Allergan: $600 Million Poorer, but Closer to New Botox Uses

Sounds like Allergan may have been getting a little greedy and got busted....

Allergan, the maker of Botox, will pay $600 million in fines and civil settlements after pleading guilty to marketing their product for uses for which it hasn't been FDA approved.

The Justice Department accused Allergan of encouraging doctors to use the powerful neurotoxin through kickbacks and by teaching them how to forge drug reports.

"The FDA had approved therapeutic uses of Botox for only four rare conditions, yet Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by the FDA," U.S. Attorney Sally Yates explained.

Botox is most famous for its use by dermatologists to temporarily diminish the appearance of facial wrinkles, but the drug, which is scientifically known as Botulinum toxin and works by temporarily paralyzing nerves, has been approved for rare conditions like eye muscle spasms since 1989.  In March, the FDA approved Botox use to treat muscle spasms in elbow, wrist and finger injuries among adults.

According to the suit, Allergan paid doctors millions and taught them how to miscode the drug to avoid being caught, all so that they would use Botox for "off-label" treatments – uses for which it has never been approved, though it may be effective. Botox was promoted for migraine relief and juvenile cerebral palsy, for which observational data suggests it is effective.

When a drug has been approved for a certain medical use, it cannot be marketed to treat other uses, even if patients report those other uses as a side benefit. Still, marketing drugs for side benefits is common. In 2008, Bayer ran afoul of the FDA when it over-emphasized the acne reducing benefits of its popular birth control pill, Yaz.

Though off-label usage is legal and often beneficial for patients, it can be dangerous. In April 2009, after repeated reports of side effects among children with cerebral palsy that mimicked botulism poisoning, the FDA ordered Botox to carry "black box labeling," the strictest possible warning for a product.  Doctors reported respiratory problems, muscle weakness, loss of bladder control and double vision among their young patients, along with hospitalizations.

Currently, the FDA is reviewing Allergan's application to approve Botox for migraine headaches. The agency is not reviewing information on juvenile cerebral palsy and no known tests are in the works, though CBS is reporting that Botox is being tested in countries like India, Poland, Serbia and Turkey for a host of ailments, including Parkinson's disease, spinal cord injuries, excessive perspiration, depression and something called "curvature of the penis."

If any of these studies abroad provide conclusive data, they could potentially spur bids for approval of new uses of Botox in the United States.

Zinc & Phytase As Botox Supplements?

In one of the emails I received today I was asked about an article in which Dr. Charles Soparkar claims that using Zinc and Phytase as Botox 'suppliments' increase how long Botox treaments last.

Evidently, Dr. Soparkars findings shows this combination improves the results of Botox injections when taken four days before treatment.

Oculoplastic surgeon Dr. Charles Soparkar found that 41 of the 44 patients to whom he gave the zinc and phytase pairing displayed a better outcome. This was especially noticeable in those suffering from blepharospasm, a form of eyelid twitching.

As a result of his findings, Dr. Soparkar plans to market a dietary supplement combining the element and enzyme, which will be called Zytaze.

"Surprisingly, the results showed that in over ninety percent of the patients studied, the zinc/phytase combination resulted in a remarkable improved responsiveness ... using the same amount of botulinum toxin as previously used," Dr. Soparkar explained. "The toxins seemed to have greater effect and last longer. Potentially, this could mean using less toxin, offering patients financial savings, greater safety, and more consistent results."

Always makes me a little leary when a new study gives someone the idea to create a product offering exactly what the study promotes.

Has anyone else heard of this? Anyone already promoting this for their Botox treatments?

Botox From China. It Play Good.

Get your Botox from China.
Then get yourself a good lawyer.

Look, I'm not in the habit of bashing anyones' second language skills considering my own inadiquacies with Japanese, French and German, but if you're going to be soliciting business in a country and promoting illegal activities, you'd better have a slicker pitch that this one for 'Botox from China'.

I get these pretty regularly now; pitches from China for Botox substitutes or cosmetic lasers and IPLs. It's interesting that they're using Gmail for their 'corporate correspondence'.

Here's the Botox from China email I just received:

Christina
christina.biochem@gmail.com
Subject: Anti- Aging and skin care products based on HA ( Dermal filler,Botox,HA cream,etc)
Message: Dear friend,

I get your information on your website and find that you are engaged in non-surgical cosmetic and aesthetic medicals.

I would like to introduce our company and products with hope to get a chance to establish business relationship with you in the future.

We can supply the botox in 150iu. It play good in contouring facial lift.

