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From 3/11/04 S-1 Overview Momenta is a biotechnology company specializing in the sequencing and engineering of complex sugars for the development of improved versions of existing drugs, the development of novel drugs and the discovery of new biological processes. We are also utilizing our ability to sequence sugars to create near-term technology-enabled generic products. Through precise chemical structure characterization and engineering of complex sugars, our proprietary technology provides a more complete understanding of the roles that sugars play in cellular function, disease and drug action. Based on our understanding of complex sugars, we have developed a diversified pipeline of novel discovery and development candidates and near-term product opportunities. Our most advanced product candidate, M-Enoxaparin, is designed to be a technology-enabled generic version of Lovenox® (enoxaparin), a low molecular weight heparin, or LMWH, used to prevent and treat deep vein thrombosis, or DVT, and treat acute coronary syndromes, or ACS. Aventis SA, or Aventis, reported worldwide sales of Lovenox of approximately $1.9 billion in 2003, and analysts project sales to exceed $3.0 billion in 2010. We expect to file an Abbreviated New Drug Application, or ANDA, or other regulatory application as determined by the United States Food and Drug Administration, or FDA, for M-Enoxaparin in the next 12 months. In addition, we intend to develop a technology-enabled generic version of Fragmin® (dalteparin), another LMWH. Our novel development opportunities include: M118, which is a rationally designed LMWH to treat patients with ACS; a sugar-mediated technology that is designed to improve the non-invasive delivery of therapeutic proteins; and capabilities that are designed to enable engineering of complex sugars on therapeutic proteins to improve the efficacy, reduce side effects and modify the dosage of protein drugs. Our drug discovery program, which is focused initially in oncology, is designed to leverage our understanding of sugar biology to develop sugar-based drugs and identify new biological mechanisms that can be targeted with small molecule or antibody drugs. Background on Sugars Sugars, together with DNA and proteins, are the information-rich molecules that regulate critical biological processes and pathways, or sequential protein interactions, in the human body. The technical and analytic challenges associated with sequencing complex sugars, however, have hindered the comprehensive understanding of their biologic activity. As a consequence, the development of sugar-based drugs to date has been through more of a "trial-and-error" approach. Because of the density of information contained in complex sugars relative to DNA and proteins and the lack of sophisticated tools to sequence such sugars, development of therapeutics based on sugars has been difficult. We believe understanding the structure, specific function and manner in which complex sugars affect critical biological processes and existing therapeutics will provide significant commercial opportunities for drug discovery and development. Our Technology Solution Our proprietary technology enables rapid, precise and comprehensive sequencing and characterization of complex sugars and allows us to correlate specific sugar sequences with biological activity. With proprietary enzymes and reagents, improvements to established analytical techniques and patent-protected mathematical methods, our technology has distinct advantages in characterizing complex sugars over other approaches. Our comprehensive analysis can specifically identify the detailed sequences and the complete chemical structure of complex sugars, not simply the basic underlying backbone of the sugar chain. We intend to utilize our technology to develop generic versions of complex drugs, enhance existing therapeutics, engineer novel drugs and identify the roles sugars play in regulating biological processes to facilitate the discovery of new sugar-based and small molecule drugs, as well as diagnostic and prognostic markers. Our Product Pipeline Near-Term Product Opportunities M-Enoxaparin. Our most advanced product candidate, M-Enoxaparin, is designed to be a technology-enabled generic version of Lovenox. Lovenox is distributed worldwide by Aventis, and is the most widely-prescribed LMWH in the world. In 2003, Aventis reported worldwide sales of Lovenox of approximately $1.9 billion. We have formed a collaboration with Sandoz N.V., and Sandoz Inc., collectively Sandoz, an affiliate of Novartis AG, to jointly develop, manufacture and commercialize a generic version of Lovenox. We intend to file our regulatory application with the FDA in the next 12 months for this product. As is common with generic applications, we anticipate that Aventis will initiate patent infringement proceedings against Sandoz and us to prevent the marketing of M-Enoxaparin. Lovenox is a heterogeneous mixture of complex sugar chains that has not been adequately analyzed to date. Under FDA guidelines, any regulatory application for a generic product, such as a generic version of Lovenox, must demonstrate