Pfizer added two potential blockbusters to its product arsenal in the course of just two days last week, earning approvals for its inhaled insulin Exubera (inhaled human insulin powder) and cancer drug Sutent (sunitinib).
Last Friday the FDA approved Exubera, Pfizer’s eagerly anticipated inhaled insulin combo for type 1 and 2 diabetes.
Deutsche Bank large-cap pharmaceuticals analyst Barbara Ryan told MM&M that Exubera has the potential to be a $2 billion-per-year drug. “It’s a huge patient population,” said Ryan. “It won’t take a lot of penetration,” for Pfizer to see positive results, she added.
Upon approval, Exubera was hailed by the FDA as “the first new insulin delivery option produced since the discovery of insulin in the 1920s.” The approval followed a protracted review over pulmonary concerns and a tiff between Sanofi-Aventis and Pfizer over worldwide marketing rights for the drug, which Pfizer bought for $1.3 billion last month.
Last Thursday Pfizer’s Sutent won FDA approval to treat two conditions, a rare stomach cancer and advanced kidney cancer.
The approval marks the first time the FDA has approved a new oncology product for two indications simultaneously, the agency said. Sutent, which received a priority review and was approved in less than six months, is a tyrosine kinase inhibitor that works through multiple targets to deprive the tumor cells of the blood and nutrients needed to grow.
According to the American Cancer Society, about 32,000 new cases of advanced kidney cancer and 5,000 cases of GIST are diagnosed each year.
Because of the size of the patient population, Ryan said she doesn’t expect Sutent to reach blockbuster status overnight.
“Sutent has the potential to be a $1 billion drug over the long haul,” Ryan said.
Success from these pipeline products is more crucial than ever for Pfizer, according to analysts. Key patents have either expired or will soon expire on some of the firm’s biggest-selling drugs, including the antidepressant Zoloft and hypertension treatment Norvasc. Some analysts predict the company could lose sales worth about $14 billion due to generic competition.
“While these approvals were expected, they reinforce our view that Pfizer’s pipeline and new product flow will improve in 2006,” Ryan wrote in a research note. “Additional pipeline developments in the next 9 months will be key to assessing Pfizer’s top line prospects for the next 4 to 5 years.”
Pfizer is expected to address some of the developments during a meeting with analysts scheduled for Feb. 10.