Theratechnologies (TSX:TH) announced today that the U.S. Food and Drug
Administration ("FDA") has approved EGRIFTA(TM) (tesamorelin for injection) as
the first and only treatment indicated to reduce excess abdominal fat in
HIV-infected patients with lipodystrophy (abdominal lipohypertrophy).
EGRIFTA(TM) (tesamorelin for injection) was developed by Theratechnologies and
will be exclusively commercialized in the U.S. by EMD Serono, Inc. ("EMD
Serono"), an affiliate of Merck KGaA, of Darmstadt, Germany, under the terms of
a collaboration and licensing agreement.
There are limitations of use associated with EGRIFTA(TM) (tesamorelin for
injection). Since the long-term cardiovascular safety and potential long-term
cardiovascular benefit of EGRIFTA(TM) (tesamorelin for injection) treatment have
not been studied and are not known, careful consideration should be given
whether to continue EGRIFTA(TM) (tesamorelin for injection) treatment in
patients who do not show a clear efficacy response as judged by the degree of
reduction in visceral adipose tissue ("VAT") measured by waist circumference
("WC") or CT scan. EGRIFTA(TM) (tesamorelin for injection) is not indicated for
weight loss management (weight neutral effect). There are no data to support
improved compliance with antiretroviral therapies in HIV-positive patients
taking EGRIFTA(TM) (tesamorelin for injection).
"Theratechnologies is very pleased to receive marketing approval for EGRIFTA(TM)
from the FDA. We are one of the very few Canadian biotechnology companies to
have successfully discovered, developed and brought a drug to the market on our
own. This milestone represents a significant achievement which will benefit both
patients and our shareholders," commented Yves Rosconi, President and CEO of
Theratechnologies.
"We are confident that EMD Serono will successfully commercialize EGRIFTA(TM) in
the United States, given their track record and expertise with other metabolic
disorders," noted Paul Pommier, Chairman of the Board of Directors of
Theratechnologies. "Theratechnologies will continue to focus on signing
partnerships outside of the United States in order to access additional markets
for EGRIFTA(TM) in HIV-infected patients with excess abdominal fat associated
with lipodystrophy," Mr. Pommier concluded.
"While antiretroviral therapy is extremely important in the management of
patients with HIV infection, some patients are experiencing excess abdominal fat
associated with lipodystrophy, which can be difficult to manage," said Fereydoun
Firouz, President and CEO, EMD Serono. "EMD Serono has maintained a commitment
to advancing science and medicine in this area of unmet medical need, and it
will continue to remain a focus for the organization. We are committed to making
a difference in people's lives, and look forward to making EGRIFTA(TM) available
for patients as soon as possible."
In 2008, Theratechnologies entered into a collaboration and licensing agreement
with EMD Serono, for the exclusive commercialization rights to EGRIFTA(TM)
(tesamorelin for injection) in the United States for the treatment of excess
abdominal fat in HIV-infected patients with lipodystrophy. Under the terms of
this agreement, the FDA marketing approval is associated with milestone payments
totaling US$25 million (approximately CAN$25 million). EGRIFTA(TM) is the
proposed brand name to be used globally.
The efficacy and safety of EGRIFTA(TM) (tesamorelin for injection) was evaluated
in two Phase 3 multi-center, randomized, double-blind, placebo-controlled
clinical trials, which demonstrated statistically significant decreases in VAT
and WC versus placebo in HIV-infected patients who suffer from excess abdominal
fat associated with lipodystrophy.
The FDA has requested the following three post-marketing requirements: a
long-term observational safety study for tesamorelin acetate (EGRIFTA(TM)), a
single vial formulation - the development of a new presentation of the same
formulation, and a clinical trial to assess whether EGRIFTA(TM) (tesamorelin for
injection) has an impact on diabetic retinopathy in diabetic HIV-infected
patients with lipodystrophy and excess abdominal fat.
