DELRAY BEACH, Fla. -

 

April 11, 2012

At her Delray Beach, Fla. dermatology practice, Dr. Janet Allenby focuses on a lot of faces but many of her clients are also troubled by the appearance of their nails.

"I have men and women as about nail issues," said Allenby.

The most common complaint: soft or thin nails that easily split and break.

"In layman's terms, we refer to this as brittle nail syndrome and it has many possible causes," said Allenby.

Brittleness becomes more common with age but can also be caused by over-exposure to detergents and water, as well as excessive use of harsh solvents, like nail polish remover.

"Women have to consider that their weekly manicure may be doing more harm that good if their nails are already weak," said Allenby.

Wearing gloves and moisturizing your hands after washing are musts.

"You have to understand that wetting the nail causes it to expand. As the nail dries, in contracts and that constant expansion and contraction weakens the nail," said Allenby.  "When you can't wear gloves, for example when your intention is to wash your hands, then rub a good moisturizer around your nails immediately after drying."

Doctors now also have two topical prescription medications to offer patients.  One is intended for weak nails, the other is being used off-label to grow nails.

"Genadur is an approved treatment for weak nails that split and break.  It's a nail lacquer that will actually kind of harden the nail and it has some vitamins in it that will strengthn them and provide accelerated growth," said Allenby.

Another option for nails that won't grow is off-label use of a product used for growing lashes called Latisse.

"If you continually use it, the nails will get thicker and stronger," she said.

Both Genadur and Latisse are best applied at bedtime so the products aren't washed off.

A bottle of Latisse costs $120, a bottle of Genadur costs $180 without a prescription.

Nutritionally, a diet low in iron can also cause brittle nails so it's important to eat foods that are rich in iron, including leafy greens, red meat, and eggs. 

Biotin, a B-Complex vitamin, can also help strengthen and grow nails.

"Some nail conditions can indicate underlying health issues so if the problem persists, it's a good idea to see a doctor," said Allenby


Watson Confirms LUMIGAN(R) and LATISSE(R) Patent Challenges

- Paragraph IV Litigations Underway -

Published: Tuesday, Apr. 3, 2012 - 6:25 am 

/PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed Abbreviated New Drug Applications (ANDAs) with theU.S. Food and Drug Administration (FDA) seeking approval to market Bimatoprost Ophthalmic Solution, 0.01% and Bimatoprost Ophthalmic Solution, 0.03%. Watson's ANDA products are generic versions of Allergan, Inc.'s LUMIGAN® 0.01% and LATISSE® products, respectively. LUMIGAN® 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. LATISSE® is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness and darkness.

Allergan, Inc. filed suit against Watson in the United States District Court for the Eastern District of Texas on March 23, 2012 seeking to prevent Watson from commercializing its generic version of LUMIGAN® 0.01% prior to the expiration of certain U.S. patents.  Allergan, Inc. and Duke University filed suit against Watson in the United States District Court for the Middle District ofNorth Carolina on March 30, 2012 seeking to prevent Watson from commercializing its generic version of LATISSE® prior to the expiration of certain U.S. patents. Each lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in separate stays of final FDA approval of Watson's ANDAs.  Each stay will be in effect for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the litigation, subject to any other exclusivities.

For the twelve months ending January 31, 2012, LUMIGAN® and LATISSE® had total U.S. sales of approximately $409 million and $80 million, respectively, according to IMS Health data.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.

For press release and other company information, visit Watson Pharmaceuticals' Web site athttp://www.watson.com.

Forward-Looking Statement

Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors, risks and uncertainties affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the difficulty of predicting the timing and outcome of the pending patent litigation; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's annual report on Form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

LUMIGAN® and LATISSE® are registered trademarks of Allergan, Inc.


Read more here: http://www.sacbee.com/2012/04/03/4387122/watson-confirms-lumiganr-and-latisser.html#storylink=cpy  

 

Park City, Utah (PRWEB) March 23, 2012

The makers of Latisse® have made TV’s “Mad Men” Star Christina Hendricks their newest spokeswoman and representative of their annual Latisse® Wishes Challenge to benefit the Make-A-Wish Foundation. While that fact alone ups the bombshell’s likeability factor, FaceForum.com explains why Hendricks – and other consumers of the product – might ultimately like what they see.

