Allergan, Inc. (NYSE:AGN) confirms that U.S. District Judge Andrew J.
Guilford has entered an order providing that the injunction against Merz
Aesthetics prohibiting it from, among other things, selling or
soliciting purchases of its product Xeomin® in
the facial aesthetics market, shall remain in place until January 9,
2013. The order also provides that the terms of the injunction that
restrict Merz Aesthetics’ ability to sell and solicit purchases of its
dermal fillers, as well as the terms that restrict Merz Pharmaceuticals’
ability to sell and solicit purchases of Xeomin® in
the therapeutic market, shall remain in place until November 1, 2012.
The order follows the court’s ruling in March 2012 issuing a permanent
injunction against Merz, concluding the company misappropriated
important trade secrets belonging to Allergan regarding its products
BOTOX® Cosmetic (onabotulinumtoxinA), BOTOX®
(onabotulinumtoxinA) and JUVÉDERM®.
About BOTOX® (onabotulinumtoxinA)
BOTOX® is a prescription-only medical product that contains
tiny amounts of highly purified botulinum toxin protein refined from the
bacterium, Clostridium botulinum. When injected at FDA-approved
and labeled doses into a specific muscle or gland, BOTOX®
neurotoxin is expected to diffuse locally and produce a safe
and effective result by producing a localized and temporary reduction in
the overacting muscle or gland, usually lasting up to approximately
three to ten months, depending on the indication and on the individual
patient. BOTOX® Cosmetic results have been shown to last
up to four months; individual results may vary.
BOTOX® was first approved by the FDA more than 22 years ago
for the treatment of strabismus and blepharospasm, two eye muscle
disorders, making it the first botulinum toxin type A product approved
in the world. Since its first approval in 1989, BOTOX® has
been recognized by regulatory authorities worldwide as an effective
treatment for 25 different indications in approximately 85 countries,
benefiting millions of patients worldwide. In the United States, BOTOX®
neurotoxin is also approved to treat seven medical conditions, including
the abnormal head position and neck pain that happens with cervical
dystonia (CD) in adults; symptoms of severe underarm sweating (severe
primary axillary hyperhidrosis) when medicines used on the skin
(topical) do not work well enough; for the treatment of increased muscle
stiffness in elbow, wrist, and finger muscles in adult patients with
upper limb spasticity; for the prophylactic treatment of headaches in
adults with Chronic Migraine, a distinct and severe neurological
disorder characterized by patients who have a history of migraine and
suffer from headaches on 15 or more days per month with headaches
lasting four hours a day or longer; and most recently, for the treatment
of urinary incontinence due to detrusor overactivity associated with a
neurologic condition (e.g. spinal cord injury (SCI), multiple sclerosis
(MS)) in adults who have an inadequate response to or are intolerant of
an anticholinergic medication.
In addition to its therapeutic uses, the same formulation of BOTOX®
with dosing specific to moderate to severe glabellar lines was approved
by the FDA in 2002 under the trade name BOTOX® Cosmetic
(onabotulinumtoxinA). BOTOX® Cosmetic is indicated for the
temporary improvement in the appearance of moderate to severe glabellar
lines (frown lines between the eyebrows) associated with corrugator
and/or procerus muscle activity in adult patients up to 65 years of age.
In addition to approximately 21 years of clinical experience, the safety
and efficacy of BOTOX® have been well-established in
approximately 65 randomized, placebo-controlled clinical trials and in
approximately 15,000 patients treated with BOTOX® and BOTOX®
Cosmetic in Allergan’s clinical trials.i Worldwide,
approximately 30 million vials of BOTOX® and BOTOX®
Cosmetic have been distributed and approximately 29 million treatment
sessions have been performed over the past 20 years (1990-2010).ii
With approximately 2,500 articles on BOTOX® and BOTOX®
Cosmetic in scientific and medical journals,iii BOTOX®
neurotoxin is one of the most widely researched medicines in the world.
BOTOX® (onabotulinumtoxinA) & BOTOX®
Cosmetic Important Information
Indications
BOTOX® is a prescription medicine that is injected into
muscles and used:
-
to treat leakage of urine (incontinence) in adults with overactive
bladder due to neurologic disease who still have leakage or experience
too many side effects after trying an anticholinergic medication.
-
to prevent headaches in adults with chronic migraine who have 15 or
more days each month with headache lasting 4 or more hours each day in
people 18 years or older
-
to treat increased muscle stiffness in elbow, wrist, and finger
muscles in people 18 years and older with upper limb spasticity
-
to treat the abnormal head position and neck pain that happens with
cervical dystonia (CD) in people 16 years and older
-
to treat certain types of eye muscle problems (strabismus) or abnormal
spasm of the eyelids (blepharospasm) in people 12 years and older
BOTOX® is also injected into the skin to treat the symptoms
of severe underarm sweating (severe primary axillary hyperhidrosis) when
medicines used on the skin (topical) do not work well enough in people
18 years and older.
