Innovation Pharmaceuticals Inc (IPIX)

[sox040713]

Leo’s plan to make 30 kg of Brilacidin got me thinking why so much at this point? One reasonable explanation is the ADAPT Act that was passed last year. Under the ADAPT Act, companies do not have to run phase 3 trials. I think Leo will file for approval when the phase 2b data are available.

“Specifically, the ADAPT Act would amend the FDC Act to add Section 505(x), allowing the sponsor of an antibacterial or antifungal drug intended to treat a serious or life-threatening disease or condition (or a biological products intended to treat a bacterial or fungal infection associated with a serious or life-threatening disease) to request that FDA approve the drug “to treat a limited population of patients for which there is an unmet medical need.” In determining whether to grant such approval for a limited population of patients, FDA “may rely on traditional endpoints, alternative endpoints, or a combination of traditional and alternative endpoints; datasets of limited size; pharmacologic or pathophysiologic data; data from phase 2 clinical studies; and such other confirmatory evidence as the [Agency] deems necessary.” The labeling of products approved under the limited population pathway must include the statement: “This drug is indicated for use in a limited and specific population of patients.””

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/12/adapt-act-would-create-a-new-limited-population-approval-pathway-for-antibiotics-and-antifungals.html

Leo first mentioned the ADAPT Act in this PR:

“Cellceutix is particularly excited about the timing of its recent acquisition of novel antibiotic and antifungal compounds because of the introduction last week of the ADAPT (Antibiotic Development to Advance Patient Treatment) Act of 2013 by the House of Representatives to expedite development of new antibiotics and antifungal drug candidates. The bill builds upon the GAIN (Generating Antibiotic Incentives Now) Act that was passed in 2012 to provide incentives, such as extended periods of exclusivity and smaller patient populations for clinical trials, for new antibiotics that target areas of great unmet medical need. The FDA is demonstrating its commitment to find solutions to the growing problem of bacteria infections. Cellceutix feels its drug candidates are prime candidates to benefit from these government initiatives.”

http://cellceutix.com/cellceutix-submits-application-for-irb-review-to-commence-phase-2b-clinical-trial-of-novel-antibiotic-brilacidin/#sthash.h96rqg3Q.dpbs