Grünenthal Group

First participants enrolled in Clinical Trial with Nociceptin/Orphanin peptide receptor (NOP) agonist ​29.9.2021 10:55:16 CEST | Press release

Aachen, Germany, 29 September 2021 –Today, Grünenthal announced that the first participants have been enrolled in a randomised, placebo- and active-controlled clinical trial for its peripherally restricted Nociceptin/Orphanin FQ peptide receptor (NOP) agonist. The compound is being developed to provide a non-opioid therapy option that offers a strong analgesic effect without the side effects commonly associated with opioids. The Experimental Medicine Trial will evaluate the extent and duration of the pharmacological effect of the oral NOP agonist in an experimental pain model. The results of the trial are expected to be available in early 2022. The trial explores how the NOP agonist influences pain signalling and perception using laser evoked potentials (LEPs) in an experimental pain model with 30 healthy participants. On five different occasions, the participants will receive either the NOP agonist or pregabalin or placebo. The trial explores three different doses of the NOP agonist;

First patient enrolled into a Phase III study with QUTENZA® in post-surgical neuropathic pain ​10.8.2021 09:00:00 CEST | Press release

The study AV001 aims to include the treatment of post-surgical neuropathic pain (PSNP) in the U.S. label. QUTENZA® is currently approved for use in adults in the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet. Post-surgical neuropathic pain is a debilitating complication of surgery that affects approximately 13% of all patients who undergo surgery, representing 3.3 million patients per year in the US.[1] Aachen, Germany, & Morristown, N.J., 10 August 2021 –Grünenthal announced today that its U.S. subsidiary, Averitas Pharma Inc., enrolled the first patient in the randomised, double-blind trial AV001. The Phase III study investigates the efficacy, safety, and tolerability of QUTENZA (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) to support an extension of the U.S. label. The trial will include over 400 patients who suffer from moderate

Grünenthal’s Glucocorticoid Receptor Modulator enters clinical development27.7.2021 10:50:36 CEST | Press release

Aachen, Germany, 27 July 2021 –Grünenthal announced today that the first volunteers have been enrolled in a Phase I trial of its Glucocorticoid Receptor Modulator (GRM). The oral investigational medicine aims to provide a therapy option with broad anti-inflammatory efficacy and a more favourable benefit-risk profile compared to current glucocorticoid-based therapies like prednisolone. The Phase I trial includes 80 healthy volunteers and is designed as a head to head comparison between the GRM and prednisolone, the most frequently used glucocorticoid.[1] Observing several biomarkers, the trial will assess the influence of the investigational medicine on bone metabolism and glucose levels. Reduced bone formation leading to osteoporosis as well as increased blood glucose levels leading to an increased risk of diabetes are among the most common side-effects of glucocorticoids, which are a strong limitation for their long-term use at highly effective doses.[2],[3],[4] The results of the stu

Grünenthal acquires Mestex AG and its Phase-III-ready investigational medicine MTX-071 for the treatment of pain associated with osteoarthritis of the knee12.4.2021 11:25:16 CEST | Press release

With the acquisition of Mestex AG, Grünenthal secures global rights for an attractive late-stage asset that could offer an innovative therapy option for millions of patients affected by pain related to osteoarthritis of the knee. MTX-071 (resiniferatoxin) is a highly potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist. Its administration can reversibly defunctionalise TRPV1-expressing nociceptors. This can result in long lasting pain relief. Aachen, Germany, 12 April 2021 –Today, Grünenthal has announced the acquisition of Mestex AG through the takeover of all of its shares and options. Mestex AG is a Swiss biotech company that has developed the innovative investigational medicine MTX-071 (resiniferatoxin) for the intra-articular treatment of pain associated with osteoarthritis of the knee. The investigational medicine is currently concluding Phase II of clinical development and is about to enter Phase III. Initial data showed a long-lasting and significant analgesic effect

Grünenthal is Recognized for its Strong Management of Environmental, Social and Governance (ESG) Risks7.4.2021 11:24:51 CEST | Pressmeddelande

