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THEY ARE BUT NOT IN MY SCOTTRADE ACCT.
ITS RS NOW SHOULD BE UP TOMORROW OR TUESDAY
EVEN THEIR HOLDING CO AHD
Jul 08, 2010 (Close-Up Media via COMTEX) -- Stratton Holdings, a holding
company, announced that through its Stratton Mobile subsidiary, the company
expects to launch its first mobile application on the Android marketplace in
July.
"We are encouraged to announce our first application that will be released, will
be Portfolio FEED," said Eric Stratton Racheff, President of Stratton Holdings.
"Portfolio FEED is a simple application that we believe will be appealing to
investors and traders around the planet.
With Portfolio FEED a user enters their own stock lists and then the application
is tied to RSS feeds. So in this way the user only gets alerted on their own
portfolio, or 'watch list,' when their company issues a press release. The user
is alerted in a similar manner as a text message. A trader or investor doesn't
have to be at a trading station to receive the latest news. It can be with them
anywhere and everywhere with their smart phone.
SM has set the launch date of Portfolio FEED for the middle of July onto the
Android marketplace. This will be the first version released and is expected to
go through three different upgrades prior to its move onto the iPhone market.
STONE-yes yhey do Sweet
The funds are to be used to further GO800's marketing efforts in USA/Canada and
to establish a GO800 subsidiary in China, to launch GO800 in China in 2011.
NEW YORK, NY, Jun 29, 2010 (MARKETWIRE via COMTEX) -- GoIP Global, Inc.
(PINKSHEETS: GOIG) further to yesterday's news that Mr. Ike H. Sutton, the
Company's CEO, signed a LOI (Letter of Intent) in China last week with Mr.
Yidong Fu, a Chinese Industrialist. Mr. Yidong Fu is a native of Nanjing, China
and a major Shareholder/CEO of NUS, one of the largest Stainless Steel
manufacturers in China. NUS - Nanjing Union Strong Metallurgical Group
Corporation has 13 subsidiaries, such as Nanjing Union Strong Stainless Steel
Co. Ltd., Nanjing Union Strong Specialty Steel Co. Ltd., Nanjing Union Strong
Equipment Building and Erection Co. Ltd., Nanjing Union Strong Real Estate
Development Co. Ltd., Nanjing Union Strong Construction Co. Ltd., and others.
NUS recently completed the construction of the Nanjing Union Strong
International Building in the booming Hexi District in Nanjing City facing the
Olympic Center, a steel structure that parallels the Chrysler building in
Manhattan for its importance and location.
Photos of the recent event can be seen by clicking on http://go800corp.com/p532.
Mr. Sutton's voice recording of the past weeks news can be heard by texting GOIG
to 46800.
About GoIP Global, Inc. and GO800, LLC GoIP Global offers a range of services,
solutions and tools for brands, agencies, content providers, online portals,
entertainment and media companies. GoIP Global offers brand and content
customers great flexibility in creating mobile marketing campaigns and
applications. Through its subsidiary GO800, LLC, GO800(TM), a new patent pending
text messaging service, which launched in 2010, enables advertisers to
incorporate a text prompt in their advertisements, prompting consumers to
contact them through a text message rather than calling a 1-800 toll free
number. For More Information visit www.goipglobal.com, www.go800corp.com or
www.facebook.com/go800. The GO800 video can be viewed and shared on iPhone,
Blackberry, or Android from this URL: http://go800.delivr.com/1194v.
WHATS THE RS RATIO TIA
YES IT WILL LOOKING GOOD EOM
YRC WORLDWIDE REAFFIRMS POSITIVE EBITA FOR Q2
http://www.rttnews.com/Content/BreakingNews.aspx?Node=B1&Id=1333295%20&Category=Breaking%20News
THANK YOU KINDLY EOM
WHAT NEWS
Post Unavailable
Additional Information
NEW YORK, NY, May 17, 2010 (MARKETWIRE via COMTEX) -- GoIP Global, Inc.
(PINKSHEETS: GOIG) today announced that the Company CEO Ike Sutton was recently
interviewed for the 2nd time this year by Kinsley Street Investors, a research
PR firm dedicated to discover, evaluate and incubate unique publicly traded
micro cap companies possessing significant growth potential.
To read the interview visit http://www.kinsleystreet.com/goipglobalupdate.aspx
In response to questions from Kinsley Street, Mr. Sutton highlighted several key
points and developments about GoIP's new Go800 technology, stating the company
expects $100,000 in monthly reccurring revenues to begin in June 2010 and
forecasting a 20% monthly increase. Mr. Sutton stated the Company has loaded
into our data base several thousand voice keywords and adding hundreds more
daily.
About GoIP Global, Inc. and Go800, LLC GoIP Global offers a range of services,
solutions and tools for brands, agencies, content providers, online portals,
entertainment and media companies. GoIP Global offers brand and content
customers great flexibility in creating mobile marketing campaigns and
applications. Through its subsidiary GO800, LLC, Go800(TM), a new patent pending
text messaging service, which launched in 2010, enables advertisers to
incorporate a text prompt in their advertisements, prompting consumers to
contact them through a text message rather than calling a 1-800 toll free
number. For More Information visit www.go800corp.com or www.facebook.com/go800
NEWS
May 07, 2010 (Detroit Free Press - McClatchy-Tribune Information Services via
COMTEX) -- Auto supplier Visteon filed a new reorganization plan that could sell
95% of the company to a group of bondholders if those bondholders can raise
$1.25 billion.
Visteon also has included a backup plan if bondholders can't raise the money. In
that case, 85% of the Van Buren Township-based supplier would go to Visteon's
lenders. The other 15% would go to bondholders.
In either scenario, Visteon's U.S. pension plans would remain intact, ending
fears that the pension could be moved to the government and payments could be
reduced.
If it receives approval from creditors and U.S. Bankruptcy Court in Delaware,
the plan could put an end to months of wrangling among creditors and put the
supplier on a path to emerge from bankruptcy protection.
Visteon filed for bankruptcy protection a year ago in a string of supplier
bankruptcies that commenced as auto sales plummeted and parts makers couldn't
maintain their financial covenants.
The deal with bondholders requires bondholders to pay $300 million, and raise
another $950 million in a rights offering that would allow those bondholders to
purchase shares of a reorganized Visteon.
Those bondholders would receive 95% of Visteon. The remaining 5% of the supplier
would be distributed to other bondholders, who would also be eligible to receive
a share of $50 million.
Visteon's unsecured creditors would receive as much as 50% of their claims or
their share of $141 million.
The plan would cancel Visteon's current shares, as shareholders continue their
fight to receive some kind of compensation in a company they believe is
undervalued.
Shareholders have launched a campaign claiming that gains in Visteon's stock and
bonds indicate a higher value for the company that should allow shareholders to
receive compensation for the plan. They have asked U.S. Bankruptcy Judge
Christopher Sontchi to appoint an examiner to the supplier's bankruptcy case to
investigate the question of the company's value.
NEWS
BOTHELL, WA, May 06, 2010 (MARKETWIRE via COMTEX) -- MDRNA, Inc. (NASDAQ:
MRNA), a leading RNAi-based drug discovery and development company, today
reported on advances made with the Company's proprietary UsiRNA construct for
RNA interference (RNAi). The term UsiRNA denotes inclusion of unlocked
nucleobase analogs (UNA) in the double-stranded oligonucleotide construct.
UsiRNAs demonstrate enhanced specificity and efficacy in comparison to standard
siRNAs. Today's data add to previously reported data on microarray analysis
indicating the UsiRNA construct not only significantly eliminates off-target
events, but does so with no apparent new off-target silencing. That is, UNA's
improve the efficacy of the siRNA construct without further off-target activity
related to the UNA chemistry. The data were presented by Narendra Vaish, Ph.D.,
MBA, Associate Director, Discovery Research and Pharmaceutical Development, at
the "RNAi and miRNA World Congress" in Boston, MA.
RNAi provides a means to target a specific mRNA and this "on-target" precision
is a key advantage for RNAi-based therapeutics. However, the potential exists
for "off-target" effects with standard siRNAs via the non-targeting strand
(e.g., passenger strand) or unintended interactions associated with the
targeting strand (e.g. guide strand). The UsiRNA construct was designed to
directly address these concerns. Substitution in the passenger strand is
intended to eliminate its participation in the RNAi process. Substitution in the
guide strand is intended to eliminate miRNA-like events, while preserving
siRNA-like activity. Furthermore, as described previously, UsiRNAs have a lower
potential for cytokine induction that can occur with standard siRNAs, and the
absence of alterations in cytokine related genes are likely a part of the
overall reduction in the off-target events.
Activity evaluation and microarray analysis confirmed the advantages of UsiRNAs.
Compared to the standard siRNA format, elimination of passenger strand activity
was achieved with UNA substitution. Guide strand substitution with UNA retained
intended siRNA-like activity but demonstrated no miRNA-like activity. Microarray
analysis revealed significant change in the expression of 389 genes with the
standard siRNA format. In contrast, UsiRNA altered expression of only 35 genes,
a greater than 90% reduction in off-target events with no apparent new
off-target silencing.
"These new data highlight the ability of our UsiRNA construct to achieve highly
specific inhibition while mitigating the off-target effects that can occur with
standard siRNAs," said Dr. Barry Polisky, Chief Scientific Officer of MDRNA.
"The inhibition of target mRNA in our bladder cancer model, demonstrates the
strength of pairing the UsiRNA construct and DiLA2 delivery platforms for the
development of RNAi-based therapeutics."
About MDRNA's Technology
MDRNA has a broad intellectual property estate that encompasses four key RNAi
technology platforms: siRNA constructs, chemistry, nucleic acid delivery, and
gene targets. The MDRNA-owned siRNA constructs and chemistry include its
proprietary UsiRNA construct, which is a duplex siRNA in which non-nucleotide
acyclic monomers (UNAs) have been included, and is distinct from the standard
siRNA construct used by others in the industry. UsiRNAs are fully recognized by
the RNAi machinery and provide for potent RNAi activity while specific placement
of UNAs in a duplex siRNA minimizes potential off-target effects by the guide
strand and reduces undesired passenger strand activity. Furthermore, UsiRNAs
escape the surveillance mechanisms associated with cytokine induction, and
provide protection from nuclease degradation.
The MDRNA delivery platforms include DiLA2 and nanoparticle forming peptides.
DiLA2 is an MDRNA proprietary delivery platform of novel synthetic di-alkylated
amino acid compounds used to make liposomal delivery formulations. The DiLA2
platform enables MDRNA to tailor the charge, linker and acyl chains of amino
acids in order to configure liposomes for delivery to target tissues of
interest. In addition, the platform is designed to permit attachment of various
peptides and other targeting molecules to improve a variety of delivery
characteristics. The MDRNA peptide nanoparticle platform includes exclusively
in-licensed and developed IP surrounding the use of peptides for nanoparticle
formulations that increase cellular uptake and endosomal release of siRNAs.
MDRNA is currently biopanning its patented phage display library to identify
additional peptides for targeted delivery, cellular uptake and endosomal release
of siRNA.
MDRNA owns or controls 17 issued or allowed patents, and has 41 pending patent
applications, 134 pending foreign patent applications and 6 PCT applications.
About MDRNA, Inc.
MDRNA is a biotechnology company focused on the development and
commercialization of therapeutic products based on RNA interference (RNAi). Our
goal is to improve human health through the development of RNAi-based compounds
and drug delivery technologies that together provide superior therapeutic
options for patients. Over the past decade, we have developed substantial
capabilities in molecular biology, cellular biology, lipid chemistry, peptide
chemistry, pharmacology and bioinformatics, which we are applying to a wide
range of RNAi technologies and delivery approaches. These capabilities plus the
in-licensing of key RNAi-related intellectual property have rapidly enabled us
to become a leading RNAi-based therapeutics company with a pre-clinical pipeline
in oncology. Through our capabilities, expertise and know-how, we are
incorporating multiple RNAi technologies as well as peptide- and lipid-based
delivery approaches into a single integrated drug discovery platform that will
be the engine for our clinical pipeline as well as a versatile platform for
establishing broad therapeutic partnerships with biotechnology and
pharmaceutical companies. We are also investing in new technologies that we
expect to lead to safer and more effective RNAi-based therapeutics while
aggressively building upon our broad and extensive intellectual property estate.
By combining broad expertise in siRNA science with proven delivery platforms and
a strong IP position, MDRNA is well positioned as a leading RNAi-based drug
discovery and development company. Additional information about MDRNA, Inc. is
available at http://www.mdrnainc.com.
<GOIG WILD>
NEW YORK, NY, Mar 18, 2010 (MARKETWIRE via COMTEX) -- GoIP Global, Inc.
(PINKSHEETS: GOIG) announced today that Go800, LLC (a GoIP subsidiary) Go800's
commercial service launch is advancing as planned. Network Wireless Carrier
testing and web site modifications for Ambassador reservations and customer self
provisioning is being updated and modified daily. An April commercial launch
date looks feasible with certification from 95% of the Wireless Carriers. Over
70% of the wireless carriers have certified to date for Go800 service use on
their Network -- for a commercial launch at least 90% certification is required.
The first Go800 Ambassador WEBX went well this week with a follow up meeting
schedule for the end of next week. Of the 200+ applicants, 20 participated this
week with another 20 Go800 Ambassadors scheduled for next week. We will probably
hold weekly WEBX meetings. An internal Ambassador's forum has been created and
all accepted Ambassadors applicants will be invited to join.
In regards to Voice Keywords Reservations, we have an overwhelming response and
request all potential advertisers/buyers to keep sending in the reservation
forms (which can be found on our web site). Our customer service is working to
handle the many requests and inquiries, we will be in touch with you shortly.
A Go800 video describing the ease of use of the service is in the works and we
hope once posted online it will answer many of the questions we are now getting
and would further popularize the service.
About GoIP Global, Inc. GoIP Global offers a range of services, solutions and
tools for brands, agencies, content providers, online portals, entertainment and
media companies. GoIP has both creative experience and the technical knowledge
to connect mobile marketers with their audiences by means of interactive
campaigns and mobile content distribution. GoIP Global offers brand and content
customers great flexibility in creating mobile marketing campaigns and
applications. For additional information, visit http://www.goipglobal.com/.
About Go800, LLC Go800, a new patent pending text messaging service which will
be launched in 2010, will enable advertisers to incorporate a text prompt in
their advertisements, prompting consumers to contact them through a text message
rather than calling a 1-800 toll free number. Go800 - They Text. You Connect.
For additional information, visit http://www.go800corp.com
BOTHELL, WA, Mar 08, 2010 (MARKETWIRE via COMTEX) -- MDRNA, Inc. (NASDAQ:
MRNA), a leading RNAi-based drug discovery and development company, today
announced that J. Michael French, MDRNA's President and Chief Executive Officer,
will provide an overview of the Company and its progress in key programs at the
following upcoming conferences:
-- The ROTH 22nd Annual OC Growth Stock Conference, on Monday, March 15 at
4:30 p.m. Pacific Time at the Ritz-Carlton in Dana Point, California;
and
-- The Washington Biotechnology & Biomedical Association (WBBA) 10th Annual
"Life Science Innovation Northwest" Conference on Wednesday, March 17 at
1:55 p.m. Pacific Time at the Bell Harbor International Conference
Center in Seattle, Washington.
A live audio webcast of each presentation will be available on the Event
Calendar page of the Investors section of the Company's website at
http://www.mdrnainc.com. Please allow time prior to the presentation to register
and download any necessary software. A replay of the presentation will be
available on the Investors section of the MDRNA website under Event Calendar
approximately one hour after the live presentation and will be archived for
three months.
THIS CO SUX BELIEVE ME
AND LONIEE
NEW YORK, NY, Feb 22, 2010 (MARKETWIRE via COMTEX) -- GoIP Global, Inc.
(PINKSHEETS: GOIG) today announced that its subsidiary Go800, LLC's new website,
www.go800corp.com, was launched last week and has received an overwhelming
response from the advertising community. Mr. Ike Sutton, CEO of GoIP Global,
stated today, "Go800's initial website was launched last week and we are
thrilled with the enormous amounts of inquiries already received. We are at the
very brink of the beginnings of a new revolution in the way Companies advertise
their services through our leased Voice Keywords. This new text service for
Advertisers is in its infancy and we here at GoIP Global are extremely
optimistic about what the future holds for our Company and shareholders alike."
"Go800 has also launched the Ambassador Program which allows individuals to
become Go800's Sales and Marketing Ambassadors, earning a revenue share on all
Voice Keywords leased. Interested individuals can sign up directly on
www.go800corp.com. The first online instructions for Ambassadors will be on
March 2, and we are anticipating the over 100 Ambassadors to participate."
"In regards to Pink Sheet status, GoIP Global has submitted online all the
requested Information Filings to Pink Sheets and anticipates Pink Sheets to
upgrade the Company classification shortly."
About GoIP Global, Inc.
GoIP Global offers a range of services, solutions and tools for brands,
agencies, content providers, online portals, entertainment and media companies.
GoIP has both creative experience and the technical knowledge to connect mobile
marketers with their audiences by means of interactive campaigns and mobile
content distribution. GoIP Global offers brand and content customers great
flexibility in creating mobile marketing campaigns and applications. For
additional information, visit www.goipglobal.com.
About Go800, LLC
Go800(TM), a new patent pending text messaging service which will be launched in
2010, will enable advertisers to incorporate a text prompt in their
advertisements, prompting consumers to contact them through a text message
rather than calling a 1-800 toll free number. Go800(TM) the new text message
service, a 1-800 toll free number alternative.
News for 'KATX' - (KAT Exploration Secures Large Land Packages Around Its Handcamp and Twi-lite Properties)
MOUNT PEARL, NL, Feb 08, 2010 (MARKETWIRE via COMTEX) -- KAT Exploration Inc.
(PINKSHEETS: KATX) www.KATexploration.com would like to inform its investors
that it has secured areas of interest around its Handcamp and Twi-lite
properties.
The company thought it very important to stake the land packages around both
these properties as gold is becoming the main interest amongst exploration
companies today.
A total of 5,311 acres was staked around our Handcamp property along with 5,805
acres around the Twi-lite property.
