For the fourth quarter of 2012, income from operations was $13.0 million, an increase of $9.4 million, compared to $3.6 million in income from operations for the fourth quarter of 2011. For the full year 2012, income from operations was $8.3 million, compared to a loss from operations of $17.7 million for the full year 2011.

Quarter Operational Highlights –
  • As previously reported, on December 11, 2012, Sucampo announced the receipt of a $15.0 million milestone payment from Abbott, pursuant to the existing license, commercialization, and supply agreement between Sucampo and Abbott. The milestone payment was triggered by the approval and first sale of AMITIZA at a dosage strength of 24 micrograms in Japanese adults. AMITIZA is available through Abbott in Japan as a prescription medication for chronic constipation not caused by organic diseases, and was available in Japan to primary care and specialist physicians beginning in November 2012.
  • On December 12, 2012, Sucampo announced that it received approval of a supplemental new drug application (sNDA) for RESCULA ® (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension from the U.S. Food and Drug Administration (FDA).
  • On November 30, 2012, Sucampo announced the receipt of a supplement approval from the U.S. FDA that removed pregnancy “warnings and precautions” and clarified information regarding the use of AMITIZA by pregnant and/or nursing women. In addition, the FDA expanded the labeling text of the Mechanism of Action section in the prescribing information for AMITIZA.
  • On November 30, 2012, Sucampo announced that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency’s priority review of the sNDA for an additional indication for lubiprostone for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. The revised goal date is late April of this year.

Key Value Drivers –

2012 Value Drivers Achieved:

AMITIZA

U.S.
  • Sucampo filed an sNDA with the FDA for the treatment of OIC in patients with chronic, non-cancer pain, and received priority review.

Japan
  • AMITIZA received regulatory approval in Japan for the treatment of CC (excluding constipation caused by organic disease).
  • Sucampo received the pricing reimbursement from the Japanese regulatory authorities and our partner, Abbott, conducted a comprehensive launch of AMITIZA in Japan to primary care and specialist physicians.
  • Following the November launch of the product, Sucampo received a $15.0 million milestone payment, referenced above, and recorded product sales revenue of $5.0 million for sales of AMITIZA to Abbott.

Europe
  • In Switzerland, Sucampo concluded pricing negotiations with the regulatory authorities for an appropriate reimbursement price for the treatment of chronic idiopathic constipation (CIC) and made the product available to specialists.
  • AMITIZA was approved by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of CIC and Sucampo began the process to obtain National Institute for Health and Clinical Excellence (NICE) endorsement.

RESCULA
  • Sucampo received approval of an sNDA for RESCULA for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension and prepared to launch in first quarter 2013.

Other
  • Sucampo received the binding decision from the International Court of Arbitration, International Chamber of Commerce, which has concluded our dispute with Takeda.

2013 Value Drivers:

Sucampo is pursuing the following value drivers in 2013:

AMITIZA

U.S.
  • Sucampo is pursuing approval of an OIC indication for AMITIZA, and the PDUFA goal date is late April 2013. Upon the first sale of AMITIZA for OIC, we will receive a $10.0 million milestone payment from Takeda.
  • Sucampo expects to have First Patient First Visit in our AMITIZA phase 3 trial for pediatric functional constipation by the third quarter of 2013.

Japan
  • Growth of AMITIZA sales is a priority.

Europe
  • In the U.K. and Switzerland in the first quarter of 2013, Sucampo submitted for regulatory approval of AMITIZA for the treatment of OIC.
  • In the U.K., Sucampo plans to seek endorsement from NICE for both OIC and CIC and will make AMITIZA available with reimbursement by some local budget holders.
  • Sucampo will soon begin active marketing of AMITIZA for CIC in Switzerland.
  • Sucampo will use the MHRA approval to seek expansion of AMITIZA’s CIC indication to other European markets via the mutual recognition procedure.

RESCULA
  • Following the RESCULA sNDA approval, Sucampo launched the drug in the U.S. RESCULA is now available in all major pharmacies.

Other

Oral Mucositis
  • Sucampo expects to complete its oral mucositis phase 1a trial for cobiprostone in the second quarter of 2013.
  • Sucampo plans to initiate a phase 1b/2a trial in the fourth quarter of 2013.

Spinal Stenosis
  • Sucampo plans to complete its phase 2a trial for SPI-017 in the fourth quarter of 2013.

As previously announced, in February R-Tech Ueno, Sucampo's development partner, signed an agreement for unoprostone isopropyl with the Japan Science and Technology Agency in which the Japanese government shall provide the majority of funding for phase 3 clinical development costs for unoprostone isopropyl for retinitis pigmentosa (RP). Sucampo is co-developing unoprostone isopropyl with R-Tech Ueno and may file for FDA approval of the product for RP in the future assuming the successful trials.

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