Enzon Pharmaceuticals, Inc. engages in licensing arrangements with other companies primarily related to sales of its marketed drug products. Royalties The company receives royalty revenues from existing licensing arrangements with other companies primarily related to sales of four marketed drug products, including, PegIntron, Sylatron, Macugen, and CIMZIA. It also had previously received royalty revenues from licensing arrangement related to sales of Oncaspar and Adagen until its rights to receive royalties on sales of these products expired in 2014. In addition, the company’s rights to receive royalties on sales of Macugen and CIMZIA expired in the U.S. and Great Britain in 2014. The primary source of its royalty revenues is sales of PegIntron, which is marketed by Merck & Co., Inc. (Merck). The company currently has no clinical operations and limited corporate operations. PegIntron is a PEG-enhanced version of Merck’s alpha interferon product, INTRON A, which is used both as a monotherapy and in combination with REBETOL (ribavirin) capsules for the treatment of chronic hepatitis C. Merck holds an exclusive worldwide license to PegIntron. The company is entitled to receive royalties on Merck’s worldwide sales of PegIntron until certain expiration dates set forth in the license agreement which are expected to occur in 2016 in the U.S., 2018 in Europe and 2019 in Japan. Merck is responsible for all manufacturing, marketing, and development activities for PegIntron. The company designed PegIntron to allow for less frequent dosing and to yield greater efficacy, as compared to INTRON A. In March 2011, the United States Food and Drug Administration (FDA) approved peginterferon alfa-2b (Sylatron) to treat melanoma with nodal involvement after surgical resection. In December 2013, FDA approved Gilead’s Sovaldi (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Sovaldi was approved in combination with peg-interferon alpha and ribavirin for genotype 1 and 4 patients, and in combination with ribavirin for genotype 2 and 3 patients. In January 2014, the European Commission granted marketing authorization for Sovaldi. In October 2014, the FDA approved Gilead’s Harvoni (ledipasvir/sofosbuvir), the first once-daily single tablet regimen for the treatment of genotype 1 chronic hepatitis C infection, eliminating the need for interferon and ribavirin. In November 2014, the European Commission granted marketing authorization for Harvoni. In December 2014, the FDA approved Abbvie’s all-oral treatment for hepatitis C, and in January 2015, the European Commission granted marketing authorization for this treatment. Furthermore, there are various other novel agents in various stages of preclinical and clinical development for the treatment of hepatitis C, which either include or eliminate combination with pegylated interferon. The company has out-licensed its proprietary PEGylation and single-chain antibody (SCA), technologies on its own and through agreements with Nektar and Micromet AG (Micromet). Micromet was acquired by Amgen in 2012. Under its Cross-License and Option Agreement with Nektar, Nektar had the lead role in granting sublicenses for certain of its PEGylation patents and it receives royalties on sales of any approved product for which a sublicense has been granted. Effective in January 2007, Nektar’s right to grant additional sublicenses is limited to a certain class of PEGylation patents. Existing sublicenses granted by Nektar prior to January 2007 were unaffected by this change in Nektar’s rights. The company’s U.S. rights to receive royalties under its agreement with Nektar relating to CIMZIA, Macugen and OMONTYS expired in 2014. Competition PegIntron, marketed by Merck, competes directly with Hoffmann-La Roche’s PEGASYS. History Enzon Pharmaceuticals, Inc. was founded in 1981.
enzon pharmaceuticals inc
(ENZN:OTC Markets Group Inc - Prime QX)
20 Commerce Drive
Cranford, NJ 07016
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