¿ Amgen Inc., of Thousand Oaks, Calif., reported third-quarter earnings of 30 cents per share, beating consensus estimates by 1 cent. Its net income increased to $330 million, a 5 percent increase from the same period in 2000. Its worldwide product sales increased to about $880 million, up from $851 million in 2000¿s third quarter. Combined sales of Epogen, its anemia therapy for patients on dialysis, and Aranesp, its second-generation anemia treatment, reached $520 million in the third quarter, an increase over the $496 million Epogen itself generated in the third quarter of 2000. Neupogen, Amgen¿s product used to decrease the incidence of infection during certain types of cancer chemotherapy, generated about $360 million in the third quarter, an increase from $353 million over the same period in 2000. The company posted total revenues of just over $1 billion. As of Sept. 30, the company had cash and cash equivalents of about $2.4 billion.
¿ CollaGenex Pharmaceuticals Inc., of Newton, Pa., filed with the SEC to sell 964,880 common shares from time to time. The company said it plans to use the proceeds for research and development, sales and marketing expansion, potential product acquisitions and general corporate purposes. CollaGenex¿s stock (NASDAQ:CGPI) climbed 23 cents Friday to close at $8.01. At that price, sales from the shelf registration would raise about $7.7 million.
¿ Cubist Pharmaceuticals Inc., of Lexington, Mass., presented data from its second pivotal Phase III trial (Study 9801) of its antibiotic Cidecin, for the treatment of complicated skin and soft tissue infections, at the annual meeting of the Infectious Disease Society of America. The data showed Cidecin achieved the required endpoint of statistical equivalence to the comparator agents based on criteria set forth in the protocol previously reviewed by the FDA. The data confirmed what was seen in the first Cidecin Phase III trial, the company said. The company expects to file for regulatory approval in mid-2002. The company also expects data from its first Phase III Cidecin trial in the treatment of patients with hospitalized community-acquired pneumonia in the first quarter of 2002. Last week Cubist raised $125 million through the sale of convertible notes and said it would use the funds to support Cidecin trials. (See BioWorld Today, Oct. 5, 2001, and Oct. 24, 2001.)
¿ Gene-IT SA, of Paris, reported at the Genome Sequencing and Analysis Conference in San Diego the launch of its new product, the Fast Search and Cluster Tool (Biofacet). Biofacet is designed to accelerate the search for highly similar proteins and nucleic acid sequences. Combining Blast algorithm with the speed and accuracy of Gene-IT¿s string matching algorithms, the new technology can speed computationally intense tasks from months to days, allowing for much more information to be gathered in a fraction of the time, the company said.
¿ Immunomedics Inc., of Morris Plains, N.J., licensed its method of directly labeling antibodies with technetium-99m (Tc-99m) to AGEN Biomedical Ltd., of Australia, for nonexclusive worldwide use with its clot-imaging agent under development. The agent involves a humanized antibody to a determinant expressed on deep vascular clots and pulmonary emboli. The labeling method allows the nuclear physician to directly label the antibody a few minutes before it is administered to the patient. The patient can then be imaged with standard nuclear cameras to reveal sites of trapped clots in the body. Terms were not disclosed.
¿ InforMax Inc., of Piscataway, N.J., and Amersham Biosciences, of Bethesda, Md., reported an agreement for the exclusive distribution by Amersham of the InforMax desktop software products in Latin America. InforMax labeled Latin America ¿an important emerging market.¿
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., said its Ibis Therapeutics division received an additional two-year contract with the Defense Advanced Research Projects Agency to develop a sensor to detect infectious agents used in biological warfare. This two-year contract is valued at up to an additional $7.1 million for the research program, Triangulation Identification Genetic Evaluation of Biological Risks (TIGER). Earlier this month, Isis announced the receipt of a $1.8 million award for the TIGER program, bringing the total of the TIGER contract to up to $8.9 million. Over the past year, Science Applications International Corp. (SAIC), of San Diego, and Ibis have worked together to receive the TIGER program award. That partnership combines Ibis¿ expertise in microbial genome sequence analysis and advanced mass spectrometry technology with SAIC¿s advanced signal-processing capabilities. The TIGER contract builds on the biological warfare countermeasure research Ibis has conducted in two previous programs.
¿ Microbia Inc., of Cambridge, Mass., sponsored research by Dartmouth Medical School, which found that common pathogenic bacteria appear to be genetically programmed to resist antibiotics. The research was presented at the 15th Annual North American Cystic Fibrosis Conference in Orlando. The study describes an intrinsic genetic mechanism closely linked to the organisms¿ biofilm state found on surfaces such as medical implants and teeth that may play a major role in many failures of antibiotics.
