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Results Presented at 9th IAS Conference on HIV Science (IAS 2017) in Paris, France MONTREAL, QUEBEC--(Marketwired - July 24, 2017) - Theratechnologies Inc. (Theratechnologies) (TSX:TH) announced today that results on HIV susceptibility to ibalizumab from the Phase IIb trial, TMB-202, along with new findings for EGRIFTA® (tesamorelin for injection), are being presented during poster sessions at the 9th IAS Conference on HIV Science (IAS 2017) in Paris, France. The Phase II data for ibalizumab, a long-acting monoclonal antibody, show no significant difference in susceptibility (measured by maximum percent inhibition or IC Fold Change) in patient HIV isolates that were either sensitive or resistant to other antiretroviral agents, including nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors, enfuvirtide and maraviroc. "HIV drug resistance is a key topic at the IAS conference this year, and these findings are particularly important as they suggest that ibalizumab is equally active against HIV whether it is resistant or responsive to approved antiretroviral agents," said Steve Weinheimer, Vice President, Biological Sciences at TaiMed Biologics USA. "On the heels of the BLA acceptance for priority review, these data provide additional support for ibalizumab as a potential tool for the treatment of multidrug resistant HIV-1," added Mr. Weinheimer. In a retrospective analysis of datasets from two, multicenter, randomized placebo-controlled trials of EGRIFTA® among HIV-infected adults with lipodystrophy, fat in trunk muscles decreased and trunk muscle area increased over 26 weeks in patients with excess visceral adipose tissue (VAT, abdominal fat) who had shown a clinical response to EGRIFTA® (VAT decrease of 8 percent or more). These results were seen across a number of trunk muscle groups and were independent of the change in amount of VAT for many of the measures. "This is the first study to evaluate changes in trunk muscle fat (both abdominal and spine musculature) in HIV patients who have responded to tesamorelin," said Kristine Erlandson, MD, Assistant Professor of Medicine, Divisions of Infectious Disease and Geriatric Medicine, University of Colorado. "We are pleased to continue to uncover new information on the potential effects of tesamorelin in HIV patients with excess abdominal fat," added Dr. Erlandson. EGRIFTA® is not indicated for trunk muscle fat decrease. Ibalizumab is an investigational humanized monoclonal antibody being developed for the treatment of multidrug resistant HIV-1 infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents. Ibalizumab is currently under review by the FDA following the acceptance of a Biologics License Application on June 30, 2017. EGRIFTA® is indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Do not use EGRIFTA® if you: In clinical trials, the most common EGRIFTA® adverse reactions occurring in >5% of patients during the 26-week main phase of the combined studies included hypersensitivity reactions, reactions due to the effect of GH including arthralgia, extremity pain, peripheral edema, and myalgia, and injection site reactions including injection site erythema and pruritis. For complete disclosure of EGRIFTA® product information, please read the Full Prescribing Information, Patient Information, and Patient Instructions for Use. For more information about EGRIFTA®, contact the EGRIFTA ASSIST™ toll-free at 1-844-347-EGRIFTA or 1-844-347-4382. To report suspected adverse reactions, contact the EGRIFTA ASSIST™ toll-free or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy ageing 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. This press release contains statements that are considered forward-looking information ("FLI") within the meaning of 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 approval of ibalizumab in the United States for the treatment of MDR HIV-1 infected patients, the effect of ibalizumab to treat HIV and, more particularly, the treatment of multidrug resistant HIV-1, and the growth of Theratechnologies based on such approval. 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: ibalizumab will be approved by the FDA for the treatment of MDR HIV-1 infected patients and, if approved, Theratechnologies will have set-up on time the necessary infrastructure to launch and commercialize ibalizumab in the United States, and ibalizumab will be well received by the marketplace. These risks and uncertainties include, but are not limited to, the risk that the FDA does not approve ibalizumab as a treatment for MDR HIV-1 infection and, if approved, that the FDA imposes a significant limitation on its use resulting in a smaller patient population who could benefit from ibalizumab, that additional clinical trials are requested to be conducted prior to approving, or post-approval of, ibalizumab, that sales of EGRIFTA® decrease or that untoward side effects become known leading to a recall or the withdrawal of EGRIFTA® from the market. We refer potential investors to the "Risk Factors" section of our Annual Information Form (AIF) dated February 7, 2017 for additional risks and uncertainties about Theratechnologies. The AIF is available on the Company's website at www.theratech.com and on SEDAR at www.sedar.com. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.


