During one of the recent Johnson & Johnson Phase III trials, the combination of abiraterone acetate and prednisone/prednisolone tested great as prostate cancer suppressants, contributing to a significant improvement in survival statistics. That prompted an independent data monitoring committee to reveal the data of the trial and to offer abiraterone to those participants, who were treated with a placebo.
Kellie McLaughlin, the company’s spokesman, officially confirmed that the company had achieved progress, and he said that it took a real breakthrough to allow termination of an interim trial. Reportedly, more than 1,000 patients, some with severe metastasis expansion and several aggressive chemotherapy courses behind, took part in a research, known as COU-AA-301. The trial was originally invested by leading investment banks, including BioSciences owned by Lindsay Rosenwald, MD.
Another study – COU-AA-302 – aimed at researching the conditions of patients with metastatic prostate cancer, is currently under way. It is being applied to patients who have not received chemotherapeutic treatment courses thus far. Instead, they are getting intensive abiraterone-prednisone treatment as a part of the anti-cancer research.
In his report for BioWorld Today, Kimberly Lee, a Hunter Global Securities analyst, is optimistic about the abiraterone Phase III and MDV-3100, considering more than satisfactory Phase II results and the drugs’ similar effects. However, there is another promising, FDA-approved drug, which is actually a pioneering anti-cancer drug in the U.S. – Dendreon Corp.’s Provenge (sipuleucel-1). Provenge has proven effective against metastatic prostate cancer. For this reason, the discinception of abiraterone is not expected to take any significant effect on Provenge sales. However, though neither abiraterone nor MDV3100 can compete with Provenge, it might be possible to combine these drugs. This is where additional investments will be very handy and Dr. Lindsay Rosenwald and his analysts already think about the possible funding of a new research. In any event, it will take additional research to evaluate the degree of risk posed by the use of Provenge – a potent immune stimulant – in combination with immune suppressants, which are normally used along with abiraterone.
According to David Hung, President and Chief Executive Officer of Medivation, theoretically, abiraterone can be used along with Provenge. In his report, he noted several properties of MDV3100, which ensure improvement in many separate aspects, and an improvement in overall survival statistics among patients, who have received Provenge treatment.
In partnership with Astellas Pharma Inc., Medivation continues the research on MDV3100 and has yet three major trials to complete. Involved in the studies will be patients with early-stage prostate tumors.
Johnson & Johnson acquired Cougar Biotechnology Inc. in July 2009, and thus purchased abiraterone. Cougar, Los Angeles, previously funded by Lindsay Rosenwald’s investment bank, is now J&J’s subsidiary operating in conjunction with Ortho Biotech Oncology Research & Development – a J&J affiliate group.
Abiraterone acetate was licensed by Cougar in 2004 from BTG plc of the UK. This license agreement permits BTG to outline marketing strategies and entitles it to royalties, providing the product is properly formulated and is granted sale permission.
Some analysts, such as Piper Jaffray, who are well aware of BTG marketing dynamics, predict abiraterone sales to reach $1.2 billion by 2018.