Amgen Inc. (AMGN) should have a strong presence at the upcoming annual meeting of the American Association for Cancer Research (AACR) where the company intends to present preclinical data on its emerging oncology portfolio. Amgen’s oncology portfolio currently consists of 16 molecules which are in varied stages of development.
Amgen also has plans to present results from a preclinical study of RANK ligand (RANKL) inhibitor against mammary tumor formation in animal (mouse) models. Besides this, the company will present data from a biomarker analysis of the pivotal phase III study conducted with Vectibix (panitumumab).
Vectibix, Amgen’s first fully human monoclonal antibody, is currently approved for the treatment of patients suffering from EGFR expressing metastatic colorectal cancer (mCRC). It is recommended for use in patients whose disease has progressed while on or following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.
Amgen is looking to drive Vectibix sales by expanding the label into second and first-line treatment of metastatic colorectal cancer, which will increase the patient base significantly.
The company has plans to file for regulatory approval both in the US and the EU for the use of Vectibix in the first and second-line treatment of patients with KRAS (a protein that plays an important role in cell growth regulation) wild-type mCRC.
Vectibix is also being studied for the treatment of metastatic and/or recurrent head and neck cancer (phase III) and locally advanced head and neck cancer (phase II). Vectibix sales came in at $233 million in 2009. The product competes primarily with Eli Lilly (LLY)/Bristol-Myers Squibb’s (BMY) Erbitux.
We currently have a Neutral recommendation on Amgen. The company is in a challenging growth period given the slowdown in sales of key products like Aranesp due to several reasons like labels restricting usage and other safety related issues. Moreover, products like Enbrel are facing intense competition from new competitors.
We expect investor focus to remain on the approvability of key pipeline candidate, denosumab, which is the future of Amgen. With all the key products expected to lose patent protection in the next few years, denosumab’s timely approval is an important event for the company.
Read the full analyst report on “AMGN”
Read the full analyst report on “LLY”
Read the full analyst report on “BMY”
Zacks Investment Research