The Phase II data for ibalizumab, a long-acting monoclonal antibody, show no significant difference in susceptibility (measured by maximum percent inhibition or IC Fold Change) in patient HIV isolates that were either sensitive or resistant to other antiretroviral agents, including nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors, enfuvirtide and maraviroc. "HIV drug resistance is a key topic at the IAS conference this year, and these findings are particularly important as they suggest that ibalizumab is equally active against HIV whether it is resistant or responsive to approved antiretroviral agents," said Steve Weinheimer, Vice President, Biological Sciences at TaiMed Biologics USA. "On the heels of the BLA acceptance for priority review, these data provide additional support for ibalizumab as a potential tool for the treatment of multidrug resistant HIV-1," added Mr. Weinheimer. In a retrospective analysis of datasets from two, multicenter, randomized placebo-controlled trials of EGRIFTA® among HIV-infected adults with lipodystrophy, fat in trunk muscles decreased and trunk muscle area increased over 26 weeks in patients with excess visceral adipose tissue (VAT, abdominal fat) who had shown a clinical response to EGRIFTA® (VAT decrease of 8 percent or more). These results were seen across a number of trunk muscle groups and were independent of the change in amount of VAT for many of the measures. "This is the first study to evaluate changes in trunk muscle fat (both abdominal and spine musculature) in HIV patients who have responded to tesamorelin," said Kristine Erlandson, MD, Assistant Professor of Medicine, Divisions of Infectious Disease and Geriatric Medicine, University of Colorado. "We are pleased to continue to uncover new information on the potential effects of tesamorelin in HIV patients with excess abdominal fat," added Dr. Erlandson. EGRIFTA® is not indicated for trunk muscle fat decrease. Ibalizumab is an investigational humanized monoclonal antibody being developed for the treatment of multidrug resistant HIV-1 infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents. Ibalizumab is currently under review by the FDA following the acceptance of a Biologics License Application on June 30, 2017. EGRIFTA® is indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Do not use EGRIFTA® if you: In clinical trials, the most common EGRIFTA® adverse reactions occurring in >5% of patients during the 26-week main phase of the combined studies included hypersensitivity reactions, reactions due to the effect of GH including arthralgia, extremity pain, peripheral edema, and myalgia, and injection site reactions including injection site erythema and pruritis. For complete disclosure of EGRIFTA® product information, please read the Full Prescribing Information, Patient Information, and Patient Instructions for Use. For more information about EGRIFTA®, contact the EGRIFTA ASSIST™ toll-free at 1-844-347-EGRIFTA or 1-844-347-4382. To report suspected adverse reactions, contact the EGRIFTA ASSIST™ toll-free or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy ageing 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. This press release contains statements that are considered forward-looking information ("FLI") within the meaning of 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 approval of ibalizumab in the United States for the treatment of MDR HIV-1 infected patients, the effect of ibalizumab to treat HIV and, more particularly, the treatment of multidrug resistant HIV-1, and the growth of Theratechnologies based on such approval. 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: ibalizumab will be approved by the FDA for the treatment of MDR HIV-1 infected patients and, if approved, Theratechnologies will have set-up on time the necessary infrastructure to launch and commercialize ibalizumab in the United States, and ibalizumab will be well received by the marketplace. These risks and uncertainties include, but are not limited to, the risk that the FDA does not approve ibalizumab as a treatment for MDR HIV-1 infection and, if approved, that the FDA imposes a significant limitation on its use resulting in a smaller patient population who could benefit from ibalizumab, that additional clinical trials are requested to be conducted prior to approving, or post-approval of, ibalizumab, that sales of EGRIFTA® decrease or that untoward side effects become known leading to a recall or the withdrawal of EGRIFTA® from the market. We refer potential investors to the "Risk Factors" section of our Annual Information Form (AIF) dated February 7, 2017 for additional risks and uncertainties about Theratechnologies. The AIF is available on the Company's website at www.theratech.com and on SEDAR at www.sedar.com. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.


