Last night, just hours after New York drug giant Pfizer (NYSE: [[ticker:PFE]]) reported first-quarter profits that suffered from generic competition on its blockbuster cholesterol drug atorvastatin (Lipitor), the company announced that the FDA approved its new drug to treat Gaucher Disease. It was easy to overlook the news. Pfizer’s net income in the quarter announced yesterday fell 19 percent year-over-year to $1.79 billion, on sales that dropped 7 percent to $15.4 billion. What’s more, Gaucher is a rare genetic disease, and therefore not lucrative enough to make up for the loss of atorvastatin.
But there’s little doubt the folks at Sanofi’s Cambridge, MA-based unit Genzyme were paying close attention to Pfizer’s new drug approval. Genzyme dominates the Gaucher market with its drug imiglucerase (Cerezyme), which brought in about a half-billion dollars in sales last year. But the product has been plagued by supply shortages stemming from production problems at its Allston Landing, MA plant. Rivals have been lining up to try to fill the void, including Cranbury, NJ-based Amicus Therapeutics, which is researching a treatment for Gaucher, and Irish drug giant Shire (NASDAQ: [[ticker:SHPGY]]) , which markets a drug for the disease called velaglucerase alfa (Vpriv).
Pfizer got into the Gaucher market in 2009 by partnering with Israel-based Protalix BioTherapeutics to develop its drug, called taliglucerase alfa (Elelyso). The two companies suffered a setback in February 2011, when the FDA delayed approval of the drug due to questions about chemistry, manufacturing, and controls.
Gaucher is an enzyme disorder that causes symptoms such as enlargement of the liver and spleen, bone disease, and anemia. The drugs from Genzyme and Pfizer are both designed to replace the enzyme that’s deficient in the disease. Pfizer’s study program included a trial in which patients were switched from Genzyme’s imiglucerase to the new drug. The company reported that after the switch, the patients’ livers and spleens were stable, as were their blood counts.
Still, physicians who treat Gaucher might need a bit more of an incentive to abandon Genzyme’s stalwart treatment in favor of Pfizer’s new entry. Pfizer says it will price the new drug at 25 percent less than imiglucerase, which can cost $200,000 annually per patient. And Pfizer is playing up a program it introduced called Gaucher Personal Support, which will reimburse some patients for prescription co-payments and other expenses. Yesterday’s approval was applauded by Rhonda Buyers, CEO of the National Gaucher Foundation, who said in Pfizer’s statement that the addition of a treatment option “is especially important for this group of patients who have suffered from supply shortages in recent years.”
For now, though, Pfizer’s Gaucher drug is not even on Wall Street’s radar. Analysts have not yet factored the drug into their earnings estimates, instead focusing on the blockbuster potential of other molecules in the company’s pipeline, including the Alzheimer’s treatment bapineuzumab. Pfizer is expected to release data from late-stage trials of that drug in the second half of this year.
Pfizer’s shares were largely unchanged yesterday, closing at a price of $22.78 per share.
