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Algeta-Bayer Prostate Cancer Metastases Trial is Stopped

BioWorld International Correspondent

LONDON – Algeta A/S said its lead product Alpharadin is on course for blockbuster status after the Phase III trial was stopped on the basis of statistically significant efficacy in the treatment of bone marrow metastases in patients with castration-resistant prostate cancer.

The decision to stop the Phase III Alsympca trial after a planned interim analysis by the independent data monitoring committee delivers a positive outcome more than a year earlier than was expected. That puts Oslo, Norway-based Algeta and its partner Bayer Schering Pharma AG on target to file Alpharadin for marketing approval in 2012. Algeta is now in line for milestone payments amounting to $160 million up to approval. In addition, it has retained 50 percent co-promotion rights in the U.S. and is entitled to double-digit royalties on sales by Bayer.

"We are well positioned for commercial success, with the potential to be first to market with a new class of [treatment], which is a potential blockbuster," said CEO Andrew Kay.

Algeta also is developing Apharadin to treat bone metastases in other cancer types and on Tuesday announced positive preliminary results in a 23-patient Phase IIa trial in breast cancer.

Shares in Algeta rose 37 percent, to NOK210 (US$37.50) when the news about the Phase III pancreatic cancer trial was announced on Monday morning.

Patients in the placebo arm of the stopped trial will now be offered a full course of treatment with Alpharadin, which is an alpha-particle-emitting formulation of radium-223. Overall survival in the trial was 14 months for Alpharadin vs. 11.2 months for placebo, with other quality-of-life improvements in a patient group where currently the only therapeutic option is chemotherapy.

Alpharadin was "consistently well tolerated" and "met the primary endpoint of an overall increase in survival, with a 30 percent reduction of the risk of death," said Gillies O'Bryan-Tear, chief medical officer. "We will now discuss with our partner Bayer the strategy for filing."

The Phase III trial recruited 922 patients in 140 countries worldwide who were suffering from symptomatic bone metastases, which affect 90 percent of those with advanced prostate cancer.

"There is no effective treatment; the mainstay at the moment is chemotherapy, but 50 percent [of patients] can't tolerate [this]. Given there are few options, with these results, we can satisfy an unmet need," Kay said.

There are around 100,000 patients per annum in the U.S. and the five largest markets in Europe. "The pricing environment is encouraging, and there is a large number of patients," Kay said.

Algeta will now start planning toward taking up its 50 percent co-promotion rights in the U.S. The $160 million that the company is due in milestones will pay for the U.S. marketing infrastructure, he noted. "We are preparing Alpharadin for commercialization with an eye to making it the first choice treatment for bone metastases."

The principal investigator in the trial, Chris Parker at the Royal Marsden Hospital in London, said bone metastases are the main cause of disability and death in advanced prostate cancer.

"Treatment options are limited. Based on the observed survival benefit and its safety profile, Alpharadin may become an important treatment for patients with bone metastases," Parker said.

With the results from the Phase III previously not expected for another year, one possible source of delay is in completing and licensing the manufacturing facility, which is under construction currently. "The plans on the building were to coincide [with the end of the trial] at the end of 2012. But we are well on track with construction and will be looking at resources to see what we can do to accelerate manufacturing," Kay explained.

Backing up the positive results in pancreatic cancer, the preliminary data from the Phase IIa study of Alpharadin in the treatment of bone metastases in patients with endocrine-refractory breast cancer showed positive results for bone markers. The results showed that Alpharadin reduced the levels of bone alkaline phosphatase, and urine N-telopeptide, which are key biomarkers of bone involvement in breast cancer. The product was safe and well tolerated.

Published in BioWorld International: June 8, 2011