"Having a FDA-approved treatment available for this condition is an important
goal for the HIV population," said Steven Grinspoon, M.D., Professor of Medicine
at Harvard Medical School, Director of the Massachusetts General Hospital
Program in Nutritional Metabolism, and lead investigator for EGRIFTA(TM)
(tesamorelin for injection) trials in the U.S. "Although lifestyle modification
could be a valuable first step for HIV patients with abdominal fat accumulation,
results to date from lifestyle and exercise studies have been inconsistent with
respect to the reduction in abdominal lipohypertrophy. Until today, physicians
did not have access to approved drug options to treat this complication," added
Dr. Grinspoon. "Having been involved in the clinical development of EGRIFTA(TM)
over the past 7 years, I am pleased that we have published data demonstrating
that EGRIFTA(TM) reduces VAT, with no adverse effects on subcutaneous adipose
tissue. It is also important to monitor IGF-1 levels and impaired glucose
tolerance in patients receiving EGRIFTA(TM). I am encouraged that, for the first
time, patients in the United States with this serious condition will have a
FDA-approved treatment option available to them," concluded Dr. Grinspoon.
About EGRIFTA(TM) (tesamorelin for injection) Phase 3 Trials
The FDA approval of EGRIFTA(TM) (tesamorelin for injection) was based on two
multi-center, randomized, double-blind, placebo-controlled Phase 3 studies
consisting of a 26-week main phase and a 26-week extension phase of 816
HIV-infected patients with excess abdominal fat associated with lipodystrophy.
The primary endpoint of the 26-week main phase was the percent change in VAT
from baseline, as assessed by computed tomography ("CT") scan at the L4-L5
vertebral level.
In both Phase 3 studies, patients received either EGRIFTA(TM) (tesamorelin for
injection) or placebo for 26 weeks. Patients initially randomized to EGRIFTA(TM)
(tesamorelin for injection) were then re-randomized to receive either
EGRIFTA(TM) (tesamorelin for injection) or placebo for an additional 26-week
treatment period, whereas patients receiving placebo were switched to
EGRIFTA(TM) (tesamorelin for injection). In the first study, at baseline, mean
VAT was 178 cm2 for the patients who received EGRIFTA(TM) (tesamorelin for
injection) and was 171 cm2 for the patients who received placebo. In the second
study, at baseline, mean VAT was 186 cm2 for the patients who received
EGRIFTA(TM) (tesamorelin for injection) and was 195 cm2 for the patients who
received placebo. Patients treated with EGRIFTA(TM) (tesamorelin for injection)
experienced a statistically significant least-squares mean decrease from
baseline in VAT of 27 cm2 compared to an increase of 4 cm2 for patients on
placebo ((95% CI for the mean treatment difference of -31 cm2 (-39 cm2, -24
cm2)) in the first study, and a statistically significant decrease from baseline
in VAT of 21 cm2 compared to no change in VAT for patients on placebo ((95% CI
for the mean treatment difference of -21 cm2 (-29 cm2, -12 cm2)) in the second
study during the 26-week main phase. This represents a statistically significant
least-squares mean decrease from baseline in VAT of 18% for patients treated
with EGRIFTA(TM) (tesamorelin for injection) compared to an increase of 2% for
patients on placebo ((95% CI for the mean treatment difference of -20% (-24%,
-15%)) in the first study, and a statistically significant decrease from
baseline of 14% for patients treated with EGRIFTA(TM) (tesamorelin for
injection) compared to a decrease of 2% for patients on placebo ((95% CI for the
mean treatment difference of -12% (-16%, -7%)) in the second study during the
26-week main phase.
In the first study, at baseline, mean waist circumference was 104 cm for the
patients who received EGRIFTA(TM) (tesamorelin for injection) and was 105 cm for
the patients who received placebo. In the second study, at baseline, mean waist
circumference was 105 cm for the patients who received EGRIFTA(TM) (tesamorelin
for injection) and for the patients who received placebo. Treatment with
EGRIFTA(TM) (tesamorelin for injection) resulted in a statistically significant
least-squares mean decrease from baseline in waist circumference of -3 cm
compared to a decrease of -1 cm for patients on placebo ((95% CI for the mean
treatment difference of -2 cm (-2.8 cm, -0.9 cm)) in the first study, and a
statistically significant decrease from baseline of -2 cm compared to a decrease
of -1 cm for patients on placebo ((95% CI for the mean treatment difference of
-1 cm (-2.5 cm, -0.3 cm)) in the second study during the 26-week main phase. The
decreases in VAT and waist circumference observed after 26 weeks of treatment
were sustained in patients who received EGRIFTA(TM) (tesamorelin for injection)
over 52 weeks.
