SEATTLE--(BUSINESS WIRE)-- Targeted Genetics Corporation (Pink Sheets:TGEN) (the “Company”) announced today that its licensing partner, Celladon Corporation, has reported today that Celladon’s first Phase II trial with MYDICAR® for the treatment of advanced heart failure has met its primary safety and efficacy endpoints, as prospectively defined in the Phase II trial protocol.
The Company and Celladon first entered into collaboration and manufacturing agreements in 2004. In 2009, Targeted Genetics licensed its adeno-associated virus (AAV) vector serotype and manufacturing technology to Celladon and manufactured clinical supplies of MYDICAR. If MYDICAR is developed and commercialized by Celladon, then the Company could receive multiple milestone payments totaling up to $20 million, starting with a milestone payment should a MYDICAR Phase III human clinical trial commence. In addition, the Company could receive up to a 10% royalty on commercial sales of MYDICAR, subject to certain conditions. Alternatively, if Celladon enters into a partnering or other strategic transaction related to MYDICAR, the Company could receive a percentage of future partnering income or strategic transaction value received by Celladon and, in certain circumstances, a royalty of up to 10% on sales of MYDICAR.
Although Targeted Genetics’ AAV technology has been utilized to develop and manufacture MYDICAR, the MYDICAR clinical trials are sponsored, managed, funded, and the data are analyzed by Celladon without participation from Targeted Genetics. Targeted Genetics has not reviewed the data obtained by Celladon in its Phase II clinical trial. Please refer to the press release issued by Celladon as seen at www.celladon.net for additional information regarding the development of MYDICAR and Celladon’s MYDICAR clinical trial results.
“We look forward to disclosure of the full data from Celladon’s clinical trial at the Heart Failure Congress 2010 on May 30, 2010, and to the plans for future development of MYDICAR,” said Susan Robinson, President and CEO of Targeted Genetics. Ms. Robinson continued, “Should the product candidate MYDICAR proceed successfully through development and onto commercialization, it could provide a much needed advancement for the treatment of patients with heart failure, a significant clinical validation for the field of gene therapy, and a revenue stream for Targeted Genetics.”
About MYDICAR® and Celladon
To learn more about Celladon and MYDICAR, visit Celladon’s Web site at www.celladon.net.
About Targeted Genetics Corporation
Targeted Genetics Corporation is a biotechnology company committed to the development and commercialization of innovative therapies for the prevention and treatment of diseases with significant unmet medical need. To learn more about Targeted Genetics, visit its website at www.targetedgenetics.com.
DISCLAIMER, CERTAIN FORWARD-LOOKING STATEMENTS AND FACTORS THAT MAY AFFECT FUTURE RESULTS
The Company does not have any independent knowledge of the data that Celladon has relied upon to report that it has met the MYDICAR Phase II clinical trial endpoints. Accordingly, this press release should not be considered an endorsement or confirmation of the Phase II trial results obtained by Celladon. In addition, this press release contains certain forward-looking statements concerning the Company’s financial position and results of its third-party licensees, including, without limitation, Celladon Corporation’s product development efforts, and the potential future impact of such product development efforts, if any, on the Company. These forward-looking statements involve significant risks and uncertainties. Although the Company believes that the expectations reflected in such forward-looking statements are based on reasonable assumptions, readers are cautioned that the Company can provide no assurances that such expectations will prove correct and that actual results and developments may differ materially from those conveyed in such forward-looking statements. Factors that could cause actual results to differ materially from the expectations reflected in the forward-looking statements in this press release include, but are not limited to, the risk that the MYDICAR program data will not support further development of the product, that MYDICAR product development will be unsuccessful or not continue as planned, on the timeline anticipated, or at all, the risk that the Company's current financial resources and future financial resources (if any) will be insufficient to enable the Company to fund continuing operations, the risk that the Company will not receive anticipated future revenue streams, the risk that the Company will run out of cash earlier than expected, the risk that the Company will not receive milestone or other payments from the Company’s product development partners and collaborators or that the Company’s and its collaborators’ product development efforts will be unsuccessful, the risks of accomplishing the Company’s business plan, as well as those factors described in the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2009, filed November 16, 2009, with the Securities and Exchange Commission. In addition, the Company has deregistered its common stock and is no longer subject to certain periodic financial reporting obligations with the Securities and Exchange Commission. Accordingly, the financial data available to the public in respect to the Company are dated, the Company is under no current obligation to update such data, and such data cannot be relied upon to accurately reflect the Company’s current or future financial condition or results of operations.
Targeted Genetics Corporation
For Media and Investor Inquiries:
Susan Robinson, 206-521-7330
President and Chief Executive Officer
KEYWORDS: United States North America Washington
INDUSTRY KEYWORDS: Health Biotechnology Cardiology Clinical Trials Genetics Pharmaceutical