Global Pharma Briefs: News from J&J, Viatris, Teva, and GSKBy
A roundup of news from Germany (CureVac, Merck KGaA), Israel (Teva, Bioeq), the UK (GSK), and the US (J&J, Viatris, Sanofi, Teva, MacroGenics, and Senti Biosciences).
Merck KGaA, BioMed X Launch Oncology Research Program
Merck KGaA and BioMed X, a Heidelberg, Germany-based independent research institute, have formed a new research program that will explore the role of extrachromosomal DNA (ecDNA) in cancer. The pact will complement the research of two ongoing oncology programs at BioMed X in the fields of DNA damage response and RNA splicing.
The key aim of the new project will be to generate an atlas of ecDNA in human cancer tissues to investigate how oncogenes in ecDNA could contribute to tumorigenesis, disease progression, tumor heterogeneity, metastasis, and treatment resistance and to develop therapeutic strategies based on oncogenic alterations in ecDNA.
Source: BioMed X
Merck KGaA, Inbrain in Pact for Bioelectronic Therapies
Merck KGaA and Innervia Bioelectronics, a start-up and subsidiary of Inbrain Neuroelectronics, a Barcelona, Spain-based bioelectronics company, have entered into a collaboration to co-develop graphene-based bioelectronic vagus nerve therapies targeting chronic diseases.
Merck KGaA will contribute its bioelectronic research facilities to develop devices. Innervia will add its technical expertise in the development of graphene interfaces, device development, and signal processing for clinical applications. Initial work will focus on inflammatory, metabolic, and endocrine disorders.
Source: Merck KGaA
CureVac Appoints New COO and Mfg Head
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, appointed Dr. Malte Greune as Chief Operating Officer (COO), effective July 1, 2021. In this position, Dr. Greune will head, with others, CureVac’s clinical and commercial manufacturing activities.
Dr. Greune joins CureVac with experience in the global pharmaceutical industry, including manufacturing of vaccines and fill–finish of biologics.
Dr. Florian von der Mülbe, company co-founder and Chief Production Officer, will now focus his production expertise exclusively on the expansion and accelerated development of The RNA Printer, CureVac’s proprietary solution for mobile, autonomous and automated manufacturing of GMP-grade RNA vaccines and therapeutics.
Teva, Bioeq in Biosimilar Pact
Teva Pharmaceutical Industries and Bioeq, a Swiss bio/pharmaceutical joint venture between the Polpharma Biologics Group and the Strüngmann Group, have formed a strategic partnership for the exclusive commercialization in Europe, Canada, Israel and New Zealand of Bioeq’s FYB201, a biosimilar candidate to Roche’s Lucentis (ranibizumab), a drug for treating macular degeneration and which had 2020 global sales of CHF 1.4 billion ($1.6 billion).
Bioeq in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer, Formycon.
Under the agreement, Bioeq will be responsible for the development, registration, and supply of the biosimilar while Teva will be responsible for commercializing the product. Teva and Bioeq will share revenue from the commercialization of the biosimilar.
Source: Teva Pharmaceutical Industries
Viiv Healthcare, Halozyme in $740-M Drug-Delivery Pact
ViiV Healthcare, a specialist HIV company of GlaxoSmithKline, Pfizer, and Shionogi, and Halozyme Therapeutics, a San Diego, California-based company, have entered into a global collaboration and license agreement for Halozyme’s Enhanze drug0delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV, in a deal worth up to $215 million ($40 million upfront and up to $700 million in milestones).
Halozyme’s technology provides the opportunity to develop ultra-long-acting medicines (dosing intervals of three months or longer). Plans are underway to initiate the first experiments with the technology by the end of 2021 for investigational, long-acting cabotegravir, an HIV drug, which is currently administered every two months.
Under the agreement, ViiV Healthcare will make an upfront payment of $40 million to Halozyme for the exclusive license to four HIV small- and large-molecule targets and is obligated to make potential future payments of up to $175 million in development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain specified sales milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialized medicines using the technology.
GSK, Siemens Partner for Digital Twin of Vaccine Mfg
GlaxoSmithKline (GSK) is working with Siemens, a process automation company, and Atos, a digital and technology company, for the use of a “digital twin,” a virtual replica for building simulation of the vaccine-manufacturing process.
The digital twin enables the ability to simulate, monitor closely, anticipate failures, and optimize quality and self-learning. The performance data obtained are fed back into the development process and helps optimize products and processes at an early stage.
After completion of a proof-of-concept project with Siemens and Atos focusing on the production of particles of a vaccine adjuvant, digital twins are being gradually implemented into GSK’s development activities. In addition to production, GSK says it is exploring the potential of a digital twin to transform the process of vaccine R&D further upstream.
J&J Reaches Opioid Settlement with New York State
Johnson & Johnson (J&J) and its US-based Janssen Pharmaceutical Companies have settled an agreement with New York State and its participating subdivisions resolving opioid-related claims against the company.
The settlement will provide New York and its participating subdivisions with up to $263 million in funding to address opioid-related issues as well as reimbursement for attorney fees and costs. With this agreement, J&J is removed from a trial that had been scheduled to begin in Suffolk County on June 28, 2021.
