From under the sea
SALT LAKE CITY—A companion diagnostic agreement between Myriad Genetics Inc. and Pharma Mar could pave the way for developing diagnostic and treatment options for women with breast and ovarian cancer.
Under the terms of the agreement, Myriad, which develops molecular diagnostic tests based on an understanding of the role genes play in human disease, will conduct BRCA 1 and BRCA 2 testing on patients to be enrolled in a Phase II clinical study of Pharma Mar's PM1183, a novel drug candidate that induces double-stranded DNA breaks to cause cell death. Myriad will assess the BRCA status in patients who respond to PM1183. The company has similar agreements with Abbott Pharmaceuticals, AstraZeneca, BioMarin Pharmaceuticals and Cephalon to provide companion diagnostic testing with the Myriad BRACAnalysis test for clinical trial enrollment.
In describing PM1183 as "an exciting compound," Peter Meldrum, president and CEO of Myriad, says the agreement and others like it demonstrate "the importance of a patient's BRCA status in identifying potential responders to this class of drugs."
BRACAnalysis, a molecular diagnostic test developed by Myriad, analyzes the BRCA1 and BRCA2 genes to assess a woman's risk for developing breast and ovarian cancer and guide treatment decisions for women with hereditary breast and ovarian cancer. A woman who tests positive with the BRACAnalysis test has, on average, up to an 86-percent risk of developing breast cancer during her lifetime, and up to a 44- percent risk of developing ovarian cancer.
Myriad, which focuses on strategic directives to introduce new products, including companion diagnostics, is "a leading molecular diagnostics company dedicated to revolutionizing patient care through the discovery and commercialization of transformative tests to address pressing clinical and health economic needs," according to Rebecca Chambers, director of investor relations and corporate communications. The company aims to improve an individual's decision-making process for monitoring and treating disease, she says.
Pharma Mar, a member of the Zeltia Group based in Madrid, Spain, develops antitumor drugs of marine origin. Founded in 1986, Pharma Mar has a marine organism library containing more than 115,000 specimens, according to Jose Maria Fernandez Sousa-Faro, the company's president. The biopharmaceutical company, which has discovered 700 new chemical entities and identified 30 new families of compounds, attempts to advance cancer treatment by discovering, developing, producing and marketing innovative drugs of marine origin. Pharma Mar has more than 1,800 patents that either have been awarded or are in the processing stage, and has established an extensive worldwide collaborative network including more than 60 centers of marine biology, chemistry and cancer biology research.
"We continue seeking to establish collaborations with local governments and institutions for the exploration of local biodiversity and establishing joint drug discovery programs for novel marine-derived anticancer compounds," Sousa-Faro says.
The global market for marine- derived drugs was $4.8 billion in 2011 and is expected to be $5.3 billion in 2012. This global market is forecasted to reach $8.6 billion in 2016 at a compound annual growth rate of 12.5 percent for the five-year period of 2011 to 2016, according to BCC Research.
Meanwhile, Myriad scored another victory when the U.S. Court of Appeals for the Federal Circuit ruled that the composition of matter claims covering isolated DNA and cDNA of the BRCA1 and BRCA2 genes are patent-eligible under Section 101 of the U.S. patent act and that the use of the genetic material to screen potential cancer therapeutics is eligible on subject matter terms. This decision reversed a previous ruling of the U.S. District Court for the Southern District of New York that the compositions of matter claims for Myriad's BRACAnalysis product were invalid because the isolated DNA was not really different from the DNA in the body.
The case was filed in May 2009 on behalf of breast cancer and women's health groups, individual women, geneticists and scientific associations. Known as The Association for Molecular Pathology, et al. v. Myriad Genetics Inc., the court battle over patents and genes has been viewed as a legal struggle for dominance between nature and biotechnology. Because about 20 percent of all human genes are patented, the outcome of the case has major ramifications.