Dr. Wolff Group increases turnover again in 2021 to a new record level – 2022 off to a good start despite global crises

28.06.2022

New drug “Axhidrox®” against pathological sweating in the armpits available in Germany as of August
New studies in caries- & hairloss research

Also, in the second Corona year Bielefeld-based Dr. Wolff Group accomplished stable growth. Strong brands, innovative products, ongoing internationalisation, and further digitalisation formed the foundation in turbulent times. As in the previous year, the focus in 2021 was on the following topics: employee health, supply chain, cash management as well as research and development of new products. Thus, in 2021, Bielefeld-based Dr. Wolff Group recorded the highest turnover to date in the company’s 117-year history at 357.2 million euros (2020: 341.1 million euros), achieved a plus of almost five percent and increased turnover despite Corona in the past two years.

Expansion of international locations

Exports also continued to grow worldwide despite Corona. Finland was added as a new international location, while the teams in the USA, in Singapore and in China were further expanded. In total, the company now globally operates 12 locations for marketing and sales in the regions. “We are focusing on further very dynamic growth. To achieve this, we will continue to expand our markets, consistently defy possible crisis scenarios in the coming years and actively invest in research and in our brands,” says Eduard R. Dörrenberg, Managing Partner of Dr. Wolff Group.

Potentials of innovative products and progressive digitalisation

Due to the outbreak of war in Europe, the consequences of emerging inflation, increasing cost pressure and a still unstable Corona situation, the challenges have grown significantly. Nevertheless: “We will remain optimistic for the long term, and we will continue to globalise our successful and evidence-based products, and further expand our team, too, which today consists of 785 employees. Furthermore, we have made great progress with our digitalisation strategy, which we started back in 2014, and will continue to expand it,” Dörrenberg stated at the annual balance press conference. In general, the company is focusing on research for new innovative products. At the top of the agenda are continuing internationalisation in the cosmetics sector, and expansion in the oral care division. In the pharmaceuticals sector Dr. Wolff Group has opened another business area with the EU-wide launch of the new “Axhidrox®” drug.

Product from Bielefeld supports virus prophylaxis

From the beginning of the pandemic on Dr. Wolff’s maxim has been to complement existing Corona protection measures in the best possible way, and to make an effective contribution. In 2021, the oral care segment developed a concept to support virus prophylaxis based on an antiviral mouth and throat rinse. Most recently, a group of 13 scientists¹ confirmed its effectiveness in reducing the SARS-CoV-2 viral load in the mouth and throat area. A special mention was made of the surfactant-based efficacy concept used by Dr. Wolff, while in particular antiseptic agents showed hardly any effects. “We do not replace any vaccination or any of the established hygiene measures. We complement them. It is remarkable that especially consumer protection centres publicly doubt the work of respected scientists and university clinics and sometimes even fight it legally,” describes the 54-year-old managing partner the current discussion about the antiviral mouth and throat rinse.

Research success and new therapy option: drug against excessive sweating

After about ten years of research and development, Dr. Wolff launched a new drug against excessive sweating in the armpits in 2022. Following approval, the drug named “Axhidrox®” is already available in Austria. The launch in Germany is scheduled for August. In Germany, at least four million people suffer from so-called primary hyperhidrosis, a chronic disease with a high number of unreported cases. Those affected sweat excessively without any recognisable cause. With the development of the cream containing 1% glycopyrronium bromide (GPB), the dermatology division at Dr. August Wolff has succeeded in providing patients with so-called severe primary axillary hyperhidrosis with a new treatment option.

“Our preparation is the only anticholinergic cream in Europe to date that allows for the external treatment of severe primary axillary hyperhidrosis with the active ingredient GPB. We are convinced that with this drug we can also help patients who have not achieved satisfactory results with previous treatment options so far,” says the family businessman. Data from several clinical trials provided the basis for the approval in eleven European countries. The data of the phase 3a trial relevant for approval were already published in 2021 in the highly respected “British Journal of Dermatology”.² The publication of the phase 3b research data is expected shortly. In Germany, the preparation will be presented to dermatologists for the first time in mid-July at a scientific congress. Dr. Wolff will gradually put the preparation on the market in the eleven EU countries directly or via partners.

