BOTOX® (Allergan's Botulinum Toxin Type A) Recommended by the National Institute for Health and Clinical Excellence (NICE) for the Prevention of Chronic Migraine in Patients Who Have Failed Previous Treatments

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Allergan

10 May, 2012, 23:01 GMT

MARLOW, England, May 11, 2012 /PRNewswire/ --

Allergan announced today that the National Institute for Health and Clinical Excellence (NICE) is recommending BOTOX® (botulinum toxin type A) for the prophylaxis (prevention) of headache in adults with chronic migraine*, specifically in patients who have not responded to at least three prior preventative treatments and whose condition is appropriately managed for medication overuse.[1] The Final Appraisal Determination (FAD) means that headache specialists in England and Wales will have a cost-effective, well- tolerated and licensed prophylactic treatment to help manage this debilitating condition. Once the final guidance is published in June, Primary Care Trusts (PCTs) will have 90 days to make funding and resources available. Allergan's BOTOX® is the only botulinum toxin type A to have received authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for the prevention of headache in chronic migraine.[2] The appraisal decision by NICE has been keenly awaited by headache specialists, chronic migraine sufferers and payers in the UK and around the world, and has the potential to significantly change the care of chronic migraine.

Chronic migraine is a disabling condition that disrupts the lives of patients as well as their families, with many sufferers unable to work or struggling to manage household and family responsibilities.[3] Patients with chronic migraine frequently struggle to adequately control their headaches and migraine, often using many different types of pain relief and preventative medications. While there are an estimated 700,000 adults in the UK[4,5] with chronic migraine, only 20% of people with the condition are properly diagnosed.[6] Allergan estimates that about a third of diagnosed patients with chronic migraine have already tried three or more preventative medications and may now be eligible for treatment with BOTOX®.

Dr Fayyaz Ahmed, Chair of the British Association for the Study of Headache (BASH) says "The medical evidence shows that BOTOX® can provide significant benefit to patients with chronic migraine, helping to reduce the number of days disrupted by migraine or headache and improving their quality of life. Those who respond to BOTOX® describe the treatment as life changing and for refractory patients who have exhausted other options, a reduction in the number of headache days can have a very significant impact on everyday life, like being able to do the school run, attend a meeting or visit relatives. As headache experts with first-hand experience of treating chronic migraine patients, the final draft guidance by NICE is welcomed."

Historically, treatment for chronic migraine has consisted of a combination of acute and prophylactic treatments available either over-the-counter or by prescription, such as triptans, tricyclic antidepressants, β-blockers and anti-epileptics. Current prophylactics for migraine are poorly adhered to for a variety of reasons including tolerability issues, unrealistic expectations of treatment, and dosing frequency.[7]

"Chronic migraine is a disabling condition which has a major impact on quality of life. The consequences of chronic migraine can have a detrimental impact on a sufferer's work, home and social life. The condition affects an estimated 2% of the population, and for the many patients who do not respond well to acute pain medications or to preventative medications, BOTOX® may offer an effective alternative," said Wendy Thomas, Chief Executive of The Migraine Trust. "The announcement today will help these patients gain access to badly needed preventative treatment," said Joanna Hamilton-Colclough, Director of Migraine Action. "For some patients, BOTOX® treatments can provide a significant benefit, helping them get back in control of their chronic migraine."

Allergan worked extensively with the headache community to develop a submission reflecting best clinical care, incorporating appropriate stopping rules. According to the final draft NICE guidance, treatment with BOTOX® should be stopped in people whose condition is not adequately responding to treatment (defined as less than a 30% reduction in headache days per month after two treatment cycles) or has changed to episodic migraine (defined as fewer than 15 headache days per month) for three consecutive months.

"Once the final guidance is published, this will represent the first NICE recommendation for any preventative treatment in the management of chronic migraine and is excellent news for patients," said Mr. Douglas S. Ingram, President of Allergan, Europe, Africa and the Middle East. "The anticipated positive NICE guidance has been supported by the considerable work of the UK migraine community and their belief that BOTOX® is a valuable treatment option for patients suffering from this crippling condition. We look forward to working with neurologists, headache specialists, hospitals and commissioning groups to support the National Health Service in adopting BOTOX® to minimise the significant effects chronic migraine can have on the lives of patients and their families in the UK."

~~Ends~~

Notes to Editor

About BOTOX®

BOTOX® is a brand name. It is a prescription-only medication that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. In the UK, BOTOX® is indicated for the treatment of adult patients with:[2]

  • blepharospasm (uncontrolled blinking of the eyelids)
  • hemifacial spasm (a neuromuscular disorder characterised by unpredictable and involuntary twitching of facial muscles on one side of the face)
  • cervical dystonia (a muscle condition affecting the neck making it difficult to hold the head up straight)
  • severe axillary hyperhidrosis (excessive sweating) of the armpits
  • upper limb spasticity (wrist and hand disability associated with stroke in adults)
  • prophylactic (prevention) of headache in adult patients with chronic migraine

BOTOX® is also approved for the treatment of glabellar lines (frown lines). In addition, BOTOX® is approved for the treatment of dynamic equinus foot deformity in paediatric patients with cerebral palsy aged two years and older. Refer to the Summary of Product Characteristics for full prescribing information at http://www.medicines.org.uk/emc/medicine/112.  

About Allergan

Allergan, Inc. 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 more than 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, over-the-counter medicines and medical devices, 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 ophthalmology, neurosciences, obesity, urologics, medical aesthetics and dermatology, 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.

Forward-Looking Statement

This press release contains "forward-looking statements", including but not limited to the statements by Douglas S. Ingram, Dr. Fayyaz Ahmed, Wendy Thomas and Joanna Hamilton-Colclough and other statements regarding the NICE recommendation, likelihood of National Health Service adoption, research and development 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 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 products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; 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 U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2011 Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. ® and ™ Marks owned by Allergan, Inc.

References

1. National Institute for Health and Clinical Excellence. Final appraisal determination: Botulinum toxin type A for the prevention of headaches in adults with chronic migraine. Issue date May 2012.

2. Botox® Summary of Product Characteristics http://www.medicines.org.uk/EMC/medicine/112/SPC/BOTOX+100+Units/

3. Lipton RB. Chronic Migraine, Classification, Differential Diagnosis and Epidemiology. Headache. 2011;51(suppl2):77S-83S.

4. Natoli J, Manack A, Dean B, Butler Q, Turkel C, Stovner L, et al. Global Prevalence of Chronic Migraine: a systematic review. Cephalalgia. 2009 Jul 10

5. Population of the UK http://www.statistics.gov.uk/statbase/product.asp?vlnk=15106

6. Bigal ME, et al. Chronic Migraine in the Population. Neurology. 2008;71:559-566.

7. Cady R, Schreiber C. Botulinum toxin type A as migraine preventive treatment in patients previously failing oral prophylactic treatment due to compliance issues.Headache. 2008;48:900-13

Media contacts
For any further information please contact:
Janet Kettels, Allergan, kettels_janet@allergan.com or +44(0)7738-506476
Julia Cross, CCA, j.cross@cca-uk.com or +44(0)207-632-1896