Das Diabetes-Medikament kommt in den nächsten Tagen und könnte PFE über 25 USD hieven. Zurzeit steht PFE wegen Schwäche im Pharma-Sektor (JNJ-Zahlen, s. 0.) bei 24,79. Exubera soll in den nächsten 5 Jahren bis zu 1 Mrd. Umsatz generieren. Viele andere Firmen entwickeln allerdings vergleichbare Konkurrenzprodukte. Hier könnte Pfizer den Vorteil des "first movers" erhalten - aber nur, wenn die FDA am Freitag mitspielt.
FDA expected to rule on Exubera
By Val Brickates Kennedy, MarketWatch Last Update: 7:58 AM ET Jan. 24, 2006
§ BOSTON (MarketWatch) -- The Food and Drug Administration is expected in coming days to grant at least tentative approval to Pfizer Inc.'s inhalable insulin, analysts said Monday.
The regulatory agency had been scheduled last October to decide on Exubera, the first drug of its kind, but then told Pfizer (PFE) and its partner Nektar Therapeutics (NKTR) it would take an additional three months to study the product.
Its new deadline is Saturday, which means the decision will likely come on Friday or possibly the following Monday, analysts said.
If approved, Exubera would be launched during the second half of 2006, reaching peak sales of over $1 billion in about five years, according to Oppenheimer & Co.
Most Pfizer watchers believe that the FDA will either approve Exubera outright or at least grant it an "approvable" letter. Such a letter means the agency believes the drug is worthy of approval, but that the company either has to supply more data or work on its labeling before the FDA will allow it on the market.
Analysts believe a key issue for Exubera would be with labeling, such as instructions on how it should be used and by whom.
"Generally, people think it will get an approvable letter," said Scott Henry, an Oppenheimer & Co. analyst. "An unapprovable letter is unlikely."
In September, an FDA advisory panel voted to approve Exubera for the treatment of type 1 and type 2 diabetes. Although that vote was nonbinding, the full FDA generally goes with the recommendations of its expert panels.
Deutsche Bank's Barbara Ryan said the FDA's delay on issuing a ruling is probably due to the product's unusually complicated application, as the product consists of both a new drug formulation and a new device.
Exubera uses a powdered form of the hormone insulin that is delivered into the lungs via a portable inhaler. Like injected insulin, the drug would need to be taken several times a day.
Ryan said the FDA is likely to issue an approvable letter contingent on labeling, adding that she doesn't believe decision will come before Friday.
On Jan. 13, Pfizer announced it had bought out former partner Sanofi-Aventis' (SNY) rights to Exubera, a move that some interpreted as Pfizer's confidence in the drug winning approval. The buyout also calls for Pfizer to assume ownership of an insulin production plant in Frankfurt, Germany.
If approved, Exubera will be the first inhaled version of insulin to reach the market, an innovation that many diabetes specialists say will encourage more diabetics to take the life-sustaining drug. Currently, insulin is administered by needle up to several times a day, a regimen that is cumbersome and somewhat painful.
Several other companies are also developing inhaled insulin products, though none are as far along in their development as Pfizer's and Nektar's.
Eli Lilly (LLY) have a late-stage product in development, as does European drugmaker Novo Nordisk with Aradigm (ARDMD). Valencia, Calif.-based Mannkind (MNKD), meanwhile, has a product in Phase III clinical trials.
Val Brickates Kennedy is a reporter for MarketWatch in Boston.
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