ViroPharma's Buccolam®▼ (Midazolam, Oromucosal Solution) now Available in Wales for Treatment of Prolonged Acute Convulsive Seizures

MAIDENHEAD, England, June 21, 2012 /PRNewswire/ --

- First Paediatric Licensed Treatment Option for Children and Adolescents Under 18 Now Available for Use by NHS Wales -

- AWMSG Take Rare Decision to Advise Prescription by Brand Name -

Clinicians and carers of children and adolescents from 3 months to <18 years suffering from prolonged, acute, convulsive seizures now have access to Buccolam^® (midazolam, oromucosal solution) through NHS Wales, following the approval from the All Wales Medicines Strategy Group (AWMSG).^[1] Buccolam will be marketed in Wales by ViroPharma Limited, a wholly-owned subsidiary of ViroPharma Incorporated (NASDAQ: VPHM).  

The full advice reads as follows:

Midazolam (BUCCOLAM®) is recommended as an option for use within NHS Wales for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to <18 years). For infants between 3–6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.

Midazolam (BUCCOLAM®) should be prescribed by brand name to reduce the risk of medication errors.

Buccolam has anti-convulsant, sedative, and muscle-relaxant effects and is effective when given by the oromucosal route, i.e. administered to the space between the cheek and gums to be absorbed through the membrane lining of the mouth (buccal administration). This class of medicine is considered a welcome alternative to the rectal administration of diazepam, a widely used treatment in Europe.^[2]

The AWMSG has highlighted in its guidance the importance of prescribing Buccolam by brand name to reduce the risk of medication errors.^[1] Buccolam is provided as ready to use, pre-filled oral syringes that are colour-coded, with age-specific doses to reduce the risk of medication error at a time when the parent or carer is already under significant emotional stress.

In the UK, various midazolam preparations have been used in children as unlicensed medicines over the years, and until recently, no licensed preparation was available. In September 2011, Buccolam became the first product to receive a licence via the Paediatric Use Marketing Authorisation (PUMA) procedure,^[3] designed specifically to encourage the development of medicines for children. Buccolam is the first buccal midazolam to be licensed for the treatment of prolonged, acute, convulsive seizures in children up to the age of 18. The Medicines and Healthcare products Regulatory Agency (MHRA) has been advocating for the increased availability of "specific childrens-only medicines for several years in recognition that many adult medicines are offered to children in cut-down doses".^[4]

Matthew Mason, ViroPharma General Manager for the UK and Ireland commented "At ViroPharma we are committed to delivering solutions that address critical gaps in care for patients living with few, if any, clinical treatment options. The availability of Buccolam now in Wales offers an effective and convenient emergency solution for children and adolescents who suffer from prolonged, acute, convulsive seizures, and the AWMSG's decision to prescribe by brand name is a testament to the potential role this new treatment will play in making a difference to patients' lives."

About Buccolam^®(Midazolam, Oromucosal Solution)

Buccolam is oromucosal midazolam provided in an individual dose formulation for buccal delivery. It is provided as convenient, portable, ready to use, pre-filled oral syringes containing age-specific doses. Buccolam is approved throughout the European Union and the EEA for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from three months to less than 18 years of age.^[5]

Buccolam must only be used by parents/carers where the patient has been diagnosed to have epilepsy. For infants between 3-6 months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.^[5]

Hypersensitivity to midazolam, benzodiazepines or to any of the excipients may occur. Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration. Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function. Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.^[6]

The most common adverse reactions in clinical trials associated with oromucosal midazolam were sedation, somnolence, depressed levels of consciousness, respiratory depression, and nausea and vomiting. No severe adverse events were reported. The safety profile was similar to rectal or intravenous diazepam in the comparative clinical trials.^[5]

