Quotes

The two most important activities in the near term for the company – the registration process for the nail fungus treatment MOB-015 in Europe and patient enrollment in the new North American Phase 3 study – are progressing according to plan. Together with our partners, we are continuing preparations ahead of the expected approval and initiation of launch next year
Anna Ljung, CEO of Moberg Pharma
Patients are now being enrolled in the new North American Phase 3 study, which is fully financed thanks to the rights issue we carried out. Concurrently, the registration process for MOB-015 is underway in Europe, where the company submitted a registration application in March of this year and expects an approval and launch next year,
Anna Ljung, CEO of Moberg Pharma
This is the sixth commercial agreement for MOB-015, this time with a leading provider of extended topical and other specialty pharmaceuticals in Israel. We look forward to work with Padagis and making MOB-015 available in Israel, contributing to our vision of making MOB-015 the leading nail fungus treatment worldwide
Anna Ljung, CEO of Moberg Pharma
As a leading pharmaceutical company in Israel, Padagis Israel welcomes the signing of this agreement with Moberg Pharma and look forward to a fruitful cooperation and collaboration between the two companies
Shlomi Leibovich, SVP & CEO of Padagis Israel
I would like to thank existing and new investors for the support in this rights issue. We are pleased to have secured the financing and look forward to devoting our time on executing on our business with full force. Our new North American Phase 3 study, where patient recruitment is ongoing, is fully financed and the capital injection gives us the opportunity to utilize MOB-015's full potential, both through registration activities and launch preparations in Europe. We now look forward to expected market approval in 2023, launching MOB-015 and creating long-term shareholder value
Anna Ljung, CEO of Moberg Pharma
In March, the company submitted a marketing authorization application for MOB-015 in Europe – a key milestone in our journey to launch a new and improved nail fungus drug. The new North American Phase 3 study has started and is fully financed thanks to the guaranteed rights issue
Anna Ljung, CEO of Moberg Pharma
The initiation of patient enrollment in the North American Phase 3 study for MOB-015 is a major milestone for Moberg Pharma
Anna Ljung, CEO of Moberg Pharma
Our long-term vision is to become a global leader in onychomycosis and we believe that MOB-015 has the potential to establish a new standard of care. The Phase 3 study have been designed to support registration in North America and runs in parallel with the registration process in Europe where our goal is to receive first market approval and launch in 2023
Anna Ljung, CEO of Moberg Pharma
The financing we have secured gives us the opportunity to fully exploit MOB-015’s potential, both through the registration activities and launch preparations in Europe and an additional clinical study for the US market. The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect
Anna Ljung, CEO of Moberg Pharma
Submitting the Marketing Authorization Application in Europe is a key milestone in our journey to launch a new and improved nail fungus drug. MOB-015 is uniquely positioned through its high antifungal efficacy, since there is significant need for a treatment that truly cures the nail infection
Anna Ljung, CEO of Moberg Pharma AB.
For market approval in the U.S., the FDA typically requires two studies that demonstrate statistical superiority of the active drug versus its vehicle (placebo) for the primary endpoint. The first study was successfully completed in 2019 and we are now conducting the second study. The North American study is a top priority in the near future, in addition to the registration process in Europe where our goal is to receive first market approval and launch in 2023.
Anna Ljung, CEO of Moberg Pharma AB
The most important event in the quarter was that the Medical Products Agency in Sweden has agreed to be reference member state for MOB-015 in Europe. The company also signed a new collaboration agreement with Allderma for the launch in Scandinavia in 2023. In addition, preparations are fully underway for the new North American Phase 3 study,
Anna Ljung, CEO of Moberg Pharma
We are advancing toward the company’s goal to register a new and improved nail fungus drug. The need for a treatment alternative that can truly cure the nail infection is great, which means that MOB-015 can achieve a unique position through its high antifungal effect
Anna Ljung, CEO of Moberg Pharma AB
We would like to thank Peter for his valuable contributions to Moberg Pharma as chairman in recent years and previously as CEO of the company. The Nomination Committee will present its complete proposal for a new Board of Directors, including Peter’s replacement, well in advance of the Annual General Meeting.
Gillis Cullin, Chairman of the Nomination Committee.
Moberg Pharma is a very interesting company. We developed the company from the start to revenues of almost half a billion SEK before the commercial business was divested in 2019. The company's pipeline now includes MOB-015, which builds on previous successes and has demonstrated world-leading ability to cure patients from nail fungus. I look forward to continuing as Chairman until the AGM and to maintain close contact with the company as a major shareholder thereafter.
Peter Wolpert.
