PARIS—A collaboration between two diabetes experts, globalpharmaceutical company Sanofi and the Joslin Diabetes Center, has the potentialto be "an alliance for early success in advancing science to better serve thepatient community," in the words of Dr. Nandan Pakudone, vice president of theOffice of Commercialization and Ventures at Joslin, a clinical, teaching andresearch affiliate of Harvard Medical School.
After two years of discussions with leaders in universitiesand research institutions, Sanofi decided to ally with Joslin to enhance itsown offerings of insulin products by developing new kinds of insulin to work onspecific cell types.
The partnership to promote the development of noveltherapeutic approaches for diabetes and related disorders was announced at the2012 Bio International Convention in Boston. It combines Joslin's focus on"genomic and other approaches to understand the mechanisms of diabetes and itscomplications" with Sanofi's ability to "translate discoveries and bring themto the clinic as quickly as possible, using its experience with using medicinalchemistry 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' northeastregion.
"Like cancer, diabetes is moving toward more personalizedmedicine," says Natesan. "Some patients encounter complications because ofgenetic and epigenetic factors. We want to create new medications and invest ina device to monitor blood glucose so that patients can be in communication withtheir doctors and help to control their food intake to manage the disease moreeffectively."
To improve the lives of people with diabetes and relateddisorders, the collaboration will focus on four key areas to identify potentialnew biologics or small-molecule drug candidates for the treatment of latecomplications of diabetes and new insulin analogs with more targeted efficacy.Research will also address the challenges of insulin resistance andpersonalized medicine.
Using a co-development model without a "silo approach," bothparties will have access to intellectual property for internal research use,Pakudone says. Under the terms of the agreement, Sanofi has options tocommercialize the results of the research and believes that there is"tremendous commercial potential for therapies in seven to 10 years," Natesanadds.
"Better targets will bring about better outcomes, andattention to the factors causing complications will bring about bettertreatments," Pakudone notes.
Nearly 26 million Americans have diabetes. There is no cure,but management of the disease can help people to avoid or minimize thecomplications.
Joslin, which began as a clinic to treat diabetes andrelated disorders in 1898, now cares for 25,000 patients per year in 47affiliated clinics in the United States. Offering a "holistic solution todiabetes," Joslin also does research into the mechanisms of the disease and itscomplications 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 theprincipal role in identifying early leads and determining what research targetsmake 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 thesecomplications, "so clearly, certain molecules protect them." He adds, "if wecan identify these factors, we can build better drug compounds from theseproteins to work on specific molecular pathways for certain segments of thepopulation."
Sanofi's diabetes division markets both injectable and oralmedications for people with type 1 or type 2 diabetes and has variousinvestigational compounds in its pipeline, including an injectable GLP-1agonist being studied as a single agent in combination with basal insulinand/or in combination with oral antidiabetic agents. The company hasestablished a number of partnerships to offer diagnostics, therapies, servicesand devices for the prevention and cure of diabetes.
Sanofi licenses Oxford BioMedica programs
OXFORD, United Kingdom—Sanofi also recently announced thatit has acquired two exclusive, worldwide licenses to develop, manufacture andcommercialize two Oxford BioMedica programs: StarGen, a gene-based treatmentfor Stargardt's disease, and UshStat, a gene-based treatment for Usher syndrometype 1B. Both of these programs were designed and developed by Oxford BioMedicausing the company's LentiVector platform technology.
Under the terms of the ocular agreement signed with Sanofiin April 2009, Oxford BioMedica will receive a total option exercise payment of$3 million and is eligible for further development and commercializationmilestone payments and royalties on any future sales of the products. OxfordBioMedica is currently conducting the two ongoing Phase I/IIa trials forStarGen and UshStat. The companies will continue to work together to plan thenext stages of development and finalize the terms of the worldwide licenseagreements.
On the basis of preclinical data, it is anticipated that asingle application of StarGen or UshStat to the retina could potentially eitherprovide long-term or permanent therapeutic benefit for patients. There arecurrently no approved treatments available for Stargardt's disease or Ushersyndrome type 1B. Both programs have received orphan drug designation in theUnited States and Europe.