24th October 2014

Sucampo Pharmaceuticals, Inc. Announces Third Quarter 2014 Earnings Call

Filed under: Uncategorised — djm @ 11:06 am

BETHESDA, MD., October 24, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP), a global biopharmaceutical company, today announced that it will host its third quarter 2014 financial results teleconference and webcast at 8:30 a.m. Eastern on Thursday, November 6, 2014. The press release announcing the financial results and operating highlights is expected to be released before the opening of capital markets that day.

 

Individuals interested in accessing the live audio webcast of the teleconference may do so at http://investor.sucampo.com/phoenix.zhtml?c=201197&p=irol-calendar and should log on 10 to 15 minutes before the teleconference begins to download any software required. Presentation slides will be available via the webcast link. A replay of the webcast will also be available on Sucampo’s website for several days after the live event. Alternatively, individuals may dial 866-953-6858 (domestic) or 617-399-3482 (international) and use passcode 19360046. A replay of the teleconference will be available by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 31546071, approximately two hours after the teleconference concludes. The archive of the teleconference will be available for 30 days.

 

About Sucampo Pharmaceuticals, Inc.

 

Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of medicines that meet major unmet medical needs of patients worldwide. Sucampo has two marketed products – AMITIZA® and RESCULA® – and a pipeline of drug candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the United Kingdom. For more information, please visit www.sucampo.com.

The Sucampo logo is the registered trademark and the tagline, The Science of Innovation, is a registered/pending trademark of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.

 

Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo Pharmaceuticals).

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Sucampo Forward-Looking Statement

 

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; the ability of Sucampo to develop and commercialize existing and pipeline products; 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 U.S. 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 most recent Form 10-K as filed with the Securities and Exchange Commission on March 12, 2014 as well as its filings with the Securities and Exchange Commission on Form 10-Q and 8-K, which Sucampo incorporates by reference.

 

Contact:

Silvia Taylor

Senior Vice President, Investor Relations and Corporate Communications

Sucampo Pharmaceuticals, Inc.

1-240-223-3718

staylor@sucampo.com

 

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23rd October 2014

Sucampo Solidifies Leadership Team with Additions of CSO and Heads of Business Development, Regulatory Affairs

Filed under: Uncategorised — djm @ 10:51 am

Bethesda, Md., October 23, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP), a global biopharmaceutical company, today announced three executive appointments that expand and solidify the leadership team in line with the company’s strategic plan. The appointments are Peter Kiener, D.Phil            , as Chief Scientific Officer (CSO); Matthias Alder as Executive Vice President, Business Development and Licensing; and Steven Caffé, M.D., as Senior Vice President, Regulatory Affairs.

 

“We are building a stronger, focused company, and filling our key leadership roles with these high-caliber executives is essential for Sucampo’s continued evolution,” said Peter Greenleaf, Chief Executive Officer of Sucampo. “The addition of tenured biopharmaceutical executives gives us the depth of scientific leadership to expedite our company’s transformation and to execute on our priorities of leveraging Sucampo’s strengths in drug development, securing and growing revenue from sales of AMITIZA, increasing our pace of current pipeline development and diversifying our portfolio through the acquisition of new science. Each of the new executives brings to Sucampo functional expertise and a track record of success, and each of them sees, as I do, the potential of our strategic vision for Sucampo.”

 

Dr. Kiener is recognized for his expertise in the development of next-generation biologics. Most recently, he was CSO of Ambrx Inc., a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates. Prior to joining Ambrx, Dr. Kiener was President and Co-founder of Zyngenia Inc., an early stage biopharmaceutical company. Before this, he was Executive Vice President and Global Head of Biologics Research and Development at MedImmune, LLC, the global biologics arm of AstraZeneca. During his tenure there, Dr. Kiener assisted with building the company’s industry-leading protein and antibody engineering capabilities and oversaw the submission of multiple investigational new drug and new drug applications. Earlier in his career, he held multiple positions at Bristol-Myers Squibb over an 18-year period, where he worked on biologics. Dr. Kiener has served on the scientific advisory boards of KAI Pharmaceuticals Inc., Genocea Biosciences Inc., NKT Therapeutics Inc. and VLST Corporation. Dr. Kiener has also served as a director of Receptor BioLogix Inc., Synovex Corporation and Virdante Pharmaceuticals Inc. He received his bachelor’s degree in chemistry from the University of Lancaster and doctorate of philosophy in Biochemistry from the University of Oxford. Dr. Kiener has published more than 120 papers in peer-reviewed journals and is an inventor on more than 40 patents and patent applications.

