Global Pharma Briefs: News from CSL, Roche, GSK, AstraZeneca, BMS, SanofiBy
A roundup of news from Australia (CSL’s Seqirus), China (Pfizer), The Netherlands (Roche), the UK (Eisai, GSK, AstraZeneca), and the US (BMS, Sanofi, Daiichi Sankyo, J&J).
Seqirus To Invest $584 M in Influenza Vaccine Mfg Facility
Seqirus, a subsidiary of CSL and a developer and manufacturer of influenza vaccines, has announced plans to invest AU$800 million (US$584 million) to construct a manufacturing facility in Australia to supply influenza vaccines.
The facility will use cell-based technology to produce influenza vaccines for use in both influenza pandemics and seasonal vaccination programs. The facility will also manufacture Seqirus’ proprietary adjuvant, MF59, a substance added to some vaccines to improve immune response and to reduce the amount of antigen needed for each vaccine. Additionally, the facility will produce antivenom for Australian snakes, spiders and marine creatures, and a human vaccine for Q-Fever, a disease caused by the bacteria Coxiella burnetii.
The facility will be built in Tullamarine, in the Melbourne Airport Business Park, and is expected to be operational in 2026.
This announcement follows an agreement with the Australian government for onshore manufacture and supply over 10 years of influenza pandemic vaccines, anti-venoms, and Q-Fever vaccine.
Seqirus was formed in 2015 following CSL’s $275-million acquisition of Novartis’ influenza vaccines business and its subsequent integration with bioCSL, a CSL subsidiary.
Pfizer, LianBio Form Pact for Pharma Products in China
Pfizer and LianBio, a Shanghai-based biopharmaceutical company, have entered into a collaboration for developing and commercializing pharmaceutical products in Greater China.
In addition to Pfizer’s participation in LianBio’s recent crossover financing, under the terms of the collaboration, Pfizer will contribute up to $70 million toward in-licensing and co-development. At LianBio’s discretion, products will be presented to Pfizer for joint development. Pfizer will have a right of first negotiation to obtain commercial rights to jointly developed assets, and each will carry separate financial considerations. During the collaboration, Pfizer may provide support for marketing, development and regulatory activities.
Roche, Lead Pharma in $320-M Deal for Small-Molecule Development
Roche has entered into a license agreement, in deal worth up to EUR 270 million ($320-million), with Lead Pharma, an Oss, The Netherlands-based clinical-stage pharmaceutical company, to develop oral small molecules for immune-mediated diseases.
Under the agreement, Lead Pharma will receive an upfront payment of EUR 10 million ($12 million) and will be eligible to receive research funding and preclinical milestone payments. Total potential payments, including research, development, regulatory and sales milestones may add up to an aggregate of EUR 260 million ($308 million), plus royalties on worldwide sales.
Lead Pharma and Roche will collaborate in research activities up to the selection of a preclinical candidate after which Roche will be responsible for further development and global commercialization.
Source: Lead Pharma
Eisai To Invest $15 M in New Packaging Lines in the UK
Eisai has announced a £11.5million ($15 million) investment to fund two new packaging lines and create new jobs at its Hatfield production plant in Hertfordshire, UK.
Eisai is expanding its facilities to triple product output within the next three years (as reported on November 16, 2020) and is targeting a four-fold increase by 2025.
The Hatfield plant serves as a global supply center for Eisai’s medicines. The company is expanding its global packaging capabilities with blistering, serialization, and high-containment product capabilities.
As part of the investment, two local firms have been appointed, based in St. Albans and Rickmansworth, for the design and fit out of the new facilities due to be completed in July 2021.
GSK, AstraZeneca, University of Cambridge Launch AI Center
GlaxoSmithKline (GSK), AstraZeneca, and the University of Cambridge have entered into a pact to fund the Cambridge Center for AI in Medicine (CCAIM), a research group for applying artificial intelligence (AI) and machine-learning technologies for biomedical science, medicines, and healthcare.
CCAIM has been set up as a research group. Its faculty of 10 University of Cambridge researchers, in addition to PhD students currently being recruited, are using AI and machine-learning technologies for clinical trials, personalized medicine, and biomedical discovery.
Under a five-year plan, AstraZeneca and GSK will support five new PhD studentships per year. This program will enable students in machine learning and bioscience to partner with industry and academia.
FDA Issues CRLs to Sanofi, Alkermes for Mfg Issues, Delays Review of BMS CAR-T Therapy for FDA Inspection Issues
The US Food and Drug Administration (FDA) has issued separate Complete Response Letters (CRLs) for manufacturing issues to Sanofi and Alkermes and has notified Bristol-Myers Squibb (BMS) of a delay in reviewing its biological license application (BLA) for a CAR-T therapy due to limitations in conducting an inspections due to the COVID-19 pandemic.
The FDA issued Sanofi a CRL regarding Sanofi’s BLA for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with cold agglutinin disease. The CRL refers to certain deficiencies identified by the FDA during a pre-license inspection of a third-party facility responsible for manufacturing. Sanofi says there were no clinical or safety deficiencies noted in the CRL and that satisfactory resolution of the observations by the third-party manufacturer is required before the BLA can be approved.
