• Alkermes Inc., of Cambridge, Mass., and Eli Lilly and Co., of Indianapolis, reported the results of a single-dose Phase I trial in which an inhaled formulation of human growth hormone based on Alkermes' AIR technology demonstrated acceptable pulmonary bioavailability, achieved dose equivalence to subcutaneous injection of human growth hormone and was well tolerated. The preliminary findings were presented at the 14th International Society for Aerosols in Medicine conference in Baltimore.

• Altana Pharma AG, of Bad Homburg, Germany, said it netted $22 million after selling its two product lines to KV Pharmaceutical Co., of St. Louis. Its Chromagen and StrongStart lines comprise six different products used in the U.S. to treat anemia in pregnancy. They were marketed and produced by Altana's U.S. subsidiary, Savage, and generated sales of €16 million in 2002. The sale is part of Altana's strategy of concentrating on therapeutic products from its own research and development facilities.

• Amgen Inc., of Thousand Oaks, Calif., reported data at the European League Against Rheumatism meeting in Lisbon, Portugal, showing a favorable response with the combination of Enbrel (etanercept) plus methotrexate, compared with either treatment alone, on both the signs and symptoms and joint damage of rheumatoid arthritis. Separately, Amgen reported data at the European Hematology Association meeting showing that three times as many anemic patients with lymphoid cancers receiving Aranesp (darbepoetin alfa) experienced increases in hemoglobin levels compared to those receiving placebo, data the company said support a recent recommendation by European regulatory authorities to extend Aranesp's label to include treatment of chemotherapy-induced anemia in adult patients with nonmyeloid malignancies.

• Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, reported results from a Phase III study at the American Diabetes Association meeting in New Orleans, showing that more than half of the participants who completed 20 weeks of exenatide treatment achieved average glucose levels within the association's target range. In 63 patients in the ongoing study, the average level of hemoglobin A1c (A1C), a measure that provides a three-month average of glucose levels, dropped 1.4 points to 7.2 percent. In addition, exenatide decreased both fasting and post-prandial glucose levels.

• AnorMED Inc., of Vancouver, British Columbia, reported that new results from a Phase I trial in 13 multiple myeloma and non-Hodgkin's lymphoma patients showed AMD-3100 administered alone mobilizes stem cells. The study results were presented at the 8th Congress of the European Hematology Association in Lyon, France.

• Aradigm Corp., of Hayward, Calif., said its partner Novo Nordisk A/S, of Bagsvaerd, Denmark, reported data at the American Diabetes Association meeting in New Orleans, showing that the AERx insulin Diabetes Management System did not impact lung-function testing, resulted in compliance in the majority of patients, and physicians acknowledged its key features. In one study of the inhaled insulin system, moderate increases and decreases in pulmonary function tests were observed in inhaled and subcutaneous insulin groups that did not appear drug related. Another trial showed that 88 percent of the patients using the AERx iDMS took their prescribed doses 90 percent of the time.

• Barrier Therapeutics Inc., of Princeton, N.J., said it received orphan drug designation from European regulatory authorities for Liarozole, for congenital ichthyosis. Liarozole is the first molecule in a new pharmacological class, the RAMBAs (retinoic acid metabolism-blocking agents), to be recognized as a potential treatment for the disease, it said.

• Bavarian Nordic A/S, of Copenhagen, Denmark, manufactured and released 5,000 doses of MVA-BN to the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md., two months ahead of schedule as a part of the U.S. government's effort to develop a smallpox vaccine.

• BioVex Ltd., of Oxford, UK, entered an agreement to supply its NeuroVEX vectors to Merck & Co. Inc., of Whitehouse Station, N.J. Merck will evaluate the vectors, which are designed to allow nontoxic gene delivery to the cells and tissues of the nervous system, at laboratory sites in the U.S. and UK. BioVex said NeuroVEX can be used to establish long-term foreign gene expression in nerve cells and might be useful in identifying new gene targets for small-molecule drugs to treat diseases and disorders of the central and peripheral nervous systems. Financial terms were not disclosed.

• Cell Therapeutics Inc., of Seattle, received fast-track designation from the FDA for Xyotax (CT-2103), its polyglutamate paclitaxel, for the treatment of non-small-cell lung cancer in patients with a poor performance status (PS2). Xyotax is in two Phase III trials for PS2 patients with advanced non-small-cell lung cancer. The company said it plans to submit a new drug application for that indication at the end of 2004. Cell Therapeutics' stock (NASDAQ:CTIC) gained $1.73 Monday, or 13.3 percent, to close at $14.75.

