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6:45AM Sucampo Pharma achieves orphan designation for unoprostone isopropyl for treatment of retinitis pigmentosa by European Medicines Agency (SCMP) 8.64 : Co announced that it has received orphan drug designation in the European Union for unoprostone isopropyl for the treatment of retinitis pigmentosa (RP). There are no drugs or therapeutic procedures currently approved for the treatment of RP today.
Check form 4s. Some stock selling in progress.
Sucampo Pharma SCMP MLV & Co Buy $14
http://www.breifing.com/investor/calendars/upgrades-downgrades/
Another $trong close today!!!!!
$9.64 May run past PT of $10. today.
Strong close! May be heading to $10 by Friday.
How about EOD!
Oh, and there are now only 6 million shares available in the float..
This OIC approval for Amitiza delivers $.24 to the earnings for this quarter. Japan sales for the CIC indication started in Q1 2013, Along with Rescula sales in the USA starting in Q1 2013. This company will be profitable in the second half of 2013, and beyond. The remaining risk is execution of the bussiness plan. Can the individuals they have deliver on the plan? We will know in 12 months, and I fully expect the founders of this company, who control 25 million shares, will make sure the results are delivered..
6:49AM Sucampo Pharma and Takeda Pharma (TKPYY) announce FDA approved supplemental new drug application for AMITIZA (lubiprostone), the first oral treatment for opioid-induced constipation in adults with chronic non-cancer pain (SCMP) 6.82 : Sucampo Pharma and Takeda Pharmaceuticals (TKPYY) announced that the FDA has approved Sucampo's supplemental new drug application (sNDA) for AMITIZA (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of AMITIZA in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.
Yes, it will go to 8.50 by eow.
Hit 7.95 in pm.
6:49AM Sucampo Pharma and Takeda Pharma (TKPYY) announce FDA approved supplemental new drug application for AMITIZA (lubiprostone), the first oral treatment for opioid-induced constipation in adults with chronic non-cancer pain (SCMP) 6.82 : Sucampo Pharma and Takeda Pharmaceuticals (TKPYY) announced that the FDA has approved Sucampo's supplemental new drug application (sNDA) for AMITIZA (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of AMITIZA in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.
FDA APPROVES SUCAMPO'S OIC DRUG.
Sucampo Pharmaceuticals (NASDAQ:SCMP) PDUFA for Amitza sNDA April 26
Sucampo pharmaceuticals has an April 26th PDUFA date for it's supplemental NDA for Amitza for the opioid induced constipation (OIC) indication. Amitza was approved in 2006 for chronic idiopathic constipation (CIC) and in 2008 for constipation predominant irritable bowel syndrome (IBS-C). The OIC sNDA was granted priority review last year, but, in November, SCMP revelaed that the PDUFA date had been shifted back due to new information submitted late in the review cycle that constituted a major amendment to the NDA.
We believe Amitza is likely to be approved for the OIC indication. Amitza is a chloride channel activator and does not act on the Mu-opioid receptors in the gut; therefore, recent concerns over CV safety of Mu-opiod receptor agonists such as Relistor should not affect Amitza. It is interesting to note that the SCMP announcement of delay in sNDA PDUFA date occurred just 9 days after Salix Pharmaceuticals (NASDAQ:SLXP) revealed that FDA was requiring a CV outcomes study for Relistor prior to approving for OIC in chronic non-cancer pain. We have confirmed with SCMP management that the PDUFA delay for Amitiza in OIC is unrelated to the FDA CV concerns for Mu-opioid receptor agonist drugs.
In the past, SCMP has had a somewhat rocky relationship with commercialization partner Takeda due to disappointing sales ramp-up. SCMP took Takeda to arbitration over breach of contract due to, in SCMP's opinion, less than best-effort sales rollout. Last July, the International Chamber of Commerce's International Court of Arbitration handed down a decision that SCMP had failed to demonstrate a material breach of contract. According to the company, while this dispute was not resolved in Sucampo's favor, the silver lining from the incident is that in the process of pursuing the arbitration much new information was brought to light regarding what could be done to improve the ramp-up of promotion and sales of Amitiza. Whether or not this has led to a change in efforts by Takeda remains to be seen; however, it is noteworthy that, in January 2013, after Linzess entered the market, Amitza posted its highest sales to date. The OIC indication will give SCMP's Amitiza a new talking point and an edge over Linzess since Linzess is not, at the present time, approved for OIC.
