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Addex Reports Positive Preclinical Data for GABA-BR PAM Oral Small Molecule in Overactive Bladder
By (Addex Therapeutics Staff) on April 16, 2012
Addex Therapeutics / Addex Reports Positive Preclinical Data for GABA-BR PAM Oral Small Molecule in Overactive Bladder . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
Program on track for IND filing before end of 2012
GABA-BR PAM compounds have potential in several major Indications
Geneva, Switzerland, 16 April 2012 - Addex Therapeutics (SIX:ADXN), a leading organization pioneering allosteric modulation-based drug discovery and development, announced today positive data from studies of its lead GABA-B receptor (GABA-BR) positive allosteric modulator (PAM) oral small molecule in validated disease-relevant preclinical models of overactive bladder (OAB).
"Current treatments for OAB are associated with marginal efficacy and significant side effects, which limits their use in treating the millions of people suffering from this condition," noted Dr. Sonia Poli, Head of Non-Clinical Development at Addex Therapeutics. "We believe that a well tolerated and efficacious oral treatment would represent a major advance in OAB treatment. We are delighted with the efficacy and safety profile of our GABA-B receptor PAM oral small molecules and are rapidly advancing the lead candidate towards a regulatory filing to initiate clinical trials by the end of 2012."
The Addex lead compound (ADX71441), an oral small molecule, with potential for once daily dosing, selectively activating GABA-BR function, was evaluated in female guinea pigs with bladder overactivity. ADX71441 (1 and 3 mg/kg, i.v.) induced a strong increase in inter contraction interval (ICI), a validated measure of bladder muscle control, in the first 15 min post-administration compared to vehicle. The efficacy of ADX71441 was well correlated with its pharmacokinetic properties. ADX71441 also significantly decreased micturition (urination) frequency compared to vehicle at the 1 mg/kg dose.
In an independent mouse diuretic stress-induced model of overactive bladder, administration of ADX71441 dose-dependently normalized urination latencies. ADX71441 also dose-dependently reduced micturition frequency in furosemide-treated animals. The magnitude of the effect in response to 10 mg/kg ADX71441 was similar to those observed in oxybutynin (a commonly prescribed anti-cholinergic medication for OAB) - treated animals. At this dose, however, unlike oxybutynin-treated animals, ADX71441 was well tolerated and had no marked effects on body temperature, locomotor activity or motor coordination.
These data on ADX71441 will be presented at the American Urology Association (AUA) Annual Meeting in Atlanta (May 19-23, 2012).
"We look forward to a regulatory filing for clinical testing for this molecule at the end of this year as we drive forward our strategy of filing one IND per year. These data along with our recent announcement of positive phase 2 data in Parkinson's disease levodopa-induced dyskinesia demonstrate the strength of our pipeline based on allosteric modulator oral small molecule platform and its ability to generate multiple high value novel product opportunities" said Bharatt Chowrira, President and CEO of Addex Therapeutics.
About Overactive Bladder
Approximately 11-16 million U.S. women suffer from overactive bladder, with some estimates claiming an equal number of men suffer from the condition. Patients with an overactive bladder feel a strong and sudden need to urinate, which is usually associated with frequent nocturia (excessive trips to the bathroom in the middle of the night). These symptoms arise due to involuntary contractions of bladder muscle when filling with urine. Current standard of care is inadequate due to limited efficacy and side effects, such as dry mouth, blurred vision, tachycardia, CNS effects, ranging from cognitive impairment to episodes of psychosis, which significantly limit their use.
About GABA-BR Activation
Activation of gamma-aminobutyric acid subtype B (GABA-B) receptor, a Family C class of GPCR, is clinically & commercially validated. Generic GABA-B receptor agonist, baclofen, is marketed for spasticity and some spinal cord injuries, and used for OAB, but is not commonly used due to severe CNS side effects of the drug and rapid clearance. Orthosteric GABA-B receptor agonists have also shown clinical validation in gastroesophageal reflux disease (GERD). Addex' GABA-B receptor PAMs have shown efficacy in multiple preclinical models including: OAB, pain, osteoarthritis pain and anxiety.
