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Partnering up for mutual gain
RESEARCH TRIANGLE PARK, N.C.—Quintiles Transnational Corp. touts itself as the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide, as it "helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant." The end of October and beginning of November saw the company use one of its subsidiaries to do that philosophy one better and secure two strategic alliances for itself—with AstraZeneca in the European Union and Eisai Co. in Japan.
Through its NovaQuest company, which structures and manages unique alliances with biopharma, Quintiles struck an alliance with AstraZeneca to deliver its clinical pharmacology studies across multiple therapy areas and around the globe, and formed a strategic alliance with leading global pharmaceutical company Eisai to develop six potential oncology products in its research and development pipeline.
"[Our] breadth and depth enable Quintiles to work with pharma to concentrate on outcomes not projects. Through NovaQuest, a Quintiles company, we also structure and manage unique alliances with biopharma," notes Mari Mansfield, senior director of global corporate communication for Quintiles. "These alliances, which may or may not include a capital component, enable biopharma to transform its business both today and into the future. Importantly, we don't simply set up partnerships and hand them off. NovaQuest stays involved to ensure that both parties fully realize the benefits of the partnership. We are a true ally to our customers, and we believe that this is a real differentiator within our industry. The AstraZeneca and Eisai deals are examples of this approach."
Of course, they are also examples of Quintiles being a partner and not just a facilitator, and as NovaQuest Vice President Geoff Owen notes, this marks the second and third big risk-sharing deals that NovaQuest has signed for partnerships with Quintiles itself this year, following a major co-promotion deal with U.S.-based Allegan in late September. And since 2000, he notes, NovaQuest has created and managed more than 80 risk-based partnerships, facilitating more than $2.7 billion of capital.
Looking to the first of these two most recent Quintiles alliances, Owen says Quintiles is proud to be partnering with Eisai to bring risk-based capital to early-stage oncology development, "at a time when very few others are taking this type of approach."
"We're offering biopharma companies, in this case, Eisai, a transformational tool," he adds. "Together, we are sharing the risk of early-stage oncology development, while simultaneously providing Eisai with expanded expertise, infrastructure and capital."
Under the terms of the agreement, Quintiles' oncology experts will conduct Phase II proof-of-concept studies for 11 solid tumor indications, with a key goal being to determine the efficacy of the products in the shortest possible time in order to bring therapies to market faster. The alliance will be structured on a risk-sharing basis, with Quintiles funding, in part, the design and conduct of the clinical studies in exchange for success milestone payments. Other financial terms were not disclosed. The agreement is designed to enable Eisai to extend its oncology program, increasing the number of indications investigated for the six potential products, including eribulin (E7389), E7080, Ontak (denileukin diftitox), E7820, E6201 and E7050. These assets will remain the property of Eisai, with Quintiles having development accountability through the Phase II proof-of-concept stage. In addition to projects covered under the agreement with Quintiles, Eisai will continue ongoing development of 18 additional indications for the same six compounds.
"Quintiles has first-hand experience in working with partners to rebalance operational, portfolio and resource risk," says Ron Wooten, executive vice president of Quintiles corporate development. "This goes beyond the traditional boundaries of the pharma business model, offering a more nimble, modular and variable way of leveraging resources to increase the value of assets."
Although Quintiles operates facilities in about 20 Asian cities—from Singapore to Seoul, Beijing to Bangalore, and Tokyo to Taipei—this is the first deal of this kind that it has inked with a Japanese company, Owen says.
"I am pleased that Quintiles and Eisai share the same goals and our incentives are aligned for speed, quality and efficiency," notes Hideki Hayashi, senior vice president and chief product creation officer for Eisai. "We will explore multiple indications in parallel so that we can deliver our compounds as fast, widely and appropriately as possible for cancer patients' benefit."
