Enzon and Inhale Announce Formation of Broad Strategic Alliance.Business Editors PISCATAWAY, N.J. and SAN CARLOS San Carlos (săn kär`lōs), residential city (1990 pop. 26,167), San Mateo co., W Calif.; inc. 1925. The chief manufactures are plastic products, hardware, and machine parts. , Calif.--(BUSINESS WIRE)--Jan. 7, 2002 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) and Inhale in·hale v. 1. To breathe in; inspire. 2. To draw something such as smoke or a medicinal mist into the lungs by breathing; inspire. Therapeutic Systems, Inc. (NASDAQ:INHL INHL Institute for Nursing Healthcare Leadership ) announced today the formation of a broad strategic alliance that will serve to enhance each company's business model. The most significant terms of the alliance are: -- Enzon and Inhale will collaborate to develop three products to be specified over time based on the Inhale Inhance(TM) pulmonary delivery platform and SEDS(TM) supercritical fluids platform. The collaboration will have a particular focus on the development of products in the oncology field. Enzon will be responsible for the commercialization and clinical development while Inhale will be responsible for the product development and manufacturing of the products. -- Inhale will be solely responsible for licensing Enzon's PEG Patents, which includes over 40 U.S. patents, to third parties. Inhale will also have the option to license Enzon's PEG Patents for use in Inhale's proprietary products. Enzon will receive a royalty or a share of profits on final product sales of any products that use Enzon's patented PEG technology, including branched PEG. Enzon retains the right to use its PEG technology for its own proprietary products and those it may develop with co-commercialization partners. -- Enzon will have the option to license Inhale's PEGylation patents for Enzon proprietary products and Inhale will receive royalties on any such products. -- Enzon and Inhale will explore the development of non-invasive delivery of single-chain antibody (SCA(R)) products via the pulmonary route. Inhale will become the exclusive pulmonary technology provider for Enzon's single-chain antibody technology using Inhale's proprietary Inhance pulmonary drug delivery technology for at least three years assuming success in the initial proof of concept program. -- Enzon will purchase $40 million of newly issued Inhale convertible preferred stock. -- Enzon and Inhale have agreed to settlement of the patent infringement litigation filed by Enzon against Inhale's Shearwater subsidiary. "We believe this alliance with a premier company in the drug delivery field will further accelerate the growth of Enzon's product pipeline," said Arthur J. Higgins, Enzon's chairman and chief executive officer. "We believe several new products will result from this alliance and hope to have our first collaborative program in the clinic within the next twelve months. The licensing arrangement will enable our extensive PEG patent portfolio to generate revenue without placing any significant limitations on our own use of the technology. We see great benefit to Inhale now being able to offer a full package of PEGylation solutions to its drug delivery customers. The 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. collaboration is particularly exciting as we see the development of an inhaled antibody fragment as offering significant patient benefits that are not possible with full monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). . We believe Inhale has the leading technology position in the pulmonary delivery of proteins and macromolecules Macromolecules A large molecule composed of thousands of atoms. Mentioned in: Gene Therapy macromolecules , and we are pleased to embark upon such an exciting endeavor." "This strategic alliance is a landmark for Inhale and for the drug delivery industry," said Ajit Gill, president and chief executive officer of Inhale. "First, it transforms the landscape for use of PEGylation technology. PEGylation can benefit almost every protein, peptide, and antibody fragment and many small molecules. While we have built an outstanding position in the PEGylation field, adding Enzon's pioneering technology enables us to offer an even wider range of solutions to biopharmaceutical partners. We believe Inhale's ability to offer Enzon's technology to partners should further accelerate the acceptance of PEGylation as the industry standard for improving the efficacy, safety, and convenience of macromolecule macromolecule, term that may refer either to a crystal such as a diamond, in which the atoms are identical and held by covalent bonds (see chemical bond) of equal strength, or to one of the units that compose a polymer. drugs. Second, this alliance will expand our product pipeline significantly. We believe Enzon will be an excellent commercialization partner for the three products we plan to develop with them. In addition, we are excited about working with Enzon to explore inhaleable applications of its single chain antibody technology. This alliance moves us closer to our goal of becoming the leading provider of drug delivery solutions." Product Development Agreements Enzon and Inhale will jointly develop up to three products using Inhale's platform