6 min read

Emergent BioSolutions Secures Multi-Year Development and Manufacturing Agreement with Providence Therapeutics for its mRNA COVID-19 Vaccine Candidate, PTX-COVID19-B

By Emergent CDMO on Sep 14, 2021 9:09:49 AM

  • Total baseline value for Emergent is approximately $90 million USD, further expanding the collaboration between the companies, which began in February 2021

GAITHERSBURG, Md. and CALGARY, Alberta, Sept. 14, 2021 (GLOBE NEWSWIRE)-- Emergent BioSolutions Inc. (NYSE:EBS) and Providence Therapeutics today announced they have entered into a five-year contract development and manufacturing (CDMO) services agreement spanning Emergent’s integrated capabilities, including development services, bulk drug substance formulation and drug product manufacturing, to support Providence’s COVID-19 messenger RNA (mRNA) vaccine development. In 2022, Emergent will manufacture tens of millions of doses of PTX-COVID19-B drug product, as well as batches of PTX-COVID19-B formulated bulk drug substance with the potential to yield hundreds of millions more doses, for global populations in need of pandemic relief.

Topics: COVID-19 news
4 min read

Emergent BioSolutions on Track with Respect to COVID-19 Contractual Commitments

By Emergent CDMO on Apr 4, 2021 11:45:00 PM

EMERGENT BIOSOLUTIONS ON TRACK WITH RESPECT TO COVID-19 CONTRACTUAL COMMITMENTS; RECEIVES MODIFIED TASK ORDER FROM THE U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES TO SUPPORT THE OPPORTUNITY FOR FURTHER EXPANSION OF MANUFACTURING CAPACITY FOR JOHNSON & JOHNSON’S COVID-19 VACCINE

  • HHS has increased Emergent’s task order by $23 million to purchase additional biologics manufacturing equipment
  • Reaffirms 2021 financial guidance

GAITHERSBURG, Md., April 04, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the Company continues to be on track with its manufacturing agreements related to COVID-19 vaccines and confirmed that there are no changes to its financial guidance for 2021. In addition, the Company received a contract modification to increase the original task order by $23 million from Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS).

Topics: COVID-19 news

Emergent Enters Into a New CDMO Agreement with Providence Therapeutics to Provide Fill/Finish Drug Product Manufacturing

By Catherine Hanley on Feb 12, 2021 2:00:00 PM

Emergent has entered into a new CDMO agreement with Providence Therapeutics to provide fill/finish drug product manufacturing services for their investigational mRNA vaccine candidate (PTX-COVID19-B) at its facility in Winnipeg, Manitoba, Canada. This is Emergent's 8th COVID-19 CDMO collaboration, and first outside of the U.S. in Canada.

Topics: COVID-19 news
6 min read

Humanigen and Emergent BioSolutions Announce Contract Development and Manufacturing Agreement for Phase 3 COVID-19 Therapeutic Candidate Lenzilumab™

By Catherine Hanley on Jan 25, 2021 9:23:46 AM

GAITHERSBURG, MD. and BURLINGAME, CA. – Jan. 25, 2021  Emergent BioSolutions Inc. (NYSE:EBS) (Emergent) and Humanigen, Inc. (NASDAQ:HGEN) (Humanigen) today announced that they have entered into a contract development and manufacturing (CDMO) services agreement to accelerate the drug product manufacturing of lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called “cytokine storm.” Emergent will provide access to manufacturing capacity reserved for and provided by the U.S. government under Humanigen’s Cooperative Research and Development Agreement (CRADA) with the Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services. Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19. Humanigen intends to file for emergency use authorization (EUA) in the first quarter of 2021.

Topics: COVID-19 news
6 min read

Emergent BioSolutions Signs Agreement with AstraZeneca to Expand Manufacturing for COVID-19 Vaccine Candidate

By Catherine Hanley on Jul 27, 2020 8:56:21 AM

  • Emergent will provide contract development and manufacturing services beginning in 2020 to produce drug substance at large scale for commercial supply
  • Agreement is valued at approximately $174 million through 2021 and brings the total AstraZeneca commitment to $261 million
  • Parties may enter into additional commercial manufacturing commitments as the candidate progresses over three years through Emergent’s flexible capacity deployment model

GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation.

Topics: COVID-19 news
5 min read

Emergent BioSolutions Signs Five-Year Agreement for Large-Scale Drug Substance Manufacturing for Johnson & Johnson’s Lead COVID-19 Vaccine Candidate

By Catherine Hanley on Jul 6, 2020 9:35:00 AM

  • Emergent will provide contract development and manufacturing services beginning in 2021 to produce drug substance at large scale for commercial manufacturing with first two years valued at approximately $480 million
  • For the remaining three years beginning in 2023, Emergent will provide a flexible capacity deployment model to support annual dose requirements

GAITHERSBURG, Md., July 06, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced a five-year manufacturing services agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for large-scale drug substance manufacturing for Johnson & Johnson’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant based on the AdVac® technology. Emergent will provide contract development and manufacturing (CDMO) services to produce drug substance at large scale over five years, valued at approximately $480 million for the first two years.

Topics: COVID-19 news

On the Radio: Sean Kirk Discusses Emergent's Role in Supporting COVID-19 Vaccine Candidates

By Catherine Hanley on Jun 26, 2020 1:40:26 PM

Washington Wonk-FM's Stacy Lyn recently spoke to Emergent Executive Vice President, Manufacturing and Technical Operations Sean Kirk regarding the company's recent partnerships and ongoing efforts to support COVID-19 vaccine candidates.  

Listen to the full interview here. 

Topics: news
4 min read

Emergent BioSolutions to Invest $75 Million in Canton Site and Expand Viral Vector and Gene Therapy Capability

By Catherine Hanley on Jun 18, 2020 9:15:00 AM

  • Company acquires property adjacent to its Canton, Massachusetts live viral drug substance development and manufacturing facility to increase campus footprint and build out advanced therapy capability
  • Advanced therapy CDMO drug substance manufacturing services expected to be available beginning in 2023
  • Expansion will enable molecule-to-market CDMO services in viral vector and gene therapy utilizing Emergent’s integrated network with development services and drug product manufacturing to be offered out of its Gaithersburg and Rockville, Maryland facilities, respectively   

GAITHERSBURG, Md., June 18, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced that it will further strengthen its contract development and manufacturing (CDMO) capabilities by expanding into viral vector and gene therapy. The company will invest $75 million in its Canton, Massachusetts facility, which is focused on the development and manufacturing of drug substance for live viral vaccines, including the company’s smallpox vaccine.

Topics: news
4 min read

Emergent BioSolutions Signs Agreement with Novavax to Manufacture NanoFlu™

By Catherine Hanley on Mar 31, 2020 5:00:00 PM

  • CDMO agreement for NanoFlu to support pathway to licensure
  • Expanded collaboration now includes NanoFlu and COVID-19 vaccine candidate

GAITHERSBURG, Md., March 31, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced an agreement with Novavax, Inc. (NASDAQ: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™ 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.

Topics: news

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