Global Pharma Briefs: News from J&J, BMS, AbbVie and Bayer
A roundup of news from Africa (J&J), Germany (Bayer, BioNTech), India (BMS, Syngene), Poland (Moderna), the UK (Clarivate) and the US (Biogen, AbbVie, others).
J&J Supplies WHO with Vaccine To Prevent Spread of Ebola in West Africa
The World Health Organization (WHO) and the government of Sierra Leone have begun administering Johnson & Johnson’s (J&J) Ebola vaccine regimen as part of a WHO early-access clinical program aimed at preventing further spread of Ebola in West Africa.
The vaccine regimen, developed by the Janssen Pharmaceutical Companies of J&J in collaboration with Bavarian Nordic, a Kvistgaard, Denmark-based company, is being donated to WHO by Janssen for the purposes of the early-access clinical program.
The J&J Ebola vaccine regimen, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo), was granted WHO prequalification in April 2021. This follows marketing authorization for the vaccine which by the European Commission in July 2020 for the active immunization for the prevention of Ebola Virus Disease caused by the Zaire ebolavirus species in individuals aged one year and above. WHO prequalification is often a prerequisite for national registrations of new vaccines and medicines in developing countries.
Health authorities in Guinea, West Africa officially declared a new Ebola outbreak in February 2021 after the country experienced its first cases of disease since the end of the 2014-2016 Ebola outbreak.
Source: Johnson & Johnson
EMA, Brazilian Regulatory Agency In Info-Sharing Agreement
The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety have signed a confidentiality arrangement with the Agência Nacional de Vigilância Sanitária (ANVISA), the Brazilian national health surveillance agency.
The arrangement allows the agencies to exchange information on the safety, quality, and efficacy of both human and veterinary medicines (already authorized or under evaluation) as well as information on inspections, regulatory guidance and legislation.
The confidentiality arrangement, which came into effect on March 26, 2021, is valid for an indefinite period of time and does not require a renewal. It provides the framework under which EU and Brazilian authorities will develop their regulatory cooperation.
The EMA notes that confidentiality arrangements of this type contribute to timely information exchanges on fast emerging issues with global impact such as shortages of medicines, quality concerns or safety questions and are the corner stone on global cooperation, for example in crises such as the current COVID-19 pandemic.
Source: European Medicines Agency
Bayer Invests $90 M in Digital Health Company Ada Health
Bayer has invested $90 million in Ada Health, a Berlin, Germany-based digital health company, through Leaps by Bayer, the investment arm of Bayer AG, by leading a Series B financing round.
Ada Health has developed an artificial intelligence-based health assessment and care navigation platform that helps users to understand their symptoms, to identify and differentiate conditions, and to navigate care. Ada’s consumer symptom assessment app has over 23 million assessments completed since its global launch.
In addition, Bayer and Ada Health are in discussions about entering into a longer-term strategic partnership.
BioNTech Publishes First Sustainability Report
BioNTech, a Mainz, Germany-based immunotherapy company, has published its first Sustainability Report
The company aims to become climate neutral by 2030. Additionally, 85% of its total energy consumption is covered by renewable electricity, climate neutral natural gas, and climate-neutral district heating.
BMS, Syngene Extend Research Pact Until 2030
Bristol-Myers Squibb (BMS) and Syngene International, a Biocon subsidiary and Bangalore, India-headquartered contract research organization, have extended their ongoing research collaboration through the end of 2030.
The collaboration will expand the breadth of drug-discovery research conducted, including chemistry, biology, drug metabolism, and pharmacokinetics, as well as translational medicine research and pharmaceutical development, including chemical process development and analytical sciences, in the coming years. The extension envisions a 40% increase in the number of scientists and the addition of a new 50,000-square-foot dedicated laboratory space.
Syngene and BMS have worked together since 1998. The research campus, known as Biocon BMS Research Center (BBRC), Syngene’s first dedicated R&D center, was fully commissioned in 2009.
Moderna To Establish International Business Services Hub in Poland
Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, plans to establish an international business services hub in Warsaw, Poland, as the company continues to build out a global infrastructure.
The Moderna International Business Services (MIBS) Center complements the six commercial legal entities that have already been established across Europe. The MIBS Center will serve Moderna’s international business by providing functions such as finance, pharmacovigilance, human resources, and digital services.
The center is expected to employ approximately 160 staff when fully operational. Moderna plans to start center operations in the third quarter of this year (2021).
Clarivate To Acquire ProQuest for $5.3 Bn
Clarivate, a provider of scientific, patent, and pharmaceutical and biotechnology business intelligence, has agreed to acquire ProQuest, a global software, data, and analytics provider, from Cambridge Information Group, an investment firm, and other partners for $5.3 billion.
ProQuest delivers content and technology services to over 25,000 academic, corporate, and research organizations in more than 150 countries. The acquisition will establish Clarivate as a provider of end-to-end research intelligence services and expand its content and data offerings as the addition of ProQuest will materially complement the Clarivate Research Intelligence Cloud.
The $5.3-billion investment includes refinancing of ProQuest debt. The consideration for the acquisition is approximately $4.0 billion in cash and $1.3 billion of equity. The transaction, which is subject to customary closing conditions, including regulatory approvals, is expected to close during the third quarter of 2021.
