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Allergan

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Benadryl is an antihistamine. Diphenhydramine blocks the effects of the naturally occurring chemical histamine in the body. It is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; and other symptoms of allergies and the common cold.

Active Ingredient: Diphenhydramine

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Heptares - News Detail

News & Events | Article

Allergan and Heptares Announce Global R&D and Commercialization Partnership for Novel Treatments in Alzheimer’s and Other Neurological Disorders

- Adds Selective Muscarinic Agonists Discovered and Developed by Heptares to Allergan’s Leading CNS Pipeline
- Reinforces Allergan’s Commitment to Development of Treatments for Alzheimer’s Disease and Other Neurological Disorders
- Heptares Eligible to Receive Upfront, R&D and Milestone Payments, Plus Royalties

DUBLIN, IRELAND and LONDON, UK – April 7, 2016 – Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Heptares Therapeutics, the wholly-owned subsidiary of Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), today announced that Allergan’s wholly-owned subsidiary, Allergan Pharmaceuticals International Limited and Heptares have entered into a definitive agreement under which Allergan will license exclusive global rights to a broad portfolio of novel subtype-selective muscarinic receptor agonists in development for the treatment of major neurological disorders, including Alzheimer’s disease.

Under the terms of the agreement, Heptares will receive an upfront payment of $125 million and is eligible to receive contingent milestone payments of up to approximately $665 million associated with the successful Phase 1, 2 and 3 clinical development and launch of the first three licensed compounds for multiple indications and up to approximately $2.5 billion associated with achieving certain annual sales thresholds during the several years following launch. In addition, Heptares is eligible to receive up to double-digit tiered royalties on net sales of all products resulting from the partnership. Allergan is also committing up to $50 million to a research and development program to be conducted jointly by Allergan and Heptares aimed at advancing multiple candidates through Phase 2 clinical studies. Allergan will be responsible for the development of licensed compounds upon initiation of Phase 2b studies and for subsequent manufacturing and commercialization of the products.

The agreement covers first-in-class selective small molecule agonists targeting muscarinic M1 and M4 receptors in the brain, discovered using Heptares’ proprietary StaR® technology platform. Allergan will receive exclusive rights to a broad clinical and preclinical portfolio of M1, M4 and dual M1/M4 agonists, including HTL9936 and HTL18318, selective M1 agonists currently in Phase 1 clinical development.

M1 selective compounds are in development for the potential treatment of symptomatic cognitive deficits in Alzheimer’s patients, with the potential upside of better tolerability and a more pronounced effect compared with available treatments. M4 selective compounds may provide a novel approach to treat the neurobehavioral symptoms (psychoses) associated with Alzheimer’s disease and related neurological disorders, through a different mechanism of action than available antipsychotics. Combined, dual M1/M4 agonists may be able to treat both cognitive impairment and neurobehavioral symptoms.

"Cognitive impairment and psychosis are progressive and debilitating symptoms associated with many CNS diseases, including Alzheimer’s disease, with few approved therapies available,” said David Nicholson, Executive Vice President and President, Global Brands Research and Development at Allergan. "The Heptares M1 compounds have shown promising results in early development in their ability to selectively target the M1 receptor without also activating the M2 or M3 receptors, which are associated with undesirable side effects. We look forward to advancing these compounds into the next stages of development, and potentially adding new approaches to helping physicians treat patients suffering from the effects of Alzheimer’s disease, an area of medicine where Allergan remains committed to continued innovation.”

The safety, tolerability and pharmacokinetic profile of HTL9936 were assessed in a recently completed Phase 1 study. The data provide strong evidence of a therapeutic window for the selective M1 agonist mechanism in general, and for progression of HTL9936 and similar molecules as medicines to treat cognitive disorders. HTL9936 exhibited good brain penetration and M1 selectivity with no adverse events typically attributed to the stimulation of M2 and M3 receptors. HTL9936 also exhibited robust and statistically significant changes in brain electrical activity measured using multiple electroencephalography (EEG) biomarkers relevant to cognition. These pro-cognitive effects were seen at low doses and low blood concentrations that were safe and well tolerated.

