* Coulter Pharmaceutical Inc., of Palo Alto, Calif., grossed an additional $6.1 million as underwriters of the company's recent public offering exercised an overallotment option of 245,000 shares at $25 per share. Underwriters were BT Alex. Brown Inc., of Baltimore; Hambrecht & Quist LLC, of San Francisco; Pacific Growth Equities Inc., of San Francisco; and Piper Jaffray Inc., of Minneapolis. With this additional sale, gross proceeds for the offering reached $66.1 million. Coulter plans to file a biologic license application for its most advanced drug candidate, Bexxar, by the end of the year. A monoclonal antibody conjugated to iodine-131, Bexxar is in development for treatment of non-Hodgkin's lymphoma. (See BioWorld Today, Aug. 3, 1998, p. 1.)
* Eli Lilly and Co., of Indianapolis, won FDA approval for the anticancer agent Gemzar (gemcitabine HCl) in combination with cisplatin as a first-line treatment for inoperable, locally advanced or metastatic non-small cell lung cancer. Thirty-nine percent of those treated with the combination in a pivotal trial were still alive after one year, compared with 28 percent of patients receiving cisplatin alone. Gemzar was FDA-approved in 1996 as a single agent for first-line treatment of locally advanced or metastatic pancreatic cancer.
* IntraBiotics Pharmaceuticals Inc., of Mountain View, Calif., reported positive results from a Phase I trial of Protegrin IB-367, a potential treatment for oral mucositis. The study showed the compound was safe in cancer patients receiving myeloablative chemotherapy and at risk of developing severe oral mucositis. Protegrin IB-367 also substantially reduced the number of microorganisms in the mouth, an effect that continued for the 10-day treatment period.
* Medarex Inc., of Annandale, N.J., received a $1.2 million milestone payment from Merck KgaA, of Darmstadt, Germany, in exchange for 192,000 shares of Medarex common stock. Clinical development progress of the anticancer treatment MDX-447 triggered the milestone. Now entering Phase II trials in head and neck cancer, MDX-447 is a bispecific antibody that targets the epidermal growth factor receptor, which is overexpressed in many solid tumors. The drug combines a Merck cancer targeting component with a Medarex immune system triggering component.
* NeXstar Pharmaceuticals Inc., of Boulder, Colo., received FDA clearance of an investigational new drug application and will soon begin clinical testing of NX 1838, an inhibitor of vascular endothelial growth factor. The indication is age-related macular degeneration (AMD), estimated to affect more than 10 percent of the U.S. population over the age of 65. The initial Phase I trial will enroll between 18 and 36 patients in a single-dose, dose-escalating study to establish the safety profile of the drug in patients with neovascular AMD and low visual acuity in one eye. NX 1838 wll be administered by direct injection into the eye in order to expose diseased tissues to maximum levels of the drug.
* SciClone Pharmaceuticals Inc., of San Mateo, Calif., won two new approvals for Zadaxin thymosin alpha 1, a hepatitis drug. The Philippines granted Zadaxin its first approval as a hepatitis C treatment; Myanmar gave the nod for hepatitis B. The drug was already approved in Argentina, the People's Republic of China, Italy, Kuwait, Peru and Singapore. SciClone also reported filing Zadaxin applications for hepatitis B in Laos and Taiwan. Zadaxin could grow to a $40 million to $60 million business in developing countries, said Donald Sellers, SciClone's president and CEO.
* Perkin-Elmer Corp., of Norwalk, Conn., said its subsidiary, Tropix, of Bedford, Mass, and Zymark Corp., of Hopkinton, Mass., reported the Allegro automation platform performed 96,000 screening assays within a 24-hour period. Tropix processed 1,000 96-well format microplates performing a 15-step assay to screen for drug candidates that inhibit the activity of the cancer-linked src kinase. A conventional high-throughput robotic screening system would have taken 15 times as long to do the work, the companies said. An expansion of the system is expected to vault capacity further, to 400,000 assays per day. Zymark developed the Allegro platform as part of a collaboration with Tropix, which designed the assay used in the kinase screen.