This will now allow the company to carry out larger exploration programs in both
these areas in a quest to extend the present gold discoveries.
As was previously mentioned in a press release, we are actively compiling data
from our latest soil and rock samples and have just transported another 714 soil
samples to Actlabs for analysis.
Upon completion of this project the final results will be posted to our website
and will also be displayed at the PDAC mining conference in Toronto early March.
News for 'MDFI' - (MedeFile Signs Marketing and Distribution Agreement with the National Homecare Network)
BOCA RATON, Fla., Feb 03, 2010 /PRNewswire via COMTEX/ -- MedeFile
International, Inc. (OTC Bulletin Board: MDFI), a leader in portable electronic
medical records management, announced today that it has signed a marketing and
distribution agreement with the National Homecare Network (NHN). The National
Homecare Network is one of the largest and fastest growing homecare provider
networks in North America. MedeFile will have direct access to the individuals
and their families that use NHN's services.
The elderly is a major demographic for MedeFile International, Inc. and anyone
seeking homecare information is an excellent candidate for a MedeFile Personal
Health Record. MedeFile will also utilize the relationships that NHN has within
the homecare industry. National Homecare Network currently is comprised of over
500 local home care providers throughout North America, giving MedeFile a very
extensive reach into this industry.
Jason Hendeles CEO says, "Partnering with MedeFile provides our customers with
secure 24/7 access to their personal medical records when they may need them
most. Many of the visitors to the National Homecare Network are the children of
the aging or elderly. These are very often the decision makers of services that
can benefit both their parents and themselves alike. Keeping family members up
to date with their loved one's healthcare is an integral part of the home care
system. This is one reason we anticipate a large adoption rate from these
visitors and expect this relationship to be a fruitful one." For more
information on National Homecare Network, please visit
www.nationalhomecarenetwork.com
Milton Hauser, CEO of MedeFile International, Inc. commented, "MedeFile's
services are perfectly matched to the individuals that are seeking out homecare
and homecare services. We anticipate the relationship with National Homecare
Network and their exceptional marketing programs will help MedeFile continue to
build its brand and increase sales accordingly."
About MedeFile International, Inc.
Headquartered in South Florida, MedeFile has a proprietary system for gathering
and digitizing medical records so that individuals can have a comprehensive
record of all of their medical visits. MedeFile's primary product is the
MedeFile system, a highly secure system for gathering and maintaining medical
records. The MedeFile system is designed to gather all of its members' actual
medical records and create a single, comprehensive medical record that is
accessible 24 hours a day, seven days a week.
Representing an advanced, yet easy-to-use, approach to portable, electronic
medical records management, MedeFile combines state-of-the-art technology and
the Internet to make medical data instantly accessible to each MedeFile
subscriber and his or her authorized healthcare providers from anywhere in the
world. In addition to accessing one's medical records through MedeFile's secure
Internet portal found at www.medefile.com, members can carry their entire
medical history and emergency information wherever they go on a unique device
called a MedeDrive -- a proprietary USB drive designed to be carried on a
keychain. The MedeDrive plugs into any USB port of a Windows-based PC; and
because MedeDrive automatically loads its own viewer, users do not require any
special programs or software to view data. MedeMobile provides on-the-go
subscribers with the ability to enjoy even greater flexibility and access to
their personal health information wherever and whenever they need it. MedeMinder
is an electronic "reminder service" that utilizes automated phone service to
assist its subscribers in remembering scheduled medication reminders, doctor
appointments, prescriptions refills, and other time-sensitive treatment
protocols. For more information about MedeFile and its annual subscription-based
programs, please visit www.medefile.com
LAVAL, QC and PRINCETON, NJ, Feb. 3, 2010 (Canada NewsWire via COMTEX) -- -
Second U.S. FDA Product Approval in Just Over a Year For Labopharm's
CONTRAMID(R) Controlled Release Technology -
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug
Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended
Release Tablets, a novel once-daily formulation of the antidepressant trazodone,
for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM)
utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls
the release of active substances within oral medications.
"OLEPTRO(TM) represents Labopharm's second CONTRAMID(R) technology-based product
to receive FDA approval in just over a year," said James R. Howard-Tripp,
President and Chief Executive Officer, Labopharm Inc. "We are excited about the
opportunity for OLEPTRO(TM) and are preparing the product for launch into the
$11 billion-plus U.S. antidepressant market. We are working towards finalizing a
commercialization path for OLEPTRO(TM) that will maximize the value of our
product in this market."
MDD is a common mental illness often characterized by a combination of social
and somatic symptoms. It affects more than 14 million adults in the U.S. and is
the leading cause of disability globally. OLEPTRO(TM) will offer physicians
another therapeutic alternative for their MDD patients.
"There's a large body of evidence demonstrating the efficacy of trazodone in the
treatment of MDD," said Dr. Stephen Stahl, Adjunct Professor of Psychiatry,
University of California, San Diego School of Medicine. "Labopharm has developed
a novel formulation of trazodone that effectively treats depression and provides
a tolerable adverse event profile."
Labopharm is actively exploring several alternatives for the U.S.
commercialization of OLEPTRO(TM). Such alternatives range from out-licensing the
product to a distribution partner while retaining the right to some degree of
co-promotion, through to a full co-promotion arrangement under which Labopharm
would share the sales function with a partner. The Company currently expects to
finalize the commercialization plan for OLEPTRO(TM) in the near term.
Labopharm expects OLEPTRO(TM) to be available for prescription in the U.S. later
this year, with specific timing for its launch to be determined within the
context of the final commercialization plan. The Company believes it is well
advanced in its preparations for the U.S. launch of OLEPTRO(TM). The Company has
completed market research with physicians and third-party payors, developed a
positioning and marketing campaign for OLEPTRO(TM), and finalized product
manufacturing and packaging arrangements.
About the OLEPTRO(TM) Pivotal Study
An eight-week randomized, double-blind, two-arm, multi-centre study in patients
with unipolar major depressive disorder demonstrated OLEPTRO(TM)'s efficacy as a
treatment for depression. The primary efficacy endpoint of the study was to
compare the change in the Hamilton Rating Scale for Depression (HAMD-17) total
score from baseline to the end of the study in the OLEPTRO(TM) group versus the
placebo group. The results of this study, which are published in the May 2009
issue of Psychiatry, include the following:
<<
- Statistical significance was achieved for the primary endpoint
(p value of 0.012).
- The overall discontinuation rate in the study was 25 percent with
21 percent in the placebo group and 30 percent in the OLEPTRO(TM)
group.
- In the OLEPTRO(TM) group, four percent of patients discontinued
treatment due to somnolence or sedation.
>>
"Our research in the clinical study leading up to FDA approval showed that
OLEPTRO(TM) was well-tolerated and demonstrated a significantly greater
improvement in the HAMD-17 primary efficacy end point over placebo," said Dr.
David Sheehan, University Health Professor and Director of the Depression and
Anxiety Disorders Research Institute, University of South Florida College of
Medicine. "When given at the recommended daily dose range, OLEPTRO(TM) was an
appropriate monotherapy for patients with MDD."
Labopharm will conduct a post-approval pediatric study. The FDA has asked
Labopharm to provide data from a long-term maintenance study and an additional
in-vitro alcohol dissolution study.
About Major Depressive Disorder
Approximately two times more prevalent in women than men, MDD often co-exists
with other illnesses. Research shows that only approximately 65 percent of
individuals with MDD are diagnosed and, of those patients, 90 percent are
treated with medication.
Treating MDD with antidepressant medications is challenging for physicians
because patient response to antidepressant drug therapy varies significantly.
Research has shown that as many as 28 percent of patients being treated with
antidepressants stop taking their medication within the first four weeks of
treatment and as many as 44 percent stop within the first 12 weeks. Reasons for
discontinuing antidepressant treatment can include suboptimal efficacy, the
exacerbation of symptoms such as sleep disturbance, agitation, and sexual
dysfunction, and adverse events such as weight gain.
The FDA's decision represents the first regulatory approval for Labopharm's
novel, once-daily formulation of trazodone. The formulation is currently under
regulatory review in Canada.
Important Safety Information About Treatment with OLEPTRO(TM)
For more complete information about the use of OLEPTRO(TM), please see the
FDA-approved Prescribing Information and Medication Guide which will be posted
on the FDA website (http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/).
<<
Black Box Warning
Warning: Suicidality and Antidepressant Drugs
See full prescribing information for complete boxed warning
Increased risk of suicidal thinking and behavior in children, adolescents
and young adults taking antidepressants for major depressive disorder
(MDD) and other psychiatric disorders. OLEPTRO(TM) is not approved for
use in pediatric patients.
Warning and Precautions
- Patients with major depressive disorder (MDD), both adult and
pediatric, may experience worsening of their depression and/or the
emergence of suicidal ideation and behaviour, or unusual change in
behaviour, whether or not they are taking antidepressant medications.
Patients should be monitored for clinical worsening and suicidality
and for the appearance of any of the following symptoms: anxiety,
agitation, panic attacks, insomnia, irritability, hostility,
aggressiveness, impulsivity, akathisia, hypomania, and mania.
Families and caregivers should be alerted about the need to monitor
patients.