In a new online article, FaceForum.com explains that Latisse® is a prescription treatment for thin or otherwise unremarkable eyelashes. It is made by Allergan, Inc. The company also makes Botox® Cosmetic and Natrelle breast implants.

“Latisse® has been shown to encourage the growth of longer, thicker and darker eyelashes,” says Shawn Miele for FaceForum.com. “Selecting Christina Hendricks as a celebrity rep was a smart move on Allergan’s part. She’s likeable, candid and beautiful.”

“She’s even openly admitted that long-term use of heavy makeup and false eyelashes have left hers a bit bare. What woman wouldn’t look up to someone that honest?”

While cosmetics counters may be filling up with other thickening and lengthening products, FaceForum.com says Allergan’s Latisse® provided consumers with the first, pharmaceutical-grade solution to hypotrichosis – inadequate or insufficient lashes.

“Allergan has sold more than 2.5 million bottles of Latisse® to date,” adds Miele. “Essentially, it encourages lash growth that’s noticeable over time. Similarly, when consumers discontinue use, their lashes take on their former appearance over time.”

“It’s the kind of product which should be used nightly, with full results usually seen in four months’ time. Lashes first appear longer, then thicker and eventually darker.” 
In a clinical study conducted by Allergan, 50% of patients who received Latisse® treatment got noticeably improved lashes within two months.

But, FaceForum.com says, consumers should weigh the product’s risks and benefits together in consultation with an experienced, board-certified plastic surgeon since knowing how to safely and effectively apply the product is essential for good results.

“One serious risk interested consumers should consider,” explains Miele, “is whether using Latisse® will interfere with their use of prescription drugs which relieve eye pressure problems caused by glaucoma or ocular hypertension. Lumigan® is one example. Upcoming eye surgery could also rule out your ability to use the product.”

Consumers can read the full article and learn more about the risks and benefits of Latisse® online at FaceForum.com. Facial cosmetic surgery procedures can be explored there, as well. The site also plays host to a board-certified surgeon database and active user discussion board.

About FaceForum.com: “Ask questions, get answers and share your experiences!” As the premier Facial Cosmetic Plastic Surgery Forum & Information Website, Face Forum provides consumers with timely answers to cosmetic surgery questions like: What’s new? Is this procedure right for me? How much will it cost? We also offer FREE, 24/7 access to our board-certified surgeon database and our active user discussion board.

SOURCE INFO: Christina Hendricks (Mad Men) new LATISSE spokeswoman 

 

 

Great article on Claire Danes using Latisse ®.  See the original one HERE.   By Lindsay Goldwert DAILY NEWS STAFF WRITER Friday, March 18th 2011,  1:08 PM Claire Danes doesn’t look down on people who have plastic surgery – in fact, she’s open to having some when and if she needs it. “I’m really fortunate [...] 

Just what it says it is.  See the original HERE.   January 27th 2011 in Latisse ® The recent progress in medicine gave start to the appearance of strong preparations used to emphasize the female beauty. Thicker, darker and longer eyelashes became possible with the newest medical preparation offered at the market – Latisse ®. Its unique [...]

Little thing on Latisse ®.  See it HERE. March 21st 2011 in Latisse ® Today to look gorgeous you just need to wish it. All the rest is the concern of highly developed medicine. Your wish and the latest medical achievements are key factors for your glaring appearance. Sometimes it is not enough to be in [...]

Another little article on Latisse ®.  See it HERE.   April 1st 2011 in Latisse ® As women have become more familiar and comfortable with the idea of a medication that can help them have long, lush and dark eyelashes, which they have always wished for, physicians started prescribing Latisse ®. The drug has recently appeared [...]

Great article on ABC News.  See it HERE.   By RADHA CHITALE ABC News Medical Unit Dec. 29, 2008 Some people might look at Meiko Catron, a native of Japan, and find her tilted eyes exotic and attractive. But 61-year-old Catron, who lives in St. Louis, finds them lacking. “I have a great head of [...]

Interesting little article on Latisse ®.  See the original HERE.   May 26th 2011 in Latisse ® It is quite unusual for pharmaceutical companies to discover that a drug intended to treat one condition can be used for other purposes. However, such cases happen from time to time. And that is the case with Latisse ® [...]

