Pfizer Acquires NextWave Pharmaceuticals, Inc.

Includes exclusive North American commercialization rights to recently approved Quillivant XR™ (methylphenidate hydrochloride), the first once-daily liquid Attention Deficit Hyperactivity Disorder treatment in the United States

Quillivant XR expected to be available in pharmacies in the U.S. in January 2013

NEW YORK--(BUSINESS WIRE)--Nov 28, 2012 - Pfizer Inc. (NYSE: PFE) today announced that it has completed its acquisition of NextWave Pharmaceuticals, Inc., a privately held, specialty pharmaceutical company focused on the development and commercialization of products for the treatment of attention deficit hyperactivity disorder (ADHD).

Upon the closing of the transaction, Pfizer now holds exclusive North American commercialization rights to 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. 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.

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 methylphenidate hydrochloride and other 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

Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with QUILLIVANT XR.

Mental (psychiatric) problems can be caused or worsened by methylphenidate hydrochloride and other stimulant medications:

 

  • New or worse behavior or thought problems
  • New or worsening bipolar symptoms
  • New or worsening psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious)

Call your doctor right away if you or your child have any heart-related symptoms such as chest pain, shortness of breath or fainting or new or worsening mental (psychiatric) symptoms or new manic symptoms while taking Quillivant XR.

Quillivant XR may not be right for you. Tell your doctor if:

 

  • 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 or about a family history of suicide, 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

Possible serious side effects of Quillivant XR are heart-related problems and mental problems, as well as slowing of growth (height and weight) in children. Children should have their height and weight checked often while taking QUILLIVANT XR. QUILLIVANT XR treatment may be stopped if a problem is found during these check-ups.

Common side effects include:

  • Decreased appetite
  • Weight loss
  • Nausea
  • Stomach pain
  • Dry mouth
  • Vomiting
  • Trouble sleeping
  • Anxiety
  • Nervousness
  • Restlessness
  • Mood swings
  • Agitation
  • Irritability
  • Dizziness
  • Shaking (tremor)
  • Blurred vision
  • Increased blood pressure
  • Fast heart beat
  • Increased sweating
  • Fever
Talk to your doctor if you or your child have side effects that are bothersome or do not go away.

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.

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.

DISCLOSURE NOTICE: The information contained in this release is as of November 28, 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 Quillivant XR, including its potential benefits as well as the anticipated timing of the availability of Quillivant XR in pharmacies in the U.S. Such information involves substantial risks and uncertainties, including, among other things, the uncertainties and variables inherent in business planning and operating performance, including, among other things, manufacturing difficulties or delays; the uncertainties regarding the commercial success of Quillivant XR in North America; 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.

 

Contact: Pfizer
Media Contact: Joan Campion, (212) 733-2798
Investors Contact: Suzanne Harnett, (212) 733-8009
 

 

 

Posted: November 2012


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