Important Risk Information
EGRIFTA(TM) (tesamorelin for injection) is contraindicated in women who are
pregnant, in patients with disruption of the hypothalamic-pituitary axis due to
hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or
head trauma, in patients with known hypersensitivity to tesamorelin and/or
mannitol (excipient) and in patients with active malignancies (either newly
diagnosed or recurrent). Any preexisting malignancy should be inactive and its
treatment complete prior to instituting therapy with EGRIFTA(TM) (tesamorelin
for injection). If pregnancy occurs, EGRIFTA(TM) (tesamorelin for injection)
therapy should be discontinued.
EGRIFTA(TM) (tesamorelin for injection) induces the release of endogenous growth
hormone ("GH"), a known growth factor, thus, patients with active malignancy
should not be treated with EGRIFTA(TM) (tesamorelin for injection). For patients
with a history of non-malignant neoplasms, EGRIFTA(TM) (tesamorelin for
injection) therapy should be initiated after careful evaluation of the potential
benefit of treatment. For patients with a history of treated and stable
malignancies, EGRIFTA(TM) (tesamorelin for injection) therapy should be
initiated only after careful evaluation of the potential benefit of treatment
relative to the risk of re-activation of the underlying malignancy. In addition,
the decision to start treatment with EGRIFTA(TM) (tesamorelin for injection)
should be considered carefully based on the increased background risk of
malignancies in HIV-positive patients.
EGRIFTA(TM) (tesamorelin for injection) stimulates GH production and increases
serum IGF-I. Given that IGF-I is a growth factor and the effect of prolonged
elevations in IGF-I levels on the development or progression of malignancies is
unknown, IGF-I levels should be monitored closely during EGRIFTA(TM)
(tesamorelin for injection) therapy. Careful consideration should be given to
discontinuing EGRIFTA(TM) (tesamorelin for injection) in patients with
persistent elevations of IGF-I levels (e.g., greater than 3 SDS), particularly
if the efficacy response is not robust (e.g., based on visceral adipose tissue
changes measured by waist circumference or CT scan). During the clinical trials,
patients were monitored every three months. Among patients who received
EGRIFTA(TM) (tesamorelin for injection) for 26 weeks, 47.4% had IGF-I levels
greater than 2 standard deviation score (SDS), and 35.6% had SDS greater than 3,
with this effect seen as early as 13 weeks of treatment. Among those patients
who remained on EGRIFTA(TM) (tesamorelin for injection) for a total of 52 weeks,
at the end of treatment 33.7% had IGF-I SDS greater than 2 and 22.6% had IGF-I
SDS greater than 3.
Fluid retention may occur during EGRIFTA(TM) (tesamorelin for injection) therapy
and is thought to be related to the induction of GH secretion. It manifests as
increased tissue turgor and musculoskeletal discomfort resulting in a variety of
adverse reactions (e.g., edema, arthralgia, carpal tunnel syndrome) which are
either transient or resolve with discontinuation of treatment.
EGRIFTA(TM) (tesamorelin for injection) treatment may result in glucose
intolerance. During the Phase 3 clinical trials, the percentages of patients
with elevated HbA1c (greater than or equal to 6.5%) from baseline to Week 26
were 4.5% and 1.3% in the EGRIFTA(TM) (tesamorelin for injection) and placebo
groups, respectively. An increased risk of developing diabetes with EGRIFTA(TM)
(tesamorelin for injection) (HbA1c level greater than or equal to 6.5%) relative
to placebo was observed (intent-to-treat hazard ratio of 3.3 (CI 1.4, 9.6)).
