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Vermillion, Oxford Genome Sciences, Medarex, Biosite, Waters, Lambda, FDA

Vermillion Regains Nasdaq Compliance on One Count
Vermillion, formerly called Ciphergen, said this week that it has been notified by Nasdaq that it has partially regained compliance with the exchange’s listing requirements. The company was able to maintain a market cap of at least $35 million for at least 10 business days, fulfilling a requirement that in order to continue being listed on the exchange, a company has to have a minimum of $2.5 million stockholders’ equity, $35 million market cap, or $500,000 of net income from continuing operations for the most recently completed fiscal year, or two of the three most recently completed fiscal years.
Nasdaq had informed Vermillion on Aug. 17 that it was not in compliance with that rule.
Earlier this month, Nasdaq told Vermillion that it was not compliant with another listing requirement that its bid price must be at least $1 per share for at least 30 consecutive business days. The company remains non-compliant with that rule and has until March 4, 2008 to regain compliance [See PM 09/13/07].

Oxford Genome Sciences Reaches Agreements with Medarex, Biosite
Oxford Genome Sciences announced this week a second partnering agreement with Medarex giving Oxford broad access to Medarex’s human antibody technology. The agreement, Oxford said in a statement, potentially could accelerate its development of a pipeline of human antibodies for cancer.
Under the agreement, Oxford will license Medarex’s proprietary transgenic mouse technology to generate antibody therapeutics against cancer targets identified by Oxford using its OGAP protein database. Oxford retains full worldwide rights to newly generated human antibodies, and Medarex has the right to receive licensing fees, milestone payments, and royalties on commercial sales of products resulting from the agreement.
The original agreement between the two companies was reached in May 2006 for the discovery, development, and commercialization of antibody therapeutics.
Oxford also established a three-way agreement with Medarex and Biosite. Medarex will provide Biosite access to its transgenic technology and Biosite will provide early stage antibody development on behalf of Oxford for “potentially a large number of Oxford’s antibody programs,” Oxford said. Biosite will receive access to Oxford’s targets in colorectal and ovarian cancer.
Biosite and Oxford established a separate agreement under which Biosite will be able to create a companion diagnostic assay on certain programs mutually agreed upon by both companies.
Financial terms for the agreements were not disclosed.

Waters to Provide Mass Specs to Lambda
Waters will provide mass spectrometry equipment and training to Indian clinical research services company Lambda Therapeutics Research when Lambda lands service contracts, a Waters spokesman told ProteoMonitor’s sister publication GenomeWeb Daily News this week.
The agreement  “paves the way” for Ahmedabad, India-based Lambda to purchase Waters’ Quattro Premier XE tandem quadrupole mass spectrometer, Acquity UPLC system, and MassLynx software for use in analyzing complex biological samples, Waters spokesman Jeff Tarmy said.
“The agreement enables Lambda to meet its international business goals by fulfilling its needs for innovative laboratory equipment, including mass spectrometry, liquid chromatography, and laboratory software solutions,” Waters said in a statement.
Tarmy said the plan means that “the agreements are in place” for Lambda to buy the tools, training, and knowledge, and that a pathway has been set for Lambda to handle orders as they come in.
Lambda works as a clinical research services partner with pharmaceutical companies, and has facilities in Mumbai, Chennai, and in Warsaw, Poland.
Financial terms of the agreement were not released.

FDA Allows More Time for Public to Have its Say on IVDMIA Guidance
The US Food and Drug Administration has extended the public comment period for its draft guidance on in vitro multivariate index assays to Oct. 17.
The agency originally issued draft guidance on IVDMIAs a year ago, then issued an updated draft during the summer. However, both versions of the guidance have left stakeholders confused about what was required and upset that they may stall innovation [See PM 09/14/06 and 02/15/07].
In extending the public comment period, the FDA said it wants to “allow sufficient time for stakeholder comment.”
More information can be found here.

The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.