About BioSpecifics Technologies

BioSpecifics Technologies Corp. operates as a biopharmaceutical company that engages in the development of an injectable collagenase clostridium histolyticum (CCH) for multiple indications. The company maintains intellectual property with respect to injectable CCH that treats, among other indications, Dupuytren’s contracture (DC), Peyronie’s disease (PD), frozen shoulder syndrome, and uterine fibroids. Injectable CCH is approved and marketed in the U.S. under the trademark XIAFLEX for the treatment of both DC and PD. The company generates revenue primarily from its license agreement with Endo International plc (Endo). The company has developed injectable CCH for 12 clinical indications to date. It is evaluating CCH as a treatment for uterine fibroids. Under its license agreement with Endo, Endo has the right to further develop CCH for frozen shoulder and plantar fibromatosis, as well as certain other licensed indications. Endo has a right to opt-in for use of CCH in the treatment of uterine fibroids. Endo-Marketed Indications DC CCH is approved and marketed in the U.S. under the trademark XIAFLEX for the treatment of DC. XIAFLEX is indicated for the treatment of adult patients with DC with an abnormal buildup of collagen in the hands, which limits or disables hand function. XIAFLEX is the drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of DC. PD XIAFLEX is approved in the U.S. for the treatment of PD. In 2013, the FDA approved the supplemental biologics license application submitted by Auxilium for XIAFLEX. This is the FDA-approved biologic therapy indicated for the treatment of PD in men with a palpable plaque and a curvature of 30 degrees or greater at the start of therapy. Frozen Shoulder (Adhesive Capsulitis) In 2015, Endo provided an update on the results of the Phase 2b study without releasing all of the data. In early 2020, Endo announced that it initiated development programs of XIAFLEX for the treatment of adhesive capsulitis. Plantar Fibromatosis In early 2020, Endo announced that it initiated development programs of XIAFLEX for the treatment of plantar fibromatosis. Other Indications In 2018, the company announced positive topline data from its Phase 1 trial of CCH for the treatment of uterine fibroids. The company is analyzing the full Phase 1 data to guide the design of potential future studies of CCH for the treatment of uterine fibroids. Agreements The company has a license agreement with the Research Foundation of the State University of New York, pursuant to which the Research Foundation granted to it and its affiliates a e license, with the right to sublicense to certain third parties, the know-how owned by the Research Foundation related to the development, manufacture, use or sale of the collagenase enzyme obtained by a fermentation and purification process (the Enzyme), and all pharmaceutical products containing CCH or injectable collagenase, in each case to the extent it pertains to the treatment and prevention of Dupuytren’s disease. The company has the license agreement with the Research Foundation, pursuant to which the Research Foundation granted to the company and its affiliates an exclusive worldwide license, with the right to sublicense to certain third parties, the know-how owned by the Research Foundation related to the manufacture, preparation, formulation, use or development of CCH and all pharmaceutical products containing CCH, which are made, used and sold for the prevention or treatment of cellulite. Additionally, the Research Foundation granted to it an exclusive license to the patent applications in respect of cellulite. The company has a license agreement with the Research Foundation, pursuant to which the Research Foundation granted to it and its affiliates an exclusive worldwide license, with the right to sublicense to certain third parties, the know-how owned by the Research Foundation related to the development, manufacture, use or sale of CCH and all pharmaceutical products containing CCH or injectable collagenase, in each case to the extent it pertains to the treatment and prevention of frozen shoulder. The company has in-licensing and royalty agreement with Dr. Zachary Gerut, pursuant to which, Dr. Gerut granted to it and its affiliates an exclusive worldwide license, with the right to sublicense to certain third parties the know-how owned by Dr. Gerut related to the manufacture, preparation, formulation, use or development of CCH and all pharmaceutical products containing CCH or injectable collagenase, in each case to the extent it pertains to the removal or treatment of fat. Research and Development The company’s research and development expenses were $0.6 million for the year ended December 31, 2019. Intellectual Property and Rights Patents The company is the assignee or licensee of various U.S. patents, which have also been issued as patents in various foreign countries. Pursuant to its August 31, 2011 settlement agreement with Auxilium, the company is co-owners of U.S. Patent No. 7,811,560, entitled Compositions and Methods for Treating Collagen-Mediated Diseases, a patent relevant to XIAFLEX, sold by Endo as a treatment for DC and PD. The company also has an issued patent directed to a method of fermenting Clostridium histolyticum to obtain collagenase, namely U.S. Patent No. 10,119,131, issued November 6, 2018 (expiration September 9, 2032). Orphan Drug Designations Two indications, DC and PD, have received orphan drug designation from the OOPD. These indications did not receive the European equivalent of orphan drug designation. Public Health Service Act and Biologics Price Competition and Innovation Act XIAFLEX is regulated and marketed as a biologic product pursuant to biologics license applications. The company and its partner’s other product candidates would also be regulated and marketed as biologic products pursuant to a biologics license application. XIAFLEX was licensed based on a determination by the FDA of safety, purity, and potency as required under the PHSA. History BioSpecifics Technologies Corp. was founded in 1957. The company was incorporated in Delaware in 1990.