News Article | July 12, 2017
Site: www.marketwired.com

MONTREAL, QUEBEC--(Marketwired - July 12, 2017) - Theratechnologies Inc. (Theratechnologies) (TSX:TH) today announced its financial results for the second quarter ended May 31, 2017. 1 See "Non-IFRS Financial Measures" below "Our second quarter results are characterized by continued EGRIFTA® revenue growth and significant planned investments required to prepare for the launch of ibalizumab. As a matter of fact, EGRIFTA® sales are the best we ever recorded for a second quarter. This was achieved without having started to reap the benefits from the expanded sales contingent which is now fully operational and will extend our reach to almost 5,000 U.S. physicians instead of 1,100. Already, we are seeing the positive impact of the expanded sales team," said Luc Tanguay, President and CEO, Theratechnologies Inc. "We also achieved several milestones towards the launch of ibalizumab in the second quarter. The Biologics Licence Application was completed, we reached an agreement with our partner, TaiMed Biologics Inc., for the commercial rights to ibalizumab in Europe and we just received confirmation from the FDA that ibalizumab will be evaluated under the priority review process with a target action date of January 3rd, 2018. Ever since we acquired the rights to ibalizumab in the United States, our goal has been to have the right team in place to ensure an optimal launch if a positive decision is received from the FDA. I am quite satisfied with our level of preparedness at this stage," concluded Mr. Tanguay. The financial results presented in this press release are taken from the Company's Management's Discussion and Analysis, or MD&A, and unaudited consolidated financial statements for the period ended May 31, 2017, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. The MD&A for the second quarter ended May 31, 2017 and the unaudited consolidated financial statements can be found at www.theratech.com and www.sedar.com. Unless specified otherwise, all amounts in this press release are in Canadian dollars and all capitalized terms have the meaning ascribed thereto in our MD&A. As used herein, EGRIFTA® refers to tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. EGRIFTA® is our registered trademark. There is no change in our previously reported guidance. Net sales revenue of EGRIFTA® for fiscal 2017 is expected to be in the range of $44,000,000 to $46,000,000. Adjusted EBITDA for fiscal 2017 is expected to be in the range of $(2,000,000) to $(3,000,000). See "Non-IFRS Financial Measures" below. An assumed average exchange rate of USD 1 = CAD 1.32 was used in providing this guidance. Consolidated revenue for the three- and six-month periods ended May 31, 2017 was $10,016,000 and $19,051,000 compared to $9,027,000 and $17,770,000 in the comparable periods of fiscal 2016. Revenue generated from net sales in the three- and six-month periods ended May 31, 2017 was $10,015,000 and $19,049,000 compared to $9,026,000 and $17,767,000 in the comparable periods of fiscal 2016. Revenue in 2017 is benefitting from increased unit volumes, higher prices and positive currency fluctuations, gains that were partially offset by changes in the mix of participating third-party payors that reduced the average net selling price. For the three- and six-month periods ended May 31, 2017, the cost of sales was $2,041,000 and $4,091,000 compared to $1,657,000 and $3,026,000 in the comparable periods of fiscal 2016. The cost of goods sold was $1,179,000 and $2,265,000 compared to $1,017,000 and $2,072,000 in the comparable periods of fiscal 2016. A reversed inventory provision of $172,000 resulted in a gain of $125,000 in other production-related costs in the second quarter of fiscal 2017; for the six-month period the expense was $53,000. This compares with gains due to reversals of inventory provisions of $26,000 and $60,000 in the comparable periods of fiscal 2016. Finally, cost of sales in the three- and six-month periods ended May 31, 2017 included royalties of $987,000 and $1,773,000 respectively compared to $666,000 and $1,014,000 in the comparable periods of fiscal 2016. Royalties became payable on EGRIFTA® sales starting January 1, 2016 under the terms of an agreement with EMD Serono, Inc. The royalty percentage varies according to sales levels and the percentage being applied in fiscal 2017 is a blended rate based on expected sales for the year. R&D Expenses in the three- and six-month periods ended May 31, 2017 amounted to $3,654,000 and $5,674,000 compared to $2,134,000 and $4,018,000 in the comparable periods of fiscal 2016. The 2017 periods include non-recurring costs associated with a batch of the F4 formulation of EGRIFTA®, produced for bio-equivalency testing, as well as the ongoing cost of additional staff members in our medical science liaison group to