Isotechnika and Atrium Medical Announce Licensing Agreement for Use of TAFA93 and ISA247 With Medical Devices
Edmonton, Canada (ots/PRNewswire)
- Trades on Toronto Stock Exchange - (TSX:ISA)
Isotechnika Inc. ("Isotechnika") and Atrium Medical Corporation ("Atrium") jointly announced today the signing of an exclusive worldwide licensing agreement for the use of TAFA93 and ISA247 specifically with drug eluting devices for the non-systemic treatment of vascular, cardiovascular disorders, target vessel and tissue disorders. A summary of the terms of the agreement is as follows:
- Atrium will pay an upfront licensing fee of US$3,000,000.
- Atrium will pay milestone and royalty payments to Isotechnika upon approval of a medical device product which incorporates TAFA93, ISA247 or the combination of both drugs.
- Isotechnika is required to complete a Phase Ib trial for TAFA93.
- Atrium will conduct and be financially responsible for all development costs of the medical device product program.
- Isotechnika will manufacture and supply both drugs for use in clinical trials and post commercialization on a cost plus basis.
- Atrium will be solely responsible for marketing the Products which incorporate the TAFA93 and ISA247 compounds.
- The license provided is for the use of TAFA93 and ISA247 in conjunction with medical devices only. No rights are granted for the oral or topical administration of either TAFA93 or ISA247 in any indication.
"The goal for Isotechnika is to develop immunosuppressive drugs which are multi-faceted in their use. As a result of this agreement, we can expand the commercialization opportunities for both TAFA93 and ISA247 beyond purely an oral or systemic administration thereby allowing these therapies to treat as many potential patients as possible," stated Dr. Robert Foster, Chairman and CEO of Isotechnika Inc. "Through this exciting relationship with Atrium, Isotechnika is able to achieve this goal with a committed and experienced partner in the medical device field."
According to Atrium's founder and CEO, Steve Herweck, "Atrium continues to invest in those leading edge technologies like its exclusively licensed TAFA93 (a prodrug of rapamycin) and ISA247 (a cyclosporine derivative) compounds for local medical device delivery, that best satisfy our long term financial goals and contribute to important advancements in patient care. Combining automation with global manufacturing resources, together with extraordinary innovations in biomaterial and pharma science, our diversified portfolio of healthcare products are leading the way to brighter, more clinical effective solutions in cardiovascular disease and critical care management."
"When we developed TAFA93 and ISA247, we wanted to maximize their unique potential in multiple fields. The physical and chemical properties of our drugs are compatible with the proprietary carrier technology incorporated in the medical devices developed by Atrium," stated Randall Yatscoff, President and COO of Isotechnika Inc. "As a result of this synergy, we believe that both TAFA93 and ISA247 have the potential to be used in numerous products which will benefit patients who require such devices."
The management team will provide an overview of the agreement to the investment community this morning commencing at 9:00 a.m. ET/ 7:00 a.m. MT. All Interested parties can access the live web cast (listen only mode) by entering http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=1252680 in their web browser. Alternatively, you may access the web cast through our corporate Web site at www.isotechnika.com. The web cast will be archived for a 90-day period on our corporate Web site or through the web cast archives at www.newswire.ca.
About Isotechnika Inc.
Isotechnika Inc. is an international biopharmaceutical company headquartered in Edmonton, Alberta, Canada. Drawing upon its expertise in medicinal chemistry and immunology, the Company is focused on the discovery and development of novel immunosuppressive therapeutics that are safer than currently available treatments. Its entrepreneurial management and world-class team of scientists are building a pipeline of immunosuppressive drug candidates for treatment of autoimmune diseases and for use in the prevention of organ rejection in transplantation. Isotechnika looks to become the leader in development of immunosuppressant therapies.
Isotechnika's lead compound, ISA247 is an immunosuppressant currently in a Canadian Phase III human clinical trial for the treatment of moderate to severe psoriasis. In addition, ISA247 has successfully completed a Phase IIa trial for kidney transplantation. The Company also has two additional immunosuppressive compounds in its drug pipeline, TAFA93 and TKB662 which are in Phase I and pre-clinical respectively.
In addition to the Company's drug pipeline, Isotechnika also has a diagnostic division, which includes the Helikit(R) and Diatest(R) breath kits. The Helikit(R), a 13C urea breath test, is used for the detection of H. pylori, a bacterium that infects a large portion of the population. The Diatest(R), a 13C glucose breath test, is used to measure insulin resistance. Isotechnika Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol ISA. More information on Isotechnika can be found at www.isotechnika.com.
About Atrium Medical Corporation
Atrium Medical Corporation of Hudson, New Hampshire is a fast growing US based healthcare company that manufactures over two million sterile medical products each year which are distributed worldwide to over 60 countries. Atrium's vast expertise in developing medical device technologies for the treatment of cardiovascular disease has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology, emergency chest trauma care and thoracic drainage, vascular surgery and state-of-the-art hernia and soft tissue repair. Atrium is also a first to market pioneer in a promising new bioabsorbable drug eluting coating technology called ALPHA3(TM), which employs a proprietary blend of omega 3 fatty acids for localized drug delivery. Maintaining a commitment to our ISO Quality Standards and medical device innovation, biomaterial discovery programs and strategic partnerships with leading edge pharmaceutical firms like ISOTECHNIKA, Atrium will continue to excel in many unmet clinical areas requiring surgical intervention.
Forward-Looking Statements
This press release may contain forward-looking statements. Forward- looking statements, including the Company's belief as to the potential of its products, the Company's expectations regarding the issuance of additional patents and the Company's ability to protect its intellectual property, involve known and unknown risks and uncertainties, which 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 research and development projects, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize its products, the ability of the Company to defend its patents from infringement by third parties, and the risk that the Company's patents may be subsequently shown to be invalid or infringe the patents of others. Investors should consult the Company's quarterly and annual filings with the Canadian commissions for additional information on risks and uncertainties relating to the forward- looking statements. Investors are cautioned against placing undue reliance on forward-looking statements.
www.isotechnika.com
Contact:
For further information: Joseph Koziak, Executive Vice President,
Isotechnika Inc., Phone: +1-(480)-329-5129, Fax: +1-(480)-502-8590,
Email: jkoziak@isotechnika.com; Stephanie Gillis-Paulgaard, Senior
Manager, Corporate Communications, Isotechnika Inc., Phone:
+1-(780)-909-4661, Fax: +1-(780)-484-4105, E-mail:
sgillis-paulgaard@isotechnika.com; Archived images on this
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