Logo

Oncology Venture obtains option to in-license the European rights to the FDA approved ixabepilone

Share this
Oncology Venture obtains option to in-license the European rights to the FDA approved ixabepilone

M&A

Oncology Venture obtains option to in-license the European rights to the FDA approved ixabepilone

H?rsholm, Denmark and Cambridge, MA, US,? ? Oncology Venture A/S?(?OV? or the Company) today announced that the company has obtained an exclusive option to in-license the European rights to IXEMPRA??(ixabepilone) from the pharmaceutical company?

R-Pharm U.S., LLC.? In July 2015 R-PHARM U.S., LLC acquired global rights to IXEMPRA??from Bristol-Myers Squibb (BMS).? The drug is approved in the USA for the treatment of breast cancer. Oncology Venture will evaluate ixabepilone together with its drug-specific DRP??companion diagnostic in order to accomplish a market approval in Europe. Oncology Venture has, based on prior treatment results and tumor gene data published by BMS in scientific literature, evaluated the ability of its DRP??companion diagnostic to identify which patients will most likely benefit from ixabepilone. The analysis indicates that patients benefitting from Ixabepilone can be identified by using our ixabepilone-specific DRP??companion diagnostic. Oncology Venture is confident that it can succeed in gaining EMA approval to market ixabepilone in Europe for the treatment of metastatic breast cancer. According to the agreement, Oncology Venture will evaluate IXEMPRA??(ixabepilone), together with its DRP??companion diagnostic, in European clinical trials in patients with metastatic breast cancer. If the results are convincing Oncology Venture has the option to exclusively in-license the commercial rights for the European Union (EU) market. The broadened pipeline is not expected to increase Oncology Venture?s cost base since the clinical development of ixabepilone will be financed through a special purpose vehicle/joint venture to be offered to interested investors while Oncology Venture will continue to control the program. Oncology Venture?s strategy is to make use of its proprietary Drug Response Prediction (DRP?) biomarker platform to progress its broad pipeline of late-stage oncology drug candidates. The company in-licenses drug candidates that have previously shown good clinical efficacy and where the DRP??technology is expected to add value for cancer patients as a companion diagnostic to the drug.? The DRP??companion diagnostic enables identification of the patient population most likely to benefit from the drug and then only treating those patients. After conducting clinical studies that prove a better efficacy of its drug candidates, Oncology Venture can apply for market approval or out-license the drug candidate at a higher value inflection point. The cancer drug ixabepilone was originally developed by the pharmaceutical company Bristol-Myers Squibb (BMS) and was approved for treating metastatic breast cancer by the FDA in the US in 2007 but was not approved by The European Medicines Agency?s (EMA) for use in Europe. R-Pharm U.S. acquired ixabepilone from BMS in July 2015 and the product is today marketed by R-Pharm in the USA, as well as certain countries in South America, Switzerland, and Lichtenstein. ?This is a great opportunity to apply our value increasing process. Ixabepilone is a top-quality FDA approved product and we believe that our DRP technology can bring the product to an European approval. Ixabepilone has all the features that we seek for and we are looking forward to pinpoint the patients that truly benefit from ixabepilone, with the ultimate goal to bring a new efficacious drug to the European/EU cancer patients,??comments Peter Buhl Jensen, M.D., CEO of Oncology Venture.??

For further information, please contact: For investor inquiries Ulla Hald Buhl, IR & Communications E-mail:?uhb@oncologyventure.com Telephone +45 21 70 10 49

Share this article on WhatsApp, LinkedIn and Twitter



Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions