Alvotech and STADA add to Strategic Alliance through Denosumab Partnership
Alvotech and STADA announced an expanded strategic alliance to market Alvotech’s biosimilar AVT03, referencing Prolia®/Xgeva® (denosumab), in Europe, including Switzerland and the UK, as well as selected markets in Central Asia and the Middle East. This partnership builds on their existing collaboration for biosimilars to Humira® and Stelara®. Alvotech will develop and manufacture AVT03, while STADA will handle marketing upon regulatory approval. Additionally, Alvotech regains commercial rights to its biosimilar AVT06, referencing Eylea® (aflibercept). The expansion aims to offer cost-effective biosimilars to patients, particularly for osteoporosis and cancer-related bone loss.
- Alvotech and STADA expand their strategic alliance, potentially increasing market share and revenue.
- STADA will handle marketing, leveraging its established presence in Europe, Central Asia, and the Middle East.
- Alvotech retains development and manufacturing control, emphasizing its expertise in biosimilar production.
- Potential for reduced costs for patients and healthcare systems through biosimilars.
- Extended rights for STADA to market biosimilars in Commonwealth of Independent States (CIS) countries.
- Alvotech regains commercial rights to AVT06, which could provide additional revenue streams.
- Potential regulatory hurdles could delay the approval and market entry of AVT03.
- Market competition from existing and new biosimilars could impact the market share of AVT03.
- Costs associated with the development and manufacturing of AVT03 could be substantial.
- Regaining commercial rights to AVT06 might lead to increased responsibilities and costs for Alvotech.
Insights
The expanded partnership between Alvotech and STADA is a strategic move with significant financial implications. The inclusion of denosumab biosimilars opens up substantial market potential, given the large incidence of osteoporosis and related bone diseases in Europe. The financial analyst must consider the immediate impact on Alvotech and STADA's stock prices, reflecting investor confidence in this strengthened alliance. By adding denosumab to their biosimilar portfolio, they are not just targeting a well-established market but also positioning themselves strongly in the competitive biosimilar sector. Revenue streams are likely to improve as new biosimilars enter the market, enhancing both companies' profitability. The move also counters potential revenue loss due to biosimilar competition for existing drugs like Humira®. Investors might see this partnership as a growth catalyst for both companies, anticipating increased
The focus on denosumab, a monoclonal antibody targeting RANKL, is particularly relevant in the context of osteoporosis and cancer-related bone loss. From a medical research perspective, this agreement could significantly enhance patient access to effective, lower-cost treatments. Denosumab's mechanism of action—binding to RANKL and preventing bone resorption—is well-documented and its application in treating osteoporosis and metastatic bone disease offers substantial clinical benefits. The move may accelerate the availability of biosimilar treatments, providing clinicians with more choices and potentially leading to better patient outcomes. Moreover, given the high prevalence of osteoporosis (32 million Europeans) and substantial healthcare costs (€56.9 billion in 2019), the availability of a biosimilar could also contribute to reducing healthcare expenditures.
From a market research perspective, STADA and Alvotech's expanded alliance appears to be a strategic response to the growing demand for biosimilars in Europe and beyond. The denosumab market, projected to benefit significantly from increased availability of biosimilars, presents a lucrative opportunity. By extending their collaboration, both companies are likely to enhance their market penetration and competitive positioning. The deal also indicates a robust pipeline and strategic foresight in capturing market share in segments with high unmet medical needs. The semi-exclusive and exclusive rights in various regions suggest a carefully crafted strategy to maximize commercial potential while mitigating risks associated with market entry. This agreement could also stimulate further alliances and partnerships within the biosimilar landscape, hinting at a dynamic and competitive future market environment.
- STADA assumes marketing license for Alvotech’s proposed biosimilar referencing Prolia®/Xgeva® (denosumab) in Europe, including Switzerland and the UK, as well as rights in selected markets in Central Asia and the Middle East
- This partnership for the osteoporosis and cancer-related molecule builds on the two company’s existing strategic alliance in Europe. The first product launched through the alliance was Hukyndra®, a high-concentration biosimilar to Humira® (adalimumab)
- Extended alliance comes as the partners prepare to launch Uzpruvo®, a biosimilar to Stelara® (ustekinumab) in Europe following the expiry of applicable intellectual-property rights1
REYKJAVIK, Iceland and BAD VILBEL, Germany, June 11, 2024 (GLOBE NEWSWIRE) -- Alvotech and STADA are strengthening their existing strategic alliance for high-quality, cost-effective biosimilars by extending their partnership to cover AVT03, a clinical-stage biosimilar candidate referencing the Prolia®/Xgeva® (denosumab) medicines for osteoporosis and cancer-related bone loss respectively.
Under the terms of the agreement, Alvotech will be responsible for development and manufacturing at its state-of-the-art facility in Reykjavik, Iceland. STADA will become marketing authorization holder, upon approval of AVT03, and will assume semi-exclusive commercial rights in Europe, including Switzerland and the UK, as well as exclusive commercial rights in selected countries in Central Asia and the Middle East.
In parallel with the commercial agreement for AVT03, the two partners have agreed to extend STADA’s commercial rights to biosimilars to Humira® (adalimumab) and Stelara® (ustekinumab) to Commonwealth of Independent States (CIS) countries in Central Asia. Alvotech will also regain commercial rights from STADA to AVT06, a proposed biosimilar to Eylea® (aflibercept).
STADA’s Global Specialty Head, Bryan Kim, commented: “As European market leader with our teriparatide osteoporosis treatment, Movymia®, STADA sees a major opportunity to offer patients and clinicians a further treatment with denosumab. With a strong presence in oncology among our six currently marketed biosimilars, broadening our alliance with Alvotech enables us to direct our resources efficiently and effectively.”
Anil Okay, Chief Commercial Officer of Alvotech, remarked: “We look forward to continuing to work with STADA on increasing patient availability of more affordable biologics in the denosumab market, as we have already done with our citrate-free, high-concentration biosimilar to Humira®. This expansion of our commercial alliance further validates Alvotech’s unique focus on biosimilar development and manufacturing, strong end-to-end capability and expertise.”
Denosumab is a human monoclonal IgG2 antibody that targets the protein RANKL, which is essential for the formation, function and survival of osteoclasts, the cell type responsible for bone resorption. Increased osteoclast activity stimulated by RANKL is a key mediator of bone destruction in metastatic bone disease. Denosumab binds to RANKL with high affinity and specificity, preventing the interaction between RANKL and RANK. This leads to a reduction in osteoclast numbers and function, and a decrease in bone resorption and cancer-induced bone destruction.
An estimated 32 million Europeans, equating to
About AVT03
AVT03 is a biosimilar candidate for Prolia® and Xgeva® (denosumab), medicines for osteoporosis and bone cancer, respectively. Denosumab is a human monoclonal IgG2 antibody that targets the protein RANKL, which is essential for the formation, function and survival of osteoclasts, the cell type responsible for bone resorption. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA Arzneimittel AG sells its products in approximately 115 countries. In financial year 2023, STADA achieved group sales of EUR 3,734.8 million and reported earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 802.1 million. As of 31 December 2023, STADA employed 11,667 people worldwide.
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1 Uzpruvo is not currently approved for the ulcerative colitis indication, as the originator still has exclusivity for this indication.
2 Key statistic for Europe | International Osteoporosis Foundation
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