Orphan Drug Status
*****************
Radio/chemotherapy-induced peripheral neuropathy
USA (2014); KRN5500 for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics (US FDA, FEB 21, 2014, View Source & Filing 8K , Dara Biosciences, FEB 25, 2014, View Source [SID:1234500151]).

On February 25, 2014 Verastem announced that it has acquired the license to VS-4718 held originally by Poniard Pharmaceuticals (Press release Verastem, FEB 25, 2014, View Source [SID:1234500140]). The previous and future developmental, regulatory and commercial royalty milestones and payments associated with the development and potential future sales of VS-4718 due to Poniard Pharmaceuticals are now owned by Verastem. Verastem retains a license to VS-4718 from The Scripps Research Institute.
Under the terms of the Asset Purchase Agreement, Verastem acquired the existing and future developmental, regulatory and commercial royalty milestones and payments associated with the development and potential future sales of VS-4718 due to Poniard Pharmaceuticals. Verastem has issued 97,500 shares of common stock in the acquisition of the asset. In addition, Verastem is now the direct licensee of VS-4718 from The Scripps Research Institute with a potential obligation of up to $3m in developmental and regulatory milestones and a low single digit royalty on potential future sales.

Last week, Merck informed Ariad that it is terminating its license agreement for the global development and commercialization of ridaforolimus in oncology (Press release Ariad, FEB 25, 2014, View Source [SID:1234500135]). By the terms of the agreement, this becomes effective in November 2014 at which time all rights related to ridaforolimus in oncology will be returned to Ariad.

On February 24, 2014 Synta reported on progress with lead compounds from its Hsp90-Inhibitor Drug Conjugate (HDC) platform at the IASLC 14th Annual Targeted Therapies of the Treatment of Lung Cancer Meeting in Santa Monica, California (Press release Synta Pharmaceuticals, FEB 24, 2014, View Source [SID:1234500122]). The new compounds, consisting of an Hsp90-inhibitor conjugated with SN-38 (HDC SN-38) and an Hsp90-inhibitor conjugated with docetaxel (HDC docetaxel), demonstrated proof of principle in multiple preclinical cancer models. Notably, complete or near complete regressions of tumors were observed in models of non-small cell lung cancer, small-cell lung cancer, breast cancer, pancreatic cancer, colon cancer, and skin cancer, in models that are generally resistant or show limited response to treatment with the unconjugated chemotherapies.
Results presented at the conference showed that up to seven times greater dosage of docetaxel may be safely administered in the animal models compared to unconjugated docetaxel. This increase was associated with near complete regressions in animals treated with the HDC vs. limited activity or progressive disease in animals treated with unconjugated docetaxel. Preclinical safety results to date show comparable or more favorable safety profile of the HDC as compared with the unconjugated chemotherapy.
In addition, both the SN-38 and docetaxel HDCs demonstrated prolonged anti-tumor activity following the last dose of the HDC. These results are consistent with retention of the HDC in tumors and sustained, slow release of the cytotoxic payload within the tumor.
Slides presented at the IASLC meeting are available here View Source .