increase awareness about excess abdominal fat in HIV-infected patients with lipodystrophy and about multi-drug resistant HIV-1. R&D expenses also include costs associated with our two Phase 4 clinical trials, which amounted to $632,000 and $1,079,000 in the three- and six-month periods ended May 31, 2017 compared to $638,000 and $1,324,000 in the comparable periods of fiscal 2016. Other components of R&D expenses include regulatory affairs and quality assurance. Selling and Market Development Expenses in the three- and six-month periods ended May 31, 2017 amounted to $7,191,000 and $10,958,000 compared to $3,333,000 and $7,236,000 in the comparable periods of fiscal 2016. The second quarter of 2017 included approximately $2,500,000 of costs associated with the planned expansion of our sales team. Approximately $600,000 of this amount is non-recurring as it relates to the implementation phase of the expansion. We also added staff to our managed markets and reimbursement groups; initiated preparatory work on branded and non-branded ibalizumab campaigns and began devising a pricing strategy for ibalizumab. Amortization of the intangible asset value established for the EGRIFTA® commercialization rights amounted to $509,000 and $1,008,000 in the three- and six-month periods ended May 31, 2017, compared to $491,000 and $1,016,000 in the prior-year periods. The year-over-year increase also reflects the growth in our business and intensified marketing efforts generally and because most of our selling and market development expenses are incurred in the United States, part of the increase is attributable to changes in the value of the CAD versus the USD. General and Administrative Expenses in the three- and six-month periods ended May 31, 2017 amounted to $1,698,000 and $2,932,000, compared to $1,109,000 and 2,192,000 reported in the comparable periods of fiscal 2016. The granting of stock options to members of the Company's board of directors as part of the annual compensation plan resulted in a non-cash expense of $297,000 in the second quarter of 2017. In fiscal 2016, the stock option grant was made in the third quarter. The balance of the increased expense in 2017 is attributable to the growth and development of the business. Finance costs for the three- and six-month periods ended May 31, 2017 were $4,625,000 and $6,897,000 compared to $1,323,000 and $2,008,000 in the comparable periods of fiscal 2016. These costs are almost entirely non-cash items. Finance costs in the second quarter of 2017 included a loss of $4,020,000 related to an increase in the fair value of outstanding warrants compared to a loss of $1,023,000 in the comparable period of fiscal 2016. Finance costs for the three- and six-month periods ended May 31, 2017 also included $384,000 and $802,000 of accretion expense on the Long-term obligation, compared to $507,000 and $1,101,000 in the comparable periods of fiscal 2016. Adjusted EBITDA for the three- and six- month periods ended May 31, 2017 was $(3,739,000) and $(3,014,000) compared to $1,362,000 and $2,464,000 in the comparable periods of fiscal 2016. In accordance with our plans, Adjusted EBITDA in fiscal 2017 is being negatively affected by the non-recurring expenses described above as well as the investments made in organizational expansion. For a reconciliation of net loss and Adjusted EBITDA see "Non-IFRS Financial Measures" below. Taking into account the revenue and expense variations described above, in particular non-recurring expenses, the investments made in organizational expansion and the $4,020,000 increase in the fair value of outstanding warrants, we recorded a net loss of $9,109,000 or $(0.13) per share in the three months ended May 31, 2017 compared to a net loss of $498,000 or $(0.01) per share in the comparable period of fiscal 2016. In the six-month period ended May 31, 2017 the net loss was $11,352,000 or $(0.16) per share compared to a net loss of $651,000 or $(0.01) per share in the comparable period of fiscal 2016. As at May 31, 2017, cash, cash equivalents and bonds amounted to $29,603,000 compared to $11,603,000 at November 30, 2016. In the second quarter of fiscal 2017, changes in operating assets and liabilities had a positive impact on cash flow of $3,898,000. These changes, which reflect the growth of our business and organizational expansion, included an increase in trade and other receivables of $1,840,000 and a $5,682,000 increase in accounts payable and accrued liabilities. In the first six months of fiscal 2017, changes in operating assets and liabilities positively affected cash flow by $5,761,000 compared to decrease in cash flow of $1,843,000 in the comparable period of fiscal 2016. As was the case in the second quarter, the most significant changes were an increase in trade and other receivables of $1,256,000, and increased accounts payable and