- The development of a potentially life-threatening serotonin syndrome,
or neuroleptic malignant syndrome (NMS)-like reactions has been
reported with antidepressants, and may occur with OLEPTRO(TM),
particularly with concomitant use of other serotoninergic drugs.
Treatment with OLEPTRO(TM) and any concomitant serotonergic or
antidopaminergic agents, including antipsychotics, should be
discontinued immediately and supportive treatment should be
initiated.
- A major depressive episode may be the initial presentation of bipolar
disorder. Prior to initiating treatment, patients should be
adequately screened to determine if they are at risk for bipolar
disorder and monitored for mania/hypomania. OLEPTRO(TM) is not
approved for use in treating bipolar depression.
- Experience with administration of immediate-release trazodone
products indicates that there may be an increased risk for QT
interval prolongation. QT prolongation may lead to Torsades de
pointes and even death especially in susceptible individuals, such as
those with hypokalemia, hypomagnesemia, or a genetic predisposition
to prolonged QT/QTc.
- Patients with pre-existing cardiac disease may be at more risk for
arrythmias. Concomitant administration of drugs that prolong the QT
interval or that are inhibitors of CYP3A4 may increase the risk of
cardiac arrhythmia in these patients.
- Orthostatic hypotension and syncope have been reported in patients
receiving trazodone hydrochloride.
- Drugs that interfere with serotonin reuptake, including trazodone
hydrochloride may increase the risk of bleeding events. Concomitant
use with NSAIDs, aspirin, or other drugs that affect coagulation may
compound this risk.
- Serious, sometimes fatal, reactions have been reported when
serotonergic drugs are used in combination with monoamine oxidase
inhibitor(s). Therefore, OLEPTRO(TM) should not be used concomitantly
or within 14 days of monoamine oxidase inhibitors.
- Rarely, cases of priapism can occur in men receiving trazodone.
OLEPTRO(TM) should be used with caution in men who have predisposing
conditions.
- There is a risk of hyponatremia when taking antidepressants. Elderly
patients may be at greater risk, as well as patients taking diuretics
or who are volume-depleted.
- OLEPTRO(TM) has the potential to impair judgment, thinking, and motor
skills. Advise patients to use caution before driving and when
operating machinery.
- Discontinuation symptoms may occur with abrupt discontinuation, and
may include anxiety, agitation and sleep disturbance. Upon
discontinuation, taper OLEPTRO(TM) and monitor for symptoms.
>>
Adverse Reactions
The most common adverse reactions (incidence greater than or equal to five
percent and twice that of placebo) are: somnolence/sedation, dizziness,
constipation, blurred vision.
These are not all the possible adverse events of OLEPTRO(TM).
About Labopharm Inc.
Headquartered in Laval, Canada with US offices in Princeton, New Jersey,
Labopharm is an emerging leader in optimizing the performance of existing small
molecule drugs using its proprietary controlled-release technologies. The
Company's lead product, a unique once-daily formulation of tramadol, is now
available in 17 countries around the world, including the U.S., Canada, major
European markets and Australia. Its second product, OLEPTRO(TM), a novel
formulation of trazodone for the treatment of major depressive disorder in
adults, has received regulatory approval in the U.S. and is under regulatory
review in Canada. Labopharm has initiated the European regulatory approval
process for its third product, a twice-daily formulation of
tramadol-acetaminophen. The Company also has a pipeline of follow-on products in
both pre-clinical and clinical development. Labopharm's vision is to become an
integrated, international, specialty pharmaceutical company with the capability
to internally develop and commercialize its own products. For more information,
please visit www.labopharm.com.
LAVAL, QC and PRINCETON, NJ, Feb. 3, 2010 (Canada NewsWire via COMTEX) -- -
Second U.S. FDA Product Approval in Just Over a Year For Labopharm's
CONTRAMID(R) Controlled Release Technology -
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug
Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended
Release Tablets, a novel once-daily formulation of the antidepressant trazodone,
for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM)
utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls
the release of active substances within oral medications.
"OLEPTRO(TM) represents Labopharm's second CONTRAMID(R) technology-based product
to receive FDA approval in just over a year," said James R. Howard-Tripp,
President and Chief Executive Officer, Labopharm Inc. "We are excited about the
opportunity for OLEPTRO(TM) and are preparing the product for launch into the
$11 billion-plus U.S. antidepressant market. We are working towards finalizing a
commercialization path for OLEPTRO(TM) that will maximize the value of our
product in this market."
MDD is a common mental illness often characterized by a combination of social
and somatic symptoms. It affects more than 14 million adults in the U.S. and is
the leading cause of disability globally. OLEPTRO(TM) will offer physicians
another therapeutic alternative for their MDD patients.
"There's a large body of evidence demonstrating the efficacy of trazodone in the
treatment of MDD," said Dr. Stephen Stahl, Adjunct Professor of Psychiatry,
University of California, San Diego School of Medicine. "Labopharm has developed
a novel formulation of trazodone that effectively treats depression and provides
a tolerable adverse event profile."
Labopharm is actively exploring several alternatives for the U.S.
commercialization of OLEPTRO(TM). Such alternatives range from out-licensing the
product to a distribution partner while retaining the right to some degree of
co-promotion, through to a full co-promotion arrangement under which Labopharm
would share the sales function with a partner. The Company currently expects to
finalize the commercialization plan for OLEPTRO(TM) in the near term.
Labopharm expects OLEPTRO(TM) to be available for prescription in the U.S. later
this year, with specific timing for its launch to be determined within the
context of the final commercialization plan. The Company believes it is well
advanced in its preparations for the U.S. launch of OLEPTRO(TM). The Company has
completed market research with physicians and third-party payors, developed a
positioning and marketing campaign for OLEPTRO(TM), and finalized product
manufacturing and packaging arrangements.
About the OLEPTRO(TM) Pivotal Study
An eight-week randomized, double-blind, two-arm, multi-centre study in patients
with unipolar major depressive disorder demonstrated OLEPTRO(TM)'s efficacy as a
treatment for depression. The primary efficacy endpoint of the study was to
compare the change in the Hamilton Rating Scale for Depression (HAMD-17) total
score from baseline to the end of the study in the OLEPTRO(TM) group versus the
placebo group. The results of this study, which are published in the May 2009
issue of Psychiatry, include the following:
<<
- Statistical significance was achieved for the primary endpoint
(p value of 0.012).
- The overall discontinuation rate in the study was 25 percent with
21 percent in the placebo group and 30 percent in the OLEPTRO(TM)
group.
- In the OLEPTRO(TM) group, four percent of patients discontinued
treatment due to somnolence or sedation.
>>
"Our research in the clinical study leading up to FDA approval showed that
OLEPTRO(TM) was well-tolerated and demonstrated a significantly greater
improvement in the HAMD-17 primary efficacy end point over placebo," said Dr.
David Sheehan, University Health Professor and Director of the Depression and
Anxiety Disorders Research Institute, University of South Florida College of
Medicine. "When given at the recommended daily dose range, OLEPTRO(TM) was an
appropriate monotherapy for patients with MDD."
Labopharm will conduct a post-approval pediatric study. The FDA has asked
Labopharm to provide data from a long-term maintenance study and an additional
in-vitro alcohol dissolution study.
About Major Depressive Disorder
Approximately two times more prevalent in women than men, MDD often co-exists
with other illnesses. Research shows that only approximately 65 percent of
individuals with MDD are diagnosed and, of those patients, 90 percent are
treated with medication.
Treating MDD with antidepressant medications is challenging for physicians
because patient response to antidepressant drug therapy varies significantly.
Research has shown that as many as 28 percent of patients being treated with
antidepressants stop taking their medication within the first four weeks of
treatment and as many as 44 percent stop within the first 12 weeks. Reasons for
discontinuing antidepressant treatment can include suboptimal efficacy, the
exacerbation of symptoms such as sleep disturbance, agitation, and sexual
dysfunction, and adverse events such as weight gain.
The FDA's decision represents the first regulatory approval for Labopharm's
novel, once-daily formulation of trazodone. The formulation is currently under
regulatory review in Canada.
Important Safety Information About Treatment with OLEPTRO(TM)
For more complete information about the use of OLEPTRO(TM), please see the
FDA-approved Prescribing Information and Medication Guide which will be posted
on the FDA website (http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/).
<<
Black Box Warning
Warning: Suicidality and Antidepressant Drugs
See full prescribing information for complete boxed warning
Increased risk of suicidal thinking and behavior in children, adolescents
and young adults taking antidepressants for major depressive disorder
(MDD) and other psychiatric disorders. OLEPTRO(TM) is not approved for
use in pediatric patients.
Warning and Precautions
- Patients with major depressive disorder (MDD), both adult and
pediatric, may experience worsening of their depression and/or the
emergence of suicidal ideation and behaviour, or unusual change in
behaviour, whether or not they are taking antidepressant medications.
Patients should be monitored for clinical worsening and suicidality
and for the appearance of any of the following symptoms: anxiety,
agitation, panic attacks, insomnia, irritability, hostility,
aggressiveness, impulsivity, akathisia, hypomania, and mania.
Families and caregivers should be alerted about the need to monitor
patients.
