Competition is needed in the follicle stimulating hormone (FSH) market

Barcelona, November 16, 2005

Ten years after the first approval of a recombinant human FSH for treatment of infertility the US$ 0.9 bln global market of recombinant human FSH (rhFSH) in 2004 was shared between Serono (63 % for follitropin alfa) and Organon (37 % for follitropin beta). Size of the duopoly market is only controlled by reimbursement presssure in some European countries and price competition with FSH products derived from human urine (urofollitropin). Life cycle management of the two rhFSH products consists in glyco-engineered variants of rhFSH in early clinical development. Recent resolution of the structure of the hormone binding domain of the FSH receptor may boost the search for orally available FSH receptor agonists, thus avoiding the daily subcutaneous injection regimen over 10 days. These results were found in a search conducted by La Merie Business Intelligence. The results were published in the November 14 issue of R&D Pipeline News , edited by La Merie.

First generation, highly purified human urine-derived FSH products still have their place in the market. Reasons may be the about 3-times lower price and the lack of striking advantages of the second generation recombinant FSH products which now are available in Pens. Attempts to administer rhFSH with more convenient drug delivery systems or as longer acting pegylated versions have been terminated or have not been advanced. Third generation FSH developments of Serono and Organon are in phase I and II clinical development (hyperglycosylated FSH and corifollitropin alfa) and may enable once a week injection. Alternative glyco-engineered FSH variants from academia and industry are not in commercial development.

The fourth generation of FSH treatment of infertility may consist in orally available drugs acting as agonists of the FSH receptor. There are already small molecule lead compounds found by traditional drug discovery methods, i.e screening, combinatorial chemistry, parallel synthesis and structure-activity relationships. The recent resolution of the structure of the hormone binding domain of the G-protein coupled receptor of FSH may spur further research of oral FSH receptor agonists.

To provide more convenient dosing for patients, non-invasive delivery via oral, pulmonary or other needle-free systems may be an alternative in the future when patents rhFSH products run out. The first potential biogeneric rhFSH is already in clinical phase III development in an Asian country.

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