Malcolm Weir, Chief Executive Officer of Heptares and Chief R&D Officer at Sosei, said: “We are delighted that the quality of our muscarinic agonist candidates, discovered and developed wholly in-house, and our translational capabilities have been recognized by Allergan, a global leader in the development and commercialization of treatments for CNS diseases. We have a highly committed and experienced partner in Allergan and look forward to working together towards the development of multiple new breakthrough medicines over the coming years.”

Shinichi Tamura, Chairman and CEO of Sosei Group Corporation, added: “This new agreement with Allergan marks an important milestone in our journey to become a global biopharmaceutical company. This agreement further endorses our strategic decision to acquire Heptares in February last year, placing its GPCR-directed drug discovery and development capabilities at the heart of our business.”

This transaction is subject to customary clearances under the Hart-Scott-Rodino Antitrust Improvements Act.

About Muscarinic Receptors

Muscarinic receptors are G protein-coupled receptors (GPCRs) found in multiple tissues. Until now, attempts to develop medicines that target M1 and M4 receptors have been unsuccessful because of side effects caused by the activation of M2 and M3 receptors. Selective M1 or M4 agonists that do not activate M2 or M3 therefore are highly sought after, and expected to address blockbuster markets.

About Cognitive Impairment in Alzheimer’s Disease and other CNS Diseases (1)

Today there is significant unmet medical need and heavy economic burden across multiple diseases characterized by cognitive impairment and dementia. In Alzheimer’s disease (AD), currently available drugs provide limited and transient effects on cognition. Healthcare costs associated with AD and dementia (estimated at over $640 billion for North America, Western Europe and Asia-Pacific) including nursing home care, continue to grow dramatically and new therapies with better and more durable efficacy are urgently needed. It is estimated that over 45 million people worldwide have dementia (4.8 million in North America, 7.5 million in Western Europe, 3.6 million in Asia-Pacific) and this is expected to increase to over 130 million in 2050. Alzheimer's disease is the most common cause of dementia and may contribute to 60–70% of cases. In addition, an estimated 1.4 million patients in the US suffer from Lewy body dementia.

(1)Sources: World Health Organization, Alzheimer’s Disease International, National Institute of Mental Health, Lewy Body Dementia Association.

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.allergan.com

Allergan Forward-Looking Statements

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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Molecular Partners, Allergan to develop and commercialize DARPins against ophthalmic diseases

Molecular Partners, Allergan to develop and commercialize DARPins against ophthalmic diseases

Published on August 21, 2012 at 5:29 AM

Allergan, Inc. (NYSE: AGN) and Molecular Partners AG today announced that they have significantly expanded their existing relationship by entering into two separate agreements to discover, develop, and commercialize proprietary therapeutic DARPin® products for the treatment of serious ophthalmic diseases.    

Molecular Partners will receive combined upfront payments of $62.5 million under the two agreements and is eligible to receive additional success-based payments, including up to $1.4 billion in aggregate development, regulatory and sales milestones, and tiered royalties up into the low double-digits for future product sales.

The first agreement is an exclusive license agreement for the design, development and commercialization of a potent dual anti-VEGF-A/PDGF-B DARPin® ("MP0260") and its corresponding backups for the treatment of exudative age-related macular degeneration (AMD) and related conditions. Under the license agreement, Allergan and Molecular Partners will work together to develop MP0260 through human proof of concept, at which point Molecular Partners has the option to co-fund Allergan's development costs in exchange for a significant royalty step up.

The second agreement is an exclusive discovery alliance agreement under which the parties will collaborate to design and develop DARPins against selected targets that are implicated in causing serious diseases of the eye. During the research phase, Allergan has the right to exercise three options to exclusively license collaboration compounds for ophthalmology. Upon execution of each option, Allergan will pay Molecular Partners an option exercise fee and be solely responsible for all downstream development, manufacturing, and commercialization activities.

