• Access Pharmaceuticals Inc., of Dallas, said its Cobalamin-based oral insulin significantly reduced glucose levels in an animal model of diabetes. Cobalamin delivery technology involves attaching vitamin B12, which is absorbed in the gastrointestinal tract, to polymers and nanoparticles carrying encapsulated drugs. Access plans to select a lead candidate in the insulin program and seek a partner. The company is also in the process of acquiring Somanta Pharmaceuticals Inc., of Irvine, Calif. (See BioWorld Today, Feb. 22, 2007.)

• Acologix Inc., of Hayward, Calif., said preclinical study results demonstrated that AC-100, a novel synthetic peptide derived from an endogenous human protein produced by bone and dental cells, promoted cartilage defect repair in an animal model. In the study, goats with an osteochondral femoral condylar, or knee cartilage, defect were used to evaluate the effects of AC-100 on cartilage regeneration. Cylindrical defects were created in the knee cartilage and were filled with a collagen sponge containing AC-100 at two different doses or a collagen sponge soaked in saline. Postoperative treatments included intra-articular injections of the test articles into the operated knee joint at weeks one, two and three post-surgery. Cartilage regeneration was evaluated in one group after 84 days and 168 days in another group. The groups treated with the higher dosage of AC-100 had greater healing outcome scores than the saline control groups. The firm said there was no evidence of an inflammatory response.

• Amgen Inc., of Thousand Oaks, Calif., said it is in discussions with the FDA to update safety information for all erythropoiesis-stimulating agents (ESAs) labeling based on safety data from the PREPARE study interim results in neoadjuvant breast cancer reported last week and the recently published follow-up data from the Gynecologic Oncology Group study in cervical cancer. Amgen also said it was advised that an Oncology Drugs Advisory Committee meeting will take place in the first quarter of 2008, as part of the ongoing pharmacovigilance review of ESA therapies. Aranesp, Amgen's top-selling ESA, was approved in 2001 for anemia associated with chronic renal failure, and later gained approval for anemia caused by concomitantly administered chemotherapy in patients with nonmyeloid malignancies. The drug has been used widely off-label, though data released this year have not supported some of that usage. Data released early this year contributed to the Centers for Medicare & Medicaid Services' decision to restrict payments for ESAs in patients with cancer whose hemoglobin levels decrease to less than 10 g/dL. In November, the FDA revised the ESA product labels to include stronger warnings. Most recently, interim data from the PREPARE study showed no significant difference in tumor response during treatment, but as of the end of October, patients receiving Aranesp had a higher mortality rate (14 percent) compared to those on placebo (10 percent). Analyst Joel Sendek, of New York-based Lazard Capital Markets LLC, maintained a "sell" rating - and a $46 price target - and wrote in a research note that his firm expects "negative data points on Aranesp to continue through 2010, as data rolls out from 13 ongoing or planned Aranesp trials." Shares of Amgen (NASDAQ:AMGN) fell $3.05 Friday to close at $52.10. (See BioWorld Today, Sept. 4, 2007, and Nov. 9, 2007.)

• Celldex Therapeutics Inc., of Phillipsburg, N.J., received orphan drug designation for peptide vaccine CDX-110 in the treatment of EGFRvIII-expressing glioblastoma multiforme. CDX-110 is being studied in a Phase II/III trial. Celldex is in the process of merging with Avant Immunotherapeutics Inc., a deal that is expected to close in the first quarter of 2008. (See BioWorld Today, May 25, 2007, and Oct. 23, 2007.)

• CV Therapeutics Inc., of Palo Alto, Calif., said the FDA will review a supplemental new drug application claiming potential anti-arrhythmic benefit for Ranexa (ranolazine extended-release tablets). Ranexa is approved for second-line use in chronic angina, and the FDA is reviewing an sNDA seeking to expand the label to first-line use in angina as well as an NDA seeking to add a claim of reduction of hemoglobin A1c in coronary artery disease patients with diabetes. The expected action date for the two sNDAs and the NDA is July 27, 2008. (See BioWorld Today, March 8, 2007.)

• DOR BioPharma Inc., of Miami, reported the outcome of its End of Review conference with the FDA following the agency's not approvable letter for orBec (oral beclomethasone dipropionate) in gastrointestinal graft-vs.-host disease. DOR said the FDA will require a single, confirmatory Phase III trial, which the company is working with the agency to design and for which it will request a special protocol assessment. DOR also said the FDA would be open to reviewing the company's plan for a compassionate use program as long as such a program does not interfere with the trial. Shares of DOR (OTC BB:DORB) rose 2 cents, or 9 percent, to close at 18 cents on Friday. (See BioWorld Today, Oct. 22, 2007.)

