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ViroPharma Announces The First EU Market To Launch Plenadren® (Hydrocortisone, Modified-Release Tablet) For Treatment Of Adrenal Insufficiency, The First New Treatment Innovation For Over 50 Years

- New Treatment Addresses Unmet Need for Patients in Denmark with Chronic and Potentially Fatal Endocrine Disorder

BRUSSELS, Sept. 20, 2012 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced the launch of Plenadren® (hydrocortisone modified-release tablet) in Denmark, the first country in the EU to provide a new treatment option for adrenal insufficiency (AI) in over 50 years. Plenadren is a novel, oral, once daily hydrocortisone, modified-release tablet that is designed to better mimic the body's normal, cortisol profile, compared with standard treatment.[1] The results of a pivotal Phase II/III trial showed Plenadren to be effective and well tolerated, compared to standard treatment, demonstrating a delivery of cortisol, which is more in line with the body's own cortisol profile,[2] thus avoiding the afternoon/evening peaks. These peaks are thought to be associated with an increased risk of morbidity and premature mortality.[2],[3],[4],[5],[6],[7],[8]

"There is a clear need in the treatment of AI for an oral hydrocortisone replacement therapy that better resembles the body's natural cortisol production, that can be given once a day and that may improve patients' metabolic status and compliance to treatment," said Dr Anna G Nilsson, Principal Investigator for all Plenadren studies and Consultant in Endocrinology at the Sahlgrenska University Hospital, Goteborg, Sweden. "A new therapeutic option for the first time in 50 years, that appears to achieve this is exciting news for AI patients.  The once-daily dosing schedule will help them to manage their condition in a more simple and effective way."

AI is a rare, chronic and potentially fatal endocrine disorder characterised by a reduction or failure in the production of the hormone cortisol.[9],[10] AI is an orphan disease that affects less than 4.5 in 10,000 people in Europe.[11] Standard cortisol replacement treatments aim to restore the body's natural, daily production of cortisol over 24 hours.[2] Standard, immediate release, hydrocortisone replacement therapy, however, cannot mimic the body's natural production of cortisol, despite multiple dosing throughout the day.[12] AI patients using standard treatment are two or three times more likely to die compared to people without AI.[2],[13],[14],[15]

Plenadren is taken orally as a single dose in the morning and has been designed to provide a dual release pattern of hydrocortisone.[1] The outer coating provides a high concentration of cortisol in the morning, meeting the body's requirements. The extended-release core provides a smooth cortisol release throughout the day, followed by a cortisol-free interval during the night, avoiding the unphysiological afternoon/evening peaks observed with standard treatment.[1],[3] Furthermore, Plenadren is proven to be well tolerated with patients reporting favourable impact on quality of life compared to standard treatment, in terms of psychosocial and cognitive functioning, and psychological general well-being.[2]  In an 18-month long-term follow-up trial, 98.5% of patients rated tolerability as 'very well', 'well' or 'acceptable'.[16]

"For people living with a cortisol deficiency, conventional treatment can have an impact on quality of life, with many patients struggling with peaks and troughs in their replacements as well as managing complicated regimes," said Pat McBride, Patient Support Manager of The Pituitary Foundation, UK. "The availability of Plenadren is an important step forward for patients and may help to improve the management of their condition, helping patients to more actively take part in their work, family and social commitments."

In November 2011, the European Commission (EC) granted European Marketing Authorisation for Plenadren, an orphan drug for treatment of adrenal insufficiency in adults. Plenadren is not approved in the United States; however, it has received orphan drug designation status in the United States and has maintained orphan status in Europe.

"We are very pleased to be able to launch Plenadren in Denmark," said Arun Mistry, Senior Director, Medical Affairs, Europe "At ViroPharma, we are committed to delivering important solutions that address critical gaps in care for patients living with few, if any, clinical treatment options. We are excited to be working closely with physicians to help and support patients through the management of adrenal insufficiency."

