Singapore: Belgium's Mithra Pharmaceuticals has announced that the company has signed a Letter of Intent (LoI) with Japan's Fuji Pharmaceuticals to work towards a broad partnership on Estetrol in women's health, in multiple indications to be determined in common agreement.

Both parties intend to finalize their partnership in an agreement before the end of this year. This important partnership (involving investments and potential milestones in the double-digit million range) between Mithra and Fuji Pharmaceuticals, the market leader in Women's Health in Japan, validates Mithra's strategy of seeking out the Women's Health leaders in markets around the world.

The plan is that even as the phase III on Estetrol in the US and the EU is ongoing, Fuji Pharmaceuticals will conduct its own clinical trials in Japan, a specific requirement from the Japanese authorities for all new products to be introduced in Japan. Depending on the indication and the region, in Mithra's experience, clinical trials can have a cost of several tens of millions of euros.

The fact that Fuji Pharma would be willing to make the considerable investment involved in conducting these trials offers a potent confirmation of the potential of Estetrol-based products.

The importance of this potential partnership for Mithra is further underlined by the indicative financial terms being discussed, which offer the potential for milestones in the double-digit million euro range.

In addition, the Japanese women's health market is an interesting market with a huge upside potential, and Mithra is confident Fuji, as the market leader, could be the ideal partner to help Mithra's Estetrol-based products address and develop this market. In addition, the partnership is aimed to cover the countries of the ASEAN (Association of Southeast Asian Nations).

François Fornieri, CEO Mithra Pharmaceuticals, said, "This LoI clearly demonstrates our desire to partner-up outside the US and EU with market leaders in women's health. Fuji Pharmaceuticals is for Mithra an extremely attractive partner in that region given their market leader position. Their willingness to invest substantially into this partnership strengthens our belief in the strength of the case for products based Estetrol. Today in Japan still too many women fear hormone treatments and Fuji has been looking for safe, natural based hormones, which they found in Estetrol."