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Life Sciences News Brief
Vol. 5 no. 46 - February 8, 2006
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Pharmaceuticals Update |
Lorus announces the presentation of
Virulizin(R) Phase III clinical trial
Lorus Therapeutics Inc.
(Toronto), a biopharmaceutical company specializing in the
development and commercialization of pharmaceutical products and
technologies for the management of cancer, announced the results of
further exploratory analysis of data from its Phase III clinical
trial of Virulizin(R) for the treatment of pancreatic cancer. This
analysis showed significant survival benefit for a subgroup of
patients who continued to receive Virulizin(R) after entering
optional Stage 3(*) second-line therapy. The randomized,
double-blind, multicenter Phase III clinical trial compared
Virulizin(R) plus gemcitabine to placebo plus gemcitabine for the
treatment of chemonaive patients with locally advanced or metastatic
pancreatic cancer as first-line therapy. Optional Stage 3
second-line therapy included continuation of Virulizin or placebo
alone or in combination with 5-flurouracil. Exploratory analysis of
the clinical trial data indicates a significant survival benefit for
patients who entered optional second-line therapy after disease
progression (Stage 3 in the clinical protocol) and who continued to
receive Virulizin(R). Stage 3 patients who remained on Virulizin(R)
demonstrated a median survival of 10.9 months, compared with 7.4
months for both intent to treat (ITT) and efficacy evaluable (EE)
patients on placebo. Differences in survival times were found to be
statistically significant, with P values of 0.0178 and 0.0190 in the
ITT (N equals 167) and EE (N equals 157) populations, respectively.
Notably, the majority of Stage 3 patients from the Virulizin plus
gemcitabine group chose to remain on Virulizin , comprising about
35% to 40% of the overall ITT or EE patient population in the trial.
Microbix takes over production of
urokinase
Microbix Biosystems Inc.
(Toronto) announced that it has taken over the production of its
urokinase product from Genpharm Inc. and will directly operate the
manufacturing facilities. The two companies, which have been working
together over the past three years to commercialize the product,
have now amended their licensing agreement to reflect these changes.
Microbix will now assume the costs associated with bringing the drug
to market - costs previously funded by Genpharm, an affiliate of
Merck KgaA, In addition to producing urokinase at the facilities,
Microbix plans to use the plant to manufacture other products. "By
doing so, we expect to generate revenue and operate these facilities
on a positive cash flow basis before and after urokinase is in the
market," said William J. Gastle, President and CEO of Microbix.
U.S. FDA approves Cangene's
anti-hepatitis B product
Cangene (Toronto) announced that the U.S. Food and
Drug Administration (FDA) has approved Cangene's HepaGam B(TM) for
treatment following acute exposure to hepatitis B virus. HepaGam
B(TM) is Cangene's hepatitis B immune globulin (human), a purified
antibody or hyperimmune that is specific for the hepatitis B virus.
Hepatitis B is a highly infectious virus that can be spread through
contact with blood and other bodily fluids from an infected person
or can be transmitted from an infected mother to a newborn during
birth. |
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Diagnostics and Therapeutics Update |
Amorfix to begin therapeutic program
for neurodegenerative diseases
Amorfix Life Sciences Ltd.
(Toronto) reported that it has obtained an exclusive worldwide
license to novel targets on Superoxide Dismutase-1 (SOD1), which is
a protein known to misfold and aggregate in the neurological disease
Amyotrophic Lateral Sclerosis (ALS). The company also obtained an
exclusive five-year option to acquire the intellectual property and
know how surrounding the licensed technology. The company will use
these novel targets to initiate its therapeutic program for
neurodegenerative diseases, beginning with ALS. The SOD1 targets
were discovered by Dr. Neil Cashman, the company's Chief Scientific
Officer, in his former academic laboratory at the University of
Toronto, Centre for Research in Neurodegenerative Diseases. The
University subsequently assigned all rights to Dr. Cashman who has
licensed the technology to Amorfix. "I have attended thousands of
patients with ALS and have been frustrated at the lack of any
effective therapy," stated Dr. Cashman, who is also the Director of
the ALS Centre at the Vancouver Coastal Health Authority. "I am
overjoyed to have finally defined a starting point for the
development of a therapeutic solution for this debilitating
disease." Amorfix has committed to invest a minimum of $300,000 on
development of the technology under the terms of the license.