 

Mr. Alder brings more than 20 years of industry experience to Sucampo. Most recently, he was Executive Vice President of Corporate Development and Legal Affairs and Corporate Secretary at Cytos Biotechnology AG, a biopharmaceutical company focused on the development of targeted immuno-therapies. Prior to joining Cytos, he held various roles of increasing responsibility, including Senior Vice President Administration, General Counsel and Secretary of Micromet Inc., which was acquired by Amgen. Prior to this, Mr. Alder was a partner in the Life Sciences Transactions Practice at Cooley LLP, where he represented biotech companies in strategic transactions with pharmaceutical companies. Earlier in his career, Mr. Alder was in-house counsel at Ciba-Geigy and Novartis. He holds law degrees from the University of Basel and the University of Miami and is qualified to practice law in Switzerland and the U.S.

 

Dr. Caffé brings more than 20 years of global product development, registration and lifecycle management expertise to the company. Prior to joining Sucampo, he was Senior Vice President and Chief Development and Regulatory Officer at AMAG Pharmaceuticals Inc., a specialty pharmaceutical company, where he played a key role in the provision of strategic insight and operational expertise to ensure successful product development and advancement, and in the acquisition of assets. Prior to joining AMAG, Dr. Caffé was Senior Vice President, Head of Global Regulatory Affairs and Patient Safety at MedImmune. At MedImmune, he was responsible for all regulatory and pharmacovigilance matters for commercial and pipeline products. Prior to this, he held increasing leadership positions at Baxter International Inc., Sanofi and Merck & Co. Through various regulatory and development programs, he secured product approvals while building and leading high-performing global teams. Dr. Caffé received his medical degree from the Faculté de Médecine Saint-Antoine, Université Pierre et Marie Curie (Paris 6), and completed his internship and residency and practiced medicine at the academic hospitals of the Assistance Publique de Paris with a focus on emergency and intensive care.

 

About Sucampo Pharmaceuticals, Inc.

 

Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of medicines that meet major unmet medical needs of patients worldwide. Sucampo has two marketed products – AMITIZA® and RESCULA® – and a pipeline of product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the U.K. For more information, please visit www.sucampo.com.

The Sucampo logo is the registered trademark and the tagline, The Science of Innovation, is a registered/pending trademark of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.

 

Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo Pharmaceuticals).

 

Twitter LinkedIn

 

Sucampo Forward-Looking Statement

 

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 U.S. 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 most recent Form 8-K and 10-K, which Sucampo incorporates by reference.

 

Contact:

Sucampo Pharmaceuticals, Inc.

Silvia Taylor

Senior Vice President, Investor Relations and Corporate Communications

1-240-223-3718

staylor@sucampo.com

Comments (0)

21st October 2014

Takeda and Sucampo Enter Into Global Licensing Agreement for AMITIZA® (lubiprostone)

Filed under: Uncategorised — djm @ 10:43 am

Takeda Gains Exclusive Rights to AMITIZA Beyond U.S. and Canada for All Markets Except Japan and China

  

BETHESDA, Md., October 21, 2014 and OSAKA, Japan, October 22, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP), a global biopharmaceutical company, and Takeda Pharmaceutical Company Limited (Takeda) today announced that on October 17, 2014, they entered into a global license, development, commercialization and supply agreement for AMITIZA® (lubiprostone). Through this agreement, Takeda expanded its exclusive rights beyond the United States (U.S.) and Canada to further develop and commercialize AMITIZA in all global markets, except Japan and the People’s Republic of China.

