Biotechnology company Alkermes said earlier in the day that  it expected Lilly to drop out of their program to develop an  inhaled insulin treatment for diabetes, sending Alkermes shares  down more than 9 percent. Lilly’s decision marks the third setback in recent months  for inhaled insulin formulations, once deemed potential  blockbuster products because of their greater convenience than  standard injectable insulin. Cambridge, Massachusetts-based Alkermes, which makes the  alcohol addiction drug Vivitrol, said Lilly has the right to  terminate its license to the inhaled treatment, Air Insulin, at  its discretion. “While Lilly may elect not to commercialize Air Insulin,  Alkermes believes that the phase 3 safety and efficacy trials  should be completed,” Alkermes said in a statement. After Lilly’s announcement, the company said it was  evaluating the impact of the termination, which will become  effective in 90 days. Indianapolis-based Lilly said its decision was not due to  safety concerns, “but rather was a result of increasing  uncertainties in the regulatory environment, and a thorough  evaluation of the evolving commercial and clinical potential of  the product compared to existing medical therapies.”    Lilly Chief Operating Officer John Lechleiter said in a  statement that the company is beginning the process of halting  ongoing clinical studies. Lilly said it will record a first-quarter 2008 charge of  around $90 million to $120 million, or 5 cents to 7 cents per  share. The company said its adjusted earnings per share outlook  remains unchanged at $3.85 to $4.00, while net earnings will  range from $3.73 to $3.90. Lilly’s action comes just five months after Pfizer Inc  abandoned Exubera, the first approved inhaled form of insulin,  and returned rights to the product to longtime partner Nektar  Therapeutics. Exubera had dismal sales because patients were turned off  by the clumsy device used to administer the powdered insulin  and because doctors were concerned by the drug’s tendency to  slightly impair lung function. Alkermes Chairman Richard Pops, in an interview with  Reuters in October, said Air Insulin may have similar effects  on lung function. “We’re assuming that pulmonary insulins in that regard are  all pretty much the same,” he said, although a conclusive  picture of Air Insulin’s safety will not emerge until two-year  safety trials of the product end later this year. A second setback for inhaled insulin came in January, when  Novo Nordisk said it was halting development of its AERx  product, meant to deliver inhaled droplets. The Danish  drugmaker said AERx did not have adequate sales potential,  given the limited commercial success seen with Exubera. Morgan Stanley analyst Jami Rubin said on Friday Lilly’s  abandonment of AIR Insulin made good business sense. “We are not (at) all surprised, and have never been strong  advocates of the pulmonary insulin agents, following the poor  launch and ultimate demise of Pfizer and Nektar’s Exubera and  Novo Nordisk’s termination of its AERx program,” Rubin said in  a research note. Rubin said Alkermes, known for its drug-delivery  technology, is unlikely to continue development of Air Insulin  without Lilly, “given that this represents the third  termination of a pulmonary insulin drug.”    But she said the sharp drop in Alkermes shares represented  a buying opportunity for investors because Air Insulin had only  paltry sales potential. She said investors should be focused instead on another  product Alkermes is developing with Lilly: a long-acting  formulation of Lilly’s Byetta diabetes treatment called Byetta    “We estimate that Byetta LAR could be worth $11 to $12 for  the (Alkermes) stock,” Ryan said. Alkermes shares fell $1.14 to close at $11.26 on Nasdaq. Lilly, a far larger company with an array of big-selling  products, rose 2 cents to end at $49.70 on the New York Stock  Exchange, and was slightly lower at $49.67 in after-hours  trading.
Eli Lilly drops inhaled insulin program.