Arena Pharmaceuticals and Everest Medicines Enter into Development and Commercialization Partnership for Ralinepag and Etrasimod in China
"We are very pleased to establish a partnership with
Arena is developing ralinepag, a Phase 3-ready next-generation, oral, selective prostacyclin receptor (IP) agonist for the treatment of pulmonary arterial hypertension (PAH), and etrasimod, a Phase 2 oral, next-generation, S1P receptor modulator, being evaluated for multiple autoimmune diseases, including ulcerative colitis, a form of inflammatory bowel disease.
"We are very excited to partner with Arena to bring these two highly differentiated investigational drugs to China. We see great promise in the potential for both ralinepag and etrasimod to address significant unmet medical needs in
"Our strong belief in Everest's capability to be the partner-of-choice for companies with innovative assets with large commercial potential in
Under the terms of the agreement, Arena has granted Everest exclusive rights to develop and commercialize ralinepag and etrasimod in the Territories. In return, Arena will receive an upfront payment of
The parties plan to collaborate on development on both products; however, Everest is generally responsible for funding development and commercialization in the Territories.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China. The Everest Medicines team has deep expertise and an extensive track record of high quality clinical development, regulatory affairs, CMC, business development and operations both in
Etrasimod (APD334), is an oral, next generation, selective sphingosine 1-phosphate (S1P) receptor modulator, discovered by Arena, designed to provide systemic and local cell modulation by selectively targeting S1P receptor subtypes 1, 4 and 5, while avoiding subtypes 2, 3. Etrasimod exhibits potentially best-in-class pharmacokinetics and pharmacodynamics with rapid onset of action and rapid recovery of T lymphocytes. Selective binding with S1P receptor subtype 1 is believed to inhibit a specific subset of activated lymphocytes from migrating to sites of inflammation. The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity and immune surveillance is maintained. The receptor subtypes 4, 5 exhibit similar activity on additional proliferating immune cell types. Optimized pharmacology and pharmacokinetics may allow superior clinical utility across a broad range of autoimmune conditions.
Etrasimod is an investigational compound not approved for any use in any country.
Ralinepag (APD811) is an oral, next-generation, selective prostacyclin receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). Ralinepag was designed by Arena with the goal of achieving therapeutic activity superior to currently available oral prostacyclin receptor agonists and comparable to parenteral treatment options. In non-clinical experiments, ralinepag demonstrated potentially best-in-class activation of the IP receptor resulting in vasodilation, inhibition of smooth muscle cell proliferation and inhibition of platelet aggregation. Additionally, ralinepag pharmacokinetics in humans revealed an approximately 24-hour half-life and a low peak to trough ratio supporting therapeutic blood levels with once daily (QD) dosing.
Ralinepag is an investigational compound not approved for any use in any country.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be identified by introductory words such as "up to," "focused on," "aimed at," "potential," "opportunity," "view," "committed to," "developing," "forecasted," "hope," "belief," "capability," "will," "designed to," "believed to," "may," "intended," "goal," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about activities to be performed by Arena or Everest; responsibilities of Arena or Everest; the significance of the agreement with Everest; the payments Arena may receive from Everest; the ongoing clinical programs for etrasimod and ralinepag; the ability to complete planned trials; the expected timing of clinical data; the opportunity and potential of etrasimod and ralinepag, including to improve the treatment of patients, to meet unmet medical needs, to deliver clinical utility across a range of autoimmune conditions, to be best-in-class and to reach patients quickly; the potential of Arena's drugs and drug candidates; and Arena's focus, programs and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, without limitation, the following: the implementation of the agreement with Everest; dependence on counterparty performance; risks related to developing and commercializing drugs, including regulatory, manufacturing and supply issues and the availability and use of etrasimod and ralinepag; risks and uncertainties relating to cash and revenues that may be generated from product sales or other sources, including the impact of competition; government and third party actions, including decisions and other actions relating to approval, reimbursement and pricing; unexpected or unfavorable new data; the ability to defend patent rights; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; clinical trials and other studies may not proceed at the time or in the manner expected or at all; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; the timing and outcome of research, development and regulatory review is uncertain; topline data may not accurately reflect the complete results of a particular study or trial; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; we expect to need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; our drug candidates may not advance in development or be approved for marketing; Arena's revenues may be based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; the entry into or modification or termination of collaborative arrangements; Arena's and third parties' intellectual property rights; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the
1 IMS MIDAS database, IMS prognosis, BMI Research Report,
Arena Corporate Contact:
Executive Vice President and
Chief Financial Officer
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LifeSci Public Relations
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