• AEterna Zentaris Inc., of Quebec City, reported in vitro data on the anti-angiogenic properties of perifosine at the Strategic Research Institute's conference on angiogenesis in Cambridge, Mass. The new findings demonstrate that the first-in-class, oral signal transduction/AKT inhibitor supresses the formation of new endothelial capillaries, characteristic of angiogenesis. Previously reported in vitro data had demonstrated perifosine's ability to modulate multiple signal transduction pathways involved in growth/proliferation and survival of cancer cells, induce apoptosis, act as a radiosensitizer and to enhance radiation-induced apoptosis.

• Biolex Inc., of Pittsboro, N.C., opened a new 4,500-square-foot biopharmaceutical manufacturing facility at its headquarters. The facility will have capacity sufficient to produce 1 million doses per year of alpha interferon, a recombinant human protein used to treat infectious diseases such as hepatitis C. It expects to file an investigational new drug application with the FDA this year.

• BioMedicines Inc., of Emeryville, Calif., changed its name to Intarcia Therapeutics Inc. The name comes from an Italian art form called Intarsia in which Renaissance artisans created inlaid mosaics out of various types of hardwoods. The company develops therapies for cancer, and immunological and infectious diseases.

• Cardiff University in Wales said its researchers reported findings at this week's British Pharmaceutical Society Conference in Manchester, UK, detailing their use of the HPMA (N-[2-hydroxypropyl] methacrylamide) copolymer to deliver cancer drugs to a tumor site. They found that it is possible to deliver chemotherapy and hormonal drugs at the same time, attached to the same carrier, and early work suggests that the combination is more effective than giving the drugs separately.

• CombinatoRx Inc., of Boston, began a research collaboration with Accelerate Brain Cancer Cure (ABC2) in Burlingame, Calif., aimed at identifying multitarget drugs for the treatment of brain cancer. The sponsored research will leverage the CombinatoRx combination high-throughput screening platform. CombinatoRx will receive research funding from ABC2, and intellectual property and commercial rights to all products discovered in the collaboration.

• Connetics Corp., of Palo Alto, Calif., began its Phase III program for Desilux, a low-potency topical steroid, formulated with 0.05 percent desonide in the company's emollient foam delivery vehicle. The program will focus on atopic dermatitis and is designed to include infants from 3 months of age and children up to 17 years old. Pending positive Phase III results, Connetics plans to submit a new drug application to the FDA by the end of next year.

• Corgentech Inc., of South San Francisco, gained an exclusive license from Cyclacel Group plc, of Dundee, Scotland, to use the latter's Penetratin endonuclear delivery system with Corgentech's Transcription Factor Decoy (TF Decoy) technology platform. The Penetratin system is a peptide with carrier properties for delivery into cells, while Corgentech's TF Decoy technology is a new class of therapeutics that blocks the activity of multiple genes linked to a disease. Penetratin enables systemic cellular delivery by chemically linking to TF Decoys, and actively transporting the TF Decoy therapy into cells. Corgentech will be responsible for the development and commercialization of TF Decoys combined with a Penetratin peptide. Cyclacel will receive an up-front payment, milestone payments and royalties if licensed products are commercialized. No further financial terms were disclosed.

• DNA 2.0 Inc., of Menlo Park, Calif., was awarded a Phase I follow-up grant by the U.S. Defense Advanced Research Projects Agency (DARPA) for its Mobile Integrated Sustainable Energy Recovery program. The focus of the research is the engineering of fuel-latent plastics and their post-use conversion to a fuel useful for electricity generation in the field. The program's goal is to improve the logistics of land-based operations by reducing the quantities of solid waste from packaging materials that require personnel, fuel and critical-transport equipment for removal.

• Guilford Pharmaceuticals Inc., of Baltimore, received FDA notice that its Gliadel Wafer (polifeprosan 20 with carmustine implant) was designated an orphan drug. The brain cancer treatment is entitled to seven years of market exclusivity for the treatment of patients with malignant glioma undergoing primary surgical resection. The exclusivity period began on the date of approval last year and extends until February 2010. (See BioWorld Today, Feb. 27, 2003.)

• Human Genome Sciences Inc., of Rockville, Md., said it plans to offer $200 million worth of convertible subordinated notes, subject to market and other conditions. The company also expects to grant the initial purchasers a 30-day option to buy up to an additional $50 million of the notes. HGS plans to use all of the net proceeds to repurchase, from time to time, a portion of its outstanding convertible subordinated debt.

• Inex Pharmaceuticals Corp., of Vancouver, British Columbia, and Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said the FDA would review Marqibo at its upcoming Oncologic Drugs Advisory Committee session scheduled for Dec. 1. Formerly referred to as Onco TCS, Marqibo is being developed as a single-agent treatment for patients with relapsed aggressive non-Hodgkin's lymphoma previously treated with at least two combination chemotherapy regimens. The new drug application began last year on a rolling basis, and the submission was accepted earlier this year. The FDA established Jan. 15 as a target date for completing its review of the NDA. (See BioWorld Today, Oct. 1, 2003.)

• Inte:Ligand GmbH, of Vienna, Austria, launched a drug-design software package called ilib diverse. The technology can be used to create computer-generated molecules and test their ability to pass the blood-brain barrier or be orally administered.