 

“Takeda is committed to being a patient and customer-centric organization, making quality health products available to the patients who need them. Through this agreement, AMITIZA can now be made available to patients worldwide,” said Shinji Honda, Senior Managing Director and Corporate Strategy Officer. “Takeda forms partnerships to advance science and to provide innovative treatment options for patients, and this global agreement is an excellent example. This global collaboration leverages the expertise we have established through our gastroenterology portfolio of products.”

 

“The expansion of our collaboration with Takeda represents a critical step forward with our strategic plan and is the natural evolution of our partnership with them for North America,” said Peter Greenleaf, Chief Executive Officer of Sucampo. “This agreement allows Sucampo to remain focused on our strengths in drug development while allowing us to make AMITIZA available to more patients in need around the world. We are confident that with the combination of their extensive experience with AMITIZA and proven global infrastructure, that Takeda will build the brand in new global markets as they have done in the U.S., where AMITIZA continues to grow steadily.”

 

Under the terms of the agreement, Sucampo will receive an upfront payment of $14 million from Takeda and will also be eligible for up to $35 million in additional commercial milestones contingent on the achievement of certain net sales revenue targets. Additionally, Sucampo will be the exclusive supplier of AMITIZA to Takeda at an agreed-upon supply price.

 

Takeda will be responsible for all development activities and costs, with Sucampo assuming responsibility for the first $6 million in development expenses. In addition, Takeda will become the marketing authorization holder and will be responsible for all commercialization and regulatory activities.

 

About AMITIZA (lubiprostone)

 

AMITIZA (lubiprostone) is a prostone and is a locally acting chloride channel activator, indicated in the United States for the treatment of chronic idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated in the U.S. for irritable bowel syndrome with constipation (IBS-C) (8 mcg twice daily) in women 18 years of age and older.

 

Important Safety Information

 

 

 

 

 

 

 

 

 

 

Please see the Full Prescribing Information here. For further information on AMITIZA, please visit www.sucampo.com/products.

 

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of medicines that meet major unmet medical needs of patients worldwide. Sucampo has two marketed products – AMITIZA® and RESCULA® – and a pipeline of product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the United Kingdom. For more information, please visit www.sucampo.com.

 

The Sucampo logo is the registered trademark and the tagline, The Science of Innovation, is a pending trademark of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.

 

Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo Pharmaceuticals).

 

Twitter LinkedIn

 

Sucampo Forward-Looking Statement

 

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; the ability of Sucampo to develop and commercialize existing and pipeline products; 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 U.S. and internationally; the effects of competitive products on Sucampo’s products; 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 most recent Form 10-K as filed with the Securities and Exchange Commission on March 12, 2014 as well as its filings with the Securities and Exchange Commission on Form 10-Q and 8-K, which Sucampo incorporates by reference.

 

About Takeda Pharmaceutical Company Limited

 

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

 

Takeda Forward-Looking Statement

 

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda’s plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as “may,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “assume,” “continue,” “seek,” “pro forma,” “potential,” “target,” “forecast,” “guidance,” “outlook” or “intend” or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

 

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda’s business, including general economic conditions in Japan, the U.S. and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

 

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

 

Contact:

 

Sucampo Pharmaceuticals, Inc.

Silvia Taylor

Senior Vice President, Investor Relations and Corporate Communications

1-240-223-3718

staylor@sucampo.com

 

Takeda Pharmaceutical Company Limited

Corporate Communications Dept.

Tel: +81-3-3278-2037

 

Takeda Pharmaceuticals International, Inc.

Jocelyn Gerst

Corporate Communications Dept.

Tel: +1-224-554-5542

Comments (0)

17th October 2014

Clinical Data for AMITIZA® Lubiprostone to Be Presented at the American College of Gastroenterology 2014 Annual Scientific Meeting

Filed under: Uncategorised — djm @ 10:24 am

BETHESDA, Md., October 13, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP), a global biopharmaceutical company, today announced that clinical data for AMITIZA® lubiprostone will be presented at the American College of Gastroenterology (ACG) 2014 Annual Scientific Meeting on Sunday, October 19, and Monday, October 20, at the Pennsylvania Convention Center in Philadelphia.