About Non-Epileptic and Epileptic Seizures

Seizures are a result of sudden and abnormal electrical activity in the brain. There are many causes of seizures affecting paediatric patients; many are the result of epilepsy, but other triggers can include certain medicines, head injuries, certain diseases, and high fevers (called 'febrile seizures'). Febrile seizures are the most common type of seizure in children; approximately one in every 25 children will have at least one febrile seizure, and more than one-third of these children will have additional febrile seizures before they outgrow the tendency to have them.^[6] Epilepsy is among the most common childhood neurological disorders in developed countries, affecting nearly one percent of the population.^[7] There are approximately six million people affected by epilepsy in Europe; ^[8] nearly one million European children and adolescents have active epilepsy.^[9] Epilepsy commonly causes physical manifestations as well as numerous negative cognitive, behavioral and neurological effects. Seizures can last from a few seconds to several minutes or longer in some cases. If left untreated, prolonged, acute, convulsive seizures may lead to status epilepticus (SE) and patients may require hospitalisation and intensive care.

About ViroPharma Incorporated

ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercialising novel solutions for physician specialists to address unmet medical needs of patients living with diseases that have few, if any, clinical therapeutic options, including C1 esterase inhibitor deficiency, treatment of seizures in children and adolescents, adrenal insufficiency, and C. difficile infection (CDI). Our goal is to provide rewarding careers to employees, to create new standards of care in the way serious diseases are treated, and to build international partnerships with the patients, advocates, and healthcare professionals we serve.

ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's website, http://www.viropharma.com/. The company encourages investors to consult these sections for more information on ViroPharma and our business.

Forward Looking Statements

Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events, including physician and patient acceptance of Buccolam and the estimated number of patients that may experience non-epileptic and epileptic seizures. There can be no assurance that our commercial launch of Buccolam in Wales will be successful. The commercial success of Buccolam in Wales will depend on a number of factors including the actual number of patients that may experience non-epileptic and epileptic seizures, physician and patient acceptance of Buccolam, the timing and level of pricing approvals obtained in Wales and the level of manufacturing and supply of Buccolam produced by third-party manufacturers. These factors, and other factors, including, but not limited to those described in our annual report on Form 10-K for the year ended December 31, 2011 and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission for the period ended March 31, 2012 could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release are made as of the date hereof and may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements. These forward-looking statements should not be relied upon as representing our assessments as of any date subsequent to the date of this press release.

References:

1. All Wales Medicines Strategy Group. AWMSG Recommendations. Available at: http://www.wales.nhs.uk/sites3/Documents/371/midazolam%20%28BUCCOLAM%29%20FAR%20%28W%29.pdf  Last accessed 20 June 2012.

2. MHRA Drug Safety Update. October 2011. Available at: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON131931. Last accessed May 2012.

3. European public assessment report (EPAR) for Buccolam. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002267/WC500112313.pdf. Last accessed May 2012.

4. MHRA Press release: A big step forward for better children's medicines. 7 September 2011. Available at:  http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON129006. Last accessed May 2012.

5. Buccolam European Summary of Product Characteristics. June 2011.

6. National Institute of Neurological Disorders and Stroke. Febrile Seizures Fact Sheet. Available at: http://www.ninds.nih.gov/disorders/febrile_seizures/detail_febrile_seizures.htm. Last accessed May 2012.

7. Ekinci O, et al. Depression and anxiety in children and adolescents with epilepsy: Prevalence, risk factors, and treatment. Epilepsy Behav 2009;14:8-18.

8. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. 2010. Available at: http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf. Last accessed May 2012.

9. Forsgren L, et al. The epidemiology of epilepsy in Europe-a systematic review. Eur J Neurol 2005;12:245-53. Available at: http://www.ncbi.nlm.nih.gov/pubmed/15804240. Last accessed May 2012.

VIROPHARMA INCORPORATED Contacts: 

Matthew Mason
General Manager, UK and Ireland
Phone +44-1628-509644

Kristina M. Broadbelt (Media)
Associate Director, PR & Advocacy
Phone +1-(610)-321-2358

2012/06

UK/BUC/12/0264