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U-M sells portion of royalty interest in FDA-approved drug for $65.6M

Monday, November 24, 2014   (0 Comments)
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Less than three months after the Food and Drug Administration approved a University of Michigan-developed drug, the university made $65.6 million by selling some of the worldwide royalty interest of the licensing agreement for a drug that treats a rare disease.


Nevada-based PDL BioPharma announced Thursday, Nov. 6, that it will receive 75 percent of all royalty payments from U-M's license agreement with Genzyme for Cerdelga, an oral therapy for adult patients with Gaucher disease type 1, which was was developed by Genzyme, a Sanofi company.


The FDA approved Cerdelga on Aug. 19. In addition to the FDA approval, marketing applications for Cerdelga are under review by the European Medicines Agency and other regulatory authorities.


Cerdelga was developed to provide an effective oral treatment alternative for adult patients with Gaucher disease type 1, and to provide a broader range of treatment options for Gaucher patients and physicians.


According to the FDA, Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. The disease is an inherited disorder and affects more than 10,000 people worldwide.


The enzyme deficiency causes fatty materials to collect in the spleen, liver and bone marrow. The major signs of Gaucher disease include liver and spleen enlargement, low red blood cell counts (anemia), low blood platelet counts and bone problems.


The parties did not disclose the royalty rate used to calculate the royalties to be paid by Genzyme to U-M.


"We continue to provide leading institutions, such as the University of Michigan, with capital that will allow them to pursue their funding initiatives, while also allowing PDL to acquire meaningful income generating assets and to create shareholder value," John McLaughlin, president and CEO of PDL BioPharma, said in a statement.


Kenneth Nisbet, associate vice president for Research at U-M's Technology Transfer, said in a statement that Cerdelga represents the first chemical entity invented at the U-M to receive FDA approval and that it illustrates the societal benefits of transferring discoveries from university research.


"We're very pleased with our agreement with PDL which enables us to accelerate our investments in research and education," he said.


"We strongly believe in Cerdelga's potential, which is why we have retained a portion of the royalty rights."


[Read article online.]

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