Currently there are no approved oral medications for OIC. We believe that approval for the OIC indication will be positive for SCMP stock price because this indication adds 2 to 2.5 million patients to Amitiza's addressable market and these patients will not be on-label for competitors. Furthermore, first sale of Amitza in OIC triggers a $10 million milestone payment from Takeda to Sucampo, equivalent to 24 cents per share. SCMP stock has increase 40% since recent lows in mid-march. Downside support lies at $5 and overhead resistance at $7 followed by $8.44. Due to the strong recent run-up in share price, we expect some selling pressure in SCMP in the week prior to the expected PDUFA date of 4/26.
This has held up pretty good for a big down market. As I write we are green in a sea of red.
Sheff goes long at $6.90 on Friday 4/12, about 25 minutes before the closing bell. There are plenty of good reasons to be long, or to go long this stock, and Sheff adding it to his portfolio is yet another positive indicator.
Cantor starts coverage, PT $9. Cantor is the first large firm covering this stock. With 15% institutional ownership, we have a great glide path ahead. Many more firms w/ coverage over the next 6 months. This is not a trade, imho, as actual earnings will start this year and ramp forward.
Whats up today? Such a huge pull back today... I tought it would pull back to 6.30 or so...
A reasonable move to $7, then OIC approval in the next 30 days (I expect it may be a little early), then a bump to $10. This OIC approval should be an easy layup (lol).. This OIC indication will be a huge inflection point as the demand for this treatment is extremely large..
Sucampo Pharmaceuticals , a biopharmaceutical company focused on the discovery, development and commercialization of proprietary drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body. There are no other firms marketing prostone products, and Sucampo has over 200 patents in the space.
Sucampo has a tiny market cap ($250 million), low float, 41 M shares, $91 million in cash, product sales (Amitiza) by its partner in the USA, Takeda up 34% in 2012, at a $300 million annual run rate, Amitiza sales in January 2013 were the second highest in history, Amitiza was just approved for sale in Japan (new source of revenue), and will be sold by Abbott, with a completely new business model where Sucampo will sell the product directly to Abbott, wholesale, at 40% of cost (i.e., Sucampo books directly as revenue at 40%, verses the 18% royalty they receive from Takeda, Japan is the second most prescribed country in the world, Sucampo is now approved to sell Amitiza in the UK and Switzerland, were they will sell direct and book 100% of revenue, the OIC indication's PUDUFA date is April 26th, which will create a prescription product for an unmet need for all the regions above, and Rescula was approved in December for the treatment of glaucoma in the USA. Sucampo is targeting the glaucoma patents that can not be treated with methods (even generic) due to reactions. This represents 15%-20% of the market, from a $3 billion annual USA market. Does have $52 million in debt, down from $60 million last year, which is a loan to the CEO of Sucampo, who with his wife, own 25 million shares. Sucampo also has a stock buy back plan
Only one, maybe two firms cover this stock, so with all the irons in the fire that Sucampo has going for it, I certainly expect more coverage before this thing gets away..
This is the key message: "With the approval of the sNDA for RESCULA, we now have two FDA approved products marketed
in the US. As the first-ever prescription medicine approved in Japan for chronic constipation, we launched AMITIZA in Japan and received a $15 million milestone payment related to the first commercial sale of AMITIZA. We look forward to
upcoming catalysts for 2013, including the continued rollout of RESCULA in the US, the PDUFA date for opioid-induced constipation for AMITIZA in the US, the launch of AMITIZA in the UK and Switzerland, and the continued development of our pipeline."
Mar 22, 2013 (Datamonitor via COMTEX) -- Sucampo Pharmaceuticals, Inc., a
biopharmaceutical company, has reported that net income for the fourth quarter
ended December 31, 2012 was $13.53 million, or $0.32 per share, compared to
$2.70 million, or $0.06 per share, for the same quarter ended December 31, 2011.
Total revenues for the fourth quarter of 2012 were $34.86 million, compared to
$14.21 million for the same quarter of 2011.
Net income for the year ended December 31, 2012 was $4.84 million, or $0.12 per
share, compared to a net loss of $17.31 million, or $0.41 loss per share, for
the year ended December 31, 2011.
