IRVINE, Calif.--(BUSINESS WIRE)--Allergan, Inc. (NYSE: AGN) (“Allergan” or the “Company”) today announced that the Company’s research and development pipeline has been recognized by the Galien Foundation, which has nominated three of Allergan’s products for the 2014 U.S. Prix Galien Awards. The Prix Galien Award is considered the biomedical industry’s highest accolade and recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines and devices.
The Allergan products that have been nominated for the 2014 U.S. Prix Galien Awards are:
- Best Biotechnology Product Nominee - BOTOX® (onabotulinumtoxinA) for Chronic Migraine patients
- Best Pharmaceutical Agent Nominee - OZURDEX® (dexamethasone intravitreal implant) 0.7 mg
- Best Medical Technology Nominee - SERI® Surgical Scaffold
“For more than 64 years, Allergan has remained committed to developing innovative products to address unmet medical needs,” said David E.I. Pyott, Chairman and Chief Executive Officer, Allergan. “We are proud to be recognized for our R&D efforts by the Prix Galien Committee and especially honored to be the only company to receive nominations in all three of the 2014 Prix Galien Award categories.”
Recipients of the Prix Galien Awards will be announced at the Prix Galien USA Award Ceremony in New York this fall and are selected by a committee of 10 leaders from the biomedical industry and academia, including five Nobel Laureates.
“Innovation is a key measure of Allergan’s commitment to R&D,” said Scott M. Whitcup, M.D., Executive Vice President, Research and Development, Chief Scientific Officer, Allergan. “With a focus on basic research and clinical development in our specialty areas, we are able to bring novel treatments to market that benefit patients, and are pleased to be recognized by the Galien Foundation for three of these products.”
In the United States, BOTOX® is currently approved for eight medical conditions, including Chronic Migraine, a disease affecting approximately 3.2 million Americans. BOTOX® is the first and only preventive treatment approved by the U.S. Food and Drug Administration (FDA) to reduce headache days every month for adults with Chronic Migraine — 15 or more headache days a month with headache lasting 4 hours or more. BOTOX® is similarly indicated for the treatment of Chronic Migraine in 64 countries.
OZURDEX® is a biodegradable steroid implant that uses the proprietary and innovative NOVADUR® solid polymer delivery system to release medicine over an extended period of time. The OZURDEX® implant is approved for three ophthalmic indications in the United States, including for the treatment of non-infectious inflammation of the uvea (uveitis) affecting the back of the eye, for which it is nominated by the Galien Foundation for Best Pharmaceutical Agent. Most recently, Allergan received FDA approval June 30 of OZURDEX® for the treatment of diabetic macular edema in patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic).
SERI® Surgical Scaffold is a sterile, silk-derived bioprotein, ultrapurified using the BIOSILK™ process. This unique product is the first and only silk-derived biological scaffold cleared by the FDA for reinforcement of soft tissue in plastic and reconstructive surgery.
BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected 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.
It is not known whether BOTOX® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
IMPORTANT SAFETY INFORMATION
BOTOX® may 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®:
- Problems swallowing, speaking, or breathing, due to weakening of associated 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.
Do not take BOTOX® if you: are allergic to any of the ingredients in BOTOX® (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.
The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. These reactions 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® should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as 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®.
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; 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; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® 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® 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; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).
Other side effects of BOTOX® 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.
OZURDEX® (dexamethasone intravitreal implant) is a prescription medicine that is an implant injected into the eye (vitreous) and used:
- To treat adults with swelling of the macula (macular edema) following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- To treat adults with noninfectious inflammation of the uvea (uveitis) affecting the back segment of the eye
- To treat adults with diabetic macular edema who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic)
IMPORTANT SAFETY INFORMATION
OZURDEX® should not be used if you have any infections or diseases in the eye, or surrounding eye area, including most viral diseases of the cornea and conjunctiva, including active herpes viral infection of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases.