¿ Myriad Genetics Inc., of Salt Lake City, said it used its high-throughput DNA sequencing facility to help determine the genome sequence of the Japanese pufferfish, Fugu rubripes. The draft genome of the pufferfish was made public by the International Fugu Genome Consortium during the International Genome Sequencing and Analysis conference in San Diego. Myriad generated 1.5x sequence coverage, equivalent to 1.5 times the length of the genome, or 600 million bases of DNA, over the past four months. The pufferfish genome has roughly the same number of genes as its human counterpart, but in just one-eighth the total length. The compact Fugu genome also is widely believed to contain information about the ways in which genes are regulated. The pufferfish genes can help researchers locate human counterparts. Because there is so little DNA sequence between genes, the genes are far more readily recognized in the pufferfish. Once known in the fish, the gene sequence is compared using bioinformatics programs to known human sequence.
¿ NetGenics Inc., of Cleveland, and LabBook Inc., of McLean, Va., said NetGenics has joined IBM, of Armonk, N.Y. and a growing list of organizations supporting the BSML standard for communicating genomic information. BSML (Bioinformatic Sequence Markup Language) is an open, freely available eXtensible Markup Language format. BSML documents are composed of two independent sections, one encoding the biological content, the other encoding visualization information for communication of the content. IBM also is collaborating with LabBook and NetGenics to deliver integrated, standards-based data management solutions that give life sciences researchers greater flexibility and speed in analyzing genomic data.
¿ Nordic Bioscience A/S, of Herlev, Denmark, has been formed as a company specializing in osteoporosis. The company results from the merger of two Danish biotech companies, Osteometer BioTech A/S and Osteopro A/S. Nordic Bioscience has 85 employees.
¿ Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., reported the initiation of a collaboration with Formatech Inc., of Andover, Mass., to develop improved product formulations for PRO 542, a drug currently in Phase II testing for HIV. Terms were not disclosed. The announcement accompanies the release of new findings that PRO 542 possesses potent antiviral activity when given by multiple routes of administration, including subcutaneous injection. The new studies demonstrated that PRO 542 reduced viral load to undetectable levels in a well-recognized animal model of HIV infection and may point the way toward simplified dosing regimens in man.
¿ Sigma-Genosys, of Houston, and Compugen Inc., of Princeton, N.J., reported the commercial launch of OligoLibraries, co-branded genome oligonucleotide collections for gene expression profiling, at the International Genome Sequencing and Analysis Conference in San Diego. In June, the companies announced an alliance for three designated OligoLibraries representing the mouse, rat and human genome. Compugen works to address redundancy, incorporate alternative splicing and consider specificity and cross-homology while developing content and designs for the genome collections, and Sigma-Genosys manufactures the products. The products are co-marketed by the companies under a revenue-sharing agreement.
¿ Takeda Chemical Industries Ltd., of Tokyo, said it will establish an investment company called Takeda Research Investment Inc. in Palo Alto, Calif. The company will provide funding for biotechnology start-ups and early stage ventures conducting research or developing technologies for innovative drug discovery. TRI will have an investment fund of $100 million and its focus will be to purchase equity in target companies, then maintain a close relationship, providing further finance and other types of support to assist the venture¿s research.
¿ Trinity Medical Group USA Inc., of Rancho Santa Margarita, Calif., reported the publication of follow-up results of a clinical study of an immune-based therapy for the treatment of HIV, Remune, at five sites in Thailand. The publication, titled ¿Long-term Follow-up of HIV-1 Infected Thai Patients Immunized with Remune Monotherapy,¿ appears in the September/October 2001 issue of HIV Clinical Trials. The publication is a result of week-132 review of data from 223 asymptomatic, HIV-infected Thai subjects. The original group consisted of 297 HIV-positive patients. The results of the study after 40 weeks, which included a placebo group, were published in Clinical and Diagnostic Laboratory Immunology in September 2000. This two-year follow-up study continued with open-label dosing of Remune every 12 weeks for the remaining 223 subjects. Changes in CD4+ cells, CD8+ cells and body weight were monitored at each patient visit.
¿ Viaken Systems Inc., of Gaithersburg, Md., said it is teaming with Sun Microsystems Inc., of Palo Alto, Calif., to introduce a new suite of data and process integration platforms. Viaken is developing a suite of discovery platforms to help eliminate discovery bottlenecks, accelerate product development, decrease R&D costs and reduce development time for life science customers. Terms were not disclosed.
¿ Xenova Group plc, of Slough, UK, reported successful results of clinical trials for two vaccines to treat human papillomavirus-associated diseases, which are recognized risk factors in both anal and genital cancers. Results from an 18-patient Phase IIa trial of Xenova¿s TA-HPV vaccine in women with high-grade vulval intra-epithelial neoplasia showed that the vaccine was safe and well tolerated. It revealed that 44 percent of patients demonstrated an objective clinical response at six months and a further 22 percent showed significant symptom relief. A Phase I study was conducted for TA-CIN, a Xenova vaccine being developed for the treatment of cervical intraepithelial neoplasia. In this placebo-controlled, dose-escalating study, the vaccine was administered by intramuscular injection to 40 healthy volunteers, and TA-CIN was found to be well tolerated. The company¿s stock (NASDAQ:XNVA) gained $1 Friday, or 22 percent, to close at $5.50.
¿ Xerion Pharmaceuticals AG, of Martinsried, Germany, entered into a target validation agreement with