Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

Agree. Most ,including Leo, felt Prurisol was the least likely of CTIX's 3 primary drugs to successfully complete the FDA trials.Now with Prurisol's successful phase 2 trial, a FDA phase 3 trial expedited by the 505 b2 designation is virtually certain. This leads to the possibility Prurisol may be approved in the relatively near future as a new drug.

In terms of a partnership it may be time to think in broader terms. Rather than a partnership for Prurisol it is possible a deal for drug development may be offered for Prurisol and either Brilacidin and/or Kevetrin which would include all the pharmaceuticals in the Brilacidin Defensin -mimetic pipeline and the Kevetrin small molecule pipeline.

This strategy is consistent with Mr Ehrlich's stated ambition to become the next Regeneron. Below is a summary of Regeneron's collaboration with its first partner, Sanofi. The partnership has been very profitable for both parties. It has given Regeneron the capital and expertise to develop into a robust pharmaceutical company. Regeneron now has multiple partners and licensing agreements for a number of pharmaceuticals.

GLTA, Farrell

http://www.regeneron.com/collaborations

Sanofi

Antibody Discovery and Development
Since 2007, Regeneron has collaborated with Sanofi to discover, develop, manufacture and commercialize fully human monoclonal antibodies utilizing Regeneron's proprietary VelociSuite® of technologies. In the first three years of the collaboration, five antibodies entered clinical development.

The collaboration was expanded in 2009 with a goal of advancing 20-30 additional antibodies into clinical development by 2017. Under the terms of the expanded collaboration, Sanofi has agreed to provide $160 million in annual research funding through 2017. As part of the 2015 immuno-oncology collaboration outlined below, $75 million in aggregate over three years from the $160 million annual contribution will be ear-marked for the discovery and development of immuno-oncology antibodies.

Sanofi has the exclusive option to co-develop each drug candidate in the collaboration portfolio. Development costs are shared between the two companies, with Sanofi funding development costs up front and Regeneron reimbursing half of the development costs from its share of future profits. Regeneron has the right to co-promote all collaboration products worldwide. In the U.S., profits will be shared equally; outside the U.S., profits will be split on a pre-determined sliding scale.

Immuno-Oncology Discovery and Development
In 2015, Regeneron and Sanofi entered into a global collaboration to discover, develop and commercialize new antibody cancer treatments in the emerging field of immuno-oncology. As part of the agreement, the two companies will jointly develop Regeneron’s programmed cell death protein 1 (PD-1) inhibitor currently in Phase 1 testing (REGN2810) and plan to initiate clinical trials in 2016 with new therapeutic candidates based on ongoing, innovative preclinical programs.

This collaboration included upfront payments to Regeneron of $640 million, and the companies are investing $1 billion for discovery through proof of concept development of monotherapy and novel combinations of immuno-oncology antibody candidates to be funded 25 percent by Regeneron ($250 million) and 75 percent by Sanofi ($750 million). The companies are also equally funding an additional $650 million (or $325 million per company) for development of REGN2810, a PD-1 inhibitor. Finally, the two companies are re-allocating $75 million (in aggregate over in three years) for immuno-oncology antibodies from Sanofi’s $160 million annual contribution to their existing antibody collaboration, which otherwise continues through 2017. Beyond the committed funding, additional funding will be allocated as programs enter post-POC development.

ZALTRAP® (ziv-aflibercept)
As of an amended agreement dated February 2015, Sanofi is solely responsible for the development and commercialization of ZALTRAP for cancer indications worldwide. Sanofi bears the cost of all development and commercialization activities, and will reimburse Regeneron for its costs for any such activities. Sanofi also pays Regeneron a percentage of aggregate net sales of ZALTRAP during each calendar year (from 15% to 30%, depending on the aggregate net sales). Regeneron is responsible for the manufacture and supply of ZALTRAP and is paid by Sanofi for all quantities manufactured. Regeneron is no longer required to reimburse Sanofi for fifty percent of the development expenses that Sanofi funded for ZALTRAP under the Original Collaboration Agreement.