TIDMSKP TIDM35WJ TIDM85UF
RNS Number : 7928G
Skyepharma PLC
03 July 2012
European Commission Positive Decision on flutiform(R)
- flutiform(R) to be Approved in 21 Countries in Europe -
LONDON, UK, 3 July, 2012 - SkyePharma PLC (LSE SKP) today
announces that the European Commission has adopted a legally
binding decision in favour of granting of marketing authorisations
for flutiform(R).
This decision follows the positive opinion of the Committee for
Medicinal Products for Human Use ("CHMP") of the European Medicines
Agency ("EMA") as announced on 20 April 2012. The European
Commission decision is binding and the 21 member states in the
decentralised procedure ("DCP") are now required to grant national
marketing authorisations or approvals consistent with the
decision.
In some countries it is anticipated that the national marketing
authorisations will be granted shortly, typically between 1 and 3
months. In other countries negotiations will be required with
national pricing and reimbursement authorities before the product
can be made commercially available. The Group's development,
marketing and distribution partner, Mundipharma International
Corporation Limited, aims to launch as soon as possible through its
network of independent associated companies once national approvals
are granted and reimbursement confirmed.
Peter Grant, Chief Executive Officer of SkyePharma, commented:
"The European Commission's positive decision on flutiform is
excellent news for the Company and we look forward to launches
across Europe in the second half of this year. To get a product of
this complexity through to approval has been an immense achievement
by SkyePharma and our partner Mundipharma. It is also a strong
endorsement of the Group's capabilities in developing innovative
and complex respiratory products and good news that a new treatment
option will be available for many patients suffering from asthma
across Europe."
"Asthma is a debilitating condition which affects millions of
people across Europe, and its symptoms are still not optimally
controlled," said Antony Mattessich, Regional Director Europe,
Mundipharma International Limited. "We are very pleased that we can
now obtain approvals in 21 countries in Europe and continue to plan
for launch as soon as possible following the issuance of national
marketing authorisations."
A novel combination, flutiform(R) combines fluticasone
propionate (fluticasone), an inhaled corticosteroid (ICS), and
formoterol fumarate (formoterol), a long-acting <BETA>(2)
-agonist (LABA) in a single aerosol inhaler incorporating
SkyePharma's proprietary SkyeDry(TM) technology. flutiform(R) will
be indicated for the regular treatment of asthma in patients aged
12 years and over (50/5ug and 125/5ug strengths) and in adults
(250/10ug strength) whose symptoms are not adequately controlled on
an ICS and an as-required inhaled short-acting <BETA>(2)
-agonist (SABA), and in those patients who are already receiving
treatment with both an ICS and LABA. (1)
The member states in the DCP were the UK, as reference member
state, and Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
Denmark, Finland, France, Germany, Iceland, Ireland, Italy,
Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania,
Slovakia and Sweden.
Additional information
The SkyePharma Group commenced development of flutiform(R) in
2004 and carried out a substantial part of the development of the
product including all the pre-clinical and chemistry, manufacturing
and control work as well as a substantial part of the clinical
trials. In 2006 the Group appointed Mundipharma International
Corporation Limited as the development partner and authorised
distributor of flutiform(R) for Europe and most other territories
outside Japan and the Americas.
The Marketing Authorisation Application included a substantial
package of chemistry, manufacturing and control data together with
the results of eight phase I/II studies and nine phase III trials,
which were conducted in a population of 4,500 patients, of which
1,900 received flutiform(R). The trials were designed to evaluate
the safety and efficacy of the fluticasone/formoterol combination
compared with fluticasone and formoterol alone, the two components
administered concurrently and to a currently available combination
asthma therapy, salmeterol/fluticasone.
SkyePharma is responsible for the supply of flutiform(R) to
Mundipharma. The manufacturing processes have been validated and
some initial launch stocks have been manufactured.
Financial information
The development and marketing agreement with Mundipharma
includes milestones of up to EUR73.0 million, of which EUR15.0
million was paid upfront, EUR3.0 million was paid on 31 December
2008, up to EUR15.0 million is due in installments as the product
is launched in major European markets and up to EUR40.0 million is
sales-related. It is anticipated that EUR8.0 million of the launch
milestones will be received in 2012 and half of these receipts will
be applied as prepayments of the Paul Capital Note.
