* Idec Pharmaceuticals Inc., of San Diego, withdrew its follow-on stock offering of 2 million shares, due to market conditions. The company had filed a registration statement for the offering on Feb. 24. (See BioWorld Today, Feb. 26, 1998, p. 1.)

* Igen International Inc., of Gaithersburg, Md., agreed to sell its first ORIGEN High Throughput Screening System to Pfizer Inc., of New York. Pfizer has paid for the right to acquire initial units, with delivery expected this year. Financial terms were not disclosed.

* Merck & Co., of Whitehouse Station, N.J., said the FDA granted traditional approval of Crixivan (indinavir sulfate), the company's HIV protease inhibitor, as a combination therapy. The drug was first cleared for marketing in March 1996 under the FDA's accelerated review procedures. An analysis of surrogate endpoints — CD4 cell count increases and viral load decreases — in studies up to 24 weeks long led to that approval. The traditional approval is based on studies of Crixivan with antiretroviral agents, which showed the drug in combination therapy prolonged HIV RNA suppression and reduced the risk of AIDS-defining illness or death.

* Metra Biosystems Inc., of Mountain View, Calif., said the FDA cleared its premarket notification for use of the Pyrilinks-D bone resorption immunoassay to monitor anti-resorptive therapies, including Fosamax (alendronate sodium), in the treatment and prevention of osteoporosis. The clearance was based on a study comparing Dpd levels, an accepted biochemical indicator of bone resorption, in postmenopausal women diagnosed with osteoporosis who received either alendronate and a calcium supplement or a calcium supplement alone. Pryilinks-D was first cleared by the FDA in December 1995 for measuring bone resorption.

* Protein Design Labs Inc. (PDL), of Mountain View, Calif., said Switzerland's Intercantonal Office for the Control of Medicines granted Hoffmann-La Roche Ltd., of Basel, Switzerland, approval to market Zenapax (daclizumab), a humanized monoclonal antibody created by PDL and licensed to Roche for the prevention of kidney transplant rejection. The FDA cleared Zenapax for marketing in December 1997.

* Reprogen Inc., of Irvine, Calif., raised $5.1 million in a private placement. Participants included current investors: Oxford Ventures, of Stanford, Conn.; GIMV, of Antwerp, Belgium; UBS Securities LLC, of New York; and GeneChem Technologies Venture Fund LP, of Laval, Quebec. Reprogen is a functional genomics company focused on identifying genes regulated by hormones in the reproductive-disease process.

* Visible Genetics Inc., of Toronto, completed a retrospective trial of its human papillomavirus genotyping diagnostic test. The test uses a single nucleotide DNA sequencing method to genotype the virus. The trial was based on 115 cervical specimens collected from women who underwent colposcopic examinations for abnormal Pap smears. The test was 98.3 percent consistent with all of the genotypes found upon full DNA sequencing.

No Comments