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MONTREAL, July 31, 2018 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TH.TO) is pleased to announce that the Committee for Medicinal Products for Human Use (¡§CHMP¡¨) of the European Medicines Agency (¡§EMA¡¨) will review the application for marketing authorization of Trogarzo™ (ibalizumab-uiyk) injection under the accelerated assessment procedure.

»X¯S§Qº¸, 2018¦~7¤ë31¤é (Àô²y³q°TªÀ)--Theratechnologies ¤½¥q (Theratechnologies) (¤é­n) °ª¿³¦a«Å§G, ¼Ú¬wÃÄ«~§½ (§¡½u) ªº¤HÃþ¥ÎÃIJ£«~©e­û·| (CHMP) ±N¼f¬d Trogarzo™ (ibalizumab-uiyk) ª`®g²G¦b¥[³tµû¦ôµ{¦¡¡C

The accelerated assessment procedure reduces the timeframe for a recommendation by the CHMP to 150 review days from 210 review days for the normal procedure.

¥[³tµû¦ôµ{¦¡±N CHMP «Øijªº®É¶¡ÁYµu¬°¥¿±`µ{¦¡ªº210­Ó¼f¬d¤éªº150­Ó¼f¬d¤é¡C

¡§This is yet another positive development for Trogarzo™ and Theratechnologies. As we continue preparing the application to the EMA, we are also progressing towards the establishment of our commercial infrastructure in Europe. We will definitely be ready if a positive recommendation is issued by the EMA in the future regarding Trogarzo™,¡¨ said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.

³o¬O Trogarzo™©M Theratechnologies ªº¤S¤@¿n·¥µo®i¡C¦b§Ú­ÌÄ~Äò¬°§¡½u·Ç³Æ¥Ó½Ð®É, §Ú­Ì¤]¦b§V¤O¦b¼Ú¬w«Ø¥ß§Ú­Ìªº°Ó·~°ò¦³]¬I¡CTheratechnologies ¤½¥qÁ`µô­Ý­º®u°õ¦æ©x¿c§J Tanguay (Trogarzo™) »¡: §Ú­Ì¤@©w·|°µ¦n·Ç³Æ, ¦pªG§¡½u¦b±N¨Óµo§G¤F¤@­Ó¿n·¥ªº«Øij¡C

About Theratechnologies

Theratechnologies (TH.TO) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients. Further information about Theratechnologies is available on the Company¡¦s website at www.theratech.com and on SEDAR at www.sedar.com.

Ãö©ó Theratechnologies Theratechnologies (¤é)) ¬O¤@®a±Mªù»sÃĤ½¥q, ³B²z¥¼º¡¨¬ªºÂåÀø»Ý­n, ¥H«P¶i°·±dªº¥Í¬¡©M§ïµ½·R´þ¯f±wªÌªº¥Í¬¡«~½è¡C¦³Ãö Theratechnologies ªº§ó¦h¸ê°T, ¥i¦b www.theratech.com ©M www.sedar.com ¦C¶øªiº¸¼w•¶ë¹F•®á¤àº¸¤½¥qªººô¯¸¤W¬d¾\¡C

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 belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as ¡§may¡¨, ¡§will¡¨, ¡§should¡¨, ¡§could¡¨, ¡§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, the timeline to file a submission with the EMA and Theratechnologies¡¦ capacity to obtain approval for Trogarzo™ in Europe.

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Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies¡¦ control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include but are not limited to, the following: no additional clinical studies will need to be conducted to obtain approval of TrogarzoTM from the EMA, no event will delay the timeline to file a marketing authorization application with the EMA, and TrogarzoTM will be appro

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There are now an estimated 19.5 million people worldwide living with HIV and receiving antiretroviral therapy (ART). That¡¦s approximately half of all people thought to be living with the virus in 2017 ¡X an extraordinary achievement in global health and human solidarity. The United Nations agencies, led by ¡¯the Joint United Nations Program on HIV/AIDS (¡¯UNAIDS) and the World Health Organization (WHO), have committed to the goals of ending the AIDS pandemic as a public health threat by 2030 and ensuring that by 2020, 90% of people with HIV infection know they have it, 90% of those infected are receiving ART, and sustained viral suppression is achieved in 90% of those receiving treatment.1 This last goal is critically important both to individual health and survival and to epidemic control of HIV, since data continue to mount showing that viral suppression greatly reduces the risk of continued transmission ¡X whether sexual or perinatal ¡X of the virus.