Addex Therapeutics (www.addextherapeutics.com) discovers and develops an emerging class of small molecule drugs, called allosteric modulators, which have the potential to be more specific and confer significant therapeutic advantages over conventional "orthosteric" small molecule or biological drugs. The Company uses its proprietary discovery platform to address receptors and other proteins that are recognized as attractive targets for modulation of important diseases with unmet medical needs. The Company's two lead products are being investigated in Phase 2 clinical testing: dipraglurant (ADX48621, an mGluR5 negative allosteric modulator or NAM) is being developed by Addex to treat Parkinson's disease levodopa-induced dyskinesia (PD-LID); and ADX71149 (mGluR2 positive allosteric modulator or PAM) is being developed by our partner Janssen Pharmaceuticals Inc. to treat schizophrenia. Addex also is advancing several preclinical programs including: GABA-BR PAM for overactive bladder, pain and other disorders; mGluR4 PAM for Parkinson's, anxiety and other diseases; GLP1R PAM for type 2 diabetes; mGluR2 NAM for treating Alzheimer's disease and depression; and FSHR/LHR NAM for sex hormone dependent tumors & reproductive system disorders. In addition, Addex has discovery programs to identify allosteric modulators of: receptor tyrosine kinase (RTK) superfamily, including TrkB PAM for treating neurodegenerative diseases (e.g. Alzheimer's, Parkinson's and Huntington's diseases); and TNF receptor superfamily, including TNFR1 NAM for inflammation (e.g. rheumatoid arthritis) and other diseases.
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FDA Advisory Committee Recommends Approval of Mirabegron - Investigational Overactive Bladder Treatment From Astellas
By (PR Newswire Staff) on April 5, 2012
DEERFIELD, Ill., April 5, 2012 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that the overall risk/benefit assessment supports approval of mirabegron (YM178) for the treatment of overactive bladder (OAB) (Yes: 7, No: 4, Abstain: 1).
Today's committee recommendation, although not binding, will be considered by the FDA as it reviews the New Drug Application (NDA). The FDA is expected to issue an action letter on the mirabegron application by June 29, 2012.
Mirabegron is a once daily oral selective B3-adrenoceptor agonist discovered and developed by Astellas. Mirabegron has been studied extensively in more than 10,000 individuals over the last 10 years.
"We are pleased with the committee's recommendation, which marks an important step in bringing a new treatment option to the more than 42 million Americans living with overactive bladder," said Steven Ryder, MD, president, Astellas Pharma Global Development. "If approved, mirabegron will offer patients and physicians the first new oral mechanism of action in OAB treatment since the launch of the first anticholinergic agent 30 years ago. Mirabegron and other pipeline products are part of Astellas' commitment to advancing urological health."
Mirabegron uses a distinct mechanism of action versus antimuscarinics, the current treatment standard. Antimuscarinics work by binding to muscarinic receptors in the bladder and inhibiting involuntary bladder contractions. Mirabegron works by stimulating the B3 receptors in the detrusor muscle of the bladder, causing relaxation of the bladder muscle during the storage phase of the micturition (urination) cycle. This improves the storage capacity of the bladder without diminishing bladder contraction during bladder voiding.
Astellas submitted a New Drug Application for mirabegron to the FDA on Aug. 26, 2011. Regulatory applications for mirabegron are also under review in several other countries. In July 2011, mirabegron was granted marketing approval in Japan and was launched in September 2011.
About Overactive Bladder
According to the National Association for Continence, one in five adults has overactive bladder. However, recent studies have found that many more people may be affected, but have not talked to their physicians out of embarrassment or belief that OAB cannot be treated. For people with OAB, inappropriate signals are sent to the muscles in the bladder causing them to contract before the bladder is full. These bladder contractions may cause strong, sudden urges, and a frequent need to go to the bathroom, sometimes without any advance warning. Many patients cope with their symptoms by restricting fluids, carrying extra clothing and "mapping" bathroom locations wherever they go.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information about Astellas Pharma US, Inc., please visit our website at www.astellas.us.
SOURCE Astellas Pharma US, Inc.
Allergan Announces Positive Top-Line Results From Phase III BOTOX®Overactive Bladder Program
By Business Wire on March 28, 2012
IRVINE, Calif.--()--Allergan, Inc. (NYSE: AGN) today announced that two Phase III clinical trials of BOTOX® (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Results from both Phase III clinical trials demonstrate that BOTOX® significantly reduced urinary incontinence (bladder leakage) episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment. The summary data are being presented as part of Allergan’s Research and Development Technology Review, which will be held today at 1 p.m. Eastern Time. The full study results of the North American Phase III study are expected to be presented at an upcoming medical meeting.