- The development of a potentially life-threatening serotonin syndrome,
or neuroleptic malignant syndrome (NMS)-like reactions has been
reported with antidepressants, and may occur with OLEPTRO(TM),
particularly with concomitant use of other serotoninergic drugs.
Treatment with OLEPTRO(TM) and any concomitant serotonergic or
antidopaminergic agents, including antipsychotics, should be
discontinued immediately and supportive treatment should be
initiated.
- A major depressive episode may be the initial presentation of bipolar
disorder. Prior to initiating treatment, patients should be
adequately screened to determine if they are at risk for bipolar
disorder and monitored for mania/hypomania. OLEPTRO(TM) is not
approved for use in treating bipolar depression.
- Experience with administration of immediate-release trazodone
products indicates that there may be an increased risk for QT
interval prolongation. QT prolongation may lead to Torsades de
pointes and even death especially in susceptible individuals, such as
those with hypokalemia, hypomagnesemia, or a genetic predisposition
to prolonged QT/QTc.
- Patients with pre-existing cardiac disease may be at more risk for
arrythmias. Concomitant administration of drugs that prolong the QT
interval or that are inhibitors of CYP3A4 may increase the risk of
cardiac arrhythmia in these patients.
- Orthostatic hypotension and syncope have been reported in patients
receiving trazodone hydrochloride.
- Drugs that interfere with serotonin reuptake, including trazodone
hydrochloride may increase the risk of bleeding events. Concomitant
use with NSAIDs, aspirin, or other drugs that affect coagulation may
compound this risk.
- Serious, sometimes fatal, reactions have been reported when
serotonergic drugs are used in combination with monoamine oxidase
inhibitor(s). Therefore, OLEPTRO(TM) should not be used concomitantly
or within 14 days of monoamine oxidase inhibitors.
- Rarely, cases of priapism can occur in men receiving trazodone.
OLEPTRO(TM) should be used with caution in men who have predisposing
conditions.
- There is a risk of hyponatremia when taking antidepressants. Elderly
patients may be at greater risk, as well as patients taking diuretics
or who are volume-depleted.
- OLEPTRO(TM) has the potential to impair judgment, thinking, and motor
skills. Advise patients to use caution before driving and when
operating machinery.
- Discontinuation symptoms may occur with abrupt discontinuation, and
may include anxiety, agitation and sleep disturbance. Upon
discontinuation, taper OLEPTRO(TM) and monitor for symptoms.
>>
Adverse Reactions
The most common adverse reactions (incidence greater than or equal to five
percent and twice that of placebo) are: somnolence/sedation, dizziness,
constipation, blurred vision.
These are not all the possible adverse events of OLEPTRO(TM).
About Labopharm Inc.
Headquartered in Laval, Canada with US offices in Princeton, New Jersey,
Labopharm is an emerging leader in optimizing the performance of existing small
molecule drugs using its proprietary controlled-release technologies. The
Company's lead product, a unique once-daily formulation of tramadol, is now
available in 17 countries around the world, including the U.S., Canada, major
European markets and Australia. Its second product, OLEPTRO(TM), a novel
formulation of trazodone for the treatment of major depressive disorder in
adults, has received regulatory approval in the U.S. and is under regulatory
review in Canada. Labopharm has initiated the European regulatory approval
process for its third product, a twice-daily formulation of
tramadol-acetaminophen. The Company also has a pipeline of follow-on products in
both pre-clinical and clinical development. Labopharm's vision is to become an
integrated, international, specialty pharmaceutical company with the capability
to internally develop and commercialize its own products. For more information,
please visit www.labopharm.com.
News for 'DDSS' - (Labopharm Receives FDA Approval For OLEPTRO(TM))
LAVAL, QC and PRINCETON, NJ, Feb. 3, 2010 (Canada NewsWire via COMTEX) -- -
Second U.S. FDA Product Approval in Just Over a Year For Labopharm's
CONTRAMID(R) Controlled Release Technology -
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug
Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended
Release Tablets, a novel once-daily formulation of the antidepressant trazodone,
for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM)
utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls
the release of active substances within oral medications.
"OLEPTRO(TM) represents Labopharm's second CONTRAMID(R) technology-based product
to receive FDA approval in just over a year," said James R. Howard-Tripp,
President and Chief Executive Officer, Labopharm Inc. "We are excited about the
opportunity for OLEPTRO(TM) and are preparing the product for launch into the
$11 billion-plus U.S. antidepressant market. We are working towards finalizing a
commercialization path for OLEPTRO(TM) that will maximize the value of our
product in this market."
MDD is a common mental illness often characterized by a combination of social
and somatic symptoms. It affects more than 14 million adults in the U.S. and is
the leading cause of disability globally. OLEPTRO(TM) will offer physicians
another therapeutic alternative for their MDD patients.
"There's a large body of evidence demonstrating the efficacy of trazodone in the
treatment of MDD," said Dr. Stephen Stahl, Adjunct Professor of Psychiatry,
University of California, San Diego School of Medicine. "Labopharm has developed
a novel formulation of trazodone that effectively treats depression and provides
a tolerable adverse event profile."
Labopharm is actively exploring several alternatives for the U.S.
commercialization of OLEPTRO(TM). Such alternatives range from out-licensing the
product to a distribution partner while retaining the right to some degree of
co-promotion, through to a full co-promotion arrangement under which Labopharm
would share the sales function with a partner. The Company currently expects to
finalize the commercialization plan for OLEPTRO(TM) in the near term.
Labopharm expects OLEPTRO(TM) to be available for prescription in the U.S. later
this year, with specific timing for its launch to be determined within the
context of the final commercialization plan. The Company believes it is well
advanced in its preparations for the U.S. launch of OLEPTRO(TM). The Company has
completed market research with physicians and third-party payors, developed a
positioning and marketing campaign for OLEPTRO(TM), and finalized product
manufacturing and packaging arrangements.
About the OLEPTRO(TM) Pivotal Study
An eight-week randomized, double-blind, two-arm, multi-centre study in patients
with unipolar major depressive disorder demonstrated OLEPTRO(TM)'s efficacy as a
treatment for depression. The primary efficacy endpoint of the study was to
compare the change in the Hamilton Rating Scale for Depression (HAMD-17) total
score from baseline to the end of the study in the OLEPTRO(TM) group versus the
placebo group. The results of this study, which are published in the May 2009
issue of Psychiatry, include the following:
<<
- Statistical significance was achieved for the primary endpoint
(p value of 0.012).
- The overall discontinuation rate in the study was 25 percent with
21 percent in the placebo group and 30 percent in the OLEPTRO(TM)
group.
- In the OLEPTRO(TM) group, four percent of patients discontinued
treatment due to somnolence or sedation.
>>
"Our research in the clinical study leading up to FDA approval showed that
OLEPTRO(TM) was well-tolerated and demonstrated a significantly greater
improvement in the HAMD-17 primary efficacy end point over placebo," said Dr.
David Sheehan, University Health Professor and Director of the Depression and
Anxiety Disorders Research Institute, University of South Florida College of
Medicine. "When given at the recommended daily dose range, OLEPTRO(TM) was an
appropriate monotherapy for patients with MDD."
Labopharm will conduct a post-approval pediatric study. The FDA has asked
Labopharm to provide data from a long-term maintenance study and an additional
in-vitro alcohol dissolution study.
About Major Depressive Disorder
Approximately two times more prevalent in women than men, MDD often co-exists
with other illnesses. Research shows that only approximately 65 percent of
individuals with MDD are diagnosed and, of those patients, 90 percent are
treated with medication.
Treating MDD with antidepressant medications is challenging for physicians
because patient response to antidepressant drug therapy varies significantly.
Research has shown that as many as 28 percent of patients being treated with
antidepressants stop taking their medication within the first four weeks of
treatment and as many as 44 percent stop within the first 12 weeks. Reasons for
discontinuing antidepressant treatment can include suboptimal efficacy, the
exacerbation of symptoms such as sleep disturbance, agitation, and sexual
dysfunction, and adverse events such as weight gain.
The FDA's decision represents the first regulatory approval for Labopharm's
novel, once-daily formulation of trazodone. The formulation is currently under
regulatory review in Canada.
Important Safety Information About Treatment with OLEPTRO(TM)
For more complete information about the use of OLEPTRO(TM), please see the
FDA-approved Prescribing Information and Medication Guide which will be posted
on the FDA website (http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/).
<<
Black Box Warning
Warning: Suicidality and Antidepressant Drugs
See full prescribing information for complete boxed warning
Increased risk of suicidal thinking and behavior in children, adolescents
and young adults taking antidepressants for major depressive disorder
(MDD) and other psychiatric disorders. OLEPTRO(TM) is not approved for
use in pediatric patients.
Warning and Precautions
- Patients with major depressive disorder (MDD), both adult and
pediatric, may experience worsening of their depression and/or the
emergence of suicidal ideation and behaviour, or unusual change in
behaviour, whether or not they are taking antidepressant medications.
Patients should be monitored for clinical worsening and suicidality
and for the appearance of any of the following symptoms: anxiety,
agitation, panic attacks, insomnia, irritability, hostility,
aggressiveness, impulsivity, akathisia, hypomania, and mania.
