Advanced Tissue Sciences Inc., of La Jolla, Calif., said partner Inamed Corp., of Santa Barbara, Calif., submitted a premarket approval supplement to the FDA for human-based collagen. If approved, Inamed would market it as a dermal filler for wrinkles and lip augmentation.
Autogen Ltd., of Melbourne, Australia, said Charter Pacific, of Brisbane, Australia, bought 19.9 percent of Autogen's shares from Joseph Gutnick, his entire holdings in the company. Also, Gutnick resigned as executive chairman and David Tyrwhitt resigned as a nonexecutive director. Autogen uses its animal model and human DNA collections with its technology platform to identify targets.
BioProtein Technologies SA, of Paris, entered an alliance to produce therapeutic proteins with Eurogentec Group, of Liège, Belgium. Eurogentec becomes BioProtein's partner for the downstream processing of the recombinant proteins that are produced. Financial terms were not disclosed.
Cambrex Corp., of East Rutherford, N.J., said its board approved a plan to triple the cGMP cell therapy manufacturing capacity at the company's Walkersville, Md., facility. Construction and validation are expected to take five to six months.
CellGate Inc., of Sunnyvale, Calif., appointed Edward Schnipper its president and CEO. Previously, he was CellGate's executive vice president. Schnipper also will join the board for CellGate, which applies transport molecules to deliver medicines into cells and through tissues.
Centocor Inc., of Malvern, Pa., said the FDA granted marketing approval to Remicade (infliximab) to provide long-term remission-level control of the debilitating symptoms of Crohn's disease (CD), a gastrointestinal disorder that affects more than a half-million Americans. Remicade is the first biologic approved to reduce signs and symptoms and induce and maintain clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. The approval was based on 54-week data from the ACCENT I trial, involving 545 patients with moderate to severe CD at centers in North America, Europe and Israel. The objective of the trial was to evaluate the safety and effectiveness of Remicade as a maintenance therapy for CD. The study also evaluated the effect of maintenance regimen on steroid use and health-related quality of life. Centocor is a Johnson & Johnson company.
DeCode genetics Inc., of Reykjavik, Iceland, and Elitra Pharmaceuticals Inc., of San Diego, initiated medicinal chemistry work under their alliance to discover and develop new antibiotics to combat drug-resistant bacteria. DeCode's pharmaceuticals group (formerly MediChem Life Sciences) started the chemistry program around Elitra's lead compound series to use against a bacterial target. The target is involved in microbial viability and is conserved across Gram-positive and Gram-negative bacteria.
Digene Corp., of Gaithersburg, Md., said it delivered to Cytyc Corp., of Boxborough, Mass., on Sunday a formal notice of termination of the merger agreement between the companies. In February, Cytyc said it planned to acquire Digene in a deal then valued at $554 million. Digene said the decision came after the U.S. Federal Trade Commission (FTC) informed Digene and Cytyc last week that if the parties sought to close the transactions, the FTC would seek an injunction to block the closing. (See BioWorld Today, Feb. 20, 2002.)
Enanta Pharmaceuticals Inc., of Watertown, Mass., reported data from preclinical toxicology and ADME (absorption, distribution, metabolism and excretion) studies of its cyclosporin softdrug analogues, concluding that its metabolite did not cause toxicity, in contrast to cyclosporin. Cyclosporin-treated animals exhibited significant changes in blood chemistry values that are consistent with kidney and liver dysfunction, and mild anemia. Cyclosporin also resulted in dose-dependent adverse changes in kidney pathology, including tubular necrosis, it said.
Enzon Inc., of Piscataway, N.J., entered an agreement with Aventis SA, of Frankfurt, Germany, for Enzon to reacquire rights to market and distribute Oncaspar (pegaspargase). Enzon will conduct all marketing and sales activities for the U.S., Mexico, Canada and the Asia/Pacific region. Oncaspar is indicated for patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment regimen, but have developed hypersensitivity to native forms of L-asparaginase.
Exelixis Inc., of South San Francisco, received an undisclosed milestone payment from Dow AgroSciences LLC, of Indianapolis, after completing a project that provides new insights into the target and mechanism of action of an herbicidal compound. The 2000 collaboration calls for Exelixis to identify targets for specific fungicide and herbicide compounds that are active, yet have unknown molecular targets. Separately, Exelixis entered a nonexclusive license deal with Cancer Research Ventures, of London, for the rights to a pair of patent families related to transposon-based technologies.
