SAN DIEGO, CALIF.—Shenzhen Relin Medicine and MingSightPharmaceuticals have formed a joint venture—Jiangsu MingSight-RelinPharmaceutical—to develop and commercialize MS-553 as an oral therapy fordiabetic eye disease in China.
According to the companies, Jiangsu MingSight-RelinPharmaceutical will adhere to the development standards of both the ChineseSFDA and the U.S. Food and Drug Administration to facilitate the globaldevelopment of MS-553.
MingSight has licensed MS-553 exclusive rights toMingSight-Relin in China, which it had previously inlicensed from Pfizer.
Such therapies have a potentially huge market in China,which is home to more than 95 million people with diabetes, the highest numberin the world, according to figures from the Chinese Diabetes Society.Retinopathy is a condition in chronic diabetes patients whereby retinal bloodvessels become damaged and may leak blood, and can be treated through surgeryor corticosteroid injections.
Diabetic retinopathy also is one of the most commoncomplications of diabetes and the leading cause of blindness among workingadults in the United States. The number of Americans 40 years or older withdiabetic retinopathy is expected to triple to 16 million by 2050.
According to Relin General Manager Xintao Xia, as a newchemical entity, MS-553 has demonstrated an excellent potency and safetyprofile in extensive preclinical studies previously conducted by Pfizer.
"This solid preclinical data forms the basis of our decisionto undertake this project," Xia says. "Under the expert guidance fromMingSight, the joint venture will conduct preclinical and clinical studies inaccordance with international GLP and GCP standards."
As a result, Xia is confident that the collaboration caneffectively advance the program through future studies.
Moreover, the partnership combines Relin's track record ofleadership in developing, registering and commercializing ophthalmic productsin China with MingSight's expertise in ophthalmic drug development.
"We are pleased to collaborate with Shenzhen Relin, a provenleader in China in bringing high value therapies to patients suffering fromophthalmic diseases," adds Kai Zhang, CEO of MingSight. "I look forward toworking closely with Relin toward the goal of bringing an innovative therapyfor patients with diabetic retinopathy."
MingSight Chief Scientific Officer Michael Niesman explainsthat MS-553 has shown efficacy and safety in preclinical studies and as aneffective and safe oral treatment for diabetic eye disease.
A co-founder of Mingsight, Niesman left academicophthalmology research in 1998 to join the La Jolla, Calif.-based biotechstart-up Agouron Pharmaceuticals Inc. That company was acquired byWarner-Lambert Co. in 1999. Warner-Lambert was subsequently acquired by PfizerInc.
Niesman headed Pfizer's ophthalmology research until 2009,when the program was cut by the company as it reorganized its priorities.
After the restructuring, Niesman and some of his colleaguessought opportunities to spin out the ophthalmology assets while they were stillpart of Pfizer, but the global economic crisis hampered their efforts.
Fate then stepped in as a venture capitalist introducedNiesman to Zhang, a physician with experience in the pharmaceutical industrywho was interested in starting a company. The pair then formed MingSight.
Niesman explains that MS-553 is unusual because when it isgiven orally, it achieves a high concentration in the retina.
"Our hypothesis is that we can achieve that kind of efficacywith an oral treatment, with better compliance and no side effects from theintraocular injection," Niesman says. "An effective and safe oral treatment fordiabetic eye disease will be a significant advance for patients, potentiallyallowing them to avoid invasive therapies that often are given by injectionsinto the eye."
Niesman also explains that the compound involves componentsto treat both the leakage produced by high glucose blood levels as well as theinflammatory cascade that occurs when the condition becomes chronic, leading todiabetic macular edema.
In diabetic mouse models that received the treatment, MS-553reduced retinal leakage by 100 percent after just three days. A precedentcompound obliterated 95 percent of the retinal leakage induced by vascularendothelial growth factor—one of the key drivers of diabetic eye disease.
The collaboration between Relin and MingSight will bemanaged by a joint leadership team, consisting of members of senior managementfrom both companies. Financial details of the joint venture were not disclosed.
