Acuvax Limited

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Assets

Acuvax Ltd

Acuvax Ltd, the listed parent company (ASX: ACU) is the flagship asset of the group. It primarily derives value for shareholders through leading operations of its product development and commercialisation subsidiaries. Now that the company has been reorganized, with a rational cost and expense base and a strong and demonstrated ability to generate major revenue deals with larger overseas partners, additional value accretion of assets should benefit shareholders. Also, as a Public Company, investors now have liquidity with which to buy and sell their shares. As is common in the biotechnology industry, some holdings will be held in private investee companies possessing promising technologies, and as a listed entity ACU can simultaneously access capital from public markets as well as help shareholders access that value with liquidity. The company also intends to re-activate its ADR program to make the company more accessible to overseas investors.

The December 2006 re-organisation of the business replaced the prior management team with a new group well experienced in driving commercial licensing transactions and revenue generating partnerships with larger players in the USA market. The principal revenue deal at present is via the wholly owned subsidiary, ACT USA, controlled by ACU. On March 15, 2007, ACT entered into a strategic partnership agreement with Medingen Group of New York, to sub-license a line of nutraceutical products previously known as Revisys, which are being subsequently re-branded ‘Encore,’ and which have attracted considerable interest in the market. These are over-the-counter branded medical nutritional supplements which are used to enhance health and well being. Under the terms of the licensing agreement, ACU granted exclusive worldwide rights to market and distribute these products via Medingen Group, for a fee equal to 50% of net sales. The Directors have seen great progress and interest from major players in this space and expect this asset to progress well.

A major shareholder in the parent company is Chopin Opus 1, a Cayman-Islands based investment company (affiliated with Richard Opara, MD, the former Chairman of ACU) that controls approximately 85% of the outstanding shares. This high equity stake resulted from the strong financial commitment to developing the oncology technologies, especially RP101, until recent commercialization.

 

Avantogen Oncology Inc

(OTC: AVTO) is the US based oncology drug development and commercialisation public company. In late 2006 the company was developing three lead candidates, including Phase I and Phase II trials, in the area of chemoresistant solid tumors. The new board reviewed the portfolio, and focused all efforts on RP101, a pancreatic cancer drug which significantly improved survival rates amongst patients. RP101 also works well in combination with the commonly prescribed drug Gemcitabine, for treating solid tumors. Avantogen Oncology Inc holds the rights geographically for North America for this product (all indications), through a partnership with RESprotect GMBH of Germany. (Note: the parent company, ACU, holds a 10% shareholding in RESprotect, thus permitting the Group to benefit should licensing transactions for other geographic regions eventuate).

In April, 2007 Avantogen Oncology Inc entered into an agreement with SciClone Pharmaceuticals  (NASD: SCLN) to assign all its rights to RP101 in exchange for up front cash payments and ongoing payments for the US and Canada markets.

Key components of the deal included:

  • An up front Cash Payment of US$1.7 M, already received
  • Cash Payments for Regulatory Filings, for each of the Filing and Acceptance of NDA, for USFDA approval of first indication, USFDA approval of second indication, for USFDA approval of third indication (cancer drugs are often extended to other indications and in this deal AVTO gets paid for each indication)
  • Sales Milestone Bonus for commercialisation
  • Sales Stretch Milestone Bonus for successful market penetration
  • Net Sales Payments for commercialisation
  • Net Sales Stretch Milestone Bonus payments for strong sales
  • SciClone has a right to Buyout the RP101 asset at various stages, at broadly pre-agreed valuations.
  • The revenue stream above accrues to AOI, and could total over $23 million USD. RESprotect GMBH, the developer of the technology, has received a separate payment stream from SciClone.
 

Hawaii Biotech Inc

Currently, ACU owns 23.32% of shares in this exciting vaccine development company, which has products in all of the major areas. Investing via Acuvax Limited in Hawaii Biotech Inc (HBI)permits investors to participate in an entity with a major, stake in this growing business, and also provides liquidity (HBI is currently privately held). The research, development, and proprietary manufacturing processes comprising a manufacturing platform at this company hold great promise, and the company's products have been the subject of major awards, features in Nature and other leading medical journals, and grants from the US government (amounting to over US$35 million in the last five years) and leading research foundations.

A summary of the portfolio is shown below.

Product Phase Value to Shareholders

West Nile Virus vaccine

Clinical
  • IND accepted by US FDA December 2007
  • Dosed first subject May 2008
  • Dosed last subject December 2008
  • West Nile virus increasing in prevalence, potential epidemic in North and South America

 

Dengue vaccine

Clinical

  • IND to be filed early in 2009
  • First Phase 1 scheduled for Q2 2009
  • Promising approach to a resurgent disease widely publicised. Many big pharma companies have publicly expressed interest in this market and licensing or partnering opportunities exist

Manufacturing Platform

Patent Protected

  • Recombinant vaccine manufacturing platform permits rapid upscaling (alternative to cumbersome egg-based processes).
  • Proprietary protein expression platforms provide a range of strategic options for the company
  • Revenue currently generated by reagent sales

Adjuvant

Clinical

  • Adjuvant potentially adds to efficacy of oncology and vaccine products
  • Clinical trial conducted by licensee
  • Attractive out-licensing candidate

Infectious Diseases

Preclinical

  • Promising reasearch pipeline with R&D supported by leading reasearch grants in  Influenza, Malaria, Tick-borne Encephalitis

The company has 30 full time employees, including leading research scientists well experienced in protecting and commercialising proprietary intellectual property. Additional assets include a state of the art biotechnology laboratory which has won numerous international awards. The company has also been re-organised around a well experienced senior management team, who also serve on the Board of Directors. HBI is currently seeking up to US$20 million in equity capital through a planned new offer. Acuvax Ltd will be able to participate in this capital raising, subject to raising funds to do so.

 


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