• Acceleron Pharma Inc., of Cambridge, Mass., said preclinical results demonstrated that ACE-011, its anabolic bone agent to treat bone loss, preserved bone mass and architecture in a murine model of multiple myeloma. In the study, mice treated with ACE-011 maintained their bone mass, while untreated mice developed substantial bone loss as a result of the myeloma. Histomorphometry analysis revealed that mice given ACE-011 had normal bone formation parameters, while untreated mice had reduced bone formation and increased bone resorption. Data were presented at the International Myeloma Workshop in Kos, Greece.

• Amgen Inc., of Thousand Oaks, Calif., submitted testimony for a House Ways and Means Subcommittee on Health hearing, citing data showing that the majority of Epogen (epoetin alfa) use in dialysis has been and continues to be appropriate. The company maintained in its testimony that, when used as directed by the FDA-approved package insert, Epogen has been shown to be safe and effective in multiple clinical trials and in use in almost 1.4 million dialysis patients. Amgen also highlighted new analyses of U.S. dialysis data showing that physicians are using Epogen even more conservatively since the Centers for Medicare & Medicaid Services (CMS) announced its monitoring policy in November and the FDA amended product labeling for erythropoiesis-stimulating agents in March. Last month, the firm responded to the CMS proposal to no longer pay for ESAs in certain cases of cancer and related neoplastic conditions. That proposal could become final by the middle of August. (See BioWorld Today, May 16, 2007.)

• Bacilligen Inc., of Rockville, Md., accepted a $50,000 investment from the state's Challenge Investment Program fund, part of the Maryland Department of Business and Economic Development's Maryland Venture Fund. The company said that funding will strengthen Bacilligen's ability to advance its three technology platforms and more quickly bring to market treatments and vaccines for oncology and infectious disease, as well as to advance a rapid biologics manufacturing system.

• Bionovo Inc., of Emeryville, Calif., filed a registration statement with the SEC to raise, from time to time, up to $100 million through the sale of common stock. Proceeds are expected to fund general corporate purposes, including clinical research and development, capital expenditures and working capital needs. The company has several programs in development, including a Phase II-stage drug, MF101, to alleviate the symptoms of menopause, and a cancer drug, BZL101, in development for advanced breast cancer.

• Carrington Laboratories Inc., of Irving, Texas, intends to appeal Nasdaq's ruling that a plan submitted by the company earlier this month to achieve and maintain compliance with Nasdaq listing requirements was not sufficient. Any potential delisting will be postponed until after the hearing, which is expected to occur within 30 to 45 days.

• Cell Therapeutics Inc., of Seattle, said preclinical data demonstrated that treatment with pixantrone resulted in minimal or no significant cardiotoxicity, while doxorubicin and mitoxantrone induced significant cardiac damage. The studies compared the cardiac side effects of equiactive doses of pixantrone to the other two drugs in mice pre-treated with a cardiotoxic dose of doxorubicin as well as in mice without prior treatment. Results were published in Investigational New Drugs.

• Cerus Corp., of Concord, Calif., signed an initial two-year agreement with the French national blood service, Etablissement Francais du Sang, for the Intercept Blood System for platelets. The terms provide for Intercept equipment and disposable purchases of up to $8 million, with the actual amounts determined by the rate of implementation in EFS regional centers.

• Codon Devices Inc., of Cambridge, Mass., entered an agreement in which Huntsville, Ala.-based Open Biosystems will distribute its gene synthesis offering in North America. Under the terms, Open Biosystems will sell and distribute Codon Devices' gene synthesis platform to researchers with needs that fall below Codon's minimum order threshold, which previously limited access to researchers with large-scale requirements.

• Cytomedix Inc., of Rockville, Md., said the Centers for Medicare & Medicaid Services (CMS) agreed to the company's request to reconsider a non-coverage decision for autologous blood-derived products when used for the treatment of chronic nonhealing wounds. The decision, issued in 1992 and amended in 2003, broadly disallows Medicare coverage for those products, which includes Cytomedix's platelet-rich plasma (PRP) technology, AutoloGel. CMS has opened a national coverage determination to reconsider coverage of the PRP gel and, after considering public comments, will release a proposed decision memorandum. The expected National Coverage Analysis completion data is March 24, 2008.

• Cytori Therapeutics Inc., of San Diego, is voluntarily delisting from the Frankfurt Stock Exchange, primarily in response to a shift in trading volume since December 2005 from the FSE to Nasdaq, where the company will maintain its primary listing. Cytori's last day of trading on the FSE will be Sept. 25, and after that, its shares owned in Germany, the U.S. or elsewhere will continue trading on Nasdaq under the symbol "CYTX".

