1/25/2016 Study Shows Toviaz Is Effective In Reducing Urge Urinary Incontinence In Patients With Overactive Bladder After Suboptimal Response To Detrol LA | P...
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`Home » News & Media » Press Releases » Study Shows Toviaz Is Effective In Reducing Urge Urinary Incontinence In Patients With Overactive Bladder After
`Suboptimal Response To Detrol LA
`
`Study Shows Toviaz Is Effective In Reducing Urge Urinary Incontinence In Patients With Overactive Bladder After Suboptimal
`Response To Detrol LA
`
`Thursday, August 2,2012 -10:30pm EDT
`
`"Health care professionals often question how to treat patients who have had a suboptimal response to Detrol LA, which is commonly used but does not have a
`dose higher than ii mg, and these data may help to guide treatment decisions."
`(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that a Phase A study assessing the efficacy and safety of Toviaz® (fesoterodine fumarate) in
`patients with overactive bladder (OAB) met its primary endpoint. Toviaz reduced urge urinary incontinence (UUI) in patients with OAB who had a suboptimal
`response (less than 50 percent reduction in UUI) to Detrol LA (tolterodine tartrate extended release), a commonly-prescribed treatment for the condition. UUI is
`the involuntary leakage of any amount of urine, associated with or immediately preceded by a sense of urgency.
`
`The 14-week randomized, parallel group, placebo-controlled, double-blind multicentre study assessed Toviaz 8 mg in patients with OAB who had been taking
`Detrol LA 4 mg for two weeks and had less than 50 percent reduction in urge urinary incontinence episodes. After open-label treatment with Detrol LA in mg,
`treatment with Toviaz in mg was started for one week, followed by treatment with Toviaz 8 mg.
`
`The study demonstrated that Toviaz 1: mg for one week followed by Toviaz 8 mg statistically significantly reduced the average number of urge urinary
`incontinence episodes (-2.37 episodes from baseline) per 21: hours (p<0.0001) in OAB patients who had a suboptimal response to Detrol LA in mg. The safety and
`tolerability profiles of fesoterodine and tolterodine were consistent with previous studies. The most common treatmentemergent adverse events for both
`fesoterodine and tolterodine were dry mouth and constipation. Further analyses will be conducted and a publication of the comprehensive results is planned at a
`later date.
`
`“This study adds to the body of evidence supporting Toviaz as an effective treatment for patients with overactive bladder, including patients who may not have
`responded to Detrol LA,” said study principal investigator Dr. Steven A. Kaplan, professor of urology, Weill Cornell Medical College and director of the Iris Cantor
`Men's Health Center at New York Presbyterianlweill Cornell Medical Center in New York. “Health care professionals often question how to treat patients who
`have had a suboptimal response to Detrol LA, which is commonly used but does not have a dose higher than in mg, and these data may help to guide treatment
`decisions."
`
`Overactive bladder is a treatable medical condition often caused by involuntary contractions or spasms of the bladder muscle. Overactive bladder symptoms of
`urgency, frequency or urge urinary incontinence can be bothersome and can have a significant impact on important aspects of people's lives. Approximately 33
`million American adults are estimated to suffer from OAB symptoms. Despite its prevalence, overactive bladder is often unrecognized and untreated.
`
`Study Background
`
`Based on a screening diary, subjects who met all entry criteria started open—|abe| treatment with once-daily tolterodine in mg for two weeks. At the end of the
`tolterodine treatment period, subjects who had less than 50 percent reduction of mean urge urinary incontinence per 21: hours from the screening diary to the
`baseline diary were randomized to one of two treatment arms in a 1:1 ratio (fesoterodine 8 mg or placebo). The study treatment started with to mg/day of
`fesoterodine or matching placebo for one week; after one week of treatment, the dose increased to 8 mg/day of fesoterodine. No further dose adjustments were
`permitted for the remaining 11 weeks of the study. The subjects were instructed to take the study drug once every day in the morning.
`
`The trial was conducted worldwide at 156 sites in 15 countries. A total of 221 7 subjects were screened, of which 6142 were randomized (322 fesoterodine 8 mg,
`320 placebo).
`
`About Toviaz
`
`INDICATION
`
`Toviaz® (fesoterodine fumarate) treats the symptoms of overactive bladder (leaks, strong sudden urges to go, going too often).
`
`The recommended starting dose for Toviaz is 14 mg once daily. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily.
`Toviaz should be swallowed whole; tablets should not be chewed, divided or crushed.