 

Poster Presentations

 

The following abstracts will be presented at ACG 2014:

 

Sunday, Oct. 19, from 3:30 p.m. to 7 p.m. EDT

 

Monday, Oct. 20, from 10:30 a.m. to 4 p.m. EDT

 

 

About AMITIZA (lubiprostone)

 

AMITIZA (lubiprostone) is a prostone, and is a locally acting chloride channel activator, indicated in the United States for the treatment of chronic idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated in the U.S. for irritable bowel syndrome with constipation (IBS-C) (8 mcg twice daily) in women 18 years of age and older.

 

Important Safety Information

 

 

 

 

 

 

 

 

 

 

Please see the Full Prescribing Information here. For further information on AMITIZA, please visit www.sucampo.com/products.

 

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of medicines to meet the major unmet medical needs of patients on a global basis. Sucampo has two marketed products – AMITIZA® and RESCULA® – and a pipeline of product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the U.K. For more information, please visit www.sucampo.com.

 

The Sucampo logo is the registered trademark and the tagline, The Science of Innovation, is a pending trademark of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.

 

Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo Pharmaceuticals).

 

Twitter LinkedIn

 

Sucampo Forward-Looking Statement

 

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 U.S. 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 most recent Form 8-K and 10-K, which Sucampo incorporates by reference.

 

Contact:

Sucampo Pharmaceuticals, Inc.

Silvia Taylor

Senior Vice President, Investor Relations and Corporate Communications

1-240-223-3718

staylor@sucampo.com

 

Comments (0)

14th October 2014

Sucampo Announces Extension of AMITIZA® (lubiprostone) License and Collaboration Agreement with Takeda

Filed under: Uncategorised — djm @ 10:22 am

BETHESDA, Md., October 14, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP), a global biopharmaceutical company, today announced that it signed on October 9, 2014 an amendment to the existing collaboration and license agreement (Collaboration Agreement) covering the United States (U.S.) and Canada for AMITIZA® (lubiprostone) with Takeda Pharmaceutical Company Ltd. (Takeda). The amendment includes various modifications to the Collaboration Agreement including the extension of the current term, minimum commercial investment during the current term and various governance changes allowing Takeda additional flexibility in commercializing AMITIZA.

 

During the extended term, which will begin on January 1, 2021, Takeda will split with Sucampo the gross profits of branded AMITIZA for any dosage strength and form for the existing indications in the U.S. and Canada. In addition, on April 1, 2015 Takeda will no longer reimburse Sucampo for the product details made by Sucampo sales representatives to healthcare professionals as well as other ancillary costs of the sales force.

 

“Today’s announcement of the extended collaboration with Takeda is yet another step toward achieving our objective of securing Sucampo’s foundation and expanding the AMITIZA business. This extended collaboration also allows Sucampo to share in the long-term value of AMITIZA,” said Peter Greenleaf, Chief Executive Officer of Sucampo. “Takeda and Sucampo are aligned in our objectives for the brand, and I believe this newly extended collaboration and license agreement positions the companies more strongly than ever to help grow the AMITIZA business.”

 

 

About AMITIZA (lubiprostone)

 

AMITIZA (lubiprostone) is a prostone and is a locally acting chloride channel activator, indicated in the U.S. for the treatment of chronic idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated in the U.S. for irritable bowel syndrome with constipation (IBS-C) (8 mcg twice daily) in women 18 years of age and older.

 

Important Safety Information

 

 

 

 

 

 

 

 

 

 

Please see the Full Prescribing Information here. For further information on AMITIZA, please visit www.sucampo.com/products.

 

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of medicines that meet major unmet medical needs of patients worldwide. Sucampo has two marketed products – AMITIZA® and RESCULA® – and a pipeline of product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the U.K. For more information, please visit www.sucampo.com.

 

The Sucampo logo is the registered trademark and the tagline, The Science of Innovation, is a pending trademark of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.

 

Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo Pharmaceuticals).

 

Twitter LinkedIn

 

Sucampo Forward-Looking Statement

 

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 U.S. 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 most recent Form 8-K and 10-K, which Sucampo incorporates by reference.