Forecast

“Hardly anyone could or wanted to imagine that the pandemic would be immediately followed by another crisis. We know that we need to adjust to a ‘life with crisis’ and therefore remain very flexible,” says Dörrenberg with regard to the current circumstances. Overall, the situation in the entire supply chain is tense. For Dr. Wolff as a manufacturer of high-performance products the challenges are increasing, too, but so are the opportunities. The management consultancy McKinsey, e.g., recently provided data³ on consumer attitudes and buying behaviour that confirmed the importance of developing innovative products with real benefits. In addition, further internationalisation is to ensure independence for the Bielefeld-based company. On this path, Bielefeld-based Dr. Wolff Group is planning on further growth in the current financial year. With the launch of the “Axhidrox®” drug against heavy sweating in the armpits, we want to add company locations throughout Europe and also bring this drug to Asia as quickly as possible,” Dörrenberg states. The shampoo manufacturer also takes advantage of the start of this year’s Tour de France in Denmark and the attention given to their own professional cycling team to actively enter the Danish market with Alpecin, and from there the entire Scandinavian market. In addition to strong brands and products with a great performance promise, Dr. Wolff continues to focus on digitalisation. The eWolff business unit currently employs more than 30 digital specialists and is expected to have grown to 50 employees by the end of the year. The office space of this unit got doubled within the Dr. Wolff headquarters and the internal exchange on digital topics has been significantly increased. “Overall, we are very well prepared to tackle the upcoming challenges as well as the upcoming opportunities,” says Dörrenberg.

Business areas in detail

Pharmaceutical sector

Dermatology:

One-off effects of the pandemic that occurred in 2020 and early 2021, especially due to the intensive corona-related use of hand disinfection as well as antiviral mouth and throat rinses, were not repeated due to the easing of measures in 2021. With a total of 57.5 million euros, turnover was nevertheless around 7 million above the “pre-Corona result”. In 2019, dermatics sales amounted to about 50 million euros.

Gynaecology:

There have never been more women in Germany going through menopause. Changing demographics also lead to changing communication. “We see a new openness to address things,” Dörrenberg says and identifies further potential in this division. Dr. Wolff’s gynaecological products have been making a major contribution for years, e.g., in hormone-free therapy, which is particularly important according to the guidelines of many international markets. In the past year, the Vagisan brand again grew by 4 percent in Germany and abroad. Sales amounted to 38.6 million euros. Apposite to the new openness, sexologist Ann-Marlene Henning, who openly addresses difficult issues such as vaginal dryness, continues to be the brand ambassador.

Cosmetics

Oral Care:

With sales of over 33 million euros, Dr. Wolff’s fluoride-free products in the oral care category (+16 percent) are growing many times more dynamically than the market. According to the German Cosmetic, Toiletry, Perfumery and Detergent Association (Industrieverband Körperpflege- und Waschmittel – IKW), the entire oral care sector is stagnating at around 1.6 percent. Dörrenberg also sees great future potential in the oral care segment. The company is expanding international activities with their Bioniq® brand. In addition, the Karex brand is extremely successful with children’s toothpaste and almost doubled in sales. In June 2022, the new Junior Karex toothpaste was added to the portfolio. As a consequence, investments in infrastructure and organisational structures at the Bielefeld company headquarters were made. In the oral care area, research with far-reaching studies on modern caries prophylaxis and education about European regulations on the dosage of fluoride-containing toothpaste is a focal point. For years, international scientists have been actively working on the evidence of the active ingredient complex around the ingredient hydroxyapatite. The Canadian organisation Health Canada officially listed Kinder Karex in 2022 and recommends the fluoride-free toothpaste from Germany to all Canadian dentists. In the past ten years, more intensive research on hydroxyapatite and its positive influence on dental health has been conducted worldwide than on any other oral care ingredient. Numerous studies and publications show that hydroxyapatite is a real alternative to fluoride⁴.

Plantur:

Due to strong one-off effects caused by the lockdown measures, especially in the field of colour effect products, the Plantur range grew again by 19 percent in the previous year. With total sales of almost 85.5 million euros, the products of the female caffeine shampoo range almost reached the level of the men’s brand Alpecin. For many women as well as men, the decisive purchase criterion still is being able to actively do something about hair loss. Caffeine is the means of choice. The Bielefeld scientists have repeatedly been acknowledged by international experts, e.g., by the conclusion of a British research group led by Dr. Gil Westgate (University of Bradford), whose publication confirms that caffeine is the best-researched active ingredient of plant origin against hair loss.

Alpecin:

About one in two men is affected by hair loss in the course of his life. The cause of hair loss is hereditary in 80 percent of cases. Alpecin Caffeine Shampoo stands for slowing down the process and providing effective prevention. Education and awareness, especially of young men, is important for the Bielefeld-based company. According to IKW, the entire market for hair care products lost 2.4 percent in 2021. Alpecin, however, is a driver in this segment. The brand grew by over 5 percent in Germany. Internationally, the caffeine shampoo from Bielefeld even gained 27 percent. The cumulative turnover thus amounts to 93.4 million euros.

