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Alvotech (NASDAQ: ALVO) is a global biopharmaceutical company specializing in the development and manufacturing of high-quality biosimilar medicines aimed at enhancing patient access to affordable treatments worldwide. Established in 2013, the company has committed itself to becoming a leader in biogenerics, focusing on the creation of cost-effective biosimilars that meet stringent quality standards. Alvotech operates through a fully integrated model, addressing every step from cell line development to commercial manufacturing.
Alvotech's headquarters in Reykjavik, Iceland hosts a state-of-the-art flexible manufacturing facility that underscores the company's commitment to high-quality and efficient production. The company's portfolio includes biosimilars for autoimmune disorders, eye conditions, osteoporosis, respiratory diseases, and cancer. Alvotech has successfully launched two biosimilars and is actively working on nine more candidates.
In recent developments, Alvotech announced positive top-line results for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and has received FDA approval for AVT04, a biosimilar to Stelara®. The company is also advancing in its U.S. strategic partnership with Teva Pharmaceuticals for the high-concentration interchangeable biosimilar to Humira®, marketed under Quallent’s private label. Financially, Alvotech reported increased revenues of $37 million in Q1 2024 and strengthened its position with a strategic refinancing transaction led by GoldenTree Asset Management, enhancing its financial flexibility and reducing upcoming debt maturities.
Alvotech's global reach is bolstered by strategic commercial partnerships with renowned pharmaceutical companies like Teva, STADA Arzneimittel AG, Fuji Pharma Co., Ltd., and many others. These collaborations extend across the United States, Europe, Japan, China, and several other regions, leveraging local expertise to provide expansive market access.
For more information on Alvotech and to stay updated with the latest news, visit www.alvotech.com.
Alvotech S.A. has submitted an application to Nasdaq Iceland for its shares to be traded on the Nasdaq Iceland Main Market under the ticker symbol “ALVO.” This application is currently pending approval. Alvotech's shares are already trading on the Nasdaq Stock Market in the U.S. and the Nasdaq First North Growth Market. The company's Board of Directors announced the plan to move its listing to the Nasdaq Main Market in Iceland on August 12, 2022.
Alvotech (NASDAQ: ALVO) has successfully secured approximately $136 million in financing to advance its biosimilar pipeline, as announced on November 16, 2022. This includes a $70 million upsize of existing senior bonds and a $50 million unsecured loan from Alvogen, a major shareholder. Additionally, Alvotech is acquiring its Reykjavik manufacturing facility for $80 million using an unsecured convertible bond and will refinance secured loans for around $16 million. These moves aim to enhance operational flexibility and support the development of eight biosimilar candidates.
Alvotech (NASDAQ: ALVO) reported a remarkable revenue increase for the first nine months of 2022, reaching $59.2 million compared to $2.0 million in 2021. The company is progressing talks with the U.S. FDA regarding its biologic license applications for AVT02, targeting a U.S. launch on July 1, 2023. Furthermore, Alvotech has submitted marketing applications for AVT04 in major markets and expanded its partnership with JAMP Pharma. Total cash and equivalents stood at $12.8 million, despite significant debts of $518.6 million, while the net loss narrowed to $193.1 million.
Alvotech (NASDAQ: ALVO) announces that its biosimilar AVT02, a high-concentration, low-volume formulation of adalimumab, has received marketing authorization from the Therapeutic Goods Administration in Australia. Marketed under the names Ciptunec™ and Ardalicip™, this biosimilar is now available for various indications, including rheumatoid arthritis and Crohn's disease. This is the first biosimilar resulting from Alvotech's partnership with Cipla, aiming to enhance access to affordable biologics in Australia and other regions.
Alvotech (NASDAQ: ALVO) announced its participation in the American College of Rheumatology (ACR) Convergence Conference, where it will present two posters and host an Ignite Talk on its switching study for ATV02.
The study focuses on the pharmacokinetics, immunogenicity, efficacy, and safety of switching between Humira and AVT02, a high-concentration biosimilar candidate. The FDA accepted Alvotech’s Biologics License Application for interchangeability in February 2022, currently under review. This work emphasizes improving patient access to biologics while reducing costs.
Alvotech (NASDAQ: ALVO), a biotech company focused on biosimilars, is set to release its financial results for the first nine months of 2022 on November 15, 2022, after U.S. market close. A business update conference call will follow on November 16, 2022, at 8:00 am ET. Alvotech aims to be a leader in biosimilar medicines, with eight candidates in its pipeline targeting diseases such as autoimmune disorders and cancer. The company is partnered with numerous commercial entities globally to enhance market reach.
Alvotech (NASDAQ: ALVO), a biotech company focused on biosimilar medicines, will participate in the Jefferies London Healthcare Conference from November 15 to November 17, 2022. The leadership team plans to present on November 17 at 10:25 am GMT and will conduct investor meetings throughout the event.
A webcast of the presentation will be accessible on Alvotech’s website for 90 days post-conference.
Alvotech (NASDAQ: ALVO) has announced an expanded partnership with JAMP Pharma Group to commercialize two new biosimilar candidates, AVT16 and AVT33, in Canada. This partnership builds on their previous success with Simlandi™, a biosimilar to Humira, launched in April 2022. Alvotech will develop and supply these biosimilars, while JAMP Pharma will manage marketing and sales in Canada, aiming to enhance patient access to affordable biologics. The partnership aligns with Alvotech's goal to lead in the Canadian biosimilars market.
Alvotech (NASDAQ: ALVO), a biotech firm, has announced that its partner, Fuji Pharma Co., Ltd., has submitted a marketing approval application to Japan's Ministry of Health for their first biosimilar candidate. This marks a significant milestone in their exclusive partnership aimed at increasing access to essential biologics in Japan. Alvotech's pipeline includes eight biosimilar candidates targeting various diseases, positioning them to meet the rising demand for biosimilars in Japan and beyond.
Alvotech (NASDAQ: ALVO) announced the appointment of Sarah Tanksley as its new Chief Quality Officer, effective October 14. She succeeds Reem Malki, who stepped down for personal reasons. Tanksley, having previously consulted for Alvotech, brings over 20 years of experience from regulatory agencies like the FDA and the NIH. Her expertise in regulatory compliance and GMP is expected to facilitate a smooth transition and enhance Alvotech's capabilities.
Alvotech focuses on developing biosimilar medicines to serve patients globally.
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