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MYL Mylan NV

15.855
0.00 (0.00%)
24 May 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Mylan NV NASDAQ:MYL NASDAQ Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 15.855 15.71 15.90 0 01:00:00

Mylan CEO Stands By Earlier FDA Inspection Statement

30/07/2009 3:13pm

Dow Jones News


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Mylan Inc. (MYL) Chief Executive Robert Coury said that the generic drug maker stands by its Tuesday statement that a Food and Drug Administration inspection determined that reported quality control issues at a West Virginia plant were unfounded.

In an terse statement at the beginning of the Pittsburgh company's second-quarter conference call, Coury implied that unspecified parties were attempting to use the controversy to move the stock price and create problems with regulators.

"There are some outside the company who attempt to speak on behalf of Mylan to the point that statements being made were purposely being mischaracterized in an attempt to further insight the overreaction that we witnessed earlier in the week and even to go so far as to attempt to pit us against the regulatory agency," Coury said.

He said the company wouldn't answer any additional questions on the issue, and it was unclear who the accusations were targeting.

Mylan's stock plummeted 13% to $12.10 on Monday but then rose as high as 10.5% on Tuesday in the wake of the company's statement about the FDA inspection. The FDA subsequently disclosed that the investigation into the issues is ongoing and "statements to the contrary are untrue."

Shares were recently up 4.6% to $13.50 shortly after the market open following a report of strong second-quarter results and increased 2009 expectations.

About 24% of Mylan's float is sold short, meaning those shareholders expect the stock price to decline, which can add to price volatility.

In the call, Coury said Mylan respects the FDA's "independent processes and appreciate their speed and diligence."

On Sunday, the Pittsburgh Post-Gazette reported that Mylan had launched an internal probe to investigate whether workers at the plant had been routinely overriding computer-generated warnings about the drugs being produced at the plant. The newspaper cited an internal report and had other experts review the report and call it a significant problem.

Coury blasted the reporting in that article as "highly irresponsible" and "sensational" that containing allegations that were "false, misleading and unfounded."

He also stressed the company's 48-year reputation of manufacturing quality, a factor that many on Wall Street have stressed in recent days.

Analyst Corey Davis with Natixis Bleichroeder stressed that Mylan has only one product recall since 2005, compared to 19 from Teva Pharmaceutical Industries Ltd. (TEVA), the world's biggest generic drug maker.

Several analysts hypothesized that the mix-up came from a communication breakdown between the local inspector, who may have made comments to company officials, and the official FDA assessment of the investigation as a whole.

Coury have weight to that scenario, saying that the FDA's inspection Monday ended with a "closeout meeting" and the agency didn't issue a Form 483, which covers any findings in an inspection.

"You can rest assured that the quality of our products was never, ever compromised in any way," he said.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com

 
 

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