LEXINGTON, Mass., June 4 Indevus Pharmaceuticals, Inc.(Nasdaq: IDEV) today announced that based on a recent discussion with the U.S.Food and Drug Administration (FDA) regarding the NDA filing for NEBIDO(R), theCompany expects the FDA to formally request that the Company provideadditional safety data prior to approving NEBIDO. The Company currentlybelieves that an additional study will be required in order to supply thenecessary data. The Company expects to re-file for approval of NEBIDO inapproximately 18 months followed by a 6 month FDA review. The Company willfinalize the requirements and initiate the study following the receipt offormal communication from the FDA which the Company expects to receive by theoriginal June 27, 2008 PDUFA date.
The Company believes the requirement for additional data relates to areaction immediately following the injection and is a known rare complicationof oil-based depot injections. The reaction is believed to be the result of asmall amount of the oily solution immediately entering the vascular systemfrom the injection site and may be due to improper injection technique. Thephenomenon is characterized by short-term reactions involving an urge tocough, coughing episodes or a shortness of breath. In rare cases the reactionhas been classified as serious or the patient experiences other symptoms suchas dizziness, flushing or fainting.
The Company believes that the FDA's safety concern is derived fromspontaneous post-marketing adverse event reports of the NEBIDO 1000 mg (4ml)dose. In the Indevus U.S. clinical trials, which included a total ofapproximately 500 patients, there was a single, non-serious, instance of thisphenomenon with the 750 mg (3ml) dosage of NEBIDO. The patient did not requiremedical intervention and the event resolved without issue within 10 minutes.This patient has continued to receive regular injections without furtherincident. Because estimations of the true frequency of these events aredifficult to determine from post-marketing reports on patients having receivedthe 1000 mg (4ml) NEBIDO dose, FDA has asked for new data to more preciselycalculate the incidence of the occurrence prospectively, as well as methods orprocedures to mitigate the incidence with the 750 mg (3ml) dosage.
Glenn L. Cooper, M.D., chairman and chief executive officer of Indevusstated, "We are very surprised and disappointed by the position the FDA istaking regarding the safety profile of NEBIDO given the large Europeanexperience. Rare coughing reactions have been well-described in the Europeanproduct labeling of NEBIDO. We believe the information available on thesecases indicates these reactions resolved without consequences and that ourproposed labeling for NEBIDO in the U.S. adequately addressed this issue. Weintend to vigorously pursue the approval of NEBIDO and will allocate theresources necessary to conduct an additional study to satisfy the concerns ofthe FDA. From our verbal discussion with the FDA, we are not aware of anyother approvability issues."
Dr. Cooper continued, "Despite this disappointment we remain committed toour strategic direction. VANTAS(R) and SUPPRELIN(R) LA are both growingfranchises that we will devote additional effort to promoting and we intend toextend our SANCTURA XR(TM) sales force co-promotion agreement with Allergan bythe full six months available to us. In addition, this summer we anticipatereceiving approval to launch VALSTAR(TM) for bladder cancer and intend toinitiate the Phase III clinical program for our octreotide implant with ananticipated 2010 launch date for acromegaly. We will also continue toaggressively pursue business development opportunities."
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical companyengaged in the acquisition, development and commercialization of products totreat conditions in urology and endocrin