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Allergan plc  (AGN)
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Allergan plc Segments

 
Eye Care Pharmaceuticals
   46.68 % of total Revenue
Skin Care
   7.18 % of total Revenue
BOTOX/Neuromuscular
   31.2 % of total Revenue
Total Specialty Pharmaceuticals
   85.06 % of total Revenue
Alphagan P & Alphagan
   7.33 % of total Revenue
Lumigan
   9.39 % of total Revenue
Restasis
   16.38 % of total Revenue
Latisse
   1.45 % of total Revenue
Breast Aesthetics
   5.27 % of total Revenue
Facial Aesthetics
   9.22 % of total Revenue
Total Medical Devices
   14.94 % of total Revenue
 

Business Segments (Dec. 31. 2014)
Revenues
(in millions $)
IV. Quarter
%
(of total Revenues)
(Dec. 31. 2014)
Income
(in millions $)
IV. Quarter
%
(Profit Margin)
Eye Care Pharmaceuticals
881.70 46.68 % 0.00 -
Skin Care
135.70 7.18 % 0.00 -
BOTOX/Neuromuscular
589.30 31.2 % 0.00 -
Total Specialty Pharmaceuticals
1,606.70 85.06 % 826.20 51.42 %
Alphagan P & Alphagan
138.50 7.33 % 0.00 -
Lumigan
177.30 9.39 % 0.00 -
Restasis
309.40 16.38 % 0.00 -
Latisse
27.40 1.45 % 0.00 -
Breast Aesthetics
99.50 5.27 % 0.00 -
Facial Aesthetics
174.20 9.22 % 0.00 -
Total Medical Devices
282.30 14.94 % 110.60 39.18 %
Total
1,889.00 100 % 936.80 49.59 %

• View Income Statement • View Competition by Segment • View Annual Report

Growth rates by Segment (Dec. 31. 2014)
Y/Y Revenue
%
IV. Quarter
Q/Q Revenue
%
(Dec. 31. 2014)
Y/Y Income
%
IV. Quarter
Q/Q Income
%
Eye Care Pharmaceuticals
12.72 % 7.68 % - -
Skin Care
11.32 % -3.83 % - -
BOTOX/Neuromuscular
12.12 % 5.21 % - -
Total Specialty Pharmaceuticals
12.38 % 5.7 % 31.31 % 10.15 %
Alphagan P & Alphagan
10.89 % 6.37 % - -
Lumigan
2.72 % 7.07 % - -
Restasis
11.46 % 13.21 % - -
Latisse
17.09 % 22.32 % - -
Breast Aesthetics
11.05 % 2.05 % - -
Facial Aesthetics
26.97 % 7.93 % - -
Total Medical Devices
22.79 % 4.29 % 90.69 % 14.73 %
Total
13.82 % 5.49 % 36.32 % 10.67 %

• View Growth rates • View Competitors Segment Growth • View Market Share

To get more information on Allergan Plc's Eye Care Pharmaceuticals, Skin Care, BOTOX/Neuromuscular, Total Specialty Pharmaceuticals, Alphagan P & Alphagan, Lumigan, Restasis, Latisse, Breast Aesthetics, Facial Aesthetics, Total Medical Devices, Total segment. Select each division with the arrow.

  Allergan Plc's

Business Segments Description



Specialty Pharmaceuticals Segment

Eye Care Pharmaceuticals Product Line

We develop, manufacture and market a broad range of prescription and non-prescription products designed to treat diseases and disorders of the eye, including glaucoma, dry eye, inflammation, infection and allergy.

Glaucoma. The largest segment of the market for ophthalmic prescription drugs is for the treatment of glaucoma, a sight-threatening disease typically characterized by elevated intraocular pressure leading to optic nerve damage. Glaucoma is currently the world’s second leading cause of blindness, and we estimate that over 60 million people worldwide have glaucoma. According to IMS Health Inc., an independent marketing research firm, our products for the treatment of glaucoma, including Alphagan® (brimonide tartrate ophthalmic solution) 0.2%, or Alphagan®, Alphagan® P (brimonide tartrate ophthalmic solution) 0.15%, or Alphagan® P, Alphagan® P 0.1% (brimonide tartrate ophthalmic solution) 0.1%, or Alphagan® P 0.1%, and Lumigan® (bimatoprost ophthalmic solution) 0.03%, captured approximately 17% of the worldwide glaucoma market for the first nine months of 2006. Lumigan® is now our largest selling eye care product. According to IMS Health, Inc., Lumigan® was the third largest selling glaucoma product in the world for the first nine months of 2006.