Allergan Aesthetics To Acquire Soliton for $550 M
Allergan Aesthetics, an AbbVie company, has agreed to acquire Soliton, a Houston, Texas-based medical-device company, which includes Resonic, Soliton’s rapid-acoustic pulse device, for $550 million.
The acquisition of Soliton expands and complements Allergan Aesthetics’ body-contouring treatment portfolio that includes CoolSculpting Elite. Resonic recently received US Food and Drug Administration (FDA) 510(k) clearance and is a non-invasive treatment for the short-term improvement in the appearance of cellulite. Resonic has also received FDA 510(k) clearance for use in conjunction with laser for tattoo removal and has demonstrated clinical results in fibrotic scars.
Under the transaction, Allergan Aesthetics will pay $22.60 per share in cash for each outstanding share of Soliton. Soliton’s enterprise value for the transaction is approximately $550 million and was approved by the Boards of Directors of both companies. The transaction is subject to customary closing conditions, including clearance by the US antitrust authorities under the Hart-Scott-Rodino Act and approval of Soliton’s shareholders.
Biogen, Ginkgo Bioworks in $120-M Pact for Gene-Therapy Mfg Platform
Biogen and Ginkgo Bioworks, a Boston, Massachusetts-based biotechnology company, have entered into an agreement to develop an adeno-associated virus (AAV)-based production platform, in a deal worth up to $120 million ($5 million upfront and $115 million in potential milestones).
Under the agreement, Biogen will receive access to Ginkgo’s proprietary cell-programming platform and capabilities. Ginkgo will use its bioengineering facilities and resources with the aim of enhancing the AAV production titers of Biogen’s gene-therapy manufacturing processes. Ginkgo will receive an upfront payment of $5 million and is eligible for milestone payments up to an additional $115 million should the collaboration programs achieve certain research, developmental, and commercial milestones.
Biogen To Acquire TMS’ Stroke Drug Candidate in $353-M Deal
Biogen has exercised its option to acquire TMS-007, an investigational drug for acute ischemic stroke, from TMS Co., a Tokyo-headquartered clinical-stage biopharmaceutical company, in a $353-million deal ($18 million upfront and $335 million in potential milestones).
Biogen’s decision to acquire TMS-007 was based on positive data from a Phase IIa study.
Biogen will make a one-time $18-million payment as part of the acquisition of TMS-007. TMS is eligible to receive up to an additional $335 million in potential post-acquisition development and commercial payments should TMS-007 achieve certain developmental milestones and sales thresholds. TMS is also eligible to receive tiered royalties in the high single digits to sub-teen percentages on annual worldwide net sales. Biogen will be solely responsible for the costs and expenses related to the development, manufacturing and commercialization of TMS-007 following the acquisition.
Biogen is currently evaluating the next steps for the clinical development of TMS-007, including plans for global studies. Final data results from the Phase IIa study are expected to be communicated at a future scientific forum.
BlueRock Therapeutics, Senti Bio in Cell-Therapy Pact
BlueRock Therapeutics, a developer of cell therapies in neurology, cardiology and immunology and a wholly owned and independently operated subsidiary of Bayer, and Senti Biosciences, Inc. (Senti Bio), a South San Francisco, California gene-circuit company, have partnered in a collaboration and option agreement to apply Senti Bio’s gene-circuit technology to the development of cell therapies for a potentially broad array of therapeutic areas.
Senti Bio is developing proprietary engineered gene circuits designed to reprogram cells to sense inputs, compute decisions, and respond with outputs. BlueRock Therapeutics develops engineered cell therapies using a proprietary cell+gene platform.
Under the agreement, Senti Bio will be responsible for designing, building, and testing cell state- and disease- specific smart sensors and regulator dials for use in BlueRock Therapeutics’ regenerative medicine product candidates. Smart Sensors are gene circuits designed to precisely detect cell type or disease environments. Regulator Dials are gene circuits designed to enable the precise tuning of therapeutic activity from a cell or gene therapy product.
BlueRock Therapeutics will receive the option to license gene circuits emerging from the collaboration for cell therapy products in specified indications. Upon option exercise, BlueRock Therapeutics will be responsible for conducting preclinical, clinical and commercialization activities for any cell therapy candidates that incorporate Senti Bio’s licensed gene circuits.
FDA Holds Forum for Regulatory Advancements in Public Health
The US Food and Drug Administration (FDA) held a forum from May 26 to May 27, 2021 to highlight regulatory science advancements in protecting and promoting public health.
The 2021 FDA Science Forum, Science as the Foundation for Protecting and Promoting Public Health, is for stakeholders to engage with FDA experts about a variety of research topics on public health.
The event is hosted biannually by the FDA’s Office of the Chief Scientist, which provides leadership and support for the FDA’s regulatory science and innovation initiatives through cross-agency coordination and collaboration. It will showcase the collaborative efforts of the more than 11,000 scientists at the FDA as well as invited nationally renowned scientists, including Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases.
Key topic areas that FDA scientists and external presenters will discuss include: (1) improving clinical and post-market evaluation; (2) tools to effectively use Big Data; (3) patient and consumer centricity; (4) product development and manufacturing; (5) use of novel technologies; (6) medical countermeasures, infectious disease, and pathogen reduction technologies; (7) food and cosmetic safety; and (8) substance use, misuse, and addiction.
Source: US Food and Drug Administration