¿ Alza Corp., of Mountain View, Calif., said its pegylated liposomal doxorubicin hydrochloride, Caelyx, was approved by the European Union's Commission of the European Communities for the treatment of advanced ovarian cancer in women who've failed first-line, platinum-based therapy. Caelyx is approved in the U.S. and is marketed by Alza under the name Doxil. Schering-Plough Corp., of Madison, N.J., is partnered with Alza for marketing in Europe.
¿ Amersham Pharmacia Biotech Ltd., of London, said it signed an agreement with Riken (The Institute of Physical and Chemical Research), of Tokyo, for Amersham to provide SNiPer single nucleotide polymorphism (SNP) analysis to Riken for the analysis of genetic diversity in the Japanese population. The SNiPer system can analyze up to 50,000 geneotypes per day.
¿ ChemBridge Corp., of San Diego, entered an agreement granting non-exclusive access to its PHARMACore library with AstraZeneca plc, of London. The PHARMACore library uses a pharacophore-based, target-oriented approach with integrated hit-to-lead capabilities, and is intended to streamline the process of screening-based drug discovery. Financial terms were undisclosed.
¿ Chiron Corp., of Emeryville, Calif., posted third-quarter earnings of $43 million, or 23 cents per share (6 cents better than analysts' consensus), a 35 percent increase compared to the same period of 1999. Net product sales rose by 26 percent to $144 million, as its recombinant interleukin-2, Proleukin, had sales of $21 million for the quarter, compared to $19 million for the same period in 1999. PaineWebber Inc. forecasted $30 million in sales, and said the earnings were driven by decreased operating expenses. Chiron's stock (NASDAQ:CHIR) dropped 13.01 percent Thursday to close at $43.87, down $6.56.
¿ Connetics Corp., of Palo Alto, Calif., released data describing recombinant human relaxin's biological actions, including data from its relaxin Phase III trial in scleroderma. Data from that trial indicated a failure to reach the trial's primary endpoint. Data did, however, indicate statistically significant decreases in both diastolic and systolic blood pressure (p<0.05 and p<0.02), and a statistically significant increase in creatinine clearance (p<0.05 and p<0.02). Relaxin is a naturally occurring hormone active in the promotion of vasodilation, angiogenesis and the inhibition of fibrosis.
¿ ILEX Oncology Inc., of San Antonio, and Millennium Pharmaceuticals Inc., of Cambridge, Mass., will have their humanized monoclonal antibody Campath reviewed Dec. 14 by the Oncologic Drugs Advisory Committee. The partners submitted a biological license application in December 1999. The product has fast-track and orphan drug status.
¿ Labopharm Inc., of Laval, Quebec, filed a prospectus to place 3.9 million common shares issuable following the exercise of the same number of special warrants issued Aug. 31 in a private placement for an aggregate consideration of C$12 million (US$7.9 million). The issue price in that offering was $3.05 per special warrant, and each warrant is exercisable for one share at no additional cost until Aug. 31, 2001. Labopharm will use the funding for product development, complementary drug delivery technology acquisition and development or acquisition of new products.
¿ Medicure Inc., of Winnipeg, Manitoba, began administration of Cardaxal to volunteers in the company's first clinical trial of the oral therapeutic for the treatment of myocardial infarction and ischemic reperfusion injury. The Phase I trial is designed to evaluate the drug's safety and pharmacokinetics.
¿ Proteome Systems Inc., of Sydney, Australia, and Sigma-Aldrich Inc., of St. Louis, entered a manufacturing and exclusive distribution agreement for Sigma-Aldrich to manufacture and distribute Proteome products for proteomic analysis. Financial terms were not disclosed.
¿ Therion Biologic Corp., of Cambridge, Mass., and Aventis Pasteur Ltd., of Toronto, said they extended their collaboration to include the study of additional tumor-associated antigens for use in pox virus-based vaccines for the treatment of melanoma, colorectal and lung cancers. The collaboration's lead product, ALVAC-CEA/B7.1, is a colorectal cancer vaccine. The companies plan to conduct a large-scale pivotal trial of ALVAC-CEA/B7.1 in conjunction with standard chemotherapy, and expect the compound to enter Phase III trials within two years.
¿ Unigene Laboratories Inc., of Fairfield, N.J., received a milestone payment from Pfizer Inc., of New York, associated with ongoing clinical studies of its oral calcitonin program. It also received payments for testing services and calcitonin supplies. Unigene also said it entered further undisclosed collaborations to investigate the feasibility of an oral delivery system for peptides for the treatment of endocrine disorders.
¿ Virco Inc., of Baltimore, said data presented at the 5th International Congress on Drug Therapy in HIV Infection, identified for the first time the mutation responsible for resistance to the HIV drug d4t (stavudine). Virco will use the mutation-identifying technology, neural networks, to fine tune its VirtualPhenotype test.
¿ Vivus Inc., of Mountain View, Calif., began patient enrollment for its clinical program testing its female sexual dysfunction product, Alista. The product is a proprietary formulation of alprostadil, a synthetic version of a naturally occurring vasodilating agent, for local genital application.