A clinical-stage biopharmaceutical company focused on peptide therapies for the treatment of several unmet medical needs recognized that developing its lead asset solely as an injectable would ultimately limit the drug’s market penetration and patient acceptance.
Background:
A clinical-stage biopharmaceutical company focused on peptide therapies for the treatment of several unmet medical needs recognized that developing its lead asset solely as an injectable would ultimately limit the drug’s market penetration and patient acceptance. However, creating an oral formulation of the drug would require an innovative technology to enable the peptide to pass through the gastrointestinal tract and be absorbed into the bloodstream at therapeutically relevant levels. This would be no small task, but the potential was significant.
The value in choosing oral drug delivery route:
Oral drug delivery offers multifold advantages to both patients and pharmaceutical companies.
For patients, this approach provides a safe, easy to use and a non-invasive alternative to frequent injections. Typically oral administrations require minimal patient supervision resulting in higher patient compliance and reduced healthcare costs.
For industry, oral dosage forms offer myriad benefits, including increased market penetration, expanded patient access, and the ability to extend a product’s life-cycle well beyond its initial patent expiration.
The Enteris BioPharma Solution:
Enteris applied its proprietary Peptelligence® formulation technology to increase the bioavailability of the novel peptide up to 10%. The oral peptide is now the subject of multiple, mid-stage clinical trials, providing the company with the opportunity to target several high-need therapeutic indications. In addition to developing the oral formulation, Enteris added further benefit by manufacturing the clinical supply, enabling the company to realize key cost and time savings.
Enteris BioPharma is a partner of choice to support formulation development, life cycle management and manufacturing for the following reasons:
- Long standing collaborative relationship for over 10 years.
- Proven capabilities and expertise in handling and manufacturing high potency API drug products.
- Proven ability of proprietary Peptelligence® drug delivery platform to perform safe delivery of peptide based therapeutics with low oral bioavailability.
- Robust IP protection for Peptelligence® in the US and abroad.
- Established manufacturing track record of over 23 years combined with a seasoned management team.
- US based 32,000 sq. ft. manufacturing facility with GMP grade facilities.
- Experienced in working with biopharmaceutical companies of all sizes from early discovery programs to drug life cycle management