Global Pharma Briefs: News from Pfizer, AstraZeneca, AbbVie, LillyBy
A roundup of news from Canada (Bausch Health, Novo Nordisk), Germany (Merck KGaA), and the US (Pfizer, AstraZeneca, AbbVie, Lilly, UCB, and Century Therapeutics).
Bausch Health To Reduce Debt By $100 M
Bausch Health Companies (formerly Valeant Pharmaceuticals) has announced it will reduce its debt by $100 million through the redemption of outstanding senior secured notes, using cash generated from operations.
Bausch Health will redeem $100 million aggregate principal amount of its outstanding 7.00% senior secured notes due 2024, on March 24, 2021. The company says it will issue an irrevocable notice of redemption for the notes and a copy will be issued to the record holders.
Source: Bausch Health Companies
Novo Nordisk, University of Toronto To Invest $33 M for Diabetes Prevention
Novo Nordisk and the University of Toronto have announced a DKK 200-million ($33-million) investment to establish the Novo Nordisk Network for Healthy Populations to address diabetes and chronic disease prevention.
The network will focus on new ways to support healthier urban populations and will draw on University of Toronto’s expertise in public health research and education programs to address diabetes and other serious chronic diseases. Based at University of Toronto Mississauga, the new network will be a partnership between the Dalla Lana School of Public Health, the Temerty Faculty of Medicine, and the University of Toronto Mississauga.
Novo Nordisk’s is donating DKK 100 million ($16 million) to the network, which is being matched the University of Toronto with a further DKK 100 million ($16 million) in financial and in-kind contributions. In addition, Novo Nordisk has made an additional DKK 10 million ($1.6 million) donation to University of Toronto Banting and Best Diabetes Center in support of discovery research.
Source: Novo Nordisk
Merck KGaA in Pact for AI-Based Neuroscience Research
Merck KGaA has announced a three-year collaboration with the Transylvanian Institute of Neuroscience (TINS), a Cluj-Napoca, Romania-based private non-profit research institute, for improving the understanding of how information processing works in the human brain.
The primary focus of this collaboration between TINS and the Artificial Intelligence (AI) Research Team of Merck KGaA aims to analyze brain activity at different scales and its relevance for computational capabilities. The companies say the joint research project should lead to a better understanding of the computational principles employed by the human brain.
The AI Research Team at Merck KGaA concentrates on exploring neuroscience-inspired approaches to novel methods for AI.
Source: Merck KGaA
Pfizer To Open Multi-Service Hub in Tampa Bay
Pfizer has announced plans to open a global capability hub in Tampa, Florida to bring its services, such as finance, human resources, digital, and sourcing, into a consolidated structure.
Several other pharmaceutical companies have opened capability center in Tampa over the past several years. In 2013, Bristol Myers Squibb chose Tampa for a capability center, which was then followed by Johnson & Johnson in 2015 and Amgen in 2017.
AstraZeneca Withdraws Bladder Cancer Indication for Imfinzi in US
AstraZeneca has announced the voluntary withdrawal in the US of a bladder cancer indication for Imfinzi (durvalumab) for previously treated adult patients with locally advanced or metastatic bladder cancer. This decision was made in consultation with the US Food and Drug Administration (FDA).
In May 2017, Imfinzi was granted accelerated approval in the US based on promising tumor response rates and duration of response data from a Phase I/II trial that evaluated Imfinzi in advanced solid tumors, including previously treated bladder cancer. Continued approval was contingent on results from a Phase III trial in the 1st-line metastatic bladder cancer setting, which did not meet its primary endpoints in 2020. The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements. This withdrawal does not impact the indication outside the US and does not impact other approved Imfinzi indications within or outside the US.
Imfinzi had 2020 sales of $2.0 billion. Imfinzi is approved for other cancer indications: unresectable, Stage III non-small-cell lung cancer (after chemoradiation therapy in the US, Japan, China, the European Union (EU) and other countries; advanced bladder cancer in previously treated patients in several countries; and extensive-stage small-cell lung cancer in the US, the EU, Japan and other countries.
AbbVie, Evolus Settle Intellectual Property Litigation
AbbVie and Medytox, a biopharmaceutical company, have reached a settlement agreement with Evolus, an Irvine, California-based medical-aesthetics company, to resolve all outstanding litigation, including the United States International Trade Commission (ITC) case regarding the sale of Evolus’ Jeuveau (prabotulinumtoxinA-xvfs) for treating frown lines. A California court case filed by Medytox against Evolus will be dismissed.
