¿ 4SC AG, of Martinsried, Germany, identified small-molecule drug candidates broadly applicable for the treatment of diseases, such as cystic fibrosis, caused by bacterial biofilms. The formation of biofilms often requires bacterial cell-to-cell communication, a process known as quorum sensing. Quorum sensing-blocking molecules as identified by 4SC may provide a novel antibacterial treatment without the toxicity and resistance commonly seen with currently available treatments. 4SC uses its virtual high-throughput screening technology combined with advanced medicinal and parallel chemistry to identify small molecules with anti-quorum sensing activity.
¿ Actelion Ltd., of Allschwil, Switzerland, entered into an exclusive licensing agreement with Neopharm Ltd., of Petach-Tivka, Israel. Neopharm will be responsible for the registration, marketing and reimbursement of Tracleer in Israel. Actelion said Tracleer is the first orally active endothelin receptor antagonist for the treatment of pulmonary arterial hypertension. Once commercialized, Actelion will supply packaged Tracleer to Neopharm. The financial terms were not disclosed.
¿ Alkermes Inc., of Cambridge, Mass., announced the presentation of positive results from a Phase II clinical trial of Vivtrex, its injectable sustained-release formulation of naltrexone. The multicenter, randomized, double-blind, placebo-controlled clinical trial evaluated the safety and tolerability of repeat dose administration of the drug in 30 alcohol-dependent patients. Preliminary data after four treatment cycles indicate that, on average, patients treated with Vivitrex plus psychosocial therapy (N=25) experienced a 50 percent reduction in heavy drinking days when compared with patients treated with placebo injections with psychosocial therapy (N=5). Vivtrex was well tolerated, and the most common adverse events, headache and nausea, were seen in a similar proportion of Vivitrex and placebo-treated patients. The results were presented at the 40th annual meeting of the American College of Neuropsychopharmacology in Waikoloa, Hawaii.
¿ Amgen Inc., of Thousand Oaks, Calif., said the International Oncology Network added Aranesp (darbepoetin alfa) to its formulary for the treatment of anemia related to chronic renal failure. Since its approval in September, Aranesp has been added to the formularies of the 10 largest national physician-driven cancer treatment networks, the company said.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., said it earned a $3 million milestone payment from Sanofi-Synthelabo, of Paris. The payment is for the filing of the new drug application with the FDA for Leuprogel Three-Month Depot, leuprolide acetate for subcutaneous depot injection for the treatment of advanced prostate cancer. Atrix is in late-stage development with three Leuprogel products that release leuprolide acetate over a period of one, three and four months using Atrix¿s Atrigel Depot drug delivery system.
¿ Avanir Pharmaceuticals Inc., of San Diego, earned its final $5 million milestone payment from GlaxoSmithKline plc, of London, for Abreva, which the companies said is the only cold sore product approved by the FDA available without a prescription. The agreement provides Avanir with continuing royalties on product sales through at least 2011. GSK¿s consumer health division began marketing Abreva one year ago. Avanir said this milestone will enable the company to achieve profitability for its first fiscal quarter ending Dec. 31.
¿ Bayer Corp., of Pittsburgh, said new Phase III data for vardenafil, its investigational phosphodiesterase-5 inhibitor, suggested statistically significant results in not only achieving improvements in erectile function for patients with diabetes, but also improved key aspects of sexual function. The data were presented at the 2001 annual meeting of the Sexual Medicine Society of North America, held in Charleston, S.C. In the double-blind, placebo-controlled, randomized study of 452 men, patients taking 20-mg and 10-mg doses reported statistically significant improvements in erectile function, intercourse satisfaction, orgasmic function and overall sexual satisfaction over patients taking placebo (p<0.0001).
¿ Endovasc Ltd. Inc., of Montgomery, Texas, said the next round of meetings with the FDA regarding the upcoming Phase III trials for Liprostin will be in early January. Last week, Endovasc submitted a new revised protocol for 800 patients with critical limb ischemia. Plans are to start patient enrollment in March 2002.
¿ F. Hoffmann-La Roche Ltd., of Basel, Switzerland, and Chugai Pharmaceutical Co. Ltd., of Tokyo, entered an alliance to create a research-driven Japanese pharmaceutical company, merging Nippon Roche and Chugai. The Roche Group will become the majority shareholder a 50.1 percent interest. The new enterprise will be named Chugai Pharmaceutical Co. Ltd., and Osamu Nagayama, Chugai¿s CEO, will be the CEO of the new entity. Prior to the alliance, Chugai will spin off its 100 percent shareholding in Gen-Probe Inc., of San Diego, resulting in Chugai shareholders directly owning shares in Gen-Probe, which will be listed on the American Stock Exchange.
