Healthcare Industry News: attention deficit hyperactivity disorder
News Release - October 22, 2012
Pfizer To Acquire NextWave Pharmaceuticals, Inc.
Agreement Includes Recently Approved Quillivant XR, the First Once-Daily Liquid attention deficit hyperactivity disorder Treatment in the United StatesNEW YORK--(Healthcare Sales & Marketing Network)--Pfizer Inc. (PFE) today announced its intention to acquire NextWave Pharmaceuticals, a privately held, specialty pharmaceutical company focused on the development and commercialization of unique products for the treatment of attention deficit/hyperactivity disorder (ADHD) and related central nervous system (CNS) disorders.
NextWave is the developer of Quillivant XR™ (methylphenidate hydrochloride) for extended-release oral suspension, CII, the first once-daily liquid medication approved in the U.S. for the treatment of ADHD, and holds exclusive North American commercialization rights to Quillivant XR. Quillivant XR received approval from the U.S. Food and Drug Administration on September 27, 2012, and is expected to be available in pharmacies in the U.S. in January 2013.
Quillivant XR was developed in collaboration with Tris Pharma, NextWave’s technology and manufacturing partner. Quillivant XR is built on Tris’ OralXR+ platform.
Pfizer had previously entered into an option and merger agreement with NextWave during the second quarter 2012 and made an option payment of $20 million. Today, Pfizer is exercising its option to acquire NextWave. Under the terms of the agreement, Pfizer will make a payment to of $255 million to NextWave’s shareholders at the closing of the transaction, and NextWave’s shareholders are eligible to receive additional payments of up to $425 million based on certain sales milestones.
“This agreement demonstrates our focused expansion of the Established Products U.S. brands business to offer a diverse portfolio of high-quality medicines that meet patients’ needs,” said Albert Bourla, president and general manager in Pfizer’s Established Products Business Unit. “By combining the advantages of Quillivant XR with Pfizer’s commercialization expertise, we will be able to provide ADHD patients and their caregivers a new treatment option.”
“NextWave has been focused on helping patients and families who struggle with the challenges of ADHD. We are excited to partner with Pfizer, one of the most respected pharmaceutical organizations in the world, to bring the unique benefits of Quillivant XR to those affected by this challenging condition,” said Jay P. Shepard, president and chief executive officer of NextWave.
The transaction is expected to close during the fourth-quarter 2012, subject to regulatory approval in the United States, and other customary closing conditions.
Pfizer’s financial advisor for the transaction was Jefferies & Company, Inc. Pfizer Legal Alliance (PLA) firms Kaye Scholer LLP and Ropes & Gray LLP acted as legal counsel. The PLA is a collaborative partnership between Pfizer and 19 law firms. NextWave’s financial advisor for the transaction was Aquilo Partners, L.P., while Cooley LLP served as its legal advisor.
About Quillivant XR
Quillivant XR is a central nervous system (CNS) stimulant prescription medicine. Quillivant XR is used for the treatment of attention deficit hyperactivity disorder (ADHD). Quillivant XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Please see full Prescribing Information and Medication Guide, including BOXED WARNING regarding Abuse and Dependence, at www.quillivantxr.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
About ADHD
ADHD is one of the most common neurobehavioral disorders in the United States. According to the Centers for Disease Control and Prevention (CDC) 2009 report, almost one in 10 (9.5 percent) children aged 4–17 in the U.S. have at some time received a diagnosis of ADHD.1 The condition often lasts into adulthood, with adult ADHD affecting an estimated 4 percent of Americans.2 ADHD is characterized by symptoms that include difficulty paying attention, impulsive behaviors and, in some cases, patients being overly active.3
Pfizer Inc.: Working together for a healthier world®
At Pfizer (PFE), we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.
About NextWave Pharmaceuticals
NextWave is an emerging specialty pharmaceutical company primarily focused on the development and commercialization of unique products for the treatment of ADHD and related CNS disorders. More information about NextWave is available at www.nextwavepharma.com.
References
1. Centers for Disease Control and Prevention. Increasing prevalence of parent-reported attention deficit/hyperactivity disorder among children – United States, 2003 and 2007. MMWR. 2010;59(44):1439–43.
2. Kessler RC, Adler L, Barkley R, et al. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006;163(4):716–23.
3. American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-IV-TR. Washington: American Psychiatric Association; 2000.
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of October 22, 2012. Pfizer assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments.
This release contains forward-looking information about an agreement by Pfizer to acquire NextWave Pharmaceuticals, Inc., including NextWave’s product portfolio and research and development pipeline, and the potential benefits thereof, as well as about the anticipated timing of the closing of the transaction and of the availability of Quillivant XR in pharmacies in the U.S. Such information involves substantial risks and uncertainties, including, among other things, the satisfaction of conditions to closing the agreement, including obtaining regulatory approval in the U.S. ; the uncertainties inherent in research and development activities; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for product candidates in NextWave’s research and development pipeline as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates; and competitive developments.
A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.
Source: Pfizer
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