• DNAPrint Genomics Inc., of Sarasota, Fla., reported study results revealing that less PT-401 is bound to the EPO receptor and less is inactivated, resulting in a prolonged half-life, compared to epoetin. The company said that explains why PT-401 appears to be significantly more effective than epoetin in raising red blood cell counts. The study was presented at the European Renal Association in Barcelona, Spain. Previously, DNAPrint Pharmaceuticals, the company's wholly owned subsidiary, announced three successful milestones related to PT-401: the use of CHO cell lines; the use of SDS-PAGE, a well-established separation technique for the testing of cell lines; and a specially developed isoelectric focusing method.

• Enceladus Pharmaceuticals BV, of Amsterdam, the Netherlands, and Clinquest Group, also of Amsterdam, signed an investment and collaboration agreement under which Clinquest acquired a stake in Enceladus and led a syndicate of investors to provide additional funding. Financial details were not disclosed, but Enceladus said it will use the funds to support ongoing clinical development of its anti-inflammatory drug, Nanocort, in rheumatoid arthritis. Nanocort, which consists of corticosteroids packaged in specifically designed small lipid vesicles, also is being invested in multiple sclerosis and certain types of cancer.

• Evogene Ltd., of Rehovot, Israel, and SunGene GmbH, of Gatersleben, Germany, announced a collaboration to develop next-generation enabling technologies for the precise bioengineering of crops. The deal is supported under the Israel-Germany BioDisc program, which aims to intensify contacts between the countries in areas such as future technologies with high potential. Terms were not disclosed.

• Genmab A/S, of Copenhagen, Denmark, reached its first development milestone in its collaboration with London-based GlaxoSmithKline plc for the development of ofatumumab (HuMax-CD20) by reporting positive efficacy results in a Phase II study in rheumatoid arthritis earlier this month. Achievement of that milestone triggered a payment of DKK116.3 million (US$20.8 million). Genmab licensed exclusive worldwide rights to co-develop and commercialize ofatumumab to GSK in a December deal valued at up to $2.1 billion. (See BioWorld Today, Dec. 20, 2006.)

• Immunotope Inc., of Doylestown, Pa., said that Ben Franklin Technology Partners of Southeastern PA made a second $350,000 investment to continue funding the company's Phase I IMT-1012 immunotherapeutic vaccine trial. BFT/SEP made the first investment in August 2006 to enable the company to manufacture the vaccine and obtain necessary regulatory approvals. IMT-1012 is a multivalent cancer therapeutic vaccine that combines 12 antigens that each target different pathways present in aggressive ovarian and breast tumors.

• Intradigm Corp., of Palo Alto, Calif., selected Agilent Technologies Inc., of Santa Clara, Calif., to manufacture the active small interfering RNA (siRNA) component of Intradigm's RNAi therapeutic. Intradigm has selected ICS-283 as its lead RNAi product candidate. The compound is the only systemic RNAi therapeutic in preclinical development against a clinically validated oncology target, VEGF, it said. Under the terms of the deal, Agilent will provide the siRNA material to Intradigm, according to GMP standards, and Intradigm expects to enter the clinic with the compound next year.

• Inverness Medical Innovations Inc., of Waltham, Mass., completed its tender offer for all outstanding shares of Biosite Inc., of San Diego. A total of 15.76 million shares were tendered for $92.50 per share in cash, bringing Inverness' ownership in Biosite to 91.7 percent. Inverness extended the tender offer until June 28, after which it expects to complete the acquisition through a short-form merger, making Biosite a wholly owned subsidiary. (See BioWorld Today, April 11, 2007.)

• Kiadis Pharma, of Amsterdam, the Netherlands, completed a €15 million (US$20.2 million) private financing round led by Alta Partners, of San Francisco. Other new investors Quest for Growth and MedSciences Capital participated in the round, as well as existing investors including Life Sciences Partners, Esprit Capital Partners LLP and NV NOM (Investment and Development Agency of the Northern Netherlands). Ekaterina Smirnyagina, of Alta Partners, joined Kiadis' board. The company is developing a product pipeline in the fields of bone marrow transplants and cancer. Its lead program, ATIR, is designed to use mismatched bone-marrow donors in transplantations for terminally ill blood cancer patients.

• Micromet Inc., of Bethesda, Md., said a recently published study supports several other studies showing that EpCAM, the target for Micromet product candidates adecatumumab (MT201) and MT110, might be suitable as a target for eradication of cancer stem cells. Previous studies showed that CSCs from colon, breast, pancreatic and prostate cancers all express high levels of EpCAM. Data were published in the Proceedings of the National Academy of Sciences.

