Still on course and defying the crisis with an enormous effort

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22.04.2021

In 2020, Bielefeld-based Dr. Wolff Group recorded a turnover of 341.1 million euros (2019: 313.4 million euros), an increase of about nine percent, with exports continuing to account for more than 20 percent. Decades of evidence-based research with numerous scientific publications ensure highest product quality. Thanks to the trust of millions of consumers coupled with bold and fast action, this course could be continued in the first quarter of 2021 with more than three percent growth.

“Crisis in the morning, opportunity in the afternoon”.

In 2020, the family business had to act flexibly and quickly. The focus was on the safety of employees, on raw material supply and cash management. Within a few days, a hand disinfectant gel was brought to market maturity and nationwide availability of up to 6 million units was ensured via pharmacies by the beginning of June. Administrative districts and medical staff were also supplied with it.

Parallel development of further Corona prophylaxis products had top priority. Two milestones followed at the end of 2020: the scientific confirmation of a limited virucidal hand cream and clinical results for prophylaxis by means of a medical mouth and throat rinse. Since March 2020, Dr. Wolff research has been examining laboratory and clinical data on physical Corona protection provided by this specially developed mouth and throat rinse. In two laboratory studies and a first clinical application study on 34 COVID-19 patients, a possible prophylaxis could be achieved by significantly reducing the viral load by up to 90 percent. The results were submitted as a paper.

Another placebo-controlled clinical trial launched in February investigated the cumulative effect of several days’ use in COVID-19 patients. As was announced yesterday, an international group of authors has now come to the conclusion in their study[1] that the oral cavity is the decisive gateway for the virus to enter the body. The virus enters blood vessels via the saliva and thus reaches the lungs. Researchers concluded: “Reducing the viral load in mouth and throat can prevent severe disease progression.” Using a mouth rinse is thus the recommended corona prophylaxis.

“We are driven by the goal to complement existing Corona prophylaxis options in the best possible way and to make an effective contribution to reducing the viral load. This is not to replace vaccination, but the so-far existing steps and measures do not suffice. We need further effective means to contain the virus, to better protect ourselves and others and to break transmission chains,” says Eduard R. Dörrenberg, managing partner of Dr. Wolff Group, describing Germany’s slow progress in fighting the pandemic compared to other countries and adds: “The measures taken so far are the result of a singular approach: First, distance and hygiene rules were introduced. Then, after initial scepticism, masks had to be worn as demanded by hygienists (social distancing, hygiene and room ventilation rules), before we started striving for vaccinations and now also for testing strategies.”

Paul Ehrlich Institute also confirms, according to their president Prof. Klaus Cichutek: “If the virus load in aerosols is significantly reduced because of a reduced viral load in the throat, this might lead to less or no contact persons at all being infected.” [2]

New potentials for Dr. Wolff in drug development, familiar brands, modern products and further digitalisation

In the field of in-house drug research, Dr. Wolff is expected to soon offer a solution to pathological sweating in the armpits (so-called primary axillary hyperhidrosis): after several years of development, the pharmaceutical division submitted the application for approval of the drug, which is unique in the EU, in the decentralised procedure (DCP) for Germany, Sweden and a further 9 EU countries at the end of February. Dr. August Wolff will market the cream directly or in cooperation with experienced partners in these countries. The application for approval of the formulation containing 1% Glycopyrronium Bromide (GPB) against pathological sweating in the armpits is based on data from several clinical studies, with the phase 3a part already published in the renowned British Journal of Dermatology.[3]

Outlook

“Corona is still here!” This is the conclusion after more than a year of living with the pandemic. Asia could emerge as the winner, as they have succeeded in controlling the pandemic and in developing strategies to normalise public life and the handling of the pandemic. “We have already seen a noticeable normalisation of our Asian business with the first relaxations, for example in China,” confirms Dörrenberg, who paid a visit to the Dr. Wolff branch in Singapore at the beginning of 2021 after a year’s abstinence. “The differences are very drastic. Enormous transparency and contact tracing by means of consistent check-in processes at buildings, for example, temperature measurements and Corona tests, have brought normalisation and control to pandemic development in Singapore for months already. In Europe, on the other hand, this will take longer, and we may even lose ground. I therefore expect a slower development of our business in the second quarter,” Dörrenberg predicts.

The value and benefit of strong brands, efficient products, increasing digitalisation and own data will rise all the more. Reaching consumers – who act in an increasingly individualised manner – with the right product at the right time will make the difference in medicine and cosmetics. It will be about shaping future ways of communication and work. According to Dörrenberg the economy has already made enormous progress as to that, but there is still room for improvement: “Politics must finally follow suit, I would appreciate more transparency, more competence and more digitalisation. We must no longer just wait and see. First, we did not protect the elderly sufficiently. Now we are depriving our children of education because we fail at organising, digitalising and structuring education in an up-to-date manner. Just recently, the Scientific Advisory Council of the German Ministry of Economics described the conditions in public authorities as ‘archaic’.” Nevertheless, Dr. Wolff is optimistic about the future. We hope and wish for improved political framework conditions, with the focus remaining on research, innovations and digitalisation.