accrued liabilities of $6,292,000. Overall, operating activities used $88,000 of cash in the three months ended May 31, 2017, compared to cash flow generated from operating activities of $233,000 in the comparable period of fiscal 2016. In the six-month periods, cash flows from operating activities were $2,472,000 in 2017 compared to $622,000 in 2016. Since the end of the second quarter ended May 31, 2017, 353,150 common share purchase warrants, issued in 2015, were exercised and 353,150 common shares were issued for a cash consideration of $1,059,000. Reconciliation of net profit or loss to adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA) Adjusted EBITDA is a non-IFRS financial measure. A reconciliation of the Adjusted EBITDA to net profit (loss) is presented in the table below. We use adjusted financial measures to assess our operating performance. Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than IFRS do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. We use Adjusted EBITDA to measure operating performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our business, and because we believe it provides meaningful information on our financial condition and operating results. We obtain our Adjusted EBITDA measurement by adding to net profit or loss, finance income and costs, depreciation and amortization, and income taxes. We also exclude the effects of certain non-monetary transactions recorded, such as share-based compensation for the stock option plan and write-downs of inventories, for our Adjusted EBITDA calculation. We believe it is useful to exclude these items as they are either non-cash expenses, items that cannot be influenced by management in the short term, or items that do not impact core operating performance. Excluding these items does not imply they are necessarily nonrecurring. Share-based compensation costs are a component of employee remuneration and can vary significantly with changes in the market price of the Company's shares. In addition, other items that do not impact core operating performance of the Company may vary significantly from one period to another. As such, Adjusted EBITDA provides improved continuity with respect to the comparison of our operating results over a period of time. Our method for calculating Adjusted EBITDA may differ from that used by other companies. A conference call will be held today at 8:30 a.m. (ET) to discuss the results. The call will be hosted by Luc Tanguay, President and Chief Executive Officer. The conference call will be open to questions from financial analysts. Media and other interested individuals are invited to participate in the call on a "listen-only" basis. The conference call can be accessed by dialling 1-877-223-4471 (North America) or 1-647-788-4922 (International). The conference call will also be accessible via webcast at http://www.gowebcasting.com/8535. Audio replay of the conference call will be available until July 26, 2017, by dialling 1-800-585-8367 (North America) or 1-416-621-4642 (International) and by entering the playback code 37967002. Theratechnologies (TSX:TH) 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 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", "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 our anticipated revenue for EGRIFTA® and adjusted EBITDA for the 2017 fiscal year, the approval of ibalizumab by the FDA, our future growth in relation to the 2017 organizational expansion and our capacity to reach a certain number of physicians. Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: sales of EGRIFTA® will continue to grow and we will meet our guidance on anticipated revenue of EGRIFTA® and our anticipated Adjusted EBITDA for the 2017 fiscal year, the USD/CAD exchange rate will not vary during the 2017 fiscal year, the FDA will not issue any order or decision negatively affecting the commercialization of EGRIFTA® in the United States, the timing regarding the issuance of a decision regarding the BLA for ibalizumab will be met, the FDA will approve ibalizumab, and, if approved by the FDA, ibalizumab will be accepted by both patients and physicians, and our commercial infrastructure will be adequate to commercialize ibalizumab, . Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this press release. Some of those risks include a decrease in sales of EGRIFTA® during the 2017 fiscal year, a recall of EGRIFTA®, the issuance of an order or decision by the FDA negatively affecting the commercialization of EGRIFTA®, the non-approval of ibalizumab by the FDA and, even if approved, our incapacity to launch and commercialize ibalizumab. We refer potential investors to the "Risk Factors" section of our Annual Information Form dated February 7, 2017 for additional risks and uncertainties regarding our business. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.


