LAVAL,
QUEBEC, CANADA and TAIPEI, TAIWAN--(Marketwire - May 7, 2012) - ProMetic
Life Sciences Inc. (TSX:PLI)
- ProMetic grants
global co-exclusive rights for a plasma-derived orphan drug
- Hematech to pay
ProMetic $10M for the orphan drug development program with $1M
upfront
- Orphan drug to
be manufactured in ProMetic's Laval facility
- Hematech to
build and operate a facility in Taiwan to manufacture plasma-derived
biopharmaceuticals implementing ProMetic's Plasma Protein
Purification System ("PPPS™")
ProMetic
Life Sciences Inc. (TSX:PLI) ("ProMetic" or the "Corporation") and Hematech
Biotherapeutics Inc. ("HBI") announced today the
signature of definitive agreements for the co-development and co-exclusive
commercialization, on a world-wide basis (excluding China), of a plasma-derived
biopharmaceutical product targeting a rare medical condition ("Orphan
Drug"). The deal includes the granting of manufacturing rights by ProMetic
to HBI of plasma-derived biopharmaceuticals using ProMetic's proprietary
PPPS™.
The $10
million from HBI will fund the Orphan Drug's development program up to
regulatory approval; a $1 million upfront payment followed by $9 million staged
payments to ProMetic related to defined development milestones. $5 million of
the development fees are expected over the course of the next 15 to 18 months
leading to the filing of an IND in the second half of 2013. Following the
completion of clinical trials and regulatory approval, the Orphan Drug will be
commercialized jointly by ProMetic and HBI on a global basis (excluding China),
with both parties sharing profits equally. The Orphan Drug will be
manufactured by ProMetic in its Laval facility and in HBI's planned facility in
Taiwan.
The
deal includes a strategic alliance providing HBI rights to ProMetic's
proprietary PPPS™ as well as training and technical support to manufacture
plasma-derived biopharmaceuticals in a Taiwanese facility to be built and
operated by HBI. Under this strategic alliance, HBI will fully fund the
construction and operating costs of the new cGMP plant dedicated to manufacture
plasma-derived therapeutics for ProMetic and its licensees. The core cGMP
manufacturing area of the facility in Taiwan will be based on the same design
as ProMetic's own Laval facility. Pursuant to this alliance, the two companies
will synchronize the construction of this Taiwanese manufacturing facility
along with the advancement of other plasma-derived therapeutics currently under
development by ProMetic and its other licensees.
"This
strategic relationship will provide Hematech and ProMetic with a valuable
biopharmaceutical product with excellent market potential as well as a world
class manufacturing facility implementing ProMetic's proven manufacturing
platform," stated Dr Chan, M.D., Chairman of HBI. "We are
pleased to see our financial resources and extensive experience in the
manufacturing of biopharmaceuticals contributing to leverage the strategic fit
between our two companies. The competitive advantage provided by ProMetic's
manufacturing platform will certainly create value for Hematech as it pursues
its goal of marketing high-value, niche products targeting unmet medical
needs", added Dr. Chan.
"We
are privileged to have access to the wealth of experience brought on board by
Dr Chan and his colleagues at Hematech. Under Dr Chan's leadership as Chairman,
Adimmune Corporation in Taiwan successfully built the first commercial vaccine
facility in Asia meeting European Medecines Agency ("EMA")
standards", mentioned Dr Tom Chen, ProMetic's Senior Vice President
Product and Asia/Pacific Development. "Both parties will mutually benefit
from their respective extensive industry expertise", added Dr Chen.
"The combination of our sizeable investments to develop our manufacturing platform, our strategic decision to set up our own plasma manufacturing facility as well as the recent successful scale up of our process in China were all instrumental in securing this strategic partnership with HBI" mentioned Mr. Pierre Laurin, ProMetic's President and Chief Executing Officer. "This transaction capitalizes on our mutual synergies and common commercial visions", added Mr. Laurin.
About
Orphan Drug
An orphan
drug is a pharmaceutical agent that has been developed
specifically to treat a rare medical condition, the condition itself being referred
to as an orphan disease. The assignment of orphan status to a disease and to
any drugs developed to treat it is a matter of public policy in many
countries, and has resulted in medical breakthroughs that may not have
otherwise been achieved due to the economics of drug research and development.
Orphan drugs generally follow the same regulatory development path as any other
pharmaceutical product, in which testing focuses on pharmacokinetics and
pharmacodynamics, dosing, stability, safety and efficacy. However, some
statistical burdens are lessened in an effort to maintain development momentum.
About
the Plasma Protein Purification System
The
Plasma Protein Purification System (PPPS™) allows for the targeting and removal
of multiple high-value proteins from a single plasma sample at unprecedented
activity levels using ProMetic's Mimetic Ligand™ adsorbent
technology. This system also provides for the recovery of new
biotherapeutics as they are discovered and identified. The effect of this
process is to reduce the significant losses incurred when using the more
conventional Cohn precipitation process.
About
Hematech Botherapeutics Inc.
Hematech
Biotherapeutics Inc. is a privately held biotechnology company with
headquarters located in Taipei, Taiwan. Hematech Biotherapeutics Inc. is
extensively involved in the sponsorship, development and production of
therapeutic drug particularly in the area of hematology. Hematech
Biotherapeutics Inc. maintains an extensive collaborative network with
industrial partners and is committed to the development of safe, high-quality,
and low cost therapeutics drug. Major shareholders of Hematech Biotherapeutics
Inc. include a key supplier of vaccines and a medical service and logistics
company in Taiwan. Both companies are publicly listed in Taiwan.
About
ProMetic Life Sciences Inc.
ProMetic
Life Sciences Inc. (www.prometic.com) is
a biopharmaceutical company specializing in the research, development,
manufacture and marketing of a variety of commercial applications derived from
its proprietary Mimetic Ligand™ technology. This technology is used in
large-scale purification of biologics and the elimination of pathogens.
ProMetic is also active in therapeutic drug development with the mission to
bring to market effective, innovative, lower cost, less toxic products for the
treatment of hematology and cancer. Its drug discovery platform is focused on
replacing complex, expensive proteins with synthetic "drug-like"
protein mimetics. Headquartered in Laval (Canada), ProMetic has R&D
facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK
and business development activities in the U.S., Europe, Asia and in the
Middle-East.
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