Besides,we are also the manufacturer of hyaluronic acid filler. I have fillers in 10.000, 100.000, 200.000 particle in 1ml for deep,medium and fineline wrinkles. It also play good in nose augmentation, chin enhancement. We do not only have 20mg/ml fillers. We also have 25mg/ml one. And it do better for nose augmentation and chin enhancement.

We adopt BDDE cross-linked technology from Germany,the quality and lasting period is long and good. And our three plants are up to GMP standard.

So at first time we do not have minimum order limit in order to let you know my products.

We will delivery the products  immediatly by DHL express after we received the payment of the goods.

Should you have any questions or problems,pls let me konw freely.

We look forward to building up very good business ships based on mutual benefits.

Best quality, competitive prices & pleasant reputation are our Aim.

Have a wonderful day.

Thanks and best regards,
Christina
Qufu Haitao International Trading Co.,Ltd
Add:No.1 Guangming Road QuFu Tour & Economic Development Zone, QuFu
ShanDong, China

I don't know anyone that's ever used this kind of product... scratch that. I do know one physician who 'ordered' some of that cheap lab-animal botulism product that some doctors got in trouble with a few years ago. Of course he claims that he never used it on a patient.

Injecting with fake Botox substitutes from China is usually reserved for the wacko 'I learned to inject myself with fake Botox on YouTube' crowd, not medical practices, but It's obviously working at least a little bit if the frequency that I'm being contacted is any indication.

Is anyone else receiving these kinds of pitches?

Botox News: Allergans Profits Jump 36%

Botox continues to be a golden child for Allergan, but there are a number of other products that are bolstering the drug giant's sales.

Allergan, and most especially Botox, is always on my radar... Since we opened the first medical spa back in 2000, I'm sure that we've put more than one of Allergan's sales reps into a new house. (Perhaps not, I'm not really sure what Alergan's sales reps make.)

While there Medial Spa MD's physician members who are in a position to take advantage of our Select Partners have less expensive ways to get Botox than paying sales commissions, Allergan certainly still takes the lion's share of the profits from most Botox treatments that are performed. Botox has become something of a commodity, with almost every medical spa and laser clinic (and a few day spas) offering it.

For those of you who are interested in the Botox Behemeth's contnued rise, I give you the following compiled from their latest earnings report.

Allergans second-quarter earnings soared 36% with accelerating sales spurred on by their cosmetic products. There have also been recent developments that mark progress toward FDA approval to sell Botox injections to treat migraine headaches.

Allergan said the FDA has asked the company for certain material, such as a modified Botox "risk evaluation and mitigation strategy" that includes information about thepreventive treatment of migraines. Allergan has 3 months to provide the information. Allergan says it continues to expect an FDA answer this year.

Evidently wall street liked the news... especially the rising Botox sales since shares of Allergan traded up 5.4%. The company also raised its 2010 sales estimate for Botox. (Allergan posted total Botox sales of $1.31 billion last year, split evenly between cosmetic usage and various medical treatments.)

Allergan's total revenue rose 10% to $1.25 billion with double-digit gains in both its specialty pharmaceutical and medical device businesses. (Facial aesthetic products wer up 32% and skin-care products up 40%.)

Allergan's second quarter "benefited from a continued recovery in our cash-pay aesthetics business around the world," said Pyott said in a company press release.

Botox sales rose 7% in the quarter to $360.5 million. Looking ahead, Allergan said it now believes the drug will post sales of $1.36 billion to $1.39 billion this year, which compares with a forecast in February for $1.33 billion to $1.37 billion.

It dropped its forecast for the eyelash-enhancing drug Latisse, however, to a range of $90 million to $100 million, down from February's $140 million target. A big issue is that consumers have learned to stretch their supplies, which means Allergan has to figure out how to broaden the market to offset that effect.

Allergans Outlook For the full year of 2010

Total product net sales between $4,620 million and $4,750 million.

Total specialty pharmaceuticals net sales between $3,835 million and $3,930 million.

Total medical devices net sales between $785 million and $820 million.

