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- 40FR12B Initial registration of securities (Canada)
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Exhibit 99.43
Prometic Life Sciences Inc.
FORM 51-102F3
MATERIAL CHANGE REPORT
Item 1 - | Name and Address of the Company |
Prometic Life Sciences Inc.
440 Armand-Frappier Blvd., Suite 300
Laval (Québec) H7V 4B4
(“Prometic” or the “Corporation”)
Item 2 - | Date of Material Change |
August 13, 2018
Item 3 - | News Release |
A press release announcing the material change referred to in this report was issued by Prometic on August 7, 2018 and disseminated on newswires in Canada and United States.
Item 4 - | Summary of Material Change |
Prometic received rare pediatric disease designation from U.S FDA for small molecule drug candidate, PBI-4050.
Item 5 - | Full Description of Material Change |
Prometic Life Sciences Inc. (“Prometic”) announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation to its small molecule drug candidate, PBI-4050, for the treatment of Alström syndrome (AS). In addition to the Rare Pediatric Disease Designation, PBI-4050 was previously granted Orphan Drug Designation by the FDA and the EMA for the treatments of AS and idiopathic pulmonary fibrosis (IPF) as well as PIM (Promising Innovative Medicine) designation by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of IPF and AS.
“This is the first pediatric designation granted by the FDA to our small molecule drug candidate PBI-4050 and the third overall, following the previous two granted for our plasma-derived therapeutics candidates. This highlights the depth and value of our two drug discovery platforms,” said Mr. Pierre Laurin, President and Chief Executive Officer of Prometic. “We look forward to discussing the potential regulatory approval pathway to bring this innovative therapy to pediatric patients with Alström syndrome during our upcoming meeting with the FDA.”
The FDA grants Rare Pediatric Disease Designations for serious or life-threatening diseases wherein the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents. If and when approved, Prometic’s PBI-4050 could be eligible to receive a rare pediatric disease priority review voucher.
Item 6 - | Reliance on subsection 7.1(2) of National Instrument 51-102 |
There is no reliance on subsection 7.1(2) of National Instrument 51-102.
Item 7 - | Omitted Information |
No material information has been omitted in respect of the material change described above.
Item 8 - | Executive Officer |
The foregoing accurately discloses the material change referred to in this report and inquiries in respect of the material change referred to in this report may be made to:
Patrick Sartore
Chief Legal Officer and
Corporate Secretary
(450) 781-0115
p.sartore@prometic.com
Item 9 - | Date of Report |
August 13, 2018
Prometic Life Sciences Inc.
(s) Patrick Sartore |
Patrick Sartore |
Chief Legal Officer and |
Corporate Secretary |