technologies: the Inhance(TM) pulmonary delivery platform and SEDS SEDS Students for the Exploration and Development of Space SEDS State Energy Data System SEDS Small Expendable Deployer System SEDS System Engineering Detailed Schedule SEDS Standard Enhancement and Discrepancy System SEDS System Effectiveness Data System (TM) supercritical fluids platform. The two companies will collaborate to identify product candidates. Inhale will be responsible for formulation development, delivery system supply, and in some cases, early clinical development. Enzon will have responsibility for most clinical development and for commercialization. The two companies have agreed to collaborate on realizing the significant therapeutic and competitive potential offered by single-chain antibody (SCA(R)) products when administered by the pulmonary route. The two companies will initially focus on exploring the utility of the Inhale pulmonary platform for single-chain antibodies and then move to develop single-chain products that will complement the current use of antibodies through the injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. route. Single-chain antibodies are genetically engineered genetically engineered adjective Recombinant, see there proteins designed to expand on the therapeutic and diagnostic applications possible with monoclonal antibodies. Enzon retains all rights to its SCA products while Inhale retains all rights to its own technology. Inhale will become the exclusive pulmonary technology provider for Enzon's single-chain antibody technology using Inhale's Inhance pulmonary drug delivery technology for at least the next three years assuming a successful initial proof-of-concept program. Technology Licensing Enzon will grant to Inhale the exclusive right to grant sub-licenses for Enzon's PEG technology to third parties. Enzon will receive a share of profits for certain products that currently incorporate the Enzon branched PEG technology and royalties on new sub-licenses that Inhale grants to its partners to use Enzon's PEG technology. Enzon retains the right to use all of its PEG technology for its own product portfolio, as well as for those products it develops in co-commercialization collaborations with third parties. It is the intent of the parties that Inhale will be responsible for marketing PEG services and Enzon and Inhale PEG technology to third parties. Enzon will have an option to license Inhale's PEGylation technology for use with its own portfolio products. Inhale will receive royalties on any Enzon PEGylation products using Inhale technology. Enzon will have the ability to request PEGylation supply and services from Inhale. The terms in the product collaboration and PEG licensing agreements are subject to exclusions of certain drug molecules. Stock Purchase Agreement Enzon purchased $40 million of Inhale non-voting convertible preferred stock Convertible Preferred Stock Preferred stock that includes an option for the holder to convert the preferred shares into a fixed number of common shares, usually anytime after a predetermined date. Also known as "convertible preferred shares". . The conversion price of the preferred stock Stock shares that have preferential rights to dividends or to amounts distributable on liquidation, or to both, ahead of common shareholders. Preferred stock is given preference over common stock. Holders of preferred stock receive dividends at a fixed annual rate. shall be set at $22.79, which is based on a 25% premium to the average Inhale common stock closing bid price over the last 20 trading days. In the event Inhale's common stock price three years from the date of issuance of the preferred stock or earlier in certain circumstances is less than $22.79, the conversion price will be adjusted down, although in no event will it be less than $18.23. Conversion of the preferred stock into common can occur anywhere from 1 to 4 years following the issuance of the preferred stock or earlier in certain circumstances. Settlement Agreement In addition to establishing this major alliance, the two companies have agreed to settle the patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. suit related to Enzon's branched PEG technology filed in 1998 by Enzon against Inhale's subsidiary 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. . Inhale will receive licensing access to the contested patents under a cross-license agreement. Enzon will receive a one-time payment from Inhale to cover expenses incurred in connection with defending the branched PEG patents that both companies will now commercially exploit. Enzon Conference Call and Management Availability Company management of Enzon will be hosting a conference call on Tuesday, January 8, 2002 at 8:00 a.m. EST EST electroshock therapy. EST abbr. electroshock therapy regarding the formation of this broad strategic alliance. All interested parties can access the call using the following information: Domestic dial-in number 888/276-9995 International dial-in number 612/288-0337 Access Code 622399 Enzon's conference call will also be webcast in a "listen only" mode via the internet at http://www.vcall.com. Additionally, for those parties unable to listen at the time of Enzon's conference call, a rebroadcast will