The approval from the EMA’s paediatric committee in September is an important milestone towards our goal to submit a registration application for MOB-015 in Europe this year and enables us to pursue a full marketing authorization application with data exclusivity in Europe for up to 10 years after market approval. Hand in hand with registration preparations, commercialization preparations are underway, including through the collaboration with Allderma ahead of the Scandinavian launch
Anna Ljung, CEO of Moberg Pharma
Rapidly after launch, Nalox® became the market leader in the Nordics and grew the market by 400%. It is very valuable for us to repeat this successful cooperation for the launch of MOB-015, a drug with much greater potential. There is also a great advantage to be directly involved in an early launch prior to additional launches with our partners
Anna Ljung, CEO Moberg Pharma AB
We look forward to the launch of MOB-015, the first topical drug with equal antifungal efficacy as oral treatment, without the risk for severe side effects. The goal is the same as last time: to reach a market-leading position in Scandinavia
Mimmi Frölén, CEO of Allderma AB
The approval enables data exclusivity in Europe for up to 10 years and further strengthens our intellectual property protection of MOB-015. It is an important milestone towards our goal to submit a registration application for MOB-015 in Europe this year
Anna Ljung, CEO of Moberg Pharma AB.
The registration preparations for MOB-015 are progressing as planned, with the goal to submit a registration application in Europe in the second half of 2021. Further discussions with regulatory authorities are scheduled this autumn and a final decision from the EMA’s Paediatric Committee is expected in September, which will determine the timing for submission of the registration application,
Anna Ljung, CEO of Moberg Pharma
Registration preparations for MOB-015 are progressing at full speed, including recently received final comments on our pediatric plan from EMA. We remain on plan to submit the registration application in Europe in the second half of 2021. The spin-off of BUPI was completed through the IPO of OncoZenge in February
Anna Ljung, CEO of Moberg Pharma
The patent significantly strengthens the intellectual property for BupiZenge® in Europe
Pirkko Tamsen, CEO of OncoZenge
It protects the use of BupiZenge® in all relevant indications for treatment of pain in the oral cavity
Pirkko Tamsen, CEO of OncoZenge
The great interest from well-reputed investors is very positive and enables BupiZenge® to further progress its clinical program and OncoZenge to become a listed company in the near future. I look forward to leading the continued development focusing on our upcoming Phase 3 study in an indication area with significant need for better treatment alternatives. The goal is to offer patients much better pain relief and to create value for our shareholders
Pirkko Tamsen, CEO of OncoZenge
The separate listing on Nasdaq First North and subsequent Rights Issue provide an opportunity to develop the potential in BupiZenge® and also provide shareholders of Moberg Pharma an opportunity to invest and participate in the value creation in OncoZenge
Anna Ljung, CEO of Moberg Pharma.
With two Phase 3 studies for MOB-015 that have met the primary endpoint, we are now taking the next step to market in Europe. Registration preparations are underway whilst BUPI will be spun off into the company OncoZenge AB with a new share listing planned in Q1 2021
Anna Ljung, CEO of Moberg Pharma
The financing we have secured gives us the opportunity to fully exploit MOB-015’s potential, both through the marketing authorization application in Europe and an additional clinical study for the US market. The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect
Anna Ljung, CEO of Moberg Pharma
After a completed phase 3 study and registration, BupiZenge® will be of great benefit to all the patients who suffer from severe mouth pain during cancer treatment. I look forward to leading OncoZenge as a separate company and thereby being able to fully focus on the potential of our drug candidate
Pirkko Tamsen, CEO of OncoZenge
The spin-off into a separate company provides the opportunity to realize the potential in BupiZenge® and create significant value for our shareholders,
Anna Ljung, CEO of Moberg Pharma
After thorough analysis of the data with our scientific advisors and partners, we see strong potential for MOB-015 and are now through submission preparations pursuing the next key steps toward market approval. There is great need for better topical treatments with the ability to really cure the fungal infection. The superior mycological cure enables a unique position for MOB-015
Anna Ljung, CEO of Moberg Pharma
Vi har nu två fas 3-studier för MOB-015 som har uppnått primär effektvariabel och därmed kan vara registreringsgrundande i EU. Vårt utfall, med låg fullständig läkning och världsledande svampdödande effekt är ovanligt och nu följer diskussioner med partners och myndigheter innan beslut om nästa steg
Anna Ljung, VD Moberg Pharma
We now have two Phase 3 studies for MOB-015 that have met the primary endpoint and can serve as the basis for EU registration. Our outcome, with low complete cure and unprecedented antifungal effect, is unusual. We will discuss with partners and regulatory agencies before deciding on the next steps
Anna Ljung, CEO of Moberg Pharma
This financing can cover the company’s capital requirements to product registration following a positive outcome in the European phase 3 study. It can also secure financing for an additional study if needed before registration. We are continuing our focus on MOB-015 and look forward to the topline data from the EU study at the end of the second quarter. We are fully committed to creating the future market leader in nail fungus treatments
Anna Ljung, CEO of Moberg Pharma
The agreement provides Moberg Pharma access to flexible financing at a reasonable cost under current market conditions. As part of the agreement, Nice & Green will introduce Moberg Pharma to its wide network of biotech investors in Switzerland, Germany and France
Mark Beveridge, VP Finance at Moberg Pharma
The high mycological cure rate demonstrated is very impressive and given the rapid onset of the antifungal effect, MOB-015 offers exciting benefits. I will definitely use it for my patients. A higher complete cure rate is likely to be achieved with a shorter treatment period and this would also be much more attractive to patients
Dr Boni Elewski, Professor and Chair of the Department of Dermatology, University of Alabama.