Families and caregivers should be alerted about the need to monitor
patients.
- The development of a potentially life-threatening serotonin syndrome,
or neuroleptic malignant syndrome (NMS)-like reactions has been
reported with antidepressants, and may occur with OLEPTRO(TM),
particularly with concomitant use of other serotoninergic drugs.
Treatment with OLEPTRO(TM) and any concomitant serotonergic or
antidopaminergic agents, including antipsychotics, should be
discontinued immediately and supportive treatment should be
initiated.
- A major depressive episode may be the initial presentation of bipolar
disorder. Prior to initiating treatment, patients should be
adequately screened to determine if they are at risk for bipolar
disorder and monitored for mania/hypomania. OLEPTRO(TM) is not
approved for use in treating bipolar depression.
- Experience with administration of immediate-release trazodone
products indicates that there may be an increased risk for QT
interval prolongation. QT prolongation may lead to Torsades de
pointes and even death especially in susceptible individuals, such as
those with hypokalemia, hypomagnesemia, or a genetic predisposition
to prolonged QT/QTc.
- Patients with pre-existing cardiac disease may be at more risk for
arrythmias. Concomitant administration of drugs that prolong the QT
interval or that are inhibitors of CYP3A4 may increase the risk of
cardiac arrhythmia in these patients.
- Orthostatic hypotension and syncope have been reported in patients
receiving trazodone hydrochloride.
- Drugs that interfere with serotonin reuptake, including trazodone
hydrochloride may increase the risk of bleeding events. Concomitant
use with NSAIDs, aspirin, or other drugs that affect coagulation may
compound this risk.
- Serious, sometimes fatal, reactions have been reported when
serotonergic drugs are used in combination with monoamine oxidase
inhibitor(s). Therefore, OLEPTRO(TM) should not be used concomitantly
or within 14 days of monoamine oxidase inhibitors.
- Rarely, cases of priapism can occur in men receiving trazodone.
OLEPTRO(TM) should be used with caution in men who have predisposing
conditions.
- There is a risk of hyponatremia when taking antidepressants. Elderly
patients may be at greater risk, as well as patients taking diuretics
or who are volume-depleted.
- OLEPTRO(TM) has the potential to impair judgment, thinking, and motor
skills. Advise patients to use caution before driving and when
operating machinery.
- Discontinuation symptoms may occur with abrupt discontinuation, and
may include anxiety, agitation and sleep disturbance. Upon
discontinuation, taper OLEPTRO(TM) and monitor for symptoms.
>>
Adverse Reactions
The most common adverse reactions (incidence greater than or equal to five
percent and twice that of placebo) are: somnolence/sedation, dizziness,
constipation, blurred vision.
These are not all the possible adverse events of OLEPTRO(TM).
About Labopharm Inc.
Headquartered in Laval, Canada with US offices in Princeton, New Jersey,
Labopharm is an emerging leader in optimizing the performance of existing small
molecule drugs using its proprietary controlled-release technologies. The
Company's lead product, a unique once-daily formulation of tramadol, is now
available in 17 countries around the world, including the U.S., Canada, major
European markets and Australia. Its second product, OLEPTRO(TM), a novel
formulation of trazodone for the treatment of major depressive disorder in
adults, has received regulatory approval in the U.S. and is under regulatory
review in Canada. Labopharm has initiated the European regulatory approval
process for its third product, a twice-daily formulation of
tramadol-acetaminophen. The Company also has a pipeline of follow-on products in
both pre-clinical and clinical development. Labopharm's vision is to become an
integrated, international, specialty pharmaceutical company with the capability
to internally develop and commercialize its own products. For more information,
please visit www.labopharm.com.
Jan 27, 2010 (FinancialWire via COMTEX) -- (Comment on this article at
http://www.financialwire.net/2010/01/27/medefile-exclusive-personal-health-record-vendor-for-soren-technologys-health-information-network/)
January 27, 2010 (FinancialWire) -- MedeFile International, Inc. (OTCBB: MDFI),
a leader in portable electronic medical records management, said it has signed a
contract with Soren Technology. MedeFile was chosen to become the exclusive
Personal Health Record vendor for Soren Technology's Suite of Electronic Health
Records products and the Soren Health Information Exchange.
In an effort to increase adoption of the Obama Administration's Health Care
reform, Soren Technology and MedeFile have partnered to offer health care
providers an almost no cost EHR alternative to their current antiquated paper
systems. The combined solution will provide patients access to their medical
information 24/7 through MedeFile's Personal Health Record systems.
Both companies anticipate a roll out over the next 30 days. The project will
allow health care providers to utilize Soren's suite of EHR products at
virtually no charge. Soren's EHR includes electronic interchange for ordering
lab tests and E-prescribe, both are "Meaningful Use" components. Another
objective for "Meaningful Use" involves patient immediate access to their
medical records and MedeFile's program easily qualifies. Additionally, all
providers that use Soren Technology's suite of services and deploy MedeFile's
integrated application will be able to offer their patients automatic enrollment
in MedeFile's Personal Health Record portable account system. MedeFile
technology helps patients to be more proactive when it comes to being
knowledgeable about their health and accessibility wherever they may be. The
seamless integration allows members to easily access their medical history as
data automatically synchronizes from the EHR to the PHR safely and securely.
Both Soren Technology and MedeFile embrace and support the idea of a National
Health Information Exchange Organization (NHIEO) enabling the secure sharing of
all Electronic Health Records.
Headquartered in South Florida, MedeFile has developed a proprietary system for
gathering and digitizing medical records so that individuals can have a
comprehensive record of all of their medical visits.
Jan 27, 2010 (Close-Up Media via COMTEX) -- Budget Center Inc. announced that
the Company's plans for developing and launching its "Budget" brand group of
websites targeting the growing number of thrift minded online travel consumers
is well underway.
The Company's budgethotels.com website has generated an impressive number of
visitors and the initial feedback has been exceptionally positive. Revenues are
growing daily 24/7 and the conversion rate so far is 45 percent, which is much
higher than expected as the industry average is a 10 percent conversion rate.
Management is continuing to work with its industry IT experts, The Wendling
Group, and Sidney, Australia based Hotels Combined to add new features and
content in an effort to draw more new visitors and offer repeat customers a
better overall online experience and help save them more money on their future
travel bookings.
The Company expects to launch its second domain budgetresorts.com by the end of
January 2010 in collaboration with Minneapolis, MN based Connexions CLTS, the
provider of San Francisco-based EzRez Software Inc. and a US based provider of
travel solutions for loyalty programs. The site is expected to offer the largest
inventory of travel content available on the internet all at "budget" prices for
consumers.
The Company is also preparing to launch its budgetskiing.com domain as a result
of a joint venture and marketing agreement with former world freestyle champion
Lauralee Bowie and her company, Lauralee Bowie Ski Adventures, located in
Vancouver, British Columbia, the host city of the 2010 Winter Olympics.
President and CEO, Bob Chalmers, noted, "We are very pleased with our progress
to date and the response that we have received for our "budget" brand and
websites. We plan to continue developing and launching all 12 of our budget
URL's, which should provide the company with impressive revenue growth as we are
operating on attractive booking commissions and our conversion rates are much
higher than the industry average, which endorses our business plan of targeting
the price conscious or "budget" online travel consumer."
BIRMINGHAM, Ala., Jan 26, 2010 /PRNewswire via COMTEX/ -- BioCryst
Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi
& Co., Ltd. will launch RAPIACTA, intravenous (i.v.) peramivir anti-viral, to
treat patients with influenza in Japan, on January 27, 2010. An English version
of Shionogi's press release announcing this launch is available on the web at:
http://www.shionogi.co.jp/ir_en/news/detail/e_100126.pdf
On January 13, 2010, Shionogi received the world's first marketing and
manufacturing approval for both single dose administration of 300 mg i.v.
peramivir for adult uncomplicated seasonal influenza infection, as well as
single and multiple dose administration of 600 mg i.v. peramivir for the
patients at high-risk for complications associated with influenza. Shionogi is
authorized to supply peramivir as either a 300 mg i.v. bag or a 150 mg vial for
i.v. drip infusion.
Recognizing that novel anti-viral influenza drugs are needed for the H1N1
pandemic, Shionogi has stated it intends to prepare an adequate supply for
approximately 700,000 people within its current fiscal year, which ends March
31, 2010, and it will also make efforts to ensure the manufacturing for stable
supply in its next fiscal year.
The National Health Insurance (NHI) price listing in Japan was established
January 22, 2010 as:
5,792 yen per RAPIACTA 300 mg bag
3,117 yen per RAPIACTA 150 mg vial
About peramivir
Peramivir is a potent, intravenously administered anti-viral agent that rapidly
delivers high plasma concentrations to the sites of infection. Discovered by
BioCryst, peramivir inhibits the interactions of influenza neuraminidase, an
enzyme which is critical to the spread of influenza within a host. In laboratory
tests, peramivir has shown activity against multiple influenza strains,
including pandemic H1N1 swine origin flu viral strains. Peramivir has been
studied in over 1800 patients with complicated and uncomplicated influenza.