• Cel-Sci Corp., of Vienna, Va., said data from animal herpes simplex challenge studies were accepted for publication in a peer-reviewed journal. The herpes vaccine is derived from Cel-Sci's L.E.A.P.S. T-cell modulation technology. The publication will report how the vaccine induced protection from disease symptoms and death in animals. The publication also will detail how the vaccine directs the immune system's response to the herpes antigen in the direction of a cellular immune response that is required to protect against the herpes virus.

• Compugen Ltd., of Tel Aviv, Israel, reported the extension of the Novartis Pharma AG, of Basel, Switzerland, license of Compugen's LEADS platform for another year. Based on Compugen's knowledge of transcriptome analysis, the company will design a genome-wide collection of DNA probes for Novartis.

• Corixa Corp., of Seattle, said it raised aggregate gross proceeds of $115 million after closing a $30 million equity private placement and an $85 million private placement of 4.25 percent convertible subordinated notes due 2008. Under terms of the private equity placement, Corixa sold about 3.7 million newly issued common shares to The Sprout Group at $8.044 apiece. For an additional 12.5 cents per underlying share, Sprout also purchased five-year warrants for a total of 669,435 common shares at an exercise price of $8.044 apiece. Pacific Growth Equities LLC acted as the placement agent in the transaction, in which Sprout partner Ron Hunt joined Corixa's board. In total, Sprout is investing $45 million, including $30 million in private equity and an additional $15 million in the private placement of convertible subordinated notes. Corixa said it would use the net proceeds from both transactions for research and development and general corporate purposes, including working capital. (See BioWorld Today, June 10, 2003.)

• Curis Inc., of Cambridge, Mass., said two studies were published last week demonstrating the potential of using BMP-7 as treatment to improve kidney function and prevent vascular disease associated with chronic progressive kidney disease. The first study, published by Kidney International, showed that treatment with BMP-7 improves kidney function in a diabetes-associated model of chronic kidney disease. The second, published in the Journal of the American Society for Nephrology, showed that BMP-7 treatment prevents the development of atherosclerosis in a murine model of chronic progressive kidney disease.

• Diversa Corp., of San Diego, reported that one of its biodefense proposals was selected to receive a $1.38 million award from the Department of Defense's Chemical and Biological Defense Initiatives Fund to develop diagnostic and therapeutic antibodies against anthrax and to identify new targets associated with anthrax and plague pathology. Diversa will work with scientists at the U.S. Army Medical Research Institute of Infectious Diseases in Ft. Detrick, Md.

• Emisphere Technologies Inc., of Tarrytown, N.Y., reported results from two separate studies at the American Diabetes Association meeting in New Orleans, showing that its orally delivered eligen technology induced clinically relevant activity in Type II diabetes patients. One study pointed to the oral insulin's fast onset of action, within the first hour, and the second study highlighted the potential benefits of orally delivering the insulin to the liver.

• Endovasc Inc., of Montgomery, Texas, said the first angioplasty case using its investigational drug Liprostin was successfully performed in a patient suffering from a blocked artery in a lower limb. The Phase II, open-label trial is studying Liprostin (liposomal prostaglandin E1) as adjunct therapy with angioplasty for patients with peripheral artery occlusive disease.

• Enodar Biologic, of Seattle, a spinout of the Fred Hutchinson Cancer Research Center, said that the National Institutes of Health in Bethesda, Md., awarded Enodar a grant to validate statistical methods and develop software tools for a new generation of genetic marker called single nucleotide polymorphism (SNP). The grant, awarded by the National Human Genome Research Institute, will investigate the performance of Enodar's technology for analyzing thousands of SNPs and fund the development of a prototype software tool to assist clinical and drug researchers.

• Enzo Biochem Inc., of Farmingdale, N.Y., said the FDA removed a hold previously placed on a Phase I/II trial of its StealthVector HGTV43 stem cell gene therapy after reviewing safety features of Enzo's vector and analyzing data from the trial subjects. The agency's hold decision came early this year, when it stopped all active gene therapy trials using retroviral vectors to insert genes into blood stem cells after learning that two children who received a retrovirus in a French gene therapy study for X-linked severe combined immunodeficiency, commonly called bubble baby syndrome, were diagnosed with leukemia. Enzo said it would proceed with its clinical trials as it reactivates its sites. (See BioWorld Today, Jan. 16, 2003.)

• EpiTan Ltd., of Melbourne, Australia, said the Queensland Institute of Medical Research approved its plan to begin its first human implant trial for its lead drug candidate, Melanotan, which is designed to stimulate the production of melanin in the skin. The trial, scheduled to last six months, will include up to 24 healthy volunteers who will receive only one injection of Melanotan contained in a long-acting implant. EpiTan, which said it plans to meet with the FDA later this year regarding its investigational new drug application, partnered with the Southern Research Institute in Birmingham, Ala., to manufacture the implants, which are expected to be available in November.