Based on the results of the two Phase III clinical trials, Allergan has submitted a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) and an application with European Regulatory authorities seeking approval for the use of BOTOX®as treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. BOTOX® is currently approved in the United States and in several European countries for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
“Allergan is committed to the research and clinical development of novel treatment options for urologists and their patients, and we look forward to potentially expanding the use of BOTOX® as a treatment option following approval by the respective regulatory agencies,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development, Chief Scientific Officer. “We are pleased with the results of our idiopathic overactive bladder Phase III clinical trials, which demonstrated that BOTOX® treatment provided benefit to these overactive bladder patients with symptoms of urinary incontinence who failed or were intolerant of other therapy.”
Overactive bladder (OAB) is a medical condition that results in an uncontrolled urge to void, frequent voids and, in many patients, uncontrolled urinary leakages. In most cases, the precise cause of OAB is unknown. An estimated 13 million adults in the United States experience urinary incontinence, or bladder leakage, as a symptom of OAB. An estimated 3.2 million Americans with OAB, with or without urinary incontinence, are taking oral medications known as anticholinergics, which is the current standard of care.1 It is estimated, however, that greater than 50 percent of these patients discontinue oral medications, likely due to an inadequate response to, or intolerance of, the medication.2,3,4
Both Phase III clinical trials included patients with symptoms of OAB not caused by a neurological condition who were suffering with urinary incontinence for at least six months and who were inadequately treated with an anticholinergic therapy. Patients were randomly assigned to treatment with BOTOX® or placebo injections into the detrusor (bladder) muscle, followed by an injection with BOTOX® after a minimum of 12 weeks if desired. In both studies, there was a highly statistically significant decrease in the number of daily incontinence episodes in patients treated with BOTOX® vs. placebo (p<0.001).
In both Phase III clinical trials, BOTOX® treatments were well tolerated in patients suffering from OAB symptoms with urinary incontinence. Adverse events were primarily limited to the urinary tract, with urinary tract infection rates between 15-20 percent and urinary retention rates between 5-6 percent for patients treated with BOTOX® in both studies. Patients receiving BOTOX®treatments in both studies also reported an improvement in quality of life.
About BOTOX® (onabotulinumtoxinA)
BOTOX® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. BOTOX® has a unique, protected molecular structure that stabilizes the core toxin in BOTOX® from degradation. When injected at FDA-approved and labeled doses into a specific muscle or gland, BOTOX®neurotoxin is expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three to ten months depending on the indication and on the individual patient.
BOTOX® was first approved by the FDA more than 22 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval in 1989, BOTOX® has been recognized by regulatory authorities worldwide as an effective treatment for 25 different indications in approximately 85 countries, benefiting millions of patients worldwide. In the United States, BOTOX® neurotoxin is also approved to treat seven medical conditions, including the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults; symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough; for the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in adult patients with upper limb spasticity; for the prophylactic treatment of headaches in adults with Chronic Migraine, a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer; and most recently, for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
In addition to its therapeutic uses, the same formulation of BOTOX®with dosing specific to moderate to severe glabellar lines was approved by the FDA in 2002 under the trade name BOTOX® Cosmetic (onabotulinumtoxinA). BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age.
In addition to approximately 21 years of clinical experience, the safety and efficacy of BOTOX® have been well-established in approximately 65 randomized, placebo-controlled clinical trials and in approximately 15,000 patients treated with BOTOX® and BOTOX® Cosmetic in Allergan’s clinical trials.5 Worldwide, approximately 30 million vials of BOTOX® and BOTOX®Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1990-2010).6 With approximately 2,500 articles on BOTOX® and BOTOX®Cosmetic in scientific and medical journals,7 BOTOX® neurotoxin is one of the most widely researched medicines in the world.
BOTOX® (onabotulinumtoxinA) & BOTOX®Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® is a prescription medicine that is injected into muscles and used:
- to treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
- to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
- to treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity
- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
- to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).
It is not known whether BOTOX® and BOTOX®Cosmetic is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
It is not known whether BOTOX® and BOTOX®Cosmetic is safe or effective to treat increased stiffness in upper-limb muscles other than those in the elbow, wrist, and fingers, or to treat increased stiffness in lower-limb muscles. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.
It is not known whether BOTOX® and BOTOX®Cosmetic are safe or effective for severe sweating anywhere other than your armpits.
IMPORTANT SAFETY INFORMATION
BOTOX® and BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® or BOTOX®Cosmetic:
- Problems swallowing, speaking, or breathing, due to weakening ofassociated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.
Do not take BOTOX® or BOTOX®Cosmetic if you: are allergic to any of the ingredients in BOTOX®(see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc®(rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Do not take BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.
