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StandoutStocks.com: "Stocks that Standout" picks for today are: ACOR, ERII, GENZ, PGOG, PGYC, SCII
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RDATE:31032009
StandoutStocks.com "Stocks that Standout" picks for today are: Acorda
Therapeutics, Inc. (NASDAQ: ACOR), Energy Recovery, Inc. (NASDAQ:
ERII), Genzyme Corporation (NASDAQ: GENZ), Perf Go Green Holdings, Inc.
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Mar 31, 2009 -- Acorda Therapeutics, Inc. (NASDAQ: ACOR) announced
today that the Company received a refuse to file letter from the U.S.
Food and Drug Administration (FDA) regarding its New Drug Application
(NDA) for Fampridine-SR, a novel therapy being developed to improve
walking ability in people with multiple sclerosis (MS).
The FDA has raised what it termed "format issues" regarding the eCTD
(electronic) submission, requesting that some of the data in the NDA be
reformatted, as well as requesting that some additional supporting
information be included in the filing. The FDA has not requested or
recommended additional clinical or other studies.
"We are surprised by this development," stated Ron Cohen, M.D.,
President and CEO of Acorda Therapeutics, "We plan to address the
issues raised in this letter with FDA expeditiously as we believe
Fampridine-SR is potentially an important, first in class treatment
option for people suffering with MS."
The Company plans to request a meeting with FDA as soon as possible to
discuss its comments on the NDA filing.
Conference Call and Audiocast
corda will host a conference call Tuesday, March 31, 2009 at 8:30 a.m.
Eastern Time. To participate, please dial 866-783-2143 (domestic) or
857-350-1602 (international) and reference the access code 85118409. To
access the audio webcast, please go to the Investor Relations "Calendar
of Events" section of the Acorda website, or you may use the link:
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=194451&e
ventID=2150210.
A replay of the call will be available from 11:30 a.m. Eastern Time on
March 31, 2009 until April 30, 2009. To access the replay, please dial
888-286-8010 (domestic) or 617-801-6888 (international) and reference
the access code 59152215. The archived teleconference will be available
for 30 days in the Investor Relations section of the Acorda website at
http://phoenix.corporate-ir.net/phoenix.zhtml?c=194451&p=irol-irhome.
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for
spinal cord injury, multiple sclerosis and related nervous system
disorders. The Company's marketed products include Zanaflex Capsules(R)
(tizanidine hydrochloride), a short-acting drug for the management of
spasticity. The Company's pipeline includes a number of products in
development for the treatment, regeneration and repair of the spinal
cord and brain.
Mar 31, 2009 -- Energy Recovery, Inc. ("ERI") (NASDAQ: ERII), a global
leader of ultra-high-efficiency energy recovery products and technology
for desalination, was awarded the 75,000 m(3)/day (20 million US
Gallons (MGD)) energy recovery technology contract from Acciona Agua
for the Paraguana seawater reverse osmosis (SWRO) desalination plant in
Venezuela. The project is currently under construction and is scheduled
for completion in early 2010.
The plant is located in the Paraguana peninsula in the Falcon region in
northwest Venezuela, an area considered to be one of the driest places
in the country. The project at Petroleos de Venezuela SA's (PDVSA)
Paraguana Refinery Complex is being designed and built jointly by
Spanish water company Acciona Agua and PDVSA. The Paraguana Refinery
Complex will utilize approximately 30% of the production capacity, with
the remainder supplying a population of 350,000. This will be the
largest RO desalination plant in South America and one of the largest
plants in the Caribbean region.
EPC contractor Acciona Agua is designing the plant with ERI's energy
efficient pressure recovery solution, employing 64 model PX-260 units.
These devices will save the project an estimated 52 mega-watts of
energy per year.
This is not the first time Acciona selected PX technology for its
desalination projects. Europe's largest facility, the 240,000 m(3)/day
(64 MGD) Torrevieja plant in Spain as well as the 100,000 m(3)/day (26
MGD) Fouka project in Algeria, the 60,000 m(3)/day Tordera retrofit
plant in Spain and the 16,000 m(3)/day Arucas II plant, also in Spain,
are being built by Acciona using PX energy recovery devices. These
plants will supply fresh water for municipal, industrial and
agricultural applications.
Borja Blanco, ERI Vice President and General Manager of the Mega
Projects Division stated, "We consider Acciona Agua to be a premier
partner in delivering energy efficient solutions in desalination. They
have relied on PX technology for many of their first-of-a-kind projects
all over the world."
About ERI(R)
Energy Recovery, Inc. (ERI) is a leading manufacturer of energy
recovery devices which help make desalination affordable by
significantly reducing energy consumption. ERI's PX Pressure
Exchanger(R) (PX(R)) device is a rotary positive displacement pump that
recovers energy from the high pressure reject stream of seawater
reverse osmosis (SWRO) systems at up to 98% efficiency with no downtime
or scheduled maintenance.
The company has research, development and manufacturing facilities in
the San Francisco technology corridor as well as direct sales offices
and technical support centers in key desalination hubs such as Madrid,
UAE, Shanghai and Florida. ERI service representatives are based in
Algeria, Australia, China, India, Korea, Mexico, Taiwan and the
Caribbean.
Mar 31, 2009 -- Genzyme Corporation (NASDAQ: GENZ) announced today that
it has entered into an agreement to acquire the worldwide rights to
Campath(R) (alemtuzumab) from Bayer HealthCare, giving Genzyme primary
responsibility for the development and commercialization of this
potential break-though treatment for multiple sclerosis (MS). Bayer
will continue to fund a portion of alemtuzumab's development in MS and
will retain an option to co-promote the product in MS upon approval. In
addition, Genzyme will assume sole responsibility for worldwide sales
and marketing for Campath in B-cell chronic lymphocytic leukemia (CLL),
where it is indicated for use as a single agent in first-line and
previously-treated patients with this disease. Bayer will retain the
right to develop and commercialize alemtuzumab in solid organ
transplant indications.
The agreement further expands Genzyme's hematologic oncology commercial
presence beyond Campath through the addition of Fludara(R)
(fludarabine) and Leukine(R) (sargramostim), and provides an
opportunity to integrate members of Bayer's experienced commercial team
for all three drugs into Genzyme's global operations. Genzyme will
acquire a new, Seattle-area Leukine manufacturing facility for $75 to
$100 million and hire the plant's operating personnel following FDA
plant approval, which is expected in 2010.
The transaction is accretive and already reflected in Genzyme's 2009
revenue and non-GAAP earnings per share guidance. The deal is
structured as an earn-out arrangement. Bayer will receive payments
based on revenues (subject to an aggregate cap) and potential milestone
payments if cumulative revenue targets are achieved. There are no
upfront payments for the rights of these three drugs. The transaction
would provide Genzyme approximately $185 million in oncology revenue in
2009 and up to $700 million in revenue over the next three years.
Genzyme's Oncology segment revenues in 2008 were $117 million. Today's
announcement supports the company's goal of 20 percent compound average
non-GAAP earnings growth from 2006 to 2011.
Alemtuzumab in MS
"Alemtuzumab is a potentially transformative therapy for the treatment
of multiple sclerosis, and an important part of our future. This
strategic transaction clarifies the responsibilities of each company
and gives Genzyme control over the execution of this program," said
Henri A. Termeer, chairman and chief executive officer of Genzyme
Corporation. "We will continue to collaborate with Bayer in a more
streamlined and focused way."
Genzyme is now conducting two Phase 3 studies of alemtuzumab in MS. The
first trial, for which enrollment is complete, treats early, active
relapsing-remitting patients who have received no prior therapy. The
second study, which is expected to complete enrollment before the end
of this year, is studying relapsing-remitting patients who had active
disease while on other MS therapies. "We are very pleased with the
accelerated patient enrollment in our Phase 3 alemtuzumab multiple
sclerosis clinical trials, an outgrowth of the positive Phase 2 data
published last October," said Mark Enyedy, president of Genzyme
Oncology and Multiple Sclerosis. Data from the trials are expected to
be available in 2011, and approval is anticipated in 2012.
