Pfizer Inc.’s (PFE) Sutent recently received support from an advisory panel of the US Food and Drug Administration (FDA). The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8-2 in favor of Sutent’s benefit-risk profile for the treatment of unresectable pancreatic neuroendocrine tumors (NET).
Sutent is already approved in Europe for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (NET) with disease progression in adults. While the agency is not required to follow the panel’s advice, it usually does so.
We note that Pfizer received a complete response letter for the NET indication in May 2010 with the FDA asking the company to submit additional information.
Pancreatic NET is a rare cancer, which is estimated to impact about two to four people in a million annually. Sutent is currently approved for the treatment of gastrointestinal stromal tumors (GIST) and metastatic renal cell carcinoma (RCC). The drug has experienced very strong uptake, ending 2010 with revenues up 10.6% at $ 1.1 billion.
Pfizer Pursuing Additional Indications for Sutent
Pfizer has been consistently working on getting Sutent approved for additional indications. However, the company faced several setbacks in its attempts to expand Sutent’s label.
In late Sep 2010, Pfizer discontinued a phase III study (SUN 1120) that was evaluating Sutent, in combination with prednisone, in men suffering from advanced castration-resistant prostate cancer (CRPC) which had progressed even after being treated with a docetaxel-based chemotherapy regimen.
Earlier in August 2010, Pfizer had announced disappointing results on the candidate from a late-stage study that was being conducted in patients suffering from non small-cell lung cancer (NSCLC).
Then in April 2010, Pfizer had to discontinue a phase III liver cancer study. The trial was halted based on a review conducted by an independent data monitoring committee which said that a higher number of serious adverse events were observed in the Sutent arm compared to Onyx/Bayer’s (ONXX/BAYRY) Nexavar (sorafenib). Moreover, Sutent failed to demonstrate superiority or non-inferiority to Nexavar.
In March 2010, Pfizer had reported disappointing results from two phase III studies of Sutent in advanced breast cancer.
Pfizer is currently evaluating Sutent for renal cell carcinoma (as adjuvant therapy). Approval for additional indications would help boost Sutent revenues significantly.
Neutral on Pfizer
We currently have a Neutral recommendation on Pfizer, which is supported by a Zacks #3 Rank (short-term Hold rating). With the Lipitor patent expiration coming up later this year, near-term earnings growth at Pfizer will come in the form of cost-cutting and share repurchases.
While Wyeth brings with it an attractive biologics platform and some complementary products and businesses, we do not believe they are enough to sustain long-term top-line growth. We see the merger as mostly an opportunity for Pfizer to cut additional costs. Longer term growth will be dependent on the success of drug development.
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