• ALPHAGAN  franchise product net sales between $370 million and $390 million.
• LUMIGAN  franchise product net sales between $490 million and $510 million.
• RESTASIS  product net sales between $580 million and $600 million.
• SANCTURA  franchise product net sales between $70 million and $80 million.
• BOTOX  product net sales between $1,360 million and $1,390 million.
• LATISSE  product net sales between $90 million and $100 million.
• Breast aesthetics product net sales between $290 million and $300 million.
• Obesity intervention product net sales between $235 million and $250 million.
• Facial aesthetics product net sales between $260 million and $270 million.
• Non-GAAP cost of sales to product net sales ratio between 15.5% and 16.0%.
• Other revenue at approximately $50 million.
• Non-GAAP selling, general and administrative expenses to product net sales ratio between 39% and 40%.
• Non-GAAP research and development expenses to product net sales ratio between 15% and 16%.
• Non-GAAP amortization of acquired intangible assets at approximately $20 million. This expectation excludes the amortization of acquired intangible assets associated with the Inamed, Cornéal, EndoArt, Esprit, Samil and Serica acquisitions and the ACZONE(R) asset purchase.
• Non-GAAP diluted earnings per share attributable to stockholders between $3.11 and $3.15.
• Diluted shares outstanding between approximately 307 million and 308 million.
• Effective tax rate on non-GAAP earnings at approximately 28%.

For the third quarter of 2010, Allergan expects:

Total product net sales between $1.13 billion and $1.18 billion.

Medical Spa Horror Stories: Woman Dies From Silicone Butt Injections

Illegal medical spas and filler injection services are up and running, and actually killing people.

If it weren't bad enough that there are websites marketing "do it yourself Botox injections" and "filler injection kits" for home use, there are still people out there who are willing to go to a motel room and have non-physicians inject them will industrial silicon.

Two sisters who were selling Botox, filler injections, and butt augmentation in motel rooms are now on the run. Police say they performed illegal cosmetic surgery from inside their residential home and are the cause of one woman’s death.

Some of their patients (victims) went to police after experiencing infections and hardened body parts after receiving silicon injections. One woman, 22-year-old Mayra Lissette Contreras, would die from respiratory failure a day after getting some silicone shots in her buttocks. The sisters were arrested and charged with practicing medicine without a license but were released on bond and have probably fled to Mexico (see below). 

There's always plenty of  smartass advice to give to anyone who may ever contemplate injecting themselves with fake botox or getting cosmetic surgery while bent over someone’s kitchen counter, but I just couldn’t do better than the advice given by by Deputy Chief Kirk Albanese. “If you are receiving an injection at a home in a residential area, that should be the first warning sign that you shouldn’t be there.” But I will add that whether or not a facility is residential or not,  it’s normally not a good idea to receive cosmetic treatment from a 50-year-old woman who looks like a creature commonly seen in movies being chased around by villagers with pitchforks.

Sisters sought after woman dies from silicone butt injections

Sisters Guadalupe Viveros, left, and Alejandra Viveros, above, allegedly ran an illegal cosmetic filler injection service and squirted silicon into anyone with a check book.

Guadalupe Viveros, 53, and Alejandra Viveros, 50, may have fled the country after Mayra Lissette Contreras, 22, of Pacoima died Friday after receiving the injection, police said. An autopsy was pending Wednesday, said Ed Winter of the Los Angeles County coroner's office. Initial reports indicated that Contreras died from respiratory distress.

The Viveros sisters were investigated last month by the Los Angeles Police Department after other patients complained that the fillers, typically injected in the face or the buttocks, made them ill. The sisters were taken into custody June 21 for practicing medicine without a license, police said. They were held on $20,000 bail before being released.

They were supposed to be arraigned on Monday, but they skipped their arraignment. Police realized that they are probably on the run, and since the two women have connections in Mexico, authorities suspect they have fled south.

Police say the Viveros sisters are not doctors. Neither is licensed to perform medical procedures in the United States.

They have been allegedly operating an illegal cosmetic surgery business and performing expensive procedures in their home rather than in a licensed operating room, cosmetic clinic or doctor`s office. Patients told police they developed infections and said the silicone used by the sisters turned to hard plastic once inside their body.

LA police are searching for these two women and believe they could be in Mexico. People with information on their whereabouts as well as victims are asked to come forward and contact the Los Angeles Police Department.

LA Times article

And if you thought this was a one-of-a-kind event...

San Diego transgender woman dies after illegal silicone injections.

A 45-year-old transgender woman who received illegal silicone injections at a party in a private home in San Diego has died after nearly a month on life support, the county medical examiner said on Monday.

Patricio Gonzalez, who police said received silicone injections to her hips, buttocks, cheeks and lips, died on Sunday. Gonzalez and at least nine other people were injected at a so-called "pumping party" on June 19, police said.

"Pumping parties," where people seeking a more feminine appearance have silicone injected into their bodies, have been on the upswing in the last few years, experts say. The silicone used at the parties is often industrial-grade material like floor sealant.

The Food and Drug Administration banned direct injections of silicone in 1992 and the substance has been known to migrate within the body and cause chronic, degenerative illnesses.

