Key Developments For Targeted Genetics Corporation
Targeted Genetics Corporation (TGEN.O) (Consolidated Issue listed on NASDAQ Capital Market)
Targeted Genetics Corporation Announces Sale Of Manufacturing Assets To Genzyme Corporation
Targeted Genetics Corporation announced the sale to Genzyme Corporation of certain assets, including manufacturing technologies and other adeno-associated viral (AAV) vector technology, for up to $7 million in cash. The purchased assets consist primarily of patents, know-how and manufacturing-related equipment. Genzyme also received a license to use certain technology and materials necessary for manufacturing AAV vectors. As part of the transaction, Targeted Genetics has agreed to work with Genzyme to transfer the acquired technology and assist Genzyme in its implementation of the technology. Genzyme has agreed to pay $3.5 million within five days of the closing and an additional $3.5 million in installments payable upon successful completion of specified transfer plan deliverables. Targeted Genetics expects the transition plan to be completed by the end of 2009. In addition, Targeted Genetics will receive revenue from Genzyme in the event that Genzyme sublicenses the acquired intellectual property within specified time periods, and will receive royalties in the event of commercial sales of products containing AAV vectors covered by the acquired intellectual property. As part of the transaction, Genzyme has licensed back to Targeted Genetics the AAV manufacturing and vector technology sold to Genzyme for Targeted Genetics' use in specified product programs, including the development and sale of products in Targeted Genetics' current AAV gene therapeutic programs.
Targeted Genetics Corporation Receives Nasdaq Delisting Notice
Targeted Genetics Corporation announced that it has received a letter from the Nasdaq Stock Market indicating that the Company has failed to regain compliance with Nasdaq Listing Rule 5550(b), which requires companies listed on the Nasdaq Capital Market to maintain a minimum of $2.5 million in shareholders' equity, $35 million in market value of listed securities or $500,000 in net income from continuing operations. The Nasdaq staff has therefore determined to delist the Company's common stock from the Nasdaq Capital Market effective at the opening of business on August 3, 2009. The Nasdaq staff determination follows an April 8, 2009 notification letter from the Nasdaq Stock Market.
Targeted Genetics Corporation Terminates Bothell Facility Lease Agreement
Targeted Genetics Corporation announced the termination of the lease for its facility in Bothell, Washington. The facility was originally leased in 2000 to establish a clinical and commercial manufacturing facility, but the Company never occupied or commenced construction of the facility. The lease covered 76,000 square feet of space and, under its terms, would have expired in September 2015. Under the terms of the lease termination agreement, the Company will be released from up to approximately $12 million in estimated payment obligations and other liabilities under the lease in exchange for a termination fee of $500,000, to be paid in installments beginning at the execution of the agreement and continuing through July 2010. The termination agreement includes obligations to accelerate payments, in whole or in part, upon the occurrence of certain events that generate cash for the Company. The Company continues to pursue additional capital through strategic transactions, licensing or selling technology, product development collaborations, and sales of stock. The Company also continues its negotiations to reduce or eliminate its other facility costs.
Targeted Genetics Corporation Announces Continued Clinical Study At University College London/Moorfields Eye Hospital For Gene
Targeted Genetics Corporation announced that its collaborator at the University College London/Moorfields Eye Hospital (UCL/M) has begun the next step in its Phase 1/2 dose escalation clinical trial to treat a form of Leber's Congenital Amaurosis caused by defects in the gene encoding the RPE65 protein. Leber's Congenital Amaurosis, or LCA, is an inherited disease that typically results in blindness. Under an amended protocol to its Phase 1 /2 dose escalation clinical trial, UCL/M is approved to include younger LCA patients in the trial and treat patients with higher doses of an adeno-associated virus (AAV) vector containing the RPE65 gene. Results from the first stage of this open label, single center, Phase 1/2 clinical study were reported in April 2008 in three young adults between the ages of 23 and 17 years of age with early-onset severe retinal dystrophy. Data demonstrated that administration improved visual function as measured by visual field tests and improvement in subjective tests of visual mobility in one patient. The study resulted in no serious adverse events and findings supported further clinical studies. Completion of the current trial is anticipated in the second half of 2010. The primary endpoint of this study is to determine whether AAV vector-mediated gene delivery to the retina is safe, and the secondary endpoint is to determine whether efficacy can be demonstrated in humans.
Targeted Genetics Corporation Announces Renegotiation Of Its Relationship With Celladon Corporation
Targeted Genetics Corporation 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). 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, 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 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,
