Quebec City, Canada / CRWEPRESSRELEASE / November 25, 2015 – Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the “Company”), affirms that its business and prospects remain fundamentally strong and highlights the following developments:
• Zoptrex™ (zoptarelin doxorubicin) recently received DSMB recommendation to continue the ZoptEC Phase 3 clinical program to completion following review of the final interim efficacy and safety data
• Zoptrex™ met Phase 2 Primary Endpoint in men with heavily pretreated castration- and Taxane-resistant prostate cancer
• First patient enrolled in the confirmatory Phase 3 clinical trial of Macrilen™
• Promotion of Saizen® and EstroGel® by the Company's sales force continues to show promise
• Dilution from Series B Share Purchase Warrants has been substantially eliminated
Commenting about the fundamentals of the Company's business, Chairman, President and Chief Executive Officer David A Dodd stated, “Yesterday's announcement regarding corporate developments, which was required by IIROC on behalf of the Toronto Stock Exchange, caused some to question the fundamentals of our business. I want to reiterate that we believe the fundamentals remain strong. We have two products in Phase 3. One of the products, Zoptrex™, is in the late stage of Phase 3. We instituted a confirmatory Phase 3 clinical trial of Macrilen™ after a panel of US and EU endocrinology experts advised us to continue to seek approval for the compound because of their confidence in its efficacy and because there currently is no FDA-approved diagnostic test for adult growth hormone deficiency. That Phase 3 study recently enrolled its first patient, keeping us on track to conclude it by the end of 2016.”
Mr. Dodd also commented on the Company's business development efforts, saying “We continue discussions with others about adding to our portfolio of promoted products and about the commercial rights to and development of Zoptrex™ in markets outside the United States. Of course, our business is subject to the risks inherent in the development of biopharmaceuticals. But we are successfully moving forward with activities intended to create long-term value for our shareholders. We are confident in our activities and believe we are achieving the necessary progress to build significant value for our shareholders, employees and the medical providers and patients who will benefit from our developing portfolio.”
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health. For more information, visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. The following statements in the press release are forward-looking statements:
• The statement that the confirmatory Phase 3 clinical trial of Macrilen™ is on track for completion by the end of 2016
• The statements regarding the success of the activities we are undertaking in an effort to create long-term value for our shareholders
Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
Senior Vice President
Source: Aeterna Zentaris Inc.