11th December 2014

Sucampo Appoints John H. Johnson to Board of Directors

Filed under: Uncategorised — djm @ 11:23 am

Bethesda, Md., December 15, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP), a global biopharmaceutical company, today announced the appointment of John H. Johnson, founder, Plum Brook Advisors, to its board of directors (Board).

 

“We are pleased to welcome John to our Board during Sucampo’s continued evolution,” said Peter Greenleaf, chief executive officer of Sucampo. “As a recognized leader in the biopharmaceutical industry who has tremendous experience in building and growing science-focused companies, John will be instrumental as we continue to execute on our strategic objectives, accelerate the development of our pipeline, and diversify our science.”

 

Mr. Johnson brings more than 30 years of leadership experience in the pharmaceutical and biotechnology industry to Sucampo. He has held executive management roles at leading global corporations, including Johnson & Johnson, Eli Lilly & Company, ImClone and Pfizer, Inc. He recently served as a member of the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA) and as a member of the Health Section Governing Board of Biotechnology Industry Organization (BIO). He also served as chairman, president and chief executive officer of Dendreon Corporation and as chief executive officer and Board member of Savient Pharmaceuticals, Inc. Prior to these roles, Mr. Johnson served as president of Eli Lilly & Company’s Oncology Unit following its 2008 acquisition of Imclone Systems, Inc., where he served as chief executive officer and Board member. Before joining Imclone, he held various executive roles of increasing responsibility, including Company Group Chairman of Biopharmaceuticals at Johnson & Johnson, where he was responsible for the Johnson & Johnson Biotechnology, Immunology and Oncology commercial businesses. Earlier in his career, Mr. Johnson held multiple executive positions at Parkstone Medical Information Systems, Inc., Ortho-McNeil Pharmaceutical Corp. and Pfizer, Inc. Mr. Johnson served as the chairman of Tranzyme Pharma, Inc. and as a member of the board of BioNJ. Mr. Johnson currently serves as a member of the board of directors of Cempra Pharmaceuticals, Inc., Histogenics and Portola Pharmaceuticals.

 

“I am excited about the opportunity to join Sucampo’s board of directors and leadership team,” said John H. Johnson. “I look forward to contributing to Sucampo’s future growth and success developing and diversifying its pipeline and its delivery to patients in need and healthcare providers around the world.”

 

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; 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. compare hotels 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 Forms 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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25th November 2014

Sucampo Pharmaceuticals Announces Webcast of Its Presentation at the 26th Annual Piper Jaffray Healthcare Conference

Filed under: Uncategorised — djm @ 11:22 am

BETHESDA, Md., November 25, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, today announced that it will webcast its corporate presentation at the 26th Annual Piper Jaffray Healthcare Conference taking place Tuesday, December 2, 2014 at 10:50 A.M. ET.

The presentation will be webcast live and may be accessed from the Event Calendar page of Sucampo’s website at investor.sucampo.com . Presentation slides will be available via the webcast links. A replay of the webcast will also be available on the Company’s website for several days after the live event. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.

 

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; 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. satellite pictures 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:

Silvia Taylor

Senior Vice President, Investor Relations and Corporate Communications

Sucampo Pharmaceuticals, Inc.

1-240-223-3718

staylor@sucampo.com

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12th November 2014

Sucampo Files Patent Infringement Lawsuit Against Dr. Reddy’s

Filed under: Uncategorised — djm @ 11:21 am

BETHESDA, Md., November 12, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP), a global biopharmaceutical company, today announced that Sucampo, R-Tech Ueno, Ltd., Takeda Pharmaceutical Company Limited (Takeda), and certain affiliates of Takeda have filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, Dr. Reddy’s) related to an Abbreviated New Drug Application (ANDA) that Dr. Reddy’s filed with the U.S. Food and Drug Administration (FDA) to market, sell and use a generic version of the 8 mcg and 24 mcg AMITIZA® (lubiprostone) soft gelatin capsule products. The lawsuit claims infringement of 7 patents that are listed in the FDA’s Orange Book, with the latest expiring in 2027.

