Breaking News

Emergent BioSolutions Inc. (EBS) announced an agreement whereby Emergent will deploy its contract development and manufacturing services to support the manufacturing of Johnson & Johnson's (JNJ) lead vaccine candidate for COVID-19 that leverages the AdVac and PER.C6 technologies from the Janssen Pharmaceutical Companies of Johnson & Johnson. Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions, stated, "When mission-driven organizations combine talents and capabilities, potential solutions to serious issues like COVID-19 become more within reach to benefit patients. We are proud of our collaboration with Johnson & Johnson and are equally committed to our longstanding relationship with the U.S. government. At a time like this, we all need to be working together to achieve maximum results for public health. Emergent is committed to our mission - to protect and enhance life - by advancing our own therapies and helping partner companies advance their programs as well." Under the agreement, valued at approximately $135 million, Emergent will provide drug substance manufacturing services with its molecule-to-market CDMO offering, supported by investments from Johnson & Johnson beginning in 2020, and will reserve certain large-scale manufacturing capacity to pave the way for commercial manufacturing of Janssen's adenovirus-based COVID-19 vaccine beginning in 2021. To support Johnson & Johnson's goal of supplying one billion doses of a COVID-19 vaccine, a long-term commercial manufacturing agreement is under negotiation for large-scale drug substance manufacturing anticipated to begin in 2021. Large-scale manufacturing of drug substance for Johnson & Johnson's vaccine candidate will be done at Emergent's Baltimore Bayview facility, a Center for Innovation in Advanced Development and Manufacturing (CIADM) designed for rapid manufacturing of vaccines and treatments in large quantities during public health emergencies. Emergent's CIADM is a result of a public-private partnership with the U.S. Department of Health and Human Services (HHS).

Emergent BioSolutions (EBS) announced the appointment of Karen Smith as CMO with responsibility for leading and further establishing Emergent's global integrated capability in clinical development, medical affairs and regulatory affairs. Smith and her teams will work in partnership with the business units to advance the company's portfolio of products in development. She will be a member of the executive management team reporting to the president and CEO. Smith has previously served as CMO for Jazz Pharmaceuticals (JAZZ) and has held senior executive positions at various other pharmaceutical and biotechnology companies.

Emergent BioSolutions announced that it has entered into a formal partnership with the U.S. government to expedite development of a plasma-derived therapy for patients with coronavirus disease 2019 . Emergent has received $14.5 million from the Biomedical Advanced Research and Development Authority , part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services, in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March. COVID-HIG is a candidate human hyperimmune product being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.Emergent and the National Institute of Allergy and Infectious Diseases , part of the National Institutes of Health, have agreed to incorporate the company's COVID-HIG product candidate into one of NIAID's clinical studies for assessment of treatments for COVID-19 once clinical material is available, and the study begins. Emergent has already initiated plasma screening and collection of human plasma with antibodies to SARS-CoV-2 that will be further purified and concentrated through manufacturing of COVID-HIG.

Emergent BioSolutions announced an agreement with Novavax (NVAX) whereby Emergent will provide molecule-to-market contract development and manufacturing, CDMO, services to produce Novavax's NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M(TM) adjuvant. Novavax recently announced that NanoFlu met all primary objectives in its Phase 3 clinical trial evaluating immunogenicity and safety in adults aged 65 and older. "Emergent is pleased to expand our collaboration with Novavax to include large-scale production of NanoFlu, their novel influenza vaccine," said Syed T. Husain, SVP and CDMO business unit head at Emergent BioSolutions. "Our flexible and integrated CDMO offerings allow us to work with expedited timelines, execute on simultaneous engagements, and serve varying needs and approaches of customers like Novavax. As a trusted partner, we are committed to supporting Novavax's goals to advance their influenza program while maintaining the option to allocate capacity for a potential scaled-up COVID-19 program." Under the terms of the agreement, Emergent will provide drug substance manufacturing services, including technology transfer and process validation and performance qualification to pave the way for commercial manufacturing. This work will be conducted at Emergent's Baltimore Bayview location, which is designated by the U.S. Department of Health and Human Services, HHS as a Center for Innovation in Advanced Development and Manufacturing, CIADM, and where the COVID-19 experimental vaccine candidate of Novavax is also being produced. The collaboration allows for flexibility to deploy capacity towards an expanded COVID-19 program.