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Other News To Note
[December 01, 2008]

Other News To Note

(BioWorld Today Via Acquire Media NewsEdge) , of Santa Clara, Calif., said scientists at Cancer Research UK have used Affymetrix technology to discover the molecular basis for tamoxifen response in breast cancer cells - and the reason why some women can develop resistance to the treatment. Their findings were published in Nature. The researchers at the Cancer Research UK Cambridge Research Institute have discovered for the first time the mechanism by which the breast cancer therapy tamoxifen operates. It switches off a breast cancer gene ErbB2 via a protein called Pax2. Pax2 acts as a switch to keep ErbB2 switched off. Tamoxifen resistance occurs when ErbB2 remains switched on.

? Antigenics Inc., of New York, was notified by Nasdaq that the company is not in compliance with the $50 million minimum market value of listed securities requirement, and does not comply with an alternative requirement of $50 million of total assets and $50 million of total revenue for either the most recently completed fiscal year or two of the last three completed fiscal years. The company has 30 days to regain compliance.

? Barr Pharmaceuticals Inc., of Montvale, N.J., said the FDA has approved its subsidiary Duramed Pharmaceuticals Inc.'s new drug application for Synthetic Conjugated Estrogens-A (SCE-A) 0.625 mg/g Vaginal Cream - a plant-derived local estrogen indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse. It is administered intravaginally at a dose of 1 g daily for one week, followed by 1 g intravaginally twice a week.

? Bavarian Nordic AS, of Kvistgard, Denmark, has been awarded a contract by the Canadian government to deliver 20,000 doses of the small pox vaccine Imvamune. The Canadian authorities intend to use Imvamune as part of the country's biopreparedness program. The delivery will take place in 2009. The contract also provides for the optional purchase of an additional 180,000 doses as well as payment for investigating the requirements for obtaining a licensure of the vaccine in Canada.

? Cell Therapeutics Inc., of Seattle, said that the FDA has granted priority review status for the supplemental biologics license application for use of Zevalin ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy. The FDA has set an action date of April 2, 2009. If approved, Zevalin would be the first radioimmunotherapy available to patients as first-line consolidation therapy.

? DOR BioPharma Inc., of Ewing, N.J., has received $1.5 million under a letter of intent with Sigma-Tau Pharmaceuticals Inc., of Gaithersburg, Md., which grants Sigma-Tau an exclusive right to negotiate terms and conditions for a possible business transaction or strategic alliance regarding orBec (oral beclomethasone dipropionate or oral BDP) and potentially other DOR pipeline compounds until March 1, 2009. Under the terms of the letter of intent, Sigma-Tau has purchased $1.5 million of DOR's common stock at the market price of 9 cents per share, which will be considered an advance payment to be deducted from up-front money due to DOR by Sigma-Tau pursuant to any future orBec commercialization arrangement reached between the two parties.

? Innate Pharma SAS, of Marseilles, France, said it began preclinical testing of IPH 4201, a monoclonal antibody targeting a specific antigen on pancreatic cancer cells. The company expects to confirm the activity of the antibody in preclinical models and develop the process for production at an industrial scale before moving into investigational new drug application-enabling studies.

? Kiadis Pharma, of Amsterdam, the Netherlands, said it and Andrea Velardi, professor of clinical immunology at the University of Perugia, Italy, have extended their collaboration on Atir, a product in clinical development for enabling the use of a mismatched donor in bone marrow transplantation by preventing acute graft-vs.-host disease for end-stage leukemia patients. Velardi will continue the development on the selective depletion of allo-reactive T cells from mismatched donors using Kiadis Pharma's Atir.

? Lipoxen plc, of London, has entered into a materials transfer agreement for SuliXen with the Barbara Davis Center for Childhood Diabetes. Under the terms of the agreement, Lipoxen will provide the center with SuliXen for initial preclinical studies in models of diabetes. The evaluation is designed to explore whether SuliXen has the potential to reverse, limit or prevent the development of Type I diabetes. A similar evaluation will be conducted with Lantus (Sanofi-Aventis).

? Novogen Ltd., of Sydney, Australia, said that a research team at Yale University has found that the company's mTOR inhibitor NV-128 has the potential to act against cancer stem cells in addition to rapidly proliferating cells in established solid tumors. Cancer stem cells are becoming recognized as the underlying mechanism by which tumors recur and metastasize after primary treatment. As such, they represent a promising target by which improved cancer control may be achieved.

? Oculus Innovative Sciences Inc., of Petaluma, Calif., was notified by Nasdaq that its stockholders' equity at Sept. 30 was less than the $10 million in stockholders' equity required for continued listing. The notice has no immediate effect on the listing of the company's common stock.

? Oxford Genome Sciences, of Oxford, UK, has changed its name to Oxford BioTherapeutics to reflect the company's focus on the discovery and development of targeted antibody medicines to address large and unmet patient needs in the field of oncology.

? QLT Inc., of Vancouver, British Columbia, will proceed with a modified "Dutch Auction" tender offer to purchase up to $50 million in shares of its common stock. Shareholders can tender all or a portion of their shares at a price not less than $2.20 per share and not greater than $2.50 per share, representing a premium of 16 percent to 32 percent from the stock's closing price on Nov. 28. QLT will select the lowest per-share purchase price within the anticipated offer range that will allow it to buy up to $50 million in shares.

? Quintiles Transnational Corp., of Research Triangle Park, N.C., has acquired Targeted Molecular Diagnostics, of Westmont, Ill. TMD is a privately held, oncology-focused, specialty diagnostic laboratory and provides guidance through biomarker expression analysis for the development of targeted therapies in oncology. Financial terms were not disclosed.

? ReGen Biologics Inc., of Hackensack, N.J., said that its board of directors approved a 1-for-20 reverse split of ReGen's common stock. The split became effective Nov. 29, and trading under the new ticker RGBO began at market open Dec. 1. The reverse split affects all of ReGen's issued and outstanding common stock uniformly, and will affect all common shareholders proportionately. The reverse split will not affect the number of shares of common stock that ReGen is authorized to issue.

? Symphogen A/S, of Copenhagen, Denmark, said that John Haurum, chief scientific officer, and Michael Kragh, director of antibody pharmacology, will present positive preclinical data on the company's Sym004 program for the discovery and development of antibodies against EGF receptor (EGFR)-positive cancers. The data will be presented at two upcoming conferences: the annual European Antibody Congress in Geneva, Dec. 2, and at IBC Life Sciences' annual International Conference on Antibody Engineering in San Diego, Dec. 11.

? Tibotec Pharmaceuticals, of Mechelen, Belgium, said the European Committee for Human Medicinal Products has issued a positive opinion recommending approval for once-daily dosing of 800 mg Prezista (darunavir) with low-dose ritonavir as part of combination therapy in treatment-naive adults. Darunavir is a protease inhibitor. The committee's positive opinion is based on 48-week analyses of plasma HIV RNA levels and CD4+ cell counts from the ongoing, randomized, controlled, open-label Phase III trial in antiretroviral treatment-naive HIV-1-infected adults.

? Vical Inc., of San Diego, has received a $1 million milestone payment from Merck & Co. Inc., of Whitehouse Station, N.J., based on Merck's planned initiation of a Phase I trial of an investigational plasmid DNA cancer vaccine. The candidate vaccine is based on Vical's DNA gene delivery technology and encodes human telomerase reverse transcriptase.



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