Allergan, a multi-specialty health care company, announced that the company's research and development pipeline has been recognised by the Galien Foundation, which has nominated three of Allergan's products for the 2014 US Prix Galien Awards. The Prix Galien Award is considered the biomedical industry's highest accolade and recognises the technical, scientific and clinical research skills necessary to develop innovative medicines and devices.
The Allergan products that have been nominated for the 2014 US 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 recognised for our R&D efforts by the Prix Galien Committee and especially honoured 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 recognised 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 US. Food and Drug Administration (US 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).
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).
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.
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.