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FDA Publishes PGx Guidance in Federal Register; Document Now Due Early 2005

The US Food and Drug Administration has published in the Federal Register its draft Guidance for Industry on Pharmacogenomics Data Submissions, and now expects to release the final guidance "early next year," according to an FDA spokesperson.

The widely anticipated document, whose approval has been delayed numerous times since it was released as a draft in November 2003, is designed to encourage drug makers to use pharmacogenomics technologies in their drug-discovery efforts and submit some of their findings as a way to help the FDA broaden its knowledge of the technologies.

Published in the Federal Register on Dec. 27, the guidance may therefore be a catalyst for greater use of gene-expression and SNP-genotyping technologies, and might embolden makers of these tools to develop new versions.

As GenomeWeb News reported last month (see GenomeWeb News, 11/12/2004), an FDA official said the agency will issue the final guidance document before the end of the year. The document will be "out by January 2005," said Larry Lesko, director of the FDA's Office of Clinical Pharmacology and Biopharmaceuticals.

The guidance will appear on a special FDA website upon release, along with a companion Manual of Policies and Procedures and "frequently asked questions" documents, said Lesko. He did not disclose the website address.

Following an invited session on pharmacogenetics held Oct. 29 at the 54th annual American Society of Human Genetics meeting in Toronto, Lesko told GenomeWeb News that the guideline's release was not delayed because of revisions to the document itself. "It's been done for about four weeks," said Lesko. "There is no scientific reason it's not going out." He said at the time that the guidance would be issued as soon as final legal and other reviews of the document were completed.

The Jan. 1 due date follows a string of at least three previous, revised deadlines. Pharmacogenomics Reporter, a GenomeWeb News publication, reported in June that Lesko expected the completed guidance by the end of the summer. The regulatory agency had originally planned it to release by June 30.


Gene Logic and Affy Amend Terms of Microarray Supply Agreement; Subscription Payment to Affy Slashed

Gene Logic last week announced amendments to its 2002 microarray supply agreement with Affymetrix.

In an SEC filing, Gene Logic said that it will pay Affymetrix a mere $500,000 in annual subscription fees in 2005, instead of $4 million that it paid in prior years.

Gene Logic also said it will purchase at least $500,000 worth of Affymetrix products and services this month, and at least another $9.5 million in 2005.

The companies will also establish pricing for probe array products for the period between July 1, 2003 and Dec. 31, 2005.

The original contract, effective since Jan. 1, 2002, sets the terms for supplying Gene Logic and its subsidiaries with DNA probe arrays from Affymetrix for developing database products and services. That agreement, disclosed in a 2002 SEC filing by Gene Logic, did not provide any financial details.

The two companies first announced a supply agreement in January of 1999, which the 2002 agreement replaced.


NIH Provides Up to $30M for Proteomic Research Into Oral Diseases Resulting from AIDS

The NIH’s National Institute of Dental and Craniofacial Research issued a request for applications last month to support proteomic research into oral diseases associated with HIV/AIDS.

Under the RFA, entitled “Protein Profiles of the Oral Mucosal Tissue in HIV/AIDS,” the NIDCR will award up to $3 million each to up to 10 researchers to characterize protein profiles and protein-protein interactions in the oral mucosa in conjunction with HIV/AIDS.

The suppressed immune system resulting from HIV infection makes patients vulnerable to a variety of oral disorders, including tumors, infections, and ulcers. New research is expected to “identify novel strategies for prevention and management of oral manifestations of AIDS,” according to the RFA.

The deadline for applications is Aug. 16.


NIH, International Consortium, Set Aside $21M in RFA for Research Into Genetics in Autism

An international coalition led by the US National Institutes of Health has set aside more than $21 million to identify genes associated with autism spectrum disorders, and has issued a Request for Applications for the project, the NIH said last week.

More information on the RFA, which will award the money over five years, can be found here.


Genelabs Gets $1.25M From Affy After Amending LADA License Agreement

Genelabs Technologies has received $1.25 million from Affymetrix after amending a non-exclusive license to Genelabs’ Linker-Aided DNA-amplification technology, Genelabs said last week.

Affy licensed the technology, called LADA, from Genelabs in December 2002. According to the company, the amendment converts the license to a “fully paid up non-exclusive license” and eliminates royalties and fees that were payable under the original agreement.

The license covers inventions covered under US patent number 6,107,023, entitled “DNA Amplification and Subtraction Techniques,” as well as certain international patents. The patent claims “a method of amplifying nucleic acids by attaching DNA linkers of a known sequence to the ends of unknown DNA sequences which are targeted for amplification,” Genelabs said.

“By adding these linkers to targeted DNA molecules, users can readily design and construct primers complementary to the attached linkers and amplify the unknown, targeted DNA sequences,” the company added.

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