News

Article

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-03-04-2015
Volume11
Issue 3

Novasep to Manufacture Celladon's Mydicar API

Novasep has entered into an agreement with Celladon to provide scale-up and pre-validation studies for the drug substance for MYDICAR.

 

Novasep has entered into an agreement with Celladon, a clinical-stage biotechnology company, to provide scale-up and pre-validation studies for the drug substance for MYDICAR.

The deal includes the facility enhancement engineering Novasep will make at its Seneffe, Belgium bioproduction plant to enable it to bring MYDICAR, a heart failure drug, into commercial production.

In addition, Novasep and Celladon have agreed to negotiate further terms for a commercial supply agreement until December 31, 2018. This is subject to the early termination of certain specified MYDICAR regulatory and development outcomes, with extension options until 2020.

MYDICAR is an innovative, genetically-targeted enzyme replacement therapy for advanced heart failure based on AAV/SERCA2a, an Adeno-Associated Virus (AAV). MYDICAR is currently undergoing several clinical phases, including a phase IIb study in the United States.

Source: Novasep

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content