The company notes that the settlement is not an admission of liability or wrongdoing is consistent with the terms of a previously announced$5-billion all-in settlement agreement in principle for the resolution of opioid lawsuits and claims by states, cities, counties, and tribal governments. The dollar amount to be received by New York State is the pro-rated share it would have received under the broader agreement in principle, which will be deducted from the all-in settlement amount.
Source: Johnson & Johnson
Viatris Gains Favorable Ruling in EpiPen Class Action
A federal district court in Kansas has ruled in favor of Viatris, the new company formed from the combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business, on Mylan’s summary judgment motion in a class-action related to Viatris’ EpiPen Auto-Injector (epinephrine injection), used blocking the progression of life-threatening allergic responses, including Vitara’s anaphylaxis.
The company reported that the court’s decision dismissed all of the plaintiffs’ claims under the federal RICO statute, which include claims asserted against Mylan’s former CEO Heather Bresch. The court also dismissed claims alleging that Mylan foreclosed branded competition through rebate arrangements with pharmacy benefit managers.
The only remaining claim in this class action pertains to a patent settlement between Pfizer and Teva and other alleged actions regarding the launch of Teva’s generic epinephrine auto-injector.
This ruling follows a December 2020 decision by the same court granting summary judgment in Viatris’ favor in a separate lawsuit brought by Sanofi related to EpiPen in which the court also rejected all of Sanofi’s claims that Mylan engaged in anticompetitive practices to market EpiPen.
Teva Initiates Voluntary Recall of One Lot of Cancer Medication
Teva Pharmaceuticals has initiated a voluntary recall of one lot of topotecan injection 4 mg/4 mL (1 mg/mL) to the retail/institutional level in the US due to the presence of particulate matter.
This voluntary recall was initiated based on a complaint received from a pharmacy after a single glass particle was observed inside one vial. After further examination of the complaint sample, two other particulates were found and identified as one grey silicone particle and one translucent, colorless cotton fiber.
Topotecan injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy and for patients with small-cell lung cancer platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. It is also indicated for treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin. It is packaged in 4 mg/4 mL single-use vials.
Source: Teva Pharmaceuticals
Senti Bio Plans New Cell-Therapy Mfg Facility
Senti Biosciences (Senti Bio), a South San Francisco, California gene-circuit company, has signed a lease agreement for a property in Alameda, California for the build-out of a wholly-owned cell-therapy manufacturing facility.
Senti Bio is designing the 92,000-square-foot facility with the goal of providing clinical and commercial-scale manufacturing for multiple allogeneic, or “off-the-shelf,” chimeric antigen receptor (CAR) natural killer (NK) cell product candidates.
The facility is being designed to support planned initial clinical trials for Senti Bio’s product candidates, SENTI-202, for acute myeloid leukemia and SENTI-301 for hepatocellular carcinoma, which are both preclinical-stage allogeneic CAR-NK cell candidates engineered with gene-circuit technologies.
This manufacturing facility is being designed to give Senti Bio the ability to isolate NK cells, engineer these cells with proprietary gene circuits, perform cell-culture expansion in large batches, and cryopreserve and store the final cGMP products.
Source: Senti Biosciences
MacroGenics, Zai Lab in $1.45-Bn Pact for Bispecific Antibodies
MacroGenics, a Rockville, Maryland-based clinical-stage bio/pharmaceutical company, and Zai Lab, a Shanghai-based bio/pharmaceutical company, have entered into an exclusive collaboration and license agreement for up to four immuno-oncology molecules, in a deal worth up to $1.45 billion ($55 million in initial consideration and up to $1.4 billion in potential milestones).
The first collaboration program covers a lead research molecule that incorporates MacroGenics’ proprietary bispecifc antibody platform (DART) and binds CD3 and an undisclosed target that is expressed in multiple solid tumors. The CD3 component of the DART bispecific molecule has been designed to minimize cytokine-release syndrome while maintaining anti-tumor cytolytic activity. The second collaboration program will cover a target to be designated by MacroGenics. For both molecules, Zai receives commercial rights in Greater China, Japan, and Korea, and MacroGenics receives commercial rights in all other territories. For the lead molecule, Zai Lab receives an option upon reaching a predefined clinical milestone to convert the regional arrangement into a global 50/50 profit share.
Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules. For the four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies.
Under the agreement, MacroGenics receives initial consideration from Zai Lab of $55 million, including an upfront payment of $25 million and an equity investment of $30 million in MacroGenics’ common stock at $31.30 per share. In addition, MacroGenics is eligible to receive up to 1.4 billion in potential development, regulatory and commercial milestone payments for the four programs. If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in Zai Lab’s territories.
Sanofi, SRI International in AI-Based Drug Research Pact
Sanofi and SRI International, a Menlo Park, California-based non-profit research institute, have entered into a pact to use SRI’s artificial intelligence (AI)-guided synthetic-chemistry system to discover and develop candidates in multiple drug-discovery programs at Sanofi.
SRI’s SynFini platform combines AI and automation to accelerate small-molecule drug discovery and development. The platform comprises of three components that work to automate synthetic route design, reaction screening and optimization, and production of target molecules.
The collaboration will also use SRI’s recently implemented AI-guided molecular design tool for multi-parametric optimization in hit-to-lead and lead optimization.
Source: SRI International