Grünenthal Initiates Pivotal Phase III Trials in Complex Regional Pain Syndrome

Aachen, Germany (ots) - Grünenthal announced today that first
patients have been enrolled in two trials of the company's pivotal
phase III program investigating neridronate for the treatment of
Complex Regional Pain Syndrome (CRPS). These two trials, KF7013-02
and KF7013-04, are investigating the efficacy and safety of
neridronate in 360 patients with CRPS. Neridronate, a bisphosphonate,
is an innovative investigational medicine discovered and developed by
Abiogen Pharma and now being further developed by Grünenthal for the
US territory.

CRPS is a rare disease and one of the most debilitating chronic
pain conditions. Currently, with no FDA or EMA approved drugs
available, there is a clear need for effective treatment options to
address this significant unmet medical need. As a leading specialist
in pain therapy and pain management, Grünenthal is highly committed
to providing an innovative treatment for patients affected by CRPS.

"There is a huge unmet medical need in CRPS as this condition may
result in loss of the physical function and may lead to significant
and sometimes permanent disability. Neridronate has been granted
Breakthrough Therapy and Fast Track designation by the FDA and our
pivotal phase III development program is the next step to investigate
neridronate's potential to make a difference in the lives of patients
affected by this debilitating disease.", said Gabriel Baertschi, CEO
Grünenthal.

"I'm excited to be part of a pivotal phase III efficacy trial in
CRPS. Currently, there is no approved treatment available and
affected patients face a permanently high pain level and immense
restrictions in their daily life", said Prof. Claudia Sommer,
International Coordinating Investigator for one of the trials. "If
the efficacy of neridronate is confirmed, quality of life of the
patients could be significantly improved."

About KF7013-02 and KF7013-04

KF7013-02 and KF7013-04 are confirmatory phase III efficacy and
safety trials to investigate neridronate's effect on pain and other
CRPS symptoms like swelling/edema and allodynia. The primary endpoint
assesses the pain reduction after twelve weeks in comparison to
placebo. The trials are conducted in the US, EU and certain countries
in the Asia Pacific region. Further information is available on
www.clinicaltrials.gov.

About Neridronate

Neridronate, an aminobisphosphonate, was discovered and developed
for the Italian market by Abiogen Pharma, Pisa, Italy. Abiogen had
licensed the development and commercial rights for North, South,
Central America and the Caribbean to the U.S.-based company NovaPharm
Therapeutics and Grünenthal obtained these rights in 2013.

About CRPS

Complex Regional Pain Syndrome (CRPS; formerly known as RSD or
Reflex Sympathetic Dystrophy) is a debilitating condition
characterized by severe, continuous, burning or throbbing pain often
occurring in an extremity after injury or surgery. The excessive pain
is accompanied by changes in skin color, temperature and/or
swelling/edema. It is frequently persistent and is ranked as the most
painful form of chronic pain that exists today by the McGill Pain
Index. CRPS results in loss of physical function, and can lead to
significant and sometimes permanent disability. There are currently
no FDA or EMA approved treatments for patients with CRPS.

About Grünenthal

Grünenthal is an entrepreneurial, science-based pharmaceutical
company specialized in pain, gout and inflammation. Our ambition is
to deliver four to five new products to patients in diseases with
high unmet medical need by 2022 and become a EUR2 bn company. We are
a fully integrated research & development company with a long track
record of bringing innovative pain treatments and state-of-the-art
technologies to patients. By sustainably investing in our R&D above
the industrial average, we are strongly committed to innovation.

Grünenthal is an independent, family-owned company headquartered
in Aachen, Germany. We are present in 32 countries with affiliates in
Europe, Latin America and the US. Our products are sold in more than
100 countries and approx. 5,200 employees are working for Grünenthal
worldwide. In 2017, Grünenthal achieved revenues of approx. EUR1.3
bn.

More information: www.grunenthal.com Follow us on LinkedIn
"Grunenthal Group".

About Abiogen Pharma

Abiogen Pharma is a privately owned specialist pharmaceutical
company focused on bone metabolism and some rare diseases. The
Company was founded in 1997 as a spin-off of Istituto Gentili.
Abiogen employs about 385 people with its head quarter in Pisa,
Italy. The team of R&D of Abiogen Pharma had developed and continues
to develop several bisphosphonates, including alendronate, clodronate
and neridronic acid. For more information, please visit
www.abiogen.it .

For further information, please contact:
Stepán Krácala, Head Global Communications
Tel.: +49 241 569-1335, Stepan.Kracala@grunenthal.com
Grünenthal GmbH, 52099 Aachen, Germany

Original-Content von: Grünenthal Gruppe, übermittelt durch news aktuell