About our brands

Pharmaceutical division:

Linola:

In addition to increased demand for hand cream due to skin damage caused by washing hands and using disinfectant solutions more often, Linola is growing overall with medical skin care. The introduction of the hand hygiene series under the roof of Linola Sept brand, including hand cleanser, hand disinfectant gel and an anti-Corona hand cream strengthens the positive development. An additional component of effective Corona prophylaxis is the mouth and throat rinse, which has been available in pharmacies since January.

Vagisan:

Currently, about eight million women in Germany are going through menopause – as many as never before. Dr. Wolff’s gynaecological products have been contributing considerably for years, for example in hormone-free therapy. In the past year, the brand continued to grow both at home and abroad. Nationally, it is the sexologist Ann-Marlene Henning who, as brand ambassador, openly addresses difficult topics such as vaginal dryness and advises affected women.

Cosmetic division:

Oral care:

Research with far-reaching studies on modern caries prophylaxis and education around European regulation on the dosage of fluoridated toothpaste are a main focus in the oral care sector. Within the past 10 years, more in-depth research has been conducted worldwide on hydroxyapatite and its positive influence on dental health than on any other oral care ingredient. Numerous studies and publications show that hydroxyapatite is a real alternative to fluoride. In particular, the fluoride-free children’s tooth paste Kinder Karex increased in sales and is being consciously used by parents as an alternative to fluoride-containing dental care. With a 12 per cent increase, the next step is internationalisation.

Plantur:

The brand against female hair loss and for hair growth is up nine percent. During lockdown, products with a colouring effect against visible hairlines hit a nerve. Especially an individual, content-coordinated digital communication determined by relevant topics reached the target group. Young women with long hair are addressed with the new Plantur 21 series. A research group led by Dr. Gil Westgate (University of Bradford) also confirmed that caffeine was the best-researched active plant-based ingredient against hair loss.

Alpecin:

About every second man is affected by hair loss in the course of his life. In 80 percent of cases, the cause is hereditary. Alpecin caffeine shampoo is made for slowing down this process and providing effective prevention. Educating young men is therefore crucial. Whether this is due to a lack of sporting opportunities or more home office time: the German shampoo market declined by five percent in 2020. Alpecin performed better than the market, lost two percent compared to the previous year and remained stable in times of crisis.

Alcina:

Hairdressing business has undergone two lockdowns so far. In 2020, Alcina focused specifically on products that have been in demand of consumers in the current situation or that simplify work in the salons, e.g., with regard to hygiene and service. By means of videos and numerous digital offers, the brand took the opportunity to support its B2B customers in the best possible way in areas such as salon management or craft training. New digital formats were also created for end consumers to promote customer loyalty. Colouring and care products contributed more to sales of almost 41 million euros in the financial year than, for example, decorative cosmetics.


[1] Lloyd-Jones et al. The COVID-19 Pathway: A Proposed Oral-

Vascular-Pulmonary Route of SARS-CoV-2 Infection and the Importance of Oral Healthcare Measures. Journal of Oral Medicine and Dental Research. 2021. Genesis-JOMDR-2(1)-S1 Volume 2 | Issue 1 Open Access

[2] ARD-Morgenmagazin April 14, 2021

[3] Abels C, Soeberdt M, Kilic A, Reich H, Knie U, Jourdan C, Schramm K, Heimstaedt-Muskett S, Masur C, Szeimies RM. A 1% glycopyrronium bromide cream for the topical treatment of primary axillary hyperhidrosis: Efficacy and Safety Results from a Phase 3a Randomised Controlled Study. Br J Dermatol. 2021 Jan 14. doi: 10.1111/bjd.19810

Alcina hair division and caring cosmetics ensure stable sales

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  • Restart after lockdown phases promising
  • Repackaging: basic professional line with new categories
  • Relaunch of website and shop in 2021

In 2020, Bielefeld-based Dr. Wolff Group recorded an increase of almost nine percent with sales of 341.1 million euros (2019: 313.4 million) and also strengthened their position in the first quarter of 2021 with more than three percent growth.

With 40.9 million euros in revenue (2019: 44.1 million) Alcina contributed a 12 per cent share to the group’s total revenue in 2020. Despite two lockdowns, which led to hairdressers and beauty parlours being closed for a total of eight weeks, the hair and caring cosmetics divisions remained consistently stable. The decorative cosmetics division, on the other hand, decreased due to pandemic conditions.

