Makers Of Over-the-Counter Inhaler Leading Fight To Have Product Back On Market After Removal Due To Environmental Treaty

Primatene® Mist Critical For Millions of Asthmatics Lacking Health Insurance; All Manufacturer's Net Profits from Sales of Primatene® Mist will be Donated to Charity

WASHINGTON, July 18, 2012 /PRNewswire-USNewswire/ -- The makers of Primatene® Mist have launched a campaign to put the over-the-counter inhaler back on the market in the United States, after it was banned because it contains a small amount of chlorofluorocarbons (CFCs), leaving millions of asthmatics without an over-the-counter inhaler. The "Bring Back My Primatene®" campaign will promote a Facebook group and a petition to the Environmental Protection Agency (EPA), encouraging the agency to allow putting the remaining supply of the over-the-counter inhaler back on the market and support federal legislation with the same objective. 

Representatives of Amphastar, the company that makes Primatene® Mist, will announce the campaign as part of a House Energy and Commerce Committee Energy and Power subcommittee hearing on the "Asthma Inhalers Relief Act of 2012". The hearing will be held on July 18, 2012 at 10:15 a.m. in room 2123 of the Rayburn House Office Building. Witnesses are to be determined.

The Rancho Cucamonga, California-based pharmaceutical company, Amphastar, promises that it will donate all of the net profits from the sale of the "brought back" over-the-counter inhaler (approximately $6.50 per unit of product sold) to charity.

Primatene® Mist has been used safely by millions of people for more than 46 years to help them cope with asthma related symptoms, including shortness of breath. It was the only over-the-counter inhaler available before it was banned for sale by the EPA after December 31, 2011. This was done in accordance with the Montreal Protocol on Substances that Deplete the Ozone Layer, which was signed by the United States in 1987. That treaty determined that CFCs, which include the chemical used to propel inhalants in Primatene® Mist, were damaging the ozone layer in the upper atmosphere and should be discontinued.

The EPA has the ultimate authority to keep Primatene® Mist on the market, and has issued waivers for more expensive inhalers which also contain CFCs and require a doctor's prescription. But the EPA has not granted such a waiver to the makers of Primatene® Mist.

Before the ban, two to three million asthma sufferers in the United States relied on Primatene® Mist, because they did not have health insurance or the means to pay for a doctor's visit to get a prescription, or simply because they preferred Primatene® Mist to prescription inhalers.

"We are fighting to get Primatene® Mist back on the market, and donating all of the net profits to charity, because we believe in our product, and want it to be abundantly clear we are doing this for the millions of Americans who used to rely on Primatene® Mist and not to make money," said Jason Shandell, vice president and general counsel of Amphastar Pharmaceuticals.  "We all strive to protect the environment, but we believe it is essential to have an over-the-counter inhaler available until a replacement without CFCs is available. For the millions of Americans suffering from asthma and lacking health insurance, or those with health insurance who found Primatene® Mist was their best treatment option, we are hopeful to get these inhalers back on the market as soon as possible."

Key facts:

• Primatene® Mist is an over-the-counter (OTC) inhaler for asthma patients that has been used safely by millions of people for more than 46 years to help them cope with asthma related symptoms including shortness of breath. It is manufactured by Armstrong Pharmaceuticals, Inc. which is a wholly-owned subsidiary of Amphastar Pharmaceuticals, Inc.
• There is currently no OTC inhaler for asthma patients available.  If someone without a prescription for an inhaler is suffering from asthma symptoms, they either need to go to the emergency room -- which can cost thousands of dollars -- or simply endure the pain and shortness of breath. 
• The existing supply of Primatene® Mist inhalers (approximately 1 million units) expire in 2013, and the EPA has not granted permission for additional CFCs to be used to create additional inhalers.  If the EPA allows the current supply back on the market, it would only be until August 2013.
• Amphastar/ Armstrong has received thousands of complaints and inquiries from people who used, benefited from and want continued access to the product. 
• Amphastar has repeatedly asked for guidance from the EPA, and received no response, about how to dispose of the current supply of Primatene® Mist inhalers without releasing the CFCs into atmosphere. It is better to allow the approximately 1 million currently available units be made available to help people suffering from asthma, rather than to waste them and still have the CFCs escape into the environment.
• There are prescription inhalers still on the market which contain CFCs and they are being used by asthma sufferers.  It is difficult to understand why some prescription inhalers containing CFCs are still allowed to be sold, whereas Primatene® Mist, which was the only OTC inhaler, has been banned.

SOURCE Amphastar