UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
May 1, 2014
Commission File Number 001-35203
THERATECHNOLOGIES INC.
(Translation of registrant’s name into English)
2310 Alfred-Nobel Boulevard
Montréal, Québec, Canada
H4S 2B4
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Yes ¨ No x
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Yes ¨ No x
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No x
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-______________.
THERATECHNOLOGIES INC.
| Exhibit |
Description | |
| 99.1 | Material Change Report dated May 1, 2014 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| THERATECHNOLOGIES INC. | ||
| By: | /s/ Jocelyn Lafond | |
| Name: Jocelyn Lafond | ||
| Title: Vice President, Legal Affairs | ||
Date: May 1, 2014
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
April 30, 2014
ITEM 3 – NEWS RELEASE
A news release describing this material change was issued on April 30, 2014 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 April 30, 2014, Theratechnologies Inc. (the “Corporation”) announced that it received a notice of compliance (regulatory approval) from Health Canada for EGRIFTATM (tesamorelin for injection).
The Corporation also announced that it terminated the supply, distribution and licensing agreement entered into in February 2012 with Actelion Pharmaceuticals Canada Inc. (“Actelion”) pursuant to a termination agreement entered into with Actelion and, accordingly, regained all rights to EGRIFTATM in Canada.
ITEM 5 – FULL DESCRIPTION OF MATERIAL CHANGE
5.1 Full description of material change
On April 30 2014, the Corporation announced that it received a notice of compliance (regulatory approval) from Health Canada for EGRIFTATM (tesamorelin for injection).
Consistent with its previously announced decision to resume production of EGRIFTATM (tesamorelin for injection) in its 1mg/vial presentation, the Corporation will file a supplementary new drug submission with Health Canada to obtain authorization to commercialize this presentation.
EGRIFTATM (tesamorelin for injection) is indicated for the treatment of excess visceral adipose tissue, as assessed by waist circumference ³ 95 cm for men and ³ 94 cm for women, and confirmed by a visceral adipose tissue (VAT) level > 130 cm2 by CT scan, in treatment-experienced adult HIV-infected patients. EGRIFTATM is not indicated for weight loss management. Treatment with EGRIFTATM should be limited to patients who failed to reduce excess VAT using diet and exercise. Since the long-term cardiovascular safety and potential long-term cardiovascular benefit of EGRIFTATM treatment have not been studied and are not known, careful consideration should be given whether to continue EGRIFTATM treatment in patients who do not show a clear efficacy response, as judged by the degree of reduction in visceral adipose tissue measured by waist circumference or CT scan. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTATM.
The Corporation also announced that it completed discussions with Actelion to regain marketing rights in Canada. The Corporation and Actelion entered into a termination agreement on April 30, 2014, pursuant to which the Corporation regained all rights under the supply, distribution and licensing agreement entered into in February 2012 (the “Original Agreement”). Consistent with the terms of the Original Agreement pursuant to which no upfront payment was made by Actelion to the Corporation, the termination agreement does not provide for financial compensation to any of the parties involved. As a result, the Corporation will develop its own marketing strategy for Canada which will benefit from key learning experience in the United States.
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
May 1, 2014.