Industry Watch [to 21 March 2015]

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:: Emergent BioSolutions Signs Agreements With Oxford University, GlaxoSmithKline, and NIAID for the Production of an MVA Ebola Zaire Vaccine Candidate
– Emergent has completed proof-of concept manufacturing of an MVA Ebola Zaire vaccine candidate anticipated for use in a Phase 1 clinical study in the UK
– 200L scale production leverages Emergent’s unique expertise and capabilities in MVA-based vaccine product development and manufacturing

GAITHERSBURG, Md., March 16, 2015 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that, under several agreements signed with the University of Oxford, GSK, and the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) respectively, it has manufactured a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ) anticipated for use in a Phase 1 clinical study to be conducted by Professor Adrian Hill of the Jenner Institute. This clinical trial is being supported by a grant from the Wellcome Trust and the UK Department for International Development. The study, which will be conducted in the UK, will evaluate the safety of MVA EBOZ as a heterologous boost to GSK’s Chimp Adenovirus type 3 (ChAd3) Ebola vaccine candidate. Data from an Ebola vaccine human clinical trial published recently in the New England Journal of Medicine suggest the use of an MVA vector as a potential option to boost the levels of ChAd-primed antibody and T-cell responses.

Under these agreements, Emergent performed proof of concept work and manufactured the MVA EBOZ vaccine candidate at a 200L scale in an avian cell line, which had previously been licensed to the company. Manufacturing in this cell line has significant advantages including removing the requirement for eggs from the manufacturing process, consistency of manufactured vaccine lots, and increases in doses delivered. Manufacturing of the first clinical lot of the MVA EBOZ vaccine candidate is now complete and is undergoing acceptability and release testing. The scalable process has the potential to meet the demand for multi-million doses in a few months.

“Emergent is pleased to be collaborating with the Jenner Institute, Oxford University, NIAID, and GSK to advance this MVA EBOZ vaccine candidate into a Phase 1 study,” said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. “Emergent is well-positioned for this unique opportunity given our long standing expertise in MVA product development and our MVA manufacturing capabilities utilizing a proprietary avian cell line to which we hold rights. This is the first time an MVA EBOZ vaccine candidate has been produced at a 200L scale in an avian cell line and we look forward to continuing this collaborative effort to address this public health threat.”

Emergent manufactured the MVA EBOZ vaccine candidate at its Bayview Campus, Baltimore, Maryland manufacturing facility, which is equipped with disposable manufacturing technology such as single use bioreactors that enable production of viral and non-viral products with a quick turnaround. In this facility, Emergent has successfully manufactured product candidates for the company’s pipeline, including MVA based vaccines. This facility has also been designated by the U.S. Department of Health and Human Services as a Center for Innovation in Advanced Development and Manufacturing (CIADM) that helps facilitate advanced development and surge manufacturing of medical countermeasures to address public health threats.

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:: Shantha will provide up to 37 million doses of Shan5™
– Shan5™ pentavalent pediatric vaccine will protect children against 5 pediatric diseases –
Lyon, France – March 17, 2015 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that its affiliate Shantha Biotechnics, located in Hyderabad, India, has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5™ to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India.

In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37 million doses of Shan5™ in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, depending on country needs.

The Shan5™ vaccine will be used in the routine immunization programs of a number of Gavi-supported countries, enabling up to ten million children to receive protection from five pediatric diseases.

“This supply illustrates how Shantha and Sanofi Pasteur meet public health needs”, said Olivier Charmeil, Sanofi Pasteur President and CEO. “We are proud to contribute to making high-quality vaccines accessible to more children in developing countries.”

“We are pleased to have obtained this first tender award since Shan5™ was registered and WHO-prequalified in April 2014”, said Dr. Harish Iyer, CEO, Shantha. “As one of the strategic manufacturing platforms for Sanofi Pasteur, Shantha is delivering on its commitment to serve Indian health needs and provide access in underserved vaccine markets.”

About Shan5™
Shan5™ is a fully-liquid five-in-one, convenient, safe and high-quality vaccine that provides effective protection for children from 6 weeks of age against five diseases: diphtheria, tetanus, pertussis, Hib and hepatitis B (DTP – HepB – Hib). Shan5™ vaccine has been developed and is produced at Shantha’s state-of-the-art manufacturing facility in Hyderabad, India, and received Marketing Authorization in India in March 2014. In April 2014, Shan5™ was prequalified by the World Health Organization (WHO).

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:: A New Therapeutic Vaccine Successfully Developed Against Rabies
Mar 16, 2015
Yisheng Biopharma Co., Ltd. (“Yisheng Biopharma”), a biopharmaceutical company focusing on the research, development, manufacturing, sales and marketing of vaccine products, announced that a new vaccine for the post exposure treatment of the rabies infection was entering human…