Mfg News: Novartis, J&J, Lilly, Teva & MoreBy
A roundup of manufacturing news from Novartis, Johnson & Johnson, Legend Biotech, Teva Pharmaceutical, Marksans Pharma, Eli Lilly and Company, Alvotech, and Afrigen. Highlights below.
* Novartis To Manufacture CAR T Therapy for J&J, Legend Biotech
* Teva Sells India Mfg Facility to Marksans Pharma
* Lilly Receives FDA Complete Response Letter for Ulcerative Colitis Drug for Mfg Issues
* Alvotech Receives FDA Complete Response Letter for Biosimilar of Humira for Mfg Issues
* Afrigen, WHO Advance mRNA Mfg in Africa
Novartis To Manufacture CAR T Therapy for J&J, Legend Biotech
Novartis, Johnson & Johnson (J&J), and Legend Biotech, a Somerset, New Jersey-based bio/pharmaceutical company, have entered into an agreement for the manufacture of J&J’s/Legend Biotech’s Carvykti (ciltacabtagene autoleucel or cilta-cel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy for treating multiple myeloma.
J&J and Legend Biotech formed an exclusive worldwide license and collaboration agreement to develop and commercialize cilta-cel in December 2017. Last year (October 2022), they agreed to invest an additional $250 million in their joint CAR-T manufacturing facility in Raritan, New Jersey, to bring the total investment in the facility to $500 million.
The new agreement with Novartis is effective as of April 12, 2023, with initial technology transfer for manufacturing. The manufacturing agreement will continue for a period of three years.
Source: Legend Biotech
Teva Sells India Mfg Facility to Marksans Pharma
Teva Pharmaceutical Industries has divested a manufacturing site in Verna, Goa, India, to Marksans Pharma, a Mumbai, India-based bio/pharmaceutical company. The acquisition was first announced in October 2022 and was completed earlier this month (April 2023).
With the completion of the acquisition, Marksans will start operating at the acquired facility. As a part of the agreement, Marksans will continue to supply existing products until the end of 2023 to Teva’s affiliates.
The acquired facility will enable Marksans Pharma to potentially double its existing Indian capacity of 8 billion units per annum. Marksans plans to manufacture tablets, hard and softgel capsules, ointments, liquids, and creams from the new capacity. The manufacturing site is spread across 47,597 square meters and has approvals to manufacture products from the EU, Health Canada & Japanese Health Authority.
Source: Marksans Pharma
Lilly Receives FDA Complete Response Letter for Ulcerative Colitis Drug for Mfg Issues
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Eli Lilly and Company for the biologic license application of mirikizumab for treating ulcerative colitis (UC) due to manufacturing issues. In its CRL, the FDA cited issues related to the proposed manufacturing of mirikizumab, with no concerns about the clinical data package, safety, or label for the medicine.
Lilly recently received approval for mirikizumab as a treatment for adults with moderately to severely active UC in Japan. In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for mirikizumab as a treatment for adults with moderately to severely active UC who have had an inadequate response with, lost a response to, or were intolerant to either conventional therapy or a biologic treatment. Regulatory decisions are anticipated in additional markets around the world in 2023.
Source: Eli Lilly and Company
Alvotech Receives FDA Complete Response Letter for Biosimilar of Humira for Mfg Issues
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Alvotech, a Reykjavik, Iceland-based developer of monoclonal antibody biosimilars, for its biologics license application (BLA) for AVT02, a high-concentration biosimilar candidate for AbbVie’s Humira (adalimumab), due to manufacturing issues. The CRL noted that certain deficiencies, which were conveyed following the FDA’s re-inspection of the company’s Reykjavik facility that concluded on March 17, 2023, must be satisfactorily resolved before the application can be approved. Alvotech submitted a response to the FDA and has been informed that the responses provided are currently under review.
Teva is partnered with Alvotech for biosimilars, a collaboration that the companies formed in 2020.
Alvotech’s second BLA for AVT02, which contains data to support approval as a biosimilar and additional information supporting potential interchangeability designation, remains under review by the FDA, with a biosimilar user fee amendment goal date of June 28, 2023. Satisfactory outcome of the facility reinspection remains the key requirement for approval.
Source: Alvotech (FDA Submission) and Alvotech (FDA Update)
WHO, Afrigen Advance mRNA Mfg in Africa
The World Health Organization (WHO) has opened a mRNA technology Hub facility at Afrigen, a Cape Town, South Africa-based biotechnology company, in Cape Town, South Africa as part of WHO’s mRNA technology transfer program, a program aimed at increasing access to mRNA drugs.
Afrigen has successfully established a COVID-19 vaccine manufacturing process at laboratory scale and is currently scaling up that process to a level suitable for manufacturing vaccine batches to be used in Phase I/ II clinical trials to GMP standards. In a parallel process, Afrigen will continue to carry out training and technology transfer to network partners.
WHO has received total funding to date of $117 million to fund the technology transfer and manufacturing process, with France being the first to fund the mRNA technology transfer work. Present at a recent meeting for the projects were representatives from the European Commission, Belgium, Germany, as well as Norway, Canada, the African Union, South Africa, and the ELMA Foundation, an organization providing grants and support for philanthropic activities.
Source: World Health Organization