- Agreement enhances existing relationship between Celladon and Lonza for the manufacture of MYDICAR®
- Lonza to initiate design of a new commercial viral therapeutics facility in Portsmouth, NH (USA)
- Celladon obtains option to trigger construction of facility and commit to long-term commercial supply
- Lonza to purchase $10 million of Celladon common stock upon Celladon's decision to trigger construction and commitment for commercial supply
BASEL, Switzerland and SAN DIEGO, Nov. 3, 2014 (GLOBE NEWSWIRE) -- Lonza, a global leader in the field of viral therapy and biologics manufacturing and Celladon Corporation (Nasdaq:CLDN), a biotechnology industry leader in the field of cardiovascular gene therapy, announced today that they have entered into an agreement providing for the future commercial production of MYDICAR® (AAV1/SERCA2a), Celladon's enzyme replacement therapy for advanced heart failure that is currently in Phase 2b clinical development. This agreement follows a successful multi-year clinical manufacturing relationship and provides for initiation of pre-construction activities and the reservation of Lonza resources giving Celladon an opportunity to trigger construction of the dedicated facility and secure a long term commercial supply arrangement. The establishment of this facility construction and commercial supply agreement provides Celladon with a strategic path to commercial supply, including plans for a dedicated cGMP production train within a new state-of-the-art viral therapy facility.
In the near term, Lonza will complete a detailed engineering design for the facility to be located in Portsmouth, NH (USA). The facility will be separate from Lonza's existing clinical and commercial mammalian operations facility also located in Portsmouth. In exchange for a reservation fee, Celladon has the option to trigger construction of the facility with a multi-year commitment to Lonza for the supply of MYDICAR®. Upon the trigger, Lonza will purchase from Celladon shares of Celladon common stock valued at $10 million.
Upon completion of the new manufacturing facility, Lonza is to transfer Celladon's 2000 liter commercial-scale process from Lonza's Houston facility to the new facility in Portsmouth. Process validation is expected to be completed in the new Portsmouth facility.
"This strategic collaboration for Celladon's cGMP production and future expansion of our viral therapy manufacturing capabilities is an exciting endeavor for Lonza," said Marc Funk, COO, Lonza Pharma & Biotech. "This extended partnership continues to reflect Lonza's track record as a trusted partner for the scale-up of emerging technologies in preparation for commercial launch. We are committed to the commercial manufacturing market and to the advancement of potentially life-saving treatments like MYDICAR®."
"Our previous multi-year relationship with Lonza has helped us rapidly advance the clinical manufacture of MYDICAR", said Krisztina Zsebo, Ph.D., Chief Executive Officer at Celladon. "As we continue to progress the development of MYDICAR®, we are pleased to announce this expansion of our partnership with Lonza in support of future commercial supply."
About Lonza
Lonza is one of the world's leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 10,000 employees worldwide. The company generated sales of about CHF 3.6 billion in 2013 and is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients. Further information can be found at www.lonza.com.
About Celladon
Celladon is a clinical-stage biotechnology applying its leadership position in the field of cardiovascular gene therapy to develop novel therapies for diseases with tremendous unmet medical needs. Our lead programs target SERCA enzymes which are a family of enzymes that play an integral part in the regulation of intra-cellular calcium in all human cells. Calcium dysregulation is implicated in a number of important and complex medical conditions and diseases, such as heart failure, vascular disease, diabetes and neurodegenerative diseases. MYDICAR, the Company's most advanced product candidate, uses gene therapy to target SERCA2a, which is an enzyme that becomes deficient in patients with advanced heart failure. Celladon has completed enrollment of a 250 patient Phase 2b clinical trial evaluating the efficacy of MYDICAR in reducing the frequency of, or delaying heart failure-related hospitalizations. This randomized, double-blind, placebo-controlled, multinational trial is evaluating a single intracoronary infusion of MYDICAR versus placebo added to a maximal, optimized heart failure regimen in patients with New York Heart Association class III or IV symptoms of chronic heart failure due to systolic dysfunction. The Company has received Breakthrough Therapy designation from the FDA for this MYDICAR program and expects to report results from the Phase 2b clinical trial in April 2015. In addition, Celladon has identified a number of potential first-in-class compounds addressing novel targets in diabetes and neurodegenerative diseases with its small molecule platform of SERCA2b modulators. For more information, please visit www.celladon.com.
Additional Information and Disclaimer
Lonza Group Ltd is headquartered in Basel, Switzerland, and is listed on the SIX Swiss Exchange and secondary listed on the Singapore Exchange Securities Trading Limited ("SGX-ST"). Lonza Group Ltd is not subject to the SGX-ST's continuing listing requirements. Lonza Group Ltd is subject to the listing rules of the SIX Swiss Exchange, which does not have specific requirements equivalent to the listing rules of the SGX-ST for interested person transactions, acquisition and realizations and delisting.
Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.
Celladon Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the potential construction of the new dedicated Portsmouth facility, including Celladon's decision as to whether to exercise the option and commit to the long-term supply arrangement with Lonza; the expected attributes of the facility; plans for the transfer of the 2000 liter commercial-scale process and process validation; Lonza's purchase of the $10M in common stock of Celladon, which is contingent on Celladon exercising the option; the potential future long-term supply of MYDICAR by Lonza, as well as Celladon's plans to research, develop and commercialize product candidates, and the expected timing of the MYDICAR Phase 2b data. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Celladon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the process of conducting product development activities and clinical trials and obtaining regulatory approval to commercialize product candidates, our reliance on third parties, the need to raise additional funding when needed in order to conduct our business, and the degree of market acceptance of MYDICAR by physicians, patients, third-party payors and others in the medical community. These and other risks and uncertainties are described more fully in Celladon's filings with the Securities and Exchange Commission, including without limitation its Form 10-Q for the quarter ended June 30, 2014. All forward-looking statements contained in this press release speak only as of the date on which they were made. Celladon undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.