MedImmune

Founded in 1988.

January 29, 2004. Labs rush to cultivate bird flu vaccine Reverse genetics allows creation of weakened virus , Sabin Russell, Chronicle Medical Writer

The creation of a genetically engineered flu vaccine relies on techniques first developed in university laboratories such as that of Peter Palese, chairman of Microbiology at the Mount Sinai School of Medicine in New York. Major advances were later accomplished by Dr. Yoshihiro Kawaoka of the University of Wisconsin and by Dr. Robert Webster of St. Jude Children’s Hospital in Memphis.

Much of the know-how in reverse genetics for flu vaccine is covered under patents held by MedImmune Inc., a Gaithersburg, Md., biotechnology company. It acquired those rights when it purchased Mountain View vaccine maker Aviron in 2002 in a stock deal valued at $1.5 billion. Aviron had purchased the rights from Mount Sinai in 1993.

Under an agreement struck with the World Health Organization last year, MedImmune has agreed to license the reverse genetics technology to other drugmakers to test new vaccines in the event of a pandemic. MedImmune spokeswoman Jamie Lacey said Wednesday that the company had offered licenses “for very reasonable terms” to vaccine makers “as part of our commitment to public health.”

December 7, 2005. MedImmune Expands Patent Estate for Reverse Genetics with New Rights from Mount Sinai School of Medicine

July 13, 2006, MedImmune cleared to offer Flumist the reverse genetics treatment, Gregory Roumeliotis, Pharmatechnologist.

In a landmark decision that will speed up the manufacturing of influenza vaccines, the US Food and Drug Administration (FDA) has approved the use of reverse genetics technology in the production of MedImmune’s seasonal intranasal vaccine Flumist and its refrigerator-safe version, CAIV-T, allowing them to be the first on the market using this technique.

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Reverse genetics technology, also known as “plasmid rescue” enhances the safety, specificity, reliability and efficiency with which new vaccine strains can be produced and so has the potential to transform the face of the vaccine manufacturing industry. Most influenza vaccine manufacturing companies and governmental agencies are now using reverse genetics technology in their development of pandemic vaccine candidates because it allows them to avoid working directly with the infectious, circulating pandemic strains.

But as the owner or exclusive licensee of the key patent estates for use of the reverse genetics technology in human influenza vaccines and the FDA approval now in the bag, MedImmune has the upper hand over the competition, offering other influenza vaccine manufacturers non-exclusive licences to this technology for use in manufacturing seasonal or pandemic vaccines. “No licence agreement has been made yet but we are in touch with several parties,” MedImmune spokeswoman Clarencia Stephen told In-PharmaTechnologist.com.

January 9, 2007, MedImmune, Inc. v. Genentech, Inc. decided.

March 29, 2007. MedImmune Licenses Reverse Genetics Technology to sanofi pasteur for Use in Influenza Vaccine Production.

April 16, 2007, Carl Icahn pressured MedImmune Board to sell the company.

April 23, 2007, AstraZeneco offers to buy MedImmune for $15.6 billion.

June 2007, the National Institutes of Health (NIH) began enrolling participants in a Phase 1 H5N1 study of an intranasal influenza vaccine candidate based on MedImmune’s live, attenuated vaccine technology.

August. 23 , 2007, MedImmune, Inc. announced license of reverse genetics intellectual property to Novartis to support the development and construction of new vaccine strains to produce inactivated human seasonal, pre-pandemic and pandemic influenza vaccines.

June 16, 2010, Mount Sinai School of Medicine of New York University has sued MedImmune LLC for failing to pay at least $15 million in royalties allegedly owed on sales of the H1N1 flu vaccine to the U.S. government.

The complaint, launched Tuesday in the Supreme Court of New York, claims MedImmune has breached a licensing agreement and denied the medical school its share of a $428 million vaccine contract with the U.S. Department of Health and Human Services. MedImmune, an AstraZeneca PLC subsidiary, developed and manufactured the H1N1 vaccine using technology MSSM licensed but has refused to live up to its side of the bargain, pocketing all the cash from the 2009 sale, the university says. The licensed patents cover reverse genetics technology necessary for the production of the flu vaccine, and MedImmune is obligated to pay a royalty fee for net sales, in addition to certain milestones and other nonroyalty payments, according to the complaint. “Despite repeated demands and notice by MSSM, MedImmune has refused to pay MSSM royalties for its H1N1 vaccine sales according to the terms of the license agreement,” the complaint said. “MedImmune’s refusal to pay constitutes a breach of contract for which MSSM seeks appropriate damages and other relief.” Not only has MedImmune staunchly refused to meet its royalty obligations, but the biopharmaceutical company has also stonewalled attempts to negotiate a settlement, according to the complaint. MedImmune spokeswoman Karen Lancaster said the company has not strayed from the terms of its licensing agreement.