Under the development and marketing agreement the Group is
entitled to royalties as a percentage escalating upwards from 10%
of net sales. In the first four years following commercial launch
in one of Europe's five largest markets the net royalties and sales
milestones are subject to substantial partial reductions until
Mundipharma recovers up to EUR19 million of development costs
principally related to the high strength version of flutiform(R).
Royalties are also subject to a cap which limits the aggregate
amount of royalties and costs of product supplied to Mundipharma by
SkyePharma to a maximum of 35% of net sales.
The European asthma market
According to IMS the preventative asthma/COPD European market
size in 2010 was estimated to be U.S.$8.6 billion (GBP5.5 billion)
with a four-year compound annual growth rate of 6.6%. Preventative
treatment of asthma comprises well over half this market, which
comprises anti-leukotrienes, ICS, ICS/LABAs, LAMAs and PDE-4
inhibitors. In 2010 European sales of ICS/LABAs totalled U.S.$4.8
billion.
-Ends-
For further information please contact:
SkyePharma PLC
Peter Grant, Chief Executive Officer +44 207 881 0524
FTI Consulting
Jonathan Birt/ Julia Phillips/
Susan Stuart +44 207 831 3113
Clinical evidence behind flutiform(R)
The EC recommendation was granted based on a regulatory package
of eight phase I/II studies and nine phase III trials, which were
conducted in a patient population of nearly 4,500, of whom 1,900
received flutiform(R).
The phase III clinical trials have demonstrated the efficacy,
safety and tolerability profile of flutiform(R) across a range of
asthma severities and in comparison with two currently available
combination therapies for asthma (fluticasone/salmeterol and
budesonide/formoterol). (1,2,3,4)
Phase III clinical trial data (8-12 weeks) demonstrated that the
new combination:
- is more effective in improving asthma symptom scores,
including an improvement in the percentage of symptom-free days and
awakening-free nights, compared with a similar dose of fluticasone
alone (4)
- provides similar improvements in lung function parameters,
control of asthma symptoms and similar level of exacerbations
compared to its individual components administered concurrently via
separate inhalers (4)
- has a more rapid onset of bronchodilatory action than the
fluticasone/salmeterol combination as defined by the first time
point post-dose at which FEV1 was at least 12 percent greater than
the pre-dose value. The superiority of fluticasone/formoterol
combination (100/10 or 250/10 <MU>g b.i.d.) compared to the
fluticasone/salmeterol combination (100/50 or 250/50 <MU>g
b.i.d.) was shown over a 12-week study period (HR 1.64) (3)
- has a safety and tolerability profile similar to that of its
individual components administered concurrently via separate
inhalers (4)
About SkyePharma
Using its multiple drug delivery technologies and expertise,
SkyePharma creates enhanced versions of pharmaceutical products.
Once flutiform(R) is launched the Group will be receiving revenues
from thirteen approved products in the areas of inhalation, oral,
topical and injectable delivery as well as generating income from
the development of further products and technology licenses. The
Group's products are marketed throughout the world by leading
pharmaceutical companies. For more information, visit
www.skyepharma.com.
About Mundipharma
The Mundipharma independent associated companies have become
leaders in pain management, and are building a growing presence in
the oncology, rheumatoid arthritis and respiratory markets. Through
innovation and acquisition, the Mundipharma mission is to deliver
cutting-edge treatment solutions that meet the pressing needs of
healthcare professionals and patients. For more information:
www.mundipharma.com
1. flutiform SmPC
2. Bodzenta-Lukaszyk A, R Buhl, et al. Eur Respir J 2011a;38:153s
3. Bodzenta-Lukaszyk A, Dymek A et al. BMC Pulm Med J. 2011;11:28
4. Bodzenta-Lukaszyk A, Pulka et al. Respir Med J. 2011;105(5):674-82
This information is provided by RNS
The company news service from the London Stock Exchange
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