Scott M. Whitcup, M.D. Executive Vice President, Research and Development, Chief Scientific Officer of Allergan commented: "As a leader in ophthalmology, Allergan is committed to developing new treatments for serious eye diseases like AMD. We look forward to further developing a novel therapy that blocks both VEGF and PDGF, as a potential way to improve vision in patients with wet AMD."

Christian Zahnd, Ph.D. Chief Executive Officer of Molecular Partners said: "With Allergan we have found the ideal partner to generate a strong pipeline of DARPin-based drug candidates with the goal to treat retinal and other severe ocular diseases. This significant expansion of our agreement together with the fast progress in the ongoing phase IIb development of AGN-150998 / MP0112 is a great validation of the DARPin approach."

"This is an important step forward in our strategy to build on strong partnerships with the leaders in a therapeutic area" added Patrick Amstutz, Ph.D. Chief Business Officer of Molecular Partners, "DARPins are potent biologics which may address significant unmet medical needs in large patient populations in various disease areas."

Source: Allergan, Inc.

Allergan to Acquire Oculeve Dry Eye Disease Development Programs

Allergan to Acquire Oculeve Dry Eye Disease Development Programs

DUBLIN and SOUTH SAN FRANCISCO, Calif. July 6, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN ), a leading global pharmaceutical company, and Oculeve, a development-stage medical device company focused on developing novel treatments for dry eye disease, today announced that they have entered into an agreement under which Allergan will acquire Oculeve in an all-cash transaction.  Under the terms of the agreement, Allergan will acquire Oculeve for a $125 million upfront payment and commercialization milestone payments related to Oculeve's lead development program OD-01. The agreement also includes the acquisition of an additional earlier-stage dry eye device development program. Allergan's 2015 earnings-per-share forecast provided on May 11, 2015 is unchanged as a result of the acquisition. The Company remains committed to de-levering to below 3.5x debt to Adjusted EBITDA by the end of the first quarter of 2016.

The acquisition of Oculeve adds novel, complementary dry eye development programs to Allergan's current eye care research and development programs, including OD-01, a non-invasive nasal neurostimulation device that increases tear production in patients with dry eye disease. Oculeve has completed four clinical studies of OD-01 to date in more than 200 patients, showing positive safety and efficacy of the device.  Allergan plans to conduct two additional pivotal trials prior to FDA submission, which is expected in 2016 with potential commercial launch in 2017.

"Allergan is committed to developing a broad range of innovations that help patients address dry eye," said David Nicholson. Executive Vice President, Global Brands Research and Development at Allergan. "The OD-01 program has been shown to provide a strong safety and efficacy profile, and if approved, would provide an exciting new treatment option for patients that is complementary to our existing product offerings in this important treatment area."

"Allergan's position and expertise in eye care will maximize the development and potential commercialization of the OD-01 technology," said Michael Ackermann. President and CEO of Oculeve. "I am extraordinarily appreciative and proud of the Oculeve team that has worked so hard to develop our exciting technology, and I am thrilled for us to partner with the Allergan team on the continued development, potential approval and availability of OD-01 to patients worldwide."

Chronic dry eye is a disease that can be caused by advanced age, contact lens wear, certain medications, eye diseases, other medical conditions or environmental factors. One type of chronic dry eye is caused by decreased tear production due to inflammation. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea. Chronic dry eye is estimated to affect 25 million patients in the U.S. i

The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.  Pending approvals, Allergan anticipates closing the transaction in the third quarter of 2015.

Allergan plc (NYSE: AGN ), headquartered in Dublin, Ireland. is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.allergan.com .

About Oculeve
Oculeve, Inc. is a medical device company located in South San Francisco, CA. focused on new technologies for dry eye disease.  The company was founded out of a multi-disciplinary collaboration with the Stanford Biodesign Center and Department of Ophthalmology at Stanford University. spun-out by Michael Ackermann. CEO, Jim Loudin. VP of Research and Development, Professor Mark Blumenkranz. who serves on the Oculeve Board of Directors, and Professor Daniel Palanker. who serves on the Scientific Advisory Board.  The company is backed by investors Kleiner Perkins Caufield and Byers (who also seeded the company), New Enterprise Associates and Versant Ventures, and is represented legally by Wilson, Sonsini, Goodrich & Rosati, and Morrison Forester.

