Alkermes and Lilly Expand AIR(R) Inhaled Insulin Collaboration.Companies Sign Manufacturing Agreement Naming Alkermes the Worldwide Commercial Supplier for AIR Inhaled in·hale v. in·haled, in·hal·ing, in·hales v.tr. 1. To draw (air or smoke, for example) into the lungs by breathing; inspire. 2. Insulin CAMBRIDGE, Mass. & INDIANAPOLIS -- Alkermes, Inc. (Nasdaq: ALKS ALKS Alkermes, Inc. (stock symbol) ) and Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. (NYSE NYSE See: New York Stock Exchange : LLY) today announced that they have signed a commercial manufacturing agreement for AIR([R]) Inhaled Insulin (AIR([R]) Insulin). As a result of the agreement, Alkermes will be the exclusive commercial manufacturer of AIR Insulin powder for the AIR([R]) Inhaled Insulin System (AIR([R]) Insulin System). The manufacturing agreement provides for an additional investment by Lilly for the construction and operation of a second manufacturing line at Alkermes' commercial-scale production facility for inhaled medications, expanding the facility's powder production capacity to meet post-launch requirements. The AIR Insulin System is currently in phase 3 clinical development by Lilly and Alkermes and is being studied as an innovative treatment for type 1 and type 2 diabetes type 2 diabetes n. See diabetes mellitus. . In 2001, Lilly and Alkermes entered into a development and license agreement for the collaboration on inhaled formulations of insulin. The agreement announced today builds upon both the manufacturing and clinical development progress made to date and further advances the collaboration by establishing the supply chain for commercial supply of AIR Insulin, post the AIR Insulin System approval. "We are very pleased that Alkermes will be the exclusive worldwide commercial supplier of AIR Insulin powder," commented Richard Pops, chief executive officer of Alkermes. "Our expanded agreement with Lilly underscores the potential we see for this innovative treatment option, and plans are now underway to build the additional capacity required to support our projected future commercial demand for the AIR Insulin System." Bryce Carmine carmine /car·mine/ (kahr´min) a red coloring matter used as a histologic stain. indigo carmine indigotindisulfonate sodium. car·mine n. , president of global brand development for Lilly, added, "Lilly and Alkermes have built a very strong relationship around the development of the AIR Insulin System. This manufacturing agreement broadens that relationship, and provides the necessary AIR Insulin capacity to meet the needs of patients worldwide. Lilly looks forward to the potential addition of AIR Insulin to our portfolio of innovative diabetes products." Under the terms of the agreement, Alkermes is responsible for overseeing construction of the second manufacturing line, including process development, scale-up and validation, as well as for the manufacture and supply of inhaled insulin powder. Lilly is responsible for funding activities related to the construction, development and operation of the second manufacturing line as well as the facility expansion required to support the manufacturing line. Lilly is also responsible for all product packaging. If inhaled formulations of insulin are successfully developed and commercialized, Lilly will purchase product from the facility. Additional terms of the agreement were not disclosed. Lilly/Alkermes Inhaled Insulin Program Lilly and Alkermes are conducting phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. for an inhaled insulin system (known as the AIR Insulin System) that delivers insulin via inhalation based on Alkermes' AIR pulmonary delivery technology. The Lilly/Alkermes program is focused on developing an innovative treatment option that can help address the challenges associated with managing type 1 and type 2 diabetes. The AIR Insulin System uses a small, simple inhaler inhaler /in·hal·er/ (in-hal´er) 1. an apparatus for administering vapor or volatilized medications by inhalation. 2. ventilator (2). in·hal·er n. that fits in the palm of a hand. For more information about the phase 3 trials, visit www.lillytrials.com. About Alkermes, Inc. Alkermes, Inc. is a biotechnology company that develops innovative medicines designed to yield better therapeutic outcomes and improve the lives of patients with serious disease. Alkermes currently has two commercial products: the first and only long-acting atypical antipsychotic The atypical anti-psychotics (also known as second generation anti-psychotics) are a class of prescription medications used to treat psychiatric conditions. Some atypical anti-psychotics are FDA approved for use in the treatment of schizophrenia. medication approved for use in schizophrenia marketed worldwide by Janssen-Cilag (Janssen), a wholly owned division of Johnson & Johnson; and VIVITROL([R]) (naltrexone naltrexone /nal·trex·one/ (nal-trek´son) an opioid antagonist used as the hydrochloride salt in treatment of opioid or alcohol abuse. nal·trex·one n. An endorphin and narcotic antagonist. for extended-release injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. suspension), the first and only once-monthly injectable medication approved for the treatment of alcohol dependence and marketed in the U.S. primarily by Cephalon Ceph´a`lon n. 1. (Zool.) The head. , Inc. Alkermes' pipeline includes extended-release injectable, pulmonary, and oral products for the treatment of widespread, chronic diseases such as central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency , addiction and diabetes. Alkermes' headquarters are in Cambridge, Massachusetts This article is about the city of Cambridge in Massachusetts. For the English university town, see Cambridge, England. For other places, see Cambridge (disambiguation). Cambridge, Massachusetts is a city in the Greater Boston area of Massachusetts, United States. , and it operates research and manufacturing facilities in Massachusetts and Ohio. About Lilly Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. Certain statements set forth above may constitute forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, including, but not limited to: statements about the successful continuation of development activities for the AIR Insulin System; the Companies' ability to scale-up, manufacture, supply and successfully commercialize the AIR Insulin System; and the potential demand for the product, if approved by regulatory authorities. Although the Companies believe that such statements are based on reasonable assumptions within the bounds of their knowledge of their businesses and operations, the forward-looking statements are neither promises nor guarantees and the Companies' businesses are subject to significant risk and uncertainties and there can be no assurance that their actual results will not differ materially from their expectations. These risks and uncertainties include, among others: whether AIR Insulin is able to be successfully and efficiently scaled up and manufactured; whether the AIR Insulin System will demonstrate sufficient efficacy and safety to be approved by regulatory authorities or successfully commercialized; decisions by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. regarding the product candidate; and whether the Companies' projected future commercial demand will be the actual future demand for the AIR Insulin System. For further information with respect to factors that could cause the Companies' actual results to differ materially from expectations, reference is made to the reports the Companies filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The Companies disclaim any intention or responsibility for updating forward-looking statements made in this release. AIR([R]) is a registered trademark of Alkermes, Inc. and VIVITROL([R]) is a registered trademark of Cephalon, Inc. |
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