KaloBios Pharmaceuticals Inc (NASDAQ:KBIO), announced that it has signed an agreement to acquire a benznidazole program for the treatment of Chagas Disease fromSavant Neglected Diseases, LLC, a privately-held specialty pharmaceutical company. Under the terms of the agreement, KaloBios will pay an upfront payment of $2 million, plus regulatory milestones and a royalty based on product sales. The transaction is expected to close in the coming weeks.
Martin Shkreli, Chairman and Chief Executive Officer, said, “We are pleased to execute this agreement with Savant as it is consistent with our mission to improve the lives of patients by developing therapies for neglected diseases of high unmet medical need. An estimated 300,000 patients in the United States are afflicted with Chagas Disease and this number is growing at an alarming rate. Benznidazole is an extremely important medicine that is currently unavailable in the United Statesor Europe. KaloBios will work to bring this vital therapy to help patients avoid progression to Chagas’ cardiomyopathy by offering early disease intervention.”
KaloBios intends to file for Orphan Drug Designation and Fast Track Designation for benznidazole in Chagas Disease. Upon approval, KaloBios expects to receive a Neglected Tropical Disease Priority Review Voucher (“PRV”). In August 2015, theFood and Drug Administration determined that Chagas Disease was added to the list of designated tropical diseases whose product applications may result in the award of a PRV.
Chagas Disease is caused by the parasite Trypanosoma cruzi transmitted primarily by insects known as “kissing bugs”. TheCenters for Disease Control and Prevention estimates there are more than 300,000 individuals with Trypanosoma cruzi infection that live in the United States, with 30,000-45,000 cardiomyopathy cases and fewer than 500 congenital infections annually. Chagas disease occurs in two stages. An acute stage, where the affected persons are typically asymptomatic and, if left untreated, can progress to a chronic stage in which greater than 30% of cases develop serious heart or the digestive complications. Currently, there are only two treatments for Chagas disease available: nifurtimox and benznidazole. CDCrecommends antitrypanosomal treatment for all cases of acute and congenital Chagas disease, reactivated infection, and chronic T. cruzi infection in individuals 18 years or younger. (Original Source)
Shares of KaloBios Pharmaceuticals are up 26.53% to $37.40 in after-hours trading. KBIO has a 1-year high of $45.82 and a 1-year low of $0.44. The stock’s 50-day moving average is $8.91 and its 200-day moving average is $4.59.
KaloBios Pharmaceuticals Inc is a biopharmaceutical company. The Company is engaged in the development of monoclonal antibody therapeutics for diseases that burdens the society and to patients and their families.