Genentech: Omnitarg failure takes gloss off pipeline
Genentech (NYSE: DNA) 's cancer antibody Omnitarg has produced disappointing Phase II results.
Genentech [DNA] has released Phase II data indicating that its humanized monoclonal antibody (mAb) product Omnitarg had limited activity when used as a monotherapy to treat ovarian, breast and prostate cancers. The news is potentially damaging to the company's reputation for strong pipeline portfolio management and harnessed innovation.
Omnitarg (pertuzumab) failed to show a significant benefit in a range of Phase II trials. Trial data indicated that the product demonstrated a partial response or the ability to stabilize the disease in 15% of ovarian cancer patients, 8% of patients with metastatic breast cancer with low expression of HER2, and 12% of prostate cancer patients.
Omnitarg is the first product in the HER dimerization inhibitor class. Products in this class function by inhibiting HER2 receptor dimerization with other HER receptor family members. Herceptin (trastuzumab), one of Roche/Genentech's leading marketed mAb products, generated close to $1.2 billion in 2004 and it also targets the HER2 pathway. However, the product is only effective in patients with tumors that over-express HER2, while Omnitarg has been designed to target tumors that have normal levels of HER2, thereby expanding the target patient population. The failure of Omnitarg has therefore denied Genentech a potential key growth driver over the longer term.
In April 2005, Genentech overtook Amgen (NASDAQ: AMGN) as the leading biotech company in terms of market capitalization, largely on the back of strong clinical data for Avastin in breast and non-small cell lung cancer. Additionally, Genentech enjoyed the limelight at this week's American Society for Clinical Oncology meeting, receiving considerable praise based on the very strong performance of its marketed products. Genentech has achieved this position because of the quality of its pipeline portfolio management strategy, in which only those products that meet strict criteria progress to the next stage of development.
However, the failure of Omnitarg, together with the recent failure of Genentech/Actelion (Zurich: ATLN.S) 's Phase III acute heart failure drug Veletri (tezosentan), has left Genentech struggling to maintain pipeline innovation, and the company now has only one novel pipeline product set to launch by 2010, its ophthalmic treatment Lucentis (ranibizumab). This makes Genentech largely dependent on the lifecycle management of currently marketed products, meaning pipeline rejuvenation is an increasingly pressing need for the firm. ... |
