Skye Bioscience, Inc., a pharmaceutical company developing a synthetic cannabinoid derivative to treat glaucoma, has selected NextPharma as its contract manufacturing organization (CMO) for its Phase 2 clinical trial material.
 
NextPharma is a European pharmaceutical contract development and manufacturing organization that supplies products globally from its nine sites. The company provides services that range from pharmaceutical development, clinical supplies, scale-up and process validation to commercial manufacturing for a large range of dosage forms, including solids, semi-solids and non-sterile and sterile liquids. NextPharma also provides a wide range of packaging solutions, including blow-fill-seal for single-use products. 
 
“We worked closely with Skye’s team to understand their needs and look forward to building a long-term relationship,” said Peter Burema, NextPharma’s CEO. “NextPharma continues to build out its technological platforms, expertise and capacities and our 2019 acquisition of the ophthalmic manufacturing facility in Tampere, Finland, with capabilities to develop and manufacture three piece, preservative-free multi-dose and blow-fill-seal packaging of single-use and multi-use eye drop dispensers, which suits Skye’s needs. At our Tampere site, we currently manufacture a broad range of ophthalmic drugs being sold globally and we are well prepared to implement the production process to meet Skye’s requirements for its innovative new drug candidate.”
 
“As is typical with pharmaceutical drug production, early and late stage production of clinical trial materials are usually undertaken by CMOs with different skill sets. Skye completed an extensive search and due diligence process to choose an ideal CMO to produce SBI-100 Ophthalmic Emulsion for its next stages of development and we are pleased that NextPharma has partnered with us on this project,” said Punit Dhillon, CEO and Chair of Skye. “Apart from their broad expertise in manufacturing commercially-approved drugs for major pharmaceutical clients, NextPharma is also experienced in handling controlled substances, which will be valuable in serving Skye’s needs.”
 
“During our pre-Investigational New Drug (IND) meeting with the FDA’s Division of Ophthalmology, we confirmed that our nonclinical safety package would be sufficient to support a Phase 2 study under our first US IND,” added Dhillon. “Our plan is to file our IND for a US Phase 2 clinical study in the fourth quarter of this year. We expect to start the Phase 2 study in the first half of 2023 and report final data by year-end 2023.”