March 14, 2012 -- Recipharm and ViroPharma today signed a commercial contract to initiate supply of Plenadren® for named patient use.
In addition, ViroPharma are investing in capital equipment at the Recipharm manufacturing site - enabling large scale manufacturing for the product.
March 14th 2012: - Recipharm, the international contract pharmaceutical development and manufacturing organization, today announced that it has been contracted by ViroPharma to complete commercial scale-up manufacture of Plenadren® (Hydrocortisone, Modified Release Tablet) - used for the treatment of adrenal insufficiency in adults.
Under the contractual terms, ViroPharma is also investing in new equipment in order to increase the manufacturing capacity for Plenadren in order to support commercial product launches across Europe.
The new agreement follows the completion of Recipharm’s initial scale-up contract with DuoCort Pharma AB - a recent acquisition for ViroPharma following Plenadren’s® receipt of European Marketing Authorization and Confirmation of Orphan Drug Designation.
Additionally, Recipharm will also be able to use the new equipment for other projects, with ViroPharma retaining its status as highest priority customer.
Helene Fehrm, General Manager of Recipharm Stockholm, said: “We are really pleased ViroPharma has chosen to work together with Recipharm for commercial scale up following the highly successful relationship we had developed with DuoCort. We look forward to building a long term relationship with ViroPharma for its production. This investment and the work we are doing for ViroPharma will give us further valuable experience in tablet manufacturing with API in the coating - a unique advantage over conventional approaches - both for Plenadren® itself and other customers moving forwards.”
Marco Carli, General Manager, Principal & Senior Director, Supply Chain, Europe added: “We are delighted to continue DuoCort’s long-standing relationship with Recipharm as they have been a key component in the development process for Plenadren®, and we look forward to building a long term relationship.”
Recipharm AB is a leading contract development and manufacturing organisation (CDMO) based in Sweden employing some 1700 employees. The Company operates development and manufacturing facilities in Sweden, France,
the UK, Germany and Spain and is headquartered near Stockholm. Recipharm supplies the global pharmaceuticals market with hundreds of different products in multiple dosage forms that include solid dose, granulates and
powders, sterile liquids and lyophilisates, semi solids, beta-lactams, hormones, oral liquids, sprays and dry powder inhalers.
For more information visit; www.recipharm.com
About Plenadren® (hydrocortisone, modified release tablet)
Plenadren is the first true innovation in over 50 years in the treatment of adrenal insufficiency.
Hypersensitivity to the active substance of Plenadren or to any of the excipients may occur. During acute adrenal insufficiency, parenteral administration of hydrocortisone in high doses, together with physiological sodium chloride solution for injection, must be given. Use of Plenadren with potent CYP 3A4 inducers and inhibitors may merit an adjustment of hydrocortisone dosage. High (supra-physiological) dosages of cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. Long-term treatment with higher than physiological hydrocortisone doses can lead to clinical features resembling Cushing's syndrome with increased adiposity, abdominal obesity, hypertension and diabetes, and thus result in an increased risk of cardiovascular morbidity and mortality. All glucocorticoids increase calcium excretion and reduce the bone remodeling rate. Patients with adrenal insufficiency on long term glucocorticoid replacement therapy have been found to have reduced bone mineral density. Psychiatric adverse events may occur with systemic glucocorticoids.
The most common adverse reactions observed in clinical studies have been fatigue, gastroenteritis, upper respiratory tract infection, sedation, vertigo and dry eyes.
About Adrenal Insufficiency
Adrenal insufficiency (AI) is a disorder caused by dysfunction of the adrenal gland resulting in low levels of the hormone cortisol, which normally follows a circadian rhythm and regulates many critical body functions. To survive, AI patients need replacement therapy with glucocorticoids (usually hydrocortisone). Because it is a chronic condition, they require this life-saving therapy throughout their lives. Primary AI is referred to as Addison's disease, which affects up to 14 in every 100,000 people. Common symptoms of Addison's disease include fatigue, muscle weakness, fever, weight loss, difficulty in standing up, changes in personality, and gastrointestinal involvement. Severe adrenal insufficiency, which can manifest as shock (very low blood pressure with loss of consciousness), dehydration, and imbalance of sodium and potassium levels, can be life threatening. These cases of adrenal crisis (sometimes called 'Addisonian crisis') can occur after a significant stress such as infection or trauma, and can be fatal if not promptly diagnosed and treated with glucocorticoid therapy.
About ViroPharma Incorporated
ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing 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 health care professionals we serve. ViroPharma's commercial products address diseases including hereditary angioedema (HAE), seizures in children and adolescents, and CDI; for full U.S. prescribing information on our products, please download the package inserts at:
http://www.viropharma.com/Products.aspx; the prescribing information for other countries can be found at www.viropharma.com.
ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's web site, www.viropharma.com. The company encourages investors to consult these sections for more information on ViroPharma and our business.
Recipharm – Mark Quick,+46 8 6025 200
ViroPharma Incorporated - William Roberts, +1 610 321 6288
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