• Ester Neurosciences Ltd., of Herzliya, Israel, began a second Phase Ib trial using EN101, its antisense drug for the treatment of myasthenia gravis. The new trial is an extension study of a previous Phase Ib trial conducted earlier this year. Those results are being presented today at a meeting of the European Neurological Society in Istanbul, Turkey. The results demonstrated for the first time effective and safe use of an orally administered antisense therapy for a neurological condition, the company said. EN101 is the lead compound in Ester's disease-modifying platform technology for the pre-expression control of a specific variant of the AchE protein.

• eXegenics Inc., of Dallas, continued as the subject of a takeover as Foundation Growth Investments, in connection with its all cash tender offer for eXegenics' stock, said it planned to solicit consent from eXegenics stockholders in order to remove all directors from the eXegenics board and appoint new ones. Last week the board voted against recommending a merger with the group's wholly owned subsidiary, EI Acquisition Inc.

• Gamida-Cell Ltd., of Jerusalem, was awarded nearly $1.4 million in grants by the Israeli government, which represents half of the company's total project budget. Gamida-Cell's flagship product, StemEx, is designed to expand the stem cell supply without differentiation and is applicable to both umbilical cord blood stem cells as well as stem cells from adult organs.

• Genaera Corp., of Plymouth Meeting, Pa., reported the publication of findings describing the relationship of its mucoregulator target, the human calcium-activated chloride channel (hCLCA1), to mucus overproduction in cystic fibrosis, suggesting hCLCA1 might be a target to control mucus production. The mucoregulator target, the basis of Genaera's second genomics-based product development program, regulates abnormal mucus production and inflammation. The article was published in the June issue of Laryngoscope.

• Gene Logic Inc., of Gaithersburg, Md., launched Genesis Enterprise System 2.0, its software for data integration, management and analysis of its GeneExpress database. Gene Logic said it is introducing Genesis 2.0 at this week's CHI Beyond Genome 2003 conference in San Diego, and would make it commercially available during the fourth quarter.

• GeneGo Inc., of New Buffalo, Mich., was awarded a $1.4 million grant from the Michigan Life Science Corridor, funds the firm plans to use to further develop its MetaCore platform and expand sales, customer support and application divisions. GeneGo called MetaCore the first commercially available computational platform for human systems biology, designed to assist in target selection, prioritization, validation and biomarker identification.

• The Genetics Co. AG, of Schlieren, of Schlieren, Switzerland, acquired tools and assays to monitor amyloid-beta peptide levels from Abeta GmbH, of Heidelberg, Germany. The Genetics Co. also acquired Abeta's diagnostics business and a therapeutic approach targeting the amyloid precursor protein pathway, for a cash-and-stock transaction. The Genetics Co. said it is seeking U.S. and European partners to distribute the Alzheimer's diagnostic products. Financial terms were not disclosed.

• Guava Technologies Inc., of Hayward, Calif., said collaborative research with scientists at the Institute Jean Godinot in Reims, France, demonstrated the superiority of the Guava PCA cell analysis systems over standard microscopic methods of monitoring dendritic cells for research and therapeutic applications.

• ID Biomedical Corp., of Vancouver, British Columbia, said analysis of data from its various Phase II trials of FluINsure, an intranasal, non-live influenza vaccine, shows the drug has strong immunogenicity. FluINsure recipients who received either one or two doses of intranasal vaccine showed significant increases in nasal secretory IgA levels against all three viruses for each virus type when compared to placebo groups (p<0.001).

• IGEN International Inc., of Gaithersburg, Md., said the French Ministry of Defense purchased its biological agent detection products. The Origen-based biological detection products will be used to detect bacteria, viruses and toxins that may pose a public health threat. The French Ministry already used IGEN's Origen technology in a mobile laboratory in Evian-Les-Bain, France, to monitor air samples at a recent meeting of world leaders, the company said.

• La Jolla Pharmaceutical Co., of San Diego, reported Phase III data of Riquent, showing that lupus patients with sustained reductions in antibodies to double-stranded DNA (dsDNA) reported improved health-related quality of life and had a lower risk of major SLE flares compared with patients who did not have sustained reductions. La Jolla, which said similar results were seen in a Phase II/III trial, said the results support the disease-causing ability of antibodies to dsDNA in lupus patients. The company is planning to file its new drug application for Riquent based on data from two trials that missed primary endpoints but showed positive trends. (See BioWorld Today, May 6, 2003.)

