Eli Lilly and Company announced July 22 during a lease signing event that it has become the first tenant of New York City's new Alexandria Center for Science and Technology at East River Science Park, a development that shows tangible evidence that New York is positioning itself to become a hub for biopharmaceutical research. The biotech park – located adjacent to the NYU Langone Medical Center in Manhattan – will house ImClone's Research Division including approximately 125 ImClone scientists with plans to add scientists in those areas that support expansion of the ImClone pipeline. The new location enables unprecedented access to academic research organizations in the New York area. This move is consistent with Lilly's transformation into a fully integrated pharmaceutical network (FIPNet) in which it is increasingly collaborating with external organizations and companies to speed innovation to patients. Nearly 20 current FIPNet partners are located in proximity to the new location. ImClone's manufacturing, development and administrative operations will remain based in New Jersey.
New York City Mayor Michael Bloomberg is a major supporter of the move. "New York City has always been at the forefront of scientific innovation, but the City has never fully capitalized on its assets to create a thriving commercial bioscience industry and the jobs that come with it," said Mayor Bloomberg. "We set out to create the East River Science Park to provide today's bioscience companies with the state-of-the-art commercial lab space they need to locate and expand. Eli Lilly and Company's decision to become its anchor tenant is evidence that our work is paying off. It also serves as a major boost to our efforts to diversify New York City's economy. In recent months, we've announced initiatives to promote entrepreneurship, develop green jobs, support nonprofits, grow the media industry and add industrial jobs, and today's announcement affirms our belief that bioscience is another industry in which the City can and will succeed."
As further evidence of innovation, Lilly also said that it now has six ImClone molecules in its pipeline, bringing the company's total number of oncology molecules in clinical development to 23 and the number of unique investigational medicines in the Lilly pipeline to 66. ImClone has achieved several important milestones in advancing its pipeline of novel antibodies since being acquired by Lilly less than a year ago. One of those molecules, IMC-1121B, already in Phase III development for breast cancer, will be evaluated in another Phase III trial, this time for gastric cancer.
The purpose of the Phase III gastric cancer study is to evaluate the effect of IMC-1121B on the overall survival of patients with metastatic gastric cancer following disease progression on standard first-line chemotherapeutic regimens. This pivotal trial will be conducted at approximately 250 academic research centers across five continents.
"This is an important milestone for us as we work to develop innovative therapies to treat patients with cancer," said ImClone chief medical officer Eric K. Rowinsky, M.D. "Gastric cancer is not only a major cause of mortality and morbidity in Asia, but the incidences of certain types of gastric malignancies such as gastro-esophageal junctional cancer, which will also be evaluated in our study, are increasing in North America, Europe and outside of Asia. Gastric cancer is diagnosed more than 21,000 times each year in the United States alone and is the second leading cause of cancer death worldwide, with more than 800,000 deaths annually. Current medical techniques for the treatment of gastric cancer are primarily palliative rather than curative. There is an urgent need for medication that can do more than simply cloak the effects of this disease."
Continuing Innovation Critical
When it moves to the new East River Science Park, which is expected to open sometime in the summer of 2010, ImClone will have access to a state-of-the-art facility for conducting its innovative research. ImClone's Research group conducts the preclinical discovery efforts that have produced the clinical product candidates in ImClone's robust pipeline of therapeutic antibodies. The new location will help expand collaborative activities with local academic institutions as ImClone further accelerates its research to add new molecules to its pipeline. In addition to the second Phase III trial of IMC-1121B announced today, ImClone has made several advancements in its pipeline since being acquired by Lilly. Highlights include:
· IMC-11F8 is expected to move into Phase III development by the end of 2009;
· Phase II testing of IMC-A12 has been expanded to include colorectal, neuroendocrine and lung cancers. Phase III studies of IMC-A12 are expected to begin in either late 2009 or early 2010;
· IMC-3G3 has recently moved into Phase II development with a study in ovarian cancer, and additional Phase II studies in other tumor types are planned;
· Phase II studies of IMC-1121B have been expanded to include colorectal cancer;
· The first Phase I trial of IMC-EB10, in leukemia, was recently launched, increasing the number of ImClone molecules in clinical development to six; and
· ImClone also expects to file at least one new investigational new drug (IND) application by the end of 2009.
According to Lilly chairman, president and CEO John Lechleiter, Ph.D., "Having six monoclonal antibodies contributed by ImClone to the Lilly oncology portfolio is a great step toward achievement of the oncology powerhouse we are building. Our new location in New York with access to the latest research tools and our FIPNet partners will also help us speed innovative medicines to patients. However, to protect this innovation, we are going to need healthcare reform that encourages innovation and in turn leads to breakthrough, life-saving medicines for patients. In this case, patients battling cancer are the focus."
According to 2006 data, the biopharmaceutical industry supported more than 215,000 jobs in New York while investing $1.8 billion in research and development to reap a return of $44.6 billion in economic output.
The current proposed "Pathways to Biosimilars Act" now before Congress paves the way for innovation by allowing for a 14-year data package exclusivity period for Lilly to recoup its investment. Is it too much to ask to be able to protect the recipe for a billion-dollar investment to bring a life-saving medicine to patients? According to Lechleiter, "At Lilly, we don't think so."
