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 IMPORTANT SAFETY INFORMATION Quillivant XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Quillivant XR in a safe place to prevent misuse and abuse. Selling or giving away Quillivant XR may harm others and is against the law. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines, or street drugs. Quillivant XR should not be taken if you or your child are allergic to methylphenidate hydrochloride, or any of the ingredients in Quillivant XR, or are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI. Heart-related problems have been reported with CNS stimulant medications:
- Sudden death in patients who have heart problems or heart defects
- Stroke and heart attack in adults
- Increased blood pressure and heart rate
- New or worsening bipolar symptoms
- New or worsening psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious)
- You or your child have heart problems, heart defects, or high blood pressure
- You or your child have mental problems including psychosis (hearing voices, believing things that are not true, suspicious), mania, bipolar illness, or depression
- You are pregnant or plan to become pregnant. It is not known if Quillivant XR will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant
- You are breastfeeding or plan to breast feed. Quillivant XR passes into your breast milk. You and your doctor should decide if you will take Quillivant XR or breast feed
| || || || |
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.INDICATION 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 (NYSE: 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.