Company: CSCIF
Filing Date: 2025-04-09
Form Type: 20-F
Source: 0001641172-25-003456
Chunk: 60

Company: COSCIENS Biopharma Inc.
Filing Date: 2025-04-09
Form: 20-F
Item: Item 5
Chunk 60
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S Germany
to use a macimorelin containing composition for the assessment of GHD in adults.

  The non-provisional U. S. application 15/993,507 was filed on May 30,                                                                           
  2018 drawing the priority of both provisional applications. The related U. S. patent 10,288,629 was granted on May 14, 2019, and will           
  expire on May 30, 2038. A Patent Cooperation Treaty (“ PCT”) PCT/EP/2018/085622 application was filed December 18, 2018,                        
  drawing the priority of both provisional U. S. applications. In addition to the method of assessing GHD comprising oral administration          
  of a macimorelin containing composition and collecting one or two post-administration samples, the PCT application also covers a                
  similar method of assessing GHD using three post-administration samples. On February 24, 2022, following examination of European                
  patent application 18827044.1, a European patent with the title “ Method of assessing growth hormone deficiency comprising oral                 
  administration of a macimorelin containing composition and collecting one or two post-administration samples” has been granted.                 
  The patent will be published in European Patent Bulletin on March 23, 2022. The European patent covers the use of macimorelin according         
  to the label approved by EC to diagnose GHD in adults. The European patent is in the validation process in 12 European countries.               
  In 29 European countries the patent has been nationalized.                                                                                      
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  A related U. S. provisional patent applications Serial No. 62/607,866                                                                           

An invention has been made by inventors of AEZS Germany
to use a macimorelin containing composition for the assessment of GHD in children. The invention is directed to a method comprises providing
at least one blood sample, taken from a subject within a range from about 15 to about 100 minutes following an administration of a sufficient
amount of macimorelin to induce growth hormone secretion, measuring the growth hormone level of each blood sample and compare the level
with a single threshold value to carry out the diagnosis GHD. The method of the invention is a stand-alone test.

  A non-provisional U. S. application named “ Use of macimorelin