Mfg News: Novartis, BMS, Vertex, Gilead, UCB & More
A roundup of manufacturing news from Novartis, Bristol-Myers Squibb, Vertex Pharmaceuticals, Gilead Sciences, and UCB. Highlights below.
* Novartis To Sell UK API Mfg Facility
* Korean Conglomerate Lotte To Buy BMS Mfg Facility
* Vertex Plans To Build Cell-, Gene-Therapy Mfg Facility
* FDA Lifts Hold on Gilead’s HIV Drug Over Vial Issues
* UCB Issued FDA Complete Response Letter for Psoriasis Drug
Novartis To Sell UK API Mfg Facility
Novartis has agreed to sell its active pharmaceutical ingredient (API) manufacturing facility and assets in Grimsby, UK to Humber Industrials, a subsidiary of International Process Plants (IPP), which specializes in redeveloping manufacturing sites.
Novartis says it will continue manufacturing at the Grimsby site until the fourth quarter of 2022. Operations will then move into cleaning alongside the wider site exit program. The site will be formally transferred to the new owners in late 2023.
As part of a cost-savings move, Novartis first announced plans in 2018 to close the facility, which at that time was targeted for closure by the end of 2020. In May 2020, the company decided to maintain operations at the site through the end of 2022 due to demand for two products manufactured at the site. The site spans 229-acres and makes active ingredients for Novartis products.
With the sale of the facility to IPP, 212 employees will be not be retained as IPP’s Humber Industrials has decided not to take on the Novartis staff.
Korean Conglomerate Lotte To Buy BMS Mfg Facility
Lotte Corporation, a Seoul, Korea-based holding company of Lotte Group with holdings in chemicals, food & beverage, retail, and hotel & service, has agreed to buy Bristol Myers Squibb’s (BMS) commercial-scale biologics manufacturing facility in East Syracuse, New York.
The facility will serve as the Lotte Center for North America Operations for Lotte’s new biologics CDMO business in the US.
Upon closing, Lotte will acquire the East Syracuse site’s operations and assets, which include the property, plant and equipment, and workforce. Following the closing of the transaction, Lotte, under a newly established CDMO, will manufacture product for BMS from the East Syracuse facility. Over time, Lotte is expected to use the facility to expand its CDMO offerings.
The companies anticipate completing the transaction by the second half of 2022, subject to receipt of regulatory approvals and the satisfaction of other closing conditions. The East Syracuse site will continue to operate as part of BMS’ manufacturing network until the closing of the transaction.
Source: Bristol-Myers Squibb
Vertex Plans To Build Cell-, Gene-Therapy Mfg Facility
Vertex Pharmaceuticals, a Cambridge, Massachusetts-based bio/pharmaceutical company, plans to build a new research and manufacturing facility for cell- and genetic-therapies in Boston.
With the completion of this new 344,000-square-foot site, expected in 2025, Vertex will occupy 1.9 million square feet of real estate in the Boston Seaport across five sites.
The company already has a cell and genetic therapies research and clinical manufacturing site, which accommodates more than 400 employees, with 70% of the facility dedicated to lab and research space. This new planned expansion will house labs, offices, and manufacturing and add approximately 500 additional employees. Once this new facility is complete, the two buildings at the site will be known as the Leiden Campus and will support the company’s continued growth in multiple disease areas and modalities.
Source: Vertex Pharmaceuticals
FDA Lifts Hold on Gilead’s HIV Drug Over Vial Issues
The US Food and Drug Administration (FDA) has lifted the clinical hold placed on Gilead Sciences’ investigational new drug application (IND) for lenacapavir, an injectable treatment for HIV and HIV pre-exposure prophylaxis due to a vial compatibility issue.
In March 2022, the FDA placed a clinical hold on the use of lenacapavir in borosilicate vials due to a vial compatibility issue. The FDA removed the clinical hold following the agency’s review of Gilead’s plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative vial made from aluminosilicate glass.
Source: Gilead Sciences
UCB Issued FDA Complete Response Letter for Psoriasis Drug
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to UCB for the company’s biologics license application (BLA) for bimekizumab, a drug for treating moderate-to-severe plaque psoriasis.
The CRL indicates that the FDA cannot approve the application in its current form and states that certain pre-approval inspection observations must be resolved before approval of the application. UCB says it is cooperating with the FDA and is working to address these observations.
In August 2021, bimekizumab received marketing authorization for treating moderate-to- severe plaque psoriasis in adults who are candidates for systemic therapy in the European Union/European Economic Area and Great Britain. In January 2022, bimekizumab received marketing authorization in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis, and psoriatic erythroderma in patients who are not sufficiently responding to existing treatments. In February and March 2022, bimekizumab received marketing authorization in Canada and Australia, respectively, for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.