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ALVOTECH AND STADA AGREE ON STRATEGIC BIOSIMILAR PARTNERSHIP

  • • ALVOTECH and STADA enter into a strategic collaboration for seven biosimilar candidates in Europe


  • • STADA will exclusively commercialise the products in all key European markets as well as selected markets outside of Europe


  • • STADA CEO Peter Goldschmidt: “The agreement with Alvotech is one of the largest commercial biosimilar cooperations to date, accelerating improved patient access to high quality biosimilars.”

Reykjavik, Iceland / Bad Vilbel, Germany; 7 November 2019 – Biopharmaceutical company Alvotech and global pharmaceutical company STADA Arzneimittel AG (“STADA”) today announced that they have entered into an exclusive strategic partnership for the commercialisation of seven biosimilars in all key European markets and selected markets outside Europe. The initial pipeline contains biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions as well as ophthalmology for patients around the world.

Under this partnership agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars within the EU. STADA will be exclusively commercialising the products in the majority of the key European markets. The originator products of the seven biosimilars currently generate US$50 billion in sales globally. The agreement includes an upfront payment with subsequent milestone payments over the next four years. The financial details of the transaction are not disclosed.

Robert Wessman, Alvotech’s founder and Chairman added: “This is an important moment for biosimilars. This partnership has the resources and vision to accelerate the introduction and adoption of new biosimilars for patients in Europe who will get better access to high-quality products. It’s also another important milestone for Alvotech and crowns an exceptional year where we have continued to extend our network of partners around the globe.”

“We’re delighted to establish this latest partnership with STADA, who is an ideal commercial partner in Europe and shares the same purpose of improving the quality of life of patients around the world,” added Mark Levick CEO of Alvotech.

Peter Goldschmidt, Chairman of the Executive Board/CEO of STADA said: “The collaboration with Alvotech, with its highly experienced and fully committed team, is a great opportunity to accelerate the expansion of our biosimilar portfolio and to strengthen our market position in this segment. We are looking forward to providing patients with state-of-the-art medicine and costeffective alternatives to biologicals.”

About Alvotech
Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets. We are specialists in biotechnology, seeking to be a global leader in the biosimilar space by delivering high quality, cost-competitive products and services to our partners and to patients worldwide. Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar products.

Alvotech‘s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world.

For more information, please visit our website, www.alvotech.com or follow us on LinkedIn, Twitter and Facebook.

About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a twopillar strategy consisting of generics, including specialty pharmaceuticals and non-prescription consumer health products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2018, STADA achieved adjusted Group sales of EUR 2,330.8 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 503.5 million. As of December 31, 2018, STADA employed 10,416 people worldwide.

About biosimilars
Since their introduction in the 1980s, biopharmaceuticals have revolutionised the treatment of serious diseases, such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biopharmaceuticals will lose their patent protection – and by 2020, medications with revenues of more than US$100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, China, Canada, and Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. While the global market for biosimilars is currently more than US$5.0 billion, industry experts expect this figure to grow up to US$30 billion by the year 2025.

Strategic expansion of OTC portfolio continues – STADA acquires EMEA rights to global anti-dandruff brand Nizoral from Janssen Pharmaceutica

Bad Vilbel, June 28, 2018 – STADA Arzneimittel AG is further strengthening its position in branded over-the-counter healthcare products. The company has acquired the rights to the medicated anti-dandruff shampoo Nizoral from Janssen Pharmaceutica NV (a member of the Johnson & Johnson family of companies). The shampoo generated sales of approximately EUR 33 million in EMEA (Europe, Middle East, and Africa) in 2017.

“With Nizoral, STADA is adding a globally established brand to its portfolio that is highly recognized both by medical practitioners and customers, and which we believe has great potential for further growth. Together with head lice treatment Hedrin, Nizoral solidifies our competence in the hair and scalp product segment. The transaction is one of the largest in recent years and underlines our aspiration to be one of the leading providers of OTC products in Europe,” emphasized STADA CEO Dr. Claudio Albrecht.

Nizoral’s market share in the EMEA region is several times that of its nearest competitor, making it the clear market leader among medicated anti-dandruff shampoos. More than 50% of annual sales are generated in Russia, Italy, Great Britain, Poland, and the Middle East. In addition to the umbrella brand Nizoral, STADA is also acquiring the local brands Nizoril, Nizorelle, Terzolin, Fungarest, Ketoderm, Oranozol, and Triatop. Nizoral cream for skin infections will be part of the purchase in Italy and Denmark only; in all other countries the cream will remain with Janssen Pharmaceutica NV and its affiliates.

The anti-dandruff shampoo is marketed under the brand names Nizoral and Nizorelle in UK. “We are excited to add Nizoral into our portfolio and to further expand our presence in the consumer healthcare market. In 2017 UK achieved sales of EUR 3.92 million. In the next few months we will be working together very closely with the seller in order to ensure a smooth transition in distribution”, said Dieno George, Executive Vice President Brands at STADA.

The medical ingredient Ketoconazole, which was developed by Janssen Pharmaceutica NV and its affiliates, is the most frequently prescribed active ingredient for the treatment of dandruff. It distinguishes Nizoral from purely cosmetic anti-dandruff shampoos and makes it substantially more effective for treating symptoms such as dandruff, redness and itchiness of the scalp and their causes. Nizoral’s long duration of effectiveness of up to seven days also makes it highly effective against persistent dandruff.

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