UNITED STATES
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 5, 2007
ARIAD Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware 0-21696 22-3106987
(State or other jurisdiction (Commission (I.R.S. Employer
of incorporation) File Number) Identification No.)
26 Landsdowne Street, Cambridge, Massachusetts 02139
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (617) 494-0400
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
|_| Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|_| Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
|_| Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
ITEM 8.01 Other Events.
In a press release dated April 5, 2007, ARIAD Pharmaceuticals, Inc.
announced that the Company has received feedback from the U.S. Food and
Drug Administration (FDA) regarding its Special Protocol Assessment on the
design and endpoints for its Phase 3 pivotal trial of oral AP23573, its
novel mTOR inhibitor, in metastatic sarcoma. Based on the FDA's response,
the Company intends to pursue its Phase 3 trial in the same treatment
setting as originally proposed (patients with metastatic sarcoma following
a favorable response to chemotherapy), with overall survival as the primary
endpoint and progression-free survival as a key secondary endpoint. As a
result, the Company anticipates that initiation of patient enrollment may
be delayed from the second to the third quarter of 2007. The Company
expects to provide further details concerning the registration trial based
on receipt of follow-up Protocol Assistance from the European Medicines
Agency (EMEA) and ongoing interactions with the FDA.
A copy of the press release is filed herewith as Exhibit 99.1 and the
information contained therein is incorporated by reference into this Item
8.01 of this Current Report on Form 8-K.
ITEM 9.01 Financial Statements and Exhibits.
(c) The following exhibits are filed with this report
Exhibit
Number Description
------ -----------
99.1 Press release dated April 5, 2007.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
ARIAD Pharmaceuticals, Inc.
By: /s/ Edward M. Fitzgerald
-----------------------------------------------------
Edward M. Fitzgerald
Senior Vice President, Finance and Corporate
Operations, Chief Financial Officer
Date: April 5, 2007
EXHIBIT INDEX
Exhibit
Number Description
- ------ -----------
99.1 Press release dated April 5, 2007.