Following on the heels of two big announcements in February, Celgene CEO Robert Hugin (one of FierceBiotech’s most influential people in biopharma) participated in a fireside chat with Joel Sendek, managing director and biotechnology analyst at Stifel Nicolaus & Company, at the 15th Annual BIO CEO & Investor Conference in New York.
First, on Friday, February 8, the Food and Drug Administration (FDA) approved Celgene’s drug Pomalyst for patients with multiple myeloma whose disease has worsened after being treated with other cancer drugs – including the company’s own Revlimid (more on Revlimid below).
Multiple myeloma is a cancer that starts in plasma cells in bone marrow. The plasma cells grow out of control in the bone marrow and form tumors in the areas of solid bone. The American Cancer Society estimates there will be about 22,300 new cases diagnosed in 2013 and 10,700 deaths.
FDA approval of Pomalyst is a big advancement for patients and the drug is very complementary to Celgene’s current myeloma program, Hugin explained. The company will announce pricing in the next couple of days with the expectation that, due to the size of the patient population, they see it having a slight premium.
“We have also submitted [Pomalyst] in Europe and we are hopeful that we’ll get approval there later this year, so we can make the product available to patients in both the United States and Europe,” Hugin said.
Then, on Monday, Revlimid won full regulatory approval in China for patients. Revlimid also treats patients with relapsed or refractory multiple myeloma and they expect the drug to be available to Chinese patients in 2013. It’s already been approved in almost 70 countries.
The approval of Revlimid by China’s SFDA is an important tactical catalyst for Celgene because it demonstrates that the drug can remain a geographical growth driver for the company.
“Hopefully we’ll begin commercialization [in China] in the middle of the third quarter this year,” Hugin explained.