BOTOX® Cosmetic is a prescription medicine that is
injected into muscles and used to improve the look of moderate to severe
frown lines between the eyebrows (glabellar lines) in people 18 to 65
years of age for a short period of time (temporary).
It is not known whether BOTOX® and BOTOX®
Cosmetic are safe or effective to prevent headaches in patients with
migraine who have 14 or fewer headache days each month (episodic
migraine).
It is not known whether BOTOX® and BOTOX® Cosmetic
are safe or effective to treat increased stiffness in upper-limb muscles
other than those in the elbow, wrist, and fingers, or to treat increased
stiffness in lower-limb muscles. BOTOX® has not been shown to
help people perform task-specific functions with their upper limbs or
increase movement in joints that are permanently fixed in position by
stiff muscles. Treatment with BOTOX® is not meant to replace
your existing physical therapy or other rehabilitation that your doctor
may have prescribed.
It is not known whether BOTOX® and BOTOX® Cosmetic
are safe or effective for severe sweating anywhere other than your
armpits.
IMPORTANT SAFETY INFORMATION
BOTOX® and BOTOX® Cosmeticmay cause serious side effects that can be life threatening. Call
your doctor or get medical help right away if you have any of these
problems any time (hours to weeks) after injection of BOTOX®
or BOTOX® Cosmetic:
- Problems swallowing, speaking, or breathing, due to weakening ofassociated muscles, can be severe and result in loss of life. You
are at the highest risk if these problems are pre-existing before
injection. Swallowing problems may last for several months
- Spread of toxin effects. The effect of botulinum toxin may
affect areas away from the injection site and cause serious symptoms
including: loss of strength and all-over muscle weakness, double
vision, blurred vision and drooping eyelids, hoarseness or change or
loss of voice (dysphonia), trouble saying words clearly (dysarthria),
loss of bladder control, trouble breathing, trouble swallowing. If
this happens, do not drive a car, operate machinery, or do other
dangerous activities
There has not been a confirmed serious case of spread of toxin effect
away from the injection site when BOTOX® has been used at the
recommended dose to treat chronic migraine, severe underarm sweating,
blepharospasm, or strabismus, urinary incontinence in adults with
overactive bladder due to neurologic disease, or when BOTOX®
Cosmetic has been used at the recommended dose to treat frown lines.
Do not take BOTOX® or BOTOX®
Cosmetic if you: are allergic to any of the ingredients in BOTOX®
or BOTOX® Cosmetic (see Medication Guide for
ingredients); had an allergic reaction to any other botulinum toxin
product such as Myobloc® (rimabotulinumtoxinB),
Dysport® (abobotulinumtoxinA), or Xeomin®
(incobotulinumtoxinA); have a skin infection at the
planned injection site.
Do not take BOTOX® for the treatment of urinary
incontinence if you: have a urinary tract infection (UTI) or cannot
empty your bladder on your own and are not routinely catheterizing.
The dose of BOTOX® and BOTOX®
Cosmetic is not the same as, or comparable to, another botulinum toxin
product.
Serious and/or immediate allergic reactions have been reported.
These include itching, rash, red itchy welts, wheezing, asthma symptoms,
or dizziness or feeling faint. Tell your doctor or get medical help
right away if you experience any such symptoms; further injection of
BOTOX® or BOTOX® Cosmetic should be
discontinued.
Tell your doctor about all your muscle or nerve conditions suchas amyotrophic lateral sclerosis (ALS or Lou Gehrig's
disease), myasthenia gravis, or Lambert-Eaton syndrome, as you
may be at increased risk of serious side effects including severe
dysphagia (difficulty swallowing) and respiratory compromise (difficulty
breathing) from typical doses of BOTOX® or BOTOX®
Cosmetic.
Tell your doctor if you have any breathing-related problems. Your
doctor will want to monitor you for any breathing problems during your
treatment with BOTOX® for upper limb spasticity.
Cornea problems have been reported. Cornea (surface of the eye)
problems have been reported in some people receiving BOTOX®
for their blepharospasm, especially in people with certain nerve
disorders. BOTOX® may cause the eyelids to blink less, which
could lead to the surface of the eye being exposed to air more than is
usual. Tell your doctor if you experience any problems with your eyes
while receiving BOTOX®. Your doctor may treat your eyes with
drops, ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported. Bleeding behind the
eyeball has been reported in some people receiving BOTOX® for
their strabismus. Tell your doctor if you notice any new visual problems
while receiving BOTOX®.
Bronchitis and upper respiratory tract infections (common colds) have
been reported. Bronchitis was reported more frequently in people
receiving BOTOX® for their upper limb spasticity. Upper
respiratory infections (common colds) were also reported more frequently
in people with prior breathing-related problems.
Human albumin and spread of viral diseases. BOTOX® and
BOTOX® Cosmetic contain albumin, a protein component
of human blood. The potential risk of spreading viral diseases (eg,
Creutzfeldt-Jakob disease [CJD]) via human serum albumin is extremely
rare. No cases of viral diseases or CJD have ever been reported in
association with human serum albumin.
