Lonza Inc. and Celladon Corporation Announce Manufacturing Agreement for MYDICAR®
Published: Oct 02, 2012
HOUSTON and SAN DIEGO, Oct. 2, 2012 /PRNewswire/ -- Lonza, a global leader in the field of viral therapy manufacturing, and Celladon Corporation, a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, today announced that they have entered into a process transfer and GMP manufacturing agreement. Under the terms of the agreement, Lonza will manufacture cGMP-grade MYDICAR (AAV1/SERCA2a) for use in future clinical trials. In the event Celladon intends to commence commercial scale manufacture of MYDICAR, Celladon and Lonza have agreed to negotiate a commercial scale supply agreement.
"We are pleased to partner with Celladon in the manufacture of MYDICAR," said David Enloe, Lonza's Head of Viral-based Therapeutics. "In particular, this is an exciting project for Lonza in that we will be producing materials for Celladon beginning at the 1,000 liter scale and likely expanding to 2,000 liters, which our recently completed and validated GMP suite was specifically designed to support."
Lonza offers a full range of services that cell and gene therapy clients rely upon for commercial success. Each client is provided with a team of scientists equipped with the knowledge and experience required to translate therapies into scalable, clinical-grade products complete with process development activities, product quality testing, product storage, and distribution.
"This is an important milestone in the MYDICAR development program," said Krisztina Zsebo Ph.D., President and CEO of Celladon Corporation. "Lonza's large scale viral manufacturing expertise will greatly complement and support our future development and commercialization efforts for MYDICAR."
MYDICAR is a genetically targeted enzyme replacement therapy intended to restore levels of SERCA2a, a regulator of calcium cycling in the heart and cardiac contractility. SERCA2a levels decline in all forms of late-stage Heart Failure resulting in deficient heart function. With MYDICAR, the SERCA2a gene is delivered using recombinant adeno-associated virus (AAV) as the vector. AAV is a naturally occurring virus not associated with any disease in humans. MYDICAR is delivered in a single dose directly to the heart during a routine outpatient cardiac catheterization procedure, similar to an angiogram. MYDICAR is currently under clinical investigation in a 200 patient Phase 2b clinical trial in NYHA Class III/IV heart failure patients.
Celladon is a privately held biotechnology company founded with the goal of becoming the leader in developing molecular therapies for the treatment of heart failure and cardiac diseases. The company's lead product, MYDICAR, targets the key enzyme deficiency in advanced heart failure, SERCA2a, which regulates calcium cycling and contractility in heart muscle cells. A recent Phase 2 clinical trial demonstrated sustained improvement at one year in cardiac function parameters and quality of life. A 200 patient Phase 2b study of MYDICAR was initiated in August, 2012. Celladon also conducts pre-clinical research on a proprietary platform of small molecule activators of SERCA enzymes for the treatment of metabolic and cardiovascular diseases. Further information can be found at www.celladon.net.
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers' needs from research to final product manufacture. It is the global leader in the production and support of chemical and biological active pharmaceutical ingredients. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts, which play an important role in the development of novel medicines and healthcare products. Lonza is also the world leader in microbial control providing innovative, chemistry-based and related solutions to destroy or to selectively inhibit the growth of harmful microorganisms. Its activities encompass the areas of water treatment, personal care, health and hygiene, industrial preservation, materials protection, and wood treatment. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition and agro markets. Lonza 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 is not subject to the SGX-ST's continuing listing requirements. Lonza is subject to the listing rules of the SIX Swiss Exchange, which do not have specific requirements equivalent to the listing rules of the SGX-ST in respect of interested person transactions, acquisition and realizations, and delisting. In 2011, the company had sales of CHF 2.69 billion. Further information can be found at www.lonza.com.
SOURCE Celladon Corporation