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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
__________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported) April 27, 1998 (April 22, 1998)
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SPARTA PHARMACEUTICALS, INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 0-23076 56-1755527
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
111 Rock Rd. Horsham, PA 19044
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (215) 442-1700
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Item 1. Changes in Control of Registrant.
Not applicable.
Item 2. Acquisition or Disposition of Assets.
Not applicable.
Item 3. Bankruptcy or Receivership.
Not applicable.
Item 4. Changes in Registrant's Certifying Accountant.
Not applicable.
Item 5. Other Events
On April 22, 1998, Sparta issued a press release filed as
Exhibit 99.26 hereto announcing the signing of a license
agreement with Schering-Plough Corporation for the use of
Sparta's Spartaject(TM) technology as applied to
Schering-Plough's oral anticancer agent, TEMODAL (R)
(temozolomide).
Item 6. Resignations of Registrant's Directors.
Not applicable.
Item 7. Financial Statements and Exhibits.
(a) Financial Statements of Sparta Pharmaceuticals, Inc.
Not applicable.
(b) Pro Forma Financial Information
Not applicable
(c) Exhibits
99.26 -- Press Release, dated as of April 22, 1998,
announcing the signing of a license agreement
with Schering-Plough Corporation.
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Item 8. Change in Fiscal Year
Not applicable.
Item 9. Sales of Equity Securities Pursuant to Regulation S.
Not applicable.
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Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this amendment to be signed on its behalf by the
undersigned thereunto duly authorized.
Sparta Pharmaceuticals, Inc.
April 27, 1998 By: /s/ Jerry B. Hook
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Date Jerry B. Hook, Ph.D. President,
Chief Executive Officer & Director
(principal executive officer)
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EXHIBIT INDEX
________________________________________________________________________________
Exhibit
Number Description Page
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99.26 -- Press Release, dated as of April 22, 1998, announcing the 6
signing of a license agreement with Schering-Plough Corporation.
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Exhibit 99.26
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Contact: Jerry B. Hook, Ph.D. Martin Rose, M.D., J.D.
Chairman, President & CEO Vice President, Clinical & Regulatory Affairs
Sparta Pharmaceuticals, Inc. Sparta Pharmaceuticals, Inc.
(215) 442-1700, Ext. 205 (215) 442-1700, Ext. 219
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FOR IMMEDIATE RELEASE
Sparta Pharmaceuticals, Inc. Signs Drug Delivery Pact
with Schering-Plough Corporation
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Spartaject(TM) Technology to be applied to TEMODAL(R)
Horsham, PA, April 22, 1998, Sparta Pharmaceuticals, Inc. (NASDAQ: SPTA, SPTAU,
SPTAW, SPTAZ AND SPTAL) signed a license agreement with Schering-Plough
Corporation (NYSE: SGP) for the use of Sparta's Spartaject(TM) technology.
Spartaject will be applied to Schering-Plough's oral anticancer agent,
TEMODAL(R) (temozolomide), which is currently in development for the treatment
of patients with recurrent malignant gliomas, such as gliobastoma multiforme and
anaplastic astrocytoma.
Sparta's Spartaject technology is a drug delivery system that allows poorly
water soluble and water insoluble compounds to be given by injection. The
Spartaject technology encapsulates fine particles of a specified insoluble drug
with a fatty (phospholipid) layer, permitting the creation of a suspension of
the drug, and allowing its intravenous injection without the use of potentially
toxic solubilizing agents. Sparta originally licensed the technology from RTP
Pharma (Montreal). An advantage of the Spartaject technology is that it has the
potential to be incorporated for use with many other drugs that are already FDA
approved, yet only available by oral delivery. Currently, Phase I trials are
underway in the US and UK using Spartaject(TM) busulfan, a product developed by
Sparta.
TEMODAL is an oral cytotoxic chemotherapeutic agent with demonstrated antitumor
activity. Schering-Plough has exclusive worldwide rights to market temozolomide
through a licensing agreement with Cancer Research Campaign Technology, Ltd., of
the United Kingdom.
Sparta believes application of Spartaject to TEMODAL may allow for intravenous
administration in patients that require high concentration levels in the blood
and/or for the administration of TEMODAL in localized areas in direct contact
with certain tumors.
Dr. Jerry B. Hook, Sparta's Chairman, President and CEO commented, " We are
pleased to be working with Schering-Plough in this effort to expand the TEMODAL
product line. Spartaject Technology has proven to be an effective and
potentially less toxic delivery system for water insoluble compounds. Our
preliminary work with temozolomide has encouraged both companies to move forward
with this project."
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Sparta will receive up-front licensing fees, milestone payments and royalties on
sales. QED Technologies of Malvern, PA acted as an advisor to Sparta in this
transaction.
This press release contains certain forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. Such statements are made based on management's current
expectations and beliefs, and actual results may vary from those currently
anticipated based upon a number of factors, including uncertainties inherent in
the drug development process, including the success and timing of clinical
trials and the receipt of necessary approvals by the FDA. The Company undertakes
no obligation to release publicly any revisions which may be made to reflect
events or circumstances after the date hereof.
Sparta is a development stage pharmaceutical company engaged in the business of
acquiring rights to, and developing for commercialization, technologies and
drugs for the treatment of a number of life threatening diseases including
cancer, cardiovascular disorders, chronic metabolic diseases and inflammation.
The Company has focused on acquiring compounds that have been previously tested
in humans and animals and technologies that may improve the delivery or
effectiveness of previously tested, and in some cases marketed, drugs. Sparta's
portfolio of compounds in development includes four potential oncology products
and one for the treatment of Type II diabetes in clinical trials and an emerging
platform technology in recombinant and small molecule protease inhibitors.
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