News Article | July 7, 2017
Site: www.marketwired.com

MONTREAL, QUEBEC--(Marketwired - July 5, 2017) - Theratechnologies Inc. (TSX:TH) (Theratechnologies) announced today that it will issue its financial results for its second quarter ended May 31, 2017, on Wednesday, July 12, 2017, before markets open. A conference call will be held the same day at 8:30 a.m. (ET) to discuss the results. The call will be hosted by Luc Tanguay, President and Chief Executive Officer. The conference call will be open to questions from financial analysts. Media and other interested individuals are invited to participate in the call on a "listen-only" basis. The conference call can be accessed by dialling 1-877-223-4471 (North America) or 1- 647-788-4922 (International). The conference call will also be accessible via webcast at http://www.gowebcasting.com/8535. Audio replay of the conference call will be available two hours after the completion of the call and until July 26, 2017, by dialling 1-800-585- 8367 (North America) or 1-416-621-4642 (International) and by entering the playback code 37967002. Theratechnologies (TSX:TH) 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.


Biologics License Application (BLA) Accepted for Review with a Target Action Date of January 3, 2018 MONTREAL, CANADA--(Marketwired - June 30, 2017) - Theratechnologies Inc. (Theratechnologies) (TSX:TH) today announced that it has been notified by its partner, TaiMed Biologics, Inc., that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing. "We are excited to be one step closer to potentially bringing an important new treatment, with a new mechanism of action, to patients whose virus has become resistant to therapies in multiple classes and have limited treatment options for the long-term management of their condition," said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc. "The granting of Priority Review status is important since it confirms that, if approved, ibalizumab would represent a significant improvement in the treatment of this serious condition," added Mr. Tanguay. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 3, 2018, for the ibalizumab application. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance. In addition, ibalizumab received Breakthrough Therapy designation from the FDA in 2015, which is given if a therapy may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. The FDA also granted Orphan Drug designation in 2014. The BLA, submitted on May 3, 2017, is based on data from the phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen (OBR) in treatment-experienced patients who had high pre-existing levels of drug resistance and advanced clinical disease. The ibalizumab Expanded Access Program (EAP), or study TMB-311, is ongoing and enrolling patients. For more information about TMB-311 (NCT02707861), please refer to the ClinicalTrials.gov website (www.clinicaltrials.gov) or the study website (www.ibalizumab-eap.com). As HIV multiplies in the body, the virus may mutate to produce drug-resistant strains. Viral mutations may mean that HIV medicines that previously controlled a person's virus are no longer effective, causing treatment to fail. There are approximately 20,000 to 25,000 Americans with HIV-1 that are resistant to at least one drug out of the three different classes of antiretroviral therapies. Up to 12,000 of these patients experience a virological failure over a period of 48 weeks of treatment, requiring their physician to modify their treatment. Ibalizumab is an investigational humanized monoclonal antibody being developed for the treatment of MDR HIV-1 infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents. Theratechnologies (TSX:TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy ageing 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. This press release contains statements that are considered forward-looking information ("FLI") within the meaning of 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 approval of ibalizumab in the United States for the treatment of MDR HIV-1 infected patients, the target action date based on PDUFA, the approximate number of HIV Americans resistant to at least one drug out of three classes of antiretroviral therapies, the number of patients experiencing a virological failure and the growth of Theratechnologies based on such approval. 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: ibalizumab will be approved by the FDA for the treatment of MDR HIV-1 infected patients and, if approved, Theratechnologies will have set-up on time the necessary infrastructure to launch and commercialize ibalizumab in the United States, the target action date is accurate, the data obtained on the number of HIV Americans resistant to at least one drug out of three classes of antiretroviral therapies and the number of patients experiencing a virological failure are accurate and ibalizumab, if approved, will be well received by the marketplace. These risks and uncertainties include, but are not limited to, the risk that the FDA does not approve ibalizumab as a treatment for MDR HIV-1 infection and, if approved, that the FDA imposes a significant limitation on its use resulting in a smaller patient population who could benefit from ibalizumab, our data regarding the number of HIV Americans resistant to at least one drug out of three classes of antiretroviral therapies and the number of patients experiencing a virological failure are not accurate which could result in a smaller market for ibalizumab. We refer potential investors to the "Risk Factors" section of our Annual Information Form (AIF) dated February 7, 2017 for additional risks and uncertainties about Theratechnologies. The AIF is available on the Company's website at www.theratech.com and on SEDAR at www.sedar.com. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.


