Botox vs Dysport: Which one is more effective?

Botox vs Dysport? Well, Dysport as another few arrows in the marketing quiver with a new study that says that Dysport is more effective than Botox in treating glabellar lines.

Here's a release from the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) that claims thta Dysport is actually more effetive than Botox.

The American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) today announced positive clinical results demonstrating a significant efficacy advantage with Dysport™ (abobotulinumtoxinA) over Botox® Cosmetic (onabotulinumtoxinA) for the treatment of Crow's feet. The data were presented Friday, September 24 at a scientific session at the AAFPRS 2010 Annual Fall Meeting, taking place September 23-26 in Boston.

Downloadable photos, fact sheets and other supporting materials available here: http://www.multimedianewscenter.com/aafprs/dysport-data-shows-superiority-versus-botox-cosmetic

The 90-subject study, titled "Internally Controlled Double-Blind Comparison of Onabotulinum and Abobotulinum Toxin Type A (Nettar, Kartik D., M.D., et. al)," met its primary endpoint (p=0.01) of greater efficacy of action with Dysport™ as defined by investigator assessment of maximum contraction at Day 30 post injection compared to Day 0. Additionally, a secondary endpoint -- subject assessment at maximum contraction at Day 30 compared to Day 0 -- also demonstrated statistical significance with Dysport™ (p=0.027).

"Botox has long been considered the gold standard of injectables, so this data showing Dysport's stronger efficacy is compelling," said Corey S. Maas, M.D., F.A.C.S., AAFPRS Group Vice President for Public and Regulatory Affairs. "Since injectables are the non-surgical cosmetic procedure rising fastest in popularity, it is important to continue honing new applications for existing treatments. Dysport's potential here is exciting as Crow's feet are a common concern for many men and women."

The study concluded that Dysport™ offers a quantifiable and demonstrable advantage in wrinkle effacement (shortening) and hyperfunctional frown lines compared to Botox® Cosmetic in the treatment of Crow's feet. Study investigators recommend further studies in additional facial regions to confirm the data.

Both Botox® Cosmetic and Dysport™ are FDA approved for treatment of moderate-to-severe glabellar lines (vertical lines between the eyebrows); neither product is presently indicated for treatment of Crow's feet. The study was funded by an educational grant from Medicis Aesthetics.

Additional Study Information: The randomized, double-blind, internally-controlled (split face) study was conducted at the Maas Clinic in California. Ninety subjects (75 females, 15 males) with moderate-to-severe lateral orbital rhytids (Crow's feet) were enrolled in the study. Participants received equivalent doses of both treatments: 10 units of Botox® Cosmetic on one side of the face and 30 units of Dysport™ on the other side. Investigator and subject gradings of Crow's feet at relaxation and maximal contraction were obtained using the published validated dynamic and static Merz Crow's feet grading scale before injection (Day 0) and then two, four, six, and 30 days post injection. All patients were photographed in standard five-view series at rest and at maximal contraction in a dedicated photo lane recorded by Mirror software. Additional secondary endpoints not met in the study include investigator assessment at rest at Day 30 (p=0.41) and subject assessment at rest at Day 30 (p=0.28).

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.

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.

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.

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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Restylane Big Lips Overdose

If you're looking to see what a Restylane or Juvederm lip filler overdose looks like... well, then look no further.

This collection of lip augmentation overdoses is brought to you from Russia, where it looks like you can buy your Juvederm or Restylane wholesale and it's sold in 2-liter bottles.

Plastic surgery is booming thru Russia and it appears from these lip augmentation photos that the natural look isn't really in. There are enthusiasts in Russia tracking down Russian ladies with poor results on social networks and publishing them in special communities, sometimes making fun of them, but sometimes admiring their marvelous lips.

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Son Of Botax

I was just reading the text of the proposed changes to the Healthcare reform bill. Hidden in the middle of dozens of pages is this gem:

IN GENERAL.—There is hereby imposed on the sale of any taxable medical device by the manufacturer, producer, or importer a tax equal to 2.9 percent of the price for which so sold.

Well guess what, people - Mr. Obama & company may have backed off on the 10% cosmetic surgery tax, but he's still sticking it to you with a 2.9% tax on implants and surgical supplies.  It would also increase the cost of lasers, liposuction equipment, and many other surgical and anesthesia supplies we all use.

That's in addition to the additional 3.9% tax you'll be paying for any profit on investment income. So, if you invested and "saved your pennies" like an honest, hard-working American, you might be penalized up to 6.8% for having cosmetic surgery!

This tax also would apply to pacemakers, stents, heart valves, cataract lenses, artificial hip & knee implants, motorized wheelchairs, and implantable defibrillators. As if these things weren't expensive enough! It's the "Son-of-Bo-tax". Boo!!!

From:  Tom Fiala, MD

Allergan - Botox Cosmetic

No need to shed tears for Allergan with a market cap of nearly $18 billion last week.

Allergan Inc. Chief Executive David Pyott is guarded about 2010 as the drug maker faces competition, uncertain spending on its medical cosmetics and a relatively quiet year for product launches.

“It’s sensible to remain conservative in our forecast given there are still a number of challenges to be accounted for,” Pyott said. “You need to think about 2010 potentially being the most challenging of the coming years.”

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Allergan's Botox Profits Jump 51%

Allergan's profits bounced up an impressive 51%... Could this signal a medical spa rebound?

Allergan Inc.'s (AGN) fourth-quarter profit jumped 51% from a charge-addled period last year while product sales surged 16% amid continued improvements in markets for cosmetic medical procedures following the recession, the company said Thursday.

The Botox-maker forecast weaker-than-expected earnings in the first quarter, which it pegged to increased spending on advertising and product launches. It also projected full-year earnings mostly below Wall Street's forecast while being cautious about economic recovery and challenges for certain products.

Still, shares of the Irvine, Calif., company, which also makes eye drugs, breast implants and fillers for facial wrinkles, recently traded up 2.3% to $58.09.