Gonzalez and another transgender woman received more silicone than the other party guests and suffered immediate respiratory problems, prompting the Los Angeles-area woman who was administering the silicone to flee, police said.

Police have issued an arrest warrant for Sammia "Angelica" Gonzalez, 39, who was injecting the party guests with silicone, is believed to have fled to Mexico.

Transgender women often have humiliating experiences with traditional surgery clinics, and surgeons often require a psychological exam before they will consider treatment.

Article

Botox Effects Beyond the Obvious

US researchers suggest that people who have undergone Botox treatments not only change their appearance but may also have a weakened ability to experience emotions.

Joshua Davis from Columbia University in New York wrote about their findings in a paper published online in the journal Emotions this month.  Although it has been over a century since William James, an American pioneer of psychology proposed a theory of emotion that stated unless it can be expressed physically in the body it doesn't really exist, nowadays referred to as the facial feedback hypothesis (FFH), attempts to test it have been inconclusive.

That is until Botox (and presumably Dysport) came along, because it paralyzes face muscles used to express emotion (thus reducing wrinkles) and so you can use it to test FFH by comparing its effect with that of a cosmetic filler that does not affect facial muscles: this is essentially what the researchers did.

With the advent of Botox, it is now possible to work with people who have a temporary, reversible paralysis in muscles that are involved in facial expressions," Davis reports. 

A person who has received treatment with Botox can respond to an emotional event, for instance a sad scene in a movie, but their facial muscles will be less active, and this sends less feedback to the brain about what the face is expressing.

It thus allows for a test of whether facial expressions and the sensory feedback from them to the brain can influence our emotions," explained Davis who said Botox enabled them to design a study where they could "isolate the effects of facial expression and the subsequent sensory feedback to the brain that would follow from other factors, such as intentions relating to one's expressions and motor commands to make an expression".

For the study, Davis examined two groups of participants: one received Botox treatment and the other, the control group, received Restylane, a cosmetic filler that does not paralyze facial muscles.The participants filled in questionnaires about their emotional experiences to watching positive and negative video clips before and after treatment.

The researchers wrote that results from the Botox group showed no changes between the pre- and post-treatment emotional responses to the most positive and negative video clips, but when they compared the two groups they found that the Botox group showed an overall "significant decrease" in the strength of emotional experience.

This seems like pretty bogus info to me but you never know. It always makes me leary when there's press around terms like 'significant decrease'.

Of course, there's also this; 

A new study by the US Association for Psychological Science has found that the anti-wrinkle treatment, which works to smooth fine lines by paralyzing muscles in the face, actually has an effect on the brain as well, reports London’s Telegraph.

40 volunteers in the study, done by researchers from the University of Wisconsin, were evaluated both before and after having Botox injections. Their response time was recorded as they read a series of statements out loud, with content ranging from "angry" to "sad" to "happy."

The study found that the subjects took longer to read the more "negative" passages after the injections than before. Researcher David Havas told the Telegraph this delay was small but critical because it implies that the brain was processing the negative emotion more slowly after the drug's injection.

"Normally, the brain would be sending signals to the periphery to frown, and the extent of the frown would be sent back to the brain," explained research leader Professor Arthur Glenberg. "But here, that loop is disrupted, and the intensity of the emotion and of our ability to understand it when embodied in language is disrupted."

In other words, when your face stops frowning, your brain gets the message that you've decided there's less to frown about.

"There is a long-standing idea in psychology called the facial feedback hypothesis," Havas told the Telegraph, who believes the new study shows that, "When you're not frowning, the world seems less angry and less sad."

So does this mean that those getting Botox not only have smoother faces than their Botox-free friends but are happier too?

Not necessarily. A study published earlier this year in the Journal of Cosmetic Dermatology found that when injections of Botox are used to paralyze some facial muscles, other nearby muscles have to work overtime to compensate, creating even more lines in the face.

Pretique: Newest DIY Fake Botox Fraud Site

There's at least one new site dispensing fake Botox, dermal fillers, tanning injections, chemical peels and even Lidocane kits.

Pretique Cosmetics is selling all of this and more.

Could this get any worse? Are there really idiots out there who would knowingly buy who-knows-what from a sleazy website and inject themselves with it? This is the same kind of fake Botox that Discount Medspa was selling before they got shut down.

Part of me is just angry that this kind of blatant fraud is even possible. The only thing that they're selling on is price so it's a safe bet that the women most being hurt by this are those least able to afford real medical care.

Pretique Medspa Fake Botox & Dermal Fillers Scam Site

Here's what Pretique says about themselves while quoting nameless 'research studies':

We are North America's #1 Supplier of Pretique® 'Botulinum Type A Cosmetic . These treatments provide very little pain with amazing results.

