With goals of cutting staggering development costs and also perhaps speeding the path to market, Quintiles (NYSE: Q) is launching what it says is a first-of-a-kind drug development deal with Merck Serono in which they will collaborate on clinical development based on the “expertise and experience” of each partner.
Under an exclusive five-year contract, Quintiles will be the provider of drug development services to Merck Serono and also will be deeply involved in designing research and study protocols to evaluate and test Serono-developed compounds.
Quintiles, fresh off an IPO that produced $1 billion for investors and the company last week, has helped develop or commercialize all of the top-50 best-selling drugs now available.
“The companies will work together as a single clinical development team to determine the best development approaches for all drug candidates within the Merck Serono portfolio,” Phil Bridges, head of corporate media relations for Quintiles, told WRALTechWire.
Merck Serono is part of Germany-based Merck KGaA, which is separate from U.S.-based Merck. Subsidiaries of Merck KGaA in the U.S. and Canada operate under the brand EMD.
By striking the deal, Serono gains access to scientific and business expertise Quintiles has developed over the past 30 years in becoming the world’s lagrest life science services and contract research companies.
“Quintiles will provide relevant input in the concept to protocol phase alongside Merck Serono, in addition to the conduct phase of a trial,” Bridges explained. “Quintiles’ processes and technologies will be utilized to streamline overall approaches to clinical trials. The joint work will be built upon commitment to trust and transparency between both organizations.”
Financial terms were not disclosed.
A Different Kind of Deal
The agreement is different from others in which Quintiles has worked with developers to reduce costs as pharmaceutical firms have sought to cut expenses required to bring drugs to market. The costs are staggering – as much as $4 billion, according to a study published by Forbes magazine in 2012.
Merck Serono products are sold in 150 countries, including treatments for cancer, multiple sclerosis, infertility, endocrine and metabolic disorders, and cardiovascular diseases.
In the past, Quintiles has worked with pharmaceutical firms to share the risk: The world’s largest life science services firm provided discounted support such as clinical trials in exchange for a share in potential financial benefits from an approved product. Quintiles no longer invests directly in drug companies, having spun off its investment are under the name NovaQuest in 2006.
However, in the Quintiles-Merck Serno partnership, a Quintiles spokesperson said the Triangle-based company is not sharing in costs with expectations of a bigger payday later.
The importance of the deal is indicated by the fact that. going forward, Quintiles will share in the “strategic decision-making processes affecting the development of the Merck Serono portfolio,” the companies said in a statement.
“A Standing Member”
“We believe this is a first-of-its-kind agreement between a biopharmaceutical company and a biopharmaceutical services provider because the agreement will create a comprehensive clinical development process that integrates the expertise and experience of both organizations into a single, unified drug development team,” Bridges explained.
“There are a number of unique aspects to this collaboration, but most notably, Quintiles will be a standing member of a collaborative clinical operations team that will be responsible for clinical operations decisions related to the Merck Serono development portfolio.
“In this capacity, Quintiles has the opportunity to be involved in clinical development activities – from strategic input in clinical development plan definition and trial concept sheet design to leading and coordinating the execution of most clinical operations activities, including clinical trials for the drug candidates.”
Tom Pike, Quintiles’ chief executive officer, believes the deal will have an impact on the entire industry.
“This agreement is built upon a long-standing commitment to trust and transparency between our two organizations, and I’m confident it will only be enhanced by this innovative relationship,” Pike said in a statement. “We are excited about the opportunities this collaboration provides as we work with Merck Serono in a new and innovative manner that leverages the best of our combined capabilities. We view this as a key step forward not only for our two companies, but for the way the industry approaches the development of new therapies for the patients we ultimately serve.”
Merck Serno also sees the deal as a first for the industry.
“By combining the strengths of Merck Serono and Quintiles, we are creating a new model in clinical development that will unlock the knowledge and insights of both companies,” says Annalisa Jenkins, head of Global Development and Medical at Merck Serono. “This is an innovative and unique collaboration that will help to translate the highest-quality science into efficiency and agility throughout our clinical trials, while enhancing our competitive position in an increasingly challenging environment of clinical drug development.”
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