• Large Scale Biology Corp., of Vacaville, Calif., said it would pare organizational costs by $5 million as it looks to concentrate on commercial product development programs. The company said its staff was not affected, nor were expenses for major product initiatives or current service contracts, as it focuses its financial resources on delivering current pipeline products to the market through partnership agreements. At the same time, David McGee, a company co-founder and its executive vice president, is leaving Large Scale Biology to pursue consulting in the biotechnology field.

• MWG Biotech AG, of Ebersberg, Germany, released its MWG Inflammatory Array, a product it called the first fully validated microarray for genes involved in inflammation designed to allow for the analysis of 136 inflammatory genes in mice and men.

• NaPro BioTherapeutics Inc., of Boulder, Colo., received notice from Nasdaq indicating that the company regained compliance with the $1 minimum bid price requirement for continued listing on the Nasdaq SmallCap Market. NaPro is focused in two areas: the development and in-licensing of targeted anticancer agents and the development of genomic therapies.

• Nektar Therapeutics, of San Carlos, Calif., formerly Inhale Therapeutic Systems Inc., said Phase III data reported at the American Diabetes Association meeting in New Orleans suggested that Exubera (inhaled insulin) might provide acceptable glycemic control to significantly more subjects than rosiglitazone in Type II diabetes patients not optimally controlled on diet and exercise. Pfizer Inc., of New York, and Aventis SA, of Lyon, France, conducted studies of the product, which uses Nektar's inhaleable technology. Significantly more patients (82.7 percent) in the inhaled group achieved HbA1c levels of 8 percent over the group using rosiglitazone (58.2 percent) by the end of the study. Further improvement in glycemic control to an HbA1c level of 7 percent was achieved by 44 percent of the Exubera group compared to 17.9 percent of the rosiglitazone group. Rosiglitazone is an oral hypoglycemic agent used to reduce a body's resistance to the action of insulin as a way of lowering blood glucose. Nektar's stock (NASDAQ:NKTR) rose $1.96 Monday, or 17.1 percent, to close at $13.44.

• NeuroSearch A/S, of Bailerup, Denmark, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, initiated a Phase II trial with NS2330 in recently diagnosed Parkinson's patients in the U.S. The study is a placebo-controlled, multicenter study enrolling about 250 patients. The study is expected to be completed in the second half of 2004.

• Sanofi-Synthelabo Inc., of New York, said the FDA approved its new drug application for an extended-release, 10-mg version of alfuzosin. Partnered with SkyePharma plc, of London, the once-daily formulation of the alpha-1 blocker is used for the treatment of the functional symptoms of benign prostatic hyperplasia.

• Tm Bioscience Corp., of Toronto, said it raised C$5 million (US$3.7 million) after entering an agreement to issue about 22.7 million units at C22 cents apiece. Each unit will consist of one common share and a half-share purchase warrant, and each full common share purchase warrant entitles the holder to purchase one Tm Bioscience common share at an exercise price of C30 cents and will be exercisable for a 24-month period from the closing date. Loewen, Ondaatje, McCutcheon Ltd. is acting as lead placement agent in the offering, which is expected to close June 26, with support from Harris Partners Ltd. Tm Bioscience said it would use proceeds from the private placement to move four to five product candidates through commercialization over the next 12 months, and to provide working capital.

• Unigene Laboratories Inc., of Fairfield, N.J., received formal acknowledgment from European regulatory authorities that the list of approved indications for Forcaltonin, its injectable calcitonin product, was expanded to include its use in the prevention of bone loss associated with osteoporotic fractures. Forcaltonin was previously approved for the treatment of Paget's disease and hypercalcemia of malignancy.

• Valentis Inc., of Burlingame, Calif., revised the financial terms of an agreement with DSM Biologics, of Groningen, the Netherlands, to which it licenses its plasmid DNA manufacturing technology. The deal was modified to add a royalty to Valentis, in addition to a previous profit-sharing arrangement, and also eliminated about $1.1 million of Valentis' accrued liabilities and included a net payment of about $600,000 to Valentis. The agreement further resolves outstanding disputes regarding prior plasmid DNA manufacturing services performed by DSM for Valentis. Also, the pAlliance plasmid DNA contract manufacturing alliance that included Valentis, DSM and Qiagen GmbH, of Venlo, the Netherlands, is dissolved. Qiagen will continue to use the pAlliance trademark in its business, while the new agreement reinstates the license to DSM under the terms of the original agreement between Valentis and DSM entered in September 1998.

• Vaxim Inc., of Rockville, Md., identified and synthesized a peptide from severe acute respiratory syndrome viral proteins, named V-S26, which is confirmed to bind specifically with serum antibody from SARS recovered patients. Vaxim also integrated V-S26 with the company's carrier platforms in developing the first SARS point-of-care test kit, named V-ST11.