Total revenues for the year ended December 31, 2012 were $81.49 million,
compared to $54.76 million for the year ended December 31, 2011.
"This was a tremendous year of achievement for Sucampo," said Ryuji Ueno, M.D.,
Ph.D., Ph.D., Chairman, CEO, and Chief Scientific Officer of Sucampo. "With the
approval of the sNDA for RESCULA, we now have two FDA approved products marketed
in the US. As the first-ever prescription medicine approved in Japan for chronic
constipation, we launched AMITIZA in Japan and received a $15 million milestone
payment related to the first commercial sale of AMITIZA. We look forward to
upcoming catalysts for 2013, including the continued rollout of RESCULA in the
US, the PDUFA date for opioid-induced constipation for AMITIZA in the US, the
launch of AMITIZA in the UK and Switzerland, and the continued development of
our pipeline."
This should be a great market for them. I've heard that their USA 2 to 2.5 million estimated population is very conservative (their information).. And they will file the OIC indication in the UK and Switzerland this year. People with pain pop opioids like candy. The hospitals really want this drug.
Mr. Claiborne says the company is awaiting a decision from the FDA in late April for its supplemental new drug application for Amitiza to treat opioid-induced constipation (OIC), which results from chronic use of opioids for pain relief. Constipation is the most common reason for discontinuation of opioid therapy, affecting between 40% and 80% of patients who take opioids. There is currently no approved pharmaceutical oral product for the two million to 2.5 million moderate-to-severe OIC patients in the U.S.
Sucampo sees revenue from three continents by year end
March 19, 2013 by leonardzehr · Leave a Comment
Sucampo Pharmaceuticals (NASDAQ:SCMP) expects to be generating revenue from three continents – North America, Europe and Asia – by the end of 2013 from its two approved prostones products, Amitiza for gastrointestinal diseases and Rescula for ophthalmics.
Cary Claiborne
“This is in line with our goal to be a global company,” CFO Cary Claiborne says in an interview with BioTuesdays.com. “We are the only company developing and commercializing prostone compounds globally.”
Prostones are functional fatty acid metabolites that occur naturally in the body. Prostones work as selective ion channel activators, promoting fluid secretion, enhancing cell protection and acting locally to restore normal function in cells and tissues.
Sucampo’s two prostone-based compounds have an excellent safety profile, with Amitiza targeting the ClC-2-chloride channel and Rescula targeting the BK-potassium channel. Their therapeutic potential was first identified by Sucampo’s founders, Drs. Ryuji Ueno and his wife, Sachiko Kuno. The company has over 580 issued patents on its proprietary prostone technology.
Sucampo’s Prostones Are Highly Potent Ion-Channel Activators
Mr. Claiborne says that Amitiza has been used for more than seven years in the U.S., with more than seven million prescriptions written for patients suffering from chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). “These are big markets with quality of life issues for patients,” he said following a presentation at the BIO CEO conference in New York last month.
CIC affects 14% to 16% of the adult population globally, he notes, and accounts for 92,000 hospitalizations annually in the U.S. IBS affects 15% of the adult population globally, of which one-third have IBS-C. Phase 3 studies of Amitiza in IBS-C demonstrated rapid and long-term relief, he adds.
Mr. Claiborne says the company is awaiting a decision from the FDA in late April for its supplemental new drug application for Amitiza to treat opioid-induced constipation (OIC), which results from chronic use of opioids for pain relief. Constipation is the most common reason for discontinuation of opioid therapy, affecting between 40% and 80% of patients who take opioids. There is currently no approved pharmaceutical oral product for the two million to 2.5 million moderate-to-severe OIC patients in the U.S.
In November, the FDA raised concerns that the chronic use of so-called mu-opioid receptor antagonist constipation medicines under development by several companies may cause cardiovascular safety issues. “While other prospective products for OIC are getting delayed by FDA, we are pleased that the FDA granted priority review of Amitiza for OIC,” Mr. Claiborne suggests, noting that OIC represents the next big revenue driver for the company.
Sucampo is in line for a $10-million milestone payment from its North American marketing partner, Takeda Pharmaceutical, on the first sale of Amitiza in the U.S. for the treatment of OIC. Sucampo receives tiered royalties of 18% to 26% on annual net sales of Amitiza by Takeda, allowing Sucampo to recoup some $106-million of its R&D expenses to date.
