Clinical Data plans to launch its first molecular diagnostic later this year, a product designed to identify patients at risk for developing severe adverse events to the third-line schizophrenia drug clozapine, says Carol Reed, the company’s chief medical officer.
Clinical Data will offer the test before the end of the year through its CLIA lab, but the company is not discounting plans to talk about the test with US regulators. “We certainly have plans to discuss the implications of this with” the US Food and Drug Administration, Reed says. “Some of the groups at FDA are already aware of what we’ve been doing, and we look forward to continuing those relationships, as well as cultivating some other groups within FDA who need to know, but might not be as familiar with it.”
Approximately 0.8 percent of patients taking clozapine develop agranulocytosis, which is an inability to create white blood cells that can quickly lead to infections and death. Patients prescribed clozapine must have failed at least two other treatments, and they are required to undergo weekly blood testing to detect white blood-cell depletion.
“I think the need to seek FDA approval for [the test] will depend on the life-cycle management issues … as well as discussions with FDA and where they might like to see it go,” Reed says.
Sales for clozapine amount to approximately $200 million per year. Between 80,000 and 90,000 people in the United States take the drug, with “at least that many” in Europe, Reed estimates.
The company says it hopes the test will encourage US regulators to consider upgrading clozapine to a first-line, and thus more widely prescribed, treatment. However, the firm has not begun discussing with the FDA whether its test can play a role in the agency’s decision to make the drug a first-line therapy.
— Chris Womack
Gene Logic plans to help Organon Pharmaceuticals find new uses for a number of failed compounds, though it is not yet decided which or how many compounds are up for repositioning. In a twist on Gene Logic’s standard repositioning deal, the company will own half of any compound that Organon decides to pursue.
Writing for Nature, John Lindon and colleagues at Imperial College London and Pfizer have reported a proof-of-concept study using metabolomic profiles to predict the extent of liver damage in rats receiving acetaminophen.
Biocon intends to file for regulatory approval of its EGFR-targeting drug Biomab from the government of India. Meanwhile, the company’s subsidiary Biocon Biopharmaceuticals recently finished clinical trials for the head-and-neck anticancer compound. Biocon Biopharmaceuticals is a joint project with the Cuba-based Center for Molecular Immunology.
Canada-based Warnex has agreed to acquire PRO-DNA Diagnostic for $2 million. The genetic-testing service provider will operate as a division of Warnex Medical Laboratories and will be relocated from Montreal to the Warnex facilities in Laval, Quebec.
Digene has announced plans to market and distribute cystic fibrosis screening products made by Asuragen, the newly formed molecular diagnostic company spun out of Ambion.
US Patent 7,033,755. Diagnostics and therapeutics for glaucoma. Inventors: Abbot Clark, John Fingert, Loretta McNatt, Edwin Stone, and Wan-Heng Wang. Assignees: Alcon and the University of Iowa Research Foundation. Issued: April 25, 2006.
This patent covers methods for diagnosing and treating glaucoma, including a diagnostic method by which the expression level of mRNA encoding human frizzled related protein-1 is detected in a patient sample of trabecular meshwork cells, and wherein an aberrantly high level of the mRNA relative to that of a normal person is diagnostic of a glaucomatous state.
US Patent 7,034,135. Molecules of the NBS/LRR protein family and uses thereof. Inventors: John Bertin, Weiye Wang, and Maria Blatcher. Assignees: Millennium Pharmaceuticals and Wyeth. Issued: April 25, 2006.
Novel NBS-2, NBS-3, PYRIN-12/NBS-4, and NBS-5 polypeptides, proteins, and nucleic acid molecules are disclosed in this application. Each of the described genes has a nucleotide binding site domain, which is present in a number of proteins that transmit signals which activate apoptotic and inflammatory pathways in response to stress and other stimuli. Diagnostic, screening, and therapeutic methods using compositions of the invention are also provided.
In the first study of its kind, Pharmacogenetics Research Network scientists measured 11 different protein markers of tumor response to Pfizer’s chemotherapeutic Camptosar. The markers didn’t jibe with tumor location, implying that cancer treatment may be better guided by diagnostic data.