For over a decade Allergen has been the only company to provide these treatments, but Pretique has changed that, and that change is a very good thing Now you have a choice with Pretique  and best of all its available without a prescription.

Pretique is reported to take effect a little quicker than Allergens and in some reports is stated to last a little longer.

While the list of "fillers" has grown long in the past few years, Botox has never really had any competition.  A limited variety of creams have purported to be "better than Botox."  But, you know what?  They aren't.

What is Pretique?

For years, Pretiquehas beenused safely and effectively.  In recent head-to-head tests -- it has already confirmed Pretique efficacy.

Having digested many of these research studies, we must say that we are excited

• In all studies, Pretique has worked (just like Allergen's Botox)!

• And have identified no significant red flags for Pretique.  No allergies.  No untoward infections.  (Same is true for Botox. Both appear to be very safe medications.)

• In some studies, Pretique has not lasted as long. (And the biggest downside to Botox is that it lasts only 3-4 months.)

Here's Pretique's pitch to get you to buy Lidocane so you can't feel what you're doing to yourself when you're squirting their 'fillers' into your lips.

Of course this is the Pretique Medspa warrantee:

Disclaimers

YOUR USE OF THIS SITE IS AT YOUR RISK. THE INFORMATION, MATERIALS AND SERVICES PROVIDED ON OR THROUGH THIS WEB SITE ARE PROVIDED "AS IS" WITHOUT ANY WARRANTIES OF ANY KIND.

This websitedoes not assume any responsibility for any damages arising from use of products on this website...

Thanks to Pat Monroe RN for outing these guys.

Update on 2012-12-12 17:49 by Medical Spa MD

We contacted a pharmacy and asked if they knew anything about Pretiques Med Spa. This was their reply:

These are the kind of people everyone needs to stay away from and are definitely not legit despite what they might tell anyone. I checked it out and their actual info is:
 
 Name: Pretiques Med Spa 
 Phone: (403) 984-8969 
 Address: 11081 Macleod Trail S
  
Calgary, AB T2J 5N8 
 
The generics they are offering are definitely not from Canada, as they are not on the market here and likely are from China. The address I listed above may very well not even be real, but that is what I found.

Botox and the 80/20 rule

Are you happy with your Botox Rep?

I posted a while ago about  our dissapearing Botox sales rep.

Someone who appears to be an Allergan rep responded with the following:

Maybe your practices were not bringing in a large amount compared to the rep's quotas. We rate offices from A-Z and if you are C and below...I don't bother call on that office. 80/20 rule and so far it's been working. President's club 3 out of the past 5 years and great bonuses. Don't take it personal, but it makes sense to serve the offices who have the greatest potential in serving us. If my quota is 100 and your potential is only 5, I'm skipping you to talk to the next 5 doctors who have a potential to do 100 on their own and blow out my quotas.

So take no offense. These guys have Botox quotas of their own and I'm guessing that commission is a prime motivator. If you're not ranked as an A or B by Allergan (and I guess it goes all the way down to Z), you might just be on your own.

Anyone switching to Dysport?

DIY Botox Injections

The do-it-yourself DIY Botox movement must be stronger than I though.

Evidently there are a large number of women who aren't put off by the though of injecting themselves with a paralytic. I guess these women are not needle-phobic either.

According to a web based poll, an English beauty site found that more than one in five women would conduct DIY Botox but only 11% would dare to cut their own hair.

Taking at-home do-it-yourself cosmetic medical treatments to a scary level, according to the poll of 1,356 UK women by www.goodsurgeonguide.co.uk,  22% would consider injecting their own face or forehead with a do it yourself Botox kit.

53% said that the decision to have Botox could be influenced by word of mouth.

78% of women would rather have liposuction surgery to lose weight than diet and exercise.

34% of women want liposuction but not sure if they want laser liposuction.

Oklahoma Botox Case: Allergan loses $15 million judgement

Allergan lost a a$15 million dollar award to a physician who evidently had her 'friends' testify that she got botulism from Botox injections for wrinkles.

A jury Tuesday awarded $15 million to an Oklahoma City doctor who said she suffered botulism poisoning after using the popular anti-wrinkle drug Botox.

The Oklahoma County jury found 9-3 that Allergan Inc., the maker of Botox Cosmetic, was negligent. In civil cases, at least nine jurors must agree.

Jurors voted 10-2 to give Dr. Sharla Helton $15 million in actual damages. They did not award punitive damages.