News Article | May 9, 2017
Site: www.prnewswire.com

Another research by Global Market Insights indicates that strong R&D spending trends for synthetic biology to enable drug and vaccine development, including Europe NEST program will stimulate growth. Organizations including DBT (Department of Biotechnology) and NTBT (National Biotechnology Board) provides funding for promoting biotechnology market share. The U.S. biotechnology market size held a dominant position in terms of industry revenue share, with Europe following. This trend is likely to continue throughout the forecast period. The U.S. will further see increased adoption of products based on these platforms, as growth for personalized medicine becomes a preference. Quest PharmaTech Inc. (TSX-V: QPT) is a pharmaceutical company developing and commercializing products to improve the quality of life. Just this morning the company announced that its subsidiary, OncoQuest Inc. ("OncoQuest"), a biopharmaceutical company focused on the development and commercialization of immunotherapeutic products for the treatment of cancer has completed the enrollment of the first patient in a Phase 1/2 clinical study to evaluate the use of oregovomab in combination with Nivolumab, an anti-PD1 human monoclonal antibody which works as a checkpoint inhibitor in ovarian cancer patients in the recurrent setting. This clinical trial is being conducted at the National Cancer Centre in Singapore ("NCCS"), with Dr. Tira Tan as Principal Investigator, Adjunct Associate Professor John Chia from Oncocare Cancer Centre as the Study Chair, and Dr. Jack Chan as the co-chair. "We are extremely excited about launching this study," noted Dr. John Chia. "Ovarian cancer is a lethal disease, and this trial may offer new hope for our patients. Early clinical data suggests that oregovomab may improve the immune system's processing of cancer antigens, and enhance the immune ability to recognize these cancer targets. We believe that the combination of oregovomab and Nivolumab, which amplifies such immune activity, will have a synergistic effect to elicit a higher quality tumor immune response, and hence improve control of the cancer." This will be the first clinical trial testing the combination of oregovomab with a checkpoint inhibitor as potential treatment of ovarian cancer in the recurrent setting. "We continue to explore the potential of oregovomab in various stages of the progression of ovarian cancer," said Dr. Madiyalakan, CEO of Quest and OncoQuest. In frontline ovarian cancer, OncoQuest has recently announced positive interim results from its randomized controlled multi-center Phase 2 clinical trial with oregovomab as an indirect immunizer, in scheduled combination with carboplatin and paclitaxel. "In the recurrent setting, we are exploring the use of oregovomab with immune adjuvants in two clinical trials. The trial NCCS is conducting is in combination with a checkpoint inhibitor. We are also in the process of initiating a trial in U.S. in combination with a TLR3 agonist, Hiltonol®," continued Dr. Madiyalakan. Theratechnologies Inc. (OTC: THERF) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients. Recently, the company announced that its partner, TaiMed Biologics, Inc., has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ibalizumab for the treatment of multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing. CRH Medical Corporation (NYSE: CRHM) is a North American company focused on providing gastroenterologists throughout the United States with innovative services and products for the treatment of gastrointestinal diseases. On March 15, 2017, the company announced that it has completed an accretive transaction whereby CRH has acquired a 60% interest in a gastroenterology ("GI") anesthesia practice in Kissimmee Florida ("Kissimmee"). CRH also announces that it has entered into an exclusive agreement to develop and manage a monitored anesthesia care ("MAC", or "Deep Sedation") program with Puget Sound Gastroenterology ("PSG"), located in Washington State. Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) a clinical stage biopharmaceutical company focused on the global immunology market, today announced additional 48-week results from its global Phase IIb AURA-LV (AURA) study in lupus nephritis (LN) during the National Kidney Foundation 2017 Spring Clinical Meetings in Orlando, FL. In addition to the trial meeting its complete and partial remission ("CR"/"PR") endpoints at 48 weeks, all pre-specified secondary endpoints that have been analyzed to date were also met at 48 weeks. These pre-specified endpoints include: time to CR and PR (speed of remission); reduction in Systemic Lupus Erythematosus Disease Activity Index or SLEDAI score; and reduction in urine protein creatinine ratio (UPCR) over the 48-week treatment period. The data were presented during the late-breaking session by lead author Dr. Samir Parikh, a clinical investigator for the study and Assistant Professor of Clinical Nephrology at the Ohio State University. Concordia International Corp. (NASDAQ: CXRX) together with its subsidiaries is an international specialty pharmaceutical company focused on generic and legacy pharmaceutical products and orphan drugs. On January 3rd, the company announced it has entered into a three-year, co-promotion agreement with RedHill Biopharma Ltd. through which the companies expect to expand sales of Donnatal®, Concordia's product used in the treatment of irritable bowel syndrome. Concordia's North America segment seeks to acquire and manage drugs that are in the maturity or legacy stage of the pharmaceutical product lifecycle and continue on a predictable revenue generation path. These products have a well-established record of safety and efficacy and a history of stable demand. Please Sign Up Now at http://www.FinancialBuzz.com to receive alerts on Trending Financial News from all these companies. "The Latest Buzz in Financial News" Subscribe Now! 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Patent
Theratechnologies | Date: 2012-01-11