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

i  Market Scope®, 2011 Report on the Global Market for Dry Eye Products; 2011, 1-148.

Medical Xpress: Allergan, Pfizer call off proposed $160B merger

Allergan, Pfizer call off proposed $160B merger April 6, 2016 by Linda A. Johnson

The Pfizer logo appears on a screen above its trading post on the floor of the New York Stock Exchange, Wednesday, April 6, 2016. The biggest U.S.-based drugmaker, Pfizer Inc. will stay put thanks to aggressive new Treasury Department rules that succeeded in blocking Pfizer from acquiring rival Allergan and moving to Ireland, on paper, to reduce its tax bill. (AP Photo/Richard Drew)

Top U.S. drugmaker Pfizer and Irish rival Allergan are charting independent futures after scrapping a record $160 billion deal torpedoed by new Treasury Department rules meant to block American companies from moving their corporate addresses overseas—on paper—to avoid U.S. taxes.

The rules issued Monday, aimed at stopping the companies' "tax inversion" deal, wiped out its financial incentives and rationale for Pfizer Inc. though they had no impact on Allergan PLC.

That led Pfizer and Allergan to walk away "by mutual agreement" on Wednesday. Pfizer, which is based in New York, will pay Allergan $150 million as reimbursement for its deal-related expenses.

It was Pfizer's third, and most expensive, failed attempt at an inversion, leaving analysts to speculate Pfizer will drop the strategy for good. The merger would have moved Pfizer's address, but not its operations or headquarters, to Ireland, where it would have paid hundreds of millions of dollars less in annual U.S. corporate taxes.

Tax inversions, in which a big U.S. company buys a smaller one in another country with a lower tax rate, and then moves the combined company's address there on paper, are a hot issue in the presidential race. President Obama on Tuesday called them "one of the most insidious tax loopholes out there," adding that Treasury's new rules are meant to make wealthy corporations shoulder their tax responsibility like working-class Americans.

Allegan logos appears on screens above its trading post on the floor of the New York Stock Exchange, Wednesday, April 6, 2016. The biggest U.S.-based drugmaker, Pfizer Inc. will stay put thanks to aggressive new Treasury Department rules that succeeded in blocking Pfizer from acquiring rival Allergan and moving to Ireland, on paper, to reduce its tax bill. (AP Photo/Richard Drew)

Pfizer and Allergan regrouped Wednesday and began touting their prospects as solo companies. They are far from being in dire straits as they contemplate their next moves: Both are highly profitable, have multiple lucrative medicine franchises and strong pipelines of experimental drugs, and each have enough cash to quickly do another deal.

Shares of Pfizer rose 4.8 percent to $32.87, while Allergan shares jumped 7.7 percent to $244.20 Wednesday afternoon.

"We can pivot very quickly from combination planning to independent planning," Allergan CEO Brent Saunders told The Associated Press, adding that both companies were prepared for a Treasury move to block their deal but considered it a small risk.

Saunders already is focused on closing Allergan's $40.5 billion deal to sell its generic drug business to Israel's Teva Pharmacueticals Industries Ltd. the world's top generic drugmaker. He expects that to close by the end of June, bringing Allergan about $36 billion after taxes to invest in "opportunities."

Those include mergers and acquisitions, buying rights to experimental drugs, share repurchases and paying down part of Allergan's $40 billion in debt, Saunders told The AP.

In this Nov. 23, 2015, file photo, the Allergan logo appears above a trading post on the floor of the New York Stock Exchange. Allergan and Pfizer called off Wednesday, April 6, 2016, a record $160 billion merger after the Treasury issued new rules to make "tax inversions" less lucrative. (AP Photo/Richard Drew, File)

Best known for its Botox anti-wrinkle injections and Restasis drops for dry eye disease, Allergan had a profit of $3.7 billion on revenue of $15 billion last year. The company is the result of multiple inversions, and despite its Dublin address operates from offices in Parsippany, New Jersey.

