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Allergan rallies fat fighters, doctor chills

Allergan launches political campaign to help overweight citizens

The maker of Botox and the Lap-Band weight-loss stomach band has launched a campaign seeking a change in people’s attitude about obesity — from thinking of it as a moral failure to understanding it as a disease.

Irvine-based Allergan is also urging people to petition Congress for legislation to expand insurance coverage of weight-loss options such as the adjustable Lap-Band.

“There’s more than a principle at stake for Allergan. The Lap-Band is mostly not covered by health insurance in the U.S. As it costs about $14,000 out of pocket, only the wealthy can get it,” says the online CBS business network BNET in the article “Why Allergan Is Turning a Surgical Device Into a Political Cause.”

In the campaign, which it launched last week, Allergan wants people to get involved through:A contest for the best essays and videos describing the effects of a Lap-Band. Winners will get a free trip to Washington, D.C., to lobby for the cause. Read more

               

Earnings Preview: Allergan

Allergan (AGN) is expected to report Q1 earnings Friday, April 30 before the market open, with a conference call scheduled for 9 am ET.

Guidance

Analysts are looking for EPS of 60c on revenue of 1.11B. The consensus range is 58c-66c for EPS, and $1.07B-$1.18B for revenue, according to First Call. In early February the company gave Q1 EPS guidance of 57c-59c. At the time the EPS consensus estimate for Q1 was 68c. Botox sales may have strengthened as a result of the economic recovery and a rebound in discretionary consumer spending. Another positive for Q1 is seen coming from Latisse, a drug that has been found to enhance eyelash growth. Ophthalmic drugs should also be a positive driver for Allergan in Q1. Possible negative pressures this quarter may be seen coming from Dysport competing for Botox sales.

Analyst Views

On April 19, Goldman Sachs upgraded Allergan to Conviction Buy from Neutral.

Source:  http://seekingalpha.com/article/201757-earnings-preview-allergan

               

To Take on Botox, Rival Tries Rebate

Allergan and Medicis Pharmaceutical are the Coke and Pepsi of vanity medicine. Medicis Pharmaceuticals is turning aggressive in its marketing, offering $75 off treatments with the wrinkle drug Dysport.

Allergan makes Botox Cosmetic, the well-known injectable anti-wrinkle treatment. Medicis markets Dysport, a competing anti-wrinkle shot, in the United States. The Food and Drug Administration has approved both drugs to smooth skin furrows between the eyebrows.

And now Medicis has introduced a new marketing campaign that pits Dysport directly against Botox, essentially issuing a Pepsi challenge for the wrinkle wars. The campaign is even called the Dysport challenge.

Medicis is offering more than rebates on its own product. For customers who feel unsatisfied after trying Dysport, the company is also offering a rebate on a treatment with Allergan’s Botox. Read more

               

Allergan Celebrates 20 Years of Approved Use of Botulinum Toxin Type A (BOTOX(R)) in Canada

Twenty years ago, the first approved use of BOTOX(R) (botulinum toxin type A), a neurotoxin widely used to treat several life altering medical conditions, was granted in Canada. As part of the 20th anniversary celebrations, healthcare professionals from coast to coast reflect upon the discovery, science and evolution of a therapy that has impacted the lives of millions of patients worldwide.

BOTOX(R), a purified protein derived from the naturally-occurring bacterium Clostridium botulinum, was first approved by Health Canada on March 14th,1990 for the treatment of strabismus (crossed eyes), blepharospasm (uncontrollable blinking), and VII nerve disorder.(1) Other approvals for the medical uses of BOTOX(R) soon followed and included:

–  To reduce the subjective symptoms and objective signs of cervical
    dystonia (muscle contractions in the neck) on March 29th, 1995;
–  For the treatment of dynamic equinus foot deformity due to spasticity in
    pediatric cerebral palsy in patients two years of age or older on July
    7th, 1999;
–  For the treatment of hyperhidrosis of the axilla (excessive underarm
    sweating) on August 31st, 2001; and
–  In the management of focal spasticity (muscle tightness that can affect
    multiple areas of the body) on October 24th, 2001.(1) Read more

               

Opponents of Botox Tax Go Big: Baby Boomers! Women!

