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): JANUARY 14, 2002
EPIX MEDICAL, INC.
(Exact name of registrant as specified in its charter)
Delaware 000-21863 04-3030815
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
71 ROGERS STREET
CAMBRIDGE, MASSACHUSETTS 02142
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (617) 250-6000
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ITEM 5. OTHER EVENTS.
On August 30, 2001, the Registrant announced that Peter Wirth was elected to the
Registrant's Board of Directors. Mr. Wirth is currently the Executive Vice
President and Chief Legal Officer of Genzyme Corporation where he is responsible
for legal and corporate development functions as well as the Genzyme Molecular
Oncology and Geltex Pharmaceuticals business units. On September 30, 2001, Luke
B. Evnin resigned as a Director of the Registrant.
On September 27, 2001, the Registrant announced the results of its recently
completed Phase II trial that were presented at the XIIIth Annual International
Workshop on Magnetic Resonance Angiography in Madison, Wisconsin. Dr. Kent
Yucel, Director of Cardiovascular Imaging at Brigham & Women's Medical Center,
presented clinical results from the Phase II clinical trial involving the
Registrant's lead product in development, MS-325. The trial involved 240
patients at 20 sites in North America and was designed to compare the diagnostic
accuracy of five different doses of MS-325-enhanced MRI with that of X-ray
angiography in the aortoiliac vascular bed. The study confirmed that the
appropriate dose is the dose being administered in the Phase III trials that are
underway.
The Registrant had planned to conduct two 300-patient Phase III trials of MS-325
in the aortoiliac vascular bed. Enrollment in the first Phase III trial was
completed as of September 27, 2001 and the Registrant plans to release the
results of this trial early in 2002. The second aortioliac Phase III trial will
be complete upon the enrollment of only 150 patients. Based on the Registrant's
agreement with the U.S. Food and Drug Administration to expand MS-325's target
indication to include other vascular beds, the Registrant is submitting
protocols to the U.S. Food and Drug Administration to add arteries in the foot
and the renal arteries to the MS-325 Phase III program. As a result of these
changes, the Registrant expects to complete enrollment of these Phase III trials
in the third quarter of 2002.
The Registrant is filing a form of Placement Agency Agreement in connection
with Registrant's Registration Statement on Form S-3 (Reg No. 333-41782).
The press release announcing the election of Peter Wirth to the Board of
Directors of the Registrant, the press release announcing the results of the
Registrant's Phase II clinical trial and the form of Placement Agency
Agreement are each filed as exhibits to this Form 8-K, and are incorporated
by reference into this Item 5. The foregoing description of such documents
and the transactions contemplated therein are qualified in their entirety by
reference to such exhibits.
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ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits
10.1 Form of Placement Agency Agreement
99.1 Press Release of the Registrant, dated August 30, 2001
99.2 Press Release of the Registrant, dated September 27, 2001
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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.
EPIX MEDICAL, INC.
(Registrant)
Date: January 14, 2002 /s/ Stephen C. Knight
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Stephen C. Knight
President
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EXHIBIT INDEX
Exhibit Number Description
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10.1 Form of Placement Agency Agreement
99.1 Press Release of the Registrant, dated August 30, 2001
99.2 Press Release of the Registrant, dated September 27, 2001
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