Key Developments For Endo Pharmaceuticals Holdings Inc
Endo Pharmaceuticals Holdings Inc (ENDP.O) (Nasdaq)
Endo Pharmaceuticals Holdings Inc. And LecTec Corporation Settle Patent Dispute
Endo Pharmaceuticals Holdings Inc. announced that it has reached a settlement with LecTec Corporation on outstanding patent litigation related to LecTec's U.S. Patent Nos. 5,536,263 and 5,741,510. Endo Pharmaceuticals has agreed to make a one-time, $23 million payment for the exclusive license to these two patents for use in the field of prescription pain medicines and treatment.
Endo Pharmaceuticals Holdings Inc. Raises FY 2009 Guidance
Endo Pharmaceuticals Holdings Inc. raised its fiscal 2009 guidance and expects total revenues to be between $1.440 billion and $1.465 billion, adjusted diluted earnings per share (EPS) are projected to be between $2.67 and $2.73. he company also now estimates reported (GAAP) EPS to be between $1.41 and $1.47, and this EPS increase is primarily due to changes in the fair value of contingent consideration associated with the Indevus transaction partially offset by the addition of milestone payments associated with the company's recent deal with ProStrakan to in-license FORTESTA. According to Reuters Estimates, analysts are expecting the Company to report EPS of $2.71 on revenues of $1.447 billion for the same period.
Endo Pharmaceuticals Holdings Inc. Gives Update on Regulatory Status of FORTESTA
Endo Pharmaceuticals Holdings Inc. announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for FORTESTA (testosterone) 2% Gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.
Endo Pharmaceuticals Holdings Inc. Introduces VALSTAR To Fill Unmet Need In Aggressive Form Of Bladder Cancer
Endo Pharmaceuticals Holdings Inc. announced the availability of VALSTAR (valrubicin) for the treatment of a distinct form of bladder cancer. VALSTAR represents a new treatment option for these patients who may otherwise have exhausted all other FDA-approved treatment alternatives, including BCG.
Endo Pharmaceuticals Holdings Inc. To Partner With ProStrakan Group Plc To Commercialize FORTESTA In U.S.
Endo Pharmaceuticals Holdings Inc. announced that it has signed an agreement with ProStrakan Group Plc for the exclusive right to commercialize FORTESTA (testosterone gel) 2% in the United States. FORTESTA, a patented 2% testosterone transdermal gel for testosterone replacement therapy in male hypogonadism, utilizes a metered dose delivery system designed to permit accurate dose adjustment to individual patient requirements. This product is in registration in the U.S., where the Food and Drug Administration (FDA) is currently reviewing ProStrakan's New Drug Application submission. Under the terms of the agreement, Endo Pharmaceuticals has agreed to make an upfront payment to ProStrakan of $10 million, with the potential for up to $40 million more in milestone payments by the end of 2010 for regulatory approval and the achievement of certain commercial milestones. Endo Pharmaceuticals has also agreed to pay ProStrakan an additional $160 million upon the achievement of certain sales targets. ProStrakan will exclusively supply FORTESTA to Endo Pharmaceuticals in the U.S. for an undisclosed supply price.