"Allergan will continue to invest in the United States," Saunders said, with a focus on jobs creation, expanding factories and research facilities, and doing research on cures for diseases with huge unmet need.

Nomura analyst Shibani Malhotra wrote that Allergan's share price underestimates its stand-alone value, adding that "Allergan offers some of the best, most durable assets in the sector."

It is currently launching several new drugs: Vraylar for schizophrenia and bipolar disorder, Viberzi for irritable bowel syndrome and Kybella for reducing double chins. It's also in the final stage of patient testing of Rapastinel, a new type of depression drug.

Pfizer, the maker of Viagra, pain treatment Lyrica and pneumonia vaccine Prevnar-13, said in a statement that its "late-stage pipeline has several attractive commercial opportunities" in multiple disease areas.

In this Nov. 23, 2015 file photo, traders James Matthews, left, and John Panin work at the post that handles Pfizer, on the floor of the New York Stock Exchange. Allergan and Pfizer called off Wednesday, April 6, 2016, a record $160 billion merger after the Treasury issued new rules to make "tax inversions" less lucrative. (AP Photo/Richard Drew, File)

"We also maintain the financial strength and flexibility to pursue attractive business development," CEO Ian Read said in a statement. He declined interview requests.

Pfizer's statement said it will decide by year's end whether to separate its established products business, which sells older, mostly off-patent drugs and accounted for nearly half of Pfizer's sales and profit last year.

That could indicate Pfizer has given up on inversions and is "back to usual business once again," Bernstein analyst Dr. Timothy Anderson wrote to investors Wednesday. He kept his "Buy" recommendation on Pfizer, adding, "We need a clearer vision of what 'Plan B' might be."

Pfizer has endured years of relentless pressure from Anderson and other analysts to break up the company so growth and profits could accelerate. That's easier said than done, given Pfizer's huge scale, increasing pressure from insurers for bigger medicine discounts and revenue that's been declining for several years as multiple blockbusters such as cholesterol drug Lipitor have lost billions in annual sales to much-cheaper generic copycats.

Pfizer had $23.3 billion in cash, cash equivalents and short-term investments available at the end of 2015, when it posted a profit of $9.1 billion on revenue of $49.6 billion.

It's made several mega-acquisitions over the past two decades that allowed it to cut costs and increase sales to boost profits quickly. Deals like last year's purchase of injected drug maker Hospira have kept Pfizer among the top global drugmakers but haven't pleased investors enough, ultimately triggering the 2010 ouster of Read's predecessor.

The Allergan deal's demise could deter other tax inversions in the works—exactly the impact the Obama administration is seeking.

Other health care companies have recently done or are planning inversions, including fellow drugmakers Baxalta Inc. of Bannockburn, Illinois, and Shire PLC of Ireland, which are planning a $32 billion inversion deal. Meanwhile, Medtronic PLC, which relocated from Minnesota to Dublin in January 2015 after buying fellow medical device maker Covidien for $42.9 billion, said in a statement that it had done a preliminary review of the new Treasury rules and concluded they wouldn't have a material effect on the company.

Read has said the deal was needed because U.S.-based drugmakers are at a major disadvantage to their multinational rivals based in Europe and elsewhere, who face lower corporate tax rates. Other U.S. companies likewise have complained about the top U.S. tax rate of 35 percent—which few ever pay—and the U.S. taxing them on profits made overseas. As a result, Pfizer and other companies are keeping billions in overseas profits outside the U.S. to avoid a big tax bill if they "repatriate" those profits.

© 2016 The Associated Press. All rights reserved.

Explore further Pfizer, Allergan weigh blockbuster merger: reports

Pharmaceutical giant Pfizer recently approached Botox-maker Allergan over what would be the biggest takeover deal this year, The Wall Street Journal said Wednesday.

Bigger Pharma: Allergan in merger talks with Pfizer

Botox-maker Allergan said Thursday it was in "friendly" merger talks with Pfizer that have the potential of forming a $300 billion pharmaceutical behemoth.

