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Coulter Pharmaceutical and SmithKline Beecham Form Development and Commercialization Alliance for I-131 Anti-B1 Antibody.


PALO ALTO Palo Alto, city, California
Palo Alto (păl`ō ăl`tō), city (1990 pop. 55,900), Santa Clara co., W Calif.; inc. 1894. Although primarily residential, Palo Alto has aerospace, electronics, and advanced research industries.
, Calif.--(BW HealthWire)--Dec. 4, 1998--Coulter Pharmaceutical (Nasdaq:CLTR CLTR China Liver Transplant Registry
CLTR CPPU (Constant Pressure Power Uprate) Licensing Topical Report (nuclear) 
) and SmithKline Beecham (NYSE NYSE

See: New York Stock Exchange
:SBH SBH State Bank of Hyderabad (India)
SBH Small Business Hawaii (non-profit business advocacy organization)
SBH Sequencing By Hybridization
SBH St Barthelemy, Guadeloupe (Airport Code) 
) today announced that they have signed an agreement to jointly commercialize Coulter's lead cancer therapy, I-131 Anti-B1 Antibody (iodine I 131 tositumomab), which is in late-stage development for the treatment of non-Hodgkin's lymphoma non-Hodg·kin's lymphoma
n.
Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells.


Non-Hodgkin's lymphoma 
 (NHL NHL Non-Hodgkin's lymphoma, see there ).

The total agreement has a potential value of up to $132 million, plus shared profits and royalties.

The agreement provides for an upfront payment of $41.5 million from SmithKline Beecham (SB) to Coulter Pharmaceutical, including the purchase of $7.25 million in equity. In addition, a $15 million credit line will be provided. Coulter potentially will receive an additional $76 million in payments based upon completion of certain milestones in specific geographical areas of the world.

Future development expenses for I-131 Anti-B1 Antibody will generally be shared by both companies, with Coulter retaining responsibility for funding certain predetermined pre·de·ter·mine  
v. pre·de·ter·mined, pre·de·ter·min·ing, pre·de·ter·mines

v.tr.
1. To determine, decide, or establish in advance:
 development costs. In addition, the companies will jointly explore the potential of the I-131 Anti-B1 Antibody therapy antibody therapy Clinical immunology Any therapeutic intervention in which a monoclonal or other concentrated antibody is used to manage a condition–eg, cancer or severe infection  for other indications.

Coulter and SB will jointly market I-131 Anti-B1 Antibody in the United States following regulatory approval, and the two companies will share profits equally. Outside the United States, excluding Japan, Coulter has granted SB exclusive marketing and distribution rights in return for product royalties. SB will also have access to second generation anti-CD20 compounds.

"We are very pleased to establish this partnership with SB given their commitment to the cancer field and successful record in marketing leading oncology products such as Kytril(R) and Hycamtin(tm)," said Michael F. Bigham, president and chief executive officer of Coulter.

"The structure of this alliance allows us to build our own oncology sales force and to actively participate in marketing within the United States. Our efforts will be coordinated with SB's well-established, global sales and marketing organizations which we believe will accelerate and broaden the accessibility of I-131 Anti-B1 Antibody therapy to NHL patients."

"SmithKline Beecham's Oncology group is committed to the discovery, development and marketing of innovative products that provide greater hope and improved clinical care to people who suffer from the many diseases collectively known as cancer," said Jean-Pierre Garnier, chief operating officer Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
 of SB.

"While there have been many advances in our understanding of a wide variety of cancers in the past few years, a critical need for effective treatments remains. We believe Coulter's I-131 Anti-B1 Antibody promises to be an important product that will support SB's continued commitment to cancer patients and enable SB to provide oncologists with an effective product to treat NHL."

I-131 Anti-B1 Antibody, an antibody conjugated conjugated
adj.
Conjugate.


estrogens, conjugated Warning - Hazardous drug!

C.E.S.
 to iodine 131, attaches to the CD20 antigen. This antigen is found only on the surface of B-cells, including both non-Hodgkin's lymphoma B-cells and some normal B-cells. It is believed that through this targeted approach, the tumor cells receive a greater concentration of the therapeutic radiation from I-131 Anti-B1 Antibody relative to normal tissues.

Non-Hodgkin's lymphoma is a form of cancer that affects the blood and lymph tissues. NHL currently is the sixth leading cause of death among cancers in the United States and has the second fastest growing mortality rate.

According to statistics from the National Cancer Institute, approximately 270,000 people are afflicted af·flict  
tr.v. af·flict·ed, af·flict·ing, af·flicts
To inflict grievous physical or mental suffering on.



[Middle English afflighten, from afflight,
 with NHL in the United States alone. Of these, Coulter estimates that approximately 140,000 people have low-grade or transformed low-grade disease which is the initial targeted indication for I-131 Anti-B1 Antibody therapy. There are approximately 54,000 new cases of NHL diagnosed each year.

Coulter Pharmaceutical, Inc. is engaged in the development of novel drugs and therapies for the treatment of people with cancer. The company is developing a family of cancer therapeutics based upon two drug discovery programs: therapeutic antibodies and targeted oncologics.

The company's most advanced investigational product candidate, I-131 Anti-B1 Antibody (iodine I 131 tositumomab), consists of a monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing  conjugated with a radioisotope radioisotope: see radioactive isotope.
Radioisotope (biology)

A radioactive isotope used in studying living systems, such as in the investigation of metabolic processes.
. The company has completed a Phase III investigational clinical trial for the treatment of non-Hodgkin's lymphoma and is currently preparing the data for submission to the U.S. Food and Drug Administration. The company also is currently developing a tumor-activated peptide pro-drug version of doxorubicin doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased  to treat certain solid tumor cancers.

SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products, and provides healthcare services including laboratory testing, disease management and pharmaceutical benefit management. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com.

Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of I-131 Anti-B1 Antibody or Coulter's other product candidates and other risks detailed from time to time in Coulter's filings with the Securities and Exchange Commission (SEC). In particular, see "Risk Factors" in Coulter's Registration Statement on Form S-3, as amended, filed with the SEC on July 31, 1998.
COPYRIGHT 1998 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1998, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Dec 4, 1998
Words:841
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