Polpharma Pharmaceutical Works - API Manufacturer

Theodore Iliopoulos
Vice-President of the Management Board
Chairman of Polpharma Fine Chemicals Business Unit

Dear All,

The pressure of globalization, national and international competition and the need for growth have all gone through dramatic changes over the past few years. This has forced sales managers as well as development and service providers to rethink the strategies of the past and adjust them to today’s competitive business environments in order to be successful. A clear strategy in the area of managing Business Development, Manufacturing and Intellectual Property protection is more important than ever. Here we present the strategy of the Polpharma Fine Chemicals Business Unit, which we believe will lead us in becoming a leading player in this market segment. This can only be obtained by staying close to the market, understanding customers' needs, and providing the best solutions for them.

Our Strategy

Flexibility of our business model that allows us to adapt our cost structure while maintaining the ability to develop our own innovative products and intelligent solutions with the use of our own APIs which support the challenges of our internal and external customers.

Our Business Development Strategy

• Captive Use.
• Direct or indirect sales through commission based agents.
• First to File in the US market.
• Long-term supply agreements with major pharmaceutical companies. 
• Scale-up of other parties' development, Toll fee Manufacturing agreement and Sales Profit Sharing.
• Sale of surplus capacity on a toll fee manufacturing basis.
• Agreement with dossier developers and indirect sales of APIs through out-licensing of finished dosage forms.
• Sale of APIs through Polpharma Business Development managing finished dosage form of out-licensing.
• Partnership with major EU players in a virtual vertical integration including in-house development and manufacturing or external CRAMs.

Our Manufacturing Strategy

• Last steps of synthesis where intellectual property competition is fierce, carried out in-house.
• Outsource low value manufacturing steps out to low wage countries, through creation of effective partnerships in technological platforms.
• Focus on containing the operating fixed overheads and on the proper utilization of our available capacity.
• Reduction and optimization of our capacity to an effective utilization level. Expansion only if justified by business reasons. Use of the phase in and phase out product model for optimum profitability per utilized asset.
• Bringing together the in-house capabilities with external expertise in a collaborative way so that development meets or exceeds the expectations of customers expeditiously in order to beat the competition and be the first on the market with strong intellectual property content.
• Effective management of customer relationships.

Our R&D Project Development Strategy

• R&D in house development.
• Assignment of development projects on a fee for service basis for exclusive development of generic APIs. IP belongs to Polpharma.
• Selection of ready available technology for in house transfer on a fee for service basis. IP does not belong to Polpharma.
• Maintain a new products development pipeline of at least fifteen (15) projects with an expected success rate of 80%, in turn resulting in four (4) to six (6) new products per annum in commercial scale up.

Our Innovation & Intellectual Property Strategy

• Develop ten (10) new process patent applications per annum at minimum.
• Intensify creative work at all levels of the development stages to support a First to File strategy of our generic pharma partners.
• Respect the legal principles governing intellectual property.
  Provide financial incentive for the creation of our inventions.
• Actively pursue the protection of our intellectual property rights, however, respect the freedom of knowledge and culture movement.