`
`IMPORTANT SAFETY INFORMATION
`
`If you have certain stomach problems, glaucoma, or cannot empty your bladder, you should not take Toviaz.
`
`Toviaz may cause allergic reactions that may be serious. If you experience swelling of the face, lips, throat, or tongue, stop taking Toviaz and get emergency
`medical help right away.
`
`Medicines like Toviaz can cause blurred vision, drowsiness, and decreased sweating. Use caution when driving, doing unsafe tasks, or in especially hot
`environments, until you know how Toviaz affects you. Drinking alcohol while taking medicines such as Toviaz may cause increased drowsiness.
`
`Petitioner My|an PharmaCeutiCa|S |nC_ _
`The mostcommon sideeffectsaredrymouth and constipation.
`Tnuin-; lrwnr I-xnnnlifr nnrl rial/1' Tknrn rnn\1 I-sn no-Inn-r nntinnc Tn Inn-rn rnI\rn nlvuir Tnuin-1 nlnnrn rnn flan Enll Drnz-rrikinn and Dnfinnf Tnlnrmnfinn
`
`_ Page 1
`
`http://www.pfizer.com/news/press-re|ease/press-release-detail/study shows toviaz is effective in reducing urge urinary incontinence_inJ)atients_with_ove...
`
`1/2
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1022 - Page 1
`
`
`
`6%
`Health Professionals Careers
`
`Partners Contact Us :Env
`Search
`
`About Us
`
`Products
`
`Research
`
`Responsibility
`
`Health
`
`Investors
`
`NewsQ
`
`Home » News & Media » Press Releases » Study Shows Toviaz Is Effective In Reducing Urge Urinary Incontinence In Patients With Overactive Bladder After
`Suboptimal Response To Detrol LA
`
`Study Shows Toviaz Is Effective In Reducing Urge Urinary Incontinence In Patients With Overactive Bladder After Suboptimal
`Response To Detrol LA
`
`Thursday, August 2,2012 -10:30pm EDT
`
`"Health care professionals often question how to treat patients who have had a suboptimal response to Detrol LA, which is commonly used but does not have a
`dose higher than ii mg, and these data may help to guide treatment decisions."
`(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that a Phase A study assessing the efficacy and safety of Toviaz® (fesoterodine fumarate) in
`patients with overactive bladder (OAB) met its primary endpoint. Toviaz reduced urge urinary incontinence (UUI) in patients with OAB who had a suboptimal
`response (less than 50 percent reduction in UUI) to Detrol LA (tolterodine tartrate extended release), a commonly-prescribed treatment for the condition. UUI is
`the involuntary leakage of any amount of urine, associated with or immediately preceded by a sense of urgency.
`
`The 14-week randomized, parallel group, placebo-controlled, double-blind multicentre study assessed Toviaz 8 mg in patients with OAB who had been taking
`Detrol LA 4 mg for two weeks and had less than 50 percent reduction in urge urinary incontinence episodes. After open-label treatment with Detrol LA in mg,
`treatment with Toviaz in mg was started for one week, followed by treatment with Toviaz 8 mg.
`
`The study demonstrated that Toviaz 1: mg for one week followed by Toviaz 8 mg statistically significantly reduced the average number of urge urinary
`incontinence episodes (-2.37 episodes from baseline) per 21: hours (p<0.0001) in OAB patients who had a suboptimal response to Detrol LA in mg. The safety and
`tolerability profiles of fesoterodine and tolterodine were consistent with previous studies. The most common treatmentemergent adverse events for both
`fesoterodine and tolterodine were dry mouth and constipation. Further analyses will be conducted and a publication of the comprehensive results is planned at a
`later date.
`
`“This study adds to the body of evidence supporting Toviaz as an effective treatment for patients with overactive bladder, including patients who may not have
`responded to Detrol LA,” said study principal investigator Dr. Steven A. Kaplan, professor of urology, Weill Cornell Medical College and director of the Iris Cantor
`Men's Health Center at New York Presbyterianlweill Cornell Medical Center in New York. “Health care professionals often question how to treat patients who
`have had a suboptimal response to Detrol LA, which is commonly used but does not have a dose higher than in mg, and these data may help to guide treatment
`decisions."
`
`Overactive bladder is a treatable medical condition often caused by involuntary contractions or spasms of the bladder muscle. Overactive bladder symptoms of
`urgency, frequency or urge urinary incontinence can be bothersome and can have a significant impact on important aspects of people's lives. Approximately 33
`million American adults are estimated to suffer from OAB symptoms. Despite its prevalence, overactive bladder is often unrecognized and untreated.