Under the settlement agreements, AbbVie and Medytox will release all claims against Evolus related to the alleged misappropriation of Medytox’s trade secrets and grant a license to Evolus to continue to commercialize Jeuveau in the US and Nuceiva (prabotulinumtoxinA) for treating frown lines in all other territories in which Evolus has licensing rights. AbbVie and Medytox will receive milestone and royalty payments from Evolus. In addition, Evolus will issue common stock to Medytox.
This agreement follows the final determination of the ITC on December 16, 2020 which found a misappropriation of Medytox’s manufacturing trade secrets and strain of C. botulinum and concluded that a violation of Section 337 of the Tariff Act of 1930 had occurred. The settlement does not affect any legal rights, positions, or proceedings between Medytox and Daewoong Pharmaceutical, a South Korea-based pharmaceutical company, in South Korea and other countries.
Lilly, Welldoc in Pact To Integrate App Capabilities into Insulin Services
Eli Lilly and Company and Welldoc, a Columbia, Maryland-based healthcare technology company, have entered into a collaboration and licensing agreement to integrate Welldoc’s software into Lilly’s connected insulin services, currently in development.
Under the agreement, Lilly and Welldoc will collaborate to create a new version of the BlueStar insulin management solution that integrates insulin dosing data for several Lilly insulins. Lilly will commercialize the pen platform, which will include the new app and Lilly’s connected insulin pen services.
Welldoc’s BlueStar app is a digital health service cleared by the US Food and Drug Administration (FDA) for use by adults with Type 1 or Type 2 diabetes. The app has both prescription and non-prescription features, such as insulin titration support, a bolus calculator and personalized health coaching, and integrates blood-glucose monitoring and continuous glucose monitoring for people who use insulin.
The new app will integrate insulin dosing data for several Lilly insulins. In the first version of the pen platform, a data transfer module will attach to the top of a prefilled, disposable insulin pen. When paired with the compatible app, the module will automatically transfer insulin dosing data. Lilly is also developing a fully disposable connected insulin pen to be used in future versions of the platform.
Lilly plans to submit to the FDA in 2021 for the data-transfer module, and Welldoc plans to submit to the FDA in 2021 for the new app. The prefilled, disposable insulin pen to be used in the first version of the pen platform was approved by the FDA in late 2019. If cleared, Lilly plans to commercialize the initial pen platform in the US and will evaluate opportunities to launch the platform in other geographies. Welldoc will continue to separately commercialize the BlueStar app.
UCB, Microsoft Expand Pact for Drug Discovery, Development
UCB and Microsoft have entered into a new multi-year, strategic collaboration to combine Microsoft’s computational services, cloud, and artificial intelligence (AI) with UCB’s drug discovery and development capabilities.
The collaboration seeks to accelerate the iteration cycles required to explore chemical space and identify other areas where computing power, AI, and science can accelerate the development of treatments for severe diseases in immunology and neurology.
Century Therapeutics Expands with New Operational, Lab Facilities
Century Therapeutics, a Philadelphia, Pennsylvania-based company developing induced pluripotent stem cell (iPSC)-derived cell therapies for cancer, has announced the expansion of its operational and laboratory spaces.
The company is opening 17,000 square feet of mixed office and laboratory space at one location, with an additional 5,000 square feet of space at another location, and has signed a lease for another 25,000 square feet of space, all within the vicinity of its current headquarters in Philadelphia. Century has also committed to 33,000 square feet in life-sciences development space, which is currently under construction in the same region of the city.
Century has also signed a lease to build its own in-house manufacturing facility in Branchburg, New Jersey, with the goal of it being operational later this year (2021). Construction of the 53,000-square-foot space has begun, with preliminary plans underway for a second phase expansion in support of later clinical-stage programs. This capability will supplement existing access to Fujifilm Cellular Dynamics facilities.
In addition to the Pennsylvania and New Jersey locations, Century has a laboratory in Hamilton, Ontario, Canada, and recently opened a Seattle, Washington-based innovation hub.
The company’s iPSC-derived CAR-expressing NK cells and T cells are expected to enter clinical trials for a range of hematological and solid cancers in 2022.
Source: Century Therapeutics