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LONDON, UK, 9 May, 2013 – Ahead of its Annual General Meeting later today, Skyepharma PLC (LSE: SKP) publishes its Interim Management Statement for the period 1 January 2013 to 8 May 2013 and provides an update on key events since the 2012 results announcement issued on 21 March 2013.
Trading performance to date is broadly in line with the Board’s expectations with manufacturing revenues ahead of plan and contract R&D revenues behind due to project timing. The outlook for the year has not changed materially since the 2012 results announcement.
Pipeline and product updates
flutiform® – Europe and Rest of World
Encouraging feedback has been received on the launch of flutiform® in Europe from the Group’s development, marketing and distribution partner, Mundipharma International Corporation Limited (“Mundipharma”). Mundipharma management has stated that early indicators of uptake and initial sales are in line with their expectations. flutiform® combines for the first time in Europe the fast acting LABA (Long-Acting Beta Agonist), formoterol, and the most widely prescribed ICS (Inhaled Corticosteroid), fluticasone.
Since the 2012 decision by the European Commission in favour of granting marketing authorisations for flutiform® in 21 European countries, flutiform® has been launched in nine countries: Germany, the UK, Cyprus, Denmark, Finland, Ireland, the Netherlands, Norway and Sweden. For the remaining 12 countries, including Italy and France, further launches are anticipated during 2013/14 once pricing and reimbursement processes are concluded. Mundipharma aims to continue to launch as soon as possible through its network of independent associated companies once national approvals are granted and where relevant, reimbursement confirmed.
Mundipharma has also filed marketing authorisation applications in a number of countries in the Asia-Pacific region.
In-market sales* of flutiform® from launch (which commenced in September 2012) to the end of February 2013 totalled €2.3 million* (£1.9 million). When compared with the most recent previous launch of a new non-generic combination brand in the ICS/LABA market segment, flutiform® is tracking ahead in terms of in-market value of sales* for the same period post launch in those countries where it is available. Mundipharma has achieved a “share of voice”† in this segment competitive with the category leaders and market research shows that flutiform® messages and key data are being well received. (*Source: IMS Health, IMS MIDAS. Feb MAT 2013. †Note: “Share of voice” represents the proportion of discussions recalled by prescribers based on independent surveys.)
KRP-108/flutiform® – Japan
The Group’s partner, Kyorin Pharmaceutical Co. (“Kyorin”), continues to plan to be in a position to launch flutiform® as soon as possible after receiving approval and reimbursement prices. The review of the Japanese New Drug Application (“NDA”) for flutiform®, submitted in September 2012, is ongoing.
flutiform® – Latin America
In Mexico, Central and South America, the Group’s licensee, Sanofi, is expected to start filing NDAs for flutiform® in the next few months.
Licences to GlaxoSmithKline (“GSK”)
In 2003 the Group signed an agreement with GSK to provide access to one of the Group’s proprietary dry powder formulation technologies for inhalation products. The Group is entitled to a low single digit royalty on net sales of products using the licensed technology, that reach the market, capped at a maximum amount of £3.0 million per annum for each chemical entity for the life of the relevant patent. The technology has been incorporated in two combination products, which in aggregate involve three chemical entities and NDAs for both products have been filed for approval in the United States, Europe and Japan. The proposed brand names for these products are BREO™/RELVAR™ ELLIPTA™ and ANORO™ ELLIPTA™ (ANORO™, BREO™, RELVAR™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies). The Prescription Drug User Fee Act (“PDUFA”) target dates for the completion of review of the applications by the Food and Drug Administration (“FDA”) in the United States are 12 May 2013 for BREO™ ELLIPTA™ (for COPD) and 18 December 2013 for ANORO™ ELLIPTA™ (for COPD) respectively. BREO™ ELLIPTA™ has been recommended for approval at a recent FDA Pulmonary-Allergy Drugs Advisory Committee hearing.
Pacira reported on 8 May 2013 that in the quarter ended 31 March 2013, EXPAREL® sales totalled U.S.$10.4 million (£6.7 million), up from U.S.$7.8 million (£4.8 million) in the fourth quarter of 2012. The Group is entitled to three per cent. of net sales of EXPAREL® in the United States (based on cash received by Pacira), and a similar share of net sales, if approved and launched, in Japan, the UK, France, Germany, Italy and Spain. As disclosed in detail in the 2012 Annual Report and Accounts, the Group is also entitled to certain contingent milestone payments depending upon certain launch and sales targets being achieved.
The Group’s licensee, Horizon Pharma, Inc (“Horizon”) began detailing RAYOS® to a subset of U.S. rheumatologists in December 2012. The full launch took place in late January 2013 with a sales force of approximately 150.
In March 2013, the Group and Horizon received letters from Alvogen Pine Brook, Inc. (“Alvogen”), informing that Alvogen had filed an Abbreviated New Drug Application (“ANDA”) with the FDA for a generic version of RAYOS®, containing up to 5 mg of prednisone and that Alvogen’s submission contained Paragraph IV certifications. Alvogen did not indicate the timing or status of the FDA’s review of its filing and the validity of the letters for ANDA notification purposes were challenged by Horizon and Skyepharma. Subsequently, Alvogen has agreed that if its ANDA is accepted by the FDA, a notification letter will need to be served after such acceptance and that all time periods will run from the date of service of such letter. If such a notification letter is served and a patent infringement suit is initiated to enforce the RAYOS® patents identified in the Paragraph IV certification within 45 days after the FDA’s receipt of the notice, the FDA would be prevented from approving the ANDA until the earlier of 30 months or a decision in the infringement case that each of the patents are not infringed or are invalid. Horizon and Skyepharma will vigorously enforce their respective intellectual property rights relating to RAYOS®.
Aenova – Lyon Facility
In July 2011, Skyepharma Production SAS leased its pharmaceutical manufacturing business (“Manufacturing Business”) and premises at Saint Quentin-Fallavier, Lyon (together the “Facility”) to Aenova France SAS (“Aenova”). The lease was entered into for an initial period of two years ending 30 June 2013 following which certain termination or renewal rights may apply. Aenova and Skyepharma have commenced discussions to study all the various options for the Facility.
Peter Grant, Chief Executive Officer of Skyepharma, commented:
“We are pleased with the initial data on flutiform sales in Europe and look forward to further launches during the course of the year. Elsewhere, flutiform continues to make good progress with the filing of marketing authorisation applications underway in a number of countries in the Asia-Pacific region and further filings anticipated in Latin America by our partner Sanofi in the coming months. We remain positive about the long-term prospects for flutiform.
“We continue to benefit from our partnered and pipeline assets, including our agreement with GSK, which uses some of Skyepharma’s proprietary dry powder formulation technology for inhalation products, and provides further validation of the Group’s capabilities in developing innovative and complex respiratory products.”
For further information please contact:
Peter Grant, Chief Executive Officer +44 207 881 0524
Julia Phillips/Susan Stuart +44 207 831 3113
Shaun Dobson/Jennifer Wyllie +44 207 496 3000
Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products. The Group receives revenues from 13 marketed products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses. The products developed by the Group are marketed throughout the world by big pharma as well as speciality pharmaceutical companies. For more information, visit www.Skyepharma.com
F T I Consulting
+44 (0)20 7269 7121 direct
Holborn Gate, 26 Southampton Buildings
London, WC2A 1PB
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