• Amgen Inc., of Thousand Oaks, Calif., said a U.S. Federal District Court in Boston denied Basel, Switzerland-based F. Hoffmann-La Roche Ltd.'s motion to dismiss Amgen's patent infringement lawsuit against Roche, and also denied a motion by Bridgewater, N.J.-based Ortho Biotech Products LP to intervene as a co-plaintiff in the case. Amgen sued Roche in November claiming that Roche's peg-EPO product violates Amgen's patents and that it does not provide any clinical or patient benefit over Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa). Roche maintains that its products do not infringe on the Amgen patents. (See BioWorld Today, Nov. 10, 2005.)

• Calando Pharmaceuticals Inc., of Duarte, Calif., said results of a pilot safety study of its lead siRNA therapeutic candidate in non-human primates demonstrated that the formulation, containing Calando's delivery technology with a siRNA duplex targeting the M2 subunit of ribonucleotide reductase, was well tolerated at doses well above those of a similar formulation shown to have antitumor effects in a metastatic mouse model. Data were presented at the second annual meeting of the Oligonucleotide Therapeutic Society in New York. Calando anticipates starting a Phase I trial with the product by the end of 2007.

• Dynavax Technologies Corp., of Berkeley, Calif., reported preclinical data at the International Conference on Influenza Vaccines for the World in Vienna, Austria, showing that its influenza vaccine can improve the immunogenicity of standard flu vaccines. More specifically, data from mouse and primate models demonstrated that co-administration of the company's flu vaccine with standard vaccine enhances the immune response of the standard vaccine, allows reduction of standard vaccine dosage and provides extra layers of protection that are not strain-dependent. Dynavax's vaccine is based on its TLR9 agonist-based immunostimulatory sequence technology.

• Novartis Pharmaceuticals Corp., of East Hanover, N.J., said the FDA broadened the use of Gleevec (imatinib) for four blood cancers and a solid-tumor indication. The new uses include relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia, certain forms of myelodysplastic and myeloproliferative diseases, hypereosinophilic syndrome/chronic eosinophilic leukemia, aggressive systemic mastocytosis and dermatofibrosarcoma protuberans.

• Vical Inc., of San Diego, reported preclinical data at the International Conference on Influenza Vaccines for the World in Vienna, Austria, showing that a single injection of its lead avian influenza DNA vaccine candidate provided 100 percent protection in ferrets against lethal challenge with a virulent H5N1 virus. The three-component DNA vaccine candidate encodes two highly conserved influenza virus proteins - nucleoprotein (NP) and ion channel protein (M2) - plus the H5 avian influenza virus surface protein, and is formulated with the company's Vaxfectin adjuvant. In contrast, Vical said, conventional avian flu vaccines in development typically have required two or more doses in humans to produce the immunogenicity levels expected to provide protection.

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