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Abbott: No Lung-Cancer Signals In Inhaled-Insulin Trials
  Dow Jones April 10, 2008: 01:11 PM EST
Abbott Laboratories (ABT) has seen "no signals of lung cancer" in patient trials of its experimental inhaled insulin, a company spokesman said Thursday.
Abbott's disclosure comes a day after Pfizer Inc. (PFE) warned that a small number of users of its inhaled insulin, Exubera, developed lung cancer, though it wasn't able to determine whether Exubera was the cause. Pfizer decided last year to stop marketing Exubera due to disappointing market performance since it was approved in 2006; the company is working with doctors to switch patients from Exubera to other therapies.
Abbott, Abbott Park, Ill., inherited an early-stage inhaled-insulin development program when it acquired Kos Pharmaceutical in 2006. The product is in the middle stage, or Phase 2, of human testing.
"We've seen no signals of lung cancer in our trials," Abbott spokesman Kurt Ebenhoch told Dow Jones Newswires Thursday.
Pfizer's warning about lung cancer added to the doubts surrounding inhaled insulin, which was once viewed as a promising alternative to injectable insulin for people with diabetes. After Pfizer scrapped Exubera, Indianapolis-based Eli Lilly & Co. (LLY) and Novo Nordisk A/S (NVO) of Denmark each have halted development of inhaled insulin products.
The warning is another blow to the star-crossed Exubera, which was hailed as the only new method of delivering insulin in 80 years when it was approved in 2006.
However, less than two years later, Pfizer, the drug's maker, said it was phasing the drug out because patients and doctors had been slow to accept it
With Exubera, New York-based Pfizer said six of 4,740 users of the product in clinical trials developed lung cancer, versus one of 4,292 non-users in the trials' control arms (incidence, per 100 patient years exposure, 0.13 vs 0.02). In addition, there was a post-marketing report of lung cancer in one Exubera-treated patient. All patients who developed lung cancer had a prior history of cigarette smoking, Pfizer said.
The "Warnings" section update now states that all patients who developed lung cancer had a previous personal history of cigarette smoking. The update also says that there are too few cases to determine whether the development of lung cancer is related to use of inhaled insulin.
"Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials. We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies," Joe Feczko, MD, chief medical officer of Pfizer, said in a press release.
For reasons unrelated to this data, Pfizer said it would stop marketing its inhaled insulin in October. In the meantime, physicians should seek alternative therapies to maintain patientsf glycemic control, because of the limited availability.
Exubera was never without controversy.
Although clinical trials had demonstrated it had efficacy similar to that of short-acting insulins -- but without the need for needles -- there were worries about pulmonary toxicities, and questions about Exubera's ability to achieve a reduction in glycosylated hemoglobin (HbA1c) levels to below 7%, the accepted gold standard.
In its approval statement, the FDA noted that the safety and efficacy of Exubera had been studied in approximately 2,500 adult patients with type 1 and type 2 diabetes.
But "despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians," Pfizer CEO Jeff Kindler said last October, as he announced that the company would stop marketing the medication.
Nektar Therapeutics (NKTR), Pfizer's former partner for Exubera, said Wednesday it would no longer seek a new partner for its inhaled-insulin development programs.
The exits of Pfizer and other companies from the inhaled-insulin field leave Abbott and MannKind Corp. (MNKD) among the few that are still pursuing the concept.
MannKind said Thursday it would continue to develop its inhaled insulin, and it has not observed a higher incidence of lung cancer in patient trials than would be expected in the general population. So far, only one case of lung cancer has been seen in MannKind's trials, Hakan Edstrom, president and chief operating officer, told Dow Jones Newswires Thursday.
MannKind, Valencia, Calif., said an independent panel overseeing safety issues in its clinical trials met Wednesday and concluded that trials could continue. MannKind is testing its product, Technosphere, in late-stage, or Phase 3, trials, and expects to file for U.S. regulatory approval by early 2009, Edstrom said.
However, MannKind has suspended negotiations with potential marketing partners for Technosphere, in light of the uncertainty surrounding inhaled insulin. MannKind indicated that it would be better able to negotiate a partnership for Technosphere with a large pharmaceutical company after Phase 3 results are known.
"We felt that rather than pursuing partnership agreements and discussions in a market that's kind of a little bit under duress, it's better to wait to confirm the very clean safety profile with our product and efficacy we've seen in Phase 2," Edstrom said.
Abbott shares rose 25 cents to $54.12 Thursday. MannKind shares rose 21 cents, or 9%, to $2.57, a day after they plunged 60% on the Exubera news. Nektar rose 38 cents, or 7%, to $5.77, while Pfizer was up 15 cents at $21.04.
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