TORONTO, March 20 /PRNewswire-FirstCall/ - Tm Bioscience Corporation , a leader in the commercial genetic testing market, today announced it has signed an agreement with Sirius Genomics (Vancouver, Canada) for an exclusive commercial license to patents from Sirius for specific biomarkers related to drugs used to treat severe sepsis including vasopressin. Tm Bioscience will incorporate these markers into a diagnostic for use by critical care physicians which it expects to launch in the second half of 2007.
“Sepsis is a critical healthcare issue. One out of every three patients who develop severe sepsis will die within a month. There are limited treatments for severe sepsis,” said Greg Hines, President and CEO of Tm Bioscience. “By applying the genetic discoveries made by Sirius Genomics, we hope to develop an innovative genetic test that could be used to identify patients who are more likely to respond well to the two main drugs used to treat severe sepsis. Such tests could help save lives.”
“Our test in combination with related drug therapies could become the standard of care for sepsis treatment,” said Jim Pelot, CFO of Tm Bioscience. “Given the large market potential of this test as well as its potential importance in the selection of drugs and therapies that impact patient morbidity and mortality, we expect this test to achieve notable market penetration across North America and Europe. We anticipate that this product could generate in excess of $100 million in revenues in the aggregate over the first three years following commercial launch.”
“In the US, as many people die from sepsis as from heart attacks. This test could be a major breakthrough in the treatment of sepsis and will be invaluable to critical care physicians who deal with the challenges of treating sepsis on a daily basis,” said Dr. Jim Russell, Chief Medical Officer of Sirius. “We are excited to work with Tm Bioscience to bring this important product to market so that our genetic discoveries can benefit patients directly and save lives.”
Sepsis is a syndrome that can result from a person’s over-response to an infection. Severe sepsis is often more dangerous than the initial infection and, without rapid diagnosis and intervention, can develop within a matter of hours, leading to septic shock which can cause temporary or permanent damage to multiple organs or even death. There are more than 750,000 cases of severe sepsis per year in the US with approximately 215,000 cases resulting in death. Treating patients with severe sepsis costs US hospitals almost $17 billion annually. Two drugs commonly used for the treatment of severe sepsis are Xigris(R) and vasopressin.
The agreement covers a series of possible mutations that can occur in the genes associated with two proteins, protein C and arginine vasopressin. Under the terms of the agreement, Tm Bioscience will provide an upfront payment of $4 million which will be provided to Sirius in two equal installments in the second and third quarters of 2006. These upfronts will be repaid from net earnings on commercial sales of the severe sepsis test, with the remaining earnings shared equally by Sirius and Tm over the term of the agreement.
About Sirius Genomics Inc:
Sirius Genomics identifies important genomic variations in the biological pathways that are implicated in critical illness and severe infection. This information can be used to select the right drug for each patient. These discoveries will make possible dramatic improvements in the design and success of clinical trials and in clinical practice by enabling selection of the appropriate drug for the appropriate patient.
About Tag-It(TM) PGx reagents and genetic tests
Tm Bioscience is committed to becoming a leader in pharmacogenetics (PGx) - the application of genetic testing to identify an individual’s response to a specific drug. The Company is commercializing a suite of drug metabolism tests with initial products focused on the P450 family of enzymes, which affect the metabolism of more than 50% of all drugs. Tm offers a comprehensive menu of PGx tests including unique and proprietary PGx tests, and is dedicated to creating resources for educating laboratorians, physicians, and patients about the clinical applications of PGx.
Tm Bioscience’s product menu is focused in the fields of human genetic disorders, pharmacogenetics and infectious disease. The Company has commercialized Analyte Specific Reagents(x) and a series of Tag-It(TM) tests(xx) for a variety of genetic disorders. The Company’s Tag-It(TM) Cystic Fibrosis (CF) Kit is the first multiplexed human disease genotyping test to be cleared by the U.S. Food and Drug Administration (FDA) as an in vitro device (IVD) for diagnostic use in the United States. It has also received the CE Mark, allowing the test to be marketed for diagnostic purposes in the European Union. All genetic tests from Tm Bioscience are based on the Tag-It(TM) Universal Array platform, which utilizes a proprietary universal tag system that allows for easy optimization, product development and expansion. Assays from Tm operate on the Luminex xMAP(R) system, a well-established bead based instrument. Combined, the Universal Array and Luminex instrument enable the rapid production of flexible, high-throughput, low-cost DNA-based tests.