Alcina:

With all in all two lockdowns, the hairdressing business was compromised by the pandemic until 2021. Alcina managed to respond to this due to company-wide digital activities. The new “diversity” collection and all corresponding seminar and workshop series were presented digitally, and the content was deepened in weekly online presentations. Nevertheless, personal engagement and advice in the B2B segment came up short. With sales of 37 million euros, Alcina did not reach the “pre-Corona level” with hair-, skin care- and decorative cosmetics. For the current year, the goal is to revive business with seasonal editions and especially with hair colours.

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¹Meister T. L. et al. Mouthrinses against SARS-CoV-2 – High antiviral effectivity by membrane disruption in vitro translates to mild effects in a randomized placebo-controlled clinical trial”. Elsevier, 2022 July. https://doi.org/10.1016/j.virusres.2022.198791

2Abels 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

³McKinsey & Company Europe Consumer Pulse Survey, 4/12-4/18/2022 n= 5.075 (France, Germany, Italy, Spain, UK) sampled to match European general population 18+ years

⁴among others: Meta-Analyse Limeback et al.2021: Limeback, H., Enax, J. & Meyer, F. Biomimetic hydroxyapatite and caries prevention: a systematic review and meta-analysis. Can J Dent Hyg 55, 148-159 (2021); v55n3.pdf (cdha.ca)

First anticholinergic cream against heavy underarm sweating currently approved in 11 European countries

30.05.2022

In the future, a new therapy option will be available for patients with severe primary axillary hyperhidrosis in various European countries: After the Swedish reference authority recommended the approval of the topical medication for severe sweating in the armpits, the feedback from the individual countries is now being received.

Eleven countries have so far granted marketing authorisation for the topical cream containing 1% glycopyrronium bromide (brand name Axhidrox). The gradual market launch of the product in the respective countries is in preparation.

1. Denmark: Axhidrox 2.2 mg/dose cream (11.04.2022)
2. latvia: Axhidrox 2.2 mg/dozējumā krēms (19.04.2022)
3. Austria: Axhidrox 2.2 mg/pump stroke cream (21.04.2022).
4. Sweden: Axhidrox 2.2 mg/pumpning kräm (22.04.2022).
5. Estonia: Axhidrox 8 mg/g kreem (09.05.2022)
6. Finland: Axhidrox 2.2 mg/pumpun käyttökerta emulsiovoide (13.05.2022)
7. Croatia: Axhidrox 2.2 mg po potisku krema (13.05.2022)
8. Germany: Axhidrox 2,2 mg/Hub Creme (01.06.2022)
9. The Netherlands: Axhidrox 8 mg/g, Crème (14.06.2022)
10. Norway: Axhidrox 2,2 mg/pumpetrykk krem (11.08.2022)
11. Lithuania: Akshidroz 8 mg/g kremas (25.08.2022)

About glycopyrronium bromide

Glycopyrronium bromide (INN name, abbreviation GPB) or glycopyrrolate (USAN name) is a well-known anticholinergic drug substance approved in several products marketed in the EU and the USA for various diseases in children and adults. GPB blocks the action of acetylcholine at muscarinic acetylcholine receptors, which are responsible for sweat gland activation, among other things.

About hyperhidrosis

Approximately 5 % of people worldwide suffer from permanent excessive sweating without an identifiable cause, so-called “primary hyperhidrosis”. This chronic disease is a great burden for patients and severely limits their quality of life. Primary hyperhidrosis ranges in severity from mild wetness to heavy dripping and can lead to a significant impact on quality of life. This may significantly affect work, social relationships, physical and leisure activities, as well as emotional and mental health. Patients with primary axillary hyperhidrosis suffer from excessive sweat production in the armpits beyond the amount required to regulate normal body temperature.

About Dr. Wolff

Dr. Wolff – since 1905, the name has stood for research that solves people’s skin-, hair-, and dental problems with innovative active ingredients. We focus our effort on scientifically proven benefits of the products. Since the company was founded, Dr. Wolff has maintained close cooperation with renowned scientists. From the first branded product, Hämatopan, to today’s internationally available products, in-house research provides the basis for innovative active ingredients and product developments. The company is managed by the fourth generation of the family and is growing with 780 employees worldwide. Dr. Wolff operates in 62 countries. For more information, please go to: Dr. Wolff Group

Dr. Wolff Group continues successful course in the areas of hair, skin and dental health

03.01.2022

in 2021 the quick balance sheet reports a turnover of 355 million euros for the first time
digitisation offensive has increasingly been paying off since 2014
forecast for further strong growth despite challenges

In the past year 2021, it was once again highly innovative products that formed the basis for a growth of almost five percent of Bielefeld-based Dr. Wolff Group. With an increase to 355 million euros in preliminary turnover the family-owned company successfully stood up to the second year of the pandemic and has increased sales by around 42 million euros since 2019.