Tell your doctor about all your medical conditions, including if you
have: plans to have surgery; had surgery on your face; weakness of
forehead muscles, such as trouble raising your eyebrows; drooping
eyelids; any other abnormal facial change; pain or burning with
urination, frequent urination, fever, have problems emptying your
bladder on your own and are being treated for urinary incontinence, are
pregnant or plan to become pregnant (it is not known if BOTOX®
or BOTOX® Cosmetic can harm your unborn baby); are
breastfeeding or plan to breastfeed (it is not known if BOTOX®
or BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including
prescription and nonprescription medicines, vitamins, and herbal
products. Using BOTOX® or BOTOX® Cosmetic with
certain other medicines may cause serious side effects. Do not start
any new medicines until you have told your doctor that you have received
BOTOX® or BOTOX® Cosmetic in
the past.
Especially tell your doctor if you: have received any other botulinum
toxin product in the last 4 months; have received injections of
botulinum toxin such as Myobloc®, Dysport®,
or Xeomin® in the past (be sure your
doctor knows exactly which product you received); have recently received
an antibiotic by injection; take muscle relaxants; take an allergy or
cold medicine; take a sleep medicine.
Other side effects of BOTOX® and BOTOX®
Cosmetic include: dry mouth, discomfort or pain at the
injection site, tiredness, headache, neck pain, and eye problems:
double vision, blurred vision, decreased eyesight, drooping
eyelids, swelling of your eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with your
doctor.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
For BOTOX® and BOTOX®
Cosmetic full Product
Information including Boxed Warning and Medication
Guide click here.
Important JUVÉDERM® Safety Information
JUVÉDERM® injectable gel (including JUVÉDERM®
Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC,
and JUVÉDERM® Ultra Plus XC) is indicated for correction of
moderate to severe facial wrinkles and folds (such as nasolabial folds).
Treatment side effects are usually mild to moderate, lasting 7 days or
less, and include temporary injection-site reactions such as redness,
pain, firmness, swelling, and bumps. JUVÉDERM® is not for
people with severe allergies. For more information, please click on the
About Safety link at www.juvederm.com
or call the Allergan Product Support line at 1-877-345-5372. JUVÉDERM®
injectable gel is available by prescription only.
About Allergan, Inc.
Allergan is a multi-specialty health care company established more than
60 years ago with a commitment to uncover the best of science and
develop and deliver innovative and meaningful treatments to help people
reach their life’s potential. Today, we have approximately 10,500 highly
dedicated and talented employees, global marketing and sales
capabilities with a presence in more than 100 countries, a rich and
ever-evolving portfolio of pharmaceuticals, biologics, medical devices
and over-the-counter consumer products, and state-of-the-art resources
in R&D, manufacturing and safety surveillance that help millions of
patients see more clearly, move more freely and express themselves more
fully. From our beginnings as an eye care company to our focus today on
several medical specialties, including eye care, neurosciences, medical
aesthetics, medical dermatology, breast aesthetics, obesity intervention
and urologics, Allergan is proud to celebrate more than 60 years of
medical advances and proud to support the patients and physicians who
rely on our products and the employees and communities in which we live
and work. For more information regarding Allergan, go to: www.allergan.com.
Forward-Looking Statements
This press release contains "forward-looking statements," including
statements regarding the outcome of litigation and other statements
regarding the safety, effectiveness and adverse events associated with
BOTOX® or BOTOX® Cosmetic. These statements are
based on current expectations of future events. If underlying
assumptions prove inaccurate or unknown risks or uncertainties
materialize, actual results could vary materially from Allergan's
expectations and projections. Risks and uncertainties include, among
other things, the uncertainties associated with the litigation and
appeal process; general industry and pharmaceutical market conditions;
technological advances and patents attained by competitors; challenges
inherent in the research and development and regulatory processes;
challenges related to new product marketing, such as the
unpredictability of market acceptance for new pharmaceutical products
and/or the acceptance of new indications for such products;
inconsistency of treatment results among patients; potential
difficulties in manufacturing a new product; general economic
conditions; and governmental laws and regulations affecting domestic and
foreign operations. Additional information concerning the
above-referenced risk factors and other risk factors can be found in
Allergan's public periodic filings with the U.S. Securities and Exchange
Commission, including the discussion under the heading "Risk Factors" in
Allergan's 2011 Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q. Copies of Allergan's press releases and additional
information about Allergan are available at www.allergan.com
or you can contact the Allergan Investor Relations Department by calling
714-246-4636.
© 2012 Allergan, Inc. Irvine, CA 92612. ® marks owned by
Allergan, Inc. All rights reserved.
Myobloc®
is a registered trademark of Solstice Neurosciences, Inc.
Dysport®
is a registered trademark of Ipsen Biopharm, Ltd.
Xeomin®is a registered trademark of Merz Pharma Gmbh & Co.
i Allergan data on file; Medical Affairs
ii Allergan data on
file; Global Regulatory Affairs
iii Allergan data on file; Global
Literature & Information Services
