Sponsor Profile: Biotech and the City

ImClone Systems' SoHo headquarters ImClone Systems began its history as a New York company in 1984 when its founders, an immunologist and a pathologist both living and working in the city, set out to meld the established and respected world of New York City academia with the dynamic and fledgling biotechnology industry. Two short years after its incorporation, with a staff of 12 employees and some venture capital funding, ImClone Systems opened its laboratories in downtown New York's SoHo neighborhood in a space that formerly served as a shoe factory. ImClone Systems got its name from the three scientific areas its founders had originally intended the company to pursue: immunology, gene cloning, and information systems for the life sciences industry. The company's first Food & Drug Administration-approved products were diagnostic kits used in immunology, but it also pursued several infectious disease and cancer vaccine research programs. These early endeavors led to a number of commercial licensing agreements and successful efforts at raising capital -including the company's initial public offering in 1991 – all of which allowed ImClone Systems to continue searching for what would ultimately become its mission: The development and commercialization of novel therapeutic products in the field of oncology. During the early 1990s, the company was principally focused on developing several cancer vaccines that would induce an immune response against cancer cells in the body, as well as building out a pilot manufacturing facility in Branchburg, NJ. At that time, the decision was made to pursue a program in what the company then termed "interventional cancer therapeutics." Its first licensed product in this new area of research was an antibody to the epidermal growth factor receptor (EGFr) known as C225. The discovery and early development for C225 began around 1980 in the research lab of Dr. John Mendelsohn and Dr. Gordon Sato at the University of California, San Diego. Mendelsohn and Sato theorized that by engineering an immune system protein similar to those created by the body and using it to block the signaling pathways that allowed for the unregulated replication of cancer cells, tumor growth could be impeded. Early experiments with the murine predecessor of the antibody showed the ability to stop the growth of tumors in xenograft models. Despite licensing the drug to a pharmaceutical company in the late 1980s, its development stalled until ImClone Systems acquired the rights to it in 1991. After chimerizing the antibody and furthering its preclinical development, ImClone Systems began the process of manufacturing C225 for clinical use and dosed its first patient in 1994. Following a lengthy clinical development process, which included sucesses and setbacks, C225, now known as Erbitux® (cetuximab), was approved for use in two indications: In combination with irinotecan in patients with epidermal growth factor-expressing metastatic colorectal cancer refractory to irinotecan-based chemotherapy and as a single agent in patients with epidermal growth factor-expressing metastatic colorectal cancer intolerant to irinotecan-based chemotherapy. Erbitux is also approved for use in a combination regimen and/or as a single agent in over 30 markets in Europe and Latin America.* The clinical and regulatory development of Erbitux continues today with the help of partners Bristol-Myers Squibb and Merck KGaA of Germany. In July, ImClone Systems and Bristol-Myers Squibb established a plan with the FDA for the filing of a supplemental Biologics License Application to seek approval for use of Erbitux as a single agent and in combination with radiation in squamous cell carcinoma of the head and neck. The filing is expected to be made in the first half of next year. The three companies are also studying Erbitux in earlier stages of colon cancer, and in other tumor types, including head and neck, non-small cell lung, and pancreatic cancers. In addition, they plan to evaluate the potential of Erbitux in other solid tumors, including ovarian, cervical/ endometrial, and esophageal cancers. ImClone Systems' New Jersey campus From modest beginnings, ImClone Systems is today a fully integrated biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The company utilizes the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development. These include a variety of growth factor blockers and angiogenesis inhibitors, four of which will enter the clinic in the coming months. A strong pipeline is the perennial engine for growth at a biopharmaceutical company, and ImClone Systems' subway-ride proximity to the major New York medical centers has allowed its scientists to build relationships that promote an exchange of ideas and lead to scientific progress. The company counts Memorial Sloan Kettering, New York-Presbyterian, the NYU and Columbia Medical Centers and Mt. Sinai among its collaborators on programs ranging from the study of the kinase insert domain-containing receptor (KDr) to the study of EGFr. The company is headquartered at 180 Varick Street in downtown New York, and has expanded its reach to campuses in Brooklyn, NY – the base of its small molecule research department – and Branchburg, NJ – home to several of the company's functional areas including its rapidly expanding manufacturing capabilities. Manufacturing is among the company's largest departments, growing at such a pace that when its second commercial scale manufacturing facility is completed next year, ImClone Systems will be among those companies with the largest volume for mammalian cell production of biologics. But as CEO Daniel Lynch is fond of saying, one of ImClone Systems' greatest assets is its employees, who now number over 700 individuals working in areas that include basic and applied research, development, manufacturing, sales and marketing, legal, intellectual property, and clinical development. To this day, ImClone Systems remains as focused on its research roots as when it opened its doors in 1986. It recently announced a plan to build out a new research facility at 325 Spring Street, a few short blocks from its headquarters. When complete, the building will house between 75,000 and 100,000 square feet of lab and lab-related space that will accommodate over 150 scientists and support staff in a truly state-of-the-art environment. It is expected that this new building will support all of the company's antibody and small molecule research functions for years to come. With a novel therapeutic now reaching cancer patients and assets ranging from research to manufacturing facilities, scientists to sales teams, ImClone Systems is enjoying a period of profitability and success unparalleled in its history. In a city that helped build the company from its inception, ImClone Systems continues to employ all the benefits of its cosmopolitan, dynamic environment that is New York – from longstanding ties to its vast academic community to its undeniable status as the financial capital of the world. * Please visit http://www.Erbitux.com for full prescribing information, including important safety information. ImClone Systems Incorporated, 180 Varick Street, 6th Floor, New York, NY 10014, http://www.imclone.com Contact: info@imclone.com Phone: (212) 645-1405 Fax: (212) 645-2054

Sponsor Profile: Biotech and the City

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