Astellas Pharma Inc. announced over the weekend that Astellas and Ogeda shareholders have entered into a definitive agreement under which Astellas has agreed to acquire Ogeda, a privately owned drug discovery company. Ogeda is a clinical-stage drug discovery company that discovers and develops small molecule drugs targeting G-protein coupled receptors (GPCRs).
The lead investigational candidate, fezolinetant, is a selective NK3 receptor antagonist, and the positive data from a Phase 2a study result for the non-hormonal treatment of menopause-related vasomotor symptoms (MR-VMS) was announced in January 2017. This transaction expands Astellas’ late stage pipeline and is expected to contribute to its mid-to-long term growth.
Under the agreement, Astellas has agreed to pay up to a total of EUR 800 million ($853.1 million). Astellas will make an initial payment of EUR 500 million ($533.2 million) in consideration of 100 percent of the equity in Ogeda at the closing of the transaction. Then Ogeda shareholders will be eligible to receive an additional EUR 300 million ($319.9 million) with attainment of certain clinical development and regulatory milestones for fezolinetant.
Upon completion of the transaction, Ogeda would become a wholly owned subsidiary of Astellas. The closing of the transaction is subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of the United States, and is expected to be finalized in the second quarter of 2017.
“The transaction fits with our strategy to deliver innovative drugs in therapeutic areas with high unmet medical needs. Ogeda has been pioneering the development of a NK3 receptor antagonist fezolinetant for the treatment of MR-VMS,” commented Yoshihiko Hatanaka, President and CEO, Astellas. “We are committed to advancing science to deliver life changing medicines to people most in need. Astellas has a history of discovery and development of the unique medical treatments to improve patients’ quality of life. By leveraging this strength, we aim to deliver this potential new therapeutic option to those patients who are suffering from MR-VMS.”
Jean Combalbert, CEO of Ogeda said, “We welcome the acquisition by Astellas and look forward to developing fezolinetant, first non-hormonal treatment of Hot Flashes (HF)/ MR-VMS, inside a leading global pharmaceutical company. With its strong development and commercialization capabilities, resources and vision, I am convinced that Astellas will be able to turn fezolinetant promising clinical results into near-term value for patients.”
A recently announced Phase 2a study of fezolinetant met its primary endpoints, demonstrating significant improvement by fezolinetant compared to placebo in 80 menopausal women suffering from MR-VMS also known as HF. Fezolinetant reduced the frequency of moderate-to-severe HF at week-4 by 89% from baseline compared to 38% for placebo (p<0.001), and 93% at week-12, compared to 54% for placebo (p<0.001).
Fezolinetant also reduced HF severity at week-4 by 60% from baseline compared to 12% for placebo (p<0.001), and 70% at week-12 compared to 23% for placebo (p<0.001). No severe adverse events were reported in either treatment group. Mild-to-moderate adverse events (such as headache and nasopharyngitis) were reported in 67% of the fezolinetant group and 80% in the placebo group.
Astellas is still reviewing the impact of this transaction on its financial forecasts for the fiscal year ending March 31, 2018.
Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered by Ogeda which currently is being developed for the treatment of MR-VMS. Fezolinetant is an antagonist of the GPCR known as the tachykinin NK3 receptor and acts on specific neurons that control body temperature to directly and safely address the basis for HF in menopausal women.
(Source: PR Newswire)