Sucampo and Clinigen Announce Named Patient Program for European Union, Iceland and Norway to Provide Access to AMITIZA® (lubiprostone) for Chronic Idiopathic Constipation Patients
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that its wholly-owned subsidiary, Sucampo AG, has implemented a Named Patient Program (NPP) to permit access to AMITIZA (lubiprostone) for patients with chronic idiopathic constipation (CIC) in the European Union (EU), Iceland and Norway. Clinigen Global Access Programs (GAP) will manage the program and will allow healthcare professionals to prescribe lubiprostone for their patients until the time that it is approved within their countries.
Under an NPP, physicians can prescribe unlicensed products to qualifying patients on an individual basis. Such products can be administered to individual patients who are suffering from serious illnesses and have no other therapeutic options.
David Dodds, Commercial Affairs, Europe, said, “Named patient programs are designed to assist patients who have no other alternative therapeutic options. They are in need of access to therapies that are either approved in other parts of the world or have shown promise in clinical studies, prior to regulatory authority approval. Sucampo's mission is to provide patients with safe and effective drugs with novel mechanisms of action to the patients with unmet medical needs. Implementing this program with Clinigen GAP assists Sucampo in fulfilling that mission and meeting important business objectives.”
Mark Corbett, Vice President Clinigen GAP commented, “We are delighted that Sucampo has selected Clinigen GAP to manage a Named Patient Program to provide access to lubiprostone for patients with no therapeutic alternative. Our team has extensive global experience in developing innovative, flexible and effective Named Patient Programs that meet the necessary regulatory requirements for each individual territory and address the needs of patients, health professionals and biopharmaceutical companies. We look forward to working with Sucampo.”
Lubiprostone is a local activator of ClC-2 chloride channels in cells lining the small intestine. Lubiprostone increases fluid secretion into the intestinal tract. This increased fluid level softens the stool, facilitating intestinal motility and bowel movements. Type 2 chloride channels also play an important role in the restoration of tight junction complexes and in the recovery of barrier function in the body. Lubiprostone is not yet licensed in the EU, Iceland or Norway.
About Chronic Idiopathic Constipation (CIC)
Constipation is characterized by infrequent and difficult passage of stool and becomes chronic when a person suffers specified symptoms for over 12 non-consecutive weeks within a 12 month period. Chronic constipation is idiopathic if it is not caused by other diseases or by the use of medications. Symptoms of CIC include straining, hard stools, bloating and abdominal pain or discomfort.
Important Safety Information
Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating lubiprostone treatment.
The safety of lubiprostone in pregnancy has not been evaluated in humans. Lubiprostone should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with lubiprostone and should be capable of complying with effective contraceptive measures.
Patients taking lubiprostone may experience nausea. If this occurs, concomitant administration of food with lubiprostone may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider.
Lubiprostone should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe.
Patients taking lubiprostone may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea.
In clinical trials of lubiprostone (24 mcg twice daily vs. placebo; N=1113 vs. N=316) in patients with Chronic Idiopathic Constipation (CIC), the most common adverse reactions (incidence > 4%) were nausea (29% vs. 3%), diarrhea (12% vs. <1%), headache (11% vs. 5%), abdominal pain (8% vs. 3%), abdominal distension (6% vs. 2%), and flatulence (6% vs. 2%).
In clinical trials of lubiprostone (8 mcg twice daily vs. placebo; N=1011 vs. N=435) in patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most common adverse reactions (incidence > 4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).
Reduce the dosage in CIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.
Sucampo AG, based in Zug, Switzerland, is a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc. Sucampo Pharmaceuticals, Inc., an international pharmaceutical company is focused on the discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones, which occur naturally in the human body as a result of enzymic (15-PGDH) transformation of certain fatty acids, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief Executive Officer and currently Advisor, International Business Development, and a member of the Board of Directors. For more information, please visit www.sucampo.com.
Sucampo Forward-Looking Statements
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo's ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the US and internationally and the exposure to litigation and/or regulatory actions.
No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Sucampo's business, particularly those mentioned in the risk factors and cautionary statements in Sucampo's Form 10-K for the year ended Dec. 31, 2011, which the Company incorporates by reference.
Clinigen is a fast-growing global specialty global pharmaceutical products and services business dedicated to serving patients, the medical community and the healthcare industry. Clinigen's Global Access Programs Division (GAP) specializes in the consultancy, development, management and implementation of Global Access Programs for biotechnology and pharmaceutical companies.
Clinigen's innovative, bespoke programs provide a fully outsourced solution for managing access to unlicensed, licensed or end of lifecycle products. Clinigen understand the value of products to a company and the importance of protecting and maximizing the long-term value of assets through Global Access Programs. Clinigen's highly dedicated, multilingual and experienced team effectively manages client and product needs. Clinigen GAP have proven management experience of implementing over 30 programs, providing access for thousands of patients globally.
For more information, please visit www.clinigengroup.com