Generex Biotechnology Corp., of Toronto, reported at the Endocrine Society meeting held in San Francisco data indicating that its Oralin oral insulin formulation may be used safely and effectively in place of injected insulin to treat Type I and Type II diabetes. One study showed the oral insulin absorption and elimination was much faster than subcutaneous injection and outperformed subcutaneous injection in terms of glucose- and C-peptide-lowering capacity, as well as rise in the insulin levels. Other data showed that Oralin was rapidly absorbed and increased serum insulin by 233 percent in comparison to failing oral agents alone.
Genmab A/S, of Copenhagen, Denmark, said its human antibody therapeutic HuMax-IL15 effectively treated psoriasis in a mouse disease model. The candidate reduced thickening of skin equal to or better than cyclosporine A. HuMax-IL15 also had a more marked effect on decreasing the immaturity of the cells. In addition, HuMax-IL15 more effectively reduced Ki-67, a marker of the excessively proliferating skin cells that cause skin thickening. In a fourth marker, the decrease in the types of cells that are believed to initiate the inflammation process, HuMax-IL15 and cyclosporine A worked similarly.
GlaxoSmithKline plc, of London, is the subject of a federal lawsuit challenging its right to exclude competition from the antiviral drugs AZT, Ziagen and 3TC. AIDS Healthcare Foundation, of Los Angeles, alleges GSK misrepresented facts in securing patents to AZT and describes in the suit an alleged pattern of pricing abuse. The suit was filed in the U.S. Federal Court for the Central District of California.
Hyseq Pharmaceuticals Inc., of Sunnyvale, Calif., began a Phase I trial of its acting thrombolytic, alfimeprase, in patients with peripheral arterial occlusion. The multicenter, open-label, dose-escalation U.S. study will involve 20 patients to evaluate alfimeprase's safety and pharmacokinetics. Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot.
IDEC Pharmaceuticals Corp., of San Diego, said the European launch of Zevalin (ibritumomab tiuxetan) by Schering AG, of Berlin, will be delayed due to certain technical compliance issues at the fill/finish provider. Schering and the European regulatory authorities are in discussions concerning the issues. Zevalin, an anti-CD-20 antibody labeled with yttrium-90, targets the CD20 antigen on the surface of mature B cell and B-cell tumors. It was approved in the U.S. in February to treat non-Hodgkin's lymphoma. (See BioWorld Today, Feb. 21, 2002.)
Indevus Pharmaceuticals Inc., of Lexington, Mass., licensed exclusive rights to CT-3, an anti-inflammatory and analgesic compound, from Atlantic Technology Ventures Inc., of New York. CT-3, or ajulemic acid, is a synthetic derivative of tetrahydrocannabinol. The compound is being studied in a small Phase II trial in Europe in chronic neuropathic pain. Indevus will make an up-front licensing payment and pay potential milestones and royalties. Indevus is responsible for all development and commercialization activities. Specific terms were not disclosed.
La Jolla Pharmaceutical Co., of San Diego, presented at the Federation of Clinical Immunology Societies meeting in San Francisco data concerning LJP 394 and LJP 1082, its drug candidates for antibody-mediated autoimmune diseases. Data from a double-blind, placebo-controlled Phase II/III trial of more than 200 lupus patients showed that in the 89 percent of trial patients with high-affinity antibodies for the drug, LJP 394 treatment prolonged time to and decreased the number of renal flares and delayed the need for and decreased the number of high-dose corticosteroid and/or cyclophosphomide treatments when compared to placebo. Data from in vivo studies showed that in an immunized rat model, treatment with LJP 1082 reduced levels of disease-causing antibodies and the B cells that produce them.
MorphoSys AG, of Munich, Germany, said it received an undisclosed milestone payment from F. Hoffmann-La Roche Ltd., of Basel, Switzerland, after generating and delivering several antibodies. Roche will further characterize the antibodies in preclinical studies and thereafter determine the most promising antibody in clinical trials. MorphoSys generated HuCAL antibodies demonstrating high-affinity binding to the Roche target in both in vitro assays and in an Alzheimer's disease animal model. MorphoSys can receive development-related milestone payments and royalties on any marketed products emerging from the collaboration.
Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said it was added to the Russell 3000 Index of publicly traded companies. Official index membership will remain in place for one year. The index measures the performance of the 3,000 largest U.S. companies, representing about 98 percent of the investable U.S. equity market.
NeoPharm Inc., of Lake Forest, Ill., submitted to the FDA an investigational new drug application for Liposome Encapsulated SN38 (LE-SN38). NeoPharm said it hopes to enter into Phase I/II trials by year's end. SN38 is the active metabolite of CPT-11 (irinotecan), a chemotherapeutic prodrug marketed as Camptosar in the U.S. by Pharmacia Corp., of Peapack, N.J.
Novartis Pharmaceuticals Corp., of East Hanover, N.J., submitted marketing applications in the U.S. and Europe for Gleevec (imatinib mesylate) for the first-line treatment of patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML). The filings are based on data that demonstrate that in the first-line treatment of newly diagnosed CML patients, Gleevec achieved an 83 percent major cytogenetic response rate, compared to 20 percent for the combination of interferon-alpha and cytarabine arabinoside (IFN/Ara-C), a form of chemotherapy. Data also showed Gleevec significantly delayed the time to progression to the more advanced stages of CML compared with IFN/Ara-C.
Octapharma AG, of Lachen, Switzerland, said it will acquire the Plasma Products Division of Biovitrum AB, of Stockholm, Sweden. Octapharma will acquire the division, including operations, staff, products and production facility, as well as brand and marketing rights, on July 15. Biovitrum will retain its existing agreement with Wyeth, of Madison, N.J., for the manufacture of recombinant Factor VIII ReFacto.
Oxxon Pharmaceuticals Ltd., of Oxford, UK, said its hepatitis B virus candidate moved into Phase II trials after data from a placebo-controlled, randomized Phase I study showed the drug to be safe and well tolerated. The Phase II trials will evaluate the drug alone and in combination with antiviral drugs.
Paradigm Genetics Inc., of Research Triangle Park, N.C., and Agilent Technologies Inc., of Palo Alto, Calif., released an Arabidopsis microarray kit featuring more than 14,800 plant gene sequences derived from public domain databases. The specific gene sequences contained on one industry-standard glass slide are designed to enable high-content, genome-wide screening of Arabidopsis thaliana, a model organism used in the research and development of new plants and foods.
Sonus Pharmaceuticals Inc., of Bothell, Wash., entered into a manufacturing and supply agreement with Gensia Sicor Pharmaceuticals Inc., a division of Irvine, Calif.-based Sicor Inc., for Tocosol Paclitaxel, Sonus' drug in Phase II cancer trials.
Tripos Inc., of St. Louis, revised its financial guidance for the second quarter and for the year. For the second quarter, Tripos now expects to report total revenue of between $10.5 million and $11 million, a modest gain over the same period in 2001. The company expects to report a loss from operations of between $1.8 million and $2.1 million, with loss per basic share in the range of 20 cents to 25 cents, excluding gains from the sale of Arena stock. Also, Tripos reduced revenue estimates for the year to a range of $53 million to $58 million, the impact of which will be weighted in the third quarter. Approximately 90 percent of the low end of Tripos' revised 2002 full-year guidance is contracted revenue. The company will provide updated profitability guidance in its quarterly financial results call scheduled for July 24. Tripos' stock (NASDAQ:TRPS) fell $13.27 Monday, or 60.9 percent, to close at $8.53.
V.I. Technologies Inc., of Watertown, Mass., reached a written agreement with the FDA to initiate its Phase III program with the Inactine pathogen-reduction red blood cell system. The program will include two Phase III studies involving about 270 patients. The multicenter, double-blind, parallel-group studies will use the maximum storage time for red blood cells (42 days) using standard, licensed storage solutions.
Zygogen LLC, of Atlanta, selected as fluorescent markers to integrate into its stable transgenic zebrafish the Reef Coral Fluorescent Proteins (RCFP) from BD Biosciences Clontech, a unit of Becton, Dickinson and Co., of Franklin Lakes, N.J. BD Biosciences Clontech provides access to a family of fluorescent proteins that enable researchers to better understand cellular pathways and systems and their potential roles in disease states. Terms were not disclosed.