FDA Hopes to Issue Final PGx Guidance on June 30
The US Food and Drug Administration hopes to have a final version of its guidance on pharmacogenomics data submissions by June 30, an FDA official told SNPtech Pharmacogenomics Reporter.
Lawrence Lesko, director of the agency’s Office of Clinical Pharmacology & Biopharmaceutics, also stressed that the date is a goal, and that legal issues may hamper a final sign-off.
“This is a target date, and there are certain things here that I have control over,” he said. “But there are other issues that I do not have control over.”
The target date was announced by Lesko during a recent meeting in Prague; it is believed to be the first time that an FDA official has attached a target date to the draft guidance.
Read the following SNPtech Pharmacogenomics Reporter’s coverage on the FDA’s draft pharmacogenomics guidance:
- Commenting on FDA’s PGx Draft, Drug Makers Criticize Biomarker, VGDS Parts
- With PGx Guide 3 Weeks Away, Biopharmas Still Sweat Over Voluntary Data Submissions.
- FDA Ponders Economics of PGx. Will New Regs Drive or Slow Innovation?
- Will FDA’s PGx Draft Guide Encourage Pharma to Invest In New Technologies?
In a Nod to FDA's VGDS Initiative, Iconix Plans to Make Public its Biomarker Data
Iconix Pharmaceuticals plans to publicly release a subset of its proprietary genomic biomarker data in a move that seeks to support the US Food and Drug Administration’s ongoing pharmacogenomics initiative, the company said this week.
The firm said it will provide "immediate early access" to five of its Drug Signature gene-expression biomarkers “to qualified researchers and organizations who agree to make their findings publicly available in support of the program.”
Iconix said it plans to publish its own findings on the derivation, validation, and application of its genomic biomarkers in “leading peer-reviewed journals” later this year. The company made its remarks at the 43rd Annual Society of Toxicology Meeting in Baltimore, Md., this week.
The new initiative is designed “to make a greater body of evidence available to researchers in support of the FDA initiative to finalize guidelines on the use of pharmacogenomic data in regulatory decision-making,” the company said. In particular, Iconix said it intends to "stimulate increased public dialogue and research on the definition and application of ‘Known Valid Biomarkers’ — a concept still being developed by the FDA.
Iconix said that it has derived and validated hundreds of Drug Signatures, which it uses to predict the potential toxicity, mechanism, or side effects of a drug candidate. The five biomarkers selected for the research initiative were chosen based their “relevance to a broad cross-section of the scientific community and targeted at key drug-induced toxicities in liver, kidney, and heart tissue that are often cited as the reason for failed drug development programs,” the company said.
Molecular Devices to Buy Axon For $140M in Cash and Stock
Molecular Devices plans to acquire Axon Instruments for $140 million in cash and stock, the company said this week.
Molecular Devices, based in Sunnyvale, Calif., hopes the acquisition will help bolster product development and distribution, and is prepared to pay $70 million in cash and $70 million of its common stock to do it. The company will also acquire Axon’s $29 million in cash and marketable securities.
Axon, which makes instruments for electrophysiology as well as microarray scanners, is based in Union City, Calif. and has 128 employees. The acquisition is subject to a number of conditions, including shareholder approval from both companies, and is expected to close by the end of June.
Whitehead and Genomics Collaborative Study Role of Y Chromosome in Infertility
Researchers at the Whitehead Institute for Biomedical Research and at Genomics Collaborative plan to study the role of the Y chromosome in infertility, GCI said this week.
The scientists plan to analyze more than 20,000 DNA samples from men worldwide to find genes on the Y chromosome that, when deleted, render these men unable to produce sperm cells. In a pilot project, they will study samples from 4,000 US men.
The DNA samples come from GCI’s Global Repository, a library of 550,000 human samples and clinical records from 120,000 patients worldwide.
GlaxoSmithKline Will Use Inpharmatica’s ADME Tech
Inpharmatica has made its ADME technology available to GlaxoSmithKline, the company said this week.
Terms of the agreement call for Inpharmatica to apply its ADME technology to a number of GSK drug-discovery programs in the UK and in Europe.
Inpharmatica’s ADME technology is part of its PharmaCarta chemogenomics platform that links genomic and proteomics data with chemistry data. The company acquired ADME technology last June from ArQule.
International Team Set to Study Tumor Signatures in Breast Cancer
An international consortium of researchers plans next year to begin studying the role of molecular tumor signatures in breast cancer.
The group, TRANS-BIG, comprises 40 European and Latin American scientists and is in “late-stage negotiation” with the European Commission to fund the project, according to a press release issued during the European Breast Cancer Conference. The three-day conference was held in Barcelona, Spain, last week
A team led by TRANS-BIG member Emiel Rutgers, from the Netherlands Cancer Institute, has developed a “genetic signature that seems to be a very good instrument to predict” whether breast cancer will recur, according to the press release. This technology will be validated through the microarray-based MINDACT trial in node-negative breast cancer patients.
“If the trial outcome is as expected, it will mean that it will be possible to spare patients at low risk of relapse from over-treatment with chemotherapy,” the statement said. “Our trial will be the first to test this theory in practice on a large scale,” Rutgers added. “We are very excited about this chance to ensure that each patient receives a treatment tailor-made to manage the particularities of her disease.”
MWG Says It Successfully Opposed Applera Nucleic Acid Amplification Patent
MWG Biotech last week said it successfully opposed a European patent held by Applera over a patent for nucleic acid amplification.
MWG, based in Ebersberg, Germany, said the European Patent Office revoked Applera’s European Patent No. 236 069 B1, entitled “Apparatus and method for performing automated amplification of nucleic acid sequences and assays using heating and cooling steps,” after MWG and others had opposed the patent.
This decision is final, according to MWG. “There are no further judicial remedies,” it said in a statement. Applera has not commented publicly.
Amersham shareholders approved General Electric’s bid to acquire it for $9.5 billion
By proxy and in person during a court meeting and an extraordinary general meeting held last week in London, Amersham shareholders approved the share-exchange acquisition, the company said.
The transaction, which is still subject to approval by the British High Court, is expected to be completed on April 8. The pricing of the share exchange will be calculated based on the trading period between March 23 and April 5, Amersham said.
Under the terms of the merger, William Castell, the chief executive officer of Amersham, will become a vice chairman of General Electric and Amersham will become General Electric Healthcare Technologies, the first GE division headquartered outside the US. [For more information, see 10/16/03 SNPtech Pharmacogenomics Reporter here and here.]
St. Jude to Use CombiMatrix Arrays to Study Avian Flu
St. Jude Children’s Research Hospital and Acacia Research unit CombiMatrix unit will collaborate to study genetic variation in the bird flu virus, Acacia said.
Reseachers at St. Jude will use custom microarrays from CombiMatrix to monitor mutations in the H9 variant of the influenza A virus. H9, which is common in poultry, has the potential to spread to humans in the future, according to CombiMatrix.