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):
October 13, 2011
Unigene Laboratories, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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0-16005
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22-2328609
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(State or other jurisdiction of
incorporation or organization)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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81 Fulton Street, Boonton, New Jersey
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07005
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(Address of principal executive offices)
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(Zip Code)
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(973) 265-1100
(Registrant’s telephone number, including area code)
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Section 8 – Other Events
Item 8.01. Other Events.
Novartis Pharma AG ("Novartis") has released the first interpretable results from its two-year Phase 3 study 2302 (the “2302 Study”) in osteoarthritis conducted by its license partner Nordic Bioscience with oral calcitonin. Novartis reports that preliminary analysis of the data showed both the primary and secondary endpoints of the study were not met. However, analysis of the data provided did show a positive safety profile for the oral calcitonin study drug. These findings are consistent with a previously reported independent Data Monitoring Committee’s futility analysis released in 2010 of one year data for all patients enrolled in the 2302 Study.
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.
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UNIGENE LABORATORIES, INC.
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By:
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/s/ Gregory T. Mayes | |
| Gregory T. Mayes, Vice President | |||
| Corporate Development and General Counsel | |||
Date: October 13, 2011