Therefore, glucose status should be carefully evaluated prior to initiating
EGRIFTA(TM) (tesamorelin for injection) treatment. In addition, all patients
treated with EGRIFTA(TM) (tesamorelin for injection) should be monitored
periodically for changes in glucose metabolism to diagnose those who develop
impaired glucose tolerance or diabetes. Diabetes is a known cardiovascular risk
factor and patients who develop glucose intolerance have an elevated risk for
developing diabetes. Caution should be exercised in treating HIV-positive
patients with lipodystrophy with EGRIFTA(TM) (tesamorelin for injection) if they
develop glucose intolerance or diabetes, and careful consideration should be
given to discontinuing EGRIFTA(TM) (tesamorelin for injection) treatment in
patients who do not show a clear efficacy response as judged by the degree of
reduction in visceral adipose tissue by waist circumference or CT scan
measurements. Since EGRIFTA(TM) (tesamorelin for injection) increases IGF-I,
patients with diabetes who are receiving ongoing treatment with EGRIFTA(TM)
(tesamorelin for injection) should be monitored at regular intervals for
potential development or worsening of retinopathy.
Hypersensitivity reactions may occur in patients treated with EGRIFTA(TM)
(tesamorelin for injection). Hypersensitivity reactions occurred in 3.6% of
patients with HIV-associated lipodystrophy treated with EGRIFTA(TM) (tesamorelin
for injection) in the Phase 3 clinical trials. These reactions included
pruritus, erythema, flushing, urticaria, and other rash. In cases of suspected
hypersensitivity reactions, patients should be advised to seek prompt medical
attention, and treatment with EGRIFTA(TM) (tesamorelin for injection) should be
discontinued immediately.
EGRIFTA(TM) (tesamorelin for injection) treatment may cause injection site
reactions, including injection site erythema, pruritus, pain, irritation, and
bruising. The incidence of injection site reactions was 24.5% in EGRIFTA(TM)
(tesamorelin for injection)-treated patients and 14.4% in placebo-treated
patients during the first 26 weeks of treatment in the Phase 3 clinical trials.
For patients who continued EGRIFTA(TM) (tesamorelin for injection) for an
additional 26 weeks, the incidence of injection site reactions was 6.1%. In
order to reduce the incidence of injection site reactions, it is recommended to
rotate the site of injection to different areas of the abdomen.
Increased mortality in patients with acute critical illness due to complications
following open heart surgery, abdominal surgery or multiple accidental trauma,
or those with acute respiratory failure has been reported after treatment with
pharmacologic amounts of growth hormone. EGRIFTA(TM) (tesamorelin for injection)
has not been studied in patients with acute critical illness. Since EGRIFTA(TM)
(tesamorelin for injection) stimulates growth hormone production, careful
consideration should be given to discontinuing EGRIFTA(TM) (tesamorelin for
injection) in critically ill patients.
EGRIFTA(TM) (tesamorelin for injection) is contraindicated in pregnant women.
During pregnancy, visceral adipose tissue increases due to normal metabolic and
hormonal changes. Modifying this physiologic change of pregnancy with
EGRIFTA(TM) (tesamorelin for injection) offers no known benefit and could result
in fetal harm. Tesamorelin acetate administration to rats during organogenesis
and lactation resulted in hydrocephalus in offspring at a dose approximately two
and four times the clinical dose, respectively, based on measured drug exposure
(AUC). If pregnancy occurs, discontinue EGRIFTA(TM) (tesamorelin for injection)
therapy. If this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of the potential
hazard to the fetus.
Because of both the potential for HIV-1 infection transmission and serious
adverse reactions in nursing infants, mothers receiving EGRIFTA(TM) (tesamorelin
for injection) should be instructed not to human milk-feed. It is not known
whether EGRIFTA(TM) (tesamorelin for injection) is excreted in human milk.
Safety and effectiveness in pediatric patients have not been established.
EGRIFTA(TM) (tesamorelin for injection) should not be used in children with open
epiphyses, among whom excess GH and IGF-I may result in linear growth
acceleration and excessive growth.
There is no information on the use of EGRIFTA(TM) (tesamorelin for injection) in
patients greater than 65 years of age with HIV and lipodystrophy.
Safety, efficacy, and pharmacokinetics of EGRIFTA(TM) (tesamorelin for
injection) in patients with renal or hepatic impairment have not been
established.