In Europe, Amitiza was approved for the treatment of CIC in the UK in 2012 and in Switzerland in 2009. Mr. Claiborne says the company plans to sell the drug itself in those markets. Last week, the company also announced that it had completed filings in both the UK and Switzerland for OIC. “We also plan to submit filings in other EU markets this year to expand the use of Amitiza in CIC patients,” Mr. Claiborne adds.
In Japan, Sucampo received a $15-million milestone from marketing partner, Abbott Japan, in the fourth quarter of 2012 when it launched Amitiza for the treatment of chronic constipation, targeting primary care and specialist physicians. “Growth of Amitiza sales in Japan is a priority this year,” he contends.
Global AMITIZA Approvals and Regulatory Filings
Mr. Claiborne says Sucampo plans to take advantage of a U.S. new label for Amitiza, which removed a requirement that women had to obtain a negative pregnancy test prior to starting on the drug. The new label also clarified information about the use of Amitiza in pregnant and/or nursing women and expanded information about the drug’s mechanism of action.
The company also plans to develop and seek approval for Amitiza in pediatric constipation and develop a liquid formulation of the drug for pediatric and long-term care markets. There is currently no approved prescription medication for pediatric constipation. Sucampo also plans to evaluate the potential of Amitiza for other new indications, including mixed irritable bowel syndrome.
Last month, Sucampo, its partner company, R-Tech Ueno, and Takeda filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Anchen Pharmaceuticals and Par Pharmaceuticals related to an abbreviated new drug application that Anchen filed with the FDA to market a generic version of AMITIZA oral capsules, in both the 8 mcg and 24 mcg strengths. The lawsuit claims infringement of six patents that are listed in the FDA’s Orange Book and scheduled to expire between 2020 and 2027.
Last week, Sucampo reported that net income for 2012 jumped to $4.8-million, or 12 cents a share, from a loss of $17.3-million for 2011. Revenue rose 49% to $81.5-million from $54.8-million.
In addition to its 2013 plans for Amitiza and Rescula, the company also updated its prostone pipeline. The company said it expects to complete its oral mucositis Phase 1a trial for cobiprostone in the second quarter of 2013 and to initiate a Phase 1b/2a trial in the fourth quarter of this year. In addition, it plans to complete a Phase 2a trial for spinal stenosis with its SPI-017 prostone candidate in the fourth quarter.
Sucampo’s Clinical Pipeline
In February, Sucampo’s development partner, R-Tech Ueno, signed an agreement with the Japan Science and Technology Agency for the development of unoprostone isopropyl for retinitis pigmentosa. The Japanese government will provide the majority of funding for Phase 3 clinical development costs of the program.
Sucampo said it is co-developing unoprostone isopropyl with R-Tech Ueno and may file for FDA approval of the product for retinitis pigmentosa in the future, assuming the trials are successful.
Sucampo also has become an emerging player in ophthalmics, with the recent launch of Rescula in the U.S. for lowering intraocular pressure (IOP) in patients with open-angle glaucoma, which is the most common form of glaucoma, or ocular hypertension. “We have already received positive feedback from many in the ophthalmology and optometry communities regarding Rescula’s unique mechanism of action as a BK channel activator,” Mr. Claiborne says.
Rescula is being launched with 40 sales reps, some of whom have moved over from selling Amitiza, he notes, adding that 40 reps can cover 52% of the top prescribing physicians in the glaucoma space.
Glaucoma is a group of ocular diseases with various causes that ultimately are associated with a progressive optic neuropathy leading to loss of vision. “Reduction in IOP is currently the only modifiable risk factor for patients with glaucoma and ocular hypertension,” he says, adding that “Rescula is believed to reduce elevated IOP by increasing the outflow of aqueous humor through the trabecular meshwork in the eye.”
Mr. Claiborne explains that Rescula was originally approved in 2000 in the U.S. and was marketed by CIBA Vision. When Novartis acquired CIBA, the drug was returned by Novartis, and Sucampo acquired the rights in 2009.
“The cornerstone of our strategy was to have the FDA update the label to reflect our better understanding of how the drug worked,” he recalls. That was achieved in December, and Rescula can now be used as a first-line agent or with other topical ophthalmics to lower IOP.
