Preparation of a successful commercial launch for the new blockbuster product of Mithra Pharmaceuticals: production planning of the contraceptive pill Estelle® and its associated hormonal substance

Abstract

Founded twenty years ago, Mithra Pharmaceuticals is a Belgian biopharmaceutical company active in the women's health sector. More than ever in full growth, the company is becoming an international player in the contraceptive and menopause fields. Since 2014, Mithra has decided to focus its core activities on research and development. Its innovation activity is mainly directed towards the development of Estetrol, a natural new hormonal substance. With its innovative Estetrol-based portfolio, Mithra intends to market its first flagship product Estelle® by mid-2021. This combined oral contraceptive pill of fifth generation is expected to transform the contraceptive market, which has not seen such an innovation in over 90 years. As a potential future blockbuster with worldwide coverage, it is the subject of high expectations in terms of financial income, leaving no room for mistake. The pharmaceutical industry is subject to stringent regulatory constraints, high product quality requirements and shorter lead-time to market. This all puts a high financial pressure on healthcare companies and stresses their need for a reactive production strategy. The fast-paced launch of generic drugs after patent expiry also strengthen the competitiveness of the sector. In this context, the aim of this project thesis is to develop an appropriate production strategy for the commercial launch of this new contraceptive pill. This work aims at preparing the commercial launch in several ways: first of all, the mapping of the production process will allow Mithra to optimize and improve its efficiency by reducing its manufacturing lead time. Secondly, a strategic and tactical analysis of capacity management planning highlighted the need for alternative suppliers and the need for building safety stocks. This need is further reinforced by the unprecedented Covid-19 health crisis. Thirdly, production planning for the commercial launch emphasized the potential lack of hormone resources. With a limited amount of available hormone material, production will certainly have to be adapted and performed at tight flow, thus impacting the volume produced for the commercial launch. Finally, a comparative analysis of potential logistics providers helped the company to select the ideal partner to support its growth. This project thesis provides Mithra Pharmaceuticals with decision-support tools to best manage its first innovative contraceptive product.