Our second largest selling eye care pharmaceutical products are the ophthalmic solutions Alphagan®, Alphagan® P, and Alphagan® P 0.1%. Alphagan®, Alphagan® P and Alphagan® P 0.1% lower intraocular pressure by reducing aqueous humor production and increasing uveoscleral outflow. Alphagan® P and Alphagan® P 0.1% are improved reformulations of Alphagan® containing brimonidine, Alphagan®’s active ingredient, preserved with Purite®. We currently market Alphagan®, Alphagan® P, and Alphagan® P 0.1% in over 70 countries worldwide.

Alphagan®, Alphagan® P, and Alphagan® P 0.1% combined were the fifth best selling glaucoma products in the world for the first nine months of 2006, according to IMS Health Inc.

In July 2002, based on the acceptance of Alphagan® P, we discontinued the U.S. distribution of Alphagan®. In May 2004, we entered into an exclusive licensing agreement with Kyorin Pharmaceutical Co., Ltd., under which Kyorin became responsible for the development and commercialization of Alphagan® and Alphagan® P in Japan’s ophthalmic specialty area. Kyorin subsequently sub-licensed its rights under the agreement to Senju Pharmaceutical Co., Ltd. Under the licensing agreement, Senju incurs associated costs, makes clinical development and commercialization milestone payments, and makes royalty-based payments on product sales

The marketing exclusivity period for Alphagan® P expired in the United States in September 2004 and the marketing exclusivity period for Alphagan® P 0.1% will expire in August 2008, although we have a number of patents covering the Alphagan® P and Alphagan® P 0.1% technology that extend to 2021 in the United States and 2009 in Europe, with corresponding patents pending in Europe. In May 2003, the FDA approved the first generic form of Alphagan®. Additionally, a generic form of Alphagan® is sold in a limited number of other countries, including Canada, Mexico, India, Brazil, Colombia and Argentina.

Lumigan® is a topical treatment indicated for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who are either intolerant or insufficiently responsive when treated with other intraocular pressure-lowering medications.

In January 2004, the European Union’s Committee for Proprietary Medicinal Products approved Lumigan® as a first-line therapy for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension. In June 2006, the FDA approved Lumigan® as a first-line therapy. In May 2004, we entered into an exclusive licensing agreement with Senju Pharmaceutical Co., Ltd., under which Senju became responsible for the development and commercialization of Lumigan® in Japan. Senju incurs associated costs, makes clinical development and commercialization milestone payments and makes royalty-based payments on product sales. We agreed to work collaboratively with Senju on overall product strategy and management. In November 2003, we filed a New Drug Application with the FDA for a Lumigan® and timolol combination designed to treat glaucoma or ocular hypertension. In August 2004, we announced that the FDA issued an approvable letter regarding Ganfort®, the Lumigan® and timolol combination, setting out the conditions, including additional clinical investigation, that we must meet in order to obtain final FDA approval. In May 2006, we received a license from the European Commission to market Ganfort® in the European Union.

In addition to our Alphagan® and Lumigan® products, we have developed the ophthalmic solution Combigantm, a brimonidine and timolol combination designed to treat glaucoma and ocular hypertension (high pressure in the eye) in people who are not responsive to treatment with only one medication and are considered appropriate candidates for combination therapy. Outside the United States, Combigantm is now approved and has been launched in over 30 countries worldwide, including Canada, Australia, New Zealand, across Latin America and Asia, as well as Europe. In September 2005, we received a positive opinion from the European Union by way of the Mutual Recognition Process for Combigantm in all twenty-one concerned member states in which we filed. In March 2005, the FDA issued an approvable letter for our brimonidine and timolol combination and in December 2006, the FDA issued an approvable letter for Combigantm. The approvable letter outlines the remaining conditions that we must meet in order to obtain FDA final marketing approval.

