Context

BiosanaPharma B.V. is a private, Netherlands-based, clinical-stage biologics company developing a phase III-ready Xolair® (omalizumab) biosimilar, AVT23 (also called BP001) on a highly disruptive, proprietary cGMP continuous “3C” manufacturing platform

Headquartered in Iceland, Alvotech is a leading pure play biosimilar platform focused on the global development and manufacture of high-quality biosimilars. Alvotech’s pipeline contains eight biosimilar candidates covering autoimmune disorders, eye disorders, osteoporosis, and cancer with estimated cumulated peak originator sales of more than $80bn

Under this strategic partnership, Alvotech will receive exclusive global rights for AVT23 and will jointly develop it with BiosanaPharma through Phase III. BiosanaPharma will receive an upfront payment and tiered royalties

Omalizumab (Roche/Novartis’ Xolair®) is an anti-allergy mAb targeting free Immunoglobulin E (IgE) and indicated for the treatment of severe allergic asthma and chronic idiopathic urticaria with annual sales of c. $3.3bn in 2020

AVT 23 is one of the most advanced Xolair biosimilar projects on the market and has the potential to be one of the first biosimilar launched in the US / EU when exclusivity is lost for the PFS liquid presentation in 2025 / 2024

BiosanaPharma has completed a pharmacokinetic (PK) study showing that AVT23’s bioavailability, safety, tolerability and immunogenicity were comparable to those of Xolair. Preparation for a global Phase III clinical trial is ongoing and AVT23 will be produced using BiosanaPharma’s proprietary 3C process technology

About BiosanaPharma

BiosanaPharma B.V. is a private, Netherlands-based, clinical-stage biologics company developing a phase III-ready Xolair® (omalizumab) biosimilar, AVT23 (also called BP001) on a highly disruptive, proprietary cGMP continuous “3C” manufacturing platform.

Xolair® is an anti-allergy monoclonal antibody and the current standard of care for the treatment of severe allergic asthma and chronic spontaneous urticaria. Annual global sales of Xolair® were approx. USD3.3Bn in 2020.

BiosanaPharma’s BP001 is one of the most advanced Xolair® biosimilar projects and is expected to start its Phase III in collaboration with Alvotech in 2023.

BiosanaPharma is the first company to have performed a Phase I study with a product made on a fully integrated (USP, DSP), continuous monoclonal antibody manufacturing platform. The “3C” continuous platform is able to deliver monoclonal antibodies at significantly higher yields, at a fraction of the current market production costs (up to 90% cheaper), representing a unique opportunity for biosimilar manufacturing and beyond.

Discover BiosanaPharma

About Alvotech

Headquartered in Iceland, Alvotech is a leading pure play biosimilar platform focused on the global development and manufacture of high-quality biosimilars.

Alvotech’s pipeline contains eight biosimilar candidates covering autoimmune disorders, eye disorders, osteoporosis, and cancer with estimated cumulated peak originator sales of more than $80bn.

In December 2021, Alvotech announced that it had entered into a combination agreement with a SPAC sponsored by Oaktree Capital Management for a future listing on Nasdaq. The transaction will deliver $450m proceeds to Alvotech to accelerate its growth, valuing the company at $2.25bn

Discover Alvotech

Hervé Ronin

Investment Banking

Hervé Ronin photo

Vincent Meunier

Investment Banking

Vincent Meunier photo

Raphael Bidaut

Investment Banking

Mark Hong

Investment Banking

Deal Team

Should you want to know more about this transaction, you can contact one of the team members above

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