Sanofi Pasteur signs research deal for Zika vaccine with US Army


Sanofi has announced a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate.  Under the deal, WRAIR will transfer its Zika purified inactivated virus (ZPIV) vaccine technology to Sanofi Pasteur, opening the door for a broader collaboration with the U.S. government.

The agreement also includes Sanofi Pasteur’s production of clinical material in compliance with current GMP (Good Manufacturing Practices) to support phase II testing, optimization of the upstream process to improve production yields, and characterization of the vaccine product.  Sanofi Pasteur will also create a clinical development and regulatory strategy.

Data published last month in Nature,showed that a single dose of WRAIR’s experimental vaccine gave 100 percent protection in mice against the Zika virus. Under the deal, WRAIR will share data related to the development of immunologic assays designed to measure neutralising antibody responses following natural infection and immunisation with the vaccine candidate, biologic samples generated during the performance of non-human primate studies and biologic samples generated during the performance of human safety and immunogenicity studies using ZPIV

“In addition to exploring our own vaccine technology used in our new dengue fever vaccine, we are looking at other pathways to get a Zika vaccine into the clinic as soon as possible. Therefore, this exciting collaboration with the WRAIR creates the opportunity to rapidly move forward,” said David Loew, Executive Vice President, Head of Sanofi Pasteur.

John Shiver, PhD, Sr. VP for R&D at Sanofi Pasteur, explained that while simultaneously working on the WRAIR technology, Sanofi Pasteur is performing pre-clinical studies, utilizing a technology previously and successfully developed for both its dengue fever and Japanese encephalitis vaccines.

However, he continued, since that pathway will take longer to get a Zika vaccine candidate into the clinic, Sanofi Pasteur has been exploring partnerships with external experts to rapidly advance a vaccine candidate. “We’re looking at this from both a short- and long-term perspective, collaborating to get into the clinic quicker to provide a vaccine in response to the current emergency, and adapting our own technology to ensure production capacity of a vaccine for years to come.”   

Mylan Launches generic version of Merck’s Temodar®


Mylan N.V. has announced the U.S. launch of Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, which is a generic version of Merck’s Temodar®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Temozolomide Capsules are indicated for the treatment of adult patients with newly diagnosed cancerous tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, had U.S. sales of approximately $176.5 million for the 12 months ending May 31, 2016, according to IMS Health

Currently, Mylan has 246 ANDAs pending FDA approval representing $107.4 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.