 

Contact:

Sucampo Pharmaceuticals, Inc.

Silvia Taylor

Senior Vice President, Investor Relations and Corporate Communications

1-240-223-3718

staylor@sucampo.com

 

Comments (0)

9th October 2014

Sucampo Announces Settlement Agreement That Resolves Patent Litigation in U.S. Related to AMITIZA

Filed under: Uncategorised — djm @ 10:19 am

Company Receives Additional Paragraph IV Notice

 

Bethesda, Maryland, October 9, 2014 (GLOBE NEWSWIRE) — Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP), a global biopharmaceutical company, today announced that Sucampo, R-Tech Ueno, Ltd. (RTU), Takeda Pharmaceutical Company Limited (Takeda) and certain affiliates of Takeda have entered into a settlement and license agreement with Anchen Pharmaceuticals, Inc., Par Pharmaceutical, Inc., and Par Pharmaceutical Companies, Inc., (collectively, Par) that resolves patent litigation in the United States (U.S.) related to Sucampo’s AMITIZA® (lubiprostone) 8 mcg and 24 mcg soft gelatin capsules.

 

Under the terms of the settlement, Sucampo and RTU will grant Par a non-exclusive license to market Par’s generic version of lubiprostone 8 mcg soft gelatin capsule and 24 mcg soft gelatin capsule (licensed products) in the U.S. for the indications approved for AMITIZA beginning January 1, 2021, or earlier under certain circumstances. Beginning on January 1, 2021, Par will split with Sucampo the gross profits of the licensed products sold during the term of the agreement, which continues until each of the Sucampo patents has expired. In the event Par elects to launch an authorized generic, Sucampo will supply Par under the terms of a manufacturing and supply agreement at a negotiated price. Additional details of the agreement remain confidential.

 

“This settlement agreement is an important step for Sucampo toward securing our foundation and continuing to grow sales of AMITIZA,” said Peter Greenleaf, Chief Executive Officer of Sucampo. “We are on track with the strategic imperatives I communicated in August that include a sharp focus on our flagship product. This is not only beneficial to our company and shareholders, it is important to prescribing physicians and their patients who depend on AMITIZA for treatment.”

 

Sucampo, RTU, Takeda and Par have agreed to dismiss with prejudice the patent litigation filed in the U.S. District Court for the District of Delaware.

 

Additionally, Sucampo said it has received a Paragraph IV certification notice letter (Notice Letter) regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Dr. Reddy’s Laboratories, Inc. (Dr. Reddy’s), requesting approval to market, sell and use a generic version of the 8 mcg and 24 mcg AMITIZA® (lubiprostone) soft gelatin capsule products.

 

Sucampo is currently reviewing the Notice Letter. By statute, if Sucampo initiates a patent infringement lawsuit against Dr. Reddy’s within 45 days of the Notice Date, the FDA would automatically stay approval of the Dr. Reddy’s ANDA until the earlier of 30 months from the notice date or entry of a district court decision finding the patents invalid or not infringed. The product is currently protected by 15 issued patents that are listed in the FDA’s Orange Book, with the latest expiring in 2027.

 

“We will continue to vigorously enforce AMITIZA’s intellectual property rights,” said Greenleaf. “Generic companies have made Paragraph IV certifications a routine part of business. Sucampo is well prepared to pursue all legal pathways in defense of AMITIZA.”

 

About Sucampo Pharmaceuticals, Inc.

 

Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of medicines that meet unmet medical needs of patients worldwide. Sucampo has two marketed products – AMITIZA® and RESCULA® – and a pipeline of product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the United Kingdom. For more information, please visit www.sucampo.com.

The Sucampo logo is the registered trademark and the tagline, The Science of Innovation, is a pending trademark of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.

 

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Sucampo Forward-Looking Statement

 

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 U.S. 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 most recent Form 8-K and 10-K, which Sucampo incorporates by reference.

 

Contact:

Sucampo Pharmaceuticals, Inc.

Silvia Taylor

Senior Vice President, Investor Relations and Corporate Communications

1-240-223-3718

staylor@sucampo.com

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