MannKind says Rival's woes won't hurt its efforts; officials say they use different type of insulin.Officials for Valencia-based pharmaceutical maker MannKind Corp., which has spent at least $650 million over the past decade developing an inhalable insulin Inhalable insulin is a new (as of mid-2006) method of delivering insulin, a drug used in the treatment of diabetes, to the body. It is the first new treatment option of insulin since the discovery of insulin in 1921[1], traditionally administered by subcutaneous injection. product called Technosphere, said they are not concerned after safety issues were raised this month about a similar product by Pfizer Pharmaceutical Co. Doctors late last month voiced concerns about the long-term effects of Exubera, an inhalable insulin developed by Nektar Therapeutics and marketed by Pfizer. The device, in which insulin is delivered in a powder form through a handheld pump, received Food and Drug Administration approval in early 2006. A year later, however, some research found the product caused a small decrease in lung capacity, triggering the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to ask Pfizer to complete additional tests and issue a warning that smokers, young children and asthmatic patients avoid the drag altogether. For MannKind, which Pfizer beat to the insulin starting gate starting gate n. Sports 1. A series of stalls with interconnected doors that open simultaneously at the beginning of a race. 2. a year ago, that warning would seem like a major obstacle, since Technosphere uses the same type of flashlight-like device. But company officials for MannKind are quick to point out that Technosphere uses a completely different type of insulin, one that has not shown to cause any lung issues. "Based on trials, there's been no issue on the pulmonary side," said Julie Huang, a company spokeswoman. She pointed to a study released in September showing inhaled in·hale v. in·haled, in·hal·ing, in·hales v.tr. 1. To draw (air or smoke, for example) into the lungs by breathing; inspire. 2. insulin patients with Type 2 diabetes type 2 diabetes n. See diabetes mellitus. achieved similar improvements as an injected, rapid-acting insulin program. That doesn't mean that MannKind isn't paying attention Noun 1. paying attention - paying particular notice (as to children or helpless people); "his attentiveness to her wishes"; "he spends without heed to the consequences" attentiveness, heed, regard to its chief rival, she said. "It would be prudent for our company to learn from Exubera," Huang said, who added that the company has not been told by the FDA to do more tests. Still, the safety issue raises other longstanding concerns that Technosphere is still the lead product under development by MannKind. The product is resulting in MannKind's cash burn to add up: earlier this month the company reported fourth-quarter losses increased to $71.3 million from $33.3 million a year ago. Research and development costs also doubled to nearly $60 million, which the company credited to expanded clinical development of Technosphere. The other worry is that the product is still at least three years away from hitting the shelves. By then, the insulin market could be vastly different; already two other inhalable insulin products, by Eli Lilly Eli Lilly can refer to:
"It's a crowded market," said Grant Zeng, who follows MannKind for Zacks Investment Research Zacks Investment Research A firm that compiles earnings estimates and brokerage firm investment recommendations for thousands of publicly traded firms. in Chicago. Even though pharmaceuticals is a hot industry and Technosphere is in the pipeline, Zeng and other analysts are waving off investors from MannKind. It's too dicey, he says. "It's only in the test trials," he said. "I think the stock is risky at this point. If something goes wrong with the product, Mannkind could suffer. It's a weak line." Staff Reporter Chris Coates can be reached at (818) 316-3124 or ccoates@sfvbj.com. BY CHRIS COATES Staff Reporter |
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