-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WM65bdOea67qChs5pT1iHrxUvWEYIutkRULLzakBx/2fATwKvOL4C8HZ9HSDhdYP r6msY5Lo+hnLrsgQ1+fIyA== 0001144204-06-052584.txt : 20061214 0001144204-06-052584.hdr.sgml : 20061214 20061214145038 ACCESSION NUMBER: 0001144204-06-052584 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20061207 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061214 DATE AS OF CHANGE: 20061214 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TARGETED GENETICS CORP /WA/ CENTRAL INDEX KEY: 0000921114 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 911549568 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23930 FILM NUMBER: 061276823 BUSINESS ADDRESS: STREET 1: 1100 OLIVE WAY STREET 2: STE 100 CITY: SEATTLE STATE: WA ZIP: 98101 BUSINESS PHONE: 2066237612 MAIL ADDRESS: STREET 1: 1100 OLIVE WAY STREET 2: STE 100 CITY: SEATTLE STATE: WA ZIP: 98101 8-K 1 v060333_8k.htm Unassociated Document
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): December 7, 2006
 
Targeted Genetics Corporation 
(Exact name of registrant as specified in its charter)
 
 
 
 
 
 
Washington
 
0-23930
 
91-1549568
(State or other jurisdiction
of incorporation)
 
(Commission File
Number)
 
(IRS Employer
Identification No.)

1100 Olive Way, Suite 100, Seattle, Washington
 
98101
(Address of principal executive offices)
 
(Zip Code)

Registrant’s telephone number, including area code
 
(206) 623-7612

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 (see General Instruction A.2. below):

¨
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 1.01. Entry into a Material Definitive Agreement. 

     On December 7, 2006, Targeted Genetics Corporation and Amsterdam Molecular Therapeutics B.V., or AMT, entered into a non-exclusive license agreement, or the License Agreement. Under the License Agreement, Targeted Genetics granted AMT a non-exclusive sublicense with respect to two patents issued to the University of Pennsylvania and exclusively licensed to Targeted Genetics pursuant to a license agreement entered into between Targeted Genetics and the University of Pennsylvania with the effective date of June 1, 2002. In exchange, AMT agreed to pay Targeted Genetics an upfront payment of $1,750,000 upon execution of the License Agreement, royalties on net sales of Licensed Products (as defined therein), milestone payments upon the achievement of certain product development targets and annual maintenance payments to offset maintenance of the underlying license.

     The rights granted under the License Agreement will allow AMT to use AAV1 in the development and commercialization of therapeutic products for treating type I and type V lipoprotein lipase deficiencies, or LPL deficiencies. LPL deficiency in humans is a severe and debilitating disease associated with extremely high serum triglyceride concentrations, high morbidity and increased mortality. AMT is currently conducting Phase II trials of AMT-011, an AAV1- based therapy for type 1 LPL deficiency.
 
     Targeted Genetics’ press release regarding entry into the License Agreement is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
 
Item 9.01 Financial Statements and Exhibits. 

(d) Exhibits:
 
 
 
99.1
 
Press Release of Targeted Genetics Corporation dated December 12, 2006
 

 
SIGNATURES

     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.
 
 
TARGETED GENETICS CORPORATION
 
 
 
 
 
 
 
By:  
/s/ David J. Poston 
 
 

David J. Poston
 
 
Vice President Finance and Chief Financial Officer
 
Dated: December 14, 2006
 
 

 
INDEX TO EXHIBITS
 
 
 
 
99.1
 
Press Release of Targeted Genetics Corporation dated December 12, 2006




EX-99.1 2 v060180_ex99-1.htm Unassociated Document
Exhibit 99.1

GENETICS LOGO®

Investor and Media Contact:
Stacie D. Byars
Director, Communications
Targeted Genetics Corporation     
(206) 521-7392

TARGETED GENETICS LEVERAGES VALUE OF ITS AAV PATENT ESTATE IN LICENSING AGREEMENT WITH AMSTERDAM MOLECULAR THERAPEUTICS
-Non-exclusive license covers the use of Targeted Genetics’ AAV1 technology
in the treatment of lipoprotein lipase deficiencies-

Seattle, WA - December 12, 2006 - Targeted Genetics Corporation (Nasdaq: TGEN) today announced that the company has licensed two patents in its broad portfolio of AAV intellectual property to Amsterdam Molecular Therapeutics B.V. (AMT). The non-exclusive license to U.S. patents #6,759,237 and #7,105,345, which were issued to the University of Pennsylvania and exclusively licensed to Targeted Genetics, provides AMT with the rights to use AAV1 in the development and commercialization of therapeutic products for treating type I and type V lipoprotein lipase (LPL) deficiencies. AMT currently is conducting Phase II trials of AMT-011, an AAV1-based therapy for type I LPL deficiency, and anticipates launching the product in the European Union in 2008. LPL deficiency in humans is a severe and debilitating disease associated with extremely high serum triglyceride concentrations, high morbidity, and increased mortality.

