FDA Approves EGRIFTATM (tesamorelin for injection): First and Only Treatment for the Reduction of Excess Abdominal Fat in HIV-infected Patients With Lipodystrophy

Clinical Trials Demonstrate Reduction in Visceral Adipose Tissue and Waist Circumference

GENEVA, November 11, 2010 - Merck Serono, the pharmaceutical division of Merck KGaA,
Darmstadt, Germany, today announced 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), developed by Theratechnologies, a
Canadian biopharmaceutical company, will be marketed in the United States
exclusively by EMD Serono, a U.S. affiliate of Merck.

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
measured by waist circumference 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).

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
significant decreases in visceral adipose tissue (VAT) and waist
circumference (WC) versus placebo in HIV-infected patients who suffer from
excess abdominal fat associated with lipodystrophy. HIV-associated
lipodystrophy refers to abnormalities in body fat distribution and
metabolism.

"As HIV-infected patients are living longer, a substantial
number may develop metabolic complications associated with HIV, such as
abdominal lipohypertrophy," said Dr. Morris Schambelan, Professor of
Medicine, University of California, San Francisco. "With the approval of
EGRIFTA(TM), doctors are now able to provide appropriately selected patients
with a treatment option shown to reduce visceral adipose tissue."

"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, Inc. "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."

"Theratechnologies is very pleased to receive marketing
approval for EGRIFTA(TM) from the FDA. We are one of 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 Mr. 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," he concluded.

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.

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) 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 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% from baseline 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.

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.

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, 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 growth
hormone production and increases serum IGF-1. Given that IGF-1 is a growth
factor and the effect of prolonged elevations in IGF-1 levels on the
development or progression of malignancies is unknown, IGF-1 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-1
levels (e.g., >3 Standard Deviation Score (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-1 levels greater than 2 SDS, and 35.6% had SDS >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-1 SDS >2 and 22.6% had IGF-1 SDS >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 odd
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 (>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)

EGRIFTA(TM) (tesamorelin for injection) is a synthetic analogue
of 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.

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) at
www.emdserono.com

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) 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 will also derive
from the commercialization of EGRIFTA(TM) in other markets for HIV-associated
lipodystrophy, as well as the development of clinical programs for
EGRIFTA(TM) in other medical conditions.

About Merck Serono

Merck Serono is the division for innovative prescription
pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical
and chemical company. Headquartered in Geneva, Switzerland, Merck Serono
discovers, develops, manufactures and markets innovative small molecules and
biopharmaceuticals to help patients with unmet medical needs. In the United
States and Canada, EMD Serono operates through separately incorporated
affiliates.

Merck Serono has leading brands serving patients with cancer (Erbitux(R),
cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility
(Gonal-f(R), follitropin alfa), endocrine and metabolic disorders (Saizen(R)
and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) as well
as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R),
bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in
all markets.

With an annual R&D expenditure of more than EUR 1 billion,
Merck Serono is committed to growing its business in specialist-focused
therapeutic areas including neurodegenerative diseases, oncology, fertility
and endocrinology, as well as new areas potentially arising out of research
and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with
total revenues of EUR 7.7 billion in 2009, a history that began in 1668, and
a future shaped by approximately 40,000 (including Merck Millipore) employees
in 64 countries. Its success is characterized by innovations from
entrepreneurial employees. Merck's operating activities come under the
umbrella of Merck KGaA, in which the Merck family holds an approximately 70%
interest and free shareholders own the remaining approximately 30%. In 1917
the U.S. subsidiary Merck & Co. was expropriated and has been an independent
company ever since.

For more information, please visit www.merckserono.com
or www.merck.de

Merck Serono S.A. - Geneva, 9 Chemin des Mines, 1202 Geneve, Suisse, Media relations, Tel: +41-22-414-36-00