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BioSpecifics has modified its previously announced agreement to lowerfuture royalties payable on net sales of its injectable collagenase,XIAFLEX(TM), for Peyronie's disease. The Company has taken this strategic stepbecause of the imminent initiation of the Phase 2b clinical trial, lack ofcurrently available desirable therapeutic options for Peyronie's patients, thestrong commitment of the Company's partner Auxilium Pharmaceuticals to pursuethe development for this clinical indication and the results of the threeseparate positive clinical trials published to date.
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BioSpecifics has previously announced that its third party royaltyobligations for Dupuytren's disease are 0.5% of net sales.
Auxilium is obligated to pay low double digit royalties at a flat rate asa percentage of future worldwide net sales for all clinical indications,irrespective of territory, and independent of sales volume. BioSpecifics willalso receive a percentage of non royalty payments (upfront, milestones, etc.)if Auxilium sub-licenses the marketing rights to a third party. In addition,BioSpecifics will receive a certain percentage mark up on cost of goods basedon Auxilium's manufacturing costs.
About Peyronie's Disease
Peyronie's disease is characterized by the presence of a collagen plaqueon the shaft of the penis, which can distort an erection and make intercoursedifficult or impossible in advanced cases. The plaque is not elastic and itdoes not stretch during erection. In some mild cases, the plaque can resolvespontaneously without medical intervention. The most common plaque forms onthe top of the penis causing the penis to arc upward. In severe cases, thepenis can be bent at a 90-degree angle during erection. Significantpsychological distress has been noted in patients with Peyronie's disease whoare sexually active. Frequent patient complaints include increased pain,painful erections, palpable plaque, penile deformity, and erectiledysfunction. Patients with Peyronie's disease have been reported to have anincreased likelihood of having Dupuytren's disease, frozen shoulder, plantarfibromatosis, knuckle pads, hypertension and diabetes. Peyronie's diseasetypically affects males in the range of 40-70 years. The cause of Peyronie'sdisease is unknown, although some investigators have proposed that it may bedue to trauma or an autoimmune component. A number of researchers havesuggested that the incidence of Peyronie's disease has increased due to theuse of erectile dysfunction drugs.
Auxilium Pharmaceuticals has estimated that there are 210,000 potentialcandidates in the US and Europe for XIAFLEX treatment on an annual basis.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that hasdeveloped and licensed injectable collagenase for three clinical indications:Dupuytren's disease, Peyronie's disease and frozen shoulder (adhesivecapsulitis). The positive top line results for the Phase 3 trials onDupuytren's disease have been previously announced. BioSpecifics has adevelopment and licensing agreement with Auxilium Pharmaceuticals, Inc. Moreinformation about the Company may be found on its website atwww.biospecifics.com.
SOURCE BioSpecifics Technologies Corp.