Angiotech to Acquire American Medical
Instruments Holdings, Inc.
Angiotech Pharmaceuticals,
Inc. (Vancouver) announced that it has entered into a definitive
agreement to acquire privately held American Medical Instruments
Holdings, Inc. (AMI), a leading independent manufacturer of
specialty, single-use medical devices, for approximately CDN $900
million in cash. The transaction provides Angiotech with a
commercial platform to capitalize on its current product pipeline,
supporting a wide range of specialty therapeutic areas. At the same
time, the acquisition of AMI significantly diversifies Angiotech's
revenue base and gives the company global manufacturing, marketing
and sales capabilities. The transaction, which is anticipated to
close in the second quarter of 2006, is expected to be immediately
accretive to Angiotech's 2006 and 2007 results. AMI has global
operations in 12 locations and four countries, including over
550,000 square feet of modern manufacturing operations. Post
transaction, Angiotech will have two specialty sales forces
operating on a worldwide basis; one focused primarily on general
surgery, plastic surgery, and ophthalmic surgery, and the second
focused on vascular surgery, interventional radiology and tumor
biopsy.
Access to Cangene chickenpox product
expanded
Cangene (Toronto) announced that the U.S. Food and
Drug Administration (FDA) has approved an expanded access
investigational new drug (IND) protocol for use of VariZIG(TM),
Cangene's Varicella immune globulin. This approval means that
at-risk patients will be able to receive VariZIG(TM) if exposed to
Varicella zoster, which is the virus that causes chickenpox.
Varicella zoster infection can cause complications in certain
individuals. The only U.S.-licensed manufacturer of a similar
product has discontinued production; consequently, the FDA
anticipates a product shortage in the near future. Cangene will be
the sole provider of Varicella immune globulin under this IND.
VariZIG(TM) is approved in Canada and Cangene is now the sole
supplier of the product to Canadian Blood Services and Héma-Québec |
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Medical Devices |
Victhom and Ossur on target for
Bionic Prosthesis
Victhom Human Bionics Inc.
(Quebec City), a company dedicated to the research and development
of bionic devices, and Ossur, a global orthopedics company,
announced the completion of market trials for their joint venture,
the POWER KNEE(TM), with successful outcomes. The POWER KNEE is the
first of several new orthopedic products that will be co-developed
by Victhom and Ossur utilizing Victhom's Bionic technology platform.
So positive were the results during testing that the Alpha prototype
for the POWER KNEE, the first-ever motor-powered prosthesis for
lower limb amputees, moved on to market trials without requiring
reengineering. In these trials, the POWER KNEE tested successfully
on men and women of varying ages and activity levels living in North
America and Europe. Among the many new advantages the prosthesis
affords its users, it was found that Restored Dynamics(TM), a
compelling benefit experienced by all who participated, is breaking
new ground. To illustrate, when confronted with a sand or snow
drift, an able bodied walker is able to actively overcome the
obstacle and straighten the leg. Unlike existing knee systems that
stay in bent position under similar circumstances, the POWER KNEE
pushes through resistance and restores dynamics, thus protecting the
user from a potential stumble and fall.
Haemacure comments on U.S. FDA
Warning Letter
Haemacure Corporation (Montreal) commented on news
published on the Internet of a Warning Letter received recently from
the U.S. Food and Drug Administration. The Company's current
activities to build a new Hemaseel HMN fibrin sealant manufacturing
plant were not a part of the Warning Letter's focus. Haemacure
reported it has already undertaken to remedy the deficiencies noted
in the letter. Haemacure has communicated its remediation plan to
the FDA and intends to work closely with the FDA to show its
commitment and progress in addressing the items raised in the
Warning Letter. The Warning Letter cited certain document
deficiencies relating to two marketed devices whose sales were
$258,000 in 2006. No safety issues have been reported regarding
these devices, and the Warning Letter does not affect Haemacure's
permission to market both devices. |
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Genomic Update |
Amorfix and the Ontario Genomics
Institute announce partnership
Amorfix Life Sciences Inc. (Toronto) and the Ontario
Genomics Institute (OGI) announced they are entering into a
partnership to develop a blood test for Alzheimer's disease, EP-AD(TM),
based upon Amorfix's patent-pending Epitope Protection technology.
