Reloxin, the First Real Threat to Botox's Preeminence in America, Emerges

The first real challenger to Botox's preeminence as a beauty treatment is on the horizon. The Food and Drug Administration (FDA) is set to approve Reloxin, an injectable form of Botulinum toxin type A . Medicis and Ipsen Pharmaceutical Companies submitted a Biologics License Application (BLA) in March of last year. The expectation is that approval should be coming very soon.

Reloxin and Botox are both purified forms of the neurotoxin, Botulinum Toxin Type A. The toxin is derived from a bacterium called Clostridium Botulinum. It is the toxin best known for causing Botulism or food poisoning and comes from the German for "sausage poison". Botulinum Toxin A is known to have an effect on the nervous system. It was utilized as a biological weapon throughout World War I and II but fell out of favor because it required extensive refrigeration. However, those who worked with it noticed that it had other applications with regards to relaxing muscle spasms of the eye. As it was used for eye spasms, doctors noted that it also smoothed the muscles of the forehead. Botox was approved by the FDA, for cosmetic purposes, in 2002.

Some reports have said that Reloxin will act more quickly and have longer lasting effects than Botox. However, Dr. Ramsey Markus, Director of Laser Surgery at Baylor College of Medicine in Houston, TX believes that the duration of a Reloxin treatment will generally be about the same as Botox He shared that some studies even indicate a shorter duration for Reloxin. While Reloxin and Botox are both derivative of the same bacterium, Dr. Markus specified that Reloxin has a smaller molecular structure. As such, the toxin will spread more widely into tissues. He believes that current injection methods will need to be modified to guard against relaxing adjacent muscles such as those that hold up the eyelids.

Dr. Nancy Snyderman, NBC's chief medical editor, reports that an important factor is Reloxin's cost relative to Botox. Price competition is good for the consumer in any industry. Since Botox treatments currently run anywhere from $300 to $500, it is expected that with the advent of Reloxin, the consumer will be the beneficiary. Snyderman remarked further in an appearance on the Today show. "I think you're going to see a marketing battle. Watch for the price war. It's going to be a price war for women who really want this." Dr. Markus concurs. He believes that if the price difference is significant that a number of women in the Houston area will switch from Botox to Reloxin.

According to an article by Nicole Ostrow that was reprinted to the Pharma forum from Bloomberg.com, Gary Nachman of Leerink Swann Healthcare Investment Bank is quoted as saying that "Reloxin may be priced 15 percent less than Botox. Over time Reloxin may take 25 percent to 30 percent of market share from Botox. He also shared, "U.S. sales of Reloxin may rise to about $160 million by 2012".

Reloxin is set to enter the market at a great time. While more expensive and invasive cosmetic surgeries have dropped in the face of the contracting economy. Less invasive procedures such as Botox and Restylane have continued to increase in popularity. "I, so far, have not seen any drop off. If anything I have been getting a little busier with the minimally invasive procedures like Botox and Fotofacial," Dr. Markus shared.

In a Wall Street Journal article written by Rhonda Runkle, it was revealed that many women see these treatments an investment in themselves. Kathleen Hudson, a 57-year-old marketing consultant in Falls Church, Va.is quoted in the same article, as saying, "If you're in the business world and you want to be competitive with the younger people, you need to stay on top of your game."

Reloxin has already been approved for use in 23 countries. In the months since Medicis and Ibsen submitted Reloxin for FDA approval they have continued to test it extensively. Reloxin has been on the market for 15 years outside of the United States. Dr. Markus added that the anaphylactic reaction to Botox is incredibly low and as Reloxin is very similar, it should result in the same type of side effects as. If it undercuts Botox's price, it promises to be a boon for the customer and the beauty industry.

Sources:
http://www.msnbc.msn.com/id/28558128/
http://cosmeticsurgerytoday.wordpress.com/2009/03/26/reloxin-study-for-forehead-wrinkle-removal-shows-promising-results/
http://www.forums.pharma-mkting.com/showthread.php?t=10183 Nicole Ostrow

http://www.leerink.com/
http://www.drugs.com/nda/reloxin_080317.html

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Interview via Email with Dr. Ramsey Markus, Baylor College of Medicine