The Senate  health care bill’s 5% tax on elective cosmetic procedures (breast implants, Botox wrinkle treatments, etc.) is drawing opposition from predictable quarters: Cosmetic surgeons and companies that sell products used in cosmetic procedures.Allergan, which sells Botox, took a civil rights angle: The tax “discriminates against women,” the company said in a statement. Some 86% of cosmetic surgery patients are working women ages 35-50, with an average annual income of $55,000 per year, according to Allergan.

“What’s next? Are we going to tax people who color their hair?” the CEO of Medicis, a drug company that sells fillers, told Dow Jones Newswires. Read more

               

Pharma bracing for tougher FDA guidance on trials

Transparency welcomed, but threat of added costs creates concerns.

Pharmaceutical companies in New Jersey and elsewhere face more stringent requirements from the Food and Drug Administration on disclosures of mishaps in clinical trials.

And while industry groups and advisers have broadly welcomed the increased transparency and the move toward safer drugs, they want these actions to strike a balance with the costs of complying with them.

As of Sept. 27, the FDA requires drug manufacturers to include the general public in disclosures on “adverse” and “serious adverse” events beyond the regulator and patients participating in trials, said Satish Tadikonda, president of Virtify Inc., in Cambridge, Mass., which provides compliance services to life sciences companies.

Adverse events are side effects like rashes or headaches, while serious adverse events are those that result in death, disability or life-threatening situations, among others, Tadikonda said. Read more

               

Drug Maker Sues FDA Over Ban on Offering Doctors Info About Off-Label Uses

The makers of Botox filed a lawsuit last week against the FDA, challenging federal regulations that ban drug companies from marketing drugs for uses that they have not been established as safe and effective through the FDA approval process.

Allergan Inc. filed the complaint Thursday in the U.S. District Court in Washington, D.C., saying that the FDA’s ban on “off-label” drug promotion by pharmaceutical companies violates their first amendment rights to free speech. The ban restricts Allergan from offering information about off-label use of Botox, an antiwrinkle drug that is used by many doctors for unapproved uses, such as treatment of muscle spaticity in children with cerebral palsy.

Although doctors are allowed to prescribe medications for non-approved uses, drug makers are prohibited from marketing those applications. Allergan says that the ban is unconstitutional and prevents them from offering truthful information and other data that could help doctors prescribe the drugs effectively and safely. Read more

               

New developments in Botox

Kohala Coast, HI — When giving botulinum toxin type A (Botox, Allergan) to patients, dermatologists should tell them that it “relaxes the muscles temporarily. Let’s not say ‘paralyze’,” said Susan Weinkle, M.D., at the Winter Clinical Dermatology Conference.After offering that tip, which she said will relax patients and make them feel more comfortable about the procedure, Dr. Weinkle highlighted the pharmacology of Botox and how thought about its stability has changed throughout the years. Read more

               

FDA Approves LATISSE

New Prescription Product Increases Length, Thickness and Darkness of Eyelashes

Allergan, Inc. (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) has approved LATISSE^(TM) (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes. LATISSE^(TM) is the first and only science-based treatment approved by the FDA to enhance eyelash prominence as measured by increases in length, thickness and darkness of eyelashes. Read more

               

FDA Wants Stronger Warning for Dermal Fillers

Product labels on popular cosmetic wrinkle fillers should be strengthened to warn consumers about scarring and other problems that can crop up weeks or years after receiving the treatments, a Food and Drug Administration panel said November 18, 2008.

The panel said current product labels on fillers approved to plump certain facial lines are inadequate and only discuss immediate and temporary side effects, such as swelling. While an FDA review of reported adverse events associated with dermal fillers showed many expected side effects like temporary swelling and redness, the agency said “there are a number of adverse events that are serious and unexpected.” Read more

               

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