OXFORD, England and
PITTSBURGH, April 15, 2014 /PRNewswire/ -- Prosonix, an
innovative speciality pharmaceutical company developing a portfolio
of inhaled Respiratory Medicines by Design, today announced
that it has entered into a global licensing agreement with Mylan
Inc. (Nasdaq: MYL), one of the world's leading global
pharmaceutical companies, for its leading inhaled respiratory
products, PSX1001 and PSX1050.
PSX1001 and PSX1050, which are the first products to emerge from
Prosonix's innovative and proprietary particle engineering
platform, are being developed as generic versions to
GlaxoSmithKline's pressurised metered dose inhalers (pMDI)
Flixotide® and Flovent®, respectively.
Flixotide and Flovent contain the active ingredient fluticasone
propionate, a potent inhaled corticosteroid, and are indicated for
the treatment of asthma. According to IMS Health, Flixotide and
Flovent had global brand sales of approximately $1.3 billion for the 12 months ending
Dec. 31, 2013. A first marketing
authorisation application for PSX1001 is expected to be submitted
in the European Union in 2014.
David Hipkiss, CEO and Co-founder
of Prosonix, said: "Our agreement with Mylan for the global
development and commercialisation of PSX1001 and PSX1050 is a major
milestone that reflects the outstanding contribution of the whole
Prosonix team. As a world leader in manufacturing and
commercialising high-value, difficult-to-manufacture generics and
with a growing respiratory franchise, we believe Mylan is the ideal
partner to ensure PSX1001 and PSX1050 are a commercial success and
a strong validation of our 'Respiratory Medicine by Design'
philosophy."
Rajiv Malik, President of Mylan,
commented: "We are very excited to enter into this agreement with
Prosonix as it represents another development milestone in our
global respiratory franchise, one of our key strategic growth
drivers, and strengthens our portfolio of difficult to develop and
manufacture products. Further, Prosonix's expertise in the
development of inhaled respiratory products perfectly complements
the strength of Mylan's respiratory R&D capabilities. We look
forward to a successful collaboration with Prosonix in the coming
years as we bring to market generic versions of Flixotide and
Flovent around the world."
Under the terms of the licensing agreement, Prosonix will file
PSX1001 in the EU and retain marketing rights in certain
territories. Mylan has marketing rights for PSX1001 and PSX1050 in
the U.S., Canada, Australia, New
Zealand, India,
Japan, the EU, Iceland, Liechtenstein, Norway, Switzerland, Turkey, Russian
Federation and the Commonwealth of Independent States. All
other terms of the agreement remain confidential.
This press release includes statements that constitute
"forward-looking statements," including with regard to the
company's future growth and performance. These statements are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Because such statements inherently
involve risks and uncertainties, actual future results may differ
materially from those expressed or implied by such forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to: the impacts of
competition; changes in economic and financial conditions of the
company's business; uncertainties and matters beyond the control of
management; and the other risks detailed in the company's filings
with the Securities and Exchange Commission. The company undertakes
no obligation to update these statements for revisions or changes
after the date of this release.
About Prosonix
www.prosonix.co.uk
Prosonix is an innovative speciality pharmaceutical company
developing a portfolio of inhaled Respiratory Medicines by Design.
Its investors include Entrepreneurs Fund, Gilde Healthcare, Gimv,
Quest for Growth, Solon Ventures and Ventech.
Prosonix' proprietary particle engineering technology enables it
to design and engineer mono and combination drug particles that
precisely meet the specific requirements for inhalation, delivering
assured formulation performance using simple, cost-effective
devices for a range of generic, super-generic and novel
products.
Prosonix' pipeline focuses on near- and long-term opportunities,
and is further complemented by a select number of partnered
respiratory programmes. The in-house pipeline includes:
- PSX1001 and PSX1050, generic versions of
GlaxoSmithKline's Flixotide®/Flovent®
monotherapy containing fluticasone propionate, a potent ICS, in
development for asthma in pMDI,
- PSX2005, a generic version of GlaxoSmithKline's
Seretide® combination product consisting of fluticasone
propionate and salmeterol xinafoate (a long-acting beta agonist
(LABA)) in development for asthma and COPD in pMDI,
- PSX1002, a drug-only proprietary formulation of
glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA),
currently in Phase 2 clinical studies for COPD in pMDI, and
- PSX2000 MCP™ Series, novel dual and triple combination
products (ICS/LABA, ICS/LAMA, LABA/LAMA, and ICS/LABA/LAMA)
designed specifically for respiratory diseases and based on
Prosonix proprietary Multi-component Particles™. Uniquely, MCPs™ do
not require additional functional excipients, adjuvants, or
co-suspension agents for optimal formulation performance from pMDI
or Dry Powder Inhalers (DPI).
Current partnered respiratory programmes also include:
- PX1439, a generic LABA in pMDI
- PX1442, a generic LAMA in a capsule based DPI.
Flixotide®, Flovent® and
Seretide® are trademarks of the GlaxoSmithKline group of
companies
About Mylan
Mylan is a global pharmaceutical company
committed to setting new standards in health care. Working together
around the world to provide 7 billion people access to high quality
medicine, we innovate to satisfy unmet needs; make reliability and
service excellence a habit; do what's right, not what's easy; and
impact the future through passionate global leadership. We offer a
growing portfolio of more than 1,300 generic pharmaceuticals and
several brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately 40% of HIV/AIDS
patients in developing countries depend. We also operate one of the
largest active pharmaceutical ingredient manufacturers and
currently market products in approximately 140 countries and
territories. Our workforce of more than 20,000 people is dedicated
to improving the customer experience and increasing pharmaceutical
access to consumers around the world. But don't take our word for
it. See for yourself. See inside. mylan.com
SOURCE Mylan Inc.