Novozymes Biopharma Enables Stable Formulation of Serendex Pharmaceutical’s Drug
Denmark-based Serendex Pharmaceuticals recently announced they will initiate Phase I clinical trials for their Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) drug candidate, Molgradex. The drug uses Novozymes Biopharma’s recombinant human albumin, Recombumin, as a stabilizer to enable the development of a stable drug formulation for novel pulmonary delivery. More specifically, Recombumin prevents unwanted derivatization of the labile therapeutic protein by scavenging against the generation of reactive species, thereby helping to reduce the risk of unwanted immunological responses.
Molgradex is a recombinant version of the human GM-CSF and is intended for the treatment of rare pulmonary diseases, such as Pulmonary Alveolar Proteinosis (PAP), Acute Respiratory Distress Syndrome (ARDS), Bronchiectasis (BE), and Cystic Fibrosis (CF). Molgradex is being developed as the first inhalable treatment option for these diseases with expected market authorization for PAP in 2018.
Leading up to the clinical trials, Novozymes Biopharma and Serendex Pharmaceuticals have been working closely to implement the use of albumin in the final drug formulation.
“Novozymes Biopharma has been instrumental in smoothly moving our drug candidate through development and regulatory filings. Their regulatory and technical product support has been of great value to us in preparation for our clinical trials,” said Kim Arvid Nielsen, CEO of Serendex. “It has also been important for us to have a partner capable of providing an undisputed product safety profile as well as supply security.”
Recombumin is already being used in marketed drugs, and several pharmaceutical companies are currently evaluating Recombumin in late-stage clinical trials both under US and EU regulations.
“We are excited about our collaboration with Serendex Pharmaceuticals,” added Peter Rosholm, Vice President of Novozymes Biopharma. “I consider it additional proof that our unique recombinant albumin products offer superior stabilizing benefits when other stabilization options fail. This provides further evidence that our well-documented products and technical support deliver value to our customers and help moving better therapies to market faster.”
Novozymes is a world leader in biological solutions. Together with customers, partners, and the global community, the company improves industrial performance while preserving the planet’s resources and helping build better lives. For more information, visit www.novozymes.com.
Serendex develops drugs to treat severe respiratory conditions, such as PAP, ARDS, BE, CF, and DAH. These conditions are acute or chronic and have no existing medical treatment. All Serendex drugs are inhaled or induced to the lungs of the patient. This improves the risk/efficacy ratio of drug and treatment. Serendex has obtained orphan drug designation (ODD) for several indications in both Europe and USA. For more information, visit www.serendex.com.
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