(x) Analyte Specific Reagent. Analytical and performance characteristics are not established. (xx) For Investigational Use Only. The performance characteristics of these products have not been established About Tm Bioscience - Putting the Human Genome to Work(TM)
Tm Bioscience is a DNA-based diagnostics company developing a suite of genetic tests. Tm Bioscience’s product pipeline includes tests for genetic disorders, drug metabolism, and infectious diseases. Tm Bioscience is located in Toronto, Ontario. Additional information about Tm Bioscience can be found at www.tmbioscience.com.
Caution Regarding Forward-Looking Statements
This press release contains information that is forward-looking information within the meaning of securities laws. In some cases, forward- looking information can be identified by the use of terms such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “believe”, “intend”, “estimate”, “predict”, “potential”, “continue” or other similar expressions concerning matters that are not historical facts. Particularly, statements about the planned development of a diagnostic genetic test to identify patients who are more likely to respond well to therapies related to severe sepsis, the potential efficacy of such a test, the anticipated timing of the commercial launch of such a test, the approximate revenues that will be generated by this test, and the market penetration that Tm will obtain for this genetic test, are forward-looking information.
Forward-looking information is based on certain factors and assumptions. In particular, in making the statements in this press release, Tm has assumed that it will be able to successfully develop a test in two versions, as a real-time assay and in a form compatible with the TAG-IT Luminex system, that these tests will be successfully developed in 2006 and that these tests will meet industry analytical standards. Tm has also assumed that it will submit these tests to the FDA for regulatory approval in the United States in 2006, that it will receive the necessary regulatory approvals from the FDA for these tests in the United States within one year of submitting these tests to the FDA for approval, and that as part of such approval the FDA will have reviewed clinical and analytical validation of the test(s). In addition, Tm has assumed that these tests will receive CE marking in the European Union coincident with U.S. FDA approval. With respect to revenue generation and market penetration, Tm has assumed that it will launch this product in the United States in both forms (i.e., as a real-time assay and in a form compatible with the TAG-IT Luminex system) following receipt of the necessary regulatory approvals in the last half of 2007, and in the European Union in 2008, and that the Company will have sufficient capital to develop and commercially roll-out these tests, that the Company will be able to successfully manufacture sufficient quantities of this product, that molecular testing for sepsis will become more widespread, that the Company will be able to sell this product at a price ranging from U.S.$300 to U.S.$500 per test, that there will be reimbursement available for this test by both private and public healthcare insurers, that there will be approximately 750,000 sepsis cases a year in each of the United States and the European Union, that Tm will achieve approximately 20% market penetration in both markets by the third year following launch, that the $U.S./$Cdn. dollar exchange rate and the Euro/$Cdn dollar exchange rate remain relatively constant at current rates, that Tm sells the product directly to hospitals, that there will be no other directly competing technological or competitive advances in the treatment of sepsis, that Xigris(R) and vasopressin will continue to be widely used in the treatment of sepsis, that the Company will continue to enjoy the exclusive use of the patents to be licensed from Sirius, and that these patents are and will remain valid and enforceable. While the Company considers these assumptions to be reasonable based on information currently available to it, they may prove to be incorrect.
Forward looking-information is subject to certain factors, including risks and uncertainties, that could cause actual results to differ materially from what we currently expect. These factors include risks relating to the ability of Tm to successfully develop this proposed new product in a timely fashion, the risk that the Company may not receive the required regulatory approvals in a timely fashion, or at all, the risk that the Company may not have sufficient funds to develop and commercially roll-out these tests, the risk that competing treatments for sepsis may be developed, which could eliminate any demand for the Company’s proposed new tests, the difficulty of predicting market acceptance and demand for new products, including the proposed new test, the risk that Tm will not be able to sell the new test at its currently estimated price, or that reimbursement will not be available for this test, which could limit the price that end users would be willing to pay, the risk that the Cdn. dollar could strengthen against the U.S. dollar and/or the Euro, which would reduce the Company’s Cdn. dollar revenues from this test, the risk of technological change, which could render the Company’s proposed new test obsolete, and the risk that the Company could lose the exclusive use of the patents underlying the proposed new test, or that such patents may not be valid or enforceable. If any of these risks or uncertainties were to materialize, then this could cause our actual results to differ materially from what we currently expect. Please see the Company’s current Annual Information Form for a complete discussion of these and other risks and uncertainties involved in the Company’s operations.
You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While Tm may elect to, it is under no obligation and does not undertake to update this information at any particular time.
The TSX Exchange has not reviewed and does not accept responsibility
for the adequacy or accuracy of this release.
Tm Bioscience
CONTACT: Tm Bioscience Corporation, James Smith, The Equicom Group, Tel.:(416) 815-0700, Email: jsmith@equicomgroup.com; Sirius Genomics Inc., Tel.:(604) 484-7195; To request a free copy of this organization’s annualreport, please go to http://www.newswire.ca and click on Tools forInvestors.