²{¤µ¥þ¥@¬É¦ô­p¦³¤@¤d¤E¦Ê¤­¤Q¸U¤H»PHIV¦@¦s¡A¨Ã¥B¥¿¦b±µ¨ü§Ü¤ÏÂà¿ý¯f¬r(ART)ªºªvÀø¡C ¤H¼Æ¬ù²¤¦û2017¦~³Q»{¬°»P¯f¬r¦@¦sªºÁ`¤H¼Æªº¤@¥b¡A¦¹¬°¥þ²y°·±d¥H¤Î¤HÃþ¹Îµ²ªº¨ô¶V¦¨´N¡C ¥Ñ¡¯Áp¦X°ê·R´þ¯f³W¹º¸p(¡¯UNAIDS) »P¥@¬É½Ã¥Í²Õ´¡]WHO¡^©Ò¦@¦P»â¾ÉªºÁp¦X°ê¾÷ºc¡Aªø¤[¥H¨Ó­P¤O©ó¦b2030¦~¥H«e²×µ²³Qµø¬°¤½¦@½Ã¥Í«Â¯ÙªºAIDS¬y¦æ¶Ç¬V¯f¡A¨Ã¥B½T«O¦b2020¦~¥H«e¡A·P¬VHIV±wªÌ¤¤¦Ê¤À¤§¤E¤Qª¾¹D¦Û¤v³Q·P¬V¡A¦Ó³Q·P¬Vªº¯f±w¤¤ªº¦Ê¤À¤§¤E¤Q¥¿¦b±µ¨ü§Ü¤ÏÂà¿ý¯f¬rªvÀø¡A¥B¥¿¦b±µ¨üªvÀøªº±wªÌ·í¤¤¦Ê¤À¤§¤E¤Q¹F¨ì¦¨¥\À£¨î¯f¬r¡C ¥Ñ©ó·s¼W¼Æ¾ÚÅã¥ÜÀ£¨î¯f¬r¼Æ¶q¤j´T«×­°§C - µL½×¬O©Ê±µÄ²¡A©ÎªÌ¬O°M®W«e«á¶Ç¬V¯f¬rªº­·ÀI¡A¦]¦¹¡A³Ì«á¤@­Ó¥Ø¼Ð¡]¥¿¦b±µ¨üªvÀøªº±wªÌ·í¤¤¦Ê¤À¤§¤E¤Q¹F¨ì¦¨¥\À£¨î¯f¬r¡^µL½×¬O¹ï©ó­Ó¤H°·±d¡B¥Í¦s¥H¤Î HIV¬y¦æ¶Ç¬V¯fªº±±¨î¦Ó¨¥¡A³£¬O¦ÜÃö­«­nªº¡C

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It would arguably be enormously difficult to achieve epidemic control simply by expanding ART. Too many people and communities ¡X from adolescents in Africa, to sexual minorities and transgender people in many countries, to injection-drug users in Eastern Europe and Central Asia ¡X are currently excluded from care. We believe that enhanced primary prevention of infection, by means of targeted use of ¡¯preexposure prophylaxis (PrEP) for people at substantial risk and probably a preventive vaccine, will be required for ultimate control. Nevertheless, treatment can have ¡X and is having ¡X substantial effects on the rate of new infections, including in some of the world¡¦s most HIV-burdened countries, as shown by recent data from Swaziland.2 The emergence of HIV ¡¯drug resistance is a very real threat to these gains.

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