Tasly Pharmaceutical Group Co., Ltd. (referred to as “Tasly”) and the US-based drug maker Azurity Pharmaceuticals, Inc. (referred to as “Azurity”) announced on Sep. 6 comprehensive cooperation in the R&D and marketing of T89 in the States. According to their agreement, Azurity will contribute an amount up to US$23 million for T89-related clinical research and regulatory approval required by the FDA, and obtain the exclusive right of selling T89 targeted at relevant indications in the States; Tasly, when the drug is available on the market, will receive a milestone payment up to US$50 million and a share of the gross profits up to 50%.
Present at the signing ceremony, which was held in Maryland. Wu Naifeng, President at Tasly Holding Group and Director at Tasly Pharmaceutical Group. Mr. Yan Kaijing, Executive Chairman at Tasly Holding Group and Chairman at Tasly Pharmaceutical Group. Dr. Sun He, Vice Chairman at Tasly Pharmaceutical Group and President and CEO at Tasly Pharmaceuticals, Inc.; Mr. Ed Schutter, President and CEO at Azurity Pharmaceuticals, Mr. Thom Rowland, Vice President for Commercial Operations, Dr. Brian K. Adams, Vice President for Business Development, and Dr. Steven D. Caras, Vice President for Clinical Development.
Azurity accepts the data from previous T89 trials
Azurity, as a marketer of cardio-cerebrovascular prescriptions in the U.S., Azurity accepts the data from previous T89 trials a stringent due diligence system for the pharmaceutical introduction. According to data from the phase-two clinical study of T89, the change of Total Exercise Duration (TED), the gold endpoint in clinical trials of T89 for the prevention and treatment of recurrence of stable angina pectoris, is of both statistical and clinical significance.
Data from the phase-three clinical study indicate that the rise of TED in the high- and lose-dose T89 groups, in comparison with placebo group and Radix Notoginseng group, is of statistical significance in week 6 (P < 0.05), with the actual P-value being 0.02 and the trend and rate of increase being clinically significant; point-by-point comparison in week 4 shows statistical significance. Azurity accepts the data from previous T89 trials
Experts in data statistics employed by Azurity have analyzed the development data of T89 over 10-odd years, especially those obtained from the FDA-regulated phase-two and phase-three trials. The result shows exact consistency with Tasly’s statement.
Therefore, Azurity believes that the data from the above trials are true and reliable. In addition, Azurity has carried out due diligence in respect of T89’s seven invention patents authorized in the U.S., which cover the product, preparation, and clinical purpose of T89, and all the CMC indexes to be approved by the FDA.
“Our studies on T89’s clinical development data showed that the additional validation study following phase three would possibly succeed,” Brian K. Adams, Vice President for business development at Azurity Pharmaceuticals, said, “The previous studies in hundreds of patients have proved T89 to be effective on angina, and we believe that this natural herbal therapy, once approved, will be to the liking of some heart disease experts.”
More extensive strategic cooperation is expected in the future
Specializing in selling cardio-cerebrovascular prescriptions, Azurity has been looking for innovative drugs with good efficacy around the world. For the company, T89, a modernized compound Chinese herbal formula different from the pharmaceutical chemicals that it has introduced, is also a new challenge.
Adams said: “Azurity has set up a sales team for the U.S. cardiovascular market, selling two cardiovascular products, one for hypertension and the other for heart failure. We consider T89 as an innovative drug with the potential effect on chronic stable angina, and it quite fits for our sales team in close partnership with heart disease experts in the U.S. The T89 cooperation is just a beginning. Since Tasly has many patented cardio-cerebrovascular drugs, more extensive strategic cooperation is expected in the future.”
The FDA has responded to the phase-three T89 study that a 6-week clinical study validating statistical significance is required as the basis for NDA filing. Li Songlin, a research fellow at the Jiangsu branch of China Academy of Chinese Medical Sciences, remarked that a supplementary study after phase three had been very common.
Adams revealed that Tasly had been engaging in productive dialogues with the FDA and Azurity had also attended the recent type-c meetings between the parties. He added that Tasly was finalizing its protocol and submitting it to the FDA for review.
It is said that Tasly and Azurity are formulating the sales plan and preparing for marketing in the future while working together to move forward the clinical development of T89.
At present, Azurity has more than 500 employees, in which over 400 are sales professionals, including 200 in the cardio-cerebrovascular field. The management staff has worked in the pharmaceutical industry for more than 15 years on average, gaining considerable experience in pharmaceutical market access, product marketing, and market expansion.