OZURDEX® should not be used if you have advanced glaucoma.
OZURDEX® should not be used if you have a posterior lens capsule that is not intact.
You should not use OZURDEX® if you are allergic to any of its ingredients.
Injections into the vitreous in the eye, including those with OZURDEX®, are associated with serious eye infection (endophthalmitis), eye inflammation, increased eye pressure, and retinal detachments. Your eye doctor may monitor you regularly after the injection.
Use of corticosteroids may produce posterior subcapsular cataracts, increased eye pressure, glaucoma, and may increase the establishment of secondary eye infections due to bacteria, fungi, or viruses. Let your doctor know if you have a history of ocular herpes simplex.
There may be a risk of the implant moving into the front chamber of the eye if you had the posterior capsule of the lens removed or if you have a tear in the capsule.
The most common side effects reported in patients for retinal vein occlusion and uveitis include: increased eye pressure, conjunctival blood spot, eye pain, eye redness, ocular hypertension, cataract, vitreous detachment, and headache.
The most common side effects reported in patients with diabetic macular edema include: cataract, increased eye pressure, conjunctival blood spot, reduced vision, inflammation of the conjunctiva, specks that float in the field of vision, swelling of the conjunctiva, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid and high blood pressure.
After repeated injections with OZURDEX®, a cataract may occur. If this occurs, your vision will decrease and you will need an operation to remove the cataract and restore your vision. You may develop increased eye pressure with OZURDEX® that will need to be managed with eye drops and, rarely, with surgery.
In the days following injection with OZURDEX®, you may be at risk for potential complications including in particular, but not limited to, the development of serious eye infection or increased eye pressure. If your eye becomes red, sensitive to light, painful, or develops a change in vision, you should seek immediate care from your eye doctor. You may experience temporary visual blurring after receiving an injection and should not drive or use machinery until your vision has resolved.
Please click here for full Prescribing Information.
FDA Cleared Use
SERI® Surgical Scaffold is used to support and repair weakened soft tissue by adding the extra support needed to achieve the desired surgical result. It is used to reinforce and repair soft tissue during plastic and reconstructive surgery, and during general soft tissue reconstruction.
Important Safety Information
Who should not use SERI® Surgical Scaffold?
SERI® Surgical Scaffold should NOT be used in:
- Patients with a known allergy to silk
- Direct contact with internal organs
What else is important to know?
- Caution is recommended when SERI® Surgical Scaffold is used in pregnant women as it may be harmful
What potential issues may result from the use of SERI® Surgical Scaffold?
Issues that may occur are those that can result from a surgically implanted material. These include infection, redness, the attachment of implanted material to tissue surfaces in the body, the creation of an abnormal opening from one tissue surface to another, and when the skin breaks down and the implant appears through the skin.
For more information, please see www.allergan.com or call Allergan Product Support at 1-800-433-8871.
SERI® Surgical Scaffold is available by prescription only.
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 11,700 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, and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and customers 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.
This press release contains "forward-looking statements," including the statements by Mr. Pyott and Dr. Whitcup, as well as other statements regarding the safety, efficacy, approval and market potential of BOTOX®, OZURDEX® and SERI® Surgical Scaffold. 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, general industry and medical device market conditions; challenges related to achieving regulatory approval in a timely and cost-efficient manner; technological advances and patents attained by competitors; inconsistency of treatment results among patients; potential difficulties in manufacturing; challenges related to new product marketing, such as the unpredictability or market acceptance for new products and the acceptance of new indications for such products; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by Allergan, as well as Allergan's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's most recent Annual Report on Form 10-K and any 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 1-714-246-4636.
©2014 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc. All rights reserved.
Myobloc® is a registered trademark of Solstice Neuroscience, Inc.
Dysport® is a registered trademark of Ipsen Biopharm, Ltd.
Xeomin® is a registered trademark of Merz Pharma Gmbh & Co.