Despite long-standing jokes about the poor handwriting of doctors, the U.S. Food and Drug Administration takes the situation seriously enough that it forced a local drug maker to rename its leading drug candidate.
MannKind Corp. changed the name of its innovative inhaled insulin Alfresa, which is under review by the FDA. The agency was concerned that pharmacists might confuse a prescription for the drug with another brand of insulin: Sanofi Aventis’ Apidra, which unlike Alfresa is administered by injection.
Given the recognition that Alfresa had already developed since the name was introduced more than a year ago, executives at the Valencia biotech weren’t pleased. But they came up with what they thought was the most palatable response: a near homophone – a name that is spelled differently but sounds the same. Meet Afrezza, a name announced this month a few days before an investor conference in San Francisco.
Unfortunately, the new name isn’t likely to get the insulin treatment – which combines a fast-acting insulin with a primary inhaler – approved any sooner. The FDA told the company Jan. 8 that it was running late in inspecting a contract lab that MannKind hopes can supply the insulin.
On the bright side, MannKind hadn’t spent a bunch of money plastering Alfresa over product materials. And Chief Scientific Officer Peter Richardson reported that the company’s billionaire founder, Chief Executive Al Mann, isn’t particularly distressed by the name change.
“Mr. Mann likes the Z’s very much,” Richardson said.
Obagi Sued by Founder
Celebrity dermatologist Dr. Zein Obagi is having an ugly split with the company he founded but no longer runs, Obagi Medical Products Inc.
ZO Skin Health, a second company Obagi founded, has filed a lawsuit, accusing the Long Beach company of engaging in anti-competitive practices that have hurt ZO.
Obagi Medical, a public company that sells specialized skin-care products prescribed after cosmetic surgery and other skin procedures, said last week that it was studying the complaint and intends to defend itself vigorously.
Obagi founded the company that later became Obagi Medical Products in 1988 to market products he had developed in his Beverly Hills practice. In 1997, he sold a controlling share in the company to outside investors, primarily a private equity firm called Stonington Partners. He is still its second largest individual shareholder.
Obagi then began work on a high-quality skin line for the general public. The idea was that patients who no longer need Obagi Medical’s physician-supplied products could transition to ZO’s over-the-counter line.
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