MEDIA RELEASE PR39654
Grifols Agrees to Acquire Intellectual Property for Treatment of Post-Polio Syndrome From
Pharmalink AB
BARCELONA, Spain, May 20 /PRNewswire-AsiaNet/ --
Today, Grifols SA announced that it has reached an agreement with the
Swedish company Pharmalink AB to acquire various forms of intellectual
property (IP) associated with the treatment of post-polio syndrome (PPS). The
acquisition is expected to be finalized in the next few weeks and will
include documentation, know-how, and Swedish regulatory approvals under the
trade name Xepol. Furthermore, Grifols also acquires U.S., European and
Japanese patents for a specific PPS treatment method utilizing human
immunoglobulin and unrestricted use of existing Pharmalink clinical trial
data supporting the treatment method.
Acquisition of the PPS drug development project creates new clinical
research and therapeutic treatment areas for Grifols. "Exploring the
treatment of PPS consistent with our mission of developing therapies for
chronically ill and underserved patient populations," said Ramon Riera,
Director of Global Sales and Marketing for Grifols. Currently there are no
therapies approved for the treatment of PPS.
PPS is widely recognized as a rare disease and the U.S. FDA has granted
orphan drug designation for the use of human immunoglobulin in the treatment
of PPS. "The promise of research on potential treatments for post polio
syndrome is welcomed by the thousands who experience its debilitating
symptoms, and we hope that it is fulfilled," said Joan L. Headley, Executive
Director of St. Louis, Missouri based Post-Polio Health International (PHI),
the leading organization working to enhance the lives and independence of
polio survivors. "It has been challenging to find treatments for this
condition. We are pleased that Grifols is investing in the PPS community,"
Headley added.
Previous clinical trials on the use of human immunoglobulin for the
treatment of PPS have been sponsored by Pharmalink using Grifols' proprietary
intravenous immunoglobulin. Grifols' acquisition of the Pharmalink PPS
project will give Grifols unrestricted use of those data and set the stage
for Grifols to investigate clinically relevant research questions growing out
of prior studies.
The acquisition also includes U.S., European and Japanese patents which
will effectively give Grifols exclusive rights to the treatment method.
About PPS
Several decades after suffering acute polio infection survivors commonly
develop PPS characterized by new or increased muscle weakness, fatigue, and
pain. Ongoing denervation is the most often suggested for increased muscle
weakness associated with polio infection. Patients with PPS have increased
expression of mRNA for proinflammatory cytokines in cerebrospinal fluid which
suggests an inflammatory process in the central nervous system. Some patients
with asymmetrical weakness have increased wear and tear on joints and
muscles, including breathing muscles. While rarely fatal, the neurological
and muscular symptoms of PPS are lifelong and debilitating.
The most recent polio epidemic culminated in the Western countries around
1950. As most infections occur in children, there is nowadays a large pool of
polio survivors with varying degrees of functional decline. U.S. National
Institute of Neurological Disorders and Stroke (NINDS) gives a prevalence
interval for PPS of 25 to 50% (in primary polio infection survivors), WHO
estimates a 40 % prevalence; assuming a prevalence of 30%, only in major
Western countries there would be around 300,000 PPS patients.
Currently there is no pharmacological treatment for PPS. Several
therapeutic agents have failed in achieving positive outcomes. Treatment
practices are based on physiotherapy, non-fatiguing exercise and the use of
assistive devices. The promising results with immunoglobulin may help address
the unmet medical need of some PPS patients. In several clinical trials lead
by a team of physicians at Karolinska Institutet (Sweden) and sponsored by
Pharmalink AB, immunoglobulin has shown significant and clinically meaningful
results in endpoints such as pain, walking ability and quality of life (SF-36
scores) by down-regulating the inflammatory process in the nervous system of
PPS patients.
About Pharmalink
Pharmalink is a Swedish specialty pharma company developing high value
products for niche indications. Pharmalink draws on its extensive experience
of pharmaceutical product development and the excellence of medical science
in Sweden to identify and progress products that address significant unmet
medical needs. Pharmalink has introduced more than 15 pharmaceutical products
to the market. Using a repurposing and reformulation strategy, Pharmalink
minimizes the risk of product development. The Company's strategy is to
develop drugs to clinical proof-of-concept and then to out-license or divest
to a commercial partner. Pharmalink currently has two clinical phase
development projects, Nefecon(R) and Busulipo(TM), mature for out-licensing
to a commercial partner and is actively in-licensing promising new projects
About Grifols
Grifols is a Spanish holding company specialized in the
pharmaceutical-hospital sector and is present in more than 90 countries.
Since 2006, the company has been listed on the Spanish Stock Exchange
("Mercado Continuo") and is part of the Ibex-35. Currently it is the first
company in the European sector in plasma derivatives and the fourth in
production worldwide. In upcoming years, the company will strengthen its
leadership in the industry as a vertically integrated company, thanks to
recent investments. In terms of raw materials, Grifols has ensured its plasma
supply with 80 plasmapheresis centers in the United States and in terms of
fractionation, its plants in Barcelona (Spain) and Los Angeles (United
States) will allow the company to respond to the growing market demand.
Nevertheless, the company is preparing for sustained growth in the following
8-10 years and has launched an ambitious investment plan. Visit
Source Grifols SA
CONTACT: Raquel Lumbreras Lanchas,
raquel_lumbreras@duomocomunicacion.com, or
Borja Gomez Vazquez,
borja_gomez@duomocomunicacion.com,
both for Grifols SA; or
Grifols corporate communications,
+34-91-311-92-89, or +34-91-311-92-90,
mobile, +34-659-57-21-85
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