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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: September 2, 1999
AUTOIMMUNE INC.
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(Exact name of registrant as specified in its charter)
Delaware 0-20948 13-3489062
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(State of incorporation (Comission (IRS Employer
or organization) File Number) Identification No.)
128 Spring Street, Lexington, MA 02421
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number: (781) 860-0710
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N/A
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(Former name or former address, if changed since last report.)
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Item 5. Other Events
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AutoImmune Inc. (The "Company") has received the Phase III trial results for
Colloral, and the results preclude the Company's continued development of
Colloral as a pharmaceutical product. While the drug was demonstrated to be very
safe, it did not meet the primary endpoint specified in the protocol. Consistent
with the data from previous trials, the Colloral treated group showed
substantial improvements from baseline for each of the "core four" measures. The
size of the placebo response, however, was much greater than that observed in
earlier trials.
Based on the results of the Phase III trial, the Company plans immediately to
reduce its number of employees and operating expenses to conserve resources and
will begin to evaluate strategic options to maximize shareholder value. The
Company has a patent portfolio. In addition, there are several externally funded
clinical trials ongoing, including multi-center studies in "new-onset" type 1
diabetes and pilot trials in chronic organ transplant rejection. The results of
these trials are expected next year. Enrollment is continuing in a long-term
prevention study for type 1 diabetes (DPT-1).
The Company also has an exclusive agreement with Teva Pharmaceutical Industries,
Ltd., for two applications of AutoImmune's proprietary technology for oral
immune modulation. The agreement covers the development by Teva of an oral
formulation of COPAXONE (glatiramer acetate), Teva's currently available
injectable drug for multiple sclerosis, and an oral formulation of Teva's
product to treat myasthenia gravis. AutoImmune is entitled to receive milestone
payments and royalties if the oral formulations of Teva's products are approved.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
AUTOIMMUNE INC.
By: /s/ Robert C. Bishop, Ph.D.
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Robert C. Bishop, Ph.D.
Chairman and Chief Executive Officer
Date: September 2, 1999
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