- Partnership Maximizes Initial Sales and Marketing Support for Potential New Antidepressant
INDIANAPOLIS, Ind. and RESEARCH TRIANGLE PARK, N.C. - July 18, 2002 - Eli Lilly and Company (NYSE: LLY) and Quintiles Transnational Corp. (Nasdaq: QTRN) announced today that Quintiles will support Lilly in its commercialization efforts for Cymbalta (duloxetine hydrochloride) in the United States. Cymbalta, a serotonin and norepinephrine reuptake inhibitor developed by Lilly, is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of depression.
"This strategic partnership ensures that we maximize the initial sales and marketing support for Cymbalta in order to optimize the launch and fully realize the significant value of this antidepressant in a highly competitive retail market. This is especially important given Cymbalta is the first of a number of neuroscience products we plan to launch from our late-stage pipeline," said Gino Santini, president, U.S. operations for Lilly. "This agreement combines our strong neuroscience expertise and significant sales and marketing efforts with Quintiles' successful track record of building highly effective contract sales forces. We look forward to partnering with them in bringing this exciting new medicine to patients with depression."
Under the agreement, Innovex, Quintiles' commercialization unit, will provide, at Quintiles' expense, more than 500 sales representatives to supplement the extensive Lilly sales force in the promotion of Cymbalta for the five years following product launch. For at least the initial three years, the Innovex sales representatives also may detail other Lilly products in coordination with Lilly sales teams. PharmaBio Development, Quintiles' strategic investment group, will make milestone and marketing payments to Lilly, including $30 million that is currently payable in the third quarter of 2002. An additional $80 million will be paid in stages following Lilly's receipt of an approval or approvable letter and launch of the product. The marketing payments will augment the initial significant marketing efforts by Lilly for Cymbalta. Lilly will pay Quintiles a percentage of U.S. Cymbalta sales for depression and other neuroscience-related indications over the five-year promotion period and a reduced royalty over the subsequent three years.
Dennis Gillings, Ph.D., chairman for Quintiles Transnational, said, "We are especially pleased to partner with Lilly in this alliance. In forging this innovative agreement, Quintiles has further demonstrated its capabilities for partnering with major pharmaceutical companies. Our PharmaBio group continues to expand its strong portfolio of commercialization partnerships across several therapeutic areas. Some of these products are starting to manifest their potential and we look forward to continuing to build on this successful model."
More than 19 million Americans suffer from depression each year and many of these patients still have unmet medical needs. In fact, more than two-thirds of patients treated for depression will not fully recover. In addition, despite the improvements in tolerability with some antidepressants, at least one in three patients does not tolerate an appropriate course of therapy. Consequently, there is significant market potential for new treatments that address these unmet needs in the antidepressant market.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
About Quintiles
Quintiles Transnational helps improve health care worldwide by providing a broad range of professional services, information and partnering solutions for the pharmaceutical, biotechnology and health care industries. Headquartered near Research Triangle Park, North Carolina, Quintiles is a member of the S&P 500 and Fortune 1000. For more information, visit the company's Web site at www.quintiles.com.
This press release contains forward-looking statements about the potential of the investigational compound Cymbalta in treating depression that reflect management's current beliefs. However, as with any pharmaceutical under development, there are risks and uncertainties in the process of development and regulatory review. Quintiles and Lilly are subject to the risks of whether the product will receive regulatory approvals or prove to be commercially successful. In addition, royalty payments to Quintiles under the agreement may not be adequate to offset Quintiles' expenses in providing the sales force or in making milestone and marketing payments. For further discussion of these and other risks and uncertainties, see Exhibit 99 to the most recent Lilly Form 10-Q filed with the SEC in May 2002. Additional factors that could cause actual results to differ materially are discussed in Quintiles' recent filings with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K, its Form 8-Ks, and its other periodic reports, including Form 10-Qs.