacity at existing facilities and as new facilities come on line.

Source: Merck & Co.

FDA OKs Novartis’ Gene-Therapy Mfg Facility
The US Food and Drug Administration (FDA) has granted commercial licensure approval for a Novartis’ multi-product gene-therapy manufacturing facility in Durham, North Carolina, which

allows the 170,000 square-foot facility to make, test, and release commercial quantities, of Novartis’ gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), as well as produce gene-therapy product for current and future clinical trials.

This clearance brings on line the second commercially licensed manufacturing facility for Novartis Gene Therapies, joining the company’s Libertyville, Illinois, site, which was approved for manufacturing and distribution of Zolgensma in 2019. 

Source: Novartis

Viatris Sells West Virginia Mfg Facility
Viatris has sold the former Mylan pharmaceutical manufacturing facility in Morgantown, West Virginia, to the West Virginia University (WVU) Innovation Corporation, which has taken ownership of the plant.

Viatris is the company formed from the combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business

In December 2020, Viatris announced a $1-billion restructuring plan, which included rationalization of manufacturing facilities. The company planned to shut down the Morgantown facility, but later committed to finding a new operator for the facility. In August 2021, West Virginia Governor Jim Justice announced that WVU and Viatris began negotiating a memorandum of understanding with the aim of transferring the plant to WVU.

WVU and the West Virginia University Health System, commonly branded as WVU Medicine, will work together to oversee the future development of the facility through a reconfigured WVU Innovation Corporation, which will handle the daily operations of the facility.

According to WVU, the finalization of the purchase agreement will result in the development of short-, medium- and long-term academic, employment, and community opportunities for Morgantown and surrounding areas, as well as tuition scholarships for impacted Mylan employees. Discussions are already underway with potential tenants to lease space within the 1.1-million-square-foot facility.

Source: Office of the Governor, West Virginia

FDA Extends NDA for Alnylam’s RNAi Therapy To Include Packaging
The US Food and Drug Administration (FDA) has extended the review timeline of Alnylam Pharmaceuticals’ new drug application (NDA) for vutrisiran, an investigational RNAi therapeutic for treating transthyretin-mediated (ATTR) amyloidosis, to allow for the review of newly added information related to a new secondary packaging and labeling facility. ATTR is a disease that is caused by a buildup of amyloid deposits in the body.

Alnylam says it recently learned that the original third-party secondary packaging and labeling facility it planned to use for the vutrisiran launch was recently inspected, and the inspection requires classification for the FDA to take action on the vutrisiran NDA. The inspection observations were not directly related to vutrisiran. In order to minimize delays to approval, Alnylam has identified a new facility to pack and label vutrisiran and submitted an amendment to its NDA for review by the FDA.

The updated Prescription Drug User Fee Act (PDUFA) goal date to allow for this review is July 14, 2022. No additional clinical data have been requested by the FDA.

Source: Alnylam Pharmaceuticals