Grünenthal Press Releases 2016
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16 Dec 2016
Grünenthal receives Breakthrough Therapy Designation from U.S. FDA for neridronic acid for the treatment of complex regional pain syndrome (CRPS), a debilitating orphan disease with high medical need
Aachen, Germany, and Pisa, Italy – 16 December 2016 – Grünenthal, an R&D-driven, privately held international pharmaceutical company with headquarters in Germany, and Abiogen Pharma, privately held Italian pharmaceutical company with headquarter in Pisa, Italy announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to neridronic acid, an investigational medicine, for the treatment of complex regional pain syndrome (CRPS), a serious, disabling orphan disease. Today, with no FDA- or EMA-approved drug treatments, there is a clear need for effective treatment options to address this significant unmet medical need. CRPS is a debilitating condition characterized by severe, continuous, burning pain often occurring in an extremity after injury or surgery. It is one of the most painful conditions a patient can experience1.
14 Dec 2016
Grünenthal’s manufacturing site in Ecuador, Tecnandina, receives European GMP certification for the third time
Quito, Ecuador and Aachen, Germany. December 14, 2016. The Grünenthal Group announces today that its manufacturing site in Ecuador, Tecnandina, successfully passed the inspection to manufacture in accordance with the European GMP regulations. The certification covers the production of solid and semi-solid pharmaceuticals for the third time and now, for the first time, also liquid pharmaceuticals. This GMP Certificate will be valid for another three years.
12 Dec 2016
Aachen, December 12, 2016. Grünenthal Group today announced that it has entered into a definitive agreement with Astellas Pharma Europe Ltd., (“Astellas Pharma Europe”), the European subsidiary of Tokyo-based Astellas Pharma Inc. (“Astellas”), for the exclusive rights to the dermal patch Qutenza® (capsaicin 8%) in Europe, Middle East and Africa. Qutenza® is approved by the European Medicines Agency (EMA) for the treatment of peripheral neuropathic pain (PNP).
16 Nov 2016
Grünenthal has acquired US-based Thar Pharmaceuticals Inc. to expand its development portfolio of treatment options for CRPS (Complex Regional Pain Syndrome), a serious, disabling orphan disease.
Aachen, Germany, and Pittsburgh, PA, USA – 16 November 2016 – Grünenthal, an R&D-driven, privately held international pharmaceutical company with headquarters in Germany, has announced its recent acquisition of Thar Pharmaceuticals, a US-based clinical-stage, specialty pharmaceutical company. Thar Pharmaceuticals focused on transforming IV-only drugs into oral drugs for existing and new indications using its proprietary technology EnhanceTM development platform. With this acquisition, Grünenthal has obtained the worldwide development and commercialization rights for Thar Pharmaceutical’s lead development candidate, T121.
04 Oct 2016
The Grünenthal Group today announces that Gabriel Baertschi has taken office as new CEO of the Grünenthal Group, an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. The company’s Supervisory Board had named Gabriel Baertschi to become Grünenthal’s new CEO in June 2016. Gabriel Baertschi is joining Grünenthal from AstraZeneca, a global, science-led biopharmaceutical business where in his last appointment he served as country president for Japan. He succeeds Prof. Dr. Eric-Paul Pâques who retires at the end of 2016 after 23 years at Grünenthal.
30 Sep 2016
Grünenthal’s cebranopadol, a novel strong analgesic, meets primary efficacy endpoint in Phase 3 trial in cancer pain
Results to be presented at the 2016 IASP conference
Grünenthal presents data for the first time of its compound cebranopadol in patients with cancer-related pain1. The cebranopadol data is from a Phase 3 randomized, double-blind, double-dummy, active-controlled multiple dose study with patients randomized to either once-daily cebranopadol or twice-daily morphine sulfate PR (prolonged release). Results reached statistical significance for non-inferiority and even superiority for the primary endpoint (average amount of daily rescue medication intake over the last two weeks of the maintenance phase in the trial, p<0.05).
27 Sep 2016
A research consortium under the direction of Grünenthal will receive a grant of €1.5 million from the European Fund for Regional Development and the Federal State of North Rhein-Westphalia
- Research grant awarded by Leitmarktwettbewerb LifeSciences.NRW to improve the development of new analgesic drugs
- The consortium members, founded and led by Grünenthal, are from the University Hospitals of Cologne and Bonn, and a specialist scientific company, Life & Brain
23 Jun 2016
Aachen/Brussels, 23 June 2016. For the tenth time, young European scientists who have an innovative pain research idea, are called upon to apply for one of the most prestigious and highly regarded pain research grants worldwide: The EFIC-GRÜNENTHAL Grant (E-G-G).
07 Jun 2016
Grünenthal appoints Gabriel Baertschi as Chairman of the Corporate Executive Board and Chief Executive Officer effective October 1, 2016
Swiss native Gabriel Baertschi follows Prof. Dr. Eric-Paul Pâques who retires after 23 years with the company
Grünenthal Group today announced that its Supervisory Board has named Gabriel Baertschi to become Grünenthal’s new CEO as of October 1, 2016. Gabriel Baertschi will join Grünenthal from AstraZeneca, a global, science-led biopharmaceutical business where he currently serves as country president for Japan. He succeeds Prof. Dr. Eric-Paul Pâques, who has been the CEO of the Grünenthal Group. Grünenthal is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany with affiliates in Europe, Latin America and the U.S. In 2015, Grünenthal achieved revenues of € 1.2 bn.
02 Jun 2016
Aachen, June 2, 2016. Grünenthal Group today announced that it has entered into a licensing agreement with AstraZeneca for the exclusive rights to Zurampic™ (lesinurad) in Europe and Latin America. Zurampic™ was approved by the European Medicines Agency (EMA) in February 2016, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of adjunctive hyperuricemia in adult patients with uncontrolled gout.