SYDNEY, Australia - A buoyant local market and renewed investor enthusiasm for biotech stocks have resulted in a string of Australian initial public offerings, including one company with an antitumor product that has completed Phase III testing.
Sirtex Medical Ltd. raised A$15 million ($US8.7 million), as one of three recently announced IPOs expected to raise a total of A$28 million, to start marketing its SIR-Spheres tiny radioactive particles.
Sirtex is now selling the particles as a treatment for liver cancer in Australia, either for use by itself or in conjunction with chemotherapy, and has applied to the U.S. FDA for registration.
Sirtex CEO Colin Sutton said he recently met with an FDA subcommittee looking at the company's application and believes he had answered all its questions satisfactorily.
Not only had Sirtex reached the FDA registration process by itself, without the aid of a major pharmaceutical company, it intended to take the next step of marketing the product in the U.S., using the money raised in the IPO.
The SIR-Spheres are yttrium-90 microparticles made radioactive by neutron bombardment. Once injected into the blood supply of the liver, the particles are designed to lodge in tumors, wherever they may be, and then irradiate the tumor, leaving the surrounding tissue undamaged.
A Phase III study involved 74 patients with colorectal cancer that had spread to the liver, and for whom surgery was not possible. Conducted in Perth in Western Australia, the early clinical data were presented in May last year at a meeting of the American Society of Clinical Oncology.
The study found an injection of SIR-Spheres increased the patient response rate to chemotherapy from 31 percent to 44 percent when measured by reduction in tumor size and from 54 percent to 74 percent when measured by tumor markers. The study also found significant delays in the progression of cancer and significant increases in survival rates. There have been further studies involving 400 patients in Australia, Hong Kong and New Zealand.
The two other companies to complete or seek IPOs are Pi2 Ltd., which raised A$7 million and has listed on the stock exchange, and Analytica Ltd., which said it will undertake an IPO for A$6 million.
Pi2 is a spin-off from another company, Human Therapeutics. As Biotechnology Australia, Human Therapeutics was itself bought out from pharmaceutical company, Hoechst Australia, in January. (See BioWorld International, Jan. 12, 2000.)
Pi2 has two main products, a treatment for chronic leg ulcers and a treatment for psoriasis, both derived from the same molecule known as plasminogen activating inhibitor, or PAI-2.
Despite an apparently favorable outlook for biotech stocks in Australia at the moment, with biotech stocks being frequently featured in the media, Pi2's share price has not fared well. The stock, which went off at 50 cents a share, closed Friday at 43 cents. Analytica has a portfolio of potential treatments under development, including treatments for cancer, obesity, weight control and inflammatory disorders such as arthritis and asthma.