Monday, August 01, 2016 8:41:45 AM
Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZ) (the “Company”) and Rafa Laboratories, Ltd. (“Rafa”) today announced the signing of an exclusive license agreement for the Company’s lead anti-cancer compound, Zoptrex™ (zoptarelin doxorubicin), for the initial indication of endometrial cancer, for Israel and the Palestinian Territories (the “Territory”). Zoptrex™, a novel synthetic peptide carrier linked to doxorubicin, is currently in a fully-enrolled Phase 3 clinical trial in endometrial cancer. The Company expects to complete the Phase 3 clinical trial in the third quarter of 2016 and, if the results of the trial warrant doing so, to file a new drug application for Zoptrex™ in the first half of 2017.
Under the terms of the License Agreement, Aeterna Zentaris will be entitled to receive a non-refundable upfront payment in consideration for the license to Rafa of the Company’s intellectual property related to Zoptrex™ and the grant to Rafa of the right to commercialize Zoptrex™ in the Territory. Rafa has also agreed to make additional payments to the Company upon achieving certain pre-established regulatory and commercial milestones. Furthermore, the Company will receive double-digit royalties on future net sales of Zoptrex™ in the Territory. Rafa will be responsible for the development, registration, reimbursement and commercialization of the product in the Territory. The Company and Rafa have also entered into a supply agreement, pursuant to which the Company will supply Zoptrex™ to Rafa for the duration of the license agreement.
David Dodd, President and CEO of the Company, stated, “We are very excited about this agreement for Zoptrex™ with Rafa Laboratories. Women with advanced endometrial cancer are in need of such additional treatments, and Zoptrex™ could prove to be a significant treatment option for them. This agreement is also consistent with our strategy of leveraging our pipeline to secure future revenues with strategic development and commercial licensees for specific regions of the world. We are very pleased to have Rafa Laboratories as our licensee for the Territory. Their experience and commitment to ensuring the success of Zoptrex™ in their Territory is most assuring.”
About Zoptrex™
Zoptrex™ is a complex molecule that combines a synthetic peptide carrier with doxorubicin, a well-known chemotherapy agent. The synthetic peptide carrier is (D)-Lys6-LHRH, a modified natural hormone believed to have a strong affinity for the LHRH receptor. The design of the compound allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor-positive tumors. Potential benefits of this targeted approach include enhanced efficacy and a more favorable safety profile with lower incidence and severity of side effects as compared to doxorubicin.
About Rafa Laboratories, Ltd.
Rafa is a pharmaceutical company in Israel that markets, manufactures and distributes prescription (Rx) and over-the-counter (OTC) medicines, mainly proprietary formulations, as well as generic formulations, and consumer health products. With a history of over 75 years, Rafa is a trusted partner of some of the leading pharmaceutical companies, such as Mundipharma, Purdue, United Therapeutics, Napp, Ony, Galderma, Dr. Falk Pharma, Zambon and more. Rafa's wide range of products portfolio is complemented by world-class manufacturing facilities and a distribution network that maintains the quality and integrity of our partners’ products. The combination of its marketing expertise in market access and its extensive local presence, gives Rafa a competitive advantage that sets it apart from the competition. Rafa is part of a privately owned international group of independent associated pharmaceutical companies - the Purdue/Mundipharma/Napp group. These international companies develop and market a broad range of pharmaceutical solutions in key therapeutic areas, such as pain management, respiratory and oncology.
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. We are engaged in drug development activities and in the promotion of products for others. We are now conducting Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition or license of products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.
Forward-Looking Statements
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. 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 rejection or non-acceptance of any new drug application by one or more regulatory authorities and, more generally, uncertainties related to the regulatory process, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the degree of market acceptance once our products are approved for commercialization, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, 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, except if required to do so.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160801005459/en/
Aeterna Zentaris Inc.