Ocular Surface Disease. Restasis® (cyclosporine ophthalmic emulsion) 0.05% is the first and currently the only prescription therapy for the treatment of chronic dry eye disease. Dry eye disease is a painful and irritating condition involving abnormalities and deficiencies in the tear film initiated by a variety of causes. The incidence of dry eye disease increases markedly with age, after menopause in women and in people with systemic diseases such as Sjogren’s syndrome and rheumatoid arthritis. Until the approval of Restasis®, physicians used lubricating tears as a temporary measure to provide palliative relief of the debilitating symptoms of dry eye disease. We launched

Restasis® in the United States in April 2003 under a license from Novartis for the ophthalmic use of cyclosporine. Restasis® is currently approved in 26 countries. In April 2005, we entered into a royalty buy-out agreement with Novartis related to Restasis® and agreed to pay $110 million to Novartis in exchange for Novartis’ worldwide rights and obligations, excluding Japan, for technology, patents and products relating to the topical ophthalmic use of cyclosporine A, the active ingredient in Restasis®. Under the royalty buy-out agreement, we no longer make royalty payments to Novartis in connection with our sales of Restasis®.

In June 2001, we entered into a licensing, development and marketing agreement with Inspire Pharmaceuticals, Inc. under which we obtained an exclusive license to develop and commercialize Inspire’s INS365 Ophthalmic, a treatment to relieve the signs of dry eye disease by rehydrating conjunctival mucosa and increasing non-lacrimal tear component production, in exchange for our agreement to make royalty payments to Inspire on sales of both Restasis® and, ultimately, INS365, and for Inspire to promote Restasis® in the United States. In December 2003, the FDA issued an approvable letter for INS365 and also requested additional clinical data. In February 2005, Inspire announced that INS365 failed to demonstrate statistically significant improvement as compared to a placebo for the primary endpoint of the incidence of corneal clearing. Inspire also announced that INS365 achieved improvement compared to a placebo for a number of secondary endpoints. Inspire filed a New Drug Application amendment with the FDA in the second quarter of 2005. In December 2005, Inspire announced that it had received a second approvable letter from the FDA in connection with INS365.

Ophthalmic Inflammation. Our leading ophthalmic anti-inflammatory product is Acular® (ketorolac ophthalmic solution) 0.5%. Acular® is a registered trademark of and is licensed from its developer, Syntex (U.S.A.) Inc., a business unit of Hoffmann-LaRoche Inc. Acular® is indicated for the temporary relief of itch associated with seasonal allergic conjunctivitis, the inflammation of the mucus membrane that lines the inner surface of the eyelids, and for the treatment of post-operative inflammation in patients who have undergone cataract extraction. Acular PF® was the first, and currently remains the only, unit-dose, preservative-free topical non-steroidal anti-inflammatory drug, or NSAID, in the United States.

Ophthalmic Infection. Our Ocuflox®/Oflox®/Exocin® ophthalmic solution is a leading product in the ophthalmic anti-infective market. Ocuflox® has no patent protection or marketing exclusivity and faces generic competition.

We license Zymar® (gatifloxacin ophthalmic solution) 0.3% from Kyorin Pharmaceutical Co. Ltd., and have worldwide ophthalmic rights excluding Japan, Korea, Taiwan and certain other countries in Asia. We launched Zymar® in the United States in April 2003. Zymar® is a fourth-generation fluoroquinolone for the treatment of bacterial conjunctivitis and is currently approved in 21 countries. Laboratory studies have shown that Zymar® kills the most common bacteria that cause eye infections as well as specific resistant bacteria. According to Verispan, an independent research firm, Zymar® was the number one ophthalmic anti-infective prescribed by ophthalmologists in the United States in 2006.

Allergy. The allergy market is, by its nature, a seasonal market, peaking during the spring months. We market Alocril® ophthalmic solution for the treatment of itch associated with allergic conjunctivitis. We license Alocril® from Fisons Ltd., now a business unit of Sanofi-Aventis, and hold worldwide ophthalmic rights excluding Japan. Alocril® is approved in the United States, Canada and Mexico. We license Elestat® from Boehringer Ingelheim AG, and hold worldwide ophthalmic rights excluding Japan. We co-promote Elestat® (epinastine ophthalmic solution) 0.05% in the United States under an agreement with Inspire within the ophthalmic specialty area and to allergists. Elestat® is used for the prevention of itching associated with allergic conjunctivitis. Under the terms of our agreement with Inspire, Inspire provided us with an up-front payment and we make payments to Inspire based on Elestat® net sales. In addition, the agreement reduced our existing royalty payment to Inspire for Restasis®. Inspire has primary responsibility for selling and marketing activities in the United States related to Elestat®. We have retained all international marketing and selling rights. We launched Elestat® in Europe under the brand names Relestat® and Purivist® during 2004, and Inspire launched Elestat® in the United States during 2004. Elestat®/Relestat®/Purivist® is currently approved in 38 countries and was the third best selling ophthalmic allergy product in the world (and second in the United States) for the first nine months of 2006, according to IMS Health, Inc.

