Mr. Cleveland’s appointment follows the mutual determination by
Mr. Cleveland has more than two decades of leadership experience with significant operational and financial expertise. He currently serves as the Chairman of the Board of
“I joined the Alder Board in 2015 because of my deep appreciation of Alder’s mission to transform the treatment paradigm for migraine prevention,” said Mr. Cleveland. “I look forward to leveraging my prior CEO and CFO experience in this interim role as we work to identify a permanent successor and further build out the team for the next stage of Alder’s growth and development. On behalf of the Board and the Alder team, I want to thank Randy for his immense dedication and invaluable contributions since co-founding the Company in 2004. Randy’s leadership has positioned Alder for continued growth as we advance towards the commercial launch of eptinezumab.”
Dr. Schatzman said, “It has been an honor to lead Alder since co-founding the Company in 2004 and work with such a bright and passionate group of employees to change the lives of highly impacted episodic and chronic migraine patients. I am proud of all that we have accomplished at Alder during my tenure including the development of two late-stage therapeutic candidates, eptinezumab and clazakizumab, assembling a talented team of over 190 employees, the majority of which are scientists and drug developers, and positioning Alder to positively impact the lives of migraine sufferers. Now is the right time to pass the baton to the next generation of leadership. I am confident that Alder is well-placed to set a new standard for what can be achieved in migraine prevention to benefit patients and their families.”
Mr. Cleveland concluded, “Alder has made tremendous progress over the last year. We achieved positive Phase 3 pivotal data for both episodic and chronic migraine patients, demonstrating that eptinezumab's clinical profile is highly differentiated and consistently delivered predictable results for rapid, effective and sustained migraine prevention across the spectrum of migraine disease. We plan to share additional data from our PROMISE 1 and PROMISE 2 pivotal trials, and the results from our open-label safety study of eptinezumab, in the first half of this year. We also continue to expect our pharmacokinetic comparability study to be completed in the second half of 2018. In addition, through our recent IP settlement and licensing agreement with Teva, we now have a non-exclusive license to Teva’s CGRP patent portfolio, which, importantly, clarified our ability to develop, manufacture and commercialize eptinezumab in the U.S. and globally. The submission of our planned Biologics License Application (BLA) for eptinezumab is the top priority, and we continue to make progress on all key clinical data milestones, BLA and commercial preparedness activities, including our CMC and manufacturing initiatives. I look forward to reviewing these programs thoroughly in my new role and plan to provide a business update in connection with the announcement of our first quarter 2018 financial and operating results.”
This press release contains forward-looking statements, including, without limitation, statements relating to: Alder’s search for a permanent Chief Executive Officer and expectations for a smooth transition; Alder’s mission to transform the treatment paradigm for migraine prevention; the continued development and clinical, therapeutic and commercial potential of eptinezumab; the anticipated commercial launch of eptinezumab; the availability of results from clinical trials; the planned BLA submission and the potential regulatory approval of eptinezumab; progress on clinical data milestones, BLA and commercial preparedness activities; and the benefits to Alder under its settlement and license agreement with Teva. Words such as “serve,” “ensure,” “assist,” “mission,” “look forward,” “build,” “next stage,” “positioned,” “continue,” “growth,” “advance,” “towards,” “well-placed,” “new,” “plan,” “expect,” “clarified,” “priority,” “progress,” “milestones,” “provide,” or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Alder's current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder’s development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption "Risk Factors" in Alder's Annual Report on Form 10-K for the fiscal year ended
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Source: Alder BioPharmaceuticals, Inc.