Green Cross Corp. has filed for regulatory approval in Korea. On October 23,
2009, BioCryst announced that the U.S. Food and Drug Administration (FDA) issued
an emergency use authorization (EUA) for intravenous peramivir in certain adult
and pediatric patients with confirmed or suspected 2009 H1N1 influenza A
infection who are admitted to a hospital. Additional information regarding the
peramivir EUA is available on the web at: http://www.cdc.gov/h1n1flu/eua/.
About BioCryst
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule
pharmaceuticals that block key enzymes involved in infectious diseases, cancer
and inflammatory diseases. BioCryst has progressed two novel compounds into
late-stage pivotal clinical trials; peramivir, an anti-viral for influenza, and
forodesine, a purine nucleoside phosphorylase (PNP) inhibitor for cutaneous
T-cell lymphoma (CTCL). Utilizing crystallography and structure-based drug
design, BioCryst continues to discover additional compounds and to progress
others through pre-clinical and early development to address the unmet medical
needs of patients and physicians. For more information, please visit the
Company's Web site at www.biocryst.com.
BOTHELL, WA, Jan 26, 2010 (MARKETWIRE via COMTEX) -- MDRNA, Inc. (NASDAQ:
MRNA), a leading RNAi-based drug discovery and development company, today
announced that the State Intellectual Property Office of the People's Republic
of China (PRC) has issued a Notification of Granting Patent Rights for PRC
200480018784 which includes the use of nucleic acids, e.g., an siRNA, for the
treatment of cancer. The patent describes modulation of claudins, which are
proteins implicated in tumor progression and metastasis.
"China's pharmaceutical markets are growing nearly 20% a year," said J. Michael
French, President and CEO of MDRNA. "China has seen significant expansion in
both the pharmaceutical and biotech sectors, which provides an ideal environment
for our ongoing efforts to seek international R&D collaborations and investment
opportunities. With this patent and our recent allowance of a patent covering
RNAi-based modulation of JAM-1 for the treatment of cancer we continue to extend
our oncology patent estate worldwide."
About MDRNA's Technology
MDRNA has a broad intellectual property estate that encompasses four key RNAi
technology platforms: siRNA constructs, chemistry, nucleic acid delivery, and
gene targets. The MDRNA-owned siRNA constructs and chemistry include its
proprietary UsiRNA construct, which is a duplex siRNA chemically modified with
non-nucleotide acyclic monomers (UNAs), and is distinct from the standard siRNA
construct used by others in the industry. UsiRNAs are fully recognized by the
RNAi machinery and provide for potent RNAi activity while specific placement of
UNAs in a duplex siRNA minimizes potential off-target effects by the guide
strand and reduces undesired passenger strand activity. Furthermore, UsiRNAs
escape the surveillance mechanisms associated with cytokine induction, and
provide protection from nuclease degradation.
The MDRNA delivery platforms include DiLA2 and nanoparticle forming peptides.
DiLA2 is an MDRNA proprietary delivery platform of novel synthetic di-alkylated
amino acid compounds used to make liposomal delivery formulations. The DiLA2
platform enables MDRNA to tailor the charge, linker and acyl chains of amino
acids in order to configure liposomes for delivery to target tissues of
interest. In addition, the platform is designed to permit attachment of various
peptides and other targeting molecules to improve a variety of delivery
characteristics. The MDRNA peptide nanoparticle platform includes exclusively
in-licensed and developed IP surrounding the use of peptides for nanoparticle
formulations that increase cellular uptake and endosomal release of siRNAs.
MDRNA is currently biopanning its patented phage display library to identify
additional peptides for targeted delivery, cellular uptake and endosomal release
of siRNA.
MDRNA owns or controls 7 issued or allowed patents, and has more than 40 pending
patent applications, 126 pending foreign patent applications and 6 PCT
applications.
About MDRNA, Inc.
MDRNA is a biotechnology company focused on the development and
commercialization of therapeutic products based on RNA interference (RNAi). Our
goal is to improve human health through the development of RNAi-based compounds
and drug delivery technologies that together provide superior therapeutic
options for patients. Over the past decade, we have developed substantial
capabilities in molecular biology, cellular biology, lipid chemistry, peptide
chemistry, pharmacology and bioinformatics, which we are applying to a wide
range of RNAi technologies and delivery approaches. These capabilities plus the
in-licensing of key RNAi-related intellectual property have rapidly enabled us
to become a leading RNAi-based therapeutics company with a pre-clinical pipeline
in oncology. Through our capabilities, expertise and know-how, we are
incorporating multiple RNAi technologies as well as peptide- and lipid-based
delivery approaches into a single integrated drug discovery platform that will
be the engine for our clinical pipeline as well as a versatile platform for
establishing broad therapeutic partnerships with biotechnology and
pharmaceutical companies. We are also investing in new technologies that we
expect to lead to safer and more effective RNAi-based therapeutics while
aggressively building upon our broad and extensive intellectual property estate.
By combining broad expertise in siRNA science with proven delivery platforms and
a strong IP position, MDRNA is well positioned as a leading RNAi-based drug
discovery and development company. Additional information about MDRNA, Inc. is
available at http://www.mdrnainc.com.
NO BUY SCOTTRADE
BOCA RATON, Fla., Jan 25, 2010 (GlobeNewswire via COMTEX) -- MedeFile
International, Inc. (OTCBB:MDFI), a leader in portable electronic medical
records management, today announced that it has signed a contract with Soren
Technology. MedeFile was chosen to become the exclusive Personal Health Record
vendor for Soren Technology's Suite of Electronic Health Records products and
the Soren Health Information Exchange.
In an effort to increase adoption of the Obama Administration's Health Care
reform, Soren Technology and MedeFile have partnered to offer health care
providers an almost no cost EHR alternative to their current antiquated paper
systems. The combined solution will provide patients access to their medical
information 24/7 through MedeFile's Personal Health Record systems.
Barry Dorfman, Chief Operating Officer, Soren Technology stated, "Health
care providers need to respond rapidly to changes in business and health care
delivery environments. Information systems and users of those systems must be
managed effectively to allow for meaningful information flow. Soren Technology
works closely with partners and the medical community to ensure that patient
information moves seamlessly between health care enterprises. Given the enormity
of the current issues facing health care, our services could not come at a
better time." Dorfman adds, "After extensive review of different
Personal Health Record providers in the market, we felt that MedeFile has the
complete package. MedeFile's ability to integrate with our suite of services is
extremely beneficial. They offer valuable tools that can increase patient
awareness, curb medical errors, dramatically reduce costs and keep patients
compliant in their medication regimen, all extremely important issues."
Both companies anticipate a roll out over the next 30 days. The project will
allow health care providers to utilize Soren's suite of EHR products at
virtually no charge. Soren's EHR includes electronic interchange for ordering
lab tests and E-prescribe, both are "Meaningful Use" components.
Another objective for "Meaningful Use" involves patient immediate
access to their medical records and MedeFile's program easily qualifies.
Additionally, all providers that use Soren Technology's suite of services and
deploy MedeFile's integrated application will be able to offer their patients
automatic enrollment in MedeFile's Personal Health Record portable account
system. MedeFile technology helps patients to be more proactive when it comes to
being knowledgeable about their health and accessibility wherever they may be.
The seamless integration allows members to easily access their medical history
as data automatically synchronizes from the EHR to the PHR safely and securely.
Both Soren Technology and MedeFile embrace and support the idea of a National
Health Information Exchange Organization (NHIEO) enabling the secure sharing of
all Electronic Health Records.
Milton Hauser, CEO of MedeFile International, Inc. states, "it is long
overdue for providers to have an effective choice of EHR services to bring them
in to the technology age. With SorenTech, providers now have that option. We are
very pleased and excited to be able to offer all health care providers this
technology and platform as well as have all of their patients be able to take
advantage of the PHR feature. We believe this relationship will create a better
health care environment. Together, we will help fill communication gaps between
the patient and the provider, educate patients to become more responsible, and
play a much more active role in their own health care."
About MedeFile International, Inc.
Headquartered in South Florida, MedeFile has developed a proprietary system for
gathering and digitizing medical records so that individuals can have a
comprehensive record of all of their medical visits. MedeFile's primary product
is the MedeFile system, a highly secure system for gathering and maintaining
medical records. The MedeFile system is designed to gather all of its members'
actual medical records and create a single, comprehensive medical record that is
accessible 24 hours a day, seven days a week.
Representing an advanced, yet easy-to-use, approach to portable, electronic
medical records management, MedeFile combines state-of-the-art technology and
the Internet to make medical data instantly accessible to each MedeFile
subscriber and his or her authorized health care providers from anywhere in the
world. In addition to accessing one's medical records through MedeFile's secure
Internet portal found at www.medefile.com, members can carry their entire
medical history and emergency information wherever they go on a unique device
called a MedeDrive -- a proprietary USB drive designed to be carried on a
keychain. The MedeDrive plugs into any USB port of a Windows-based PC; and
because MedeDrive automatically loads its own viewer, users do not require any
special programs or software to view data. MedeMobile provides on-the-go
subscribers with the ability to enjoy even greater flexibility and access to
their personal health information wherever and whenever they need it. MedeMinder
is an electronic "reminder service" that utilizes automated phone
service to assist its subscribers in remembering scheduled medication reminders,
doctor appointments, prescriptions refills, and other time-sensitive treatment
protocols. For more information about MedeFile and its annual subscription-based
programs, please visit www.medefile.com
News for 'MTPR' - (MetaPower Announces Changes to Capital Structure
LAS VEGAS, NV, Jan 20, 2010 (MARKETWIRE via COMTEX) -- MetaPower International,
Inc. (PINKSHEETS: MTPR) (the "Company") is pleased to announce that on January
13, 2010 it changed the number of its authorized shares of Common Stock to
2,200,000,000 (two billion two hundred million).