 

Sucampo commenced the lawsuit within 45 days from the receipt of a Notice letter sent by Dr. Reddy’s, dated October 1, 2014, regarding its filing of its ANDA. Under the Hatch-Waxman Act, as a result of the patent infringement lawsuit, final FDA approval of Dr. Reddy’s ANDA will be stayed up to 30 months from the date of receipt of the Notice letter.

 

“Protecting AMITIZA’s intellectual property is of paramount importance to Sucampo,” said Peter Greenleaf, Chief Executive Officer of Sucampo. “We believe that the AMITIZA patents, granted by the U.S. Patent & Trademark Office, are valid, enforceable, and infringed by Dr. Reddy’s proposed lubiprostone products, and we will vigorously defend them.”

 

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; 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:

Silvia Taylor

Senior Vice President, Investor Relations and Corporate Communications

Sucampo Pharmaceuticals, Inc.

1-240-223-3718

staylor@sucampo.com

 

 

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11th November 2014

Sucampo Pharmaceuticals Announces Webcast of Its Presentation at the Stifel 2014 Healthcare Conference

Filed under: Uncategorised — djm @ 11:17 am

BETHESDA, Md., November 11, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, today announced that it will webcast its corporate presentation at the Stifel 2014 Healthcare Conference taking place Tuesday, November 18, 2014 at 4:45 PM ET.

The presentation will be webcast live and may be accessed from the Event Calendar page of Sucampo’s website at http://investor.sucampo.com/phoenix.zhtml?c=201197&p=irol-calendar. Presentation slides will be available via the webcast links. A replay of the webcast will also be available on the Company’s website for several days after the live event. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.

 

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).

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:

Silvia Taylor

Senior Vice President, Investor Relations and Corporate Communications

Sucampo Pharmaceuticals, Inc.

1-240-223-3718

staylor@sucampo.com

Comments (0)

6th November 2014

Sucampo Announces Third Quarter 2014 Financial Results

Filed under: Uncategorised — djm @ 11:10 am

Strong Revenue and Sales Growth for AMITIZA®

 

Raises 2014 Earnings Guidance, Excluding Special Items

 

CEO Peter Greenleaf to Provide Update on Significant Progress Against Strategic Plan

 

Sucampo to host conference call today at 8:30 am Eastern

 

BETHESDA, Md., November 6, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP) today reported consolidated financial results for the third quarter and nine months ended September 30, 2014. Sucampo reported year over year growth of 49% to $31.5 million in total revenue, 24% to $16.8 million in product royalty revenue and 118% to $11.7 million in product sales. Sucampo also reported net income of $1.5 million and fully-diluted earnings per share (EPS) of $0.03 during the third quarter of 2014.

 

Sucampo raised its full year 2014 earnings guidance to $15.0 million to $20.0 million net income, excluding special items, versus previous guidance of $4.0 million to $6.0 million. During the third quarter of 2014, Sucampo recorded a non-cash impairment to its intangible assets of $5.6 million to reflect a reduction in the expected future cash flows received from the sales of RESCULA for the approved indication, which Sucampo has ceased marketing, and no further orders have been made. Details of the impairment charge are discussed in the Cost of Goods and R&D expenses sections below.

 

__________________________

  1. Sucampo is providing certain 2014 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of Sucampo’s performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.
  2. Net income is attributable to Sucampo Pharmaceuticals, Inc. on a consolidated basis.

 

“In the third quarter, Sucampo’s strong financial performance continued, and I am pleased that we made significant progress against our strategy,” said Peter Greenleaf, Chief Executive Officer of Sucampo. “Our total revenue grew 49% driven by AMITIZA’s continued growth in the US and Japan. The prospects for additional growth of the product are greater than ever given the agreements we signed this quarter: creating a global partnership with Takeda, expanding the current AMITIZA agreement with Takeda for North America, and settling our generic litigation. This is a time of great opportunity for Sucampo, as we continue to execute on our strategy with a focus on the development of our pipeline and the diversification of our science.”

 


 

Third Quarter 2014 Operational Review

 

AMITIZA

United States (U.S.)

