Double Approvals, Accelerated Growth

• Email
• Share
• Print

Genzyme's (Nasdaq: GENZ) guidance was for nice growth in revenue this year as long as it could get by some regulatory milestones early on. So far, so good. Yesterday the company announced it had received two approvals -- one from each side of the Atlantic -- for two different products.

To lead off, European regulators approved the sale of Myozyme, its treatment of a rare disease called Pompe, at its large manufacturing site in Belgium. The company hadn't expected this approval until April, but European officials must have stepped on the gas because supplies have been limited and patients have had to ration the drug.

Before this, the drug had been manufactured in Europe in a 2,000-liter bioreactor, but now the company can sell product made from the new 4,000-liter bioreactor. In the U.S., sales are only authorized from a small, 160-liter bioreactor, which severely limits supply and, of course, sales. The agencies’ concern is that because Myozyme is a biological molecule rather than a relatively simple chemical, different manufacturing scales might produce slightly different product.

Scale-up plans are still on hold in the States. The company is waiting for FDA approval to manufacture Myozyme at a 2,000-liter bioreactor in this country. The agency's goal is to let the company know by tomorrow, but it has been missing a lot of its goals lately, so don’t hold your breath. (Besides, you don't look too good in that shade of blue.) As long as an approval comes fairly soon, though, Genzyme should be able to ramp up supply to meet demand.

With margins on drugs so high, companies can usually stay well ahead of the curve and investors usually don't have to worry about supply constraints. Trucks, like the one containing Biovail (NYSE: BVF) and GlaxoSmithKline's (NYSE: GSK) Wellbutrin XL, do occasionally overturn, but supply constraints aren't usually a major problem. In Myozyme's case, though, it's turned out to be different.

Genzyme's other approval came in the U.S. for its osteoarthritis drug Synvisc-One. The one-injection version of the drug -- as opposed to three injections within six months required by the standard Synvisc -- might help woo patients away from oral pain medications like Pfizer's (NYSE: PFE) Celebrex, Wyeth's (NYSE: WYE) Advil, and Johnson & Johnson's (NYSE: JNJ) Motrin. Of course, this came two months after the PDUFA date, but approval is certainly better than a complete-response letter.

Two approvals in one day is certainly a nice sign of things to come for this high-growth company, and the news should help the company to meet its growth goals for the year.