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HEALING SURGICAL WOUNDS WITH HUMAN PLASMA

Haemacure is developing human biological products for use during surgery to stop bleeding, seal tissues, and speed healing.

Key Points

• *Pivotal Phase II -III clinical trials for its fibrin sealant planned to commence in Q1-09.
• *Manufacturing facility under construction - to be completed mid-2008
• *Production of laboratory samples of its fibrin sealant is underway, for evaluation and testing purposes by potential clients and partners in drug delivery and regenerative applications.
• *One of two plasma fractions contains eleven proteins and enzymes that may have potential to become therapeutics to treat various diseases, including orphan diseases.
• *$12.5M non-brokered private placement completed in January 2007.
• *Scheduled to be in full commercial mode as early as 2010.
• *Exclusive patented ownership of its high-yield extraction technology platform
• *Haemacure’s technology is patented and was successfully defended against Aventis-Behring.
• *Over $50 million to date has been invested to develop Haemacure’s technology.
• *Haemacure has a market capitalization of approximately $20 million. Fully developed competitors have market caps greater than $500 million.
• *Proprietary plasma fractionation technology platform for producing surgical haemostats and therapeutic proteins and enzymes.
• *Applications include: regenerative medicine, adhesion prevention, drug delivery, combination with biomaterials and wound management.

Haemacure vs. The Current Marketplace

Haemacure’s lead product candidate is a fibrin sealant, containing two proteins derived from human plasma. Fibrin sealants are biologics used by surgeons mainly to seal surgical wounds and stop or control bleeding. Haemacure’s fibrin sealant has been applied to 151 persons in clinical trials without any serious adverse events attributable to the product being reported. The product was found safe and performed very well.

Haemacure’s second product candidate is thrombin, an active, absorbable haemostatic agent; thrombin is one of the two proteins of its fibrin sealant. Haemostatic agents are also used by surgeons, to stop or control bleeding.

Haemacure’s products do not contain aprotinin, a potentially harmful bovine component. Haemacure’s biosurgical products will provide significant clinical advantages by reducing the immunological risks and the potential for cross-species disease transmission associated with bovine-derived products.

Preliminary findings of a clinical trial involving Bayer HealthCare Pharmaceuticals Inc.’s Trasylol® (aprotinin) suggest that aprotinin, compared to other drugs, increases the risk of death. Bayer has subsequently withdrawn aprotinin from the market.

Competitors’ products on the market are the following:

Fibrin Sealant:

• *The incumbent is Tisseel®VH, marketed by Baxter International Inc. (BAX-NYSE). Baxter’s product contains aprotinin, a protein that has been associated with severe adverse reactions.

• *A recent addition to the market is Evicel™, marketed by Ethicon, a Johnson & Johnson company. The product contains human proteins.

Thrombin:

• *The incumbent is Thrombin-JMI®, marketed by King Pharmaceuticals, Inc.’s (KG-NYSE). King’s thrombin is of bovine origin and has, on occasion, been associated with abnormalities in haemostasis, including severe bleeding and thrombosis.

• *Evithrom™, a thrombin produced by OMRIX Biopharmaceuticals Inc (NASDAQ:OMRI). and marketed by Ethicon, was approved by the US FDA in August 2007

• *In January 2008, the FDA approved Recothrom™ Thrombin, a recombinant thrombin produced by Zymogenetics Inc. (NASDAQ:ZGEN). The product is not yet available on the market.

In addition to its human plasma advantage, Haemacure believes that its technology to extract key elements from plasma will enable it to retrieve drastically higher yields. Specifically, estimates are that Haemacure’s patented process can achieve up to 10 times the industry averages.

Market Opportunities & Trends

• *The current worldwide general haemostasis market is estimated at approximately US$675 million and expected to reach US$1.5 billion by 2015. Fibrin sealant use is expected to grow with its increasing acceptance by surgeons, widening fields of use, and an increasing number of surgeries.

• *The overall number of surgeries being performed is expected to increase substantially over the next 10 years due to the aging North American and European population and an increase in the number of elective surgeries.

• *The fastest growing segment of this population consists of individuals over the age of 65; their numbers are expected to increase 13.3% by 2010 and 53.2% by 2020. [Census2000].

• *The plasma protein market was valued between approximately $8.5 billion and $9 billion in 2004 and is forecast to grow to approximately $12.9 billion by 2010.

Next Steps For Haemacure

2008

• *Completion of manufacturing facility
• *Production of fibrin sealant for pivotal Phase II- III clinical trials
• *Amendment of open IND application with US FDA to commence fibrin sealant pivotal clinical trials
• *Partnerships - Haemacure is pursuing partnerships in the areas of regenerative medicine, adhesion prevention, drug delivery, combination with biomaterials and wound management.

2009

• *Haemacure is scheduled to begin pivotal Phase II - III trials for its fibrin sealant during the first quarter of 2009

2010

• *Haemacure is aiming to receive regulatory approval in the US and Europe toward the end of 2010, or the beginning of 2011

Conclusion

Over the next decade it is expected that the North American 60+ population will more than quadruple [Census2000]. The effect of this demographic shift will greatly increase demands on the current medical system and will dramatically increase the number of surgeries performed. Seniors will look to take advantage of an expanding array of new technologies for managing chronic illness and promoting active lifestyles. In addition, elective surgery for both young consumers and senior citizens is expected to become even more frequent as discretionary spending increases.

As such, there will increasing demand for better, faster and healthier surgical sealants.

Haemacure has positioned itself to meet this demand head on by leveraging its position as a developer of next-generation bio-surgical haemostatic, and therapeutic protein products. Plasma-based fibrin sealants and haemostats are believed to improve patient outcome. Significant cost savings are also achievable as they reduce the duration of surgical operations, the number of blood transfusions required during surgery, and they may reduce the duration of patient hospitalisation.