¿ Galapagos Genomics NV, of Mechelen, Belgium, and Euroscreen SA, of Brussels, Belgium, entered a collaboration to identify activators of G protein-coupled receptors, for which no ligands are known. Galapagos will provide an arrayed collection of secreted proteins and peptides from human cells infected with the Galapagos PhenoSelect library that includes tens of thousands of human genes. Euroscreen will screen the peptide library in cellular assays for ligands that activate orphan GPCRs. The companies plan to out-license the validated ligands.
¿ Genaera Corp., of Plymouth Meeting, Pa., said an article was published describing the discovery by its scientists of a calcium-activated chloride channel that regulates abnormal mucus production and has potential as an important therapeutic target for asthma and other respiratory and sinus diseases. The article appears in the American Journal of Respiratory Cell and Molecular Biology and describes the discovery of this gene in the lungs of asthmatic mice, and the identification of the equivalent human gene, hCLCA1.
¿ Gene Logic Inc., of Gaithersburg, Md., said GlaxoSmithKline plc, of London, adopted GeneLogic¿s GeneExpress suite of information products for use in its drug discovery and development efforts. GSK will gain access to the BioExpress module, the largest data subset of the GeneExpress suite, which consists of gene expression and associated clinical information from a range of normal and deceased human tissues, tissues from model animal systems, and human and animal cell lines. Also, Gene Logic will construct with GSK a customized database containing segments of GSK¿s in-house data, which will be fully integrated with the BioExpress data.
¿ Genome Express, of Grenoble, France, a provider of high value-added solutions for functional genomics and pharmacogenomics, completed a second round of financing, raising EUR12.4 million (US$11.02 million). Genome express will use the funds to accelerate its international development in leveraging its know-how in high-throughput DNA sequencing and related products, as well as the discovery of new therapeutic targets particularly in the fields of microbiology and the central nervous system.
¿ GenOway SA, of Lyon, France, said it completed the first successful post-implantation in vivo development of a cloned rat embryo. It conducted a joint nuclear transfer program to produce genetically manipulated rats, primarily focusing on knockout and knock-in rats. This achievement was reported by the company¿s CEO at the Physiological Genomics & Rat Models conference last week in Cold Spring Harbor Laboratory, in New York.
¿ Genzyme Corp., of Cambridge, Mass., and Pharming Group NV, of Leiden, the Netherlands, said they entered into an agreement that enables Pharming to continue operations, move forward with its clinical development programs and implement its plans for the future. Genzyme will obtain all of Pharming¿s remaining assets related to the diagnosis and treatment of Pompe disease, including licenses to intellectual property and preclinical and clinical data. This will help Genzyme continue the extension of a clinical trial previously conducted through a joint venture with Pharming. The agreement also calls for Genzyme to produce clinical supplies of human C1 inhibitor for Pharming on a contract basis until June 2003.
¿ ILEX Oncology Inc., of San Antonio, said preliminary results from two ongoing clinical studies show that Clofarex (clofarabine) may be an effective treatment for acute refractory leukemias in adult and pediatric patients. Interim Phase II study results showed adults with myelogenous leukemia achieved a 45 percent clinical response rate, and acute lymphocytic leukemia patients achieved a 20 percent clinical response rate when treated with clofarabine. Data from a separate Phase I dose-escalation study demonstrated a 44 percent clinical response rate in children with acute leukemias who failed in previous therapy. Pivotal Phase II trials in pediatric acute leukemias are scheduled to begin early next year.
¿ Odyssey Pharmaceuticals Inc., of San Ramon, Calif., succeeded in visualizing the protein network representing the tumor necrosis factor (TNF) response pathway in living cells, which the company said has never before been observed. TNF is implicated in rheumatoid arthritis and inflammatory bowel disease, among other diseases. The process combines genomics, biology and pharmacology.
¿ SemBioSys Genetics Inc., of Calgary, Alberta, opened its new corporate headquarters, located in Calgary. The 25,000-square-foot facility contains its old headquarters, research and development facilities and pilot plant. SemBioSys uses a variety of genetic engineering technologies to express proteins in the seeds of safflower.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., initiated a second Phase I trial of Triapine in patients with advanced chronic and acute leukemias who are no longer responding to standard chemotherapies. The trial is designed to determine the maximum tolerated dose of Triapine administered by continuous infusion specifically in patients with hematologic malignancies. Triapine is an inhibitor of the enzyme ribonucleotide reductase.
¿ XTL Biopharmaceuticals Ltd., of Rehovot, Israel, said interim results from a Phase IIa study of XTL-001 in chronic hepatitis B patients in combination with lamivudine, the standard treatment, showed a significant lowering of viral DNA and antigen levels after only one week of treatment. The multicenter, double-blind, dose-ranging study is expected to enroll a total of 60 patients in five dosing regimens. Interim results from 15 patients receiving the combination at four weeks indicated that HBV viral DNA was reduced to undetectable levels in nine out of 15 patients (60 percent). A greater than 50 percent reduction in HBV viral surface antigen levels was seen in 47 percent of the patients.