The dose of BOTOX® and BOTOX®Cosmetic is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. These reactions include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX® or BOTOX® Cosmetic should be discontinued.
Tell your doctor about all your muscle or nerve conditions suchas amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® or BOTOX®Cosmetic.
Tell your doctor if you have any breathing-related problems. Your doctor will want to monitor you for any breathing problems during your treatment with BOTOX® for upper limb spasticity or for detrusor overactivity associated with a neurologic condition. The risk of pulmonary effects in patients with compromised respiratory status is increased in patients receiving BOTOX®.
Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX®for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.
Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX® for their upper limb spasticity. Upper respiratory infections (common colds) were also reported more frequently in people with prior breathing-related problems.
Autonomic Dysreflexia and Urinary Retention in Patients Treated for Detrusor Overactivity Associated With a Neurologic Condition
Autonomic dysreflexia associated with intradetrusor injections of BOTOX®could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX®200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n=33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n=7).
Among patients not using CIC at baseline, those with MS were more likely to require CIC post-injection than those with SCI.
Due to the risk of urinary retention, only patients who are willing and/or able to initiate catheterization post-treatment, if required, should be considered for treatment.
In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post-treatment and periodically as medically appropriate up to 12 weeks. Catheterization should be instituted if PVR urine volume exceeds 200 mL and continued until PVR falls below 200 mL. Patients should be instructed to contact their physician if they experience difficulty in voiding as catheterization may be required.
Human albumin and spread of viral diseases. BOTOX® and BOTOX® Cosmetic contains albumin, a protein component of human blood. The potential risk of spreading viral diseases (e.g., Creutzfeldt-Jakob disease [CJD]) via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin.
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence. Symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever; have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® or BOTOX® Cosmetic can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® or BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® or BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® or BOTOX® Cosmetic in the past.
Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).
Other side effects of BOTOX® and BOTOX®Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; urinary tract infection and/or inability to empty your bladder on your own (in people being treated for urinary incontinence).
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Allergan, Inc.
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have approximately 10,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
This press release contains “forward-looking statements,” including the statements by Dr. Whitcup and other statements regarding research and development and regulatory outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding BOTOX®. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry, biologic and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical and biologics products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2011 Form 10-K. Copies of Allergan's press releases and additional information about Allergan are available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
© 2012 Allergan, Inc. Irvine, CA 92612. ®marks owned by Allergan, Inc. All rights reserved.
Myobloc®is a registered trademark of Solstice Neurosciences, Inc.
Dysport®is a registered trademark of Ipsen Biopharm, Ltd.
Xeomin®is a registered trademark of Merz Pharma Gmbh & Co.
1 2011 SDI, Allergan Data on File
2 D’Souze et al. Persistence, Adherence, and Switch Rates Among Extended-Release and Immediate-Release Overactive Bladder Medications in a Regional Managed Care Plan. J. Managed Care Pharm. 2008;14(3):291-301
3 Yu et al. Persistence and Adherence of Medications for Chronic Overactive Bladder/Urinary Incontinence in the California Medicaid Program. Value in Health. 2005:495-505
4 Shaya et al. Persistence With Overactive Bladder Pharmacotherapy in a Medicaid Population. The American Journal of Managed Care. 2005:11:S121-S129
5 Allergan data on file; Medical Affairs
6 Allergan data on file; Global Regulatory Affairs
7 Allergan data on file; Global Literature & Information Services
Bonnie Jacobs, (856) 912-9965; (714) 246-5134 (media)
Heather Katt, (714) 697-2981; (714) 246-6224 (media)
Jim Hindman, (714) 246-4636 (investors)
Joann Bradley, (714) 246-4766 (investors)
David Nakasone, (714) 246-4474 (investors)
Recent Stories from Allergan, Inc.
Bladder Issues Top Money, Family and Work Problems as Sensitive Topic for Canadian Men
By (CNW Staff) on February 15, 2012
The Locker Room addresses need for bladder health information, offers Canadian men online resource
TORONTO, Feb. 15, 2012 /CNW/ - Think talking about money, family concerns, or issues at work might be touchy topics? Try talking about bladder problems. According to a new poll conducted by Ipsos Reid, many Canadian men feel bladder issues are a more delicate topic of discussion than other typically sensitive subjects.i
The Locker Room (www.intheLockerRoom.ca), launched today, aims to help facilitate the bladder health conversation, offering men an educational program developed to improve their quality of life by helping them better understand and seek help for bladder-related issues such as overactive bladder (OAB).