Pfizer, Allergan to merge in $160 bn tax-saving deal (Update 3)

US-based Pfizer announced Monday a $160 billion merger with Ireland-based Allergan to create the world's biggest pharmaceutical group and shift to a lower-tax jurisdiction despite government policies discouraging such deals.

Pfizer, Allergan CEOs: Tie-up aims for growth, not cost cuts

The heads of drugmakers Pfizer and Allergan said Tuesday that the record $160 billion combination they're planning is meant to produce more medicines and boost revenue, not to just slash jobs and other costs as the companies.

Pfizer adds $784.6 M charge for Protonix deal to 4Q results

Drugmaker Pfizer Inc. swung to a fourth-quarter financial loss, instead of a modest profit, as a result of a just-announced charge to settle a long-running federal case over reimbursements for its former blockbuster heartburn.

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Allergan, Inc

Allergan, Inc. incorporated in 1948, is a global healthcare company that discovers and develops specialty pharmaceutical and medical device products for the ophthalmic, neurological, medical aesthetics, medical dermatological, breast aesthetics, obesity intervention and other specialty markets. It provides specialty pharmaceutical research, targeting products and technologies related to specific disease areas, such as glaucoma, retinal disease, dry eye, psoriasis, acne and movement disorders. Allergan, Inc. discovers, develops and markets medical devices, aesthetics-related pharmaceuticals and over-the-counter products. The Company is focusing research and development efforts on therapeutic areas, including gastroenterology, neuropathic pain and genitourinary diseases.

In October 2007, the Company completed the acquisition of Esprit Pharma Holding Company, Inc. In February 2007, the Company completed the acquisition of Swiss medical technology developer, EndoArt SA, which is engaged in the field of telemetrically controlled (or remote-controlled) implants used in the treatment of morbid obesity and other conditions. The acquisition complements the Company's existing obesity intervention product portfolio, which includes the LAP-BAND Adjustable Gastric Banding System, an implant device for individualized weight loss, and the BIB. In January 2007, the Company acquired Groupe Corneal Laboratoires (Corneal), which is a medical device manufacturer and marketer. In March 2006, the Company completed the acquisition of Inamed Corporation, which is a global healthcare manufacturer and marketer of breast implants, a range of dermal products to correct facial wrinkles, and bariatric medical devices.

Specialty Pharmaceuticals Segment

Allergan, Inc. develops, manufactures and markets a range of prescription and non-prescription products designed to treat diseases and disorders of the eye, including glaucoma, dry eye, inflammation, infection and allergy. The Company's products for the treatment of glaucoma include 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.

Lumigan is the Company's eye care product. Allergan, Inc. sells Lumigan in over 50 countries worldwide. Sales of Lumigan represented approximately 11% of the Company's total consolidated product net sales in 2006. In June 2006, the United States Food and Drug Administration (FDA) approved Lumigan as a first-line therapy. In November 2003, the Company filed a New Drug Application with the FDA for a Lumigan and timolol combination designed to treat glaucoma or ocular hypertension. In August 2004, the Company announced that the FDA issued an approvable letter regarding Ganfort, the Lumigan and timolol combination, setting out the conditions, including additional clinical investigation that it must meet in order to obtain final FDA approval. In May 2006, Allergan, Inc. received a license from the European Commission to market Ganfort in the European Union.

The Company has developed the ophthalmic solution Combigan, 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. In September 2005, Allergan, Inc. received a positive opinion from the European Union by way of the Mutual Recognition Process for Combigan in all 21 concerned member states, in which it filed. In March 2005, the FDA issued an approvable letter for its brimonidine and timolol combination, and in December 2006, the FDA issued an approvable letter for Combigan. The approvable letter outlines the remaining conditions that it must meet in order to obtain FDA final marketing approval.

The Company launched Restasis in the United States, in April 2003, under a license from Novartis for the ophthalmic use of cyclosporine. Restasis is approved in 26 countries. The Company's ophthalmic anti-inflammatory product is Acular (ketorolac ophthalmic solution) 0.5%. Its Acular LS (ketorolac ophthalmic solution) 0.4% product is a version of Acular that has been reformulated for the reduction of ocular pain, burning and stinging following corneal refractive surgery. The Company's Ocuflox/Oflox/Exocin ophthalmic solution is a product in the ophthalmic anti-infective market. It launched Zymar in the United States, which is a fourth-generation fluoroquinolone for the treatment of bacterial conjunctivitis and is approved in 21 countries. Allergan, Inc markets Alocril ophthalmic solution for the treatment of itch associated with allergic conjunctivitis.

