RESEARCH TRIANGLE PARK, N.C.—Quintiles Transnational Corp.touts itself as the only fully integrated biopharmaceutical services companyoffering clinical, commercial, consulting and capital solutions worldwide, asit "helps biopharmaceutical companies navigate risk and seize opportunities inan environment where change is constant." The end of October and beginning ofNovember saw the company use one of its subsidiaries to do that philosophy onebetter and secure two strategic alliances for itself—with AstraZeneca in theEuropean Union and Eisai Co. in Japan.
Through its NovaQuest company, which structures and managesunique alliances with biopharma, Quintiles struck an alliance with AstraZenecato deliver its clinical pharmacology studies across multiple therapy areas andaround the globe, and formed a strategic alliance with leading globalpharmaceutical company Eisai to develop six potential oncology products in itsresearch and development pipeline.
"[Our] breadth and depth enable Quintiles to work withpharma to concentrate on outcomes not projects. Through NovaQuest, a Quintilescompany, we also structure and manage unique alliances with biopharma," notesMari Mansfield, senior director of global corporate communication forQuintiles. "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. NovaQueststays involved to ensure that both parties fully realize the benefits of thepartnership. We are a true ally to our customers, and we believe that this is areal differentiator within our industry. The AstraZeneca and Eisai deals areexamples of this approach."
Of course, they are also examples of Quintiles being apartner and not just a facilitator, and as NovaQuest Vice President Geoff Owennotes, this marks the second and third big risk-sharing deals that NovaQuesthas signed for partnerships with Quintiles itself this year, following a majorco-promotion deal with U.S.-based Allegan in late September. And since 2000, henotes, 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 Quintilesalliances, Owen says Quintiles is proud to be partnering with Eisai to bringrisk-based capital to early-stage oncology development, "at a time when veryfew others are taking this type of approach."
"We're offering biopharma companies, in this case, Eisai, atransformational tool," he adds. "Together, we are sharing the risk ofearly-stage oncology development, while simultaneously providing Eisai withexpanded expertise, infrastructure and capital."
Under the terms of the agreement, Quintiles' oncologyexperts will conduct Phase II proof-of-concept studies for 11 solid tumorindications, with a key goal being to determine the efficacy of the products inthe shortest possible time in order to bring therapies to market faster. Thealliance will be structured on a risk-sharing basis, with Quintiles funding, inpart, the design and conduct of the clinical studies in exchange for successmilestone payments. Other financial terms were not disclosed. The agreement isdesigned to enable Eisai to extend its oncology program, increasing the numberof indications investigated for the six potential products, including eribulin(E7389), E7080, Ontak (denileukin diftitox), E7820, E6201 and E7050. Theseassets will remain the property of Eisai, with Quintiles having developmentaccountability through the Phase II proof-of-concept stage. In addition toprojects covered under the agreement with Quintiles, Eisai will continueongoing development of 18 additional indications for the same six compounds.
"Quintiles has first-hand experience in working withpartners to rebalance operational, portfolio and resource risk," says RonWooten, executive vice president of Quintiles corporate development. "This goesbeyond the traditional boundaries of the pharma business model, offering a morenimble, modular and variable way of leveraging resources to increase the valueof assets."
Although Quintiles operates facilities in about 20 Asiancities—from Singapore to Seoul, Beijing to Bangalore, and Tokyo to Taipei—thisis the first deal of this kind that it has inked with a Japanese company, Owensays.
"I am pleased that Quintiles and Eisai share the same goalsand our incentives are aligned for speed, quality and efficiency," notes HidekiHayashi, senior vice president and chief product creation officer for Eisai."We will explore multiple indications in parallel so that we can deliver ourcompounds as fast, widely and appropriately as possible for cancer patients'benefit."
Quintiles reports that it brings a unique core strength inoncology product development to the partnership with Eisai, in part becausesince 2000, Quintiles has conducted 640 oncology studies, involving more than131,000 patients at nearly 20,000 investigator sites in 68 countries. Thecompany also helped develop or commercialize many of today's most widelyprescribed anticancer drugs. All of this is bolstered by added expertise inclinical oncology biomarker development, courtesy of Quintiles having recentlyacquired Targeted Molecular Diagnostics.