• Genesis Bioventures Inc., of Los Angeles, completed its planned name change to Abviva Inc. That new name is intended to emphasis the company's goal to commercialize its Mammastatin Serum Assay and to pursue the development of the mammastatin protein as a possible first-line therapy in breast cancer.

• Gentium SpA, of Villa Guardia, Italy, said, as a corollary to its Phase III trial of Defibrotide in veno-occlusive disease with multiple organ failure (severe VOD), it also initiated an expanded access program to treat severe VOD. That program is not expected to impact enrollment in the ongoing study, but the company will be able to collect additional data from the program to support its planned new drug application for Defibrotide.

• Janssen-Cilag, of Stockholm, Sweden, said it has submitted a marketing authorization application (MAA) for dapoxetine, a treatment for premature ejaculation in men ages 18-64. The MAA was submitted under the so-called decentralized procedure, in which Sweden will act as the reference member state and Austria, Finland, Germany, Italy, Portugal and Spain will act as the concerned member states for the application, the firm said, adding that regulatory submissions in other regions of the world are expected to follow. Dapoxetine is the first oral pharmacologic agent developed specifically for the treatment of men with premature ejaculation, the company said. The safety and efficacy trials showed increases in average intravaginal ejaculatory latency time and improved patient-reported outcomes of increased control over ejaculation and reduced personal distress related to ejaculation.

• Medarex Inc., of Princeton, N.J., said it will receive an undisclosed milestone payment from Centocor Inc., a subsidiary of Johnson & Johnson, of New Brunswick, N.J., related to Centocor's filing of regulatory applications in the U.S. and Europe for ustekinumab (CNTO 1275) in the treatment of plaque psoriasis. Ustekinumab is a human monoclonal antibody that targets interleukin-12 (IL-12) and interleukin-23 (IL-23). Medarex and Centocor began collaborating in 1997 on antibodies created using Medarex's technology.

• Neurochem Ltd., of Ecublens, Switzerland, said it has been informed that its response to the FDA July 2007 approvable letter for its application for Kiacta (eprodisate) for the treatment of Amyloid A amyloidosis, a progressive and fatal condition linked to chronic inflammatory disorders and infections and certain inherited diseases, is complete and has been granted a Class 2 review. The FDA is expected to make an approval decision by April 2, 2008, the Prescription Drug User Fee Act action date.

• Neurocrine Biosciences Inc., of San Diego, closed its sale and leaseback agreement with Veralliance Properties for its real estate assets in exchange for a total consideration of $109 million. Neurocrine leased back its corporate headquarters for a 12-year term, with renewal options, and retains certain options to repurchase all of the properties at specific times during the lease period. The company expects to receive cash of about $61 million, net of fees, expenses and existing indebtedness.

• Pluristem Therapeutics Inc., of New York, said Nasdaq approved its application to list its shares, expected to begin trading today under the symbol "PSTI." Pluristem develops allogeneic cell therapy products for malignant, ischemic and autoimmune disorders.

• Replikins LLC, of Boston, reported that a gene related to rapid replication and lethality has been found to be present in, and to contain some identical protein sequences to tobacco mosaic virus and non-small-cell lung cancer. That gene's activity appears to be measured by the AMAS test, an early cancer diagnostic developed by Oncolab Inc., also of Boston. The newly identified gene was named the Replikin Peak Gene, and Replikins said specific RPGs have been identified and quantified in infectious organisms, including viruses, bacteria and trypanosomes.

• SuperArray Bioscience Corp., of Frederick, Md., said it has entered into an RNA interference (RNAi) license agreement with the Carnegie Institution, of Washington. Under the deal, SuperArray will develop, manufacture and distribute worldwide RNAi-based gene function and mechanism of action research tools. The firm said the agreement enables it to offer RNAi-based gene silencing products for gene function studies, including gene-specific small interfering RNA and DNA-based RNAi expressing short hairpin RNA. The agreement, the company added, also allows SuperArray to pass on rights to end-user customers in the research field for the performance of DNA-based RNAi.

• Xencor Inc., of Monrovia, Calif., said data demonstrated that XmAb5871, a humanized anti-CD19 antibody therapeutic, suppressed autoimmunity through B-cell inhibition without depleting B cells. Researchers at Xencor engineered XmAb5871 to inhibit the activation of B cells by enabling cross-linking of the B cell antigen receptor and the inhibitory Fc receptor, FcãRIIb, via the antigen CD19, a part of the BCR co-receptor complex, the firm said. Researchers using Xencor's PDA technology engineered the constant region, or Fc, of the antibody to increase its affinity for binding FcãRIIb by about 200-fold.

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