`
`Study Background
`
`Based on a screening diary, subjects who met all entry criteria started open—|abe| treatment with once-daily tolterodine in mg for two weeks. At the end of the
`tolterodine treatment period, subjects who had less than 50 percent reduction of mean urge urinary incontinence per 21: hours from the screening diary to the
`baseline diary were randomized to one of two treatment arms in a 1:1 ratio (fesoterodine 8 mg or placebo). The study treatment started with to mg/day of
`fesoterodine or matching placebo for one week; after one week of treatment, the dose increased to 8 mg/day of fesoterodine. No further dose adjustments were
`permitted for the remaining 11 weeks of the study. The subjects were instructed to take the study drug once every day in the morning.
`
`The trial was conducted worldwide at 156 sites in 15 countries. A total of 221 7 subjects were screened, of which 6142 were randomized (322 fesoterodine 8 mg,
`320 placebo).
`
`About Toviaz
`
`INDICATION
`
`Toviaz® (fesoterodine fumarate) treats the symptoms of overactive bladder (leaks, strong sudden urges to go, going too often).
`
`The recommended starting dose for Toviaz is 14 mg once daily. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily.
`Toviaz should be swallowed whole; tablets should not be chewed, divided or crushed.
`
`IMPORTANT SAFETY INFORMATION
`
`If you have certain stomach problems, glaucoma, or cannot empty your bladder, you should not take Toviaz.
`
`Toviaz may cause allergic reactions that may be serious. If you experience swelling of the face, lips, throat, or tongue, stop taking Toviaz and get emergency
`medical help right away.
`
`Medicines like Toviaz can cause blurred vision, drowsiness, and decreased sweating. Use caution when driving, doing unsafe tasks, or in especially hot
`environments, until you know how Toviaz affects you. Drinking alcohol while taking medicines such as Toviaz may cause increased drowsiness.
`
`Petitioner My|an PharmaCeutiCa|S |nC_ _
`The mostcommon sideeffectsaredrymouth and constipation.
`Tnuin-; lrwnr I-xnnnlifr nnrl rial/1' Tknrn rnn\1 I-sn no-Inn-r nntinnc Tn Inn-rn rnI\rn nlvuir Tnuin-1 nlnnrn rnn flan Enll Drnz-rrikinn and Dnfinnf Tnlnrmnfinn
`
`_ Page 1
`
`http://www.pfizer.com/news/press-re|ease/press-release-detail/study shows toviaz is effective in reducing urge urinary incontinence_inJ)atients_with_ove...
`
`1/2
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1022 - Page 1
`
`
`
`1/25/2016 Study Shows Toviaz Is Effective In Reducing Urge Urinary Incontinence In Patients With Overactive Bladder After Suboptimal Response To Detrol LA | P...
`IUVIUL nu) ucn::m.> unu ll)l\). incl: inuy uc uuici upuun>. nu Icuin mun: LILJUIJL IUVIUL, pucuoc 3:: Ln: I un rncsuuunnig unu ruucnt JIIIUIIIIULIUII.
`
`About Detrol LA
`
`INDICATION
`
`Detro|®LA (tolterodine tartrate extended release capsules) treats the symptoms of overactive bladder (leaks, strong sudden urges to go, going too often).
`IMPORTANT SAFETY INFORMATION
`
`If you have certain stomach problems, glaucoma, or have trouble emptying your bladder, you should not take Detrol LA.
`
`Detrol LA may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat, or tongue. If
`you experience these symptoms, you should stop taking Detrol LA and get emergency medical help right away.
`
`Medicines like Detrol LA can cause blurred vision, dizziness, or drowsiness. Use caution while driving or doing other dangerous activities until you know how Detrol
`LA affects you.
`
`The most common side effects with Detrol LA are dry mouth, constipation, headache, stomach pain.
`
`Detrol LA has both benefits and risks. There may be other options. Ask your doctor if Detrol LA is right for you.
`
`To learn more about Detrol LA, please see Full Prescribing and Patient Information.
`
`Pfizer Inc.: Working Together for a Healthier Wor|d®
`
`At Pfizer, 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.
`
`Contact:
`
`Pfizer Inc.
`MocKayJimeson, 212-733-2324 (media)
`Suzanne Harnett, 212-733-8009 (investors)
`
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`http://www.pfizer.com/news/press-re|ease/press-release-detail/study shows toviaz is effective in reducing urge urinary incontinence_inJ)atients_with_ove...
`
`2/2
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1022 — Page 2
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1022 - Page 2
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