Salix Pharmaceuticals introduces Rx topical foam to treat a form of inflammatory bowel disease
RALEIGH, N.C. — Salix Pharmaceuticals last week announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.
The FDA has issued an action date of Sept. 15, 2014 under the Prescription Drug User Fee Act.
“Patients with distal ulcerative colitis, also known as proctitis or proctosigmoiditis, are often difficult to treat and present the most challenging subset of patients given the limitations of available treatment options," stated Bill Forbes, EVP medical and research and development and chief development officer for Salix. "For these patients with disease limited to the rectum and sigmoid areas of the colon, treatment with currently approved oral therapies is often ineffective due to insufficient distribution of active drug to the distal colon," he said. "Distal ulcerative colitis remains an unmet medical need, and we believe the availability of a rectally administered corticosteroid such as budesonide foam may help overcome limitations of existing products to treat this condition.”
Budesonide is a high potency corticosteroid that was developed to minimize the systemic adverse consequences of classic corticosteroids, such as hydrocortisone, which have higher levels of systemic absorption. In several large studies budesonide 2 mg rectal foam was highly effective in the treatment of distal ulcerative colitis. Clinical trials suggest that the budesonide foam formulation demonstrates improved reach (or spread) and rapid distribution of budesonide to the sigmoid colon and the rectum, without the difficulties and inconvenience associated with retention of enema formulations. These trials also suggest that the foam provides more immediate and targeted therapy for distal ulcerative colitis than is available with oral therapies.
The oral foam formulation for rectal administration was designed to improve both the patient’s ability to retain the drug in the rectum following administration as well as distribution of the active drug to the rectum and sigmoid colon.
Salix licensed this budesonide foam product from Dr. Falk Pharma. The product was approved in Europe in 2006 and is marketed in Europe by Dr. Falk Pharma.
Chiesi Farmaceutici S.p.A. acquires specialty pharmaceutical company Cornerstone Therapeutics
CARY, N.C. — Cornerstone Therapeutics, a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets, on Monday announced that its stockholders have approved, at a special stockholder meeting, the previously announced merger agreement, under which Chiesi Farmaceutici S.p.A. will acquire all of the outstanding common shares of Cornerstone for $9.50 per share in cash.
Votes for the adoption of the merger agreement totaled approximately 22.5 million shares, or 83.7% of Cornerstone’s outstanding shares of common stock.
Approximately 4.4 million shares, or 50.2% of the shares not owned by Chiesi or any of its subsidiaries or by any officer or director of Cornerstone, voted for the merger.
PhRMA partners with NIH on drug development
WASHINGTON — The Pharmaceutical Research and Manufacturers of America on Tuesday announced a partnership with the National Institutes of Health that will help spur drug development, the association stated.
The Accelerating Medicines Partnership — an initiative of NIH, several non-profit disease foundations, 10 biopharmaceutical companies and PhRMA — aims to transform the current model for developing new diagnostics and treatments by joining forces to identify and validate promising biological targets of disease.
AMP represents a new, integrated approach to treatment discovery and seeks to increase the number of new diagnostics and therapies for patients while reducing the time and cost associated with their development. The initiative will begin with three- to five-year pilot projects focused on three disease areas: Alzheimer’s, Type 2 diabetes and autoimmune disorders, including rheumatoid arthritis and lupus. AMP data and analyses will be publicly accessible to the biomedical community.