Philip A. Theodore, 843-900-3223
Senior Vice President
IR@aezsinc.com
_________________________________________
AEZS
Recent AEZS News
- Aeterna Zentaris Announces Effective Date of Share Consolidation • GlobeNewswire Inc. • 05/01/2024 11:55:00 AM
- Ceapro Receives Final Court Approval for Merger with Aeterna Zentaris • GlobeNewswire Inc. • 03/28/2024 11:55:00 AM
- Ceapro Receives Final Court Approval for Merger with Aeterna Zentaris • GlobeNewswire Inc. • 03/28/2024 11:55:00 AM
- Aeterna Zentaris Reports Fourth Quarter and Full Year 2023 Financial Results and Announces Completion of Enrollment in Ongoing Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency • GlobeNewswire Inc. • 03/27/2024 12:05:00 PM
- Aeterna Zentaris and Ceapro Merger Approved by Securityholders at Special Meetings • GlobeNewswire Inc. • 03/12/2024 06:10:53 PM
- Aeterna Zentaris and Ceapro Merger Approved by Securityholders at Special Meetings • GlobeNewswire Inc. • 03/12/2024 06:10:00 PM
- Leading Independent Proxy Advisory Firm ISS Recommends Aeterna Zentaris and Ceapro Securityholders Vote FOR the Arrangement Agreement to Approve the Merger of Equals to Create a Diversified Biopharmaceutical Company • GlobeNewswire Inc. • 02/26/2024 12:30:00 PM
- Leading Independent Proxy Advisory Firm ISS Recommends Aeterna Zentaris and Ceapro Securityholders Vote FOR the Arrangement Agreement to Approve the Merger of Equals to Create a Diversified Biopharmaceutical Company • GlobeNewswire Inc. • 02/26/2024 12:30:00 PM
- Aeterna Zentaris Issues Letter to Shareholders and Management Proxy Circular Ahead of Special Meeting of Shareholders to Approve Merger of Equals with Ceapro • GlobeNewswire Inc. • 02/15/2024 10:50:00 PM
- Form F-1 - Registration statement for certain foreign private issuers • Edgar (US Regulatory) • 02/15/2024 09:54:45 PM
- Form 20-F/A - Annual and transition report of foreign private issuers [Sections 13 or 15(d)]: [Amend] • Edgar (US Regulatory) • 02/15/2024 02:33:18 PM
- Form 6-K/A - Report of foreign issuer [Rules 13a-16 and 15d-16]: [Amend] • Edgar (US Regulatory) • 12/22/2023 09:42:20 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/14/2023 12:50:09 PM
- Aeterna Zentaris and Ceapro Announce Merger of Equals to Create a Diversified Biopharmaceutical Company • GlobeNewswire Inc. • 12/14/2023 12:50:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/09/2023 01:05:28 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/09/2023 01:05:15 PM
- Aeterna Zentaris Reports Third Quarter 2023 Financial Results • GlobeNewswire Inc. • 11/09/2023 01:00:00 PM
- Aeterna Zentaris to Participate at the Virtual Investor Ask the CEO Conference • GlobeNewswire Inc. • 10/11/2023 12:00:00 PM
- Aeterna Zentaris to Present at the H.C. Wainwright 25th Annual Global Investment Conference • GlobeNewswire Inc. • 09/05/2023 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/09/2023 12:05:31 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/09/2023 12:05:18 PM
- Aeterna Zentaris Reports Second Quarter 2023 Financial Results • GlobeNewswire Inc. • 08/09/2023 12:05:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/13/2023 11:30:15 AM
- Aeterna Zentaris Outlines Progress on Development Pipeline Programs and Provides Corporate Update • GlobeNewswire Inc. • 07/13/2023 11:30:00 AM
- Aeterna Zentaris to Participate in the Virtual Investor Summer Spotlight Series • GlobeNewswire Inc. • 07/05/2023 12:45:00 PM
FEATURED Element79 Gold Corp Reports Exceptionally High-Grade Results from Lucero • May 14, 2024 7:00 AM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM