COSCIENS Biopharma Inc T.CSCI

New Diagnostic Licensing Deal:

[prophetoffactz]

In July 2023, in a news release, AEZS said "...based upon our active outreach and discussions, we expect to secure an alternate development and commercialization partner for Macrilen® for the U.S. and Canada.” As a Director of AEZS Gilles was in a catbird seat to understand the potential value of a deal. CZO and AEZS agreed to a proposed merger five months later. The pediatric clinical trial is expected to report top-line and full results this quarter. The company's forward-looking statements recognize the clinical trial risks and the risks to regulatory approval and to a new deal. There is no guarentee. CSCI is also using Macimorelin in its preclinical ALS program. Using an FDA approved agent for this program could significantly derisk the program from a safety standpoint. The news releases suggest CSCI is still pursuing development of this program. 

What could a new diagnostic deal be worth?    

The US$24 million upfront payment AEZS received from Strongbridge, adjusted for inflation, would now be worth about C$40 million.

With no adjustment for inflation the US$5 million pediatric milestone would be worth about another ~C$6.81 million bringing the total to C$46.81 million. The pediatric trial has now been completed.

The pediatric trial cost were estimated at US$4 million over three years with Strongbridge responsible for 70% of the costs. Total costs would therefore be about C$5.71 million with no adjustment for inflation or trial risk. That would bring the total to ~C$52.5 million. 

What is the patent life now? How will a new deal be adjusted based on commercial results in the adult market which have been disappointing. Being inside of AEZS Gilles should have had a good idea about potential deal terms given AEZS expected a licensing deal in its Jult 2023 news release based on its outreach. A new deal could be signed with the pediatric trial completed and in hand. Certain areas of the world like China also only largely test for pediatric growth hormone deficiency.

prophetoffactz wrote:Will AEZS sign a licensing deal for the diagnostic and on what terms? How could the terms change from below?
 
Perplexity Ai:

The terms of the deal between Aeterna Zentaris and Strongbridge for Macrilen (macimorelin) in the U.S. and Canada included:

1. Upfront payment: Strongbridge agreed to pay Aeterna Zentaris US$24 million within 5 days of the effective date.
2. Royalties: Aeterna Zentaris will receive tiered royalties on net sales:15% on net sales up to US$75 million
3. Post-patent royalty: 5% royalty on net sales after patent protection ends in the U.S. or Canada.
4. Commercial milestone payments:US$4 million at US$25 million in annual net sales
5. Pediatric indication milestone: US$5 million upon FDA approval of a pediatric indication for Macrilen.
6. Pediatric development program: Strongbridge will fund 70% of the costs for a worldwide pediatric development program, estimated at approximately US$4 million over three years.
7. Joint steering committee: A committee of four persons, with two appointed by each company, to oversee the pediatric development program.
8. Commercialization rights: Strongbridge received exclusive rights to manufacture and commercialize Macrilen in the U.S. and Canada.