Recipharm, the international contract pharmaceutical development and manufacturing organization, 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.”
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 AI, 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.
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 AI, 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.
Recipharm AB is a leading contract development and manufacturing organisation (CDMO) 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.
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).