The fact is, 12 to 18 per cent of Canadian men suffer from overactive bladder.ii While women tend to discuss the condition and seek treatment for OAB more than their male counterparts, both men and women have the same chances of developing this condition.iii
"Credible online resources such as The Locker Room are essential to helping men - and women - better understand the conditions they might not be comfortable discussing," says Dr. Gerald Brock, Professor of Surgery, Division of Urology, Urology Program Director, University of Western Ontario. "In the case of overactive bladder, the condition can be well managed but that success begins with quality information and open discussion with a healthcare professional."
The survey also suggests that even if they're not sharing bladder health concerns with one another, Canadian men do seem open to discussing their health with a physician and searching out credible health information. In fact, while nearly one half (45%) say it would be 'difficult' to talk about an issue like having bladder problems (going to the bathroom too many times, leakage, etc.), eight in ten (78%) say that they would consult their doctor if they needed more information on a health issue they had, and nearly half (45%) of Canadian men would consult the internet.iv
About Overactive Bladder
Overactive bladder (OAB) is a chronic medical condition that is marked by the sudden and sometimes uncomfortable need to urinate. This can occur at any time during the day or night, and it may or may not result in the leakage of urine.
Overactive bladder occurs when the bladder's smooth muscle, known as the detrusor muscle, squeezes while the bladder is still filling instead of when it is completely full. When this muscle squeezes, signals are sent to the brain resulting in the urge to urinate.
This urgency sometimes leads to more trips than normal to the bathroom and for some people, an involuntary loss of urine. Overactive bladder can be both frustrating and embarrassing. For patients who experience urge incontinence - the involuntary leakage of urine accompanied or preceded by urgency - this can be distressful and sometimes debilitating.
It is recommended that people who have symptoms of overactive bladder undergo a medical and physical examination by their doctor to evaluate their medical history, severity of symptoms, the impact of the condition on their lifestyle and assessment of treatment options.v
It is not uncommon for people with an overactive bladder to avoid or even stop physical or public activities altogether and put their lives on hold. A proper diagnosis and discussion around overactive bladder with a doctor is essential to long-term solutions for OAB.vi
About The Locker Room
The Locker Room (www.intheLockerRoom.ca) is a national and fully bilingual educational program developed to improve the quality of life of men with OAB by helping them to understand, manage and treat the condition.
The Locker Room was developed in collaboration with Canadian healthcare professionals and is supported by a grant from Astellas Pharma Canada, Inc., a leader in the field of urology.
More information can be found at www.intheLockerRoom.ca.
i Lifting the Lid of Men's Bladder Health. Ipsos Reid Survey, 2011
ii The Locker Room "A Quick Guide to Overactive Bladder" Slim Jim
iii The Locker Room "A Quick Guide to Overactive Bladder" Slim Jim
iv Lifting the Lid of Men's Bladder Health. Ipsos Reid Survey, 2011
v The Locker Room "A Quick Guide to Overactive Bladder" Slim Jim
vi "OAB Diagnosis" www.inthelockerroom.ca
For further information:
For more information or to book an interview, please contact
Tel : 416.425.9143 x17
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Les hommes canadiens ont davantage de difficulté à aborder le sujet des problèmes de vessie que celui de l'argent, de la famille ou des ennuis au travail
By on February 15, 2012
Les hommes canadiens ont davantage de difficulté à aborder le sujet des problèmes de vessie que celui de l'argent, de la famille ou des ennuis au travail
« Dans le vestiaire » répond aux besoins des hommes canadiens en matière de santé urinaire en leur proposant une ressource en ligne
TORONTO, le 15 févr. 2012 /CNW/ - Si l'argent, les problèmes familiaux ou les ennuis au travail vous semblent être des soucis délicats à aborder, alors essayez de parler des problèmes de vessie. Selon un récent sondage réalisé par Ipsos Reid, de nombreux hommes canadiens considèrent que le sujet des troubles de vessie est plus délicat que d'autres sujets jugés de nature sensiblei.
Dans le vestiaire (www.danslevestiaire.ca), dont le lancement a lieu aujourd'hui, a pour objectif de contribuer à faciliter la discussion autour du sujet des problèmes de vessie en offrant aux hommes un programme éducatif conçu pour améliorer leur qualité de vie. À cette fin, Dans le vestiaire cherche à améliorer la compréhension des hommes et à les amener à trouver l'aide dont ils ont besoin en lien avec leurs problèmes de vessie, comme l'hyperactivité vésicale.
