Global Pharma Briefs: News from AstraZeneca, Novartis, and SanofiBy
A roundup of news from China (AstraZeneca), Switzerland (Novartis), and the US (IFF, DuPont, Sanofi, Regeneron, Fresenius Kabi, Mallinckrodt, and bluebird bio).
AstraZeneca, Hong Kong Launch Biomedical Oncology Co-Incubation Program
AstraZeneca and the Hong Kong Science and Technology Parks (HKSTP) have launched a co-incubation program to support local and overseas biomedical start-ups developing oncology diagnostics and treatment.
Successful applicants will be eligible for professional support from HKSTP, including funding of up to HKD $6 million ($774,000), working space, and laboratory facilities, as well as use HKSTP’s platform, which provides business matching opportunities with partners and potential investors, and talent support.
AstraZeneca will assist start-ups in connecting with industry stakeholders and partners. Additionally, AstraZeneca will also use its existing networks with Mainland China and global markets, including the Wuxi International Life Science Innovation Campus co-built with local government and emerging markets health innovation hubs, SLUSH and Cambridge Network, to provide platforms for exploring opportunities overseas.
This is the first oncology-related partnership launched by AstraZeneca Hong Kong and HKSTP. The plan will last for two years (as reported on February 10, 2021). Participating start-ups will also become members of HKSTP Incu-Bio.
Novartis, Gates Foundation in Pact for Gene-Therapy Development
Novartis has entered into a grant agreement with the Bill & Melinda Gates Foundation to discover and develop an in vivo gene therapy for sickle-cell disease (SCD), a hereditary blood disease. The Gates foundation will provide funding support for the discovery and development of a single-administration, in vivo, gene therapy for SCD. The project brings together Novartis drug-discovery and gene-therapy expertise with the Gates Foundation’s charitable objectives to expand access to healthcare in low-resource settings.
Novartis envisions developing an accessible in vivo gene therapy for SCD that could potentially be administered once directly, without the need to modify the cells in a lab. To facilitate the research, the Gates Foundation has agreed to provide funding support for a research team within the Novartis Institutes for BioMedical Research; Novartis will provide support and access to its suite of technologies and resources.
IFF Completes Acquisition of DuPont’s Nutrition and Biosciences Business
International Flavors and Fragrances (IFF) has completed its acquisition of DuPont’s Nutrition and Biosciences business. The companies had announced the acquisition in December 2019.
The merger brings together IFF’s expertise in food, flavors and fragrances and the former DuPont business in probiotics, enzymes, food protection, and food and pharma ingredients, including excipients. The combined company has estimated 2020 pro forma revenue of more than $11 billion, and earnings before tax, interest, depreciation and amortization of approximately $2.5 billion, excluding synergies. IFF says the combined company has leadership positions in taste, texture, scent, nutrition, enzymes, cultures, soy proteins, and probiotics.
In connection with the closing of the transaction with IFF, DuPont received a special cash payment of about $7.3 billion, approximately $5 billion of which will be used to strengthen its balance sheet by retiring outstanding debt. As a result of the merger completion, DuPont now has three business: segments: Electronics & Industrial, Mobility & Materials, and Water & Protection. DuPont also agreed to sell to a private equity consortium the DuPont Clean Technologies business for $510 million. The company has also moved its Tedlar Microcircuit Materials and the DuPont Teijin Films joint venture and has realigned these businesses to Mobility & Materials.
With the closing of the deal, IFF organized into these divisions: Scent, Health & Biosciences, and Pharma Solutions, which develops, ingredients, products, and applications that support global production of pharma and dietary supplements.
Sanofi, Regeneron Get Favorable Court Ruling in Praluent Patent Litigation
A US federal appeals court has ruled in favor of Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, over Amgen in patent litigation for Praluent (alirocumab), a cholesterol-lowering drug.
The US Federal Circuit Court of Appeals upheld a decision by the US District Court for the District of Delaware that Amgen’s asserted patent claims directed toward PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies are invalid based on lack of enablement. The ruling means that Regeneron and Sanofi have successfully invalidated all five of Amgen’s asserted claims relevant to Praluent, according to Regeneron. The decision followed an October 2020 ruling by the European Patent Office’s Technical Board of Appeal that also invalidated certain functional claims of Amgen’s European patent directed to PCSK9 antibodies.
Regeneron has sole rights for Praluent in the US and Sanofi has sole rights for Praluent outside the US. Amgen has a competing PCSK9 antibody, Repatha (evolocumab) for treating high cholesterol.
Source: Regeneron Pharmaceuticals
Fresenius Kabi Resolves Investigation Over FDA Inspection Records
Fresenius Kabi Oncology has reached an agreement with the US Department of Justice to resolve an investigation over records during a US Food and Drug Administration inspection that occurred in 2013.
In 2013, Fresenius Kabi Oncology notified the FDA upon discovering that certain employees at the company’s plant in Kalyani, India had failed to provide relevant records during an FDA inspection. “These individuals acted in violation of Fresenius Kabi’s compliance requirements, code of conduct and values,” said the company in a February 9, 2021 statement. “As a consequence, their employment was terminated immediately. Fresenius informed the public about these events in July 2013.”
As part of the agreement, which still must be reviewed and accepted by the United States District Court for the District of Nevada, Fresenius Kabi Oncology has agreed to make a payment of $50 million (in fines and forfeiture). The agreement includes a compliance addendum under which the company will build on its existing quality compliance management system to monitor compliance and provide the US Department of Justice with regular reports on its effectiveness.
COVID-19 Restrictions Delay FDA Inspection of Mallinckrodt Facility
Mallinckrodt reports that the US Food and Drug Administration (FDA) has informed the company that it is deferring action (pending a site inspection) on the company’s biologics license application (BLA) for StrataGraft, an investigational treatment to reduce autograft in patients with severe thermal burns, due to COVID-19-related travel restrictions, which are delaying a required manufacturing site inspection.
Mallinckrodt acquired Stratatech Corporation, a privately held regenerative medicine company focused on skin-substitute products, in 2016. Mallinckrodt gained StrataGraft from the acquisition.
The FDA granted the BLA for StrataGraft priority review. Previously, the FDA granted StrataGraft orphan drug status.
bluebird bio Temporarily Suspends Studies of SCD Gene Therapy
bluebird bio, a Cambridge, Massachusetts-based clinical-stage gene-therapy company, has placed its Phase I/II and Phase III studies of LentiGlobin (betibeglogene darolentivec), a gene-therapy for treating sickle-cell disease, on a temporary suspension due to a reported suspected unexpected serious adverse reaction of acute myeloid leukemia (AML).
The company placed the studies on temporary suspension following a report received last week (as reported on February 16, 2021) that a patient who was treated more than five years ago in was diagnosed with AML. The company is investigating the cause of this patient’s AML in order to determine if there is any relationship to the use of the BB305 lentiviral vector used in the manufacture of the LentiGlobin gene therapy. In addition, a case of myelodysplastic syndrome in a patient was reported to the company and is currently being investigated.
The company says that no cases of hematologic malignancy have been reported in any patient who has received treatment with betibeglogene autotemcel for transfusion-dependent β-thalassemia (licensed as Zynteglotm in the European Union and the UK), However, because that gene therapy is also manufactured using the same BB305 lentiviral vector used in the LentiGlobin gene therapy for sickle-cell disease, the company has decided to temporarily suspend marketing of Zynteglo while the AML case is assessed.
The independent safety review board monitoring the company’s studies as well as the US Food and Drug Administration and the European Medicines Agency have been advised of these cases, and bluebird bio says it will continue to work with regulatory agencies to complete its investigation.
Source: bluebird bio