I am a strong supporter of this concept. With an optimized dosing regimen this product has great potential and may become the preferred therapeutic option, not only for monotherapy, but also as maintenance therapy to reduce recurrence after oral treatment
Dr Aditya Gupta, Professor, Department of Medicine, University of Toronto
Based on decades of experience with terbinafine and the excipients used in MOB-015, I believe a shorter treatment period has the potential to provide higher complete cure rates. Killing the fungus is the driver of also reaching complete cure
Dr Jan Faergemann, Professor in Dermatology, Sahlgrenska Academy, University of Gothenburg, Sweden.
From a medical and commercial perspective, a regimen with daily dosing for up to three months followed by less frequent treatment, is highly attractive and further improves the target product profile of MOB-015. This is further supported by U.S. market data indicating that real-life usage of current topicals on average is 3-4 months, despite being labeled for 48 weeks’ daily treatment
Dr. Amir Tavakkol, CSO of Moberg Pharma AB
We are very grateful for the thorough analysis of the key opinion leaders which not only shed light on the conflicting data points, but also strengthened our conviction that MOB-015 has the potential to become the future market leader in onychomycosis
Anna Ljung, CEO of Moberg Pharma AB.
The mycological cure rate in the study is remarkably high for a topical treatment. We believe this is due to fungicidal activity of terbinafine in MOB-015. We would normally expect more patients reaching complete cure following eradication of the infection in such a clear majority of the patients. This will be further investigated and we expect additional insights from the European study (n=452), in which MOB-015 is compared head to head against the most widely used topical treatment. A safe, efficacious topical terbinafine product eradicating the infection and progressing healthy nail growth for many patients is highly attractive for practicing physicians worldwide
Amir Tavakkol, Senior Advisor R&D at Moberg Pharma AB.
To cure 70 percent of the patients from their fungal nail infection is a superior result and better than expected for a topical product. We were however expecting a higher complete cure rate, following the high mycological cure, despite the well-known challenges in demonstrating completely cleared nails at 52 weeks even after the fungal infection is cured. The study confirms the rapid visible improvement experienced by patients, where four out of five patients reported some improvement already at the first follow up visit, and at the end of the study, 33 percent of patients rated their nail to be cured or almost cured
Anna Ljung, CEO of Moberg Pharma AB
This is the fourth commercial agreement for MOB-015, this time with the market leader in dermatology in Korea with excellent coverage of the dermatology clinics. We look forward to work with DongKoo and making MOB-015 available in Korea, contributing to our vision of making MOB-015 the leading nail fungus treatment worldwide
Anna Ljung, CEO of Moberg Pharma
I look forward to continue working together with Mark Beveridge. I would also like to thank Sarah Hellerfelt for her excellent contributions to the company over the past years and wish her all the best in the future
Anna Ljung, CEO of Moberg Pharma
We are excited to partner with Taisho for the large and growing Japanese onychomycosis market, contributing to our vision of making MOB-015 the leading nail fungus treatment worldwide
Anna Ljung, CEO of Moberg Pharma
This is the third major agreement for MOB-015 and further validates the significant market potential for our lead asset and the focused commercialization preparations by our team
Peter Wolpert, Executive Chairman of Moberg Pharma
After the successful divestment of the OTC portfolio, the business is progressing as planned with a focus on the Phase 3 studies for MOB-015, further commercialization preparations and preparations for the share redemption in November 2019
Anna Ljung, CEO of Moberg Pharma
The divestment of our OTC business represents a major change for Moberg Pharma and recognize the compelling value of both components of the business. Since April 1, 2019, Moberg Pharma has a fully funded business whose main goal is to make MOB-015 the future market leader in onychomycosis
Peter Wolpert, VD Moberg Pharma
I look forward to the opportunity to transition to a role as Executive Chairman while remaining close to the new management. After 13 intensive years as CEO of Moberg Pharma, it is important for me to be able to spend more time with my family, as well as continuing to contribute in a valuable way according to the company’s new needs
Peter Wolpert, CEO of Moberg Pharma AB
We are excited about this opportunity – being able to offer our shareholders a significant distribution while retaining the considerable upside of the fully funded MOB-015 program. The transaction enables us to increase the focus on making MOB-015 the future market leader in onychomycosis. I would also like to thank the OTC team for their exceptional contributions to Moberg Pharma over the past years and wish them continued success
Peter Wolpert, Moberg Pharma´s CEO
Completing the Phase 3 enrollment for MOB-015 is truly an important milestone. I am very grateful to the team for the hard work in completing the recruitment for both studies. More than 5,000 patients have been screened to recruit 800+ patients in the rigorous screening process, ultimately increasing the probability of strong phase 3 results for MOB-015
Peter Wolpert, Moberg Pharma’s CEO