Home Health Products BioSyent Announces Health Canada Approval of New Women’s Health Product – Yahoo Finance

BioSyent Announces Health Canada Approval of New Women’s Health Product – Yahoo Finance

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<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="TORONTO, May 13, 2019 (GLOBE NEWSWIRE) — BioSyent Inc. (“BioSyent”, “the Company”, TSX Venture: RX) announces that Health Canada has approved Tibella® (tibolone), indicated for the short-term treatment of vasomotor symptoms due to estrogen deficiency in postmenopausal women, more than one year after menopause.&nbsp; BioSyent Pharma Inc., a subsidiary of the Company, has exclusive distribution rights in Canada for this drug.&nbsp;&nbsp;
” data-reactid=”11″>TORONTO, May 13, 2019 (GLOBE NEWSWIRE) — BioSyent Inc. (“BioSyent”, “the Company”, TSX Venture: RX) announces that Health Canada has approved Tibella® (tibolone), indicated for the short-term treatment of vasomotor symptoms due to estrogen deficiency in postmenopausal women, more than one year after menopause.  BioSyent Pharma Inc., a subsidiary of the Company, has exclusive distribution rights in Canada for this drug.  

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="“We are pleased to have received an approval from Health Canada for Tibella®,” said René Goehrum, President and CEO of BioSyent. &nbsp;&nbsp;“This product complements and enhances the existing portfolio of women’s health products in our Community and Women’s Health Business and we are looking forward to launching a proven product for a large and growing patient population.”” data-reactid=”12″>“We are pleased to have received an approval from Health Canada for Tibella®,” said René Goehrum, President and CEO of BioSyent.   “This product complements and enhances the existing portfolio of women’s health products in our Community and Women’s Health Business and we are looking forward to launching a proven product for a large and growing patient population.”

Dr. Robert Reid MD, Gynaecologist and Adjunct Professor at the Department of Obstetrics and Gynaecology, Queen’s University, commented, “Available hormonal treatment options for menopausal vasomotor symptoms while generally effective are often accompanied by side effects related to combination therapies that add a progestational agent to estrogen therapy as a protection against endometrial neoplasia. As a result, many women discontinue therapy and seek help from complementary and alternative medicines that are mostly unregulated, unproven and lacking safety information.”  Dr. Reid continued,  “Tibolone has unique properties that allow it to be used alone without the need for progestin co-therapy. It has been in use in Europe for treatment of menopausal symptoms for many years and has a proven efficacy, tolerability and safety profile.”

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Tibolone, sold under brand names such as Livial®(1) and Tibelia®(2) among others, has been approved and marketed in Europe for over 30 years, and is also approved and marketed in other countries around the world. &nbsp;In Canada, Tibella® belongs in a sub-segment of the women’s health market valued at approximately CAD $200 million (source: IQVIA market data for the 12 months ending December 2018).” data-reactid=”14″>Tibolone, sold under brand names such as Livial®(1) and Tibelia®(2) among others, has been approved and marketed in Europe for over 30 years, and is also approved and marketed in other countries around the world.  In Canada, Tibella® belongs in a sub-segment of the women’s health market valued at approximately CAD $200 million (source: IQVIA market data for the 12 months ending December 2018).

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="About Tibella®” data-reactid=”15″>About Tibella®

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Tibella® is a prescription hormone replacement therapy (“HRT”) consisting of tibolone. Tibella® is different from other HRTs, as it does not contain actual hormones. Instead, the body breaks down tibolone to make three substances that act like estrogen, progesterone, and testosterone. &nbsp;These substances act on different tissues in the body to help treat symptoms of menopause.&nbsp; Tibella® substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms.&nbsp;” data-reactid=”16″>Tibella® is a prescription hormone replacement therapy (“HRT”) consisting of tibolone. Tibella® is different from other HRTs, as it does not contain actual hormones. Instead, the body breaks down tibolone to make three substances that act like estrogen, progesterone, and testosterone.  These substances act on different tissues in the body to help treat symptoms of menopause.  Tibella® substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms. 

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="About BioSyent Inc.” data-reactid=”17″>About BioSyent Inc.

Listed on the TSX Venture Exchange under the trading symbol “RX”, BioSyent is a profitable growth-oriented specialty pharmaceutical company focused on in-licensing or acquiring innovative pharmaceutical and other healthcare products that have been successfully developed, are safe and effective, and have a proven track record of improving the lives of patients.  BioSyent supports the healthcare professionals that treat these patients by marketing its products through its community, hospital and international business units.  

