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6-K Filing
Theratechnologies (THTX) 6-KCurrent report (foreign)
Filed: 19 Sep 13, 12:00am
Exhibit 99.1
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
Form 51-102F3
ITEM 1 – NAME AND ADDRESS OF COMPANY
THERATECHNOLOGIES INC.
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4
ITEM 2 – DATE OF MATERIAL CHANGE
September 18, 2013
ITEM 3 – NEWS RELEASE
A news release describing this material change was issued on September 18, 2013 on “Marketwire”. A copy of the news release is available on the SEDAR website at www.sedar.com.
ITEM 4 – SUMMARY OF MATERIAL CHANGE
On September 18, 2013, Theratechnologies Inc. (the “Corporation”) announced that EMD Serono had notified the U.S. Food and Drug Administration (“FDA”) concerning an upcoming shortage of tesamorelin in the United States.
ITEM 5 – FULL DESCRIPTION OF MATERIAL CHANGE
5.1 | Full description of material change |
On September 18, 2013, the Corporation announced that EMD Serono had notified the FDA of an upcoming shortage of tesamorelin in the United States.
EMD Serono has notified the FDA that, after conduction a review of all available supply, EMD Serono estimates a drug shortage will start to occur inmid-October with a completestock-out by mid-November.
To reduce the duration of the shortage, EMD Serono will implement a mitigation plan.
EMD Serono also informed the FDA that lots of tesamorelin are scheduled to be manufactured at the end of September to facilitate drug supply replenishment, which should start by mid-December 2013.
5.2 | Disclosure for restructuring transactions |
Not applicable.
ITEM 6 – RELIANCE ON SUBSECTION 7.1(2) OR (3) OF NATIONAL INSTRUMENT 51-102
Not applicable.
ITEM 7 – OMITTED INFORMATION
Not applicable.
ITEM 8 – EXECUTIVE OFFICER
For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and Corporate Secretary of the Corporation at(514) 336-4804, ext. 288.
ITEM 9 – DATE OF REPORT
September 19, 2013.