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: July 18, 2006
(Date of earliest event reported)
Theravance, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction
of incorporation)
000-30319
(Commission File Number)
94-3265960
(IRS Employer
Identification Number)
901 Gateway Boulevard, South San Francisco, CA
(Address of principal executive offices)
94080
(Zip Code)
650-808-6000
(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:
- o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
- o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
- o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
- o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01. Entry into a Material Definitive
Agreement On July 18, 2006,
Theravance, Inc., a Delaware corporation ("Theravance") and Astellas
Pharma Inc., a Japanese corporation ("Astellas") amended their license,
development and commercialization agreement dated November 7, 2005 to
include Japan in their collaboration for the development and
commercialization of Theravance's investigational antibiotic, telavancin
(the "Amendment").
Under the terms of the
Amendment, Theravance grants Astellas an exclusive license to develop and
commercialize telavancin in Japan, and Astellas will pay Theravance a $10
million up-front payment. The Amendment also provides for a $5 million
regulatory milestone payment to Theravance if the marketing and sale of
telavancin is approved by Japanese regulatory authorities. In addition,
Theravance is entitled to royalties on global sales of telavancin that
will now include sales in Japan, and which, on a percent basis, range from
the high teens to the upper twenties. Astellas has the right to terminate
the collaboration in Japan for cause in certain circumstances, including
those based on the results of the complicated skin and skin structure
infections (cSSSI) clinical studies currently being conducted by
Theravance.
Under the terms of the
collaboration agreement, as amended, Theravance will lead the development
of telavancin for cSSSI and hospital-acquired pneumonia (HAP) and
collaborate substantially with Astellas in marketing in the U.S. for the
first three years. Astellas will lead all other development, regulatory,
manufacturing, sales and marketing activities worldwide, including Japan.
Theravance will be responsible for substantially all costs to develop
telavancin for cSSSI and HAP, and Astellas will be responsible for
substantially all costs associated with further development and
commercialization of telavancin.
In addition
to the license rights to telavancin in Japan, Astellas will also receive
an option to further develop and commercialize TD-1792 in Japan. TD-1792
is a unique heterodimer antibiotic compound that combines the
antibacterial activities of a glycopeptide and a beta-lactam in one
molecule. TD-1792 is currently in Phase 1 human clinical studies.
Item 9.01. Financial Statements and Exhibits
(d)
Exhibits
99.1 Press Release dated July 18, 2006 -
Theravance and Astellas Add Japan to Collaboration on Telavancin,
Investigational Antibiotic for Serious Infections
99.1 Press
Release of Theravance, Inc. dated July 18, 2006
SIGNATURE
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.
Dated: July 18, 2006
THERAVANCE, INC.
By: /s/ Rick E Winningham
Rick E Winningham
Chief Executive Officer
Exhibit Index
Exhibit No.
Description
99.1
Press Release of Theravance, Inc. dated July 18, 2006