Improved methods for determining normal IGF-1 levels in HIV infected subjects, based on a determination of the log of IGF-1 values obtained in blood-derived samples from a population of HIV-infected subjects, are disclosed. Also disclosed are methods of determining whether a given HIV-infected subject exhibits a normal IGF-1 level, based on a comparison of either the IGF-1 value or the log of the IGF-1 value obtained from a blood-derived sample of the subject with a normative IGF-1 range determined using the exponentiation of the log of IGF-1 values or the log of IGF-values obtained in blood-derived samples from a population of age- and gender-matched HIV-infected subjects. Such methods are useful for example to monitor GH stimulation therapy in HIV-infected subjects.


Stabilized solid and liquid pharmaceutical formulations comprising a GRF molecule as active ingredient, such as GRF analogs including those comprising an N-terminal-attached hydrophobic moiety, such as [trans-3-hexenoyl]hGHRH (1-44) amide, are disclosed. The formulation comprises a GRF molecule or a pharmaceutically acceptable salt thereof and a -cyclodextrin which is not conjugated to the GRF molecule or salt thereof. Also disclosed is the use of the formulation for the treatment of various conditions, methods of preparing the formulation, as well as kits containing it. Methods of stabilizing (e.g., with respect to chemical stability) such GRF molecules, as well as methods of inhibiting their deamidation at Asn^(8), are also disclosed.


Patent
Theratechnologies | Date: 2012-04-17

Novel GRF analogs having GRF activity are described herein, as well as uses thereof for example as a GRF receptor agonist, e.g., to induce growth hormone secretion in a subject or biological system.


Patent
Theratechnologies | Date: 2012-10-18

Peptide compounds derived from human melanotransferrin, and compositions thereof, are described. Uses of these peptide compounds, for example to modulate angiogenesis and/or cell migration, and/or to treat angiogenesis-related disorders (e.g., cancer), are also described.

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