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.
Obagi alleges in the lawsuit filed in Los Angeles County Superior Court that he approached Obagi Medical to see if it wanted to market ZO’s products, but instead of negotiating in good faith. the company employed delaying tactics and intimidated other potential marketing partners. He even accuses it of blocking ZO’s sale to a Japanese drug company in the fall.
Obagi said ZO and Obagi Medical would have made good partners.
“This line represents a whole new philosophy for consumer skin-care products and it does not compete with the medical products that Obagi (Medical) makes,” he told the Business Journal.
As animal rights advocates have made progress in restricting the use of animals to test products for side effects, drug and cosmetic companies have stepped up their search for effective laboratory alternatives.
Now, Beverly Hills biotech Hurel Corp. and one of its corporate research partners, French cosmetics giant L’Oreal, said they have reached an important milestone for a technology that should make animal testing less important.
The technology, called Allergy Test on a Chip, involves an array of small laboratory dishes, called biochips, that contain modified cells from human organs. The biochips are connected so fluids can flow between them much as fluids flow through the human body. The chips are then tested for allergic reactions.
“Allergy Test on a Chip, if globally adopted, may dramatically reduce the use of animal tests in safety evaluation,” said Chief Executive Robert Freedman, an L.A. resident who founded Hurel in 2005 with his own and private equity money.
Hurel is working on another version of the technology with drugmaker Merck & Co. Inc. Freedman said live animal testing is a $4 billion industry yet to be tapped by such technologies.
Staff reporter Deborah Crowe can be reached at email@example.com or at (323) 549-5225, ext. 232.
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