Novozymes enables stable formulation of Serendex Pharmaceutical's inhalable drug for treatment of severe pulmonary diseases

Building on Novozymes Biopharma’s recombinant human albumin, Recombumin®, Serendex Pharmaceutical’s leading drug candidate has now entered clinical trials.

Denmark-based Serendex Pharmaceuticals recently announced that 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.
 
Faster to clinical trials
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”, says 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”, says 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”.

“This whole process has been very fast and the collaboration with Novozymes has enabled us to quickly move to clinical trials and ultimately closer to market”, says Kim Arvid Nielsen.

The collaboration is not expected to impact Novozymes’ financial outlook for 2015.

About Novozymes
Novozymes is the world leader in biological solutions. Together with customers, partners and the global community, we improve industrial performance while preserving the planet’s resources and helping build better lives. As the world’s largest provider of enzyme and microbial technologies, our bioinnovation enables higher agricultural yields, low-temperature washing, energy-efficient production, renewable fuels and many other benefits on which we rely today and in the future. We call it Rethink Tomorrow. www.novozymes.com
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About Serendex Pharmaceuticals A/S

Serendex develops drugs to treat severe respiratory conditions such as PAP (pulmonary alveolar proteinosis), ARDS (acute respiratory distress syndrome), BE (bronchiectasis), CF (cystic-fibrosis-related lung infections) and DAH (diffuse alveolar hemorrhage). 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. The company’s sole business focus is drug repositioning, i.e. finding new indications and administration routes for existing drugs. Serendex Pharmaceuticals is listed at Oslo Axess. Please visit www.serendex.com for more information.
 
About Novozymes’ Recombumin® - rAlbumin Human USP-NF*
Recombumin is the world's first and only commercially available, animal-free, recombinant human albumin, approved for use in the manufacture of human therapeutics. Recombumin is an effective versatile stabilizer that is particularly suited for the formulation of protein and peptide drugs that are not readily stabilized with standard excipients. Through various modes of action, Recombumin protects biological products from degradation, adsorption and aggregation. For example, Recombumin® has been shown to reduce particle formation in high-concentration protein formulations as well as stabilize various peptide and protein therapeutics by hindering fibrillation and protein aggregation, respectively.

Key customer benefits - Recombumin
®
  • Simple, stable formulation
  • Speed to clinical studies
  • Ease of regulatory approval
  • Reliable drug dosing
  • Quicker access to market
  • Stable and assured long-term supply 
*Meets National Formulary (NF) standards as published by United States Pharmacopeia (USP).