Healthcare Industry News: sublingual tablet
News Release - March 30, 2010
Biodel Announces Senior Leadership ChangesCompany Appoints Dr. Errol De Souza as President and CEO and Dr. Charles Sanders as Chairman; Dr. Solomon Steiner Becomes Chief Scientific Officer and Remains on Biodel Board
Conference Call Today at 11:00 a.m.
DANBURY, Conn.--(HSMN NewsFeed)--Biodel Inc. (Nasdaq: BIOD ) announced today the appointments of Dr. Errol De Souza as president and chief executive officer and Dr. Charles Sanders as board chairman, effective immediately. Dr. Solomon Steiner, who co-founded Biodel in 2003, will become the company’s chief scientific officer, devoting his full-time attention to the development of Biodel’s product candidates to treat diabetes, and will remain a member of the board. Dr. Sanders is former chairman and CEO of Glaxo and was appointed to Biodel’s board in 2006. Dr. De Souza was previously president and CEO of Synaptic Pharmaceuticals, president and CEO of Archemix Corp., co-founder and chief scientific officer of Neurocrine Biosciences, senior vice president and U.S. site head of drug innovation and approval (R&D) at Aventis and director of CNS diseases research at DuPont Merck; he is currently a board member of several biopharmaceutical companies. With Biodel’s appointment of a non-executive board chairman, the company has eliminated the role of lead director, which had been held by Biodel director Scott Weisman.
Dr. Sanders stated: “The board and I thank Sol for his inspiring vision, leadership and success as our company’s founder, chairman and CEO. We congratulate him on his enviable record of achievement in drug development and the strong scientific and commercial foundation he has established for Biodel’s future success. As chief scientific officer, Sol will continue to guide our drug discovery and development programs and lead the effort to advance our portfolio of early-stage product portfolio, which has much promise for the development of the next-generation artificial pancreas. Errol De Souza shares this commitment to innovation and to developing the company’s promising product pipeline. His extensive industry and executive experience will help ensure that this management transition will be seamless while our commercial plans remain on track and our drug development programs continue to advance. We welcome Dr. De Souza’s leadership and contributions to our future success.”
Dr. De Souza stated: “I appreciate the board’s vote of confidence and thank them and Sol for the opportunity to lead Biodel’s talented team. I am especially pleased that we will continue to benefit from Sol’s scientific talents and leadership. Together, we will be working to improve the standard of care in diabetes treatment by gaining FDA approval of our most advanced product candidate, VIAject®, and by developing our innovative early-stage product candidates, such as our sublingual tablet formulation of insulin (VIAtab™), our adjustable and “smart” basal insulins, and our injectable stable glucagon. I look forward to building on Biodel’s impressive scientific achievements, promising drug-delivery technology and innovative product pipeline to create a successful pharmaceutical company that rewards all of our stakeholders – employees, patients, physicians and shareholders.”
Conference Call and Webcast Information
Biodel's senior management will host a conference call on March 30, 2010 beginning at 11:00 a.m. Eastern Daylight Time to discuss this announcement. Live audio of the conference call will be available to investors, members of the news media and the general public by dialing 1-877-303-8028 (United States) or 1-760-536-5167 (international). To access the call by live audio webcast, please log on to the investor section of the company's website at www.biodel.com. An archived version of the audio webcast will be available at Biodel's website.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes. Biodel's product candidates are developed using VIAdel™ technology, which reformulates existing FDA-approved peptide drugs. Biodel’s new drug application for its most advanced product candidate, VIAject®, has been accepted for review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act action date of October 30, 2010. Earlier stage product candidates include VIAtab®, a sublingual tablet formulation of insulin, a line of adjustable basal insulins, a “smart” basal insulin and a stabilized formula of glucagon. For further information regarding Biodel, please visit the company's website at www.Biodel.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to have our VIAject(R) NDA accepted for filing by the FDA; our ability to secure FDA approval for VIAject(R) and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel(TM) technology, particularly VIAject(R); the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the FDA's findings regarding data anomalies observed in India in our Phase 3 clinical trial of VIAject(R) for patients with Type 1 diabetes; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent quarterly report on Form 10-Q for the quarter ended December 31, 2009. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
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