As of the date of this press release, the Company has 14,098,515 common shares issued and outstanding.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="For a direct market quote for the TSX Venture Exchange and other Company financial information please visit www.tmxmoney.com.” data-reactid=”20″>For a direct market quote for the TSX Venture Exchange and other Company financial information please visit www.tmxmoney.com.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="For further information please contact:” data-reactid=”21″>For further information please contact:

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Mr. René C. Goehrum
President and CEO
BioSyent Inc.
E-Mail: investors@biosyent.com
Web: www.biosyent.com” data-reactid=”22″>Mr. René C. Goehrum
President and CEO
BioSyent Inc.
E-Mail: investors@biosyent.com
Web: www.biosyent.com

Footnotes:

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="1.&nbsp; Livial® is a trademark of Merck Sharp &amp; Dohme
2. Tibelia® is a trademark of Mithra Pharmaceuticals S.A.” data-reactid=”24″>1.  Livial® is a trademark of Merck Sharp & Dohme
2. Tibelia® is a trademark of Mithra Pharmaceuticals S.A.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="This press release may contain information or statements that are forward-looking.&nbsp; The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements.&nbsp; Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obtaining regulatory approvals.” data-reactid=”25″>This press release may contain information or statements that are forward-looking.  The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements.  Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obtaining regulatory approvals.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.” data-reactid=”26″>Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

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font-family: Verdana, Arial, Helvetica, Geneva, Swiss, SunSans-Regular !important; .gnw_media_bgcolor background-color: transparent !important; .gnw_table border-collapse: separate !important; border-spacing: 6px !important; .gnw_videotitle font: bold 12px Arial !important; color: #1d5296 !important; td.gnw_heading font: 16px Arial; text-align: center !important; td.gnw_subhead font: 12px Arial; text-align: center !important; td.gnw_colhead font: 12px Arial; text-align: center !important; td.gnw_colhead_uline font: 12px Arial; text-align: center !important; border-bottom: solid black 1.0pt; td.gnw_colhead_dline font: 12px Arial; text-align: center !important; border-bottom: double black 2.5pt; td.gnw_label font: 12px Arial; vertical-align: bottom !important; text-align: left !important; td.gnw_label_uline font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: solid black 1.0pt; td.gnw_label_uline_i10 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: solid black 1.0pt; padding-left: 10.0px; td.gnw_label_uline_i15 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: solid black 1.0pt; padding-left: 15.0px; td.gnw_label_uline_i20 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: solid black 1.0pt; padding-left: 20.0px; td.gnw_label_uline_i25 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: solid black 1.0pt; padding-left: 25.0px; td.gnw_label_uline_i30 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: solid black 1.0pt; padding-left: 30.0px; td.gnw_label_dline_i10 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: double black 2.5pt; padding-left: 10.0px; td.gnw_label_dline_i15 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: double black 2.5pt; padding-left: 15.0px; td.gnw_label_dline_i20 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: double black 2.5pt; padding-left: 20.0px; td.gnw_label_dline_i25 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: double black 2.5pt; padding-left: 25.0px; td.gnw_label_dline_i30 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: double black 2.5pt; padding-left: 30.0px; td.gnw_label_ulinetop font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-top: solid black 1.0pt; td.gnw_label_dline font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: double black 2.5pt; td.gnw_label_i10 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; padding-left: 10.0px; td.gnw_label_i15 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; padding-left: 15.0px; td.gnw_label_i20 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; padding-left: 20.0px; td.gnw_label_i25 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; padding-left: 25.0px; td.gnw_label_i30 font: 12px Arial; vertical-align: bottom !important; text-align: left !important; padding-left: 30.0px; td.gnw_num font: 12px Arial; vertical-align: bottom !important; text-align: right !important; white-space: nowrap !important; td.gnw_num_uline font: 12px Arial; vertical-align: bottom !important; text-align: right !important; white-space: nowrap !important; border-bottom: solid black 1.0pt; td.gnw_num_ulinetop font: 12px Arial; vertical-align: bottom !important; text-align: right !important; white-space: nowrap !important; border-top: solid black 1.0pt; td.gnw_num_dline font: 12px Arial; vertical-align: bottom !important; text-align: right !important; white-space: nowrap !important; border-bottom: double black 2.5pt; td.gnw_num_dlinetop font: 12px Arial; vertical-align: bottom !important; text-align: right !important; white-space: nowrap !important; border-top: double black 2.5pt; td.gnw_data font: 12px Arial; vertical-align: bottom !important; text-align: left !important; white-space: nowrap !important; td.gnw_data_uline font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: solid black 1.0pt; td.gnw_data_dline font: 12px Arial; vertical-align: bottom !important; text-align: left !important; border-bottom: double black 2.5pt; td.gnw_media_caption font-size: 8pt !important; font-family: Verdana, Arial, Helvetica, Geneva, Swiss, SunSans-Regular !important; td.gnw_videotitle font: bold 12px Arial !important; color: #1d5296 !important; ;}

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