• Neogenix Oncology Inc., of Great Neck, N.Y., and Goodwin Biotechnology Inc., of Plantation, Fla., entered an agreement for process development and manufacturing of Neogenix's first therapeutic product, NPC-1C, a monoclonal antibody intended to treat advanced pancreatic cancer. Financial terms were not disclosed. On successful completion of that development, and pending FDA approval, Neogenix plans to begin Phase I and Phase II trials in the first half of 2008.

• Oculus Innovative Sciences Inc., of Petaluma, Calif., said results of a study evaluating the impact of its Microcyn Technology, a super-oxidized oxychlorine compound, on degranulation and cytokine release in mast cells showed in vitro that Microcyn might inhibit the cell machinery for secretion of histamine and pro-inflammatory molecules induced by IgE-antigen receptor crosslinking. Cells were incubated in serial dilutions of Microcyn for a short period of time before being activated, and the in vitro test results showed that a single application of Microcyn inhibited degranulation of mast cells for up to 12 hours without affecting the cells' viability or other normal psychological processes. Data were published in International Immunopharmacology.

• Pharmion Corp., of Boulder, Colo., submitted a marketing authorization application with the European Medicines Agency for satraplatin in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer who have failed to respond to chemotherapy. The submission is based on data from the double-blind, randomized Phase III trial called SPARC (Satraplatin and Prednisone Against Refractory Cancer). Pharmion gained European rights to the product from GPC Biotech AG, of Martinsried, Germany. In the U.S., an FDA advisory panel meeting on satraplatin is about a month away. (See BioWorld Today, June 26, 2007.)

• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., said its stock is listed on the American Stock Exchange under the ticker "PP." Pipex is a specialty pharma firm developing drug candidates for neurologic and fibrotic diseases.

• Sirtris Pharmaceuticals Inc., of Cambridge, Mass., said activation of SIRT1, a member of the sirtuin family of enzymes, was shown to protect against neurodegenerative diseases, such as Alzheimer's disease and amyotrophic lateral sclerosis, in animal models. Findings demonstrated that resveratrol, a SIRT1 activator, reduced the loss of neuronal function in the brain and prevented learning impairment in an AD animal model. Resveratrol also promoted neuronal survival in cell-based models of AD and ALS. Results were published in The European Molecular Biology Organization Journal.

• SkyePharma plc, of London, entered an exclusive agreement with Somnus Therapeutics Inc., of Princeton, N.J, for the worldwide development and commercialization of SkyePharma's sleep therapeutic, SKP-1041, a controlled-release formulation of a non-benzodiazepine hypnotic agent based on technology known as Geoclock. SkyePharma will formulate and manufacture SKP-1041, and could receive up to $35 million in milestone payments, of which $4 million is payable on signature, up to $11 million is payable during the development phase - mainly on product approval - and $20 million is sales-related. The first milestone payment would be triggered by the successful completion of a Phase I study. SkyePharma also would receive an escalating royalty on future sales. Somnus will be responsible for the majority of the development and clinical trial costs.

StemCells Inc., of Palo Alto, Calif., and Neuralstem Inc., of Rockville, Md., agreed to stay their lawsuits and counterclaims against each other relating to various stem cell patents held by each company. Neuralstem said the U.S. Patent Office recently ruled in its favor and ordered re-examinations of all the StemCells patents.

• Ventana Medical Systems Inc., of Tucson, Ariz., said Basel, Switzerland-based F. Hoffmann-La Roche Ltd. offered to acquire all outstanding shares of Ventana for $75 per share, or about $3 billion in cash, representing a 55 percent premium to Ventana's three-month average share price. The deal would allow Roche to broaden its diagnostic offerings with Ventana's tissue-based testing expertise. The pharma firm said it made multiple efforts to engage in discussions with Ventana's chairman and board before opting to commence a tender offer. Ventana, which employs about 950 people, had sales of $238.2 million in 2006. Upon closing of the transaction, Roche intends to operate Ventana as a dedicated business within its Diagnostics Division and plans to retain Ventana's Tucson headquarters. Roche's offer boosted Ventana's stock (NASDAQ:VMSI) 47.7 percent, or $24.69, Tuesday to close at $76.43. In separate news, Roche Diagnostics completed its acquisition of Bioveris Corp., of Gaithersburg, Md., for about $600 million. The companies entered the merger agreement in early April. (See BioWorld Today, April 5, 2007.)

• Vitro Diagnostics Inc., of Aurora, Colo., said it developed a new method to derive human pancreatic beta islets from adult pancreatic stem cells. Through research and development of stem cell differentiation methods, Vitro discovered a process that yields islets that appear structurally equivalent to those derived from the pancreas gland. The company's efforts now are directed toward further characterization of stem cell-derived beta islets produced by that method and scale-up of production capacity to support anticipated commercial distribution.