The Phase 2 study published in the New England Journal of Medicine
showed that patients with early, active relapsing-remitting MS
experienced significant reductions in the risk of sustained
accumulation of disability and annualized relapses after two annual
cycles of alemtuzumab when compared with the active comparator Rebif(R)
(interferon beta-1a), a currently approved therapy.
Oncology Expansion
Campath and Fludara are important therapy options for patients with
B-cell chronic lymphocytic leukemia. Both drugs are approved in the
United States and Europe as well as in other countries around the
world. Leukine, which is marketed in the United States, reduces the
incidence of severe and life-threatening infections in appropriate
patients with acute myelogenous leukemia (AML) following chemotherapy.
Fludara and Leukine complement Genzyme's hematologic oncology product
portfolio.
"Through the acquisition of these hematologic oncology assets, we
enhance our commercial presence in the oncology market with a
comprehensive product portfolio," said Enyedy. "Genzyme is committed to
this important disease area and to deepening our relationship with the
specialist providers in this field around the world."
The long-term growth of Genzyme Oncology will be driven by regulatory
approvals for Mozobil(TM) (plerixafor injection) in new markets and new
indications for Clolar(R) (clofarabine injection). The addition of
members of Bayer's global commercial team will support the introduction
of Mozobil and Clolar for adult AML.
Mozobil, launched in the United States earlier this year, mobilizes
hematopoietic stem cells in patients with non-Hodgkin's lymphoma and
multiple myeloma for subsequent autologous stem-cell transplants.
Because of the clinical benefits Mozobil offers patients, and the
potential economic benefits to transplant centers, the U.S. product
launch is proceeding well. European Union approval of Mozobil is
expected in the second half of 2009, and additional applications in up
to 60 countries are planned.
Clolar is in several clinical trials to secure new therapeutic
indications. The U.S. Food and Drug Administration will review
Genzyme's supplemental New Drug Application for Clolar to treat adult
AML at its September Oncologic Drugs Advisory Committee meeting.
European authorities have asked Genzyme to include in its submission
for Clolar in adult AML data from a randomized clinical trial, several
of which are ongoing. Clofarabine is currently approved in the United
States and Europe (where it is marketed under the tradename Evoltra(R))
for the treatment of acute lymphoblastic leukemia in relapsed and
refractory pediatric patients, and has become a standard of care in
this setting. Additional approvals are expected in Latin America and
Canada this year.
Key Terms of the Agreement
The agreement creates efficiencies for the alemtuzumab MS development
program, and expands the Genzyme Oncology business unit revenues. The
new agreement contains the following key terms:
Alemtuzumab in MS
-- Genzyme will lead the development program. Bayer, which has been
co-developing alemtuzumab in MS with Genzyme, will continue to fund
development at current levels until the investigational compound is
approved for this indication.
-- After approval, Bayer will receive payments contingent on annual
revenue until $1.25 billion in payments is realized. The agreement
includes a ten-year time cap on payments. Bayer may also receive future
milestone payments as a percentage of worldwide sales beginning in 2021
if Genzyme does not exercise a buyout option in 2020 for up to $900
million.
-- Genzyme will assume primary responsibility for the
commercialization. Bayer, which currently markets Betaseron(R)
(interferon beta-1b) for MS, retains an option to co-promote
alemtuzumab in MS.
Oncology Drugs
-- For the oncology drugs Fludara, Leukine, and Campath/MabCampath,
Bayer will receive payments contingent on annual revenue, capped at
$500 million or eight years.
-- In addition, Bayer could receive $150 million in total milestone
payments beginning in 2011 if certain annual revenues are met across a
three-year time period.
-- Bayer will supply Fludara and Leukine. Genzyme will take over the
production of Leukine following FDA approval of a new, Seattle-area
Leukine plant.
The transaction is expected to close in the second quarter, pending
Federal Trade Commission review and international regulatory
clearances. Genzyme and Bayer will work closely to allow for an orderly
transition of drug sales and distribution. This process is expected to
take place over a period of months following the close of the
transaction, during which Bayer will provide transition services.
