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8-K - FORM 8-K - AVANIR PHARMACEUTICALS, INC. | a59613e8vk.htm |
Exhibit 99.1
Congress of the United States
Washington, DC 20515
May 23, 2011
Keith Katkin
President and CEO
Avanir Pharmaceuticals
101 Enterprise, Suite 300
Aliso Viejo, CA 92656
President and CEO
Avanir Pharmaceuticals
101 Enterprise, Suite 300
Aliso Viejo, CA 92656
Dear Mr. Katkin:
As Members of Congress with leadership positions on Committees of jurisdiction over health care
issues, we take very seriously our responsibility to protect the interests of our nations health
consumers and taxpayers, and the public and private health care systems that they pay and rely on
for affordable drugs.
As such, we continue to be concerned about high drug prices generally, and specifically with
reports that your company is charging high prices for Nuedexta, a medication used to treat
involuntary emotional outbursts known as pseudobulbar affect. Neudexta is a combination of
quinidine and dextromethorphane, generic drugs that have been available for decades and cost a
fraction of Neudexta. In October 2010, Avanir obtained FDA approval for this combination and
received a three year term of exclusive marketing. Although we recognize that we all benefit when
FDA approves a new, safe and effective formulation, it is not clear that the significantly higher
prices charged for this drug are justified given that it is merely a combination of long-used and
inexpensive generic medications.
Doctors and patients were understandably upset at the news that this drug, once available for about
$20, was now going to be $600. In order to address these concerns, we request that Avanir
Pharmaceuticals submit written documentation in response to the following questions and requests
for information. The Attachment of this letter will specify in full detail what materials are to
be included in response to this request.
1. | What was the total cost of the clinical trials that led to the approval of Nuedexta? Please detail all expenditures. Has the company committed to post-market studies, and if so, what is the cost of those studies? | ||
2. | Please provide copies of all correspondence with FDA related to Nuedexta, including emails and formal letters. | ||
3. | How was the initial list price of Nuedexta established? Please provide all internal documentation relating to the determination of the price, including but not limited to emails, correspondence with shareholders, and internal memos. | ||
4. | How much has Avanir Pharmaceuticals spent on marketing Nuedexta since its approval? How much does Avanir Pharmaceuticals plan to spend on marketing this drug in the next year? What percentage of the marketing budget will be directed to Nuedexta over the next year? | ||
5. | Some analysts project revenue from Nuedexta to be approximately $4,365/patient after stocking fees and discounts are subtracted from Nuedextas stated annual wholesale cost of $5,868. Is this accurate? What is the total cost, and estimated unit costs, to manufacture Nuedexta, and the components of such costs? What are the expected revenues and profits from sales of Nuedexta? What are the anticipated revenues and profits from sales of Nuedexta to Medicare, Medicaid, and other federal or state health care programs? | ||
6. | Is Nuedexta available outside the United States? If so, what is the list price and profit margin in all other countries? |
7. | How many people have taken advantage of co-pay cards made available by Avanir to reduce the out-of-pocket cost of Nuedexta? | ||
8. | How much is Avanir Pharmaceuticals projecting in Nuedexta sales and profits for fiscal year 2011? |
Please furnish this documentation by electronic mail, fax, or hand delivery, no later than close of
business on June 10, 2011. Any questions concerning this request may be directed to Jack Mitchell
or Sarah Molinoff of the Senate Special Committee on Aging staff at (202) 224-5364. Thank you.
Sincerely, |
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/s/ Herb Kohl | ||||
Senator Herb Kohl | ||||
/s/ Henry Waxman | ||||
Congressman Henry Waxman | ||||
/s/ Frank Pallone | ||||
Congressman Frank Pallone | ||||
/s/ Diana DeGette | ||||
Congresswoman Diana DeGette | ||||