RESCULA: Only Nonprostaglandin That Lowers IOP Throughout Day (12 h) With Excellent Systemic Safety Profile
Even though 67% of the glaucoma market is now generic, Mr. Claiborne points out that there is a subset of patients who can’t tolerate the side-effects of standard of care prostaglandin drugs for IOP, including severe red eye. “Because of that, those patients have to come off prostaglandins and find an alternative treatment,” he adds. “That’s the subset we’re going after. We believe it represents 15% to 20% of patients being treated for glaucoma by prostaglandins. Overall, the glaucoma market is a $3-billion-a-year market. And we think we stack up well, because our new label reflects the differences in how Rescula works and how prostaglandins work.”
xx
Related Posts -
¦Sucampo appoints Munder and O’Connell to board
¦Sucampo partner gets Japanese funding for RP trial
upgrade to $10
• 1 hour 30 minutes ago
MAXIM 19.03.13 Initiation Buy target 12 month 10$
Sucampo Pharmaceuticals, Inc.
Specialty Pharma: Approved Products with Cash Flow
We are initiating coverage of Sucampo Pharmaceuticals, Inc. with a Buy rating and $10.00 price target. We believe the company’s two approved drugs, AMITIZA (constipation) and Rescula (ophthalmology), can return to the market (US & EU) with new label indications and improvements, supported by a refreshed and differentiated marketing strategy. In Japan (AMITIZA) will be sold through Abbott – ABT, $33.46 – NR and Sucampo will receive a manufacturing revenue stream.
Moving beyond OTC. In the constipation paradigm, most sufferers seek out over-the-counter remedies. These are, for the most part, effective. However, for chronic sufferers—regardless of the underlying cause: IBS, UC, or OIC—a prescription therapeutic is needed. This is the target niche in which AMITIZA is now being positioned to compete with other new products, such as linaclotide (Ironwood - IRWD - $16.55 - NR).
Is Takeda engaged? We believe, Hai, so desu: (yes). The dispute between Sucampo and Takeda Pharmaceuticals surrounding Takeda’s lack of focus in promoting AMITIZA has in our opinion, ?woken up? Takeda to the opportunity. This coupled with new indications and niche marketing by Sucampo should help drive U.S. revenue growth. The challenge is to accomplish this with new competition in the marketplace. We believe the combined efforts of both Ironwood (and their partner Forest (FRX-$37.61-NR) and Sucampo should together raise physician and patient awareness and expand the marketplace.
Launches in Europe and Japan. AMITIZA is initially being launched in the UK and Switzerland, while a mutual recognition (EU-5) process is now underway. We believe Sucampo’s EU strategy—to launch country by country—is risk mitigating for investors. We look for EU revenues to build in 2014 as NICE reimbursement is achieved. Meanwhile, Abbott is launching AMITIZA in Japan Less
sold my 1.2k shares @$5.35 from an average $4.72. don't trust the overall markets and so i wanted to lock in profits.
~ $SCMP ~ Parabolic SAR Buy Signals ~ Criteria alert for last trading session!
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TY, and nice buy too.
should see a decent move into april even if markets stop going up every day. GLTY
Nice buy.
I also bought 2000 shares @$4.74 the same day you made your purchase. Best of luck to everybody.
bought 1200 shares @4.70 today. company has a nice catalyst with the PDUFA end of april for AMITIZA after a 3 month delay and priority review. weekly 200SMA is @$4.66 so i'm fine with that buy.
1:33AM Sucampo Pharma announces commercial availability of RESCULA in U.S. pharmacies (SCMP) 5.20 : Co announces that RESCULA 0.15% is now available by prescription across the United States. The FDA approved a sNDA for RESCULA for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension on December 7, 2012. According to the approved product labeling, RESCULA may be used as a first-line agent or concomitantly with other topical ophthalmic drug products to lower intraocular pressure. RESCULA is a BK channel activator, which is different from other IOP lowering agents.
SCMP - bought 2K shares to poke and hope with on this one the other day in mid $5.20's....PDUFA date is April 26th, thin stock that should do some climbing soon as we get into March/April, jmo, we shall see....hope so anyway....