Prior to this agreement, Genzyme received two-thirds of Campath net
profits on U.S. sales and a significant royalty on foreign sales from
Bayer. Genzyme acquired Campath in the 2004 acquisition of Ilex
Oncology, while Bayer obtained the marketing and distribution rights to
Campath in its 2006 acquisition of Schering, which had been the
exclusive distributor of Campath for Ilex. As a precondition to FTC
clearance of the Ilex acquisition, Genzyme agreed to divest to Schering
the right to develop and commercialize alemtuzumab in solid organ
transplant. Bayer will retain such right under this agreement.
About Campath(R) (alemtuzumab) Alemtuzumab is a humanized monoclonal
antibody that binds to a specific target, CD52, on cell surfaces and
directs the body's immune system to destroy those cells. It is the
first and only monoclonal antibody approved by the FDA for the
treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL).
Safety Data from the alemtuzumab in MS Phase 2 Trial
A total of six alemtuzumab-treated patients, and one Rebif-treated
patient, in this study developed a serious adverse event, immune
thrombocytopenic purpura (ITP). ITP is a disorder characterized by a
low platelet count and corresponding increased risk of uncontrolled
bleeding. A patient monitoring program was instituted in the trial.
Common non-serious adverse events in the trial included
infusion-associated reactions in the alemtuzumab patients and flu-like
symptoms in patients using Rebif. Alemtuzumab-treated patients were
more likely than Rebif patients to experience infections, particularly
of the upper respiratory tract; infections were predominantly mild to
moderate in severity and there were no life-threatening or fatal
infections. Though alemtuzumab transiently lowers white blood cell
counts, the trial did not show an increased risk of opportunistic
infections. Serious infections were infrequent in the
alemtuzumab-treated patients. Some alemtuzumab-treated patients
developed autoimmune thyroid-related adverse events, including Graves'
disease, and were managed using conventional therapies. Alemtuzumab is
an investigational drug for the treatment of MS and must not be used in
MS patients outside of a formal, regulated clinical trial setting in
which appropriate patient monitoring measures are in place.
About Leukine(R) (sargramostim)
Leukine(R) (sargramostim) is a growth factor that helps fight infection
and disease in appropriate patients by enhancing immune cell function.
Leukine was approved in the United States in 1991. Leukine is the only
growth factor approved in the U.S. for use following induction
chemotherapy in older adults with acute myelogenous leukemia (AML) to
shorten the time to neutrophil recovery and reduce the incidence of
severe and life-threatening infections and infections resulting in
death. Leukine also has been approved in the U.S. for use in four
additional indications: myeloid reconstitution following allogeneic and
autologous bone marrow transplantation (BMT), peripheral blood stem
cell (PBSC) mobilization and subsequent myeloid reconstitution in
patients undergoing PBSC transplantation, and bone marrow
transplantation failure or engraftment delay.
About Fludara(R) (fludarabine phosphate for injection)
Unlike alkylating cytotoxic chemotherapies, Fludara(R), a purine
nucleotide analog, inhibits the synthesis of new DNA, thus preventing
leukemia cells from multiplying. The intravenous (i.v.) formulation of
Fludara was first approved in 1991 and is available in 98 countries
worldwide as a second-line therapy for B-CLL patients who have failed
previous treatment with alkylating agents. In addition, Fludara i.v.
has been approved as a first-line therapy of B-CLL in 62 countries. In
29 countries, Fludara i.v. is also approved for the second-line
treatment of low grade non-Hodgkin's Lymphoma (lg-NHL). The oral
formulation has the same effect as the i.v. formulation and was
approved in Europe in 2001.
About Mozobil(TM) (plerixafor injection)
Mozobil, a novel small molecule CXCR4 chemokine receptor antagonist,
has been shown in multiple earlier studies to rapidly and effectively
increase the number of stem cells in circulation in the blood in
patients with non-Hodgkin's lymphoma and multiple myeloma. Once
circulating in the blood, stem cells can be collected for use in an
autologous stem cell transplant.
About Clolar(R) (clofarabine injection)
Clolar is indicated in the U.S. for the treatment of pediatric patients
one to 21 years old with relapsed or refractory acute lymphoblastic
leukemia after at least two prior regimens. This use is based on the
induction of complete responses. Randomized trials demonstrating
increased survival or other clinical benefit have not been conducted.
In the European Union, clofarabine is marketed as Evoltra(R) and Clolar
is indicated in ALL pediatric patients who have relapsed or are
refractory after receiving at least two prior regimes and where there
is no other treatment option anticipated to result in durable response.
Clolar received FDA approval in 2004, and EMEA approval in 2006. Clolar
has Orphan Drug designation for adult and pediatric ALL, and seven
years of market exclusivity in the United States for
relapsed/refractory pediatric ALL. The FDA also granted six months of
extended market exclusivity to Clolar under the Best Pharmaceuticals
for Children Act.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. Since 1981, the company has grown from a small
start-up to a diversified enterprise with more than 11,000 employees in
locations spanning the globe and 2008 revenues of $4.6 billion. In
2007, Genzyme was chosen to receive the National Medal of Technology,
the highest honor awarded by the President of the United States for
technological innovation.
With many established products and services helping patients in
approximately 100 countries, Genzyme is a leader in the effort to
develop and apply the most advanced technologies in the life sciences.
The company's products and services are focused on rare inherited
disorders, kidney disease, orthopaedics, cancer, transplant and immune
disease, and diagnostic testing. Genzyme's commitment to innovation
continues today with a substantial development program focused on these
fields, as well as cardiovascular disease, neurodegenerative diseases,
and other areas of unmet medical need.
Mar 31, 2009 -- Perf Go Green Holdings, Inc. ("Perf Go Green") (OTCBB:
PGOG) the leader in biodegradable plastic products and everyday green
solutions, today announced its partnership with Six Flags, Inc.
(NYSE:SIX), the world's largest regional theme park company, to support
its green initiatives. Six Flags will use Perf Go Green biodegradable
commercial trash bags throughout the company's twenty locations in the
United States, Mexico and Canada.
"We at Perf Go Green believe in reusing, recycling, and reducing our
impact on the environment as much as possible. From development to
disposal, all Perf Go Green products respect our cradle-to-cradle
philosophy," CEO Tony Tracy said. "Formed with one purpose, one goal in
mind -- to stop trashing the planet, and embrace solutions that will
help achieve this goal, we are happy to provide more products to meet
the demand of the eco-conscious consumer and reach the thousands of
people that visit Six Flags each year."
"We believe that protecting the environment is everyone's
responsibility and we've made a commitment to introduce everyday
sustainability solutions within our family of parks," said Mark
Quenzel, Six Flags EVP, Park Strategy and Management. "These
initiatives will help to ensure healthier environments and more vibrant
communities for current and future generations."
Perf Go Green commercial trash bags complement the company's existing
consumer product line, which currently includes the 13-gallon tall
kitchen trash bag and 30- and 39-gallon lawn & leaf bags. Perf Go
Green's corporate name reflects its "Go Green" mission to develop
market and distribute biodegradable plastic products as a practical
solution to eliminating plastic waste from the world environment.
Founded in November 2007, Perf Go Green premiered at the March 2008
International Home and Housewares Show in Chicago, where its products
received an honor for their design quality and innovation. One year
later, in 2009 Perf Go Green launched 0% cadmium, 0% lead, 0% mercury,
PerfPower(tm) Alkaline Batteries with free recycling, through
www.i-recycled.com, and their all-natural and sustainable Perf Go
Clean(tm) line of household and commercial cleaning products.
About Perf Go Green
Perf Go Green, Holdings Inc. is a New York-based biodegradable plastics
company. The corporate name reflects the "Go Green" mission from
inception to create a Green company for the development and global
marketing of eco-friendly, non-toxic, food contact compliant,
biodegradable plastic products as a practical and viable solution to
eliminating plastic waste from the world environment.
Mar 31, 2009 -- Patriot Energy Corporation (PINKSHEETS: PGYC) is
pleased to report that Pink Sheets Electronic OTC Markets has accepted
all current information filed and consequently officially updated
Patriot Energy Corporation's information as of March 30, 2009.