The FDA issued Alkermes a CRL for its new drug application (NDA) for ALKS 3831 (olanzapine/samidorphan), a drug for treating schizophrenia and bipolar I disorder. Following a remote review of manufacturing records, the FDA said that resolution of certain conditions related to the tablet-coating process at the company’s Wilmington, Ohio facility is required before ALKS 3831 may be approved. The company says the CRL did not identify or raise any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application. The observations noted in the CRL were specific to certain development batches of ALKS 3831. The company says it believes this issue has since been resolved and that sufficient data are available to address these observations.
The FDA has informed BMS that the FDA’s review of the company’s BLA for lisocabtagene maraleucel (liso-cel), a chimeric antigen receptor (CAR) T‑cell immunotherapy for treating relapsed or refractory large B-cell lymphoma, will not be completed by the Prescription Drug User Fee Act action date of November 16, 2020. The FDA was unable to conduct an inspection of a third-party manufacturing facility in Texas during the review cycle due to travel restrictions related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until the inspection can be completed. The application remains under review. The FDA did not provide a new anticipated action date.
Fresenius Kabi Issues Recall of One Lot of Sedative
Fresenius Kabi USA, a Lake Zurich, Illinois-based healthcare company, is voluntarily recalling a single lot of dexmedetomidine hydrochloride in 0.9% sodium chloride injection (200 mcg/50 mL (4 mcg /mL), 50-mL fill in a 50-mL vial), due to a trace amount of lidocaine present in the lot.
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is approved for intravenous use and is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
The recalled lot was distributed nationwide in the US to wholesalers, distributors, hospitals and pharmacies between April 9, 2020 and April 13, 2020. To date (as reported on November 19, 2020), the company says no adverse drug experience reports have been received for the recalled lot.
Source: US Food and Drug Administration
Amgen Ends Pact with Cytokinetics for Heart Failure Drugs
Amgen reports it will terminate its collaboration with Cytokinetics, a South San Francisco-based biopharmaceutical company, with the intention to transition the development and commercialization rights for certain heart failure drugs.
Upon the effective date of the termination, research, development and commercialization rights for compounds, including omecamtiv mecarbil, an investigational drug in Phase III development to treat chronic heart failure, and AMG 594, a drug in Phase I development for treating heart failure and other diseases, will transition to Cytokinetics.
In addition, Amgen will have certain obligations set forth in the agreement. The full obligations can be found here.
Daiichi Sankyo To Create New Oncology Business Unit
Daiichi Sankyo reports it will create a new oncology business unit for US and Europe markets, effective April 1, 2021.
The move will align the company’s US and European oncology businesses and the functions of marketing, market access and pricing, medical affairs, and alliance management under one team.
Ken Keller, currently President and Chief Executive Officer (CEO) of the company’s US affiliate, Daiichi Sankyo, Inc. and American Regent, will lead this new team as Head of the Oncology Business Unit, effective, April 1, 2021, and will remain President and CEO of Daiichi Sankyo, Inc. Paul Diolosa, currently Senior Vice President of Operations of American Regent, will succeed Mr. Keller as President and CEO of American Regent as of April 1, 2021.
Mr. Keller joined Daiichi Sankyo in 2014 and has more than 30 years of experience in the pharmaceutical industry in general management, commercial, international and joint-venture leadership, as well as chief operating officer experience in several therapeutic areas, including oncology, bone health, rheumatology, dermatology and primary care. Prior to joining the Daiichi Sankyo Group, Mr. Keller was the President and Chief Operating Officer at Spectrum Pharmaceuticals, a Henderson, Nevada-based company, and prior to that, spent 21 years at Amgen as Vice President and General Manager.
Source: Daiichi Sankyo
J&J To Invest $100 M To Promote Health Equity
Johnson & Johnson has announced it will invest $100 million in commitments and collaborations over the next five years to invest in and promote health equity for Black people and other communities of color in the US.
The company’s commitment prioritizes three key areas: (1) healthier communities by investing in programs that help provide equitable healthcare for underserved communities; (2) enduring alliances by forging partnerships and alliances to address racial and social health determinants; and (3) diverse and inclusive corporate culture to ensure a diverse and inclusive workforce.
Full details of the commitments can be found here.
Source: Johnson & Johnson
BMS Launches $100-M Program for Clinical Trial Diversity
The Bristol-Myers Squibb Foundation and National Medical Fellowships, a nonprofit organization, have entered into a partnership to launch a $100-million program to improve diversity in clinical trials.
Using $100 million of a previously announced commitment from Bristol Myers Squibb and the Bristol Myers Squibb Foundation for diversity and inclusion, the partnership will develop a program to extend the reach of clinical trials into underserved patient populations in urban and rural US communities.
This program will train and develop 250 new clinical investigators who are racially and ethnically diverse or who have a demonstrated commitment to increasing diversity in clinical trials. It will also expose 250 minority medical students across the US to clinical research career pathways. Additionally, the program will assist program investigators in building capacity and setting up new clinical trials sites in communities with diverse and burdened patient populations.
Source: Bristol-Myers Squibb