Quintiles reports that it brings a unique core strength in oncology product development to the partnership with Eisai, in part because since 2000, Quintiles has conducted 640 oncology studies, involving more than 131,000 patients at nearly 20,000 investigator sites in 68 countries. The company also helped develop or commercialize many of today's most widely prescribed anticancer drugs. All of this is bolstered by added expertise in clinical oncology biomarker development, courtesy of Quintiles having recently acquired Targeted Molecular Diagnostics.
The deal with AstraZeneca, announced three days later, involves Quintiles assuming the operational responsibilities for the majority of AstraZeneca's clinical pharmacology delivery. As they work together, AstraZeneca and Quintiles says they will focus their efforts on leveraging leading-edge science and establishing operational efficiency and consistency to support AstraZeneca's goal to shorten delivery timelines and bring innovative medicines more quickly to patients.
The alliance is extensive and involves the engagement of a sole provider for clinical pharmacology delivery, with a simple, standardized pricing model, Wooten says. In addition to clinical conduct and medical oversight of studies, the agreement is said to cover "a range of activities across the end-to-end study process."
"This model gives us access to the right scientific and medical expertise plus the quality, flexibility and capacity we need to work efficiently and cost-effectively to deliver these studies," notes Anders Ekblom, executive vice president for global drug development for AstraZeneca.
Quintiles has been working successfully on a number of early-phase projects for Astra Zeneca over the past few years, and it was that existing relationship and AstraZeneca's experience of Quintiles' commitment to quality delivery that set the scene for discussing a strategic alliance, says Eddie Caffrey, senior vice president, Global Phase I for Quintiles.
Although it is not an all-inclusive list of what Quintiles will do for AstraZeneca, Caffrey says that pharmacokinetic, pharmacodynamic and bioavailability studies are among the major areas of interest.
"I am very proud that we were selected to take on this key role for AstraZeneca. It means we are being recognized as having the talented and engaged people we need to deliver on our promises," Caffrey says. "I believe passionately that the biopharmaceutical industry must bring new drugs to market faster, and with greater predictability, to address declining research and development productivity. The smartest move is to invest in intelligent, early-stage development because, when done well, it has significant impact on speed and cost of the overall development process. We must not forget that people are living longer and leading more productive lives as a result of these new medicines."
Quintiles and Allergan announce co-promotion agreement
By Jeffrey Bouley
RESEARCH TRIANGLE PARK, N.C.—Although the Eisai and AstraZeneca deals are more recent and a bit splashier, they actually represent the second and third of three big strategic alliance, risk-sharing-style deals in 2009 for Quintiles that were signed through its subsidiary company, NovaQuest. The first was a co-promotion deal with Irvine, Calif.-based Allergan, under which Quintiles will co-promote Allergan's Sanctura XR (trospium chloride extended release capsules), an anticholinergic approved for the treatment of overactive bladder in the United States.
Under the terms of the agreement, Quintiles will leverage its expertise in the primary care channel to rapidly deploy a specialized sales force to detail Sanctura XR until Dec. 31, 2011. Allergan will continue its promotion of Sanctura XR in the urology specialty channel using its existing sales force. As part of the agreement, Quintiles will recruit and hire the new sales force, maintain responsibility for its performance and contribute to Allergan's investment in consumer and professional marketing. Allergan will continue to record all sales of Sanctura XR to physicians and provide royalty payments to Quintiles through the end of 2013.
"This strategic partnership will allow us to maximize our sales and marketing support for Sanctura XR by extending our own sales force capacity and establishing our presence in the primary care channel so that we can reach more patients and fully realize the value of this important medication," said Julian Gangolli, Allergan's corporate vice president and president for North America, in the news release about the deal.
"In today's rapidly changing pharmaceutical environment, a greater number of companies are realizing the benefits of strategic partnerships to communicate with and educate physicians and patients in a targeted and cost-efficient manner," says Ron Wooten, executive vice president, corporate development of Quintiles, when the deal was announced. "Allergan and Quintiles are innovators in the life sciences industry, leveraging our core competencies and resources to improve patients' lives and achieve commercial success to continue investing in scientific advancements. We look forward to partnering with Allergan in offering Sanctura XR to primary care physicians."