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Collaboration targets complications
PARIS—A collaboration between two diabetes experts, global pharmaceutical company Sanofi and the Joslin Diabetes Center, has the potential to be "an alliance for early success in advancing science to better serve the patient community," in the words of Dr. Nandan Pakudone, vice president of the Office of Commercialization and Ventures at Joslin, a clinical, teaching and research affiliate of Harvard Medical School.
After two years of discussions with leaders in universities and research institutions, Sanofi decided to ally with Joslin to enhance its own offerings of insulin products by developing new kinds of insulin to work on specific cell types.
The partnership to promote the development of novel therapeutic approaches for diabetes and related disorders was announced at the 2012 Bio International Convention in Boston. It combines Joslin's focus on "genomic and other approaches to understand the mechanisms of diabetes and its complications" with Sanofi's ability to "translate discoveries and bring them to the clinic as quickly as possible, using its experience with using medicinal chemistry and garnering regulatory approval," explains Dr. Srideran Natesan, scientific site head of research and development at Sanofi in Cambridge, Mass., and head of external innovation and partnering for the United States' northeast region.
"Like cancer, diabetes is moving toward more personalized medicine," says Natesan. "Some patients encounter complications because of genetic and epigenetic factors. We want to create new medications and invest in a device to monitor blood glucose so that patients can be in communication with their doctors and help to control their food intake to manage the disease more effectively."
To improve the lives of people with diabetes and related disorders, the collaboration will focus on four key areas to identify potential new biologics or small-molecule drug candidates for the treatment of late complications of diabetes and new insulin analogs with more targeted efficacy. Research will also address the challenges of insulin resistance and personalized medicine.
Using a co-development model without a "silo approach," both parties will have access to intellectual property for internal research use, Pakudone says. Under the terms of the agreement, Sanofi has options to commercialize the results of the research and believes that there is "tremendous commercial potential for therapies in seven to 10 years," Natesan adds.
"Better targets will bring about better outcomes, and attention to the factors causing complications will bring about better treatments," Pakudone notes.
Nearly 26 million Americans have diabetes. There is no cure, but management of the disease can help people to avoid or minimize the complications.
Joslin, which began as a clinic to treat diabetes and related disorders in 1898, now cares for 25,000 patients per year in 47 affiliated clinics in the United States. Offering a "holistic solution to diabetes," Joslin also does research into the mechanisms of the disease and its complications and provides education and training programs for doctors, nurses, educators, payers and other personnel, Pakudone says.
Such experience puts Joslin in the position to take the principal role in identifying early leads and determining what research targets make sense. The organization is especially focused on diseases—such as eye, kidney and heart—that emanate from diabetes.
According to Pakudone, some patients never encounter these complications, "so clearly, certain molecules protect them." He adds, "if we can identify these factors, we can build better drug compounds from these proteins to work on specific molecular pathways for certain segments of the population."
Sanofi's diabetes division markets both injectable and oral medications for people with type 1 or type 2 diabetes and has various investigational compounds in its pipeline, including an injectable GLP-1 agonist being studied as a single agent in combination with basal insulin and/or in combination with oral antidiabetic agents. The company has established a number of partnerships to offer diagnostics, therapies, services and devices for the prevention and cure of diabetes.
Sanofi licenses Oxford BioMedica programs
OXFORD, United Kingdom—Sanofi also recently announced that it has acquired two exclusive, worldwide licenses to develop, manufacture and commercialize two Oxford BioMedica programs: StarGen, a gene-based treatment for Stargardt's disease, and UshStat, a gene-based treatment for Usher syndrome type 1B. Both of these programs were designed and developed by Oxford BioMedica using the company's LentiVector platform technology.
Under the terms of the ocular agreement signed with Sanofi in April 2009, Oxford BioMedica will receive a total option exercise payment of $3 million and is eligible for further development and commercialization milestone payments and royalties on any future sales of the products. Oxford BioMedica is currently conducting the two ongoing Phase I/IIa trials for StarGen and UshStat. The companies will continue to work together to plan the next stages of development and finalize the terms of the worldwide license agreements.
On the basis of preclinical data, it is anticipated that a single application of StarGen or UshStat to the retina could potentially either provide long-term or permanent therapeutic benefit for patients. There are currently no approved treatments available for Stargardt's disease or Usher syndrome type 1B. Both programs have received orphan drug designation in the United States and Europe.