Good article on Latisse’s ® origin.  See the original HERE.   By Jordan Lite |Dec 29, 2008 03:45 PM | Could a new eyelash-lengthening drug curb the envy of stubby-lashed ladies? The Food and Drug Administration (FDA) has green-lighted Latisse ®, which lengthens, thickens and darkens eyelashes when dabbed daily on the lash line on the [...]

Nice, lengthy article on Latisse ®.  See the original HERE.   Article Date: 27 Dec 2008 – 8:00 PDT Allergan, Inc. (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) has approved LATISSEā„¢ (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for having [...]

This was a huge step forward for Latisse ®.  See the original HERE. The U.S. Food and Drug Administration (FDA) has approved Latisse ® (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes. Latisse ® is a once-daily prescription [...]

 

Latisse may soon be inducted into the hair club for men (and women, too).
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The drug, which in its earliest, unsexiest incarnation existed solely as a glaucoma treatment, is best known as the U.S. Food and Drug Administration-approved wonder drug that can grow and darken your poor listless lashes . Now, it's being tested for a new use: growing hair on your dome.
No one tracks just how many doctors across the country are using Latisse off-label to target hair loss, but Dr. Alan Bauman, a Boca Raton, Fla., board-certified hair restoration physician has been using the drug this way for about three years, beginning around the time the FDA approved it for eyelash growth in December 2008. He describes his own personal "eureka!" moment:
"Patients who were using it for eyelashes sometimes have eyebrow problems, so it’s a short hop to the eyebrows," he explains. "So, of course, if it was working there, too — from the eyebrows, it’s just a short hop to the hairline."
Allergan, the health care company that manufactures the eyelash enhancer, is currently testing the safety and efficacy of a new formulation of bimatoprost, the active pharmaceutical ingredient in Latisse, in growing hair on the scalp, says Heather Katt, a spokeswoman for Allergan.
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The appeal of using Latisse for hair loss is its ease and convenience, as it seems to only require one drop to the affected area once a day; minoxidil (better known as Rogaine) requires two, and Propecia requires daily pill taking.
Bauman says he sees about 1,000 new hair loss patients each year, about 700 of which end up on some kind of medical management — and so far, he's only used Latisse on a "couple dozen" patients, usually those who are allergic to the usual treatments, which is what happened to 70-year-old Rhoda Kelly.
Kelly's hair was thinning a bit on the back of her head, so she tried Rogaine, but suffered a bad allergic reaction. So Bauman suggested she try Latisse.
Kelly started to see noticeable results about four months after starting Latisse, as her thin hair started to grow in thicker. Now, 14 months later, Kelly says, "My hair is in much better condition — it looks healthy." She's still using Latisse, combined with "a slew of other vitamins," including a pharmaceutical-grade biotin and a marine-derived protein-polysaccaride, and a protective sun hat.

Courtesy of Dr. Alan Bauman
On the left is a photo of Rhoda Kelly's hair before using Latisse, which had started to thin a bit. On the right, Kelly's hair is thicker after using Latisse daily.
Kelly, by the way, has strawberry blonde hair, which has gotten lighter after years in the Florida sun. It hasn't darkened after using Latisse. When Latisse first hit the market, much ado was made about one of the more surprising risks: In rare cases, it could cause light eyes to turn brown. Bauman says he hasn't seen any evidence that this applies to hair, or the skin on the scalp, for that matter.
The major drawback: It's expensive. Each 2-ounce bottle costs $100 to $150 — and some patients will run through two or three bottles a month, Bauman says.
"Expense is a big disadvantage, but perhaps the biggest problem with this technology is that it does not restart hair growth for hair that has stopped growing," points out Perry Romanowski, a cosmetic chemist and one of the brains behind the popular beauty blog, The Beauty Brains. "If it works on scalp hair at all (and this hasn't been definitively proven), it will only be able to thicken existing, working hair follicles."
Basically: If you already have a bald patch, Latisse can't help you there.
"Since what people really want from this product is something that will bring their hair back, I suspect that they will be disappointed because that will not happen," Romanowski says. "Are a few thicker, fuller strands going to be worth the expense? Perhaps to some people."
Would you try Latisse for your hair? Have you tried it on your eyelashes? Discuss the eyelash enhancer and its new hair loss gig on our Facebook page.  
   
USA TODAY  
   
Another drug is getting a second life because of desirable side effects.  

Botox was originally approved by the Food and Drug Administration to reduce eye spasms. Then the world realized it also made people look younger by eliminating wrinkles.

Human growth hormone was intended for children with growth disorders, but older people seeking the fountain of youth and athletes wanting a boost started finding illegal suppliers of HGH for muscle growth and overall toning.

The latest development involves Lumigan, a drug Allergan produced to treat glaucoma. The disease can lead to blindness if left untreated. The medication decreases pressure within the eye either by slowing the production of a fluid in the eye or by increasing fluid drainage. One of the side effects of Lumigan is longer, thicker and darker eyelashes.

Allergan developed a spinoff called Latisse, which the FDA approved for eyelash enhancement in December. Lumigan drops are used in the eyes; Latisse is applied to the upper eyelid. Bimatoprost is the active ingredient common to both drugs.

"Forget about fake lashes, they end up on your cheeks," says Liz Weber of Washington, D.C. "This is my favorite stuff ever."

Weber, 52, was distressed about having short lashes and bald spots, a condition called hypotrichosis. Her dermatologist told her the condition can be persistent after menopause. Weber had used fake eyelashes and was ready to try eyelash extenders when she found out about Latisse.

"Now, my daughter calls them my Bambi lashes," she says.

Dermatologists say customers are lining up. Richard Glogau, a member of the American Academy of Dermatology who practices in San Francisco, says he got his first shipment of 60 boxes three weeks ago and was sold out within a week. A box is a month's supply. The latisse price per vial is very good at www.latisse.bz

"I had no idea how big eyelashes were with women until this came along," Glogau says. "The response has been impressive. I was a little taken aback at first, but they report that their eyelashes got thinner as they got older or they were too blond."

One of the warnings for both Lumigan and Latisse is possible change in pigmentation of the eyelid and darkening of the iris. Though not harmful, once change of the iris does occur, it is permanent.

Weber's dermatologist, Marilyn Berzin of Dcdermdocs in Washington, D.C., says she believes Latisse is safe and is not likely to alter the iris color because it's not applied directly to the eyes.

Still, Andrew Iwach, a glaucoma specialist and spokesman for the American Academy of Ophthalmology, cautions people who have eye inflammation, glaucoma or macular edema to consult with their eye doctor before using Latisse.

It costs about $4 a day, and insurance doesn't cover it. Berzin says that after 16 weeks of daily application, it is possible to cut back to once or twice a week for maintenance of the lashes. If you discontinue use altogether, eyelashes return to their previous appearance.

David Pyott, chairman of the board and CEO of Allergan, expects Latisse to ultimately equal the cosmetic use of Botox. "Botox is for an aging population," he says. "Latisse can benefit anyone," including cancer patients who have had chemotherapy and lost their lashes. Their lashes eventually will grow back without Latisse.

The FDA did not approve Latisse for people under 18 or for pregnant or lactating women.

 

NEW YORK TIMES

First it was frozen foreheads. Now it’s Betty Boop eyelashes.
Enlarge This Image

Alex Quesada for The New York Times
Cindy Ross participated in the clinical trial for Latisse.

Allergan, the company that turned an obscure muscle paralyzer for eyelid spasms, Botox, into a blockbuster wrinkle smoother, hopes to perform cosmetic alchemy yet again. At the end of the month, the company plans to introduce Latisse, the first federally approved prescription drug for growing longer, lusher lashes.

The product has the same formula as Allergan’s eye drops for glaucoma, called Lumigan. It is one of several drugs in a category known as prostaglandin analogs, which are meant to reduce dangerous pressure in the eyeball. But as a side effect, the treatment tends to make the eyelashes of many patients longer and fuller.

Some medical experts say they worry that cosmetic customers may occasionally experience some of the glaucoma drug’s other side effects, which can include red, itchy eyes and changes in eyelid pigmentation. Some financial analysts, meanwhile, wonder how many people will want to spend $120 for a monthly dose of lash-lengthening Latisse.

But other analysts predict that in a world where people spend about $5 billion a year on mascara, Latisse could be the biggest thing to hit cosmetic medicine since, well, Botox. Sales for the cosmetic use of Botox were $600 million in 2007.

“I think this is a fairly big deal,” said Ronny Gal, a senior research analyst in specialty pharmaceuticals at Sanford C. Bernstein, an equity research company. “It is a new idea in a market that loves new ideas and, frankly, it works.”

David E. I. Pyott, Allergan’s chief executive, predicted that in the long term, worldwide sales of Latisse would exceed $5o0 million. And he suggested that many women would not blink at spending $120 for a one-month, three-milliliter supply of the drug. He compared the cost of longer lashes to a daily cup of coffee.

“If you think about it in terms of luxury, it’s four dollars a day,” he said. “We think this is fairly acceptable to a large segment of people even in these times.”

But one analyst, Gary Nachman, director of specialty pharmaceuticals at the investment bank Leerink Swann, said the expense of Latisse and the inconvenience of obtaining a doctor’s prescription might deter many women from trying it. Health insurance does not typically cover such cosmetic treatments.

Mr. Nachman said Latisse might have more value to Allergan as a gateway drug that brings new patients to cosmetic medicine and leads them to try Botox. He predicted Latisse would have sales of only $80 million by 2012. “I don’t think this is going to be a huge game changer,” Mr. Nachman said.

Indeed, Jennifer Nobriga, one of a pair of stay-at-home mothers behind the Web site beautyinreallife.blogspot.com, said she intends to stick with plain old mascara rather than splurge on the eyelash drug.

“It would not be at the top of my list,” said Ms. Nobriga of Woodbridge, Va. “I would rather spend the money on a good under-eye cream.”

Some doctors said that while Lumigan had a track record as a safe glaucoma drug, they were nonetheless concerned that the cosmetic version could have some of the same minor side effects.

Dr. Harry A. Quigley, a professor of ophthalmology at Johns Hopkins School of Medicine, said that frequent complaints of glaucoma patients included temporarily red eyes, itching and darker eyelid skin. But in a few glaucoma patients who used eyedrops containing a prostaglandin, he said, green or hazel irises permanently turned darker after 6 to 12 months of treatment.

“It’s like the country-western song “Don’t It Make My Brown Eyes Blue,” but in this case it’s ‘Don’t it make your blue eyes brown,’ ” Dr. Quigley said.

Allergan held a clinical trial with about 280 volunteers, half of whom used Latisse daily for 16 weeks. The study results were reviewed by the Food and Drug Administration, which approved the drug in late December. In that study, eyelashes typically grew 25 percent longer, 106 percent thicker and 18 percent darker. While 3.6 percent of patients experienced eye itching and red eyes, none had a change of eye color, Allergan said.

But the Latisse data, Dr. Quigley said, was short-term and involved too few patients to draw conclusions about side effects. “I would bow to data that says ‘we have 100,000 patients in F.D.A. studies and no one’s eye color changed.’ ”

Mr. Pyott of Allergan says that darker iris color is extremely unlikely with Latisse because each daily application to the lashes involves 5 percent of the amount prescribed to glaucoma patients. “We can assume that that kind of scale must lead to a drastically lower risk,” Mr. Pyott said.

In the application for F.D.A. approval of Latisse, Allergan established the basic safety of the drug with data from multiple studies of Lumigan. Allergan has sold 65 million bottles of Lumigan since its approval in 2002, Mr. Pyott said, with worldwide sales last year of about $430 million.

Latisse will cost slightly more than Lumigan, which is $73 to $84 for a 2.5 milliliter bottle for patients who pay for it themselves. But analysts do not expect many eye doctors to write prescriptions for people to use Lumigan only cosmetically.

Allergan plans to introduce Latisse this month, primarily to cosmetic doctors like dermatologists. Some women who have already tried Latisse are fans.

“People would say to me ‘Are you wearing false eyelashes?’ — even my own mother asked,” said Cindy Ross, vice president for sales at Young Pharmaceuticals in Wethersfield, Conn., who participated in the Latisse clinical trial.

Ms. Ross said she liked the effect so much that she had a doctor prescribe the glaucoma drug to use on her lashes until Latisse becomes commercially available. “I wouldn’t stop,” Ms. Ross said. “I found a way to get it.”

Some doctors, meanwhile, are wondering whether Latisse could be used on hair elsewhere.

“Someone will call to say ‘I am Dr. Jones in wherever, and I would like to conduct a study on eyebrows,’ ” Mr. Pyott said. “For a lot of women, the eyebrow is every bit as important as the eyelash.”