By filing all current and updated company information, Pinksheets.com
lifts the caveat and as a result the public is presented with the
opportunity to see a complete overview of the business, management
team, board members and financial condition of Patriot Energy
Corporation, through the most recent period ending February 28th, 2009.
Patriot Energy Corporation is committed to assure transparency for its
shareholders and investors by maintaining all company information
current. Investors and other interested parties may view this filing on
pinksheets.com.
About Patriot Energy Corporation
Patriot Energy Corp. is a management holding corporation, which owns a
wholly owned subsidiary named TelTeck Solutions and owns a 99 year
exclusive leased license agreement with Tectane Technologies
Corporation for the Dual H2O Engine Oxygenator and New Tri-Brid Engine
(Electric/Flex-Fuels/H2O) Technologies. Patriot Energy specializes in
the development and marketing of energy efficient technologies with a
focus on reducing America's dependence on Foreign Oil.
Total Shares Outstanding (fully diluted): 199,500,000
Mar 31, 2009 -- Stem Cell Therapy International, Inc. (OTCBB: SCII) --
soon to be known as AmStem International after a successful merger with
Histostem Ltd, of South Korea ("the Company") -- is proud to announce
today that the Company is now ready to replicate, on an international
scale, the remarkably successful Stem Cell Leadership Program developed
by Dr. Hoon Han in South Korea. The Company and Histostem Ltd. leaders
will collaborate to establish a dynamic system -- that can be operated
virtually anywhere in the world -- of stem cell collection, storage,
research and therapeutic services, based on the proven success of
Histostem, Ltd. in Asia.
"We will be creating a mentoring system from AmStem's proprietary
technologies (as acquired from Histostem Ltd's state-of-the-art
facilities and accomplished clinical successes) to launch a program of
leadership and replication that will exponentially increase our
revenue-producing and product development operations," announced David
Stark, President of AmStem International. "We already have our first
amazing new product ready to roll out, which will be announced in the
next few days," he added, "And I have personally been negotiating with
government officials and leading clinics in other countries; making
excellent progress toward our mutual goals."
"Our proven combination of cord blood collection and storage,
ethically-based clinical trials, and therapeutic applications of
promising technologies will be a boon to the economy of any country,
and will allow us to make new scientific discoveries in collaboration
with international stem cell leaders," he added. "Basically, we will be
replicating the incredible success that Histostem has had in South
Korea; greatly expanding our revenue-producing and product development
operations in a dynamic, modern, international setting."
Histostem Ltd. currently operates the largest accredited cord blood and
stem cell bank in the world (more than twice as large as its nearest
competitor), and is already successfully treating hundreds of patients
with patented, Korean FDA-approved stem cell therapies derived from its
own sources. It is one of the few stem cell companies in the world that
is profiting from its stem cell operations. "To my knowledge, no other
company in the world has the type of approval from its home country's
regulatory agencies that Histostem Ltd. has from the Korean FDA,"
affirmed Mr. Stark. "This in effect gives us carte blanche to study the
treatment of virtually any appropriate medical condition with stem
cells as an approved 'surgical technique,'" he added. "We can use this
precedent to seek similar approvals in other countries that want to
come to the forefront of the international stem cell stage."
"Adult stem cell technology is far less controversial in many countries
than embryonic stem cells," explained Dr. Han. "We will immediately
explore the fantastic revenue opportunities for offering world-class
stem cell treatment from Histostem's patented technologies in receptive
international settings, which would also establish a robust and ethical
clinical trials program that will benefit the local population for
years to come."
About Stem Cell Therapy International, Inc.
Stem Cell Therapy International, Inc. ('SCII') is in the field of
regenerative medicine. SCII is a company devoted to the treatment of
patients with stem cell transplantation therapy as well as providing
the supplies of biological solutions containing new lines of stem cell
products.
About Histostem Corporation, Ltd:
Histostem, Co., Ltd. started in Seoul, Korea in 2000. To date it has
treated more than 500 patients with stem cells and currently have 56
full-time employees and 28 part-time employees. Histostem's
intellectual property portfolio consists of five patents that have been
granted and 6 patents pending. To its knowledge Histostem is one of the
very few stem cell companies in the world currently earning several
million dollars in income from its products and technology.
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