Innovation Pharmaceuticals Inc (IPIX)

[MinnieM]

The following was put out by the company and discusses the route to approval chosen for Prurisol.

Leveraging the Benefits of the 505(b)(2) Drug Development Approach
http://www.ipharminc.com/new-blog/2016/10/5/leveraging-the-benefits-of-the-505b2-drug-development-approach-1?rq=505

The following discusses more about that route and includes language that makes it appear possible for approval with only a ph2. But, I suspect that even with excellent results a small ph3 is likely for Prurisol. I'm thinking 300 patient and don't see them going on their own. I'd expect to see this partnered out if the upcoming results warrant the next step.

Let's just hope we get good results from the Prurisol ph2b and this becomes an issue.

https://www.pharmacytimes.com/contributor/ryan-chandanais-ms-cpht/2017/11/505-b2-regulatory-pathway-for-new-drug-approvals-

The 505 (b)(2) pathway provides manufacturers who have certain types of drugs with an opportunity to acquire FDA approval without performing all the work that’s required with an NDA. These drugs are not strictly generics, but are often not entirely novel new molecular entities either. 505 (b)(2) can be an option for drugs with a new aspect related to indication, dosage form or regimen, strength, combination with other products, or other unique traits.1

A key feature of the 505 (b)(2) pathway is that it allows a manufacturer to submit their product for FDA review by including data and/or study results originally collected by another manufacturer or researcher. The manufacturer of the 505 (b)(2) eligible product needs to build a connection between their version of the product, or the active ingredients in it, and the reference product. For example, this could include data and results of bioanalytical testing, pre-clinical studies, or even clinical trial results. If successful in their effort to include supporting evidence from other researchers in their submission, the manufacturer of the 505 (b) (2) candidate won’t have to re-run these studies themselves. While the 505 (b) (2) path allows for using the research of others as a component of their FDA submission, the manufacturer of the 505 (b) (2) product may still need to complete some of their own research in other areas to help fulfill all the various requirements of the FDA to earn approval.4

Another appealing aspect of gaining approval through the 505 (b)(2) is that the approved product is eligible for 3-5 years of market exclusivity. A drug approved via a full NDA is normally granted a 5 year market exclusivity period, while a generic product approved through the ANDA pathway may earn 6 months of market exclusivity if it’s the first generic approved. 5 During the period of market exclusivity the product will be protected from competitors.

505 (b)(2) may represent an appealing pathway for drug approval for manufacturers for certain products. The ability to utilize previously completed research as part of the FDA submission can save a great deal of time and money compared to the traditional full NDA. Additionally, a drug being approved through this pathway is not a simple generic of a previously approved product, so it may reach additional patients or perhaps be an improvement over a currently available treatment. Manufacturers have recognized the potential benefits of 505 (b)(2) with 48 drugs gaining FDA approval through the pathway in 2016, a new yearly high since at least prior to 2004. 6505 (b)(2) is expected to continue to be an important pathway for drug development in the future.

In Reply to 'biopa'
Is the P phase 2trial powered enough for the FDA to consider approval based on outstanding results?