Expanding Options in Aesthetics Practice

Botox is finally getting some competition.

BY JERRY HELZNER, SENIOR EDITOR

In the world of marketing, very few products make it to the iconic status in which the brand name of a single product becomes synonymous with the entire category of similar products.

For example, Kleenex is a brand name owned by Kimberly-Clark but when people say “please hand me a Kleenex” they are usually talking about facial tissue in general. Similarly, we do not make copies of documents, we “Xerox” them.

In the same vein, it is highly likely that no matter how many new products challenge Allergan's Botox in the future, the procedure to remove wrinkles by injection of botulinum toxin will always be known as Botox. Thus, any challengers to Botox already face an uphill fight.

The Challenges Have Begun

Botox has achieved singular status largely because it has had the US injectable wrinkle-removal market to itself for many years, starting with its initial approval in 1989 for the treatment of strabismus, blepharospasm and hemifacial spasm.

That first approval led to increasing off-label aesthetic use, eventually culminating in an FDA approval for treatment of glabellar (frown) lines in 2002. With the popularity of Botox continuing to grow, Allergan is now recording annual sales of more than $1.3 billion from the product.

But the challenges to the Botox franchise have now begun. In April of last year, Medicis received FDA approval for the use of its botulinum toxin A product Dysport as a treatment for the removal of glabellar lines. There was also a Dysport approval for cervical dystonia (abnormal head position and neck pain). Despite a name that lacks the cachet and consumer awareness of the Botox brand, Dysport is no Johnny-come-lately and should not be taken lightly.

The product has been used safely and effectively in Europe and other international markets for many years, though it has not taken significant market share away from Botox. In addition, Medicis has already built up a strong position in aesthetic products and can market Dysport to an existing customer base of plastic surgeons, dermatologists and ophthalmologists who already use and trust the company's products. Also waiting in the wings for anticipated FDA approval are two other botulinum toxin products, PurTox, which is now owned by Johnson & Johnson after J&J acquired die original developer, Mentor Corp, and Xeomin, which is owned by the German company Merz and has been approved in several international markets.

No Clinical Comparisons

While everyone agrees that all of the botulinum toxin products are similar, there are also real — and perceived — differences. For example, the FDA and the manufacturers strongly emphasize that Botox and Dysport cannot be used interchangeably, primarily because a unit of Botox has about three times the strength as a unit of Dysport. However, in the hands of a skilled practitioner, a patient can try both products at different times, or even on different areas of the face, and decide which product produces the better results.

In answer to a question in regard to comparing the two products, Medicis replied that “there are no adequate and well-controlled US clinical studies comparing Dysport to other botulinum toxin products. Physicians will draw their own conclusions regarding Dysport compared to other products.”

Allergan spokesperson Kellie Lao concurs. “While there have been a lot of reports in the media that have compared the onset of action and duration between Botox Cosmetic and Dysport, there are no published, well-controlled, double-blind, head-to-head comparative trials between Botox Cosmetic and Dysport that substantiate these claims. For that reason, we cannot comment on comparisons without this type of data.”

Consumers and physicians alike are well acquainted with successful Botox results (shown above). New options Dysport and PurTox seek to challenge Botox's dominant position.

Anecdotal Reports Make Comparisons

Despite the lack of clinical comparisons between the two products, there are non-scientific and unproven anecdotal reports that attempt to make comparisons.

Writing in the “Consumer Guide to Plastic Surgery,” Brian M. Kinney, MD, FACS, who reports no ties to either Allergan or Medicis, says that “initial reports suggest that Dysport may act quicker. Botox takes three to five days to work, while Dysport seems to work within one to two days.“

Dr. Kinney also indicates that Dysport may have a longer duration of effect, although experts say duration of effect is dose-dependent and it is almost impossible to make that comparison with two products of unequal strength.

Another comparison that has appeared in anecdotal reports is that Dysport spreads more quickly into muscle tissue. One reviewer, writing on the web site www.simplyantiaging.com, sees rapid spreading action as a double-edged sword, creating an advantage in treating “difficult forehead wrinkles” but imposing a disadvantage if the toxin spreads into areas where it is not intended to go.

Another issue that has been widely discussed is the creation of antibodies that would gradually diminish the effectiveness of repeated injections. This argument has been used for and against both Botox and Dysport, with no real proof to link the antibody issue to either product.

And finally, one North Carolina plastic surgery practice says that they use Botox with some patients and Dysport with others, depending upon their evaluation of the patient's needs.

If these reports aren't confusing enough, the developers of PurTox have already indicated that they will market their product as a “purer” (and thus supposedly better) form of botulinum toxin A.

One Practitioner's View

An ophthalmologist who has experience using both Botox and Dysport offered to give an informed opinion on the products to Ophthalmology Management.

This doctor says he “would agree” that Dysport has a bit of a quicker onset, a difference of “perhaps a day or so.” He also agrees that the two products spread a bit differently, but he suggests that this may be controlled by the way the physician performs the injections.

This doctor says it has so far it has been a challenge for Dysport to crack through the brand loyalty that Botox has developed over time. “Patients are instrumental in determining the product they would like to be treated with, assuming the product that they choose is appropriate and will lead to a positive outcome,” he says.

Competing on Cost

Some observers have compared the emerging competition between Botox and Dysport to the “Coke and Pepsi” wars because of the already fierce nature of the rivalry.

Cost represents a particularly thorny area of the competitive landscape and offers a major opportunity for Dysport to attempt to take market share from Botox, especially if patients view the two products as equals in terms of results.

Medicis says that Dysport for the aesthetic indication is “competitively” list-priced at $475 per 300-unit vial, which roughly equates to about 100 units of Botox in terms of effectiveness. But with an aggressive, recently extended rebate program aimed at consumers and called “The Dysport Challenge,” Medicis appears to be positioning Dysport as a value brand. The rebate program is aimed at getting consumers to try Dysport once or twice at a steep discount and then winning them over for the long-term based on the product's results. Medicis says more than nine out of 10 people who have tried “The Dysport Challenge” have expressed satisfaction with the product.

For its part, Allergan is, at least publicly, trying to stay above the fray.

“Since the approval of Dysport last year, it has been business as usual at Allergan and we have not adjusted our pricing,” says Ms. Lao. “Our perspective is that competition is healthy as it generally spurs market growth. That said, we believe that it is critical to ensure proper education on the differences between botulinim toxin type A therapies to avoid medication errors and that has been a focus in physician and consumer marketing initiatives.”

However, as the reigning king of the botulinum toxin realm, Allergan cannot resist a swipe at its upstart competitor.

“For nearly 20 years, physicians have been able to rely on the science, outcomes and value that Botox Cosmetic brings to their patients, which has resulted in a great deal of knowledge, expertise, and confidence in the risk-benefit profile of the product,” asserts Ms. Lao. “Therefore, importantly, physicians should not presume that they can use another product, such as Dysport, and obtain the same precise and predictable results, with the same risk-benefit profile, as they do with Botox. Physicians will need to erase the education they have received and their own clinical experience with Botox Cosmetic and learn a new language to administer Dysport.” OM