NASHVILLE - Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, has announced that it has entered into and closed on a definitive agreement to acquire the FDA-approved oncology-supportive care medicine SANCUSO® (granisetron transdermal patch), from Kyowa Kirin, Inc. the U.S. affiliate of Japan-based Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company focused on discovering and delivering novel medicines.
SANCUSO is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment. The active drug in SANCUSO, granisetron, slowly dissolves in the thin layer of adhesive that sticks to the patient's skin and is released into their bloodstream over several days, working continuously to prevent chemotherapy-induced nausea and vomiting (CINV). It is applied 24 to 48 hours before receiving chemotherapy and can prevent CINV for up to five consecutive days. Alternative oral treatments must be taken several times (day and night) to deliver the same therapeutic doses.
"In 2020 there were nearly two million new cases of cancer in the U.S. and each year over half a million Americans undergo chemotherapy, with many suffering from the side effects of their treatment. With SANCUSO, patients are given a simple, easy-to-apply preventative solution that doesn't require swallowing any pills – which can be difficult for patients experiencing nausea," said A.J. Kazimi, chief executive officer at Cumberland Pharmaceuticals. "We are honored to take responsibility for the brand and introduce it through our commercial organization, ensuring that it is delivered to the patients who need it."
Under the terms of the agreement, Cumberland will acquire U.S. rights to SANCUSO and will assume full commercial responsibility for the product – including its marketing, promotion, distribution, manufacturing and medical support activities. Net sales of the brand in the U.S. were over $14 million in 2020. The financial terms of the acquisition include a $13.5 million payment to Kyowa Kirin upon closing, up to $3.5 million in milestones and tiered royalties of up to 10% on U.S. net product sales. Kyowa Kirin will retain international rights, continuing to deliver the product to address oncology patients' needs throughout the rest of the world.
"Since its launch in 2008, we have established SANCUSO as an important supportive therapeutic solution for oncology patients across the country," said Gary Zieziula, president of Kyowa Kirin North America. "We believe that Cumberland is well positioned to optimize the value of the brand and ensure that this unique product continues to deliver important therapeutic benefits to oncology patients."
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high-quality, prescription brands designed to improve patient care. The Company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and rheumatology market segments. The Company's portfolio now includes eight FDA-approved brands.
The Company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD").
More information can be found on the Company's website at www.cumberlandpharma.com.
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based global specialty pharmaceutical company with a more than 70-year heritage, the company applies cutting-edge science, including expertise in antibody research and engineering, to address the needs of patients across multiple therapeutic areas such as nephrology, oncology, immunology/allergy and neurology. Across its four regions – Japan, Asia Pacific, North America and EMEA/International – Kyowa Kirin focuses on its purpose, to make people smile, and is united by its shared values of commitment to life, teamwork, innovation and integrity.
Learn more about the Company at www.kyowakirin.com.
About SANCUSO®
SANCUSO is the only skin patch approved by the U.S. Food and Drug Administration for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the SANCUSO patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient's bloodstream. It can be worn for up to seven days in a row for chemotherapy regimens of up to five consecutive days.
Learn more at www.sancuso.com.