Les faits démontrent que 12 à 18 % des hommes canadiens souffrent d'un problème de vessieii. Si les femmes semblent avoir davantage de facilité que les hommes à discuter de leur état et à aller chercher l'aide nécessaire en cas d'hyperactivité vésicale, les risques de souffrir de ce problème sont les mêmes pour les hommes et les femmesiii.
« Les hommes peuvent se sentir intimidés par l'idée de discuter de problèmes personnels, comme l'hyperactivité vésicale. Voilà pourquoi il est important de leur rappeler qu'il est possible de gérer leur état. En fait, la première étape consiste à en parler ouvertement avec un médecin de confiance » explique Luc Valiquette, M.D., FRCS (C), urologue au Centre Hospitalier de l'Université de Montréal. En plus de consulter un professionnel de la santé, les hommes peuvent se tourner vers des sites d'information crédibles, tels que Dans le vestiaire, afin de mieux comprendre ce trouble médical et de trouver l'assurance dont ils ont besoin pour s'ouvrir aux autres. »
L'étude suggère également que bien qu'ils ne discutent pas des problèmes de vessie entre eux, les hommes canadiens sont toutefois ouverts à l'idée d'en discuter avec un médecin et de chercher de l'information de sources crédibles sur le sujet. En fait, près de la moitié d'entre eux (45 %) ont affirmé qu'il serait « difficile » de discuter d'un sujet comme celui des problèmes de vessie (besoin trop fréquent d'aller à la salle de bain, fuites, etc.); huit hommes sur dix (78 %) iraient consulter leur médecin s'ils avaient besoin d'information concernant un problème de santé, et près de la moitié (45 %) d'entre eux se tourneraient vers les ressources en ligneiv.
À propos de l'hyperactivité vésicale
L'hyperactivité vésicale est un trouble médical chronique caractérisé par une envie soudaine et parfois inconfortable d'uriner. Il peut se manifester le jour ou la nuit, avec ou sans écoulement d'urine.
L'hyperactivité vésicale se manifeste lorsque le muscle lisse de la vessie, le détrusor, se contracte alors que la vessie n'est pas encore pleine. Lorsqu'il se contracte, ce muscle transmet un signal au cerveau, qui se traduit par un besoin urgent d'uriner.
Cette sensation d'urgence occasionne parfois des visites plus fréquentes aux toilettes et, chez certaines personnes, des fuites urinaires involontaires. L'hyperactivité vésicale peut se révéler tout aussi frustrante qu'embarrassante. Chez les personnes qui souffrent d'incontinence impérieuse (fuite involontaire d'urine accompagnée ou précédée d'une urgence mictionnelle), ces situations peuvent être stressantes et, parfois, décourageantes.
Les personnes aux prises avec certains symptômes de l'hyperactivité vésicale devraient se soumettre à des examens physiques et médicaux afin qu'un médecin puisse évaluer leur historique de santé, la sévérité des symptômes, les répercussions de leur état sur leur style de vie, de même que les options de traitementv.
Il arrive souvent que les personnes qui souffrent d'hyperactivité vésicale cessent toute activité physique ou publique et mettent leur vie en suspens. Un diagnostic adéquat et une discussion avec un médecin concernant l'hyperactivité vésicale sont essentiels pour trouver une solution à long terme pour ce problèmevi.
À propos de Dans le vestiaire
Dans le vestiaire (www.danslevestiaire.ca) est un programme d'éducation national entièrement bilingue conçu pour améliorer la qualité de vie des hommes souffrant d'hyperactivité vésicale, en les aidant à comprendre et à gérer leur état, de même qu'à y trouver un traitement.
Le programme Dans le vestiaire a été mis sur pied en collaboration avec des professionnels de la santé canadiens, et bénéficie d'un soutien financier par Astellas Pharma Canada, inc., un chef de file dans le domaine de l'urologie.
