Valeant Pharmaceuticals Acquires U.S. Rights to Targretin® from Eisai Inc.

Valeant Pharmaceuticals Acquires U.S. Rights to Targretin® from Eisai Inc. 
WOODCLIFF LAKE, NJ. and MONTREAL, Quebec, Feb. 21, 2013 /CNW/ - Eisai Inc., 
the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., and Valeant 
Pharmaceuticals International, Inc. (NYSE: VRX)(TSX: VRX) announced today that 
Valeant has acquired U.S. rights for Targretin(®) (bexarotene) capsules and 
Targretin(®) (bexarotene) gel 1% from Eisai for $65 million upfront, plus 
potential contingent payments based on certain milestones. 
(Photo: http://photos.prnewswire.com/prnh/20130221/LA63958) 
As part of the transaction, which takes effect immediately, Eisai has 
transferred the New Drug Application (NDA) for Targretin to Valeant, with 
Valeant assuming responsibilities for all regulatory obligations associated 
with the product in the United States. Eisai will retain its rights to 
Targretin outside of the United States and continue to meet the needs of its 
distribution partners outside of the United States. 
Targretin Capsules 
Indication Targretin (bexarotene) capsules are used to treat the skin problems 
arising from a disease called cutaneous T-cell lymphoma, or CTCL when at least 
one systemic therapy has not worked. Your doctor must supervise the use of 
Targretin capsules. 
Important Safety Information Do not take Targretin® capsules if you are 
pregnant or if you plan to become pregnant. 


    --  Targretin® capsules may harm your fetus (unborn baby). You
        should contact your doctor immediately if you believe or
        suspect you are pregnant while you are taking Targretin®
        capsules and until one month after you stop taking Targretin®
        capsules.
    --  If you are capable of becoming pregnant, you must have a
        pregnancy test within one week before you start Targretin®
        capsule therapy and monthly while you are taking, confirming
        you are not pregnant.
    --  You must use effective contraception (birth control)
        continuously starting one month before beginning treatment with
        Targretin® capsules until one month after you stop taking
        Targretin® capsules. It is strongly recommended that two
        reliable forms of contraception be used together. At least one
        of these two forms of contraception should include condoms,
        diaphragms, cervical caps, IUDs, or spermicides.
    --  If you are male and your partner is pregnant or capable of
        becoming pregnant, you should discuss with your doctor the
        precautions you should take.

Do not take Targretin capsules if you are allergic to this medicine or 
retinoid medications (for example: Accutane® [isotretinoin], Soriatane® 
[acitretin], Tegison [etretinate], Vesinoid® [tretinoin])‡.

Targretin capsules can greatly increase blood levels of lipids (triglycerides 
and cholesterol) and these levels must be monitored and, if elevated, treated.

Targretin capsules can cause an underactive thyroid and periodic blood tests 
will be needed to detect this. Medication to control the condition may be 
necessary.

Before you start to take this medicine, tell your doctor if you are pregnant, 
have or previously had an inflamed pancreas, are breastfeeding, are taking 
gemfibrozil (Lopid®)* a medicine to reduce high triglyceride cholesterol 
levels in the blood, or are taking tamoxifen (Nolvadex®)†.

Your skin may become more sensitive to sunlight while taking this medicine. 
Minimize exposure to sunlight and do not use a sunlamp.

The most common side effects with Targretin capsules are increase in blood 
lipids, headache, weakness, underactive thyroid, decreased white blood cells 
and diarrhea.

Please also see full prescribing information including boxed warning and 
patient instructions for use.

Targretin Gel

Indication Targretin gel is used to treat the skin problems arising from a 
disease called cutaneous T-cell lymphoma, or CTCL (stage I) when other 
therapies have not worked or were not tolerated. Your doctor must instruct you 
on the proper use of Targretin gel.

Important Safety Information Do not use Targretin gel if you are pregnant or 
if you plan to become pregnant. Targretin gel may harm your fetus (unborn 
baby). You should contact your doctor immediately if you believe or suspect 
you are pregnant while you are using Targretin gel and until one month after 
you stop using Targretin gel. Do not use Targretin gel if you are breast 
feeding.

Do not use Targretin gel if you are allergic to this medicine or retinoid 
medications (for example: Accutane ® [isotretinoin], Soriatane® [acitretin], 
Tegison [etretinate], Vesinoid® [tretinoin]).

Because vitamin A in large doses may cause some side effects which are similar 
to those seen in patients applying Targretin gel, do not take more than the 
recommended daily dietary allowance of vitamin A (4000 to 5000 International 
Units). If you are not sure, ask your doctor or pharmacist.

Do not apply Targretin gel to the healthy skin around the lesion and avoid 
application of the gel on or near mucosal surfaces of the body such as eyes, 
nostrils, mouth, lips, vagina, tip of the penis, rectum, or anus.

Your skin may become more sensitive to sunlight while using this medicine. 
Minimize exposure to sunlight and do not use a sunlamp.

Do not use insect repellents or other products containing DEET while using 
Targretin gel.

Store Targretin gel at room temperature. Keep away from heat or flame.

The most common side effects include redness, itching, burning, irritation and 
scaling at the area of application.

Please also see full prescribing information including boxed warning and 
patient instructions for use.

Eisai Inc.  Eisai Inc. was established in 1995 and began marketing its first 
product in the United States in 1997. Since that time, Eisai Inc. has rapidly 
grown to become a fully integrated pharmaceutical business. Eisai's key areas 
of commercial focus are neurology and oncology. The company serves as the U.S. 
pharmaceutical operation of Eisai Co., Ltd., a research-based human health 
care (hhc) company that discovers, develops and markets products throughout 
the world.

Eisai has a global product creation organization that includes U.S.-based R&D 
facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as 
well as manufacturing facilities in Maryland and North Carolina. The company's 
areas of R&D focus include neuroscience; oncology; vascular, inflammatory and 
immunological reaction; and antibody-based programs. For more information 
about Eisai, please visit www.eisai.com/US.

Eisai Co., Ltd. Eisai Co., Ltd. is a research-based human health care (hhc) 
company that discovers, develops and markets products throughout the world. 
Through a global network of research facilities, manufacturing sites and 
marketing subsidiaries, Eisai actively participates in all aspects of the 
worldwide healthcare system.

Valeant Pharmaceuticals International, Inc. Valeant Pharmaceuticals 
International, Inc. (NYSE/TSX: VRX) is a multinational specialty 
pharmaceutical company that develops, manufactures and markets a broad range 
of pharmaceutical products primarily in the areas of dermatology, neurology,  
and branded generics. More information about Valeant Pharmaceuticals 
International, Inc. can be found at www.valeant.com.

(Logo: http://photos.prnewswire.com/prnh/20101025/LA87217LOGO)

 _____________________________________________________
|Eisai          |                  |Valeant           |
|_______________|__________________|__________________|
|Media Inquiries|Investor Inquiries|Investor Inquiries|
|_______________|__________________|__________________|
|Lynn Kenney    |Alex Scott        |Laurie W. Little  |
|_______________|__________________|__________________|
|908-442-6103   |201-746-2177      |949-461-6002      |
|_______________|__________________|__________________|

http://www.valeant.com

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SOURCE: Valeant Pharmaceuticals International, Inc.

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CO: Valeant Pharmaceuticals International, Inc.
ST: Quebec
NI: HEA MTC ORDER 

-0- Feb/21/2013 13:03 GMT


 
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