Puma anticancer drug neratinib peak sales is expected to exceed $6000000000

Biotech Corp Puma released the July 23rd experimental anticancer drug neratinib(to the imatinib, code PB272) phase III clinical study (ExteNET) positive top linedata. The ExteNET study was a double-blind, placebo-controlled phase III study,in 2812 cases accepted operation and Hessaitin (Herceptin) early female patients with HER2 positive breast cancer adjuvant treatment of development, study,patients in the Herceptin adjuvant, randomly assigned to receive neratinib or placebo treatment for a period of one year. In the experiment, after the patientsrandomly assigned to 2 years of follow-up, the statistical disease recurrence, in situ tubular adenocarcinoma (DCIS) or death, the primary endpoint of the studywas disease-free survival (DFS).

Data show that, compared with placebo, neratinib makes the disease free survival was improved in 33%, with statistically significant difference (p=0.0046).In addition, compared with placebo, neratinib makes the secondary endpoints in situ tubular adenocarcinoma disease free survival (DFS-DCIS) improvement of up to 37%, also has a statistically significant difference (p=0.0009). Details of thestudy will be submitted to the future scientific meeting. According to positive data for the study in the first quarter of 2015, Puma plans to submit neratinibregulatory documents to the FDA for an extended period of time, to seek the approval of adjuvant therapy.

News release, Puma shares rose 220%. On the expression of neratinib in phase III clinical color, analysts hold optimistic views of different. Some analysts believe that, the drug III successful, is expected to make neratinib annual sales exceeded$1000000000 blockbuster drugs. While some analysts think, this medicine will reach the peak sales of $6000000000 in 2028.

In April this year, Puma announced neratinib, a phase II study (I-SPY 2) of positive data, show that the neratinib for HER2 positive breast cancer, curative effect is better than that of Roche herceptin.

Details: "Puma pharmaceutical neratinib for better therapeutic effect than HER2positive breast cancer Herceptin" Roche

About neratinib:

Neratinib is an oral, irreversible, pan ErbB receptor tyrosine kinase inhibitor, can effectively inhibit the ErbB1 and ErbB2, its mechanism and Roche Herceptin(trastuzumab) and the breast cancer drug Perjeta (pertuzumab), 2 formonoclonal antibody drugs, targeting on the surface of HER2 positive cancer cells HER2 receptor. Perjeta combined with Herceptin and docetaxelchemotherapy is thought to provide more complete blockade of HER2 signal transduction pathway.