SALT LAKE CITY—A companion diagnostic agreement betweenMyriad Genetics Inc. and Pharma Mar could pave the way for developingdiagnostic and treatment options for women with breast and ovarian cancer.
Under the terms of the agreement, Myriad, which developsmolecular diagnostic tests based on an understanding of the role genes play inhuman disease, will conduct BRCA 1 and BRCA 2 testing on patients to beenrolled in a Phase II clinical study of Pharma Mar's PM1183, a novel drugcandidate that induces double-stranded DNA breaks to cause cell death. Myriadwill assess the BRCA status in patients who respond to PM1183. The company has similar agreements withAbbott Pharmaceuticals, AstraZeneca, BioMarin Pharmaceuticals and Cephalon toprovide companion diagnostic testing with the Myriad BRACAnalysis test forclinical trial enrollment.
In describing PM1183 as "an exciting compound," PeterMeldrum, president and CEO of Myriad, says the agreement and others like itdemonstrate "the importance of a patient's BRCA status in identifying potentialresponders to this class of drugs."
BRACAnalysis, a molecular diagnostic test developed byMyriad, analyzes the BRCA1 and BRCA2 genes to assess a woman's risk fordeveloping breast and ovarian cancer and guide treatment decisions for womenwith hereditary breast and ovarian cancer. A woman who tests positive with theBRACAnalysis test has, on average, up to an 86-percent risk of developingbreast cancer during her lifetime, and up to a 44-percent risk of developingovarian cancer.
Myriad, which focuses on strategic directives to introducenew products, including companion diagnostics, is "a leading moleculardiagnostics company dedicated to revolutionizing patient care through thediscovery and commercialization of transformative tests to address pressingclinical and health economic needs," according to Rebecca Chambers, director ofinvestor relations and corporate communications. The company aims to improve anindividual's decision-making process for monitoring and treating disease, shesays.
Pharma Mar, a member of the Zeltia Group based in Madrid,Spain, develops antitumor drugs of marine origin. Founded in 1986, Pharma Marhas a marine organism library containing more than 115,000 specimens, accordingto Jose Maria Fernandez Sousa-Faro, the company's president. Thebiopharmaceutical company, which has discovered 700 new chemical entities andidentified 30 new families of compounds, attempts to advance cancer treatmentby discovering, developing, producing and marketing innovative drugs of marineorigin. Pharma Mar has more than 1,800 patents that either have been awarded orare in the processing stage, and has established an extensive worldwidecollaborative network including more than 60 centers of marine biology,chemistry and cancer biology research.
"We continue seeking to establish collaborations with localgovernments and institutions for the exploration of local biodiversity andestablishing joint drug discovery programs for novel marine-derived anticancercompounds," Sousa-Faro says.
The global market for marine-derived drugs was $4.8 billionin 2011 and is expected to be $5.3 billion in 2012. This global market isforecasted to reach $8.6 billion in 2016 at a compound annual growth rate of12.5 percent for the five-year period of 2011 to 2016, according to BCCResearch.
Meanwhile, Myriad scored another victory when the U.S. Courtof Appeals for the Federal Circuit ruled that the composition of matter claimscovering isolated DNA and cDNA of the BRCA1 and BRCA2 genes are patent-eligibleunder Section 101 of the U.S. patent act and that the use of the geneticmaterial to screen potential cancer therapeutics is eligible on subject matterterms. This decision reversed a previous ruling of the U.S. District Court forthe Southern District of New York that the compositions of matter claims for Myriad'sBRACAnalysis product were invalid because the isolated DNA was not reallydifferent from the DNA in the body.
The case was filed in May 2009 on behalf of breast cancerand women's health groups, individual women, geneticists and scientific associations.Known as The Association for Molecular Pathology, et al. v. Myriad GeneticsInc., the court battle over patents andgenes has been viewed as a legal struggle for dominance between nature andbiotechnology. Because about 20 percent of all human genes are patented, theoutcome of the case has major ramifications.