T Cell Sciences Inc. and SmithKline Beecham said they havesigned a letter of intent to modify their agreement relating toproduct development and licensing of sCR1, a complementinhibitor product being evaluated in a Phase I human clinicaltrial for the treatment of adult respiratory distress syndrome.
Under the modified agreement, T Cell would assumeresponsibility for clinical development of sCR1 in exchange forreceiving all sales and marketing rights in North America.SmithKline would retain manufacturing responsibility forclinical and commercial supplies and have an exclusive optionfor sales and marketing rights in the rest of the world (exceptJapan, which is covered in an agreement between thecompanies and Yamanouchi Pharmaceutical).
T Cell spokeswoman Susan Primrose said the Cambridge, Mass.,company wanted to rework the agreement because it now hasthe financial and internal capabilities to handle clinicaldevelopment. She said T Cell also wanted to regain marketingrights in the U.S.
The original agreement, concluded in November 1989, calledfor SmithKline to fund clinical development in exchange forexclusive, worldwide marketing rights. At certain sales levels, TCell would receive co-promotional rights in the U.S. androyalties on worldwide sales.
T Cell is reviewing the scope and timing of its Phase I trial inburn patients because of the transition and difficulty in gettingpatients who meet protocol. The company plans to submit aninvestigational new drug application for an improvedproduction process and a second indication in the next fewmonths.
In a separate matter, T Cell and Incstar Corp. on Thursdayannounced that T Cell's subsidiary, T Cell Diagnostics Inc.,entered into a distribution agreement with Incstar to marketcertain microtiter plate diagnostic kits in North America,Europe and other areas.
T Cell Diagnostics will receive a signing fee and a milestonepayment (after FDA marketing clearances), royalties on salesand a purchase price for the products. -- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.