OGI will assist Amorfix in accelerating its program for diagnosis of
neurodegenerative diseases drawing on OGI's portfolio of
state-of-the-art genomics and proteomics facilities, research and
pre-commercial development in Ontario. Dr. George Adams, Amorfix's
CEO said, "Alzheimer's Disease affects 10% of people over 65 years
old and there is no definitive way to confirm a diagnosis before
death. I am very pleased to have OGI's support as we aim to be the
first to develop a definitive blood test for Alzheimer's."
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Industry Briefs |
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Chromos Molecular
Systems Inc.
(Burnaby) announced that it has acquired Targeted
Molecules Corporation (TMC), a privately held biotechnology
company based in San Diego, CA. With the acquisition, Chromos
gains two antibody product candidates for treatment of multiple
sclerosis (MS) and acute thrombosis. Concurrent with the
acquisition, Chromos completed a Cdn. $6 million financing, the
funds from which will be used to finance operations…….
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Transition Therapeutics Inc.
(Toronto), announced that the syndicate of underwriters of
Transition's recent bought deal financing, co-led by Versant
Partners Inc. and GMP Securities LP and including Dundee
Securities Corporation and National Bank Financial Inc., have
exercised a portion of their over-allotment option and have
purchased an additional 575,000 common shares at the price of
$0.69 per share, bringing the aggregate gross proceeds under the
financing to $10.75 million……
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Welichem Biotech Inc. (Burnaby),
a biotechnology company developing therapeutic drugs in the
fields of autoimmune diseases and cancer, announced the
appointment of York Yingping Guo as CEO and Board member of the
Company, effective immediately……
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Bioniche Life Sciences Inc.
(Belleville), a research-based, technology-driven Canadian
biopharmaceutical company, announced that it has closed the sale
of Bioniche Pharma Group Limited, its sterile injectibles
manufacturing subsidiary based in County Galway, Ireland, to
RoundTable Healthcare Partners, a U.S. healthcare focused
private equity group based in Lake Forest, Illinois……..
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Helix BioPharma Corp. (Aurora)
announced the signing of an agreement with the National Research
Council of Canada's Institute for Biological Sciences (NRC-IBS),
to assist with the ongoing characterization of the lung cancer
specific antibody previously licensed to Helix for its L-DOS47
new drug candidate; as well as to identify further novel tumor
targeting antibodies…….
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ARIUS Research Inc. (Toronto)
announced that it intends to complete a private placement
financing of units for gross proceeds of up to US$20 million.
The private placement is being arranged through a syndicate of
agents, co-lead by Dundee Securities Corporation and Loewen,
Ondaatje, McCutcheon Limited and including Canaccord Capital
Corporation……
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Coastal Contacts Inc.
(Vancouver), announced it completed a bought deal private
placement of 9,000,000 Special Warrants at a price of $2.50 per
Special Warrant for aggregate proceeds of $22.5 million which
includes the underwriters' exercise of an over-allotment option
of $2,500,000. The net proceeds from the offering will be used
to accelerate its international mergers and acquisition
strategy, increase sales and marketing initiatives and improve
working capital to fund growth in new distribution channels……
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Rockwell Medical Technologies, Inc.,
a leading, innovative dialysis products manufacturer serving the
healthcare industry, reported that it has signed an exclusive
distribution agreement with Genpharm, Inc., of
Toronto……
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Pharmion Corporation and
MethylGene Inc. (Montreal) announced a license and
collaboration agreement for the research, development and
commercialization of MethylGene's histone deacetylase (HDAC)
inhibitors in North America, Europe, Middle East and certain
other markets. This collaboration includes MGCD0103,
MethylGene's lead HDAC inhibitor, as well as the company's
pipeline of second generation HDAC inhibitor compounds for
oncology indications……
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Quest PharmaTech Inc. (Edmonton)
announced the appointment of Dr. Madi R. Madiyalakan as
Executive Chairman effective immediately. This change was
necessitated by the resignation of Dr. David Cox, President &
CEO effective March 24th, 2006. Dr. Cox intends to pursue other
activities…..
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(Life Sciences News Briefs © 2005 is prepared by Armar
International for the Life Sciences Branch of Industry Canada (contact:
Louise Leduc Tel: (613) 954-4715; E-mail: Leduc.Louise@ic.gc.ca).
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