The most commonly reported adverse reactions (greater than 5% and more frequent
than placebo) are arthralgia (13.1% of patients receiving EGRIFTA(TM)
(tesamorelin for injection) and 11.0% of patients receiving placebo), pain in
extremity (6.1% of patients receiving EGRIFTA(TM) (tesamorelin for injection)
and 4.6% of patients receiving placebo), myalgia (5.5% of patients receiving
EGRIFTA(TM) (tesamorelin for injection) and 1.9% of patients receiving placebo),
injection site erythema (8.5% of patients receiving EGRIFTA(TM) (tesamorelin for
injection) and 2.7% of patients receiving placebo), injection site pruritus
(7.6% of patients receiving EGRIFTA(TM) (tesamorelin for injection) and 0.8% of
patients receiving placebo), and peripheral edema (6.1% of patients receiving
EGRIFTA(TM) (tesamorelin for injection) and 2.3% of patients receiving placebo).
During the first 26 weeks of treatment (main phase), discontinuations as a
result of adverse reactions occurred in 9.6% of patients receiving EGRIFTA(TM)
(tesamorelin for injection) and 6.8% of patients receiving placebo. Apart from
patients with hypersensitivity reactions identified during the studies and who
were discontinued per protocol (2.2%), the most common reasons for
discontinuation of EGRIFTA(TM) (tesamorelin for injection) treatment were
adverse reactions due to the effect of GH (4.2%) and local injection site
reactions (4.6%).
About EGRIFTA(TM) (tesamorelin for injection)
EGRIFTA(TM) (tesamorelin for injection) is a synthetic analogue of the human
growth hormone releasing factor ("GRF") shown to reduce visceral fat in
HIV-infected patients with excess abdominal fat associated with lipodystrophy.
GRF is a hypothalamic peptide that acts on the pituitary cells in the brain to
stimulate the synthesis and release of endogenous growth hormone.
EGRIFTA(TM) (tesamorelin for injection) is approved for sale in the United
States only.
About HIV-Associated Lipodystrophy
Several factors, including a patient's antiretroviral drug regimen and the HIV
virus itself are thought to contribute to HIV-associated lipodystrophy, which is
characterized by body composition changes. The changes in body composition may
include excess abdominal fat accumulation, which is known as abdominal
lipohypertrophy.
Please see full prescribing information for EGRIFTA(TM) (tesamorelin for
injection) at www.emdserono.com.
Conference Call and Webcast
Theratechnologies will hold a conference call and webcast today at 8:30 a.m.
(Eastern Standard Time) to discuss the approval of EGRIFTA(TM) (tesamorelin for
injection) by the FDA.
To participate, please dial: 1-416-981-9005 or 1-800-931-6427 (toll free).
Please dial in five minutes prior to the conference in order to ensure your
participation. The webcast will be accessible at the following links:
www.gowebcasting.com/2099 and www.theratech.com/.
A replay of the conference call will be available from 10:30 a.m. today,
November 11, 2010, until November 26, 2010 at 11:59 p.m. at the following
number: 1-416-626-4100, pass code 21488561# or 1-800-558-5253, pass code
21488561#. The webcast will be posted for 30 days at the links indicated above.
About Theratechnologies
Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company that
discovers and develops innovative therapeutic products, with an emphasis on
peptides, for commercialization. The Company targets unmet medical needs in
specialty markets where it can retain all or part of the commercial rights to
its products. Its most advanced compound, tesamorelin, is an analogue of the
human growth hormone releasing factor. Tesamorelin will be exclusively
commercialized in the U.S. by EMD Serono under the brand name EGRIFTA(TM). The
Company's growth strategy is centered on the commercialization of EGRIFTA(TM)
(tesamorelin for injection) in the United States through an agreement with EMD
Serono, Inc. for the reduction of excess abdominal fat associated with
lipodystrophy in HIV-infected patients. Moreover, Theratechnologies' growth
strategy will also derive from the commercialization of EGRIFTA(TM) (tesamorelin
for injection) in other markets for HIV-associated lipodystrophy, as well as the
development of clinical programs for EGRIFTA(TM) (tesamorelin for injection) in
other medical conditions.
