By Randall Osborne
Coulter Pharmaceutical Inc. and Amylin Pharmaceuticals Inc. registered for public offerings that would raise $66 million.
Palo Alto, Calif.-based Coulter filed for an offering of 2 million shares. At Friday's closing price (NASDAQ:CLTR) of $27.50 (down $1.375), the sale would raise $55 million.
Amylin, of San Diego, proposed to offer 3 million shares. The company's stock (NASDAQ:AMLN) ended Friday at $3.687, unchanged. At that price, the offering would raise $11 million.
Coulter's lead product is Bexxar, a monoclonal antibody conjugated to iodine 131 for the treatment of non-Hodgkin's lymphoma. It attaches to a protein found only on the surface of B cells (including non-Hodgkin's and some normal B cells), in order to provide a greater concentration of therapeutic radiation to tumor cells.
Interim Phase III trial data showed encouraging results, and the company expects to file a biologics license application with the FDA by the end of this year. The company said success rates, as measured by the primary endpoint of tumor response, were running at about 77 percent. (See BioWorld Today, May 13, 1998, p. 1.)
Coulter said that, if approved, Bexxar would be the first radioimmunotherapy approved in the U.S. for non-Hodgkin's lymphoma.
Amylin's lead product is pramlintide, a synthetic analogue of the human hormone amylin, for diabetes. The company's partner, Johnson & Johnson, of New Brunswick, N.J., pulled out of their deal in March.
J&J's move came as a surprise to Amylin, which had expanded its Phase III studies of pramlintide in November 1997. Amylin said it still expects to file a new drug application with the FDA in mid-2000 for pramlintide against Type I and Type II diabetes. A regulatory filing in Europe for pramlintide for Type II diabetes is expected in the first half of 2000. (See BioWorld Today, Nov. 14, 1997, p. 1, and March 3, 1998, p. 1.)
Amylin said it has completed enrollment of more than 880 patients at 135 sites in the U.S. for its two Phase III clinical trials of pramlintide with revised protocols.
A committee established by the company's board of directors will establish pricing for the offering.
Coulter's offering is managed by 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. *