Neuromodulator

Our neuromodulator product, Botox® (Botulinum Toxin Type A), is used for a wide variety of treatments that continue to expand. Botox® is accepted in many global regions as the standard therapy for indications ranging from therapeutic neuromuscular disorders and related pain to cosmetic facial aesthetics. There are currently in excess of 100 therapeutic and aesthetic uses for Botox® reported in the medical literature. The versatility of Botox® is based on its localized treatment effect and approximately 18 years of safety experience in large patient groups. Marketed as Botox®, Botox® Cosmetic, Vistabel® or Vistabex®, depending on the indication and country of approval, the product is currently approved in approximately 75 countries for up to 20 unique indications.

Botox®. Botox® is used therapeutically for the treatment of certain neuromuscular disorders which are characterized by involuntary muscle contractions or spasms. The approved therapeutic indications for Botox® in the United States are as follows:


• blepharospasm, the uncontrollable contraction of the eyelid muscles which can force the eye closed and result in functional blindness;

• strabismus, or misalignment of the eyes, in people 12 years of age and over;

• cervical dystonia, or sustained contractions or spasms of muscles in the shoulders or neck in adults, along with associated pain; and

• severe primary axillary hyperhidrosis (underarm sweating) that is inadequately managed with topical agents.


In many countries outside of the United States, Botox® is also approved for treating hemifacial spasm, pediatric cerebral palsy, and post-stroke focal spasticity. We are currently pursuing approvals for Botox® in the United States and Europe for new indications, including headache, post-stroke focal spasticity, overactive bladder and benign prostatic hypertrophy. In April 2005, we announced plans to move forward with a large Phase III clinical trial program to investigate the safety and efficacy of Botox® as a prophylactic therapy in a subset of migraine patients with chronic daily headache, and in May 2005, we reached agreement with the FDA to enter Phase III clinical trials for Botox® to treat neurogenic overactive bladder and Phase II clinical trials for Botox® to treat idiopathic overactive bladder. In December 2005, we initiated Phase II clinical trials for Botox® to treat benign prostatic hypertrophy.

Botox® Cosmetic. The FDA has approved Botox® for the temporary improvement in the appearance of moderate to severe glabellar lines in adult men and women age 65 or younger. Referred to as Botox®, Botox® Cosmetic, Vistabel® or Vistabex®, depending on the country of approval, this product is designed to relax wrinkle-causing muscles to smooth the deep, persistent, glabellar lines between the brow that often develop during the aging process. Currently, over 50 countries have approved the glabellar line indication for Botox®, Botox® Cosmetic, Vistabel® or Vistabex®. Health Canada, the Canadian national regulatory body, also approved Botox® Cosmetic for the treatment of upper facial lines in November 2005. In 2005, we extended our previously launched direct-to-consumer marketing campaigns in Canada and the United States. These campaigns included television commercials and print advertising aimed at consumers and aesthetic specialty physicians. We continue to sponsor training of aesthetic specialty physicians in approved countries to further expand the base of qualified physicians using Botox®, Botox® Cosmetic, Vistabel® or Vistabex®. With the integration of the former Inamed medical products into our TOTAL FACIAL REJUVENATIONtm portfolio, we now have a worldwide leadership position in the facial aesthetic market.