Consultez le site www.danslevestiaire.ca pour de plus amples renseignements.
i Lifting the Lid of Men's Bladder Health. Étude menée par Ipsos Reid, 2011.
ii Dans le vestiaire. Guide de consultation rapide sur l'hyperactivité vésicale. Slim Jim
iii Dans le vestiaire. Guide de consultation rapide sur l'hyperactivité vésicale. Slim Jim
iv Lifting the Lid of Men's Bladder Health. Étude menée par Ipsos Reid, 2011.
v Dans le vestiaire. Guide de consultation rapide sur l'hyperactivité vésicale. Slim Jim
viDiagnostic de l'hyperactivité vésicale www.danslevestiaire.ca
Pour de plus amples renseignements, ou pour obtenir un entretien, veuillez communiquer avec :
Tél. : 514-288-8500, poste 235
Numéro sans frais : 1-888-764-6322, poste 235
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New App Helps Urology Patients Find Bladder Friendly Foods
By on February 10, 2012
Newswise — When one cup of coffee, tea or cranberry juice can trigger days of pain and/or bladder discomfort, interstitial cystitis, overactive bladder and other urology patients often develop an unhealthy fear of food. A new iPhone and iPad application, (ICN Food List) seeks to change that by giving patients an easy to use food list and database that they can use while shopping and eating out at restaurants.
“It comes as no surprise to most interstitial cystitis/bladder pain syndrome (IC/BPS) patients that some foods can exacerbate their symptoms. Several studies have revealed that 90% of patients report sensitivity to a variety of foods, particularly coffees, teas, citrus fruits, carbonated beverages, hot spicy foods and alcohols” offered Jill Osborne MA, President of the Interstitial Cystitis Network. She continued “Typically, foods high in caffeine and acid, such as coffees, green teas, regular teas and soda, are the worst offenders but there are many other foods that can trigger bladder discomfort.”
The application contains an easy to use food database developed from published research studies and food lists created by support groups. The more than 250 foods in the list are divided into three general categories: bladder friendly foods, foods worth trying cautiously and foods to avoid. Foods that patients generally find soothing during IC “flares” are highlighted. It is also the first list to cover wine, beer and spirits, listing the results of a study conducted by the IC Network in 2009. Lower acid wines and pale ale beers were more bladder friendly. Surprisingly, some patients even tolerated mixed drinks provided that they were used with IC friendly mixers.
“This app is also a powerful educational tool that can be used by clinicians, nursing staff and registered dietitians,” Ms. Osborne continued, “It’s designed to help anyone struggling with urinary tract food sensitivity including IC/BPS, overactive bladder, hypersensitive bladder syndrome, prostatitis, chemotherapy induced cystitis, radiation cystitis, ketamine cystitis, trigonitis and urethritis.”
The app is currently available in the App Store for iPhones and iPads at just 99 cents. Additional information can be found at: http://www.ic-network.com/apps/
Founded in 1995, the Interstitial Cystitis Network (http://www.ic-network.com) is a woman owned, "social advocacy" health education company dedicated to interstitial cystitis and other pelvic pain disorders. Using the internet, we create innovative solutions to the pressing problems facing patients diagnosed with urologic conditions, medical care providers who care for them and the research community seeking new treatments and cures. For the past 16 years, we have provided critical 24/7 support to patients in need, developed new educational materials, conducted vital research, provided webinars/lectures and created IC awareness campaigns, all at NO COST to the patients who visit our website.
You Docs Tips to Avoiding Incontinence
By (The You Docs Staff) on January 28, 2012
What embarrassing health secret do teen athletes, guys in their 40s to 90s, mid-life women and military parachute trainees share but rarely ‘fess up to? Bladder problems. We’re talking dribbles, sudden leaks, mad dashes to the bathroom and pad-soaking floods.
Thanks to the billion-dollar absorbent-products industry — there are now even padded boxer shorts — it’s easier than ever to hide incontinence. But should you?
You may have heard that this wet-underwear issue is on the rise. More than half of women deal with it, and it’s increased 30 per cent in men just since 2002. Aging, hormone changes, pregnancy, childbirth, physical stress (gymnastics to parachuting) all play roles, but so do new factors like the obesity-plus-diabetes epidemic and the increase in radiation and surgery for prostate cancer. About 156,000 men have potentially life-saving prostate cancer surgery each year; 80 per cent leak for at least six months, and up to 65 per cent still have incontinence issues after five years.
More guys than once thought — as many men as women — also have bladder muscle spasms (a.k.a. overactive bladders), triggering panicky “gotta go” urges; however, these often are misdiagnosed as enlarged prostate problems. See a urologist to be sure.
That’s a lot of Depends and daily difficulties for loads of people (you?). Incontinence dampens your enthusiasm for exercise, sex, going out (you’re always looking for a restroom), even attending meetings (gotta . . . hold . . . it . . . till break time).
