Prospect Profile: Celladon Corporation
Prospect Profile highlights a newly funded bio/pharmaceutical company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities.
Celladon Corporation is a U.S. public pharmaceutical company that develops treatments for cardiovascular diseases through the application of scientific discoveries in molecular cardiology. As reported in the August 21, 2014 issue of the PharmSource Lead Sheet, Celladon raised $43.7 million in the closing of a secondary public offering.
- Celladon was originally incorporated in California in December 2010. The company reincorporated in Delaware in April 2012.
- Corporate Headquarters: San Diego, California – 2,270 square feet of office space.
- As of March 24, 2014, Celladon had 16 employees.
- Celladon will use the proceeds for R&D activities related to MYDICAR, including activities related to seeking regulatory approval for the product and its companion diagnostic for the treatment of systolic heart failure and other indications, for the development of commercial manufacturing capabilities, and for working capital and general corporate purposes.
- The company relies on third parties to conduct some or all aspects of vector production, product manufacturing, combination product commercial supply, companion diagnostic testing, reagent manufacturing, and protocol development.
To date, Celladon has only entered into a single clinical-scale binding manufacturing agreement with Lonza to support clinical trials.
- The company relies on third parties to conduct, supervise, and monitor preclinical and clinical trials.
Celladon relies on third parties to store and distribute vectors and products for all clinical trials.
The company currently does not have an organization for sales, marketing and distribution of products.
- In January 2008, Celladon entered an agreement with AskBio for a license to recombinant AAV vectors to develop MYDICAR.
- In February 2009, Celladon entered into an agreement with AdVec to use human embryo kidney cells transformed by Adenovirus 5 DNA, or 293 Cells, and AdVec expertise in testing MYDICAR.
- In November 2010, Celladon entered into an agreement with Virovek for a license to AAV baculovirus technology for AAV1/GFP vector reagents for a companion diagnostic.
- In June 2012, Celladon entered into an agreement with AmpliPhi for AAV1 vectors for the development of companion diagnostics for MYDICAR.
- In August 2012, Celladon entered into an agreement with Lonza for clinical production of MYDICAR.
- In February 2014, Celladon and Servier entered into an agreement under which Celladon gave compounds from its SERCA 2B modulator program to Servier.1
|Product Candidate||Indication||Dosage Form||Status||Next Anticipated Step|
|MYDICAR (SERCA 2A)||AV-Fistula Maturation Failure||Parenteral||Preclinical||Data expected in 2015. Company anticipates initiation of Phase IIa trial.|
|MYDICAR (SERCA 2A)||Diastolic Heart Failure||Parenteral||Preclinical||Initiation of clinical trials expected in 2015|
|SERCA 2B Small Molecule||Diabetes & Metabolic Disease||Unknown||Preclinical||TBA|
|SERCA 2B Small Molecule||Neurodegenerative Disease||Unknown||Preclinical||TBA|
|Stem Cell Factor||Cardiovascular||Unknown||Preclinical||TBA|
|MYDICAR (SERCA 2A)||Advanced Heart Failure with left-ventricular assist device (LVAD)||Parenteral||Phase I/II||TBA|
|MYDICAR (SERCA 2AA)||Systolic Heart Failure||Parenteral||Phase II/III||Data expected in April 2015|
|(In $ thousands)||2013||2014|
|General & Administrative Expenditures||3,037||2,631|
|Total Operating Expenses||19,964||15,945|
1 Celladon Corp Annual Report, SEC.gov
|Celladon Corporation||Key Officers|
|11988 El Camino Real, Suite 650||Krisztina M. Zsebo, PhD, CEO|
|San Diego, CA 92130, USA||Paul Cleveland, President & CFO|
|Phone: 858-366-4288||Ryan K. Takeya, VP, Manufacturing|
|Fax: 858-964-0974||Jeffrey J. Rudy, VP, Clinical Operations|
|Web: www.celladon.com||Roger Provost, Senior Director, R&D|