Positive European Commission Decision on flutiform® (fluticasone propionate/formoterol fumarate), a New Combination Therapy for Asthma

Cambridge, England (ots/PRNewswire) -

First national approvals expected by the end of
2012

Mundipharma today announced the positive European Commission (EC)
decision for flutiform(R) (fluticasone propionate/formoterol
fumarate), a new combination therapy for the maintenance treatment of
asthma, in Europe. This decision is binding on all 21 Concerned
Member States involved in the decentralised procedure (DCP) and the
first national approvals of flutiform are expected across a number of
countries by the end of 2012. Timings of these will be dependent on
negotiations with the national regulatory and, where relevant,
reimbursement authorities.*

The combination of fluticasone propionate (fluticasone), an
inhaled corticosteroid (ICS), and formoterol fumarate (formoterol), a
long-acting beta2-agonist (LABA) therapy is delivered via a single
aerosol inhaler for the first time. flutiform will be indicated for
the regular treatment of asthma in patients aged 12 years and over
(50/5microg and 125/5microg strengths) and in adults (250/10microg
strength) whose symptoms are not adequately controlled on an ICS and
an as-required inhaled short-acting beta2-agonist (SABA), and in
those patients who are already receiving treatment with both an ICS
and LABA.[1]

"Asthma still represents an important clinical challenge despite
current available treatments," said Alberto Papi, Professor of
Respiratory Medicine, University of Ferrara, Italy.

"With flutiform, the characteristics of two very effective asthma
medications are combined for the first time in a single inhaler: a
potent inhaled corticosteroid, fluticasone, and a fast-acting LABA,
formoterol. The pharmacological characteristics of this combination
offer an important treatment option for patients with asthma."

"We welcome the decision of the European authorities and consider
this a significant step in establishing Mundipharma's presence in the
respiratory market," said Antony Mattessich, Regional Director
Europe, Mundipharma. "Asthma is a serious public health issue,
affecting approximately 30 million people in Europe, and we are
committed to the research and development of new treatment solutions
for this debilitating condition."

This EC decision follows the positive opinion of the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) announced on 20 April 2012.

Mundipharma International Limited is licensed by Jagotec AG, a
SkyePharma Group company, as the authorised distributor of the
fluticasone/formoterol combination for Europe and most other
territories outside Japan and the Americas.

*Please note flutiform(R) is currently not available for use
within Europe

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.

The phase III clinical trials have demonstrated the efficacy,
safety and tolerability profile of flutiform 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 mug b.i.d.) compared to the
fluticasone/salmeterol combination (100/50 or 250/50 mug 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 Mundipharma

Mundipharma International provides fully integrated support
across multiple disciplines for a network of independent
pharmaceutical companies across Europe. 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: http://www.mundipharma.com

(R) denotes a registered trade mark

References

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

ots Originaltext: Mundipharma International
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information please contact: Lara Dow, Head of
European Communications and Congress, Lara.Dow@mundipharma.co.uk,
+44(0)1223-397-674; Lisa Henry, lhenry@websershandwick.com,
+44(0)2070-670-0808