Thursday July 22, 8:12 pm Eastern Time
Company Press Release
SOURCE: Inflazyme Pharmaceuticals Ltd.
Inflazyme quarterly shareholder letter
VANCOUVER, July 22 /CNW-PRN/ -
To our shareholders:
This past quarter marks the first anniversary of my appointment as President and CEO of Inflazyme. During this past quarter,
and indeed throughout the past year, the Inflazyme team and I have worked to strengthen the Company and establish a strong
position in the area of anti-inflammatory therapeutics. During this time, we have accomplished several key milestones and are
now positioned to continue to build our franchise in this area.
Commencement of human clinical trials with IPL576,092
Throughout this past quarter we have made several key advancements with our technology culminating in June with the
commencement of our first human clinical trials with our lead asthma compound, IPL576,092. The Phase I clinical trial program
is being conducted in association with Inveresk Research, of Scotland and the first part of the program is expected to be
completed and results obtained during the latter half of 1999. We are targeting to complete all stages of the Phase I program by
the end of the first quarter of 2000. Subject to satisfactory results being achieved, Inflazyme would expect to be able to file an
IND with the US, FDA sufficient to allow Phase II human clinical studies to commence in the first half of 2000.
Advancement of IPL423
Our second class of compounds, IPL423 has been shown in vitro to inhibit a process that contributes to inflammation. We are
currently studying IPL423 in disease-specific in vivo models of inflammation and we expect to complete these studies and select
lead clinical candidates from the IPL423 family of compounds within the coming quarter. Inflazyme plans to eventually seek
potential partners for the development of IPL423 for the treatment of arthritis and potentially other indications, including
psoriasis and inflammatory bowel disease.
C$137m collaboration agreement with Hoechst Marion Roussel
In May, we were pleased to announce that we had signed the definitive agreements for our collaboration with Hoechst Marion
Roussel to develop two novel series of compounds for the treatment of asthma and allergies: Inflazyme's IPL576 series and
Hoechst Marion Roussel's H1/NK1 dual antagonists. The collaboration provides Inflazyme with an up-front fee and an equity
investment by Hoechst Marion Roussel totaling up to C$24 million. To date, Inflazyme has received approximately C$18 million
under the terms of the collaboration and we expect to access the remainder through preferred equity investments in the future. In
addition, Inflazyme will be entitled to payments totaling C$113 million if development milestones specified in the agreement are
achieved. Inflazyme will also receive double-digit royalties on future sales of products developed under the agreement.
Extension of our technology base
The addition of Hoechst Marion Roussel's H1/NK1 dual antagonists provides Inflazyme with a third pre-clinical development
program. H1/NK1 dual antagonists are a novel class of compounds developed by scientists at Hoechst Marion Roussel.
H1/NK1 dual antagonists combine, in a single molecule, an antihistamine and a neuro-peptide inhibitor. In pre-clinical studies to
date, H1/NK1 dual antagonist compounds have demonstrated antagonist activity at both the H1 and NK1 receptors, which
indicates that they may have the potential to relieve both the itchiness and the congestion associated with allergies. Inflazyme will
develop H1/NK1 dual antagonists through Phase IIa clinical trials, after which Hoechst Marion Roussel will have the option to
acquire exclusive worldwide rights to an oral dosage form of a product developed from the H1/NK1 dual antagonists upon
payment of a milestone to Inflazyme. Inflazyme will retain the rights to any topical ocular formulation of H1/NK1 dual
antagonists.
Completion of financing and strong cash position
Also in May, Inflazyme completed a special warrant financing for gross proceeds of approximately C$15.5 million. These
monies, combined with the monies received to date from Hoechst Marion Roussel, position the Company with approximately
C$34.0 million. These funds provide Inflazyme with approximately two to three years of cash and added flexibility to develop
additional compounds from the IPL576 series, to progress development of IPL423 and H1/NK1 and to undertake other
strategic activities with the aim of accelerating the advancement of our technologies and the building of the Company.
Achievement of TSE Listing
In June, we announced that we had received conditional approval for listing on The Toronto Stock Exchange (TSE). I am
pleased to report that our shares began trading on the TSE on July 7, 1999. Obtaining this listing on Canada's senior stock
exchange is an important step in our continuing efforts to build a strong Company.
We are very pleased in having achieved so many significant milestones during the past year. In the near-term, our goal will be to
continue to progress our technologies whilst seeking to develop and implement strategies that maximize shareholder value. I
look forward to providing you with another positive update in the Fall.
Our Annual General Meeting is scheduled to take place on September 23, 1999. We will be providing details regarding the
location in the near future. I hope to have the opportunity to meet many of you at that time.
On behalf of everyone at Inflazyme, thank you for your continued interest in and support for Inflazyme.
Ian McBeath
President & CEO
This press release contains statements of a forward-looking nature relating to the future of Inflazyme Pharmaceuticals Ltd. These
statements are based upon information currently available to the Company, and they involve risks and uncertainties that could
cause actual results to differ materially from current expectations. Additional risks and uncertainties that could affect the
Company's actual results, performance, or achievements include, but are not limited to, the ''Risk Factors'' set forth in the
Company's annual Report, and general financial, economic, regulatory and political conditions affecting the biopharmaceutical
industry in general. Given these uncertainties, current or prospective investors are cautioned not to place undue reliance on any
such forward-looking statements.
SOURCE: Inflazyme Pharmaceuticals Ltd.
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