As for 2020 promotions and new products, Alcina focused specifically on products that have been in consumer demand in the current situation or that simplified work in the salons, for example, in terms of hygiene and service. By means of videos and numerous digital offers, the brand took the opportunity to support B2B customers in the best possible way in areas such as salon management or further craft training. “We remained in intensive contact with our salon partners in 2020 and supported them as much as we could. Our digital offers have been well received by our customers and are constantly being expanded in the seminar sector,” says Eduard R. Dörrenberg, managing partner of Dr. Wolff Group. Also new digital formats for end consumers were created to promote customer loyalty.

Temporary colour refreshers in demand – haircare restart

Since many consumers demanded products that give their hair a new shade and nurture it at the same time, Alcina developed a new generation of glossing with the Color Gloss & Care series. In addition to colour treatments on site, hairdressers may offer their customers one of 20 special colour refreshers for home use as well as blend individual colours. With colour refreshers, clients may bridge the time in case their hairdresser appointment is cancelled and keep their colour intense for longer. This offer – as well as colour shampoos and colour rinses – generated sales during the pandemic.

After ten years with an unchanged look, Alcina started a successive repackaging of haircare in late summer. Haircare got divided into four categories, got a modern design and optimised packaging size. Thanks to new colour codes and names that highlight the main benefits, it will henceforth be easier to grasp which products are suitable for a particular hair need. The aspect of sustainability also plays an important role. Since the recyclable bottles do not require a folding box and instruction leaflet, packaging material is reduced. “We made sure that the changeover is done gradually. This way, it will put less strain on the hairdressers’ cost apparatus in these difficult times as they don’t have to keep a large depot on hand. The changeover will be completed in summer of 2021,” says Dörrenberg.  

Skin care has high priority

The skin underneath a facial mask needs more attention, so cleansing, soothing, moisturising and nourishing are more important than ever in pandemic times. Stressed by frequent washing, hands also need more care. A new hygiene hand cream nourishes the hands and at the same time fights bacteria and viruses. Alcina completed their hygiene range with a hand disinfectant gel that cleans hands without soap and water, as well as with the travel-size Handwunder (hand wonder) gel, which was also launched as a biocidal product with a new formula. In addition, the popular Cashmere range was complemented by a shower balm and a warming and soothing eye mask.

Lower consumption of decorative cosmetics – focus on eyes

With mouth and nose areas often covered by facial masks, especially the eyes are in focus. New eyeliner pencils, eye shadows and brow mascara turned the eye area into an eye-catcher. Lip and colour products have been struggling since 2020. As the care aspect is becoming more and more important, Alcina added rich caring lip balms and a lip oil to their range, in addition to new textures. A colour correcting (CC) cream for a delicately tinted, even complexion was added to the portfolio. For a target group that wants to make impure skin or visible blemishes disappear, the high covering make-up “Authentic Skin Foundation” in three shades was added at the end of the year. This make-up perfects the skin’s appearance, while vitamin E and pomegranate extract prevent premature skin ageing.

The first quarter of 2021 – good start after repeated lockdown

After salons closed due to Corona at the beginning of the year, hairdressers experienced an unprecedented appreciation from the public. In terms of sales, the brand remained, as expected, behind previous year’s result after the closures in the first two months. The restart was successful, so that March brought good results with the hair segment being the sales driver. “If there are no more severe impacts due to Corona, we expect business to be good and positive,” Dörrenberg said. “In the past months we prepared the relaunch of our website and online shop. Alcina Online Professional is a 24/7 companion that provides important and necessary information at any time. Our former B2B partner site has already been very popular; after the relaunch it will offer even greater benefits for our customers,” outlines Dörrenberg.

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

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13.04.2021
  • Promising German-Spanish partnership between Dr. August Wolff and Cantabria Labs officially sealed
  • Cantabria Labs acquired the exclusive right to commercialize an oil-in-water cream containing 1 % glycopyrronium bromide (GPB) in Spain, Italy and Portugal
  • Unique cream formulation is indicated for primary axillary hyperhidrosis and is currently nearing completion of a pivotal (phase 3b) trial in Europe.

Bielefeld/Madrid: The German pharmaceutical company Dr. August Wolff GmbH & Co. KG 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”, said Eduard R. 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 Dermatology[i].

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.
Cantabria Labs

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. For further information please visit Dr. Wolff Group.

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.


[i] Abels C, Soeberdt M, Kilic A, Reich H, Knie U, Jourdan C, Schramm K, Heimstaedt-Muskett S, Masur C, Szeimies RM. A 1% glycopyrronium bromide cream for the topical treatment of primary axillary hyperhidrosis: Efficacy and Safety Results from a Phase 3a Randomised Controlled Study. Br J Dermatol. 2021 Jan 14. doi: 10.1111/bjd.19810.