SEATTLE, WA, Mar 02, 2009 (MARKET WIRE via COMTEX) -- Targeted Genetics Corporation (NASDAQ: TGEN) today announced the
continuation of a product-focused realignment strategy that includes
a renegotiation of its relationship with Celladon Corporation and the
transfer of its Adeno-Associated Viral (AAV) vector manufacturing
know-how to contract manufacturing organizations (CMOs).
"While we have begun internal efforts in connection with our
manufacturing campaign with Celladon that is expected to run through
the first half of 2009 and continue to seek financing for our
therapeutic development and manufacturing operations, we have
concluded that accessing a CMO in addition to, or instead of, funding
our own internal manufacturing capabilities could provide operational
and financial flexibility in addressing future manufacturing needs,"
said B.G. Susan Robinson, president and chief executive officer of
Targeted Genetics. "Relying on CMOs for future manufacturing needs
could significantly reduce the funding we need to continue our
operations."
As part of this strategy to transfer its manufacturing technology,
Targeted Genetics has entered into new license and manufacturing
agreements with Celladon that replace the prior agreements with
Celladon.
Under the terms of the new agreements, Targeted Genetics granted
Celladon exclusive use of certain proprietary Adeno-Associated Viral
(AAV) vector technology in an expanded field, including heart
failure, where changes in calcium cycling have contributed to or
caused disease conditions. The agreements enable Celladon to
manufacture MYDICAR(R), a genetically-targeted enzyme replacement
therapy for heart failure, through CMOs or a commercial product
development partner. Celladon agreed to increase the payments to
Targeted Genetics in the first six months of 2009 to support Targeted
Genetics' manufacture of MYDICAR for phase III clinical studies.
Targeted Genetics also granted Celladon control over CMOs it may use
for future manufacturing of therapeutic product candidates in the
permitted field. In addition, Celladon and Targeted Genetics agreed
to a new milestone and royalty structure on development and
commercialization of products in the permitted field. Celladon also
has the right to terminate the agreement without cause on sixty days
notice after June 30, 2009. If Celladon is successful in
commercializing a product covered by the license agreement, Targeted
Genetics could receive significant future revenue pursuant to the
milestone and royalty provisions of the agreements.
Based on the increased Celladon revenue expected in 2009 in
combination with reduced infrastructure costs, decreased external
program support costs and other spending reductions, Targeted
Genetics now projects adequate cash and short term investments to
support operations through the first half of 2009.
As a result, the Company continues to seek financing for continued
operations. Such efforts include equity financing, strategic
transactions, and the sale of individual technology assets. If
raised, the Company expects that funding would be utilized to support
ongoing product development efforts in ocular and neurological
indications and/or earlier stage opportunities identified by the
company focusing on AAV to deliver RNA therapeutics, which include
interfering RNA sequences and microRNAs. If the Company is not
successful in the near-term with raising additional capital, it
intends to phase out its manufacturing operations infrastructure
following completion of the current Celladon manufacturing campaign.
Such a reduction would include reducing its manufacturing headcount
from approximately 35 full-time equivalent staff to five or fewer
manufacturing-related staff and also include other infrastructure
cost reductions. Targeted Genetics is also evaluating other
alternatives if the Company is unable to secure sufficient funding
for its continued operations.
Targeted Genetics' product development efforts are focused on a
treatment for severe retinal dystrophies, most commonly diagnosed as
Leber's Congenital Amaurosis (LCA), and additional programs in
Huntington's Disease (HD) and Amyotrophic Lateral Sclerosis (ALS).
The Company is also reaching the end of its current HIV/AIDS vaccine
product candidate work with the Children's Hospital of Philadelphia
as that program enters clinical testing, has suspended most external
spending on its Company-funded programs and expects to advance its
inflammatory arthritis candidate only with funding from a partner or
collaborator.
Ms. Robinson added, "We believe the Targeted Genetics technology
platform and product pipeline are built on a solid foundation of gene
delivery intellectual property and on core capabilities in critical
functions that include preclinical development, clinical and
regulatory affairs and manufacturing of innovative gene-based product
candidates. Although market conditions are challenging, our efforts
continue to be focused on maximizing value for our stakeholders."
About Targeted Genetics Corporation
Targeted Genetics Corporation is a biotechnology company committed to
the development of innovative therapies for the prevention and
treatment of diseases with significant unmet medical need. A key
area of focus for Targeted Genetics is applying its proprietary
Adeno-Associated Virus (AAV) technology platform to deliver genetic
constructs to increase gene function or silence gene function.
Targeted Genetics' lead product development efforts target ocular and
neurological indications, two therapeutic areas where AAV delivery
may have competitive advantages over other therapeutic modalities.
To learn more about Targeted Genetics, visit its website at
www.targetedgenetics.com.
Safe Harbor Statement under the Private Securities Litigation Reform
Act of 1995:
This release contains forward-looking statements regarding the
Company's liquidity and financial resources, its ability to fund
ongoing and future operations and its business strategy and product
development strategy and manufacturing capabilities strategy,
including statements regarding the Company's ability to continue its
operations, raise capital or secure other financial resources in the
near term, the extent of the Company's cash horizon, the potential
benefits of the Company's agreements with Celladon and the potential
impact of the results of such programs on the Company's operations,
the nature and results of the Company's research and development
programs and the potential impact of the results of such programs on
the Company's operations, the Company's ability to monetize assets
and other statements about the Company's 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 and cause actual results to differ
materially from those expected or implied by the forward-looking
statements. Factors that could affect actual future events or
results include, but are not limited to, the risk that the Company
will run out of cash earlier than expected, the risk that the Company
will not be able to raise capital or secure other financial resources
in the near term, the risk that Celladon will not successfully
commercialize a product covered by its license agreement with the
Company or that such product development efforts will be delayed or
terminated, the risk that payments under the agreements with Celladon
are not received when expected or at all, the risk that Celladon
will terminate the relationship with the Company' or that the
relationship with Celladon will not be as successful as expected, the
risk that the Company's research and development programs are not
successful or are delayed or terminated, the risk that the Company
will not successfully transfer its manufacturing processes and
know-how to a third party contract manufacturing organization, the
risk that payments anticipated by the Company under its product
development collaboration, contracts and grant are not earned or
received when expected or at all, the risk that the Company will not
be able to sell or otherwise monetize its assets and the risk that the
Company will not be able to maintain its listing on the NASDAQ Capital
Market as well as other risk factors described in "Item 1A. Risk
Factors" in the Company's most recent quarterly report on Form 10-Q
for the period ended September 30, 2008 filed with the SEC. You
should not rely unduly on these forward-looking statements, which
apply only as of the date of this release. The Company undertakes no
duty to publicly announce or report revisions to these statements as
new information becomes available that may change the Company's
expectations.
Media Contact:
Stacie D. Byars
206.660.2588
Email Contact
SOURCE: Targeted Genetics