Digene Corporation Announces Exclusive Marketing And Distribution Agreement With Asuragen, Inc. For Signature Cystic Fibrosis Screening Products
GAITHERSBURG, Md. and AUSTIN, Texas, April 19 /PRNewswire-FirstCall/ -- Digene Corporation and Asuragen, Inc., a newly formed molecular diagnostic company and formerly a division of Ambion, Inc., jointly announced today that the parties have entered into an exclusive, worldwide agreement for the marketing and distribution of Asuragen's cystic fibrosis (CF) screening products. Digene has made an up-front payment to Asuragen and will make additional payments based on regulatory milestones. Additional financial details of the agreement were not disclosed.
Under the agreement, Digene will have the exclusive rights to market and distribute Asuragen's Signature(R) CF products world-wide. In addition, Asuragen will develop, also for Digene's exclusive distribution, the next generation CF test, Signature CF Expand, which expands the mutation panel to include ethnic-specific mutations that can be adapted for use in carrier screening and may find additional utility for neonatal and newborn testing. In addition, Digene will have the first right of refusal on future genetic test products developed by Asuragen. The Signature products utilize the Luminex(R) xMAP(R) technology.
Cystic Fibrosis is the most common autosomal recessive disease in the Caucasian population with a prevalence estimate of 1 in 2,500 to 3,300 live births. In April 2001, the American College of Medical Genetics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG) issued statements and developed guidelines for population CF carrier screening. It was recommended that genetic screening for CF mutations should be offered to identify carriers among adults with a positive family history of CF, partners of individuals with CF, couples currently planning a pregnancy and couples seeking prenatal care.
Evan Jones, Chairman and CEO of Digene commented, "Underscoring Digene's commitment to women's health, we are pleased to offer this important genetic screening product. Through this collaboration, Digene will leverage its strong physician and reference lab sales forces to market and distribute CF products that are developed and manufactured by Asuragen, a leader in the development of innovative nucleic acid products. This agreement will allow Digene to offer its customers reliable and easy-to-use solutions for carrier screening, thus enabling enhanced patient care through better informed decisions."
Matt Winkler, CEO of Asuragen, commented, "This is a very exciting opportunity for Asuragen to partner with Digene, a leader in women's health molecular diagnostic testing. The expertise of Digene's extensive sales force will greatly expand the reach of Asuragen's Signature Genetic Testing products into the testing community, which will provide increased opportunities to affect patient care."
Digene Corporation , based in Gaithersburg, MD, develops, manufactures and markets proprietary DNA and RNA testing systems for the screening, monitoring and diagnosis of human diseases -- with a focus on women's cancers and infectious diseases. The company's hc2 High-Risk HPV DNA Test(R) is the only test for human papillomavirus approved by the FDA, and is approved for both follow-up evaluation in women with inconclusive Pap results and for primary adjunctive screening with the Pap test in women age 30 and older. For primary adjunctive screening, it is marketed as both The Digene HPV Test and the DNAwithPap(R) Test. These brand names do not refer to the Digene product that tests for several types of the virus commonly referred to as "low-risk HPV," which are not associated with cervical cancer. For more information, visit http://www.thehpvtest.com. Digene's product portfolio also includes DNA tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea, as well as tests for blood viruses. For more information, visit the company's Web site, http://www.digene.com. Investors also may contact Charles Fleischman at (301) 944-7000; journalists may contact Pam Rasmussen, (301) 944-7196. Digene(R), Hybrid Capture(R), hc2 High-Risk HPV DNA Test(R) and DNAwithPap(R) are registered trademarks of Digene Corporation.
About Asuragen, Inc.
Asuragen, Inc. is a newly formed company led by Matt Winkler, founder and former CEO of Ambion, Inc. The sale of the Research Products Division of Ambion, Inc. to Applied Biosystems Group , an Applera Corporation business, in December, 2005, resulted in the simultaneous spin-off of Asuragen, Inc. Asuragen is comprised of Ambion's Diagnostic and Service divisions, along with two research groups from the core reagent division, to create a new Discovery group whose mission is to transform cutting edge research into clinical products. The vision for Asuragen is to become a fully integrated diagnostic company focused on molecular oncology and early detection of cancer. Comprised of over 100 employees from a well-established company, Asuragen is empowered with not only scientific expertise, but also assets and business infrastructure that allow it to span the spectrum of discovery, development, production and commercialization. Asuragen's product portfolio also includes Signature ACP (Ashkenazi Carrier Panel), Signature LTx (Leukemia Translocation Panel), as well as controls and standards engineered using its patented Armored RNA(R) technology. For more information, visit http://www.asuragen.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of the future as there are a number of meaningful factors that could cause the Company's actual results to vary materially from those indicated by such forward-looking statements. Meaningful factors, which could cause actual results to differ from expectations include, but are not limited to, the degree of acceptance of cystic fibrosis testing by physicians, uncertainty of the company's future profitability, its ability to scale up manufacturing operations to meet any increased demand, the uncertainty regarding patents and proprietary rights, the success of the Company's marketing efforts, competition, risks inherent in international transactions, and the inability to obtain requisite additional financing, as well as other factors discussed in the Company's Securities and Exchange Commission filings. For other factors, reference is made to the discussion in the Company's annual and quarterly reports filed with the Securities and Exchange Commission.Digene Corporation
CONTACT: Charles Fleischman, President, +1-301-944-7000, or Media: PamRasmussen, +1-301-944-7196, both of Digene Corporation; or Investors:Jonathan Birt, +1-212-850-5634, or Media: Sean Leous, +1-212-850-5755, bothof Financial Dynamics, for Digene Corporation; or Jeffrey Williams, SeniorVice President, +1-512-651-0191, or Media: Craig Miller, Director, Salesand Marketing, +1-512-651-0590, both of Asuragen