"Hopefully, now people will wake up to the real dangers,” Helton, 48, said of the negligence verdict. "It’s a stepping stone for now for public awareness.”

Her attorney, Ray Chester, of Austin, Texas, said, "I think there’s a lot of people out there that have been hurt by the product and maybe now they’ll have the courage to come forward.”

Allergan that produces Botox plans to appeal.

"The negligence verdict … is inconsistent with all credible scientific and medical evidence,” said a company spokeswoman, Caroline Van Hove. "Botox does not cause botulism.”

Helton complained of severe side effects after getting injections of 50 units of Botox Cosmetic on July 14, 2006. It was her fifth treatment for wrinkles. She eventually sold her medical practice and stepped down as medical director of Lakeside Women’s Hospital in Oklahoma City because of pain and weakness.

Attorneys for Botox told jurors the drug does not cause botulism. They also told jurors the doctor never had botulism. They said the diagnosis of botulism came from her friends, who are not experts.

The trial took three weeks. Jurors were deadlocked 8-4 at one point Monday night after hours of deliberations. They deliberated about three hours more Tuesday.

The jury found Tuesday in Allergan’s favor on a second claim against it – that its product was somehow defective.

A key issue in the trial was whether Allergan gave sufficient warning in product labeling about possible problems from Botox Cosmetic use. The labeling in 2006 did not include botulism.

"All they care about is sales,” Chester told jurors in closing arguments Monday. "They were intentionally concealing this evidence.”

Allergan’s attorney, Vaughn Crawford of Arizona, argued that "every known and even remotely possible side effect was in the labeling.” He said the warning in 2006 even included the possibility of death. He said Helton still was willing to use it.

Jurors were instructed they could find negligence if they decided Allergan failed to act like "a reasonably careful pharmaceutical company would” under similar circumstances. One juror told The Oklahoman that the jury found negligence because Allergan’s 2006 product labeling did not have adequate information about side effects. The juror said the jury came to that conclusion after comparing a 2006 label with the 2009 label.

Millions have used Botox since the Food and Drug Administration first approved it in 1989. Helton said Tuesday she is still debilitated by weakness but hopes to get back to practicing medicine again in some way. story

I guess even physicians want to chase an ambulance when possible... Anyone have some thoughts?

Allergan Q1 Profits: Botox, Dysport, Juvederm Ultra XC

Allergan's Q1 Earnings Call: Allergan's thoughts on it's Botox and Juvederm Ultra XC growth.

First quarter sales increased year-over-year 11.2% in dollars and 6.9% in local currencies, boosted by the strong pickup in the sales of medical devices, which grew 18.4% in dollars and 13.4% in local currencies. The growth in the Medical Aesthetics businesses was even stronger outside the U.S. in all regions and across a wide range of countries, with surprisingly strong performance in Europe.

Operating performance was strong, with non-GAAP earnings per share at $0.65, marking an increase of 18.2% versus the result for Q1 of 2009, and comfortably exceeding the Q1 expectations shared with you, the investment community, of $0.57 to $0.59.

Earnings growth was driven by strong gross margin expansion, especially in the Medical Device segment. Careful spending in the selling, general administrative area, whilst we increased investment in R&D by 11.1% on a non-GAAP.

Within SG&A, we however doubled our DTC expenditures versus Q1 of 2009, which of course was the low watermark for spending when the world economy was in crisis. Our plan is to continue to invest in 2010 across our brands and into the recovery of our markets.

During the quarter, we were pleased that we continued to strengthen our R&D pipeline, supplementing our internally development programs with acquisitions and licenses. In January, we acquired Serica, a company with proprietary technology for use in tissue regeneration especially applicable to breast reconstruction, as well as the license for Ser-120 in Phase III clinical development for nocturia. Strategically, we have made good progress in building up a portfolio of urology assets.

We also furthered our aspirations to be the leader in medical aesthetics also in Asia, by reacquiring the rights to BOTOX Cosmetic in Japan and China and expanded our footprint in fast-growing emerging markets by establishing direct operations for all of our businesses in Turkey, effective from the second quarter.

After the out-licensing transaction with Bristol-Myers for neuropathic pain, we've increased our degree of R&D focus on our core specialty areas.

Now I’d like to comment on our expectations for 2010. For the full year earnings outlook, we have brought up the bottom of the EPS range by $0.02 to $3.11 and have left the top end of the range at $3.15 which at the time of the last earnings call expressly excluded the costs of any healthcare reform bill in the United States. With the increase of the Medicaid rebate, extension to managed Medicaid and expansion of eligible hospitals in the so-called 340B program, we estimate that the cost of healthcare reform in 2010 will be approximately $12 million. This is now included in our outlook.