be available following the call from Tuesday, January 8, 2002 at approximately 1:15 p.m. This rebroadcast will end on Tuesday, January 15, 2002 at 11:59 p.m. The rebroadcast may be accessed using the following information: Domestic dial-in number: 800/475-6701 International dial-in number: 320/365-3844 Access Code 622399 Enzon and Inhale Management will also be available from 1:30 to 3:00 p.m. PST PST Paroxysmal supraventricular tachycardia, see there on Wednesday, January 9 at the Grand Hyatt San Francisco San Francisco (săn frănsĭs`kō), city (1990 pop. 723,959), coextensive with San Francisco co., W Calif., on the tip of a peninsula between the Pacific Ocean and San Francisco Bay, which are connected by the strait known as the Golden , 349 Stockton, The San Francisco A Room near the Westin St. Francis hotel The Westin St. Francis is a luxury hotel in the Union Square district of San Francisco, California. The hotel opened on March 21, 1904. The interior was destroyed in the 1906 Earthquake but the structure survived and the hotel re-opened in late 1907. where the JP Morgan H&Q 20th Annual Healthcare Conference is being held. Inhale Conference Call and Management Availability Company management of Inhale will be hosting a conference call on Tuesday, January 8, 2002 at 10:00 a.m. EST regarding the formation of this broad strategic alliance. All interested parties can access the call using the following information: Dial-in number: 712/271-3632 Passcode: Inhale Leader name: Rob Chess Inhale's conference call will also be webcast via the internet at http://www.inhale.com and will be available on this WEB site for two weeks. Additionally, for those parties unable to listen at the time of Inhale's conference call, a replay will be available shortly following the completion of the call. This replay will end on Tuesday, January 18, 2002 at 5:00 p.m. The replay may be accessed using the following information: Dial-in number: 402/998-1062. Inhale Management will also be available from 1:00 to 2:00 p.m. PST on Tuesday, January 8 at the Handlery Union Square Hotel at 351 Geary St., San Francisco, CA across the street from the Westin St. Francis hotel where the JP Morgan H&Q 20th Annual Healthcare Conference is being held. The room number will be posted at the hotel. Enzon and Inhale Management will also be available from 1:30 to 3:00 p.m. PST on Wednesday, January 9 at the Grand Hyatt San Francisco, 349 Stockton, The San Francisco A Room near the Westin St. Francis hotel where the JP Morgan H&Q 20th Annual Healthcare Conference is being held. Inhale Therapeutic Systems, Inc. develops advanced drug delivery solutions for the biopharmaceutical industry. Inhale offers the Inhance pulmonary delivery platform for the inhaleable delivery of macromolecules and small molecules for systemic and local lung delivery; supercritical fluid processing for powder particle engineering; and advanced PEGylation for enhanced delivery performance of most major drug classes. The company is collaborating with major pharmaceutical and biotechnology companies Top 100 Biotechnology Companies The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies. , including Amgen, AstraZeneca, Aventis Behring, Biogen, Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were , Chiron, GlaxoSmithKline, Johnson & Johnson subsidiaries' R.W. Johnson Pharmaceutical Research Institute (RWJPRI) and the Janssen Research Foundation (JRF JRF Joseph Rowntree Foundation (UK social policy research and development charity) JRF Jewish Reconstructionist Federation JRF Journal of Religion and Film JRF Jordan River Foundation JRF Jackie Robinson Foundation ), Lilly, Pfizer, Pharmacia, Roche and Schering-Plough. 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(R)) protein technology. Three products are currently marketed which utilize Enzon's technology: PEG-INTRON marketed by Schering-Plough for hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. , 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 Malignant Melanoma Definition Malignant melanoma is a type of cancer arising from the melanocyte cells of the skin. Melanocytes are cells in the skin that produce a pigment called melanin. . 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 Eli Lilly can refer to:
This release contains forward-looking statements that reflect the current views of Enzon and Inhale managements respectively as to future products, product development and other future events and operations. These forward-looking statements involve uncertainties and other risks that are detailed in reports and other filings with the Securities and Exchange Commission, including Forms 10-K and 10-Q. These documents identify important factors that could cause the companies' actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review, manufacturing capabilities and marketing effectiveness Marketing Effectiveness is the function of improving how marketers go to market with the goal of optimizing their marketing spend to achieve even better results for both the short-term and long-term. Also related to Marketing ROI and Return on Marketing Investment (ROMI). . This release is also available at http://www.enzon.com and http://www.inhale.com. |
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