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Last updated on April 25, 2014 at 1:22 EDT

The 340B Prime Vendor Program Adds AstraZeneca’s Asthma Drug SYMBICORT(R) to Its List of Branded Drugs Available for Participants

September 27, 2007

The 340B Prime Vendor Program (PVP), managed by Apexus Inc., announced today that SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler (pMDI) is now available to PVP participants for the long-term maintenance treatment of asthma in patients 12 years of age and older.

Effective Aug. 1, 2007, AstraZeneca is providing SYMBICORT to 340B Prime Vendor Program participants through the PVP, which provides low-cost drugs to clinics, hospitals and programs for low-income Americans.

Administered twice daily, SYMBICORT is a combination of two proven asthma medications — budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA). For many patients, this combination treatment offers improved asthma control as early as day one that is sustained over 12 weeks. SYMBICORT also delivers improved lung function occurring within 15 minutes of beginning treatment. The FDA requires all long-acting beta2-agonist (LABA)-containing products on the market in the U.S. to carry a boxed warning, and as a LABA-containing product, SYMBICORT is labeled appropriately.

“We are very pleased AstraZeneca has added SYMBICORT to the Prime Vendor Program contract portfolio. Their decision will go a long way toward improving the product’s access to a large segment of the patient population requiring combination therapy to control their asthma symptoms,” said Chris Hatwig, Sr. Director of the 340B Prime Vendor Program.

Asthma is one of the most serious chronic medical conditions in the United States, with an estimated 22 million Americans suffering from the disease. If not properly managed, asthma can be life-threatening. With the recent U.S. launch of SYMBICORT, for the first time, millions of asthma patients have a new choice of fixed combination treatment to help them achieve asthma control.

SYMBICORT is available in two dose strengths, 80/4.5 and 160/4.5 ug of budesonide and formoterol, respectively. SYMBICORT is approved for patients whose disease is not adequately controlled on another asthma-controller medication (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. SYMBICORT does not replace fast-acting inhalers for sudden attacks.

“AstraZeneca is committed to helping people afford the medications they need,” said Jim Helm, vice president, primary care respiratory, AstraZeneca Pharmaceuticals LP, U.S. “With the addition of SYMBICORT to the 340B Prime Vendor Program, more U.S. asthma patients will have the ability to take better control of their asthma.”

Apexus Inc. is the contractor, awarded by the Office of Pharmacy Affairs, to serve as the Prime Vendor for the 340B Program. The Prime Vendor Program was established to increase the discounts already offered under Section 340B of the U.S. Public Health Service Act, providing low-cost drugs to clinics, hospitals and programs for low-income Americans. Over 14,000 providers across the country qualify to participate in the discount program at no cost, and more than 5,300 facilities are currently enrolled. Visit the Section 340B Prime Vendor Program web site at http://www.340bpvp.com/ for more information about the program.

 Media Contact John Barnes 972.910-6634 Email Contact

SOURCE: 340B Prime Vendor Program