• LemnaGene SA, of Lyon, France, opened its new laboratory and biomanufacturing facility in the incubation space for new projects located at the Ecole Normale Superieure de Lyon. The space will allow LemnaGene to provide a full range of biomanufacturing services to the pharmaceutical, vaccine, veterinarian, diagnostic, nutraceutical and industrial protein markets. LemnaGene also produced its first transgenic Spirodela containing genes of interest to industrial partners. LemnaGene was established in October 2003 and focuses on the aquatic plant Spirodela from the Lemnaceae family.

• MacroPore Biosurgery Inc., of San Diego, said that adipose tissue-derived regenerative cells improved heart function following myocardial infarction in a preclinical safety study performed in swine. The study confirmed previous preclinical work by MacroPore suggesting that its technology is safe and might be clinically useful in treating heart disease. Intracoronary infusion of adipose-derived regenerative cells 48 hours after infarction was found to be safe, with all 13 swine surviving the six-month follow-up period.

• Mayo Clinic in Rochester, Minn., said its researchers published findings in the Sept. 25, 2004, issue of The Lancet detailing their discovery that a duplication of the alpha-synuclein gene caused Parkinson's disease in a French family. In affected individuals, age of onset, symptoms and symptom progression were similar to that observed in people with sporadic or unexplained cases of the disease. The findings suggest a direct relationship between the amount of alpha-synuclein produced, the onset of Parkinson's disease, its severity and progression.

• MDS Sciex, the analytical instrumentation and technology solutions division of MDS Inc., of Toronto, said it will open a new manufacturing facility in Singapore as part of a larger business strategy to maintain market leadership and low-cost capability in the manufacturing of its scientific instruments. The second facility will complement the existing facility in Concord, Ontario. The new facility is expected to become operational in 2005 for the manufacturing of the cellular analysis (MiWave) product line, and the transition of selected mass spectrometer manufacturing will begin in 2006.

• Morphotek Inc., of Exton, Pa., signed a Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md., for the development of biochemicals and antibodies for detection and therapy against pathogenic agents. The company will apply its Morphodoma technology to develop fully human antibodies that can target pathogenic agents, and employ its Direct-Line technology to develop evolved human epithelial cells that are naturally resistant to biological pathogens for discovery and product development.

• NexMed Inc., of Robbinsville, N.J., filed an investigational new drug application for InnoNyx, its nail lacquer treatment for nail fungal infection. The company said early clinical results were encouraging and suggest that the product might be an effective treatment for the infection.

• Novavax Inc., of Malvern, Pa., opened new corporate headquarters in Malvern. Its former headquarters were in Columbia, Md. Novavax is engaged in the research, development and commercialization of products focused on drug delivery and vaccine development.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., is expanding its sales force for its FDA-approved antibiotic, Factive, which was launched earlier this month. The expansion will add sales representatives in more than 150 territories by early next year, complementing the sales force of more than 100 field representatives. Factive was approved in 2003 to treat acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., received an undisclosed milestone payment after reaching a research target in its collaboration with Neurocrine Biosciences Inc., of San Diego. The payment was triggered by Neurocrine's acceptance of the compounds delivered by Pharmacopeia in the lead discovery phase of the collaboration. Pharmacopeia is entitled to additional preclinical and clinical development milestone payments as the program progresses, and is entitled to royalties on commercial sales of any resulting products.

• Pharmion Corp., of Boulder, Colo., increased sales guidance for Vidaza (azacitidine for injectable suspension) for the second half of this year to a range of $40 million to $45 million, up from a previous range of $20 million to $27 million. The company based its higher forecast on greater-than-anticipated sales in the initial months of its Vidaza launch. The product received FDA approval earlier this year for the treatment of all five subtypes of myelodysplastic syndromes. (See BioWorld Today, May 21, 2004.)

• Qiagen NV, of Venlo, the Netherlands, acquired key assets of Molecular Staging Inc., of New Haven, Conn. Privately held Molecular Staging has developed products and services based on its Multiple Displacement Amplification technology, which is applied in whole-genome amplification. Qiagen acquired more than 160 applied or issued patents for $28.5 million in cash, plus potential earn-outs of up to $6.75 million, and expects to incur one-time charges relating to the acquisition of about $2 million this quarter. It expects the deal to have a positive and slightly accretive impact on its 2005 net income per share and revenue growth, adding about $6 million in net sales and about $1 million in net income.

• Squalus Biotech Inc., of Las Vegas, said its shares began trading on the Pink Sheets as "SQBT." The company is developing therapeutics for cancer and other angiogenesis-related diseases. Its Squalamatrix technology is a biologically active group of substances extracted from the water-soluble portion of shark liver tissue. Squalus was founded by Larry Raithaus, its president and CEO. Other executive team members include Greg Shafransky, the vice president of marketing and sales, and Kin-Ping Wong, who will head the company's research and development division.

• Stanford University School of Medicine in Palo Alto, Calif., said that for the second time in two years, scientists there discovered a new type of regulatory T cell that reduces asthma and airway inflammation in mice, bolstering the theory that a deficiency of such cells is a prime cause of the breathing disorder as well as allergies.

• Vitro Diagnostics Inc., of Aurora, Colo., said it has developed new methods for the growth and development of human pancreatic beta islets. The company said its in vitro model system can be induced to form beta islets, adding that it has produced significant numbers of islets that contain and secrete insulin in response to elevated glucose stimulation. The islets have been maintained and expanded for several months in cell culture.

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