Posted by: bibmomma | September 1, 2010

Letter From MERCK About SINEMET Shortage

Heinrich Emanuel Merck

Decendants of Heinrich Emanual Merck, an apothecary, founded Merck Co.

I received a copy of this letter from the Parkinson’s Action Network yesterday regarding the shortage of Sinemet world-wide.  I hope this helps answer some of your questions regarding the shortage and how MERCK is responding to it.

Michael Rosenblatt, M.D. Merck & Co., Inc.
Executive Vice President WS3A-20
Chief Medical Officer One Merck Drive

P. O. Box 100
Whitehouse Station, NJ 08889
michael.rosenblatt@merck.com
Tel 908 423 6446
Fax 908 423 1447
August 19, 2010

Amy Comstock Rick, J.D.
Chief Executive Officer
Parkinson’s Action Network
1025 Vermont Avenue, Suite 1120
Washington D.C. 20005

Dear Ms. Rick:

Merck (known as MSD outside the U.S. and Canada) is currently managing a temporary global
supply shortage of SINEMET® (carbidopa-levodopa) and SINEMET CR® (carbidopa-levodopa
controlled release), which are Merck’s Parkinson’s disease products. I would like to personally
express our sincere apology for this supply interruption. Merck is doing its best to restore
supplies as soon as possible and sincerely regrets any inconvenience or distress this
interruption has caused to people who rely on SINEMET.

The extent of this supply shortage varies from country to country. Although our supply
estimates change from time to time, all dosage strengths of SINEMET IR (immediate release)
are now fully available in most countries, and SINEMET CR is in the process of being resupplied.
We expect SINEMET CR to be fully available by mid 2011 to most countries,
contingent on regulatory approvals. With respect to your question about the supply status of
SINEMET in the United States, supply is currently available. Attached is a grid that provides a
summary of current supply status in the U.S., Canada, and Europe. Please note that while
Merck manufactures SINEMET for supply in the United States, as well as globally, Bristol Myers
Squibb distributes the product in the United States.

The global supply shortage arose as Merck changed the supply source of an active ingredient
used in SINEMET, a process that requires qualification of the new active ingredient to meet
Merck standards and regulatory approvals of the source change. The shortage is not related to
any product safety or quality issues. Merck continues to work with regulatory authorities to
obtain the necessary approvals of the source change. In the meantime, we are managing
available supply of SINEMET through an allocation system to optimize use of available stock.
The allocation system primarily takes into account various considerations, including availability
of alternative generic equivalents, contract requirements, and patient needs.

Amy Comstock Rick, J.D. August 19, 2010 Page Two

For obvious ethical reasons, whether alternative generic equivalents are available from other
manufacturers in a country is an important criterion we take into consideration for supply
allocations. With respect to these generic equivalents – which are tablets containing the same
active ingredient as SINEMET – Merck understands how difficult it is for any patient who may
not be able to receive their usual medication. We know that it can be difficult to find the
optimum treatment regimen for Parkinson’s patients and we know that it can be difficult to
change therapies. While we recognize that some patients may object to having their physicians
switch their therapy from a branded to a generic medicine, it is a medically appropriate option
and a common occurrence in clinical practice. We encourage all patients and caregivers who
have questions about their treatment options to speak to their health care provider.

Any patient, caregiver or health care professional in the United States who has a medical
information question about SINEMET should contact Bristol-Myers Squibb’s Medical Information
Center at 1-800-321-1335.

Please be assured that Merck takes this matter very seriously and intends to always act in the
best interests of patients in these difficult circumstances. We are committed to urgently working
towards a stable supply of SINEMET as soon as possible.

Sincerely,

Dr. Michael Rosenblatt
Chief Medical Officer
Merck & Co., Inc.
One Merck Drive
Whitehouse Station, NJ 08889

Country SINEMET CR SINEMET IR
Belgium Available* Available*
Canada Available* Available*
Israel Available* Not marketed
Luxembourg Available* Available*
Poland Available* Not marketed
Portugal Available* Available
Spain
France
Available*
Available* 2nd half 2010
Available*
Available*
Germany
Italy
UK
Available* 2nd half 2010
Available* 2nd half 2010 contingent on regulatory approval
Available* 2nd half 2010
Available*
Available*
Available*
U.S. Available* Available*
Austria Early to mid 2011 contingent on regulatory approval Available*
Bulgaria Early to mid 2011 contingent on regulatory approval Available*
Czech Republic Early to mid 2011 contingent on regulatory approval Not marketed
Estonia Early to mid 2011 contingent on regulatory approval Available*
Faeroe Islands Early to mid 2011 contingent on regulatory approval Available*
Finland Early to mid 2011 contingent on regulatory approval Available*
Hungary Early to mid 2011 contingent on regulatory approval Not marketed
Iceland Early to mid 2011 contingent on regulatory approval Available*
Lithuania Early to mid 2011 contingent on regulatory approval Available*
Norway Early to mid 2011 contingent on regulatory approval Available*
Sweden Early to mid 2011 contingent on regulatory approval Available*
Switzerland Early to mid 2011 contingent on regulatory approval Available*
Cyprus Mid to late 2011 contingent on regulatory approval Available*
Denmark Mid to late 2011 contingent on regulatory approval Available*
Ireland Mid to late 2011 contingent on regulatory approval Available*
Netherlands Mid to late 2011 contingent on regulatory approval Available*
Croatia Not marketed Not marketed
Georgia Not marketed Available*
Greece Not marketed Available*
Romania Not marketed Available*
Russia Not marketed Available*
Slovenia Not marketed Available*
Turkey Not marketed Available*
Ukraine Not marketed Available*
Malta Not marketed Not marketed
Serbia Not marketed Not marketed

* Periodic interruptions in supply may occur until such time that product is re-supplied to full
stock levels.
Information current as of August 16, 2010.

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