• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said Phase III data reported at the American Academy of Neurology meeting in San Diego showed that Tysabri (natalizumab) produced significant effects on pre-specified health-related quality-of-life measures among multiple sclerosis patients, in addition to those previously reported on disability progression, relapse rate and MRI. The findings also showed an impact on additional pre-specified measures of disability progression, including visual and cognitive function. The drug remains under FDA review for its possible reintroduction to the market, following a positive advisory panel meeting a month ago. (See BioWorld Today, March 9, 2006.)

• Celgene Corp., of Summit, N.J., said the European Medicines Agency accepted for review its marketing authorization application for Revlimid (lenalidomide). The application, submitted in February, was based upon safety and efficacy results from two pivotal Phase III trials evaluating the drug plus dexamethasone in multiple myeloma patients who have received at least one prior therapy. A separate application for the MDS indication is under review by the EMEA.

• Epeius Biotechnologies Corp., of San Marino, Calif., said the Philippine Bureau of Food and Drugs approved an expanded access program for Rexin-G, Epeius' lead product for metastatic cancer. The program enables Epeius Biotechnologies to recoup some of the costs of its ongoing clinical trials in Manila. The compound has been approved by the Philippine BFAD for systemic use in a Phase I/II trial for all metastatic cancers. In the U.S., a Phase I study is under way in metastatic colorectal cancer.

• Galenea Corp., of Cambridge, Mass., aligned its strategy to focus exclusively on drugs to treat central nervous system diseases. The company decided in February to sell its siRNA program to treat influenza and other respiratory viruses to Nastech Pharmaceutical Co. Inc., of Bothell, Wash. The value created by the siRNA program will enable Galenea to in-license additional CNS programs to augment its pipeline. It will continue to support its February 2005 collaboration with Otsuka Pharmaceutical Co. Ltd., of Tokyo, focused on developing drugs to treat schizophrenia and other CNS disorders. (See BioWorld Today, Feb. 22, 2005, and Feb. 24, 2006.)

• Genelabs Technologies Inc., of Redwood City, Calif., received a staff deficiency letter from Nasdaq stating that the company does not comply with the Nasdaq rule requiring the company to have a minimum of $2.5 million in shareholder's equity or a $35 million market value. Nasdaq is reviewing Genelabs' eligibility for continued listing and requested that Genelabs submit a plan to achieve and sustain compliance. Genelabs also said it closed its data management and statistical office in New Jersey. Also, Mumtaz Ahmed, vice president, drug development, is retiring from the company. The company's stock (NASDAQ:GNLB) fell 34 cents Friday, or 21 percent, to close at $1.27.

• Noven Pharmaceuticals Inc., of Miami, and Shire plc, of Basingstoke, UK, said the FDA approved Daytrana (methylphenidate transdermal system), the first and only non-oral medication for the treatment of attention deficit hyperactivity disorder. A once-daily transdermal patch formulation of methylphenidate, Daytrana will be available in 10-mg, 15-mg, 20-mg and 30-mg dosage strengths. Launch is expected in the middle of this year.

• Reata Pharmaceuticals Inc., of Dallas, said its third development candidate, RTA 402, has received FDA clearance to begin clinical testing in patients with solid tumors, lymphoma and myeloma, and a study has been initiated with this agent at the M. D. Anderson Cancer Center. RTA 402 (also known as CDDO-Me) is a novel targeted cancer therapy that exploits differences between cancerous and noncancerous cells by modulating oxidative stress response pathways.

• Sequenom Inc., of San Diego, said its public accounting firm classified it as a going concern in documents filed with the SEC. Ernst & Young LLP issued the qualification based on year-end financial statements that pointed to significant operating losses and insufficient cash and investments to fund operations past this quarter. But the company, which develops genetic analysis products, recently received commitments for a $33 million stock and warrant placement, subject to shareholder approval and other closing conditions.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said results of a Phase II marker lesion study of EOquin (apaziquone) by intravesical instillation in superficial bladder cancer demonstrated that complete tumor disappearance was documented in 30 of the 46 patients. Patients in the study received six weekly instillations of EOquin into the bladder following surgical removal of all but one marker lesion. Spectrum expects to initiate a small pilot study, to be followed by a randomized Phase III trial before the end of the year.

• Sunesis Pharmaceuticals Inc., of South San Francisco, entered a research and license agreement with the University of California at San Francisco, granting the school a limited license to the company's fragment-based drug discovery technology, Tethering, for academic purposes to identify small-molecule drug candidates. In return, Sunesis receives an exclusive royalty-free license to any improvements to the technology or fragment libraries that emerge from UCSF's research. In the event that any small molecules are discovered, Sunesis will have a right of first negotiation to in-license the compounds. UCSF is precluded from using the technology for commercial purposes and from conducting research in the kinase field or on any other drug target on which Sunesis is currently working. More specific financial terms were not disclosed.

• XDx, of South San Francisco, said leading transplant physicians will present data at the International Society for Heart and Lung Transplantation 26th annual meeting in Madrid, Spain, highlighting the potential of AlloMap molecular expression testing, a non-invasive method to detect the absence of acute cellular rejection in heart transplant patients by measuring gene expression in a patients' peripheral blood. The presentation will touch on future applications for AlloMap testing, including its potential ability to monitor immunosuppression and to predict cardiac allograft vasculopathy in patients, as well as its success in determining markers in lung transplantation.