that it has the same active ingredients as the branded version. Our ability to sequence and analyze complex sugar mixtures has allowed us to study the many sugar structures in Lovenox that contribute to its overall biological activity and develop a process for making a generic version of Lovenox we believe will meet the FDA requirements for an ANDA approval. M-Dalteparin. We intend to develop a technology-enabled generic version of Fragmin, a LMWH that is approved for the prevention of DVT and treatment of ACS. In 2002, Fragmin had worldwide sales of approximately $270 million. Our plan is to file a regulatory application for M-Dalteparin approximately six to 12 months after our M-Enoxaparin filing. Improved Development Products M118. M118 is a LMWH that we rationally designed to provide improved efficacy and flexible administration as baseline therapy for treating patients with ACS. M118 is currently in preclinical development. We intend to file an investigational new drug application, or IND, prior to the end of the first quarter of 2005 and begin Phase I clinical trials shortly thereafter. Sugar-mediated non-invasive delivery. We have identified a novel biological mechanism by which sugars facilitate the transport of molecules, including proteins, across mucosal membranes like those found in the lung. We believe our approach to pulmonary delivery of therapeutic proteins could result in significant advantages over current technologies, including an improved safety profile, higher bioavailability, or levels of drug in the blood, and delivery of larger therapeutic proteins. We are focusing our initial development on pulmonary formulations of interferon-beta, erythropoietin, insulin and human growth hormone, or HGH. Capabilities that enable engineering of complex sugars on therapeutic proteins. Our analytical and sequencing technologies can also be applied to characterize and reengineer sugars that exist on therapeutic proteins. Altering the complex sugar coat of a protein can potentially improve efficacy and tissue targeting, reduce negative side effects and modify the dosing frequency of a protein drug. Discovery Product Candidates Recent research has shown that sugars play a critical role in influencing signaling between proteins in pathways to fundamentally affect basic biology. We believe our technology can be utilized to understand the relationship between sugars and disease progression to advance the discovery of novel sugar-based small molecule and antibody drugs to treat a range of diseases, including cancer, cardiovascular disease and inflammatory disease. For example, we have identified specific sugar sequences that have demonstrated potent anti-cancer effects in animals. Our Business Strategy Our objective is to become a leading biotechnology company by applying our understanding of complex sugars and our proprietary technologies to drug discovery, development and commercialization. The key elements of our strategy are to (i) maximize the commercial potential of M-Enoxaparin and leverage our analytic capabilities to commercialize other near-term opportunities, (ii) advance our improved development product opportunities into clinical trials, (iii) leverage our proprietary technology and apply our understanding of sugars to create novel therapeutics to address critical unmet needs, (iv) enhance our internal development programs through selective partnering, and (v) establish development capabilities and sales and marketing capabilities focused on key in-hospital markets. Management Team We are led by a team of experienced biotechnology and pharmaceutical industry executives and recognized experts in glycobiology, or the study of complex sugars. We believe this team provides us with significant capabilities in the discovery, development and commercialization of therapeutics, resulting from our understanding of complex sugars. Early-Stage Company We have a limited operating history and have not yet commercialized any products. We have not been profitable in any quarter since inception. As of December 31, 2003, we had an accumulated deficit of approximately $15.6 million. We recognized net losses of $7.9 million for the year ended December 31, 2003 and $4.9 million for the year ended December 31, 2002. We expect to incur substantial and increasing losses for the next several years as we develop our product candidates, expand our research and development activities and prepare for the commercial launch of our product candidates. We do not know when or whether we will become profitable. Corporate Information We were incorporated in Delaware in May 2001 as Mimeon, Inc. In September 2002, we changed our name to Momenta Pharmaceuticals, Inc. Our principal executive offices are located at 43 Moulton Street, Cambridge, Massachusetts 02138. Our telephone number is (617) 491-9700. Our website address is www.momentapharma.com. The information on our website is not incorporated by reference into this prospectus and should not be considered to be a part of this prospectus. We have included our website address as an inactive technical reference only. .... | ||||||||||||||
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