For more information, please visit www.theratech.com
About EMD Serono, Inc.
EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in
the US biopharmaceutical arena, integrating cutting-edge science with
unparalleled patient support systems to improve people's lives. The company has
strong market positions in neurodegenerative diseases, with Rebif(R) (interferon
beta-1a), as well as in endocrinology, with Saizen(R) (somatropin (rDNA origin)
for injection) and Serostim(R) (somatropin (rDNA origin) for injection). EMD
Serono is a leader in reproductive health, with Gonal-f(R) (follitropin alfa for
injection), Luveris(R) (lutropin alfa for injection) and Ovidrel(R) Prefilled
Syringe (choriogonadotropin alfa injection). In addition, EMD Serono is growing
its expertise and presence in the area of oncology, with more than 10 projects
currently in development. With a clear focus on the patient and a leadership
presence in the biopharmaceutical industry, EMD Serono's US footprint continues
to grow, with more than 1100 employees around the country and fully integrated
commercial, clinical and research operations in the company's home state of
Massachusetts.
For more information, please visit www.emdserono.com
Forward Looking Information
This press release contains certain statements that are considered
"forward-looking information" within the meaning of applicable securities
legislation. This forward-looking information includes, but is not limited to,
information regarding the receipt of milestone payments by EMD Serono as a
result of the obtaining of marketing approval for EGRIFTA(TM) (tesamorelin for
injection), the efficacy of EGRIFTA(TM) (tesamorelin for injection) in
selectively reducing VAT, the capacity of the Company to obtain regulatory
approval and commercialize EGRIFTA(TM) (tesamorelin for injection) in additional
markets, the growth of Theratechnologies through the development of EGRIFTA(TM)
(tesamorelin for injection) in additional clinical programs in other medical
conditions and the capacity of the Company to enter into commercial agreements
with partners for the commercialization of EGRIFTA(TM) (tesamorelin for
injection) in additional markets. The Company disclaims any liability resulting
from the statements made by EMD Serono in this press release and under the
section "About EMD Serono, Inc."
Forward-looking information is based upon a number of assumptions and is subject
to a number of risks and uncertainties, many of which are beyond the Company's
control, and, accordingly, could cause actual results to differ materially from
those that are disclosed in or implied by such forward-looking information.
These risks and uncertainties include, but are not limited to: the risk that the
Company may not receive the regulatory milestones under the collaboration and
licensing agreement entered into with EMD Serono, that the administration of
EGRIFTA(TM) (tesamorelin for injection) does not have the same effect in
reducing VAT on all patients, that EGRIFTA(TM) (tesamorelin for injection) is
not approved for commercial sale by regulatory agencies in geographies other
than the United States, that the design of additional clinical programs may not
be begun or, if begun, must be suspended, or that the Company will not find
additional partners or that, if and when found, it will not be able to enter
into commercialization agreements with such partners on reasonable and
commercially-acceptable terms.
Certain assumptions made in preparing the forward-looking information include,
among others, that EMD Serono will meet its obligations under the collaboration
and licensing agreement and that the Company will receive these milestones, that
patients administered with EGRIFTA(TM) (tesamorelin for injection) will benefit
from a reduction in VAT, that regulatory agencies in other geographies will also
approve EGRIFTA(TM) (tesamorelin for injection), that results from additional
clinical programs will be positive, and that the Company, by itself or through
third parties, will be able to commercialize EGRIFTA(TM) (tesamorelin for
injection) in additional markets.
All of the forward-looking information is qualified by the foregoing cautionary
statements. Forward-looking information reflects current expectations regarding
future events only as of the date of release of this press release. The Company
refers potential investors to the "Risks and Uncertainties" section of its
Annual Information Form (the "AIF") dated February 23, 2010. The AIF is
available at www.sedar.com under the Company's public filings. The reader is
cautioned to consider these and other risks and uncertainties carefully and not
to put undue reliance on forward-looking statements. Forward-looking information
reflects current expectations regarding future events and speaks only as of the
date of this press release and represents the Company's expectations as of that
date.
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