Yet few women and fewer men ask for help. The price of silence: missing out on improving stay-dry solutions. Among them:
Squeeze this. The exercises called Kegels help more than 80 per cent of women with stress incontinence — the leak-when-you-sneeze type — stay way dryer. The surprise? They work for guys, too. Men with overactive bladders — the gotta-go-now-oops-didn’t-make-it type — have fewer accidents when they do Kegels daily. So do men who’ve had prostate surgery.
The trick? Working the right muscles. Many people squeeze their butt, thigh or tummy muscles by mistake. To find your pelvic-floor muscles, do this: On your next bathroom trip, stop your stream of urine, then throw in the clench you’d use to hold back gas (yep, a fart). Those are the muscles you’re after. Squeeze, then completely relax them. Build up to 20 to 30 a day. Since nobody can see this, you can do Kegels anywhere: pumping gas, at your desk, in a grocery line.
Skip go-go-go drinks. It’s a no-brainer that your bladder’s going to yell after chugging a giant bottle of water, but you may be overstimulating it in other ways. Caffeine, fizzy drinks, artificial sweeteners, alcohol, tomatoes and citrus can all trigger an overwhelming urge to go.
Keep a “pee diary.” For three days, write down what you do and when your bladder loses control. Then look for connections. You may find patterns you can change easily, like the afternoon urge that always hits after your big-gulp diet cola. You may also find connections your doctor can help with (see below), like a bladder that always acts up when you walk in the front door.
Work with your doc. You owe it to yourself if you’re not staying dry.
• Get a check for health problems or medications (like some blood pressure drugs) that can cause trouble.
• Be sure you’re doing Kegels correctly. If not, a physical therapist can quickly make a big difference.
• For overactive bladders, discuss hypnosis, visualization, acupuncture and bladder retraining techniques. All can put your brain back in control so you can stroll — not sprint — to the toilet.
• There are also prescription drugs that calm overactive bladders.
• Surgical techniques can help tightly shut your urethra (the tube that carries urine out of the body) or reposition a bladder that shifted during childbirth.
• For women, a plastic ring called a pessary can also stabilize a shifty bladder or tighten a leaky urethra.
• There are other treatments too, including muscle injections and nerve stimulants.
Speak up. Soon you’ll be walking right past those pads in the drugstore and taking long road trips worry-free.
YouDocs Mehmet Oz and Mike Roizen are authors of YOU: Losing Weight. Order it at StarStore.ca. Submit questions and find more info at RealAge.com
How To Prevent Leaks And Dribbles Down There
By (The You Docs Staff) on January 16, 2012
Topping off the growing stack of great stuff that vitamin D-3 does for you is this good news: Keeping your levels up dramatically lowers your risk for PDQ (Pee Doesn't Quit).
Medically, it's called urinary incontinence. You probably call it "Oh no." Turns out there's one thing many of the 10 million women struggling with it share: low levels of D-3. It makes them (you?) a whopping 170 percent more likely to leak than those with a healthy level of D-3. Why? The vitamin may help muscle tone in your sphincter, the muscle that stops dribbles. (By the way, men leak, too; it's just a better-kept secret. We don't know yet whether low D affects guys.)
The Department of Defense should be so lucky as to have such a simple way to prevent leaks.
How to be sure you're not D-ficient? A simple blood test. We like to see D-3 levels between 50 and 80. If you're low (up to 75 percent of folks are, especially in winter), take 1,000 IU of D-3 a day; 1,200 after age 60. Include what's in your multivitamin and combo calcium-D-3-magnesium pill. Don't go over 2,000 IU unless your doc says to. Too much can harm bones and kidneys.
Also, take 900 mg of DHA omega-3s daily. These healthy fats help you absorb vitamin D-3 (and do good things for your heart and brain). However, it's not easy to get enough DHA from food.
Bonus: While helping to keep you dry (what a relief), D-3 also protects you against asthma, dementia and the flu!
Distributed by King Features Syndicate, Inc.
Bladder Cancer Linked to Smoking Research Shows
By (Powder Room Admin) on October 28, 2011
Diagnosing Bladder Cancer
Bladder Training Tips to Reduce Bathroom Trips
By Anne Harding on September 27, 2011
It's important to go the bathroom when you need to. "Holding it" can actually stretch your bladder, making it difficult to empty it completely.
But there's such a thing as going too often. (The norm is around seven bathroom trips daily.)
An overactive bladder contracts abnormally, triggering the urge to urinate too often. This can lead to urge incontinence, which occurs when you suddenly feel a strong urge to urinate but don't make it to the bathroom in time.
The good news is that bladder training can help.