King and Inyx Establish Ten-Year Co-Marketing Collaboration for King's Intal and Tilade Respiratory Products
08 September 2005
King Pharmaceuticals, Inc. has entered into a strategic collaboration relating to Intal® (cromolyn sodium) and Tilade® (nedocromil sodium), which includes the continued development of a new formulation of Intal® utilizing hydrofluoroalkane (HFA), an environmentally friendly propellant. Intal® and Tilade® are King's currently marketed inhaled anti-inflammatory agents for the management of asthma.
Brian A. Markison, President and Chief Executive Officer of King, stated, "Inyx's focus on respiratory products and technical expertise with aerosol delivery provide King with a good strategic partner for enhancing the development and growth of our lead respiratory products, Intal® and Tilade®. These capabilities should prove particularly valuable as we collaborate with Inyx to continue the development of an HFA formulation of Intal®." Mr. Markison added, "Inyx will have many of the manufacturing responsibilities related to the production of our Intal® and Tilade® product lines. We believe that Inyx's manufacturing capabilities should provide a high quality continuous supply of these products."
"We are extremely pleased to enter into this strategic alliance with King Pharmaceuticals. The contractual relationship with King is expected to generate significant revenues and income for Inyx starting in 2006 and building in coming years," said Jack Kachkar, M.D., Chairman and Chief Executive Officer of Inyx.
The strategic alliance includes several 10-year agreements, with renewal options, and the formation of an Alliance Management Committee comprised of three senior executives from each company. Pursuant to the agreements, King and Inyx will co-market Intal® and Tilade® and each have a share in net revenues. King will continue marketing to hospitals and primarycare physicians, while Inyx will pursue direct sales to the specialist markets, including pediatricians, allergists and pulmonologists. Inyx also plans to supervise the distribution of Intal® HFA in Canada, following the receipt of necessary Canadian regulatory approval.
"This is Inyx's first revenue-sharing deal with a client, and it is the single most material agreement that Inyx has signed to date," said Inyx CEO Dr. Kachkar. Inyx's co-marketing of Intal® and Tilade® will be conducted by a newly established wholly owned Inyx subsidiary, Exaeris, Inc., which will be independent of the company's contract development and manufacturing operations.
About Intal® and Tilade®
Intal® and Tilade® are the only mast-cell stabilizers (non-steroidal anti-inflammatory, nonbeta-2 agonist agents) currently available for the treatment of asthma. Intal® is administered with either an inhaler or a nebulizer and is indicated for the long-term management of bronchial asthma in adults and children five years of age or older. Intal® is not indicated for the treatment of acute asthma attacks. Intal® is contraindicated in patients with known hypersensitivities to cromolyn sodium. Tilade® is administered with an inhaler and is indicated for the long-term treatment of bronchial asthma and associated chronic cough in adults.
Tilade® is not a bronchodilator and, therefore, should not be used for the reversal of acute bronchospasm. A new Intal® inhaler formulation utilizing hydrofluoroalkane, an environmentally friendly propellant, is currently under review by the U.S. Food and Drug Administration. The HFA formulation of Intal® is patented in the United States until September 2017.
