BRUSSELS. - 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. 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, thus avoiding the afternoon/evening peaks. These peaks are thought to be associated with an increased risk of morbidity and premature mortality.
"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. AI is an orphan disease that affects less than 4.5 in 10,000 people in Europe. Standard cortisol replacement treatments aim to restore the body's natural, daily production of cortisol over 24 hours. Standard, immediate release, hydrocortisone replacement therapy, however, cannot mimic the body's natural production of cortisol, despite multiple dosing throughout the day. AI patients using standard treatment are two or three times more likely to die compared to people without AI.
Plenadren is taken orally as a single dose in the morning and has been designed to provide a dual release pattern of hydrocortisone. 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. 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. In an 18-month long-term follow-up trial, 98.5% of patients rated tolerability as 'very well', 'well' or 'acceptable'.
"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. The Plenadren tablet is available in 5 and 20 mg strengths. 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.
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 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. Sustained and consistent results across all patients have been seen for up to 27 months.
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. In a 12-week trial, 85% of patients were found to prefer once-daily Plenadren to standard treatment. Furthermore, in an 18-month, long-term follow-up trial, 98.5% of patients rated tolerability as 'very well, 'well' or 'acceptable'.
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. AI affects less than 4.5 in 10,000 people in Europe.
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. The many symptoms of AI include fatigue, anorexia, weight-loss, fever, muscle weakness, abdominal pains, dizziness and headaches. Because these symptoms can be attributed to other disorders, diagnosis can be difficult and delayed, leading to unnecessary morbidity and mortality. 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.
There are two main types of AI:
- 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.
- 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. NOTE: THIS IS US, cyclical Cushies, post op Cushies, and those with bilateraladrenalectomies.
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.
