Dr. August Wolff and Cantabria Labs enter into an exclusive commercialization agreement for Southern Europe for hyperhidrosis product

11 mins read

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. 

About Hyperhidrosis 

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. 

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