The German pharmaceutical company Dr. August Wolff GmbH & Co. KG Arzneimittel Arzneimittel (“Dr. Wolff”) and the Spanish pharmaceutical company Cantabria Labs (“Cantabria Labs”) concluded a strategic partnership on March 12th 2021 by entering into an exclusive licensing agreement for a newly developed medicinal product for the treatment of hyperhidrosis. Under the terms of the license agreement, Cantabria Labs will have the exclusive right to commercialize an oil-in-water cream with 1 % glycopyrronium bromide (GPB) in Spain, Italy and Portugal. In return, Dr. Wolff Group will receive upfront, milestone as well as royalty payments and will additionally be the exclusive supplier for the finished product.
March 12th 2021 was a historic day for both companies and paves the way for a promising partnership. With Cantabria Labs’ strength in the Dermatologic Field as well as the reach of their distribution channels in Southern Europe, we couldn’t be more pleased to have Cantabria Labs as our first partner for GPB cream. Once approved, the cream will be the first topical GPB treatment for primary axillary hyperhidrosis in Europe. Given that many hyperhidrosis patients do not achieve satisfactory results with existing treatments, we believe that our product might contribute significantly to improve the outcomes for patients suffering from this disease–Dörrenberg, one of Dr Wolff’s Managing Partners
“This deal represents the beginning of what will be a long, rewarding partnership between our two companies based on common commitment to innovation, entrepreneurship and caring. It allows our laboratories to introduce an innovative new product into a market offering few effective alternatives. GPB cream will further strengthen our position in dermatology built up over the years through close collaboration with physicians. These physicians will undoubtedly appreciate the innovation and continue to provide support for our product development”, commented Susana Rodríguez, Cantabria Labs CEO.
Despite the challenges of the COVID-19 pandemic, Dr. Wolff was able to file the Marketing Authorisation Application (MAA) – the submission of the 1st DCP in the European Union regarding GPB cream took place on Feb 26th. If approved, the Marketing Authorisation (MA) would apply to Germany and 10 other European countries. Cantabria Labs will follow with an independent Southern European DCP covering Italy, Portugal and Spain. Further Marketing Authorization Applications in additional global markets will follow. Dr. August Wolff intends to commercialize the GPB Cream directly or with experienced partners globally.
The drug is currently in the long-term open-label extension of the clinical trial (phase 3b), which will be completed beginning of Q4 2021. Positive results of the Phase 3a part of the pivotal Phase 3 study in patients with primary axillary hyperhidrosis were recently published in British Journal of Dermatologyi.
About Cantabria Labs
With its innovative products and entrepreneurial spirit, today Cantabria Labs is a leading brand in dermatological prescription in Europe (leader in Spain, Italy and Portugal) with the aim of improving people’s health and quality of life. Its presence in over 80 countries and subsidiaries in France, China, Italy, Morocco, Mexico and Portugal have earned it an excellent international reputation and support. Cantabria Lab’s production centres work in accordance with the highest quality standards for manufacturing and distributing its over 30 million product units yearly.
Cantabria Labs has an entrepreneurial, nonconformist and joyful spirit, and aims to offer people products that allow them to enjoy an excellent quality of life: celebrate life.
About Dr Wolff
Ever since its establishment in 1905, Dr. Wolff, together with leading scientist in the field, develops products that solve the skin, hair and dental problems. The focus of the company are products with scientifically proven benefits. From the first branded product Haematopan to the products available internationally today, Dr. Wolff´s innovative product development provides the basis for new active ingredients and product developments.
The company is now in its fourth generation of family-run management and is on a worldwide growth course with 780 employees. Dr. Wolff operates in 62 countries.
About Glycopyrronium bromide
Glycopyrronium bromide (INN name, abbreviation GPB) or glycopyrrolate (USAN name) is a well-known anticholinergic acting drug substance approved in several marketed products in the EU and the USA for various diseases of children and adults. GPB blocks the action of acetylcholine at cholinergic receptors responsible among others for sweat gland activation.
Approximately 5% people worldwide suffer from permanent excessive sweating, so-called “primary hyperhidrosis” which is a great burden for the patients and has severe impact on the quality of life. Yet, more than 50% of all hyperhidrosis patients receive no treatment. Patients with primary axillary hyperhidrosis suffer from an excessive amount of sweat production in the armpits beyond what is needed in order to regulate normal body temperature. Primary hyperhidrosis can range in severity from mild dampness to severe dripping and can result in substantial impairment in quality of life. This may significantly affect work, social and romantic relationships, physical and leisure activities as well as emotional and mental health.
Detailed study results of the phase 3a part
The Phase 3a part of this pivotal Phase 3 study, conducted in Germany, Hungary, Poland, Sweden, Denmark and UK, evaluated a total of 171 subjects randomized 1:1 to apply 1% GPB (n=84) or vehicle cream (placebo, n=87) to the axillae for 28 days. All subjects had Hyperhidrosis Disease Severity Scale (HDSS) scores ≥ 3 and ≥ 50 mg/5 min gravimetric sweat production in each axilla at baseline. Overall favourable results for 1% GPB Cream over Placebo were shown as follows:
Mean sweat production was reduced by 197.08 mg for the 1% GPB cream and 83.49 mg for placebo. Absolute reduction in sweat production from Baseline to Day 29 in logarithmic values was statistically larger in the 1% GPB cream compared to placebo (p = 0.0038; mixed effects model). Hence, the primary endpoint of the study was met. HDSS showed a change from baseline clearly favoring 1% GPB treatment over placebo at day 15 (difference in median: -1.0; p = 0.0020) and day 29 (p = 0.0138). Response to treatment based on the HDSS (an improvement of 2 points or more), a key secondary endpoint (for day 29) nearly reached statistical significance (p = 0.0542).
For the HidroQoL© the median improvement in the total score, a key secondary endpoint, was significantly greater for 1% GPB cream (- 6.0 points) than for placebo (-1.0 point) (p < 0.0001) on day 29. Similar results were observed for the individual domains daily life activity and psychosocial life. The proportion of HidroQoL©-responders with 1% GPB cream (59.8%) compared to placebo (26.2%) (p < 0.0001) was significant as determined in a post-hoc analysis (MCID ≥4).
Overall, the proportion of patients achieving sweat reduction was approximately two-fold higher for the 1% GPB cream (-197.08 mg) than for placebo (-83.49 mg). Similar results were seen for HDSS (23% GPB vs 11.9% placebo) and HidroQoL© (59.8% GPB vs. 26.2% placebo). Treatment was safe, most TEAEs were mild or moderate and transient and did not lead to discontinuation of the study. Local tolerability was very good with 9.2% of patients having only mild or moderate application site reactions. The most reported ADR was dry mouth (16.1%), an expected anticholinergic effect of the treatment. Application site reactions were reported in 9.2% of patients in the 1% GPB group and 7.1% of patients receiving placebo and were primarily mild to moderate in severity.
About ongoing phase 3b part
Ongoing Phase 3b part is investigating the long-term safety and efficacy of 1% GPB cream up to 72 weeks. Enrollment of the Phase 3b part has been completed. In total, 517 patients have been enrolled. For the MAA dossier, long-term safety data over 6 months are available for 315 patients, and 12-month data are available for 100 patients. The study is continuing treatment for 72 weeks, to collect further long-term safety data.