Mylan Laboratories’ share price rose almost 6% on the New York Stock Exchange yesterday after the US Food and Drug Administration said that the company’s anti-hypertensive, nebivolol, was “approvable.” In a statement, Mylan said that final approval was contingent upon successfully satisfying additional FDA requirements regarding certain aspects of the pre-clinical data, as well as finalising the product’s label.
Nebivolol was originally filed with the FDA in April last year. The pre-clinical data submitted as part of the dossier were based on studies previously conducted by Janssen Pharmaceutica (currently Johnson & Johnson Pharmaceutical Research and Development), the company from whom Mylan licensed the US and Canadian rights to the product. Mylan says it is currently conducting a pre-clinical study designed to address questions posed by the FDA. “We believe that the data from the ongoing pre-clinical study will satisfactorily resolve the FDA’s questions,” said Mylan’s chief scientific officer, John O’Donnell. “We will be responding to the FDA in an expeditious manner to move forward with the hypertension approval process,” he added.
Chief executive, Robert Coury, heralded the approvable letter “an extremely important milestone” for the company.
- Meanwhile, in another piece of good news for the company, billionaire investor, Carl Icahn, has dropped a lawsuit against Mylan and company investor, Richard Perry. The lawsuit, which he filed late last year [[14/12/04b]], accused Mylan’s chief executive, Robert Coury, and other unnamed investors of allowing Mr Perry to buy a large tranche of shares and wrest the title of Mylan’s largest shareholder through a process known as “hedging.”
The filing of the lawsuit was just one move Mr Icahn took in a bid to derail Mylan’s proposed merger with King Pharmaceuticals, which he opposed from the outset.
On February 28, Mylan and King announced that they had terminated merger talks [[28/02/05b]], and Mr Icahn dismissed his lawsuit after it was confirmed that the Perry Corporation “does not beneficially own any shares of common stock of Mylan… has no right to vote any shares of Mylan common stock; and has no current intention to acquire any shares of Mylan common stock.”