In October 2005, we entered into a long-term arrangement with GlaxoSmithKline (GSK) under which GSK agreed to develop and promote Botox® in Japan and China and we agreed to co-promote GSK’s products ImitrexSTATdose System® (sumatriptan succinate) and Amerge® (naratriptan hydrochloride) in the United

States. Under the terms of the arrangement, we licensed to GSK all clinical development and commercial rights to Botox® in Japan and China, markets in which GSK has extensive commercial, regulatory and research and development resources, as well as expertise in neurology. We received an up-front payment and receive payments for research and development and marketing support, and royalties on GSK’s Japan and China Botox® sales. We also manufacture Botox® for GSK as part of a long-term supply agreement and collaboratively support GSK on new clinical developments for Botox® and strategic marketing in those markets. In addition, we obtained the right to co-promote GSK’s products ImitrexSTATdose System® and Amerge® in the United States to neurologists for a 5-year period. ImitrexSTATdose System® is approved for the treatment of acute migraine in adults and for the acute treatment of cluster headache episodes. Amerge® tablets are approved for the acute treatment of migraine attacks with and without an aura in adults. Our agreement with GSK provides that we receive fixed and performance payments from GSK in connection with our co-promotion of ImitrexSTATdose System® and Amerge®.

Skin Care Product Line

Our skin care product line focuses on the psoriasis and acne markets, particularly in the United States and Canada.

Tazarotene Products. We market Tazorac® gel in the United States for the treatment of plaque psoriasis, a chronic skin disease characterized by dry red patches, and acne. We also market a cream formulation of Tazorac® in the United States for the treatment of psoriasis and the topical treatment of acne. We have also engaged Pierre Fabre Dermatologie as our promotion partner for Zorac® in certain parts of Europe, the Middle East and Africa.

Our product Avage® is a tazarotene cream indicated for the treatment of facial fine wrinkling, mottled hypo- and hyperpigmentation (blotchy skin discoloration) and benign facial lentigines (flat patches of skin discoloration) in patients using a comprehensive skin care and sunlight avoidance program. We launched Avage® in the United States in January 2003.

In January 2005, we launched Prevagetm cream, containing 1% idebenone, a clinically tested antioxidant designed to reduce the appearance of fine lines and wrinkles, as well as provide protection against environmental factors, including sun damage, air pollution and cigarette smoke. In May 2005, we entered into an exclusive co-marketing agreement with Elizabeth Arden, Inc. to globally market a new formulation of Prevagetm containing 0.5% idebenone, to leading department stores and other prestige cosmetic retailers. In September 2005, we began marketing Prevagetm MD, containing 1% idebenone, to physicians.

Azelex®. Azelex® cream is approved by the FDA for the topical treatment of mild to moderate inflammatory acne vulgaris and is licensed from Intendis GmbH, a division of Bayer Schering Pharma AG. We market Azelex® cream primarily in the United States.

M.D. Forte®. We develop and market glycolic acid-based skin care products. We market our M.D. Forte® line of alpha hydroxy acid products to physicians.

Finacea®. Through a collaboration with Intendis GmbH, we jointly promote Intendis’ topical rosacea treatment, Finacea® (azelaic acid gel 15%). Finacea® is approved by the FDA for the treatment of rosacea and holds a leading position in the market.

Medical Devices Segment

Breast Aesthetics

We develop, manufacture, and market a diverse line of breast implants, consisting of a variety of shapes, sizes, and textures. Our breast implants consist of a silicone elastomer shell filled with either a saline solution or silicone gel with varying degrees of cohesivity. This shell can consist of either a smooth or textured surface. We market our breast implants under the trade names McGhan® and CUI® and the trademarks BioCell®, MicroCell®, BioDimensionaltm, and Inamed®. Our breast implants are available in a large number of variations to meet customers’ preferences and needs.


Saline-Filled Breast Implants. We sell saline-filled breast implants in the United States and internationally for use in breast augmentation for cosmetic or revision reasons and for reconstructive surgery. The U.S. market is the primary consumer of our saline-filled breast implants.