About Plenadren ® (hydrocortisone, modified-release tablet)
Plenadren, is a novel, once daily hydrocortisone, modified-release tablet, designed to better mimic the body's natural cortisol production compared to standard treatment.[1],[2],[17] The Plenadren tablet is available in 5 and 20 mg strengths.[1] The immediate release outer coating provides physiological cortisol concentrations within 20 minutes of intake; the extended release core provides a smooth serum cortisol level with reduced exposure in the late afternoon and over the 24 hour period. In addition there is no dose accumulation.[2]

Plenadren is proven in a pivotal Phase II/III trial to be effective and well tolerated compared to standard therapy, demonstrating a delivery of cortisol, which is more in line with the body's own cortisol profile [2] thus avoiding the unphysiological cortisol peaks seen with standard glucocorticoid therapy.  These peaks are thought to be associated with an increased risk of morbidity and premature mortality.[2],[3],[4],[5],[6],[7],[8] Sustained and consistent results across all patients have been seen for up to 27 months.[16]  

Plenadren's once-daily dose simplifies treatment management, with patients reporting favourable impact on quality of life compared to standard treatment in terms of psychosocial and cognitive functioning, and psychological general well-being.[2] In a 12-week trial, 85% of patients were found to prefer once-daily Plenadren to standard treatment.[2]  Furthermore, in an 18-month, long-term follow-up trial, 98.5% of patients rated tolerability as 'very well, 'well' or 'acceptable'.[16]

The safety profile was similar to standard hydrocortisone tablets given three times daily. The most common adverse event reported in clinical trials associated with Plenadren was fatigue. There were also some common adverse reactions in the form of gastroenteritis, upper respiratory tract infection, viral infection, sedation, vertigo, dry eye, oesophagitis, nausea, upper abdominal pain, tooth erosion, pruritic rash, Joint swelling, HDL decrease and weight increase. There were also some adverse reactions observed in the eight week period after first changing from standard hydrocortisone tablets three times daily to Plenadren. These adverse reactions were abdominal pain, diarrhoea, nausea and fatigue and were mild or moderate, transient, of short duration.

About Adrenal Insufficiency
Adrenal insufficiency (AI) is a rare, chronic and potentially fatal endocrine disorder characterised by a reduction or failure in the production of the hormone cortisol.[9],[10] AI affects less than 4.5 in 10,000 people in Europe.[11]

AI can lead to serious, life-threatening conditions such as cardiovascular, malignant or infectious diseases, as well as disorders which impact on health and quality of life.[2],[17] The many symptoms of AI include fatigue, anorexia, weight-loss, fever, muscle weakness, abdominal pains, dizziness and headaches.[9],[10],[18] Because these symptoms can be attributed to other disorders, diagnosis can be difficult and delayed, leading to unnecessary morbidity and mortality.[9],[18] To survive, AI patients need replacement therapy with glucocorticoids (usually hydrocortisone) and because it is a chronic condition, they require this life-saving therapy throughout their lives.[9]

There are two main types of AI:[9],[10]

  1. Primary (Addison's disease) AI occurs when there is gradual destruction of the adrenal cortex usually by the body's own immune system and occurs when at least 90 per cent of the adrenal cortex has been destroyed.
  2. Secondary AI occurs when the pituitary gland fails to produce enough adrenocorticotropin (ACTH), a hormone that stimulates the adrenal glands to produce cortisol. Often, the cause is damage to the pituitary gland following a pituitary tumour or surgery. Secondary adrenal insufficiency is more common than primary.[19]

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.

