“We are very pleased that Marathon accepted to amend the Credit Facility to allow us to access the second tranche without requiring the filing to the FDA of the HFS related to EGRIFTA SV®. Having reached this agreement with Marathon at this stage speaks to the very good work the team has made thus far on the advancement of the HFS”, said Paul Lévesque, President and CEO, Theratechnologies.
As previously announced, the FDA required the Company to conduct a HFS following our submission to the FDA in March 2021 of a change being effected (“CBE”) supplement to the Instructions For Use (“IFU”) included in the EGRIFTA SV® product labeling after we received complaints from patients relating to the reconstitution of EGRIFTA SV®. The Company implemented the changes to its IFU per the timelines set forth in the regulation. The FDA subsequently responded to our CBE supplement with a complete response letter asking us to carry out a HFS to ensure that patients reconstitute EGRIFTA SV® in the proper manner. We have until September 15, 2023, to resubmit a CBE supplement in response to the letter issued by the FDA. The first part of the HFS, the formative study, has now been completed and the Company filed its proposed HFS protocol with the FDA for its review prior to initiating the summative study. The Corporation has not yet received a response from the FDA on its proposed HFS protocol.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company’s website at www.theratech.com, on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. A copy of the Credit Facility is available on both SEDAR and EDGAR at the addresses set forth above.
About Marathon Asset Management
Marathon is a global credit manager with approximately $20 billion in assets under management as of November 30, 2022. The firm was formed in 1998 by Chairman & CEO Bruce Richards and CIO Louis Hanover. With offices in New York City, Miami, Los Angeles, London, Luxembourg, and Tokyo the firm has approximately 173 employees worldwide. Marathon deploys capital in the public and private credit markets, corporate loans and bonds, emerging market debt and structured credit markets, including real estate and asset-based lending.
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, statements regarding the availability of the US$20 million second tranche under the Credit Facility, compliance with the terms of the Credit Facility and the advancement of the HFS.
2