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New high-performance excipients in pharmaceutical industry: an innovative solution for a more efficient and sustainable drug manufacturing process.

Periodic Reporting for period 1 - HPE1 (New high-performance excipients in pharmaceutical industry: an innovative solution for a more efficient and sustainable drug manufacturing process.)

Reporting period: 2016-12-01 to 2017-04-30

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.
During the Phase 1 feasibility assessment, 73100 accomplished a deep analysis of the technical and business potential of HPE1 – a Chitin-Glucan Complex based biocomposite, a superior rheology excipient to be used for the production of solid dosage forms or pills. Throughout the duration of the project, Pharma73 expanded their knowledge of excipient use by both generics and branded pharmaceutical companies. The company defined their go-to-market plan including customer type and geographical location. The company also planned the roadmap to bring their technology to market and identified all the additional third party expertise required to complete the next steps in the project including scale-up and assessment. Dissemination and communication actions have also been planned. As a conclusion to the business feasibility assessment, Pharma73 have determined that HPE1 is the source of a viable commercial application, and that it has the potential to efficiently provide high-functionality excipients to a very large market.
Pharma73 has developed a biopolymer production technology platform, using microbial fermentation, capable of producing biopolymers that can be tuned to have high functionality properties, ideal to be used as novel excipients for the pharmaceutical, cosmetics and food industries. Pharma73’s first product to be launched on the market is HPE1, a Chitin-Glutan Complex based Biocomposite, consisting in a superior rheology excipient to be used for the production of solid dosage forms (pills). Pharma73’s products aim at solving one of the key aspects in the pharmaceutical industry today: increase the production efficiency and lower its costs. HPE1 promises to set a new standard for excipients for the production of pills and tablets by direct compression.

High quality excipients are important as the European Union is introducing a system for implementing standards of good manufacturing practices for medicine excipients after a long campaign for the imposition of GMP standards by excipient manufacturers in the region. The move follows the creation of new EU rules for GMP standards for imported APIs; full enforcement began in 2013. The imposition of the two sets of GMP standards, which is laid down in the EU’s Falsified Medicines Directive (FMD), is seen by European manufacturers of active substances and excipients as necessary to stop the increasing numbers of substandard products imported into the EU in recent years. Better manufacturing practice f pharmaceuticals will also contribute to making the healthcare sector more sustainable.