Merz Pharma Canada Announces the Approval of Radiesse® (+) With Integral 0.3% Lidocaine

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Merz Pharma Canada Announces the Approval of Radiesse® (+) With Integral 0.3% Lidocaine


TORONTO–(BUSINESS WIRE)–Merz Pharma Canada, Ltd., affiliate of the global Merz Pharma Group,
today announced that Radiesse®
(+) with integral 0.3% Lidocaine (“Radiesse® Plus“) has
received Health Canada approval and will be available to Canadian
physicians in July 2015. Treatment with Radiesse® (+)
immediately replenishes lost volume as well as providing significant
reduction in pain due to the addition of lidocaine.1

“With the introduction of Radiesse® (+), we are proud to be
able to provide physicians in Canada with a safe, effective volumizing
filler that enhances patient comfort and eliminates the need for
in-office lidocaine mixing,” said Bob Bennett, President and General
Manager for Merz Pharma Canada. “As we continue to expand our presence
in the aesthetics space, we look forward to bringing new products and
additional indications to the market in order to expand the options
available to our physician customers.”

Radiesse® (+) injectable implant is an opaque, dermal filler
that contains a small quantity of local anesthetic (lidocaine). Radiesse®
(+) is indicated for subdermal implantation for the correction of
moderate to severe facial wrinkles and folds, such as nasolabial folds
and for the rejuvenation of the hands. The presence of lidocaine is
intended to reduce the patient’s pain during treatment.

“Merz continues to make meaningful investments in research and
development programs in order to continue to bring new products to
physicians and patients in North America,” said David Dobrowski, Vice
President and Head of North American Research and Development. “The
Health Canada approval of Radiesse®
(+) with integral 0.3% Lidocaine is the result of those efforts and
provides an important complementary addition to our current aesthetics
portfolio.”

In a clinical study, 101 patients received Radiesse® on one
side of the face and Radiesse® (+) on the other side of the
face. Patients rated their pain on a scale of 0 to 10. On the scale, 0
was no pain and 10 was very severe pain. Immediately after injection,
patients rated their pain about 6.7 on a scale of 0 to 10 for the side
of the face injected with Radiesse® compared to about 2.3 on
the same scale for the side of the face treated with Radiesse®
(+). Sixty (60) minutes after treatment, patients rated their pain about
1.1 on a scale of 0 to 10 for the side of the face injected with Radiesse®
compared to about 0.3 on the same scale for the side of the face treated
with Radiesse® (+).

About RADIESSE® (+)

Radiesse® (+) is an opaque dermal filler that contains a
small quantity of local anesthetic (lidocaine). Radiesse® (+)
is indicated for subdermal implantation for the correction of moderate
to severe facial wrinkles and folds, such as nasolabial folds and for
the rejuvenation of the hands. Radiesse® (+) is composed of
calcium hydroxylapatite (CaHA) microspheres suspended in a water-based
gel carrier. Radiesse® was first approved by Health Canada in
November 2005 for the correction of moderate to severe facial wrinkles
and folds, such as nasolabial folds and for the rejuvenation of the hand.

About Merz North America

Merz North America is a specialty healthcare company that develops and
commercializes innovative, high-quality treatment solutions in
aesthetics, dermatology and neurosciences in the U.S. and Canada. As
part of the Merz Pharma Group of companies, our ambition is to become
the most admired, trusted and innovative aesthetics and neurotoxin
company. By developing products that improve patients’ health and help
them to live better, feel better and look better, we will continue to
make significant contributions to the well-being of individuals around
the world. With the acquisitions of NEOCUTIS and Ulthera, Merz is
building an aesthetics portfolio with a range of treatment options
(device, injectables and topicals) that allow physicians to use Merz
technologies to treat a broader range of patients and concerns.

For more information about Merz Pharma Canada, Ltd. or their product
portfolio, please visit www.merzcanada.com.
For information regarding Merz products and operations in the United
States, please visit www.merzusa.com.

RADIESSE is a registered trademark of Merz North America, Inc.

RADIESSE® (+) IMPORTANT SAFETY INFORMATION

Contraindications: RADIESSE (+) injectable implant is
contraindicated for patients with severe allergies manifested by a
history of anaphylaxis, or history or presence of multiple severe
allergies; with hypersensitivity to any of the components; with bleeding
disorders, that are prone to inflammatory skin conditions; with a
tendency for developing hypertrophic scars; and with patients with
systemic disorders which cause poor wound healing or will lead to tissue
deterioration over the implant. It is contraindicated in the presence of
foreign bodies such as liquid silicone or other particulate materials.
It should not be used for correction of the glabellar folds; a higher
incidence of necrosis has been associated with glabellar injection. It
should not be used in areas where there is inadequate coverage of
healthy, well vascularized tissue. It is not intended for use in the
breasts and in the lips.

Warnings: Use of RADIESSE (+) in any person with active skin
inflammation or infection in or near the treatment should be deferred
until the inflammatory or infectious process is controlled. Injection
procedure reactions have been observed, mainly short-term (less than 7
days) bruising, redness, Special care should be taken to avoid injection
into the blood vessels. Introduction into the vasculature may occlude
the vessels and could cause infarction or embolism leading to ischemia,
necrosis or scarring; this has been reported to occur in the lips, nose,
glabellar or ocular area. Although rare, loss of vision is also
possible; this has been reported to occur in the nasolabial folds, oral
commissures, lips, nose, glabellar or ocular area. Do not overcorrect
(overfill) a contour deficiency with RADIESSE (+) because the depression
should gradually improve within several weeks as the treatment effect of
RADIESSE (+) occurs. The safety and effectiveness for use in the lips
has not been established.

Precautions: RADIESSE (+) contains calcium hydroxylapatite,
radiopaque particles, that are visible on CT Scans and may be visible in
standard radiography. Nodules may form, requiring treatment or removal.
Irregularity of the implant may occur which may require a surgical
procedure to correct. As with all skin-injection procedures, there is a
risk of infection with RADIESSE (+). Patients using medications that can
prolong bleeding, such as aspirin or warfarin, may experience increased
bruising or bleeding at the injection site. Patients should minimize
exposure of the treated area to extensive sun or heat exposure for
approximately 24 hours after treatment or until any initial swelling and
redness has resolved. Safety of RADIESSE (+) beyond 3 years; in the
periorbital area; with concomitant dermal therapies or other drugs or
implants; in patients with susceptibility to keloid formation and
hypertrophic scarring; in pregnancy, in breastfeeding females or in
patients under 18 years has not been established. Patients with a
history of herpetic eruption may experience reactivation of herpes.

Adverse Events: The most commonly reported serious adverse events
in post-market surveillance of with RADIESSE include serious edema,
infection, allergic reaction, and necrosis.

To report a problem with RADIESSE, please call Merz Pharma Canada
Customer Service at 1-866-815-8715.

1 IFU Radiesse® with Lidocaine



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