Santhera enters license agreement with Chiesi Group; Tonix's cocaine intoxication drug, Iovance's cervical cancer treatment win FDA's breakthrough status
→ Swiss-based Santhera has entered an exclusive global — except for the US and Canada— license agreement with international research-focused healthcare group Chiesi Farmaceutici. The company says that Chiesi Group will in-license Raxone for the treatment of LHON for a total consideration of CHF 105 million (about $104 million), and this will constitute an upfront of about $49.5 million and near-to mid-term sales milestone payments of up to about $54.5 million. Following the completion of “certain reimbursement and post-regulatory commitments on the part of Santhera,” Chiesi Group will have the option to fully acquire Santhera’s Raxone business.
→ The FDA has designated Tonix’s $TNXP experimental drug, TNX-1300, as a breakthrough therapy for the treatment of cocaine intoxication. The company says that results in their Phase II randomized, double-blind, placebo-controlled clinical study demonstrated that the enzyme was effective in degrading and metabolizing cocaine in cocaine abusers. There is no current pharmacotherapy indicated for cocaine intoxication. In 2017, about 13,900 deaths occurred in the U.S. due to cocaine overdose, the company noted.
→ Iovance Biotherapeutics $IOVA has scored a breakthrough therapy designation for LN-145, a tumor-infiltrating lymphocyte-based immunotherapy it’s designed for recurrent, metastatic, or persistent cervical cancer that has progressed on or after chemotherapy.