The deal with AstraZeneca, announced three days later,involves Quintiles assuming the operational responsibilities for the majorityof AstraZeneca's clinical pharmacology delivery. As they work together,AstraZeneca and Quintiles says they will focus their efforts on leveragingleading-edge science and establishing operational efficiency and consistency tosupport AstraZeneca's goal to shorten delivery timelines and bring innovativemedicines more quickly to patients.
The alliance is extensive and involves the engagement of asole provider for clinical pharmacology delivery, with a simple, standardizedpricing model, Wooten says. In addition to clinical conduct and medicaloversight of studies, the agreement is said to cover "a range of activitiesacross the end-to-end study process."
"This model gives us access to the right scientific andmedical expertise plus the quality, flexibility and capacity we need to workefficiently and cost-effectively to deliver these studies," notes AndersEkblom, executive vice president for global drug development for AstraZeneca.
Quintiles has been working successfully on a number ofearly-phase projects for Astra Zeneca over the past few years, and it was thatexisting relationship and AstraZeneca's experience of Quintiles' commitment toquality delivery that set the scene for discussing a strategic alliance, saysEddie Caffrey, senior vice president, Global Phase I for Quintiles.
Although it is not an all-inclusive list of what Quintileswill do for AstraZeneca, Caffrey says that pharmacokinetic, pharmacodynamic andbioavailability studies are among the major areas of interest.
"I am very proud that we were selected to take on this keyrole for AstraZeneca. It means we are being recognized as having the talentedand engaged people we need to deliver on our promises," Caffrey says. "Ibelieve passionately that the biopharmaceutical industry must bring new drugsto market faster, and with greater predictability, to address declining researchand development productivity. The smartest move is to invest in intelligent,early-stage development because, when done well, it has significant impact onspeed and cost of the overall development process. We must not forget thatpeople are living longer and leading more productive lives as a result of thesenew medicines."
Quintiles and Allergan announce co-promotion agreement
By Jeffrey Bouley
RESEARCH TRIANGLE PARK, N.C.—Although the Eisai andAstraZeneca deals are more recent and a bit splashier, they actually representthe second and third of three big strategic alliance, risk-sharing-style dealsin 2009 for Quintiles that were signed through its subsidiary company,NovaQuest. The first was a co-promotion deal with Irvine, Calif.-basedAllergan, under which Quintiles will co-promote Allergan's Sanctura XR(trospium chloride extended release capsules), an anticholinergic approved forthe treatment of overactive bladder in the United States.
Under the terms of the agreement, Quintiles will leverageits expertise in the primary care channel to rapidly deploy a specialized salesforce to detail Sanctura XR until Dec. 31, 2011. Allergan will continue itspromotion of Sanctura XR in the urology specialty channel using its existingsales force. As part of the agreement, Quintiles will recruit and hire the newsales force, maintain responsibility for its performance and contribute toAllergan's investment in consumer and professional marketing. Allergan willcontinue to record all sales of Sanctura XR to physicians and provide royaltypayments to Quintiles through the end of 2013.
"This strategic partnership will allow us to maximize oursales and marketing support for Sanctura XR by extending our own sales forcecapacity and establishing our presence in the primary care channel so that wecan reach more patients and fully realize the value of this importantmedication," said Julian Gangolli, Allergan's corporate vice president andpresident for North America, in the news release about the deal.
"In today's rapidly changing pharmaceutical environment, a greaternumber of companies are realizing the benefits of strategic partnerships tocommunicate with and educate physicians and patients in a targeted andcost-efficient manner," says Ron Wooten, executive vice president, corporatedevelopment of Quintiles, when the deal was announced. "Allergan and Quintilesare innovators in the life sciences industry, leveraging our core competenciesand resources to improve patients' lives and achieve commercial success tocontinue investing in scientific advancements. We look forward to partneringwith Allergan in offering Sanctura XR to primary care physicians."