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Allergan Gets FDA Approval
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Determined
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Sat Dec 27, 2008 12:49 pm      Reply with quote
From Business Week:
NEW YORK

Cosmetic drugmaker Allergan Inc. said Friday its eyelash treatment Latisse received Food and Drug Administration approval.

The drug treats the condition hypotrichosis of the eyelashes and is applied once-daily to increase thickness and fullness, the company said. The treatment has full results within 16 weeks, it said.

"Latisse fulfills a significant and previously unmet need in the medical aesthetic marketplace with a product approved by the FDA that increases the growth of eyelashes, making them longer, thicker and darker," said Dr. Scott Whitcup, Allergan's executive vice president of research and development, in a statement.

The drug's active ingredient, bimatoprost, was first approved in 2001 as a treatment to lower intraocular pressure in people with a type of glaucoma or hypertension within the eye.

Allergan expects to launch Latisse in the first quarter and forecasts peak annual sales exceeding $500 million.

Shares of the Irvine, Calif., company rose 49 cents to $36.93 in morning trading.
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Sun Dec 28, 2008 4:36 am      Reply with quote
Allergan is great~
Another hit after Idebenone.
flitcraft
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Sun Dec 28, 2008 1:41 pm      Reply with quote
Hmmm...I thought I remember Allergan taking the position that the drug might have harmful side effects when they were leaning on companies like Jan Marini to cease and desist using it in their lash growth products. Now that they have defended their patent rights and driven off competitors, there's no problem... Rolling Eyes
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Sun Dec 28, 2008 1:54 pm      Reply with quote
flitcraft wrote:
Hmmm...I thought I remember Allergan taking the position that the drug might have harmful side effects when they were leaning on companies like Jan Marini to cease and desist using it in their lash growth products. Now that they have defended their patent rights and driven off competitors, there's no problem... Rolling Eyes


Is it the same active ingredient as JM used? What rats!

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Determined
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Sun Dec 28, 2008 2:18 pm      Reply with quote
Allergan, Inc. (NYSE:AGN) announced today that it has agreed to dismiss its legal action against Jan Marini Skin Research, Inc. ("Jan
Marini"), one of the defendants in Allergan's patent infringement lawsuit pending in the United States District Court for the Central
District of California. The dismissal is based on Jan Marini acknowledging the validity of Allergan's relevant patents covering the
use of certain drug substances, such as prostaglandin analogs, to promote eyelash enhancement and also agreeing to cease its
distribution of eyelash products containing these ingredients in the United States and other countries worldwide where Allergan owns
related patents.
As recently announced, Allergan has completed a clinical program with its patented formulation of bimatoprost, a synthetic prostaglandin analog, and will pursue United States Food and Drug Administration approval to market a product to stimulate eyelash growth in the United States.

"We are pleased that Jan Marini has acknowledged that Allergan's
U.S. and foreign eyelash growth patents are valid and enforceable and has agreed to cease further distribution of its eyelash growth
products," said Douglas S. Ingram, Allergan's Executive Vice President, Chief Administrative Officer, General Counsel and secretary. "Allergan has a significant intellectual property estate covering this area. Allergan has sued, or is evaluating suit against, a number of infringers for refusing to respect our intellectual property rights. As evidenced by our ongoing lawsuit against those
companies and individuals who have chosen to market unapproved eyelash products containing active pharmaceutical ingredients, Allergan will
not idly stand by while others infringe our intellectual property rights."

I(Determined) believe that Allergan spent a great deal of $$ and time doing the research required for FDA approval and I believe their patent rights should be protected
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Sun Dec 28, 2008 2:41 pm      Reply with quote
Yes, Determined, they certainly deserve credit for their hard work, but they also have the major capital to put out for R&D! Small companies don't stand a chance against the Big Boys as far as marketing their innovative products.

Not arguing with you or putting down your excellent info, just sayin....

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flitcraft
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Sun Dec 28, 2008 6:58 pm      Reply with quote
Actually, it probably didn't cost Allergan much to do the testing needed for FDA approval, since all they were asking for is an off-label use for an already approved drug. So, instead of the whole battery of safety and efficacy tests needed for new drugs, all they needed to do was to show efficacy. And, given the good results that folks on this forum were having, that wasn't too hard to do.

Honestly, it doesn't bother me much that the cost of the product will get jacked up in the US till the patent runs out and generics can compete. For me, mascara will be a better deal than spending hundreds a month on this stuff. I do feel for the elderly who have to pay these prices when they use it for glaucoma treatment--one of my neighbors (who for obvious reasons I will not further identify) goes to Canada to get hers because otherwise, it would be a question of whether she heats her house or gets her glaucoma meds... Sad
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Tue Dec 30, 2008 10:53 am      Reply with quote
The fact that if it gets into the eyes it can change your eye color really sort of freaks me out.

* * *

...Allergan also notes that Latisse may cause darkening of the eyelid skin, which may be reversible, and it "may also cause increased brown pigmentation of the colored part of the eye, which is likely to be permanent."

* * *

Also, as much as I'd love longer, fuller lashes, not wild about something that can eventually stain my eyelid skin and that it "may" be reversible, either!
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Tue Dec 30, 2008 11:29 am      Reply with quote
FDA approval is one thing. So, my question is this, is this product going to be sold by "prescription only" through doctors?? The active ingredient is a glaucoma drug. Since the active is a "drug" it ABSOLUTELY, POSITIVELY CANNOT be sold as a cosmetic available on store and drug store shelves!! That's the rule...cosmetics cannot have drug actives and cannot change or alter any bodily function...such as growing hair (eyelashes). That was one of the MAIN reasons why JM was told to cease and dissist and destroy all remaining inventory. They were selling a "drug" as a cosmetic.

Allergan is going to have to abide by the same rules or they are going to get hammered by the FDA as well.

John

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Wed Dec 31, 2008 11:59 am      Reply with quote
What Doctor should i go to to get the precription when available to try? Regular MD possible? Cause I don't have a derm or eye doctor that I go to. Thanks!

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Wed Dec 31, 2008 12:12 pm      Reply with quote
John, you're right on the FDA rules. I did see in one of the announcements that it will be prescription only. I wonder what diagnosis you will need in order to get a prescription--short eyelash syndrome?
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Wed Dec 31, 2008 2:53 pm      Reply with quote
flitcraft wrote:
John, you're right on the FDA rules. I did see in one of the announcements that it will be prescription only. I wonder what diagnosis you will need in order to get a prescription--short eyelash syndrome?


haha,you are so funny ~~
and how to use it is a problem too.
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Thu Jan 01, 2009 2:40 am      Reply with quote
It will be just a matter of time before it will be available without a prescription. There are countless products here in Oz that were once prescription only and now they can be purchased otc in a chemist, no questions asked.

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Thu Jan 01, 2009 4:57 am      Reply with quote
I just saw in the latest post from futurederm.com that the eyelash treatment Latisse is going to cost $120 for a one month supply. I honestly wonder if customers are willing to invest that much money in their eyelashes in recession times, or if Allergan is pricing themselves out of the market... Rolling Eyes

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flitcraft
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Thu Jan 01, 2009 1:58 pm      Reply with quote
Until the patent to Allergan expires--twenty years after the patent was applied for--you can expect the price to remain high while Allergan has a monopoly on sales. Of course, there are always the off-shore pharmacies that we've talked about a lot here. You know, the ones that sell generic Retin A for about a twentieth the cost charged for prescription Retin A in the US.

Has anyone checked to see if Medsmex, Alldaychemist and Inhousepharmacy are stocking a generic version of Latisse yet?
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