The Company's neuromodulator product, Botox (Botulinum Toxin Type A), is used for a variety of treatments ranging from therapeutic neuromuscular disorders and related pain to cosmetic facial aesthetics. Marketed as Botox, Botox Cosmetic, Vistabel or Vistabex, depending on the indication and country of approval, the product is approved in approximately 75 countries for up to 20 unique indications.

The Company's skin care product line focuses on the psoriasis and acne markets, particularly in the United States and Canada. The Company markets Tazorac gel in the United States for the treatment of plaque psoriasis, a chronic skin disease characterized by dry red patches, and acne. It also markets a cream formulation of Tazorac in the United States for the treatment of psoriasis and the topical treatment of acne. Allergan, Inc. has also engaged Pierre Fabre Dermatologie as its promotion partner for Zorac in certain parts of Europe, the Middle East and Africa.
The Company's 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. In January 2005, it launched Prevage 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.

Medical Devices Segment

The Company develops, manufactures, and markets a diverse line of breast implants, consisting of a variety of shapes, sizes, and textures. Its 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. Allergan, Inc. markets under breast implants under the trade names McGhan and CUI.

The Company sells saline-filled breast implants in the United States and internationally for use in breast augmentation for cosmetic or revision reasons and for reconstructive surgery. It sells silicone gel-filled breast implants primarily in Europe, the Middle East, Latin America, Australia, New Zealand and Asia. In October 2006, Health Canada granted Allergan, Inc. medical device license with conditions to sell and market silicone gel-filled breast implants, including its 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 its round silicone gel-filled breast implants for breast augmentation. FDA approval was conditioned on the Company's continuation of its core clinical study and its pre-clinical studies, completion of a focus group study regarding format and content of patient labeling, distribution of labeling to physicians and patients within sufficient time prior to surgery to fully consider the risks associated with breast implant surgery, termination of new enrollment into an adjunct study, and continuation of follow-up for enrolled patients and its 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. The Company sells a line of tissue expanders for breast reconstruction and as an alternative to skin grafting to cover burn scars and correct birth defects. The Company develops, manufactures, and markets dermal filler products designed to improve facial appearance by smoothing wrinkles and scars and enhancing the definition of facial structure. Its primary facial aesthetics products are Zyderm and Zyplast, CosmoDerm and CosmoPlast, the Juvéderm/Hydrafill/Surgiderm product range, the Hylaform product range and Captique. The Company's product Juvederm is a non-animal based, cross-linked hyaluronic acid-based dermal filler, and is indicated for wrinkle correction, facial contouring and lip enhancements. In June 2006, the FDA approved the Juvederm dermal filler family of products, and in September 2006, the Company launched the next-generation hyaluronic acid-based dermal filler products, Juvéderm Ultra and Juvéderm Ultra Plus through an experience trial with a group of physicians with expertise in facial aesthetics. Captique dermal filler is a non-animal stabilized hyaluronic acid injectable product indicated for the correction of moderate to severe facial wrinkles and scars.
The Company develops, manufactures, and markets several devices for the treatment of obesity. Its 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. Allergan, Inc also sells the BIB 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 BIB 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.

Contigen is the Company's collagen product used for treatment of urinary incontinence due to intrinsic sphincter deficiency. The Company also provides other collagen products for use by other medical manufacturers.

The Company competes with Alcon Laboratories, Inc. Bausch & Lomb, Pfizer, Novartis Ophthalmics, Merck & Co. Inc. Sanofi-Aventis, Galderma, Medicis, Stiefel, Schering-Plough Corporation, Johnson & Johnson, Ethicon Endo-Surgery, Inc.

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Benadryl (Allergan) Delivery

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