6:02AM Sucampo Pharma files patent infringement lawsuit against Anchen Pharmaceuticals and Par Pharmaceuticals (SCMP) 5.22 : Co announced that it, its affiliate Sucampo AG, R-Tech Ueno, Takeda Pharmaceutical (TKPYY) and certain affiliates of Takeda have filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Anchen Pharmaceuticals, Par Pharmaceuticals, and Par Pharmaceutical related to an Abbreviated New Drug Application (ANDA) that Anchen filed with the FDA to market a generic version of AMITIZA (lubiprostone) oral capsules, 8 mcg and 24 mcg. The lawsuit claims infringement of six patents that are listed in the FDA's Orange Book and that are scheduled to expire between 2020 and 2027.
I like the possibilities here. Two product launches in the first quarter of 2013! One for CIC in Japan, the first drug of its type in Japan, sold by Abbott, and Rescula for glacoma in the USA, now offered as a first line treatment. Very Big..
7:12AM Sucampo Pharma reeives notice letter regarding an ANDA submitted to the FDA by Anchen Pharmaceuticals (SCMP) 5.04 : Co announces that on Jan 2, 2013, it received a Paragraph IV certification notice letter regarding an ANDA submitted to the FDA by Anchen Pharmaceuticals requesting approval to market, sell and use a generic version of the co's 8mcg and 24 mcg AMITIZA products. In its Notice Letter, Anchen alleges that SCMP's U.S. Patents, which cover composition, formulations and methods of using AMITIZA, are invalid, unenforceable and/or will not be infringed by Anchen's manufacture, use or sale of the products described in its ANDA. The latest of the Patents expire in 2027.
SCMP is currently reviewing the Notice Letter. By statute, if the co initiates a patent infringement lawsuit against Anchen within 45 days of the Notice Date, then the FDA would automatically stay approval of Anchen'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 co intends to vigorously enforce its intellectual property.
6:49AM Sucampo Pharma announces FDA approval of an sNDA for RESCULA (unoprostone isopropyl) (SCMP) 4.97 : Co announced that it has received approval of an sNDA for RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension from the FDA. Sucampo intends to commercialize RESCULA in the first quarter of 2013.
6:46AM Sucampo Pharma receives $15 million milestone payment from Abbott (ABT) on first sale of Amitiza in Japan (SCMP) 4.86 : Co announced that its subsidiary, Sucampo AG, has received a $15 million milestone payment from Abbott's (ABT) subsidiary, Abbott Japan Co. pursuant to the existing license, commercialization, and supply agreement between Sucampo Pharma, SPI's subsidiary, and Abbott. The milestone payment was triggered by the first sale of Amitiza, capsule 24 g in Japan. AMITIZA is available through Abbott in Japan as a prescription medication for chronic constipation not caused by organic diseases, and was launched to primary care and specialist physicians on November 21, 2012.
Whats with the 3.90 print, are SCMP and DVAX tied at the belly?
sucampo has public awareness commercial on NYC news radio.
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http://www.sucampo.com/
http://finance.yahoo.com/q/ks?s=SCMP
Sucampo Pharmaceuticals, Inc., a pharmaceutical company, engages in the discovery, development, and commercialization of drugs based on prostones. It develops prostones for the treatment of gastrointestinal, respiratory, vascular, and central nervous system diseases and disorders. The company markets AMITIZA (lubiprostone) for chronic idiopathic constipation in adults in the United States and is developing the drug for the treatment of multiple constipation-related gastrointestinal disorders. Sucampo Pharmaceuticals is also completed two pivotal Phase III clinical trials of AMITIZA for the treatment of irritable bowel syndrome with constipation. In addition, it is developing other prostone compounds, including Cobiprostone, which is under Phase II clinical trial for the treatment of ulcers induced by non-steroidal anti-inflammatory drugs, portal hypertension, non-alcoholic fatty liver disease, disorders associated with cystic fibrosis, and chronic obstructive pulmonary disease; and SPI-017, which is under preclinical trial, for the treatment of peripheral arterial and vascular disease and central nervous system disorders, as well as involves in the development an oral formulation of SPI-017 for the treatment of Alzheimer's disease. Further, the company engages in the Phase III pivotal clinical trial of AMITIZA for the treatment of opioid-induced bowel dysfunction. Sucampo Pharmaceuticals has a collaboration and license agreement with Takeda Pharmaceutical Company Limited to develop and commercialize AMITIZA for chronic idiopathic constipation, irritable bowel syndrome with constipation, opioid-induced bowel dysfunction, and other gastrointestinal indications in the United States and Canada. The company was founded in 1996 and is headquartered in Bethesda, Maryland.
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