Silicone Gel-Filled Breast Implants. We sell silicone gel-filled breast implants primarily in Europe, the Middle East, Latin America, Australia, New Zealand and Asia. More than 90% of our breast implant sales outside the United States and Canada are silicone gel-filled. There are a variety of silicone gel-filled breast implants available in these markets based upon the degrees of cohesivity of the silicone gel-filler material. In October 2006, Health Canada granted us a medical device license with conditions to sell and market silicone gel-filled breast implants, including our round, smooth and textured silicone gel-filled breast implants and Style 410 shaped and textured implants, for use in breast augmentation, reconstruction and revision surgery. In November 2006, the FDA approved our round silicone gel-filled breast implants for breast augmentation. FDA approval was conditioned on our continuation of our core clinical study and our pre-clinical studies, our completion of a focus group study regarding format and content of patient labeling, our distribution of labeling to physicians and patients within sufficient time prior to surgery to fully consider the risks associated with breast implant surgery, our termination of new enrollment into an adjunct study and continuation of follow-up for currently enrolled patients and our initiation of a 10-year prospective study, of 40,000 patients with silicone gel-filled implants and 20,000 patients with saline-filled implants, to further validate the long-term safety and effectiveness of silicone gel-filled breast implants.

Tissue Expanders. We sell a line of tissue expanders for breast reconstruction and as an alternative to skin grafting to cover burn scars and correct birth defects.

Facial Aesthetics

We develop, manufacture, and market dermal filler products designed to improve facial appearance by smoothing wrinkles and scars and enhancing the definition of facial structure. Our primary facial aesthetics products are Zyderm® and Zyplast®, CosmoDerm® and CosmoPlast®, the Juvédermtm/Hydrafilltm/Surgiderm® product range, the Hylaform® product range and Captiquetm.

Zyderm® and Zyplast®. Zyderm® and Zyplast® dermal fillers are injectable formulations of bovine collagen. Zyderm® implants are formulated for people with fine line wrinkles or superficial facial contour defects. These implants are particularly effective in smoothing delicate frown and smile lines, and fine creases that develop at the corners of the eyes and above and below the lips, and can also help correct certain shallow scars. Zyplast® implants are designed to treat deeper depressions and can be used for more pronounced contour problems, such as deeper scars, lines and furrows, and for areas upon which more force is exerted, such as the corners of the mouth. The implants take on the texture and appearance of human tissue and are subject to similar stresses and aging processes. Consequently, supplemental treatments are necessary to maintain the desired result. Zyderm® and Zyplast® implants require a skin test, with a requisite 30-day period to observe the possibility of allergic reaction in the recipient. Both of these products are formulated with Lidocaine, an anesthetic, to alleviate pain during injection. Zyderm® and Zyplast® are approved for marketing in the United States and Europe.

CosmoDerm® and CosmoPlast®. CosmoDerm® and CosmoPlast® dermal fillers are a line of injectable human skin-cell derived collagen products that we license from Smith & Nephew, Inc. CosmoDerm® implants are formulated for people with fine line wrinkles or superficial facial contour defects. These implants are particularly effective in smoothing delicate frown and smile lines and fine creases that develop at the corners of the eyes and above and below the lips and can also help correct certain shallow scars. CosmoPlast® implants are designed to treat deeper depressions and can be used for more pronounced contour problems, such as deeper scars, lines and furrows, and for areas upon which more force is exerted, such as the corners of the mouth. The implants take on the texture and appearance of human tissue and are subject to similar stresses and aging processes. Consequently, supplemental treatments are necessary to maintain the desired result. CosmoDerm® and CosmoPlast® implants do not require a skin test pre-treatment. Both of these products are formulated with Lidocaine, an anesthetic, to alleviate pain during injection. We received FDA approval for CosmoDerm® and CosmoPlast® in March 2003 and received approval from Health Canada in December 2002. We received approval to market CosmoDerm® and CosmoPlast® in a number of European countries in 2004.


Hylaform® Gel. Hylaform® gel dermal fillers are an avian-based, cross-linked hyaluronic acid injectable product for the treatment of facial wrinkles and scars, which are approved for sale and marketing in Canada, Europe and the United States. We license Hylaform® from Genzyme Corporation. Hylaform® does not require a skin test, so patients can be treated immediately. In 2001, two new formulations of Hylaform® gel were developed: Hylaform® FineLine, designed especially for people with fine line wrinkles or superficial facial contour defects, and Hylaform® Plus, formulated for treating deeper depressions and more pronounced contour problems such as deeper scars, lines, and furrows. We launched Hylaform® FineLine and Hylaform® Plus in Europe in September 2001. In December 2001, Health Canada’s Therapeutic Products Programme, or HCTPP, granted Genzyme Corporation a Medical Device License for Hylaform® gel. In January 2002, the HCTPP approved both Hylaform® Plus and Hylaform® FineLine. In April 2004, Inamed received approval from the FDA to market and sell Hylaform gel in the United States. In October 2004, the FDA granted market approval for Hylaform® Plus in the United States.

