Leaders in Annexin A5 biology and applications

Annexin Pharmaceuticals was established in 2014 in Sweden. It is now a world-leader in Annexin A5 biology and applications in the medical field. The drug candidate ANXV is produced by a patented method and has the potential to become a First-In-Class drug for several patient groups with significant unmet medical demands.

ANXV development programme

The development of ANXV has to date included product formulation work to obtain a product that is stable and suitable for use, pre-clinical evaluation to assure non-toxicity, and testing in healthy human volunteers to confirm that ANXV is safe and tolerable. The current ongoing development stage is to define an appropriate dose and evaluate efficacy in the intended indication in phase 2 studies. Whereafter efficacy is to be confirmed in larger patient groups in phase 3 studies. The last step entails authorisation by regulatory authorities before commercialisation. The development programme currently includes ophthalmology (retinal vein occlusion) and oncology. Other indications might be explored in the future, depending on patient needs, market situation, and ANXV suitability.

Introduction

This is Annexin Pharmaceuticals

Annexin Pharmaceuticals is a world-leading innovative clinical stage biotech company in the Annexin A5 field. The drug candidate ANXV has the potential to change the current standard of care in several indications, and provide a completely new treatment concept.

Annexin at a glance

Annexin Pharmaceuticals was established in 2014 in Sweden, with its headquarters in Stockholm. The company is a world-leader in Annexin A5 biology and applications in the medical field. The drug candidate ANXV contains the protein Annexin A5, a native human protein with many important healing roles in the body. ANXV is produced by a patented method, and has the potential to become a First-In-Class drug for several patient groups where there is considerable unmet demand for medical treatment. ANXV is currently being evaluated in a clinical study with patients suffering from retinal vein occlusion.

Optimising the ANXV programme

The business model of Annexin Pharmaceuticals is based on maintaining and strengthening its leading position in the Annexin A5 area for the treatment of diseases. Development risks are minimised, and the value of the ANXV programme is optimised before partnership, licensing or sale.

Business model & strategy

Company background

Annexin Pharmaceuticals AB (publ) was established 2014 in Stockholm, Sweden. It has been publicly listed on NASDAQ First North since 2017. The ANXV development programme is based on discoveries made by Dr. Anna Frostegård and Prof. Johan Frostegård at Karolinska Institutet in Stockholm, Sweden.

Management and board

The management and board of Annexin Pharmaceuticals encompasses a group with long experience within research and development of pharmaceutical products, from preclinical stage to market authorisation application, as well as acquisitions, mergers and licensing.

The board appoints the CEO who is responsible for managing the day-to-day operations in accordance with guidelines from the Board.

ANXV – an immune cell regulator

ANXV is an investigational new drug that contains the human protein Annexin A5, produced by recombinant techniques in Escherichia Coli (E.coli).

The role of endogenous Annexin A5 is to reduce cellular stress and tissue injury, and act as an immunomodulator by inhibiting the role of phosphatidylserine (PS), a lipid molecule found in all cellular membranes. Like the endogenous Annexin A5, ANXV binds to PS and can protect cells, regulate the behaviour of immune cells, and be of beneficial therapeutic effect. The therapeutic potential of ANXV is broad since PS is a factor in many diseases.

Learn more about ANXV

Strong patent portfolio

The company has gradually strengthened its patent portfolio through patent applications and granted patents for the use of Annexin A5/ANXV as a treatment of various diseases, as well as a number of approved patents regarding an efficient production method.

The patent portfolio has been expanded through licences and the protection of the focus areas RVO and cancer is secured via in-licensed use patents (patents claiming an indication, dosage regimen, method of administration, or other condition of use).

The patent that protects the manufacturing process entails built-in specific product protection for ANXV, which protects against competitors’ possible attempts to create similar molecules with recombinant technology for medical use. The strategy to maintain a broad patent portfolio is primarily aimed at increasing the opportunity for future partners/licensees/buyers to be able to conduct several clinical efficacy studies in order to expand approved indications, so-called label expansion.

Current and future collaborations

Annexin Pharmaceuticals is collaborating with highly experienced contractors, experts and companies executing, for example, manufacturing and clinical trials on Annexin's behalf.

Collaborations are also in place for performing, among other things, investigator´s Initiated trials. The goal is to extend collaborations, both with industry and academy.

Please contact CEO Anders Haegerstrand regarding any suggestions for collaboration.