MetaPower is also pleased to announce that almost all of the shares of the
Company's Series A Preferred Stock have been converted into the Company's common
stock. As of the close of business on Friday, January 15, 2010, the following
numbers of shares of its capital stock were issued and outstanding: (i)
2,029,489,138 shares of its common stock, (ii) 15,000 shares of its Series A
Preferred Stock (convertible into Common Stock), and (iii) 200,000 shares of its
Series B Preferred Stock (not convertible into Common Stock). The Company
expects that all of its outstanding Series A Preferred Stock will, during the
first quarter of 2010, either be redeemed or converted into the Company's Common
Stock.
About MetaPower International, Inc.:
MetaPower International, Inc. is a technology and services firm originally
founded in 1996 that provides information technology and change management
services to hazardous process industries. This link between technology and
services is critical to manage the changes necessary to successfully compete in
the current environment. In today's world, business operations must be
streamlined to meet the challenges of these turbulent economic times.
SARANAC, Mich., Jan 19, 2010 /PRNewswire via COMTEX/ -- Green Bridge
Industries, Inc. (Pink Sheets: GRBG) is pleased to announce that the Company has
signed an exclusive 3 year licensing agreement with wowgreen International, LLC
on January 15, 2010. Through this agreement the Company plans to produce and
market wowgreen's non-enzyme based, 2nd generation products. wowgreen currently
has twelve safe, effective, all-natural, cleaning products which include laundry
detergent, dishwasher detergent, and hand dish soap, amongst others.
As part of the agreement, Green Bridge Industries will become the exclusive
manufacturer of select wowgreen Products; Stain Remover Pen, Floor Cleaner, All
Purpose Cleaner, Wood and Dust Cleaner, Tile and Bath Cleaner, Carpet and
Upholstery Cleaner, Fabric Pre-Wash, Air Freshener, and Toilet Bowl Cleaner on
the Consumer side. Additionally Green Bridge will also become the exclusive
manufacturer for the Commercial Division with the following offerings;
Industrial Degreaser, Odor Eliminator, Carpet & Upholstery Cleaner, All Purpose
Cleaner, Wood and Dust Cleaner, Glass & Stainless Steel Cleaner, Toilet and Bath
Cleaner, and Floor Cleaner. Green Bridge Industries will pay wowgreen $250,000
for the rights to manufacture and source these as well as other new products.
wowgreen International, LLC is the provider of safe, green household cleaners
that are sold and distributed to consumers through a channel of independent
distributors. The company's mission is to free the world of toxic chemicals, one
household at a time. wowgreen's products are manufactured from a proprietary
formula that provides a safe, effective and all natural cleaning solution for
every household need.
"We are excited to have consummated our licensing agreement with wowgreen. The
addition of the wowgreen products offers us an immediate opportunity to increase
our sales revenues," stated William White, Chairman and CEO of Green Bridge
Industries, Inc.
The Company recently announced that wowgreen International, LLC had signed a
binding letter of intent with Green Bridge Industries to acquire majority
control of the Company for an undisclosed amount, which is to be paid in a
combination of cash and stock over time. The two companies are currently in
discussions to finalize the terms of the agreement.
For more information about wowgreen International, LLC, please visit:
www.wowgreen.net.
About Green Bridge Industries, Inc.:
Green Bridge Industries, Inc. offers non-toxic, environmentally friendly
cleaning products to fit the sanitation needs of the medical, agricultural,
military, and retail markets. The Company, through its proprietary technology,
has the ability to develop bio-renewable alternative cleaning products, which
are superior to the synthetic products currently offered in the marketplace. The
Company's products are safe for the surfaces it cleans, the environment, animals
and humans. For more information on Green Bridge Industries, visit:
www.greenbridgeindustries.com.
LAS VEGAS, Jan 04, 2010 /PRNewswire-FirstCall via COMTEX/ -- Cord Blood
America, Inc. (OTC Bulletin Board: CBAI), the umbilical cord blood stem cell
preservation company (http://www.cordblood-america.com) focused on bringing the
life saving potential of stem cells, a biological insurance policy, to families
nationwide and internationally, said today that it has signed a Letter of Intent
to process and store cord blood specimens for BioCells, Inc., headquartered in
Argentina, and its affiliates in Peru, Colombia, Bolivia, Panama and Puerto
Rico.
"This is an excellent example of how our new laboratory and storage facility in
Las Vegas allows us to significantly diversify our business model," said Matthew
Schissler, co-founder and CEO. "BioCells is already the second largest stem cell
storage company in Argentina with annual revenues of 1.5M (USD). The company has
12 locations throughout the country and has recently expanded internationally to
both Uruguay and Paraguay. We are confident this will be an excellent working
relationship, beneficial to both companies. We will be processing and storing
for BioCells' affiliates in Peru, Colombia, Bolivia, Panama and Puerto Rico."
"It is a revenue generator we have not had in the past. Not only do we have our
own organic sales engine, our new lab can now generate gross profit by
processing and storage agreements with other successful stem cell companies,"
Mr. Schissler commented. "BioCells has proven to be a tremendous company and we
are fortunate to have entered into this letter of intent."
Cord Blood America recently announced a grand opening of its 17,000 square foot
stem cell laboratory and headquarters in Las Vegas, near the city's
international airport, on January 22, 2010.
The deal between Cord Blood America and BioCells is pending due diligence, and
if it is completed successfully, anticipates the contract closing in the first
quarter of 2010.
About Cord Blood America
Cord Blood America (OTC Bulletin Board: CBAI) is the parent company of CorCell,
which facilitates umbilical cord blood stem cell preservation for expectant
parents and their children. Its mission is to be the most respected stem cell
preservation company in the industry. Collected through a safe and non-invasive
process, cord blood stem cells offer a powerful and potentially life-saving
resource for treating a growing number of ailments, including cancer, leukemia,
blood, and immune disorders. To find out more about Cord Blood America, Inc.
(OTC Bulletin Board: CBAI), visit our website at www.corcell.com. For investor
information, visit www.cordblood-america.com.
NEW YORK, Dec 31, 2009 /PRNewswire-FirstCall via COMTEX/ -- GoIP Global Inc.
(GOIG; http://www.goigcorp.com) announces the sale of its China based assets to
assure profit increase for its shareholders in the upcoming quarters.
Apart from selling its EE Global subsidiary as announced in the press release
from Dec 21, 2009, and in the light of the company's upcoming debut of its Go800
made-for-mobile service that the company has already submitted patent
application and registered with the largest US cell phone providers, GOIG
decided that the best way to increase shareholder value is to sell off its
remaining China based assets, namely its SPC Belize (Special Purpose Company),
namely Wuhan Media and Yezhifeng Media.
The buyer is a US based MonArc Corp www.monacorporation.com who will complete
the purchase on all stock basis of about 1.5 billion shares. Filings will be
made on Pink Sheets shortly.
Ike H. Sutton, the CEO of GOIG, said, "We've decided to sell our China based
subsidiaries and fully focus on our US operations, where our shareholders can
easily track and even contribute to our market success. We expect to launch our
Go800 service in the 1st quarter of 2010. This service has a tremendous upside
and we expect to fully capitalize on the made-for-mobile market and
substantially raise the share value. This is a new, revamped and polished GOIG,
and the shareholders will reap the rewards soon."
NEW YORK, Dec 31, 2009 /PRNewswire-FirstCall via COMTEX/ -- GoIP Global Inc.
(GOIG; http://www.goigcorp.com) announces the sale of its China based assets to
assure profit increase for its shareholders in the upcoming quarters.
Apart from selling its EE Global subsidiary as announced in the press release
from Dec 21, 2009, and in the light of the company's upcoming debut of its Go800
made-for-mobile service that the company has already submitted patent
application and registered with the largest US cell phone providers, GOIG
decided that the best way to increase shareholder value is to sell off its
remaining China based assets, namely its SPC Belize (Special Purpose Company),
namely Wuhan Media and Yezhifeng Media.
The buyer is a US based MonArc Corp www.monacorporation.com who will complete
the purchase on all stock basis of about 1.5 billion shares. Filings will be
made on Pink Sheets shortly.
Ike H. Sutton, the CEO of GOIG, said, "We've decided to sell our China based
subsidiaries and fully focus on our US operations, where our shareholders can
easily track and even contribute to our market success. We expect to launch our
Go800 service in the 1st quarter of 2010. This service has a tremendous upside
and we expect to fully capitalize on the made-for-mobile market and
substantially raise the share value. This is a new, revamped and polished GOIG,
and the shareholders will reap the rewards soon."
This guy will take every penny you have and most know it
StockEgg.com - ZENG - Volume Alert