Juvédermtm/Hydrafilltm. Our product Juvédermtm is a non-animal based, cross-linked hyaluronic acid-based dermal filler, and is indicated for wrinkle correction, facial contouring and lip enhancements. This technology is based on the delivery of a homogeneous gel-based hyaluronic acid, as opposed to a particle gel-based hyaluronic acid technology, which is used in other products. Inamed had obtained the rights to develop, distribute and market Juvédermtm dermal fillers (including product lines and extensions) from Groupe Cornéal Laboratoires, or Cornéal, in January 2004. Inamed’s rights were exclusive in the United States, Canada, and Australia, and non-exclusive in France, Spain, the United Kingdom, Italy, Germany and Switzerland. In these European countries, Juvédermtm is marketed under the trademark Hydrafilltm. Juvédermtm and Hydrafilltm are each currently available in five formulations for soft tissue augmentation of varying severities of wrinkles. Through our January 2007 acquisition of Cornéal, we expanded our marketing rights to Juvédermtm, Surgiderm®, Voluma® and other hyaluronic acid dermal fillers to all countries worldwide and obtained control over the manufacturing process and future development of Juvédermtm and the company’s R&D pipeline. Juvédermtm products are currently approved or registered in over 34 countries, including all major European markets. In these markets, Juvédermtm does not require a skin test pre-treatment. Distribution of Juvédermtm in Canada and key European markets commenced in 2004. In June 2006, the FDA approved the Juvédermtm dermal filler family of products and in September 2006, we launched the “next-generation” hyaluronic acid-based dermal filler products, Juvédermtm Ultra and Juvédermtm Ultra Plus through an experience trial with a group of physicians with expertise in facial aesthetics, in advance of U.S. product availability, which commenced in January 2007.

Captiquetm. Captiquetm dermal filler is a non-animal stabilized hyaluronic acid injectable product indicated for the correction of moderate to severe facial wrinkles and scars. We license Captiquetm from Genzyme Corporation. Captiquetm does not require a skin test, so patients can be treated immediately.
Obesity Intervention

We develop, manufacture, and market several devices for the treatment of obesity. Our principal product in this market area, the LAP-BAND® System, is designed to provide minimally invasive long-term treatment of severe obesity and is used as an alternative to more invasive procedures such as gastric bypass surgery or stomach stapling. The LAP-BAND® System is an adjustable silicone elastomer band which is laparoscopically placed around the upper part of the stomach through a small incision, creating a small pouch at the top of the stomach. This new pouch fills faster to make the patient feel full sooner, and regulates the passage of food to retain that feeling of fullness for longer periods of time. Unlike other obesity surgeries that are permanent, the LAP-BAND® System procedure is adjustable and reversible.

The LAP-BAND® System has achieved widespread acceptance in the United States, Europe, Australia, Latin America, the Middle East, and other countries around the world. In 2001, the FDA approved the LAP-BAND® System for the treatment of severe obesity in adults who have failed more conservative weight reduction alternatives. In April 2004, Inamed introduced the LAP-BAND VG®, which was approved by the FDA in January 2004. The LAP-BAND VG® meets the needs of a wider range of patients, allowing us to serve a broader market. The larger band circumference of the LAP-BAND VG® serves those who are physically larger, have thicker gastric walls, or have substantial internal fat. Over 300,000 LAP-BAND® System units have been sold worldwide since 1993.

We also sell the BIBtm System, which is a short-term weight loss therapy designed for use with moderately obese patients. Broadly approved around the world outside the United States, the BIBtm System includes a silicone elastomer balloon that is filled with saline after transoral insertion into the patient’s stomach to reduce stomach capacity and create an earlier sensation of fullness. The BIBtm System is removed endoscopically within six months of being implanted, and works best when used in conjunction with a comprehensive diet and exercise program.

Other Products

Contigen® is our collagen product used for treatment of urinary incontinence due to intrinsic sphincter deficiency. C. R. Bard, Inc. licenses from us the exclusive worldwide marketing and distribution rights to Contigen®. We also provide other collagen products for use by other medical manufacturers.

   

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