Zambon Pharma | Collaboration Committee Member | Alliance Management | Combination Product | External Innovation

Zambon Pharma entered an exclusive world-wide license agreement and partnership with Direct-Haler A/S on its Pulmonary device technology for all respiratory disease applications. Zambon Group would develop generic+ combination products for asthma therapy in the Direct-Haler DDS device.

As part of the agreement, we became member of the Collaboration Management Forum. This forum was for Alliance and Partnership management between the parties. Frequent communication and collaboration on the In the Management Forum we had a central role in monitoring and supervising:

• Formulation development (dry powder) of three off-patent drugs
• Invitro testing of dry powder formulations in Direct-Haler device
• Defining regulatory requirements for documenting bio-equivalence of three respiratory drugs
• Clinical development of Budesonide (Ph 2), Formoterol (Ph 3) and Salbutamol (Ph 1/2)
• Selection of external device component manufacturers (Europe and Asia)
• Industrialization. External development of filling & assembly machines
• Completing device acceptability studies in patients and HCPs in Europe and USA
• Develop branding and logo for finished respiratory products
• Evaluation of new applications of Direct-Haler DDS (pain management, anti-virals respiratory infections) and in-licensing of novel drug-candidates.