New milestones were achieved above all in the segment of oral care (Bioniq® and Karex). Numerous scientific publications on the active ingredient hydroxyapatite¹, the most recent one from the University of Toronto², have been leading to growing international recognition. Thus, the new biological technology (bionics) is more and more developing into an effective alternative to long-established fluoride-based dental care. This is true even beyond pure caries prophylaxis.

In hair loss research, an important milestone was achieved with the approval of caffeine as an anti-hair loss agent in Australia. The effect, which is also known in Germany, is the reason why Alpecin and Plantur brands made significant gains against the trend in a declining German hair care market.

The hygiene segment, which was newly launched during the pandemic and initially included hand disinfection under the Linola® sept brand, was expanded at the beginning of 2021 after an antiviral mouth and throat rinse had been successfully tested on hospitalised COVID-19 patients³. The world’s first antiviral hand cream rounds off the hygiene portfolio.

In 2021 Dr. Wolff Group will continue their consistent growth course of the past few years in Germany and abroad across virtually all brands and areas. Only the hair salon segment suffered from the long lockdown in the first quarter of 2021. “For 2022, we are counting on further very dynamic growth. To achieve this, we will continue to invest consistently in a wide variety of research projects in different business areas. Thus, we expect new positive findings and data in the coming year as well, which we will use to offer innovative products for consumers,” says Eduard R. Dörrenberg, Managing Partner of Dr. Wolff Group, with an optimistic outlook to 2022.

Accordingly, trials and further research are planned in the field of medical mouth and throat cleansing, including an additional clinical trial that is to also confirm an effect against a wide variety of cold viruses and a faster recovery after corona infections. In hair loss prevention, the company expects new data on an enhanced combination of active ingredients with caffeine. In the field of dental health, scientists and research groups from various international universities are working on further research studies on hydroxyapatite.

In the pharmaceutical division, the Bielefeld-based company is also awaiting the first and, so far, only approval in Europe for a new drug against primary axillary hyperhidrosis (pathological sweating in the armpits): a 1% glycopyrronium bromide cream.

Overall, according to Dörrenberg “Dr. Wolff Group is continuously turning into a highly specialised medical and cosmetic company for products with great medical benefit. This puts us in a position to meet the ever-increasing global demand for preventive health care and increasing attractiveness.” Thus, the company sees themselves on track for success in 2022 and expects another year of strong growth – despite challenges such as in the supply chain or the regular onboarding of new employees. In addition to continuing strong growth in Asia, the company is also planning major next steps in the USA and Canada for the first time. Measures for the digitisation of the corporate group, which have been ongoing since 2014, will also be further expanded with the eWolff unit. Dr. Wolff currently employs about 800 people and now, at the beginning of 2022, is hiring for many positions.⁴ “But these will not remain the only challenges we will face in the coming year,” Dörrenberg predicts and also in the third year of the pandemic does not only expect a tailwind on the planned growth path.

1 – Study database on hydroxyapatite

2 – Publication on hydroxyapatite by the University of Toronto

3 – Publication on mouth and throat rinsing

4 – Vacancies at Dr. Wolff Group

Still on course and defying the crisis with an enormous effort

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

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

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 12^th 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 1^st DCP in the European Union regarding GPB cream took place on Feb 26^th. 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

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.

Dr. August Wolff Submits Application for Marketing Authorization of 1% Glycopyrronium Bromide (GPB) Cream in the EU – Positive Phase 3a Part of Pivotal Study Results for 1% GPB Cream in Patients with Primary Axillary Hyperhidrosis

22.03.2021

Filing of the documents for marketing authorisation application (MAA) in a decentralised procedure (DCP) on February 26th, 2021
Primary endpoint (absolute change in sweat production) was met with statistical significance
Key seconday endpoints showed about 2 times as many responders to 1% GPB treatment than to placebo

The Bielefeld-based family-owned pharmaceutical developing and manufacturing company Dr. August Wolff GmbH & Co. KG Arzneimittel (“Dr. August Wolff”) announces that the “Marketing Authorisation Application” (MAA) for 1% Glycopyrronium bromide (GPB) cream was submitted on February 26^thto the Medical Products Agency (MPA, Sweden) despite the challenges of the COVID-19 pandemic. If approved, the MAA would apply to Austria, Croatia, Denmark, Estonia, Finland, Germany, Latvia, Lithuania, The Netherlands, Norway and Sweden. Dr. August Wolff will commercialize the GPB Cream directly or with experienced partners in these countries.