Under the terms of the non-exclusive license, Targeted Genetics will receive an upfront payment from AMT of $1,750,000, as well as milestone payments and royalties on the sale of any products commercialized using the licensed technology.

“This agreement demonstrates our ability to leverage our portfolio of AAV-related intellectual property assets to generate revenue for Targeted Genetics and value for our shareholders,” said H. Stewart Parker, president and chief executive officer of Targeted Genetics. “In addition, it allows us to participate, financially, in the commercialization of AAV therapeutics by others. We are truly seeing the expansion of interest in AAV-based molecular medicines as a therapeutic platform. AMT-011 could be the first commercially available AAV-based therapeutic and may provide us with relatively near-term milestones and potential royalty revenue streams to support our internal product development efforts. We wish AMT success as they move this therapeutic candidate through development.”

AMT-011 uses a recombinant AAV1 vector to deliver the gene encoding lipoprotein lipase. In preclinical studies, AMT-011 has demonstrated effective replacement of LPL gene function, leading to complete normalization of triglyceride levels in two different LPL deficient animal models. A pivotal trial of AMT-011 in patients with type 1 LPL deficiency was initiated in December 2005 and is ongoing.

"This license is a key step in AMT’s commercialization strategy of its lead drug candidate AMT-011. This breakthrough gene therapy may allow AMT to provide patients suffering from a serious, debilitating and often life-threatening metabolic disease, caused by a monogenetic defect, a fundamental cure", said Ronald H.W. Lorijn, MD, PhD, M.B.A., Chief Executive Officer of AMT.


 
About LPL Deficiency
 
LPL deficiency is caused by a deficiency or loss of LPL, the principal enzyme involved in the clearance of triglycerides from the bloodstream. Affected patients develop chronic pancreatitis, ultimately resulting in diabetes mellitus. The dysregulation in lipid metabolism that occurs in LPL deficiency also predisposes affected patients to cardiovascular diseases, including coronary artery disease and heart attack. Currently, the only effective treatment for the condition is a severe reduction in the consumption of dietary fat, a regimen to which many patients have difficulty adhering. AMT estimates the worldwide population of LPL type 1 deficiency at 4,000 patients and LPL type V deficiency at approximately 100,000.

About Targeted Genetics
 
Targeted Genetics Corporation is a biotechnology company committed to the development of innovative targeted molecular therapies for the prevention and treatment of acquired and inherited diseases with significant unmet medical need. Targeted Genetics’ proprietary Adeno-Associated Virus (AAV) technology platform allows it to deliver genes coding proteins to increase gene function, as well as RNAi to decrease or silence gene function. Targeted Genetics’ product development efforts target inflammatory arthritis, AIDS prophylaxis, congestive heart failure and Huntington's disease. To learn more about Targeted Genetics, visit the Company's website at www.targetedgenetics.com.

About AMT 
 
Amsterdam Molecular Therapeutics BV is a fully integrated gene therapy company founded by scientists of the University of Amsterdam Medical Center (AMC) in 1998. AMT focuses on the development of gene-based therapies for orphan metabolic, central nervous system and ocular diseases. AMT’s long-term gene expression technology is based on specific delivery of therapeutic genes into target organs or tissues. Its lead product, AMT-011, is in phase II for the first indication: treatment of lipoprotein lipase deficiency type I. For further information, visit AMT’s website at www.amtbv.com .

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
 
This release contains forward-looking statements regarding our licensee’s ability to develop, manufacture, accurately interpret clinical results, obtain regulatory approvals and commercialize any therapeutic products covered under the license agreement, the market prospects for any therapeutic products covered under the license agreement, our benefits, including milestone and royalty payments, that we expect to derive as a result of this license, and other statements about our plans, objectives, intentions and expectations. These statements, involve current expectations, forecasts of future events and other statements that are not historical facts. Inaccurate assumptions and known and unknown risks and uncertainties can affect the accuracy of forward-looking statements. Factors that could affect our actual results include, but are not limited to, our ability to obtain, maintain and protect our intellectual property, our ability to raise capital when needed, our licensee’s ability to recruit and enroll suitable trial participants, the timing, nature and results of research and clinical trials of our license, potential developments of alternative technologies or more effective processes by parties other than the licensee, and, our licensee’s ability to obtain and maintain regulatory or institutional approvals, as well as other risk factors described in "Part I, Item 1A. Risk Factors" in our most recent annual report on Form 10-K or "Part II, Item 1A. Risk Factors" in our most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission. You should not rely unduly on these forward-looking statements, which apply only as of the date of this release. We undertake no duty to publicly announce or report revisions to these statements as new information becomes available that may change our expectations.
 
# # #
 

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