Leader in the development of permanent seed brachytherapy in the treatment of cancer.
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IsoRay Announces Global Strategic Alliance with IBt s.a.
Alliance to focus on worldwide market expansion of brachytherapy solutions for treating prostate cancer and other malignant tissue cancers
RICHLAND, Wash.--(BUSINESS WIRE)—October 1, 2007 -- IsoRay Medical™, Inc., a subsidiary of IsoRay, Inc. (collectively IsoRay) (AMEX Symbol: ISR), announces the signing of a letter of intent between IsoRay and International Brachytherapy s.a. (IBt), a leading manufacturer and distributor of brachytherapy products based in Seneffe, Belgium, to form a global strategic alliance focusing on worldwide market expansion of brachytherapy solutions in the treatment of prostate cancer and other malignant tissue cancers.
IsoRay is a medical isotope company that focuses on brachytherapy solutions for prostate cancer and other malignant tissue cancers through use of its proprietary Cesium-131 radioisotope, marketed under the name Proxcelan™ Cesium-131 is the most significant scientific advancement in prostate cancer brachytherapy in more than 20 years.
Major elements of the proposed alliance include the future marketing of IsoRay’s proprietary Proxcelan™ Cesium-131 brachytherapy seeds and Iodine-125 brachytherapy seeds in Russia. It includes planned distribution in 19 European countries using IBt’s established distribution channels. In addition, IsoRay will also continue to develop a new generation of Cesium-131 brachytherapy sources using IBt's polymer seed technology and automated manufacturing processes, which should further differentiate Cesium-131 in the cancer therapy market.
“This letter of intent represents another major step in the strategic business plan for IsoRay as we continue to grow the domestic market for Proxcelan™ and begin taking advantage of growth opportunities and demand worldwide,” said IsoRay Chairman and CEO Roger Girard.
Girard said the increasing awareness of brachytherapy and particularly Cesium -131 as a treatment option in the U.S. and other parts of the world was a key factor in the entry into the letter of intent with IBt.
The future alliance will form the basis of a collaborative relationship between the two companies in the areas of research and development and sales and marketing. Components of the letter of intent that are intended to form the basis of future definitive agreements in each of these areas include:
Research and Development:
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IsoRay intends to collaborate with IBt to complete the research and development process to design and build new generation Cesium-131 brachytherapy sources using IBt's polymer seed technology and advanced automated manufacturing processes.
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IsoRay may in the future manufacture Iodine-125 polymer seeds for worldwide distribution, depending on market conditions.
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IsoRay and IBt plan to collaborate on efforts to optimize manufacturing processes and locations based on economic conditions and access to specific markets.
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IsoRay intends to collaborate with IBt to develop new technologies, which may include bio-absorbable polymer technology, for use in multiple cancer indications.
Sales and Marketing:
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IsoRay and IBt plan to work jointly to market both companies' Cesium-131 and Iodine-125 brachytherapy seeds in Russia.
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IsoRay and IBt will negotiate a five-year exclusive performance-based distribution agreement for IBt to sell Proxcelan™ Cesium-131 brachytherapy seeds in Europe, with rights for other parts of the world to be mutually determined.
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IBt intends to grant IsoRay the exclusive right to market the future polymer Cesium-131 seed and the polymer Iodine-125 seed in North and South America.
Each of the above elements of the proposed alliance is subject to the successful negotiation between the parties of a number of important contractual elements and the approval by their respective Board of Directors, and do not create any binding obligation on the part of either party at this time. In addition, changes in market conditions may result in changes to the research and development projects and sales and marketing efforts described above.
“Through this joint effort, we will have access to new channels to distribute Cesium-131 technology to the growing European market and other emerging markets,” said Girard. “By obtaining access to IBt’s expertise and existing distribution channels, we will be in a position to meet the increasing demand for the latest technology by patients and physicians abroad who understand the therapeutic and quality of life benefits of using brachytherapy.”
“Although we believe that Cesium-131 offers superior technology and over time could become the standard for brachytherapy treatments, there are remote regions of the world not readily accessible with this isotope due to its short half-life,” said Girard. “Iodine-125, with its longer half-life, if incorporated into the ‘next generation’ polymer seed, will allow us to provide patients in these areas access to the benefits of seed brachytherapy.”
About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of the Proxcelan™ Cesium-131 brachytherapy seed, used to treat prostate and other cancers. The Proxcelan™ seed offers a significantly shorter half-life than the two other isotopes commonly used for brachytherapy, which results in a substantially faster delivery of therapeutic radiation, lower probability of cancer cell survival and reduction of the longevity of common brachytherapy side effects (a)(b). IsoRay is based in Richland, Washington. More information is available about IsoRay at www.isoray.com.
(a) Armpilia CI, Dale RG, Coles IP, et al. The Determination of Radiobiologically Optimized Half-lives for Radionuclides Used in Permanent Brachytherapy Implants. Int. J. Radiation Oncology Biol. Phys. 2003; 55 (2): 378-385.
(b) Prestidge B.R., Bice W.S., Jurkovic I., et al. Cesium-131 Permanent Prostate Brachytherapy: An Initial Report. Int. J. Radiation Oncology Biol. Phys. 2005; 63 (1): 5336-5337.
Statements in this news release about IsoRay's future expectations, including: the advantages of our Cesium-131 seed, whether the letter of intent will result in any future definitive agreements between the parties, IsoRay's ability to gain access to and use IBt's marketing and distribution channels in Europe, Russia and elsewhere in the future, the use of the Proxcelan™ Cesium131 seed to treat cancers other than prostate cancer in the future, viability of the IBt polymer seed technology in various applications, future demand for IsoRay's existing and planned products, IsoRay's manufacturing needs and capabilities, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as IsoRay's ability to successfully negotiate terms for and enter into the proposed future definitive agreements with IBt, successful completion of future research and development activities, physician acceptance, training and use of IsoRay's products, changing levels of demand for IsoRay's current and proposed future products in specific markets worldwide; IsoRay's ability to successfully manufacture, market and sell its products, IsoRay's ability to manufacture its products in sufficient quantities to meet demand within required delivery time periods while meeting its quality control standards, IsoRay's ability to enforce its intellectual property rights, and other risks detailed from time to time in IsoRay's reports filed with the SEC.
Media Contacts:
Jonathan Hunt,
Chief Financial Officer
IsoRay, Inc.
509.375.1202
jhunt@isoray.com
Ralph Schatzmair, Director--Investor Relations
IsoRay, Inc. 416.322.2225
rschatzmair@isoray.com
Barry Bartlett, The Bartlett Group Public Relations
206.285.0673; Cell: 206.335.4694
barry@bartlettgrouppr.com
IsoRay Medical, Inc. 877.4.ISORAY
350 Hills Street, Suite 106 509.375.1202 TEL
Richland, WA 99352 509.375.3473 FAX
www.isoray.com
www.cesium131.com
www.proxcelan.com