Genentech 'to be number one by 2010'

Genentech set out its long-range strategy, in a document called Horizon 2010, and financial expectations for 2004 at its investment community meeting in New York.

Building upon the company's ongoing 5x5 plan, which lasts through 2005, it outlined the vision and goals for continuing to create sustainable, long-term growth in stockholder value through to 2010. In addition, the company provided investors with an overview of recent developments, including highlights from its extensive research, development, manufacturing and commercial efforts.

'Genentech has developed a comprehensive plan for the rest of the decade, which positions us to provide sound and consistent growth for the future,' said ceo Dr Arthur Levinson. 'Translating science into successful product development and commercialisation takes significant effort and planning throughout all areas of the company.'

Genentech's vision for Horizon 2010 is to become a leader in revolutionising the treatment of patients with cancer, immunological diseases and angiogenic disorders. Horizon 2010 includes the following specific goals:

• To aim to become the number one U.S. oncology company in sales by 2010.

•To position itself for continued leadership in its oncology franchise by bringing five new oncology products or indications for existing products into clinical development and into the market.

•To build a leading immunology franchise by expanding the fundamental understanding of immune disorders, bringing at least five new immunology products or indications into clinical development, and obtaining FDA approval of at least five new indications or products by 2010.

•To increase its leadership in developing biotherapeutics for disorders of tissue growth and repair, with a major focus on angiogenic disorders, and to move at least three new projects into late-stage research or developmental research and three or more new projects into clinical development by 2010.

•To achieve average annual EPS growth rates sufficient to be considered a growth company.

Genentech informed investors it will be focusing on the recent multiple product launches of Avastin (bevacizumab), RAPTIVA (efalizumab) and Xolair (Omalizumab), as well as potential future launches of new indications and/or products, which will contribute to delivering the near-term and Horizon 2010 goals. Rituxan is the number one anti-tumor product in the United States and the number two anti-tumor product in the world (in terms of sales). Herceptin (trastuzumab) is the number seven anti-tumor product in the United States and the number nine in the world.

The company said its future sales growth would be dependent on increasing market penetration for labeled indications and developing new markets for its existing products, as well as commercialising potential new therapies in oncology, immunological disease, vascular medicine and other areas of high unmet need. 'Genentech's disciplined, scientific approach to commercialising our products has allowed us to launch three new products in nine months, while continuing to grow our established products,' said Myrtle Potter, president, Commercial Operations.

Genentech has a broad and diverse clinical pipeline with more than 30 ongoing projects, 25 of which are in Phase II or Phase III clinical trials. In the first quarter of 2004, working in collaboration with Curis, Genentech added a new molecule to its early-stage pipeline, G-024856, an inhibitor of the Hedgehog signaling pathway. Genentech is exploring an initial indication in basal cell carcinoma, a form of skin cancer. The company has data showing activity in a variety of pre-clinical models in basal cell carcinoma. Abnormal activation of the Hedgehog signaling pathway also has been implicated in the progression of several other cancers, including small cell lung cancer, gastric tumors and medulloblastoma. In June 2003, Genentech licensed G-024856 from Curis.

The next steps for Avastin development include additional studies in colorectal cancer in first-line metastatic colorectal cancer with oxaliplatin, as well as plans to initiate exploratory combinations with Erbitux (cetuximab), Omnitarg (pertuzmab) and other biologic compounds. Genentech is pursuing a late-stage clinical development program with Avastin, evaluating its potential use in adjuvant colorectal cancer, renal cell (kidney), breast, pancreatic and non-small cell lung cancers. Avastin is also being evaluated in earlier stage trials as a potential therapy in pancreatic, prostate, ovarian, melanoma and several types of blood cancers.

The company is also building its leadership in biotherapeutics for angiogenic disorders, evaluating Lucentis (ranibizumab) in patients with age-related macular degeneration, VEGF (vascular endothelial growth factor) in patients with impaired wound healing, and Avastin for diseases outside of oncology.