Disclosure Notice
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 statements that Plenadren may improve patients' metabolic status, compliance and treatment, may help to significantly improve the management of patients' condition and quality of life. There can be no assurance that the data presented in the publications and comments by physicians referenced or included in this press release regarding Plenadren are predictive of how Plenadren will perform in commercial usage. We cannot assure that current or future studies with Plenadren will demonstrate the same or similar safety and efficacy profile of Plenadren as described in the physician comments or referenced publications. 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 10-Q for the quarters ended March 31, 2012 and June 30, 2012 filed with the Securities and Exchange Commission, 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] Summary of Product Characteristics (SmPC).  Available at: http://ec.europa.eu/health/documents/community-register/2011/20111103110069/anx_110069_en.pdf. Accessed September, 2012

[2] Johannsson G, et al. Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency: a prospective randomized trial of a novel hydrocortisone dual-release formulation. J Clin Endrocinol Metab. 2012;97(2):473-481

[3] Johannsson G, et al. Improving glucocorticoid replacement therapy using a novel modified-release hydrocortisone tablet: a pharmacokinetic study. Eur J Endocrinol. 2009:161:119-13.

[4] Plat L et al. Metabolic Effects of Short-Term Elevations of Plasma Cortisol Are More Pronounced in the Evening Than in the Morning. The Journal of Clinical Endocrinology and Metabolism 1999; 84, no.9: 3082-3092

[5] Gangwisch JE. Obes Rev 2009;10(Suppl 2):37–45 Epidemiological evidence for the links between sleep, circadian rhythms and metabolism Obesity Reviews, International Association for the Study of Obesity 2009; 10 (Suppl.2): 37-45

[6] Matthews K et al. Diurnal Cortisol Decline is Related to Coronary Calcification: CARDIA Study. Pyschosomatic Medicine 2006; 68: 657-661

[7] Garcia-Borreguero D et al. Glucocorticoid Replacement Is Permissive for Rapid Eye Movement Sleep and Sleep Consolidation in Patients with Adrenal Insufficiency. The Journal of Clinical Endocrinology and Metabolism 2000; 85, no. 11: 4201-4206

[8] Vgontzas AN et al. Chronic Insomnia is associated with Nyctohermeral Activatio nof the Hypothalamic-Pituitary-Adrenal Axis: Clinical Implications. The Journal of Clinical Endocrinology and Metabolism 2001; 86 (8): 3787-3794

[9] Addison's Disease Self-Help Group (UK). What is Addison's disease? Available at: http://www.addisons.org.uk/info/addisons/page1.html. Accessed August 2012.

[10] Patient.co.uk. Adrenal insufficiency and Addison's disease. Available at: http://www.patient.co.uk/doctor/Adrenal-Insufficiency-and-Addison%27s-Disease.htm. Accessed August 2012.

[11] European Medicines Agency (EMA). Rare disease designation. EU/3/06/372. What is the estimated number of patients affected by the condition? Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2009/11/human_orphan_000675.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d12b. Accessed September 2012.

[12] Simon N, et al. Pharmacokinetic evidence for suboptimal treatment of adrenal insufficiency with currently available hydrocortisone tablets. Clin Pharmacokinet. 2010; 49(7):455-463.

[13] Bensing S, et al. Increased death risk and altered cancer incidence patter in patients with isolated or combined autoimmune primary adrenocortical insufficiency. Clin Endo. 2008;69:697-704.

[14] Sherlock M, et al. Mortality in patients with pituitary disease. Endocrine Reviews. 2010; 31(3):301–342.

[15] Bergthorsdottir R, et al. Premature mortality in patients with Addison's disease: a population-based study. J Clin Endocrin Metab. 2006; 91(12):4849-53.

[16] Nilsson AG, et al. An open, multi-centre, phase IIIb, long-term follow-up study to assess the safety, tolerability and efficacy of once-daily, oral dual-release hydrocortisone in patients with adrenal insufficiency. Poster number 78, presented at the 15th International Congress of Endocrinology/European Congress of Endocrinology (ICE/ECE), 2012.

[17] Neary N, et al. Adrenal insufficiency – etiology, diagnosis and treatment. Curr Opin Endocrinol Diabetes Obes. 2010;17(3):217-223.

[18] Arlt W, et al. Adrenal insufficiency. The Lancet 2003; 361: 1881-1893.

[19] National Endocrine and Metabolic Diseases Information Service. Adrenal Insufficiency and Addison's disease. Available at: http://endocrine.niddk.nih.gov/pubs/addison/addison.aspx#1. Last accessed August 2012. 

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