Such alliances are yielding novel, targeted biologic therapies that promise an advance over existing chemotherapy and hormonal alternatives and are poised to drive revenue generation in the breast cancer therapeutic arena.

Over recent years, 'anaemic' late-stage product pipelines and patent expirations for blockbuster oncology therapeutics have troubled the pharmaceutical industry. Biotech companies, in the meantime, have had to contend with limited financial capital needed to push their pipeline products through more expensive, larger scale, late-stage development trials.

This has set the stage for synergistic partnerships between the pharmaceuticals industry and the biotechnology sector. "An alliance between biotechnology and pharmaceutical companies establishes possible licensing opportunities for both parties," remarks Curt A. Herberts III, Research Analyst with Frost & Sullivan's pharmaceutical and biotechnology group (pharma.frost). "While biotech companies get the financial capital required to expand, pharmaceutical companies profit from the innovative products developed by the biotechnology companies."

Aggressive clinical trials and extensive licensing activities between biotech companies and large pharmaceutical companies are expected to rapidly usher innovative therapies that specifically target cancerous tissue and have less radical side effect profiles into the market.

A strong pipeline of pioneering therapeutics- small molecules, monoclonal antibodies, gene therapy, cancer vaccines, angiogenesis inhibitors, third-generation hormonals, chemopotentiators and chemoprotectants - is now set to strongly impact the market.

The success of these new age therapies is, however, expected to hinge on the ability of small biotech companies to surmount regulatory hurdles. Demonstrating the enhanced clinical benefits of these expensive options over existing treatments is also crucial to encouraging uptake levels.

"These new products are trying to achieve FDA approval into the metastatic disease setting at first, and then eventually hope to move into the adjuvant therapeutic setting," notes Mr. Herberts. "Adjuvant therapy has substantially more revenue potential as patients are on the therapy for a longer period of time and the treatment is likely to actually cure the disease, instead of just prolonging life expectancy."

Taxotere and Xeloda are expected to be key growth drivers in the cytotoxic market, since they are likely to be used in the adjuvant setting. Novel chemopotentiators, chemoprotectants and iposomal formulations are also likely to boost use of chemotherapy agents.

Chemopotentiators such as YM Bio Sciences' Tesmilifene (in phase III clinical trials) are set to revolutionise chemotherapy treatment regimens by boosting the cytotoxic effect on tumour cells, while protecting healthy cells.

Amongst hormonal therapeutics, aromatase inhibitors are expected to be deployed in adjuvant, neo-adjuvant, and extended adjuvant therapeutic settings for post-menopausal women. Together with new-age selective estrogen receptor modulators (SERMs), aromatase inhibitors are poised to energise market growth with increased preventative benefits and decreased side-effects profile.

Currently, aromatase inhibitors such as Arimidex (anastrozole), Aromasin (exemestane) and Femara (letrozole) are being used to treat hormone receptor-positive breast cancers in multiple indications. Tamoxifen (brand name Nolvadex), the most widely prescribed SERM, has FDA approval for treatment of both early and advanced stages of breast cancer.

The success of Herceptin is reflective of the enormous profits that pharmaceuticals companies stand to gain from investing in newer biologic therapies developed by biotech companies. Herceptin is expected to power the biologic market with likely employment in the adjuvant therapeutics setting for women with HER2/neu early-stage breast cancer.

A large-scale adjuvant clinical trial with Herceptin is expected to demonstrate results by 2006. Avastin is being employed in a clinical trial for metastatic breast cancer to determine its clinical efficacy as an anti-angiogenesis therapy.

"Such new age medicines will undoubtedly impact not only the way we think about disease, but also the manner in which women live their lives in the treatment setting following the initial diagnosis," concludes Mr. Herbert.

pharma.frost