The application package for 1% GPB cream includes i.a. data from a combined Phase 3a/Phase 3b study in patients with primary axillary hyperhidrosis. The long-term part of the study 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[1]. The primary endpoint (absolute change in sweat production assessed by gravimetric measurement from Baseline (Day 1) to Day 29 in the 1% GPB group compared with the placebo group was met with statistical significance. In addition, hyperhidrosis-related quality of life improved significantly.

“We are extremely encouraged by these positive results which together with results from planned interim analyses of the Phase 3b part are used for the filing of the marketing authorization application in EU” said Eduard R. Dörrenberg, one of the Dr Wolff´s Managing Partners. “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.”

Detailed study results of the phase 3a part

About ongoing phase 3b part

About Glycopyrronium bromide

About Hyperhidrosis

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.

[1] 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.

First medical anti-COVID-19 mouth and throat wash with laboratory and clinical data

25.02.2021

– Linola® sept mouth and throat wash inactivates corona virus
– Results confirmed in patients

Based on their know-how in the field of oral hygiene, Dr. Wolff presents with Linola® sept mouth and throat wash for the first time a product, which has been confirmed in its effectiveness against the virus in several laboratory and additional clinical test results. Since March 2020, Dr. Wolff researchers have been examining laboratory and clinical data on physical corona protection through medical mouth and throat cleansing with Linola® sept mouth and throat wash.

The evaluation of the studies showed a significant decrease in viral load (90 %) after use. According to the results, not only does an existing viral load decrease, but also the risk of transmitting the viruses. The data collected indicate a success with “exceptionally high significance“, says Prof. Dr. Holger Sudhoff, head physician of the Department of Otorhinolaryngology, Head and Neck Surgery at Bielefeld hospital, and confirms: “This mouth and throat wash is different.” It is thus more tolerable because it is based neither on biocidal nor alcoholic active ingredients, but on mineral ones. Since it is about the physical masking (blocking) of corona viruses, it can be assumed that the new Linola® sept mouth and wash is effective for all mutations, regardless of the degree of mutation. Further clinical studies with the patent-pending formulation are to follow as soon as possible.

Doctors and politicians already rely on mouthwashes, but clinical data had not been available until now. Linola® sept mouth and throat wash is the first formulation with data collected in vitro and in vivo.

“It is not our intention to replace vaccination. However, as long as it is not implemented systematically and available for everyone, Linola® sept mouth and throat wash adds a very good building block to protective measures. Thus, social distancing, hygiene and room ventilation rules remain the same in first place, but are complemented by rinsing mouth and throat”, says Eduard R. Dörrenberg, managing partner of the pharmaceutical manufacturer Dr. Wolff. This mouth and throat wash is suitable wherever special protection is needed: In addition to medical personnel, it is also suitable for visitors to old people’s homes, teachers and, because it is alcohol-free, especially for schoolchildren.

Experts advise medical cleaning of mouth and throat

When speaking, coughing, laughing or singing, viruses spread in the air via aerosols and can thus be transmitted. Germany’s health minister Jens Spahn and specialist in hygiene Klaus-Dieter Zastrow also told the media that they attach great importance to mouth and throat rinsing.

Linola® sept mouth and throat wash contains surface-active substances. They attach themselves to the surface of the virus and prevent it from penetrating the host cell in the oral mucosa.

Corona viruses are inactivated in mouth and throat. In addition, rinsing and subsequent spitting out significantly reduces the viral load in the mouth area in a physical way, thus reducing transmission risks.

Easy to use:

Linola® sept mouth and throat wash is easy to dispense thanks to its dosage cap: Simply fill in 10–20 ml of the mouth and throat wash, wash the mouth with it for about 60 seconds and gargle too, so that it also reaches the throat. Then spit the rinse out. Experts advise using the product two to three times a day. It is particularly recommended to use it after social contacts. Linola® sept mouth and throat wash is also suitable for children overthe age of six, as it is alcohol-free.

Linola^® sept mouth and throat wash

375 ml, RRP 11.47 euros, available from January 11

For more information on the product see: Linola® sept mouth and throat wash (German)