Patented drug producers' business model is based on huge R&D spending and large operational margins delivered by high product prices made feasible by the patents’ protection. The critical issue is that the pharmaceutical industry is currently going through the “Patent Cliff”. During this period, that started around 2011, half of the patented drugs will lose patent protection within five years. This fact will lead to stiff competition from generics and a collapse in prices. EvaluatePharma estimated that 13% of global pharmaceutical sales are at risk from generics competition, which can lead to a reduction of up to 85% of the price of a given drug.
Generic producers' business model is based on n production and commercialization efficiency. For generic drug producers, their main objectives are to reduce production costs and improve competitiveness. The drugs manufacturing process is the only stage where pharma companies can achieve performance gains that can impact the profit margin of a final product. Despite representing a small percentage of the final price, the worldwide volume of manufactured drugs is very significant leading to a large impact on the profits. The production efficiency is a very important issue, both in big pharmaceuticals and generics industries. Both subsectors are very eager to reduce production costs and enhance their manufacturing productivities, in order to become more competitive.
The excipient HPE1 (Chitin-Glucan Complex) produced by Pharma73, due to its technical features will deliver the high functionality advantages desired by drug formulators without any need of changing their current production equipment. It has the potential to play an important role in the industry as it increases the process efficiency and productivity of drug manufacturing with advantages such as: increased manufacturing speeds; reduced steps such as weighing and blending; less equipment wear and tear; less energy requirements; less number of rejects; higher stability.
The overall objectives of the innovation project are to scale up the HPE1 excipient production and secure the necessary approvals for it to be marketed to customers.