Turning to BOTOX

Sales growth has picked up relative to trends seen across 2009, with growth versus the first quarter of 2009 at 11.3% in dollars and at 6.6% in local currencies. Sales of $331 million were only modestly lower sequentially than Q4, which is always seasonally the highest quarter of the year. Most of this increase was due to the more economically sensitive aesthetic side of the business, as the benefits of the upper-limb spasticity FDA approval in March occurred too late in the quarter to contribute to our sales results.

Outside the U.S., we enjoyed very strong double-digit increases across a wide range of countries, with surprisingly strong growth in several of the main European markets. These global markets are precisely where we are successfully dealing with multiple competitors.

It would therefore seem that the market is recovering as we can measure our market share with only a short time lag. In Europe, on the aesthetic side, we’re holding share at just under 80%, as we deal with the incursions of both Merck’s, with their Zymine and Bocatua [ph] brands and Galderma with Azzalure.

On the therapeutic side, it seems that most of ZMM’s market share gains have been at the expense of Dysport. In the U.S., BOTOX sales growth is less buoyant, as there was no base of Dysport sales in the prior year, but it is clear that the market is growing again.

We estimate that in the aesthetic market, Dysport had somewhere between 13% and 14% share in the first quarter. We'll be curious to see the lasting impact of the Dysport Love It or Leave It promotion after it terminates at the end of May.

In the therapeutic market, Dysport’s share is so far negligible, given the long history and experience of BOTOX use. In Europe and the U.S., we have recently introduced a 200-unit vial, which is useful for injectors treating large muscle groups, as well as for differentiation from competition. Regarding global market share for the fourth quarter, the last quarter for which data is available, we estimate that BOTOX held 79% share in a market growing 13% year-over-year.

Regarding the clinical program for BOTOX for chronic migraine, the clinical trial results of our PREEMPT program were published in Cephalalgia, the journal of the International Headache Society. Regarding facial aesthetics, we've experienced an even stronger rebound in sales than observed with BOTOX. Dermal filler sales grew year-over-year, a very strong 42.4% in dollars, and 34.5% in local currencies, with great growth in all operating regions of the world, with Europe again surprising on the upside.

Juvederm & Juvederm Ultra XC

In the U.S., we've seen huge growth in the JUVÉDERM line since the launch of JUVÉDERM Ultra XC, this is the lidocaine-containing product, in early February. Although we have gained some market share, it would seem that the market is responding strongly to the reduction in treatment pain experienced with this lidocaine-containing product and already a substantial share of the mix is attributable to JUVÉDERM Ultra XC.

We have just initiated print advertising for JUVÉDERM XC and have a PR campaign with TV host Dayna Devon, as our spokesperson to further drive growth. In Europe, we launched new additions to the JUVÉDERM product line, JUVÉDERM Smile at the IMCAS Conference in Paris in January and JUVÉDERM Hydrate at the Anti-Aging Conference in Monaco in March. JUVÉDERM Smile was also approved in South Africa, JUVÉDERM XC in Korea and JUVÉDERM Ultra Plus in Taiwan.

Voluma was recently launched in Brazil and also approved in Taiwan.

Based on our analysis of the world market in Q4, which we estimate grew 12%, it is clear that global market growth has accelerated since then. Our analysis also points to JUVÉDERM market share gains in all regions of the world. Beyond superior product performance characteristics, Allergan also benefits from having full product line.

At the end of the first quarter, Allergan's cash and cash net of debt positions totaled approximately $2 billion and $471 million, respectively. Allergan continued to maintain exceptional cash flow generation capabilities in the first quarter, with operating cash flow after capital expenditures of approximately $161 million, an increase of approximately $56 million over the first quarter of 2009.

Fake Botox: Houston physician sentenced

The fake Botox case in Houston comes to a close with this sentence handed down.

A Houston, Texas physician was sentenced to five months and 15 days in federal prison and three years of supervised release for injecting patients with fake Botox, prosecutors said on Friday.

Dr. Gayle Rothenberg is a local physician specialized in providing image enhancement services. She was also ordered to pay $98,426 in restitution to her affected patients. As a condition of supervised release, Rothenberg is prohibited from seeking reinstatement of her medical license.

Rothenberg and her former husband, Saul Gower, a local attorney, operated The Center for Image Enhancement located at 2000 Bering Drive in Houston.