 

 

 

 

 

Global Markets

 

 

 

 

 

 

Research and Development

 

 

 

 

Corporate

 

 

 

 

 

Third Quarter 2014 Financial Review

 

 

 

 

 

 

 

 

Earnings Excluding Special Items

 

Net income excluding special items for the third quarter of 2014 was $6.3 million, or $0.14 per diluted share, compared to a net income of $4.0 million, or $0.09 per diluted share, in the third quarter of 2013. Net income excluding special items for the first nine months of 2014 was $8.6 million, or $0.20 per diluted share, compared to a net income of $7.0 million, or $0.16 per diluted share, in the first nine months of 2013.

 

Non-GAAP (generally accepted accounting principles) EPS for the third quarter and nine months ended September 30, 2014 of $0.14 and $0.20, respectively, exclude RESCULA intangible impairment.

 

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the tables that follow.

 

__________________________

3.Represents the difference between calculated GAAP EPS and calculated non-GAAP EPS, which may be different than the amount calculated by dividing the impact of the excluded items by the weighted-average shares for the period.

 

Cash, Cash Equivalents, Restricted Cash and Marketable Securities

 

At September 30, 2014, cash, cash equivalents, restricted cash and investments were $106.4 million compared to $95.9 million at December 31, 2013. At September 30, 2014, notes payable were $48.1 million, compared to $52.7 million at December 31, 2013, including current notes payable of $26.3 million at September 30, 2014 and $26.9 million at December 31, 2013.

 

Guidance

 

Sucampo today increased its earnings guidance for 2014. Sucampo now expects full year 2014 GAAP net income, excluding special items to be in the range of $15.0 million to $20.0 million, or $0.35 to $0.45 per diluted share.

 


 

Company to Host Conference Call Today

 

Sucampo will host a conference call and webcast today at 8:30 am Eastern. To participate on the live call, please dial 866-953-6858 (domestic) or 617-399-3482 (international), and provide the participant passcode 19360046, five to ten minutes ahead of the start of the call. A replay of the call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 31546071. Investors interested in accessing the live audio webcast of the teleconference may do so at http://investor.sucampo.com and should log on before the teleconference begins in order to download any software required. The archive of the teleconference will remain available for 30 days.

About lubiprostone (AMITIZA®)

 

AMITIZA (lubiprostone) is a prostone, and is a locally acting chloride channel activator, indicated in the U.S. for the treatment of CIC in adults and 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 (8 mcg twice daily) in women 18 years of age and older. In Japan, AMITIZA (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). In the United Kingdom (U.K.), AMITIZA (24 mcg twice daily) is indicated for the treatment of CIC and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g., educational measures, physical activity) are inappropriate. In Switzerland, AMITIZA (24 mcg twice daily) is indicated for the treatment of CIC in adults and for the treatment of OIC and associated signs and symptoms such as stool consistency, straining, constipation severity, abdominal discomfort, and abdominal bloating in adults with chronic, non-cancer pain. The efficacy of AMITIZA for the treatment of OIC in patients taking opioids of the diphenylheptane class, such as methadone, has not been established.

 

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; 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.

 

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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5th November 2014

Sucampo Pharmaceuticals Announces Webcast of Its Presentation at the 2014 Credit Suisse Global Healthcare Conference

Filed under: Uncategorised — djm @ 11:07 am

BETHESDA, Md., November 5, 2014 (GLOBE NEWSWIRE) – Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, today announced that it will webcast its corporate presentation at the 2014 Credit Suisse Global Healthcare Conference taking place Wednesday, November 12, 2014 at 3:30 pm Mountain Time, or 5:30 pm Eastern Time.

The presentation will be webcast live and may be accessed from the Event Calendar page of Sucampo’s website at http://investor.sucampo.com/phoenix.zhtml?c=201197&p=irol-calendar. Presentation slides will be available via the webcast links. A replay of the webcast will also be available on the Company’s website for several days after the live event. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.

 

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).

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 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

 

 

 

Comments (0)

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).

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 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

 

Comments (0)

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

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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.

 

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

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