Navigation Links
Haemacure Confirms Operation Qualification of Production Equipment and Pursues Milestone Payment from CSL


MONTREAL, Dec. 4 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX:HAE), a Montreal-based specialty bio-therapeutics company developing high-value, human plasma-derived protein products for commercialization, announces that is has confirmed the successful operation qualification of the fibrin sealant production equipment at its new state-of-the-art plasma fractionation facility in Sarasota, Florida.

"I am very excited that we have achieved the important milestone of operation qualification, thus showing clear progress in our transition from a development to a manufacturing company. This allows us to take steps towards the next milestone of producing clinical lots of our lead product candidate, human fibrin sealant, and advancing it to market", said Joseph Galli, Chairman and CEO of Haemacure. "Achieving this milestone also triggers the contractual obligation of CSL Behring AG to pay Haemacure US$1.5 million", concluded Mr. Galli.

The successful operation qualification of the production equipment is one of three milestones the achievement of which obligates CSL Behring AG ("CSL") to pay to Haemacure US$4.5 million in total, pursuant to a settlement agreement entered into in 2002 in relation to its Hemaseel project. The achievement of each milestone obligates CSL to pay Haemacure US$1.5 million. As previously announced, CSL has advised Haemacure that, in its view, it is no longer obligated to make the milestone payments. Haemacure strongly disputes the position of CSL and has, as a result, filed a request for arbitration with the International Court of Arbitration of the International Chamber of Commerce to assert its right to collect the contractual milestone payments and, in particular, the payment due upon the operation qualification of production equipment. Haemacure plans on achieving the second milestone during the first half of 2009 and the third milestone during the following 12 months.

Plasma processing at the facility continues as planned and the product and production process are meeting expectations. Haemacure plans on achieving its first patient-in-the-clinic objective in the first half of 2009 and anticipates commercial launch of its fibrin sealant on the U.S. market in the first half of 2011, in line with previously announced guidance.

About Haemacure

Haemacure Corporation is a specialty biotherapeutics company developing high-value human plasma-derived protein products for commercialization. Haemacure's research and development effort is driven by its proprietary plasma protein extraction technology to develop next-generation products, including surgical haemostats. Haemacure's lead product candidate, Hemaseel(R)HMN, is a fibrin sealant to enter pivotal Phase II/Phase III clinical trials during the first half of calendar 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant, now in preclinical stage. Follow-on development will focus on the use of fibrin sealant in aesthetics, adhesion prevention, combination with biomaterials, drug delivery, regenerative medecine, skin graft fixation for burn injuries, and wound healing. Haemacure has identified eleven additional specialty proteins and enzymes in one if its two plasma fractions and seeks to advance these proteins and enzymes through partnerships with pharmaceutical and biotechnology companies. Haemacure is headquartered in Montreal, Canada and operates offices in Sarasota, Florida through a wholly-owned subsidiary. The Corporation is traded under stock symbol HAE on the TSX.

Forward-looking Statements

Certain of the statements contained in this news release are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the biotech industry, changes in the regulatory environment in the jurisdictions in which Haemacure does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. Haemacure disclaims any intention or obligation to update these statements.

SOURCE Haemacure Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Haemacure to Present at the Rodman & Renshaw Annual Global Investor Conference
2. Haemacure Appoints Thomas J. Lynch, J.D., Ph.D. to Board of Directors
3. Adhesion Prevention New Major Market Opportunity, Haemacure Confirms Effectiveness of its Fibrin Sealant in Second Preclinical Study in Adhesion Prevention in a Bleeding Model
4. Haemacure Raises $7.8 Million and is Fully Funded Beyond First-Patient-In-Clinic
5. Haemacure to Present at the BioInternational Convention - The Global Event for Biotechnology - at the San Diego Convention Centre, California, from June 17 - 20, 2008
6. Haemacure Achieves Major Milestone - Starts Processing Plasma in Its New Fractionation Facility
7. Haemacure Reports on Financing Progress and Second Quarter Results
8. Haemacure to Present at Busines$ Meets Finance on May 20, 2008 at the Montreal Sheraton Centre
9. Haemacure announces webcast of presentation at Rodman & Renshaw 5th Annual Global Healthcare Conference
10. Haemacure financing receives shareholder consent - Series B Warrants are amended
11. Haemacure to Present at the BioFinance 2008 Conference to be held at the Toronto Marriott Eaton Centre, May 6 - 8, 2008
Post Your Comments:
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual ... in Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon ... fun run is geared towards children of all ages; it is a non-competitive, non-timed ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a ... “The Journey: From the Mountains to the Mission Field” is the creation of published ... all ages and currently teaches a class of ladies at her church, which she ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the ... today its plans to open a flagship location in Covington, LA at 401 N. ... To Go store next to Office Depot in the Holiday Square shopping center. Its ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized ... have expanded their existing home health joint venture through an agreement, effective October ... a joint venture home health company with Asante, delivering clinically integrated care, for ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... D.C., for the 49th Congress of the International Society of Paediatric Oncology ... the Center for Cancer and Blood Disorders at Children’s National, and Stephen ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... R.I. , Sept. 25, 2017  EpiVax, ... assessment, vaccine design, and immune-engineering today announced the ... on the development of personalized therapeutic cancer vaccines. ... has provided exclusive access to enabling technologies to ... Eng., MBA will lead EpiVax Oncology as Chief ...
(Date:9/19/2017)... Mich. , Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical device company ... destruction of targeted tissues, announced three leadership team developments today:   ... PhD ... ... Veteran medical device executive Josh ...
(Date:9/13/2017)... ATLANTA , Sept. 13, 2017   OrthoAtlanta ... to the Atlanta Football Host Committee (AFHC) for the 2018 ... Monday, Jan. 8, 2018, at Mercedes-Benz Stadium in ... part of the AFHC "I,m In" campaign, participating in many ... ...
Breaking Medicine Technology: