Enzon Announces Schering-Plough In-Licensing Agreement With Roche Resolving Peginterferon Patent Disputes.Business & Health Editors PISCATAWAY, N.J--(BUSINESS WIRE)--Aug. 13, 2001 Enzon, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ENZN) announced today that Schering-Plough (NYSE NYSE See: New York Stock Exchange :SGP SGP Singapore (ISO Country code) SGP Schering-Plough (stock symbol) SGP Stability and Growth Pact SGP Southern Great Plains SGP Staatkundig Gereformeerde Partij SGP Speedway Grand Prix ) has reported that it has entered into a licensing agreement with F.Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., (Roche) that settles all patent disputes relative to the two companies' respective peginterferon products. The agreement provides for each company to manufacture and market worldwide its peginterferon products free from liability for infringement under the other's existing patent rights. Under the agreement, Schering-Plough and Roche will seek court dismissal of all patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. in the United States and Europe involving the two companies' respective peginterferon products. In addition, opposition to Roche's European peginterferon patent, filed by both Schering-Plough and Enzon, and currently pending in the European Patent Office, will be withdrawn. Under terms of the agreement, Schering-Plough and Roche will cross license to each other all patents applicable to their pegylated alpha interferon products, PEG-INTRON(TM) (peginterferon alfa-2b) and PEGASYS (peginterferon alfa-2a), respectively. In addition, each party will license to the other its patents applicable to peginterferon as combination therapy with ribavirin ribavirin /ri·ba·vi·rin/ (ri?bah-vi´rin) a broad-spectrum antiviral used in the treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants; also used in conjunction with interferon . The settlement agreement also includes a Schering-Plough sublicense of Enzon's branched PEG patents (among others) to Roche. The sublicense of Enzon patents pertains only to pegylated versions of alpha interferon. Consequently, Enzon has agreed to dismiss the patent infringement lawsuit it filed in September 2000 against Roche asserting that PEGASYS infringes Enzon's branched PEG patents. However, Enzon will continue to prosecute the patent infringement lawsuit it filed in December 1998, against Shearwater shearwater, common name for members of the family Procellariidae, gull-like sea birds related to the petrel and the albatross and including the fulmar. Shearwaters are found on unfrozen saltwaters all over the world, with 35 species in North America. Polymers Inc. for infringement of Enzon's branched PEG patents based upon Shearwater's making, using, and selling branched PEG reagents to parties other than Roche solely with regard to Roche's peginterferon product, PEGASYS. In a June 1999 amendment to Enzon's PEG-INTRON licensing agreement with Schering-Plough, Enzon had granted Schering-Plough a non-exclusive worldwide license, with a limited right to sublicense, under Enzon's branched PEG patents in exchange for an increased royalty rate on Schering-Plough's sales of PEG-INTRON. The PEG-INTRON licensing agreement entitles Enzon to royalties on worldwide sales of PEG-INTRON. In addition, Schering-Plough will cooperate should Roche wish to acquire a license from ICN ICN International Council of Nurses. Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif., under patent rights to oral ribavirin for use in combination with Roche's peginterferon product. Currently, Schering-Plough has exclusive license rights under ICN's patents through a previous licensing agreement with ICN. Financial terms of the agreement are not being disclosed. The agreement is subject to the courts' dismissal of the relevant lawsuits. PEG-INTRON is a longer-acting form of INTRON Intron In split genes, a portion that is included in ribonucleic acid (RNA) transcripts but is removed from within a transcript during RNA processing and is rapidly degraded. (R) A (interferon alfa-2b, recombinant) Injection that uses proprietary PEG technology developed by Enzon. PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy designed to optimize the balance between antiviral activity and elimination half-life. Schering-Plough holds an exclusive worldwide license to PEG-INTRON granted by Enzon. Enzon is a biopharmaceutical company developing advanced therapeutics for life-threatening diseases through the application of its proprietary drug delivery and targeting technologies, PEG Modification, Pro Drug/Transport technology and Single-Chain Antigen-Binding(SCA (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. (R)) protein technology. Three products are currently marketed which utilize Enzon's technology: PEG-INTRON marketed by Schering-Plough for hepatitis C, ONCASPAR(R) for Acute Lymphoblastic Leukemia acute lymphoblastic leukemia n. Abbr. ALL Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic leukemia. (ALL), and ADAGEN(R) a treatment for a form of Severe Combined Immunodeficiency Disease Noun 1. severe combined immunodeficiency disease - a congenital disease affecting T cells that can result from a mutation in any one of several different genes; children with it are susceptible to infectious disease; if untreated it is lethal within the first year or (SCID SCID severe combined immunodeficiency (disease); see under immunodeficiency. SCID abbr. severe combined immunodeficiency SCID severe combined immunodeficiency disease. ), commonly known as the "Bubble Boy Disease." In addition to three approved products, Enzon has several products in various stages of clinical development by itself and with partners, including additional indications for PEG-INTRON with Schering-Plough. A Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the is being conducted for PEG-INTRON for the treatment of malignant melanoma. Enzon develops and markets products on its own and through strategic alliances, which in addition to Schering-Plough Corporation, include Alexion Pharmaceuticals, Inc., Baxter Healthcare Corporation, Bristol-Myers Squibb Company, Eli Lilly & Company, and Aventis. Except for the historical information herein, the matters discussed in this news release include forward-looking statements that may involve a number of risks and uncertainties. Actual results may vary significantly based upon a number of factors which are described in the Company's Form 10-K/A, Form 10-Q's and Form 8-Ks on file with the SEC, including without limitation, risks in obtaining and maintaining regulatory approval for indications and expanded indications, market acceptance of and continuing demand for Enzon's products and the impact of competitive products and pricing. This release is also available at http://www.enzon.com |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion