PARSIPPANY, N.J., April 3, 2012 --/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 LATISSE⢠(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.
Like TODAY Health stories? "Like" us on Facebook for more!
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.”
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