- As reported previously, the Japanese Ministry of Health, Labor and Welfare approved lubiprostone (AMITIZA) for the treatment of chronic constipation (CC) (excluding constipation caused by organic diseases), Japan’s first-ever approval of a prescription drug for this indication. Following reimbursement negotiations with the Japanese regulatory authorities, we expect our partner, Abbott Japan, Ltd., to conduct a robust launch of the product by year-end 2012 to primary care and specialist physicians. This event will trigger a $15.0 million milestone payment to Sucampo.
- In July, Sucampo filed a supplemental new drug application (sNDA) with the FDA for a new indication for AMITIZA for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. This is the first oral product to be filed with the FDA for this indication.
- In the United Kingdom, Sucampo awaits a final regulatory decision from the Medicines and Healthcare products Regulatory Agency in the third quarter of 2012 for the short-term use of AMITIZA in the treatment of chronic idiopathic constipation (CIC).
- As previously reported, Sucampo received the binding decision from the International Court of Arbitration, International Chamber of Commerce (ICC) in our dispute with our U.S. and Canadian partner, Takeda Pharmaceutical Company Limited. The ICC did not agree with Sucampo’s claims and confirmed that the Collaboration Agreement and all of its terms, rights and conditions for AMITIZA including the royalty rate arrangement will remain in force until it expires in December 2020.
- With regards to the RESCULA label discussions with the U.S. Food and Drug Administration, we continue to make progress in seeking further revisions to the label to more accurately reflect current scientific understanding of its mechanism of action. We anticipate agreement on the final label during this quarter and look forward to launching RESCULA for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension in the fourth quarter of 2012.
|2012 Key Value Drivers|
|Sucampo management today reported that it has met three of its 2012 AMITIZA-related value drivers:|
|1.||In June, AMITIZA received regulatory approval in Japan for the treatment of CC (excluding constipation caused by organic disease).|
|2.||In July, we filed a sNDA for the treatment of OIC in non-cancer, non-methadone patients, with the FDA.|
|3.||In July, we received the binding decision from the ICC which has concluded our dispute with Takeda.|
|Management confirmed that it continues to pursue the following 2012 AMITIZA-related value drivers:|
|1.||In Japan, we anticipate a pricing decision later this year, to be followed by a comprehensive primary care and specialist launch in the fourth quarter of 2012 with our partner, Abbott Japan.|
|2.||In the U.K., we await regulatory action on the MAA for the treatment of CIC in the third quarter 2012. In Switzerland, we expect to conclude pricing negotiations with the authorities for an appropriate reimbursement price for CIC.|
|3.||In the U.K. and Switzerland, we expect to file MAAs for the OIC indication.|
|Management also confirmed continuing efforts to achieve these 2012 RESCULA-related value drivers:|
|1.||In the U.S., obtaining further improvements in the label to fully reflect current scientific understanding in advance of its launch during the fourth quarter 2012.|
|2.||In the E.U. and Switzerland, filing MAAs for the reduction of elevated intraocular pressure in patients with ocular hypertension or chronic open-angle glaucoma.|