Leading global ESG ratings agency Sustainalytics notes Grünenthal is in the top five percent among its peers in the pharmaceutical subindustry Grünenthal is categorized as “medium risk”, placing it ahead of its key subindustry peers and in the same league as multinational companies like Pfizer and Roche Aachen, Germany, 7 April 2021 – Grünenthal, a global science-based pharmaceutical company, today announced that Sustainalytics, a Morningstar company and a globally-recognized provider of ESG research, ratings and data, has assessed it as having overall medium ESG risk. In addition, Sustainalytics acknowledged that Grünenthal has a strong management of its ESG risks. This places Grünenthal in the top five percent of the global pharmaceuticals subsector. “The long-term success of companies can no longer be measured by financial success alone. As a science-based company, Grünenthal strives to make a net-positive impact on the society,” said Gabriel Baertschi, CEO Grünenthal. “While we are

Grünenthal and Averitas Pharma announce initiation of Phase III study with QUTENZA® to prepare label extension in the US for the treatment of post-surgical neuropathic pain​30.3.2021 14:45:28 CEST | Pressmeddelande

Post-surgical neuropathic pain (PSNP) is a debilitating complication of surgery that affects approximately 13 percent of all patients who undergo surgery, which represents 3.3 million patients per year in the US.[1] This Phase III study is Grünenthal’s next step in making QUTENZA available to even more patients in the United States. QUTENZA is the first and only prescription strength capsaicin that is a topical, non-systemic, non-opioid pain treatment; it is currently approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia, and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Aachen, Germany, & Morristown, N.J., 30 March 2021 –Grünenthal announced today that its U.S. subsidiary, Averitas Pharma, Inc. will conduct a Phase III trial to study the efficacy, safety and tolerability of QUTENZA (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) with the goal to expand t

Grünenthal successfully extends its term loan bank facilities12.2.2021 13:51:16 CET | Pressmeddelande

Grünenthal has announced the successful extension of its existing €535 million term loan bank facilities. This amendment was conducted in the broader context of the company’s acquisition of the European rights (excluding Spain and the UK) to the lipid-lowering medication CRESTOR™ completed in February 2021. The term loan maturities are now aligned with Grünenthal’s Revolving Credit Facility maturity, which further extends its debt maturity profile. More than 60 percent of Grünenthal’s debt facilities now mature in 2024 or later. “By extending the maturity of our financing, we have gained additional flexibility to further fund our growth strategy,” says Fabian Raschke, Chief Financial Officer of Grünenthal. „We will continue to explore opportunities to further support our organic growth with targeted acquisitions, that fit our EBITDA and cash flows accretive acquisition strategy.“ Grünenthal’s capital structure has enabled it to enter into a series of acquisitions and partnerships in re

Peripheral NOP agonist addressing chronic peripheral neuropathic pain enters clinical development16.12.2020 10:19:02 CET | Pressmeddelande

Aachen, Germany, 16 December 2020 –Grünenthal announced today that the first participants have been enrolled in a Phase I trial of a peripherally restricted Nociceptin/orphanin peptide receptor (NOP) agonist, an oral investigational medicine with a unique mechanism of action for the treatment of chronic peripheral neuropathic pain. The Phase I trial will include 76 healthy participants. The trial aims to demonstrate a favourable safety and tolerability profile and to confirm the pharmacokinetic characteristics of the compound following single and multiple-ascending doses. The results of the study are expected to be available in 2021. “Pain remains a high unmet medical need that we strive to address with innovative medicines. Progressing our peripheral NOP agonist into clinical development is a major success in our efforts to build an industry-leading pipeline of investigational medicines,” says Jan Adams, M.D., Chief Scientific Officer, Grünenthal. “By driving the development of innova

Grünenthal agrees to acquire European rights to CRESTOR™ (rosuvastatin) from AstraZeneca1.12.2020 09:48:44 CET | Pressmeddelande

Aachen, Germany, 1 December 2020 –Grünenthal, a global science-based, privately-owned pharmaceutical company, today announced that it has agreed to acquire the European rights (excluding Spain and the UK) to CRESTOR™ (rosuvastatin) and its associated brands for a total consideration of up to US$ 350 million. CRESTOR™ is among the leading statin products in Europe and is indicated for the treatment of dyslipidaemia, hypercholesterolaemia and the prevention of cardiovascular events. Compared to other statins such as atorvastatin, CRESTOR™ has demonstrated superior LDL- cholesterol- lowering efficacy.[1] The level of LDL is an important factor for the improvement of cardiovascular outcomes and therefore especially important in patients with high risk of cardiovascular diseases such as diabetes or stroke. “Cardiovascular diseases are among the most burdensome diseases in Europe[2] and we are excited to include such a well-established product in our portfolio”, said Gabriel Baertschi, Grüne