Rothenberg ordered and administered a drug called Botulinum Toxin Type A that was labeled with the warning “FOR RESEARCH PURPOSES ONLY, NOT FOR HUMAN USE.” Despite this label, Rothenberg injected more than 170 patients with the substance and represented to patients that they were receiving Botox Cosmetic, manufactured by Allergan Inc.

Rothenberg also admitted that she advertised in brochures, magazines and websites that she specialized in treating facial wrinkles with Botox Cosmetic, even though she intentionally stopped ordering it due to the price increase in 2004 and began ordering the unapproved drug from a company named Toxin Research International because it was half the price of the other. She admitted that she did not tell her patients that they were receiving a different substance.

Gower pleaded guilty in 2008 to misbranding of a drug while being held for sale and making false statements to an agent. He then, cooperated with agents and testified against his ex-wife in exchange for a sentence of 4 years’ probation.

Botox Study by Allergan

I hadn't actually read this study but I came across these quotes by a Dr. Roger Dailey. Has anyone got additional information or thoughts on this?

"After two years of treatment at recommended intervals, patients can potentially cut the frequency, and thus the cost, of their Botox treatments by half," professor Roger A. Dailey, MD, FACS, reported at the recent meeting of the American Society of Aesthetic Plastic Surgeons. This finding counters the typical recommendation of injections every three months to maintain results.

"We found that after the patient receives Botox Cosmetic injections every four months for two years, the frequency of the injections can be changed to every six months and still achieve good results," Dailey explained. "This demonstrates patients have the ability to achieve good results with broader treatment schedules and ultimately at a lower overall treatment cost."

The study on 50 women between ages 30 and 50, made possible by an educational grant from Allergan, also confirmed that Botox has a prophylactic effect, not only eliminating lines between the eyebrows, but preventing them, as well.

The Price Of Fake Botox

Are price increases in Botox motivating some physicians as well as non-physicians to sell fake Botox to their patients?

A Houston physician, Gayle Rothenberg was sentenced to 5 ½ months in Federal prison last Friday for injecting patients with a fake Botox product not approved by the Food and Drug Administration for human use. Apparently Dr. Rothenberg injected at least 170 patients with an unapproved botulism chemical. According to testimony, Rothenberg stopped using Botox after a price increase in January 2004 and began ordering the unapproved drug, which was half the price, despite knowing it was not for human use and labeled only for research purposes. In 2004, when fpur people became paralyzed from the counterfeit Botox, the FDA’s involvement has led to 31 arrests and 29 convictions of individuals selling the fake Botox. In addition to a jail sentence, Dr. Rothenberg must pay more than $98,000 in restitution to her patients and cannot reinstate her suspended Texas medical license.

The case of Dr.Rothenberg is no different than the case of Laurie D’Alleva, another fine citizen of my home state of Texas charged with selling counterfeit Botox. So far D’Alleva’s case has yet to be prosecuted as evidence is still being gathered. The common similarities between the two are that both individuals were motivated by greed to jeopardize patient safety ahead of financial gain.  Laurie’s case is especially intriguing to me based on public opinion. Here is someone who seems to be viewed by her customers as a “business woman” who was doing a “good service” for those individuals who felt that Botox cosmetic was too expensive because the “greedy” doctors were charging too much for the filler. While Laurie seems to be viewed by many as a caring individual, making Botulism more affordable to the masses, public commentary on Dr. Rothenberg is quite the opposite. Comments such as “5-1/2 months? Justice is not only blind, it's stupid. (and maybe corrupt) “ and “That sentence is not even one day of confinement for every defrauded patient!.” I feel the same way as the above two comments, but why is the public sentiment different with these two con-artists? Is it because one is a doctor and one is not?

Personally, I find it very frustrating that the price of Botox has doubled in since its introduction. I remember being excited when Dysport came out because I thought this product would be half the price and would drive the price of Botox down so more patients could afford the price. Sadly, this was not the case. As physicians have to pay more money for Botox, so do their patients. These increasing prices enable individuals such as Ms. D’alleva and Dr. Rothenberg to find counterfeit Botox they can buy at a cheaper price to make a greater profit, while sacrificing patient safety. Laurie d’Alleva’s “Botox” price was probably pennies on the dollar, whereas a physician’s cost for Botox is now at $600 per bottle. Hopefully another pharmaceutical company peddling botulism toxin will come along, get FDA approval and drive the price of Botox down to a more reasonable price for physicians to purchase for their patients. Until then, brace yourself for more Laurie d’Allevas and Dr. Rothenberg’s to come along. Thank heavens for the invention of ventilators!

Guest post by Wendy Hovorka, Valley Laser Surgical Solutions Vein Center,  McAllen, Texas

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