Grünenthal Group receives FDA's Expedited Access Pathway designation for VIVO

Aachen (ots) - Grünenthal announced today that Adhesys Medical
Inc., a wholly-owned subsidiary of Grünenthal, has been granted
Expedited Access Pathway (EAP) designation by the U.S. Food and Drug
Administration (FDA) for VIVO. VIVO is a surgical sealant proposed
for being an adjunct to standard closure techniques in
gastrointestinal procedures to reduce intestinal leakage. VIVO is a
candidate from Grünenthal's innovative development-pipeline of
surgical sealants. Flix®, the first product from this portfolio,
already obtained CE-Certification in Europe.

"We are delighted about the FDA's positive recognition of VIVO. We
still face a high unmet medical need in preventing intestinal
leakages after gastrointestinal surgeries - life-threatening
postoperative complications that affect up to 20% of patients[1],"
Gabriel Baertschi, Chief Executive Officer Grünenthal, explains. "We
believe VIVO may become a valuable adjunct to current closure
techniques and in combination with these provide a much higher safety
standard for patients," he adds.

"Obtaining EAP designation brings further momentum to the
development of our surgical sealants, for which we have a unique
technology platform at hand. Its combination of features is
unparalleled and comprises bonding strength, fast sealing and
flexibility", Klaus-Dieter Langner, Chief Scientific Officer
Grünenthal, adds. "Moreover, the faster, more predictive and
cost-conscious development of devices and technologies improves the
risk profile of our portfolio."

Grünenthal acquired Adhesys Medical GmbH and its US affiliate, a
medical device start-up, in April 2017 and holds the worldwide
development and commercialization rights for an innovative pipeline
of surgical sealants and the underlying technology platform.

The FDA grants EAP designation helping patients to have more
timely access to devices and breakthrough technologies that provide
for more effective treatment or diagnosis for life-threatening or
irreversibly debilitating diseases, for which no approved or cleared
treatment exists or that offer significant advantages over existing
approved or cleared therapies. Development candidates that receive
EAP designation may benefit from shorter review timelines for
pre-market approval applications (PMA) and a faster implementation of
clinical trials by the FDA.

About Grünenthal

The Grünenthal Group 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
billion company. By sustainably investing in research and development
above the industrial average, we are committing to innovation in
order to bring value-adding products to patients.

Grünenthal is an independent, family-owned pharmaceutical company
headquartered in Aachen, Germany. 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.
Grünenthal is present in 32 countries with affiliates in Europe,
Latin America and the US. Our products are sold in more than 155
countries and approx. 5,500 employees are working for the Grünenthal
Group worldwide. In 2016, Grünenthal achieved revenues of
approximately EUR 1.4 bn.

More information: www.grunenthal.com.

[1: Alberts, et al. Predicting risk and diminishing the
consequences of anastomotic dehiscence following rectal resection.
Colorectal Dissection, September 2003.]

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

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