Key Developments: Allergan Inc (AGN)
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23 May 2013
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Latest Key Developments (Source: Significant Developments)
L'Oreal SA Loses EU Trademark Battle to Allergan Inc's Botox-Reuters
Reuters reported that L'Oreal SA has lost its bid to keep a cosmetics trademark with Europe's highest court ruling it could not use the Botocyl mark as it would be riding on the coattails of Allergan Inc's Botox brand name. The Luxembourg-based European Union Court of Justice (ECJ) also rejected on the same grounds arguments by L'Oreal's Helena Rubinstein brand to keep its Botolist trademark. Full Article
Allergan Inc Receives Subpoena Over Its Anti-Obesity Device-Reuters
Reuters reported that Allergan Inc, has received a subpoena from the U.S. government over its gastric banding system that is used to treat obesity. In a filing with the U.S. Securities and Exchange Commission (SEC) on Monday Allergan said the subpoena from the Department of Health and Human Services, Office of the Inspector General, requests the production of documents relating to its Lap-Band gastric banding system. In December the U.S. Food and Drug Administration sent warning letters to eight California surgical centers and a marketing firm for providing misleading information while advertising Lap-Band. The adjustable gastric banding system reduces the amount of food that a person's stomach can hold at one time, and would help in gradually reducing body weight. Allergan did not provide further information on the subpoena in its filing. The Lap-Band system was approved by the FDA for use in the United States in 2001. Full Article
Allergan Inc Issues Q2 2012 Guidance Below Analysts' Estimates
Allergan Inc announced that for the second quarter of 2012, it expects total product net sales between $1.450-$1.500 billion. Non-GAAP diluted earnings per share (EPS) of between $1.04-$1.06. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $1.511 billion and EPS of $1.08 for the second quarter of 2012. Full Article
Allergan Inc Announces Positive Top-Line Results From Phase III BOTOX Overactive Bladder Program
Allergan Inc announced that two Phase III clinical trials of BOTOX (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Results from both Phase III clinical trials demonstrate that BOTOX significantly reduced urinary incontinence (bladder leakage) episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment. The full study results of the North American Phase III study are expected to be presented at an upcoming medical meeting. Based on the results of the two Phase III clinical trials, Allergan has submitted a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) and an application with European Regulatory authorities seeking approval for the use of BOTOX as treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. BOTOX is currently approved in the United States and in several European countries for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. Full Article
Allergan Inc Receives Favorable Rulings Against Merz In Litigation In Spain And Germany
Allergan Inc announced that in addition to the U.S. ruling, Allergan prevailed last week in two separate cases that were filed against Merz in Europe. In Germany, the Hamburg Regional Court ruled that Merz is prohibited from claiming a 1:1 dose equivalent ratio between units of Allergan’s BOTOX (onabotulinumtoxinA) and Merz’s Xeomin, which is in line with a prior decision of that Court in December 2011. In Spain, Merz was found to be in breach of the Spanish Pharmaceutical Code for referring to a conversion ratio without, at the same time, making an express warning about the fact that the unit doses are not interchangeable. Full Article
U.S. Federal Court Finds In Favor Of Allergan Inc And Issues Permanent Injunction Against Merz Pharmaceuticals And Merz Aesthetics
Allergan, Inc. confirmed that U.S. District Judge Andrew J. Guilford, after conducting a full trial, ruled that Merz Pharmaceuticals and Merz Aesthetics violated California’s Uniform Trade Secrets Act and issued a permanent injunction against them. In a written decision, Judge Guilford concluded that Merz misappropriated important trade secrets belonging to Allergan, including “the specific identities and financial details (including sales targets, actual sales amounts, and product volumes over time) of Allergan’s relationships with virtually all of its physician customers in the United States for BOTOX® Cosmetic (onabotulinumtoxinA) and JUVÉDERM and a large segment of Allergan’s physician customers in the United States for BOTOX (for therapeutic indications).” The court also found that Merz misappropriated “Allergan's strategic marketing plans, including its plans to address competition from Merz Aesthetics and Merz Therapeutics. The value of this information is incalculable.” The court concluded that the injunction, which prohibits Merz from, among other things, selling or soliciting purchases of their product, Xeomin, in the facial aesthetics market for 10 months, was necessary to serve the public interest. As the court noted, "the right of free competition does not include the right to use the confidential work product of others." Full Article
ACADIA Pharmaceuticals Announces Extension Of Drug Discovery Collaboration With Allergan, Inc.
ACADIA Pharmaceuticals announced that it has extended its drug discovery and development collaboration with Allergan, Inc.. The collaboration is currently focused on the discovery of new therapeutics for glaucoma and other ophthalmic indications and was originally established in March 2003. The research term of this collaboration has now been extended by the parties for an additional year through March 2013. ACADIA also has two other collaboration agreements with Allergan, which have led to clinical programs in the areas of chronic pain and glaucoma. During the extended term of the collaboration agreement, the parties will jointly pursue research in the area of ophthalmology. Allergan is entitled to exclusively license specified chemistry and related assets for development and commercialization. ACADIA will receive research funding and is eligible to receive license fees and milestone payments upon the achievement of agreed-upon clinical and regulatory objectives as well as royalties on future product sales, if any, worldwide. Full Article
Allergan Inc Issues Q1 2012 Guidance; EPS Guidance Below Analysts' Estimates-Conference Call
Allergan Inc announced that for first quarter of 2012, product net sales to be in the range of $1.340-$1.390 billion and non-GAAP diluted earnings per share (EPS) to be $0.84-$0.86. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $1.376 billion and EPS of $0.90 for first quarter of 2012. Full Article
Allergan Inc Declares Fourth Quarter Dividend
Allergan Inc announced that its Board of Directors has declared a fourth quarter dividend of $0.05 per share, payable on March 16, 2012 to stockholders of record on February 24, 2012. Full Article
Allergan, Inc. Declares Third Quarter Dividend
Allergan, Inc. announced that its Board of Directors has declared a third quarter dividend of $0.05 per share, payable on December 1, 2011 to stockholders of record on November 10, 2011. Full Article
Allergan delays drug that would rival Regeneron's Eylea
- Allergan Inc said approval of its Darpin eye drug could be delayed up to two years, providing a new boost to Regeneron Pharmaceuticals Inc whose successful treatment, Eylea, stands to gain from a lack of new competition.

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