To: Bucky Katt who wrote (12503 ) 9/21/1999 9:57:00 AM From: BANCHEE Respond to of 57584
William News on IMGN Tuesday September 21, 9:05 am Eastern Time Company Press Release SOURCE: ImmunoGen, Inc. ImmunoGen, Inc. Investigational New Drug Application for huC242-DM1/SB-408075 Accepted by FDA --ImmunoGen, Inc. reaches third milestone in collaboration with SmithKline Beecham, triggering $4 million payment-- NORWOOD, Mass., Sept. 21 /PRNewswire/ -- ImmunoGen, Inc. (Nasdaq: IMGN - news) today announced that its Investigational New Drug application (''IND'') for huC242-DM1/SB-408075, its lead tumor activated prodrug for the treatment of colorectal and pancreatic cancers, has been accepted by the FDA. This acceptance is the third milestone to be achieved in ImmunoGen's collaboration with SmithKline Beecham plc (''SB'') and triggers a payment of $4 million from SB. To date, ImmunoGen has earned $7 million from SB in milestone payments. ImmunoGen expects to initiate human studies of huC242-DM1/SB-408075 by the end of this year in patients suffering from refractory colorectal cancer. Patients suffering from refractory pancreatic cancer will also be included, based on laboratory tests conducted this year demonstrating the affinity of the huC242 antibody to pancreatic tumor cells as well as colorectal cancer cells. ''Our collaboration with SB has provided a solid foundation for growth and contributes to the momentum that has resulted in our steady achievement of several milestones. Included in this, of course, is the acceptance by FDA of our IND application,'' said Mitchel Sayare, Ph.D., Chairman and CEO of ImmunoGen, Inc. ''We are encouraged by the promising animal data for huC242- DM1/SB-408075, and we look forward to assessing this product in humans later this year. We believe that huC242-DM1/SB-408075 holds the promise to provide patients with a more potent, less toxic treatment for these lethal forms of cancer.'' The collaboration between ImmunoGen and SB was executed in February of 1999. Under terms of the agreement, ImmunoGen can receive up-front cash and milestone payments totaling more than $40 million. SB received worldwide rights to commercialize huC242-DM1/SB-408075, except in certain Far East territories. SB and ImmunoGen are collaborating on the remaining development. ImmunoGen will direct the product's initial assessment in humans. ImmunoGen, Inc. develops innovative biopharmaceuticals, primarily for cancer treatment. The Company has created potent tumor-activated prodrugs, consisting of drugs coupled to monoclonal antibodies, for delivery to and destruction of cancer cells. This press release includes forward-looking statements based on management's current expectations. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the ability to secure future funding; the success of the Company's research strategy; the applicability of the discoveries made therein; the difficulties inherent in the development of pharmaceuticals, including uncertainties as to the timing and results of preclinical studies; delayed achievements of milestones; reliance on collaborators; uncertainty as to whether the Company's potential products will succeed in entering human clinical trials and uncertainty as to the results of such trials; uncertainty as to whether adequate reimbursement for these products will exist from government, private healthcare insurers and third-party payors; and the uncertainties as to the extent of future government regulation of the pharmaceutical business. SOURCE: ImmunoGen, Inc.