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Pfizer ‘invests to win’
NEW YORK—The end of 2009 and dawn of 2010 saw Pfizer signing multiple collaboration deals with small pharmaceutical research and biotechnology companies as the inevitable effects—namely, thousands of job cuts—of last year's merger with Wyeth began to set in.
Providing an update to its pipeline for the first time since the close of the Wyeth transaction in October, Pfizer on Jan. 27 announced a refocused drug development pipeline of 133 programs from Phase I to registration and identified what it has dubbed six "Invest to Win" areas of research where it sees the most commercial opportunity: oncology, pain, inflammation, Alzheimer's disease, psychoses and diabetes. The retooled pipeline involves an investment in vaccines and biologics, "reflective of Pfizer's goal of becoming a top-tier biotherapeutics company by 2015," the pharma giant said in a statement.
"This pipeline of investigational medicines represents the strong future of Pfizer," stated Martin Mackay, head of Pfizer global research and development. "Since the closing of the Wyeth transaction late last year, we have made strategic decisions about our R&D resources, global footprint and high-priority projects. Our focus now turns to delivery of these health solutions for patients around the world."
Notably, most of Pfizer's recent deals involve partners in other countries. In one of several deals announced in the last month, Pfizer will collaborate with Compugen Ltd., a genomics-based drug and diagnostic discovery company based in Tel Aviv, Israel, on therapeutic peptide product candidates for three undisclosed drug targets of interest to Pfizer. Pfizer will fund the research, which is expected to take a few months, and then have the right to exercise options for worldwide exclusive milestone and royalty-bearing licenses to develop and commercialize the selected product candidates or further optimize them to obtain final potent, selective product candidates with favorable pharmacokinetic properties. Specific financial deals were not disclosed.
"The deal provides important validation of Compugen's predictive discovery platforms, including at least one platform that has yet to be disclosed," says Anat Cohen-Dayag, president and co-CEO of Compugen, which also has research deals with Medarex, Merck, Merck-Serono, Roche and Bayer Schering. "The discovery process is funded, and if successful, the peptide therapeutic candidates could result in substantial milestone and royalty payments to Compugen."
In a second deal, Pfizer and Strides Arcolab, a Bangalore, India-based manufacturer of finished dosage forms with an emphasis on sterile injectables, will commercialize off-patent sterile injectable and oral products in the United States. These finished dosage form products will be licensed and supplied by Strides and Onco Laboratories Ltd., and Onco Therapies Ltd., two joint ventures between Strides and Aspen, South Africa, in which each has a 50 percent ownership interest. The financial terms of the supply agreement were not disclosed.
The collaboration is expected to deliver 40 off-patent products, many of which are oncology therapeutics, to healthcare providers and patients in the U.S. The first of the products commercialized under this collaboration is expected to launch in 2010.
"Both Strides and Pfizer share values needed for success in the market—that of innovation and differentiation," says Arun Kumar, founder and managing director of Strides Arcolab. "In addition, we also have synergistic strengths with Pfizer's solid commercial infrastructure and our high-quality manufacturing and R&D capabilities. And finally and more importantly, we have the largest portfolio of sterile injectibles out of India. It therefore made strategic sense to work with a player like Pfizer, who is the world's leading biopharmaceutical company and has a stated objective of being among the top five injectable players in the U.S. markets."
Kumar says the collaboration is "game-changing and transformational" for Strides Arcolab.
"It fits into our strategy of being a niche pharmaceutical player with a focus on sterile injectables," Kumar adds. "It also enhances our ability to reach a larger base of customers and patients in need of quality treatment options, and we are very excited about the potential that this partnership offers."
In another deal with an overseas company, Pfizer extended a master services agreement with Banaglore, India's TCG Lifesciences, a research services and informatics company. TCG will provide Pfizer with integrated research services in the field of discovery chemistry, focusing on areas such as synthesis of monomer and templates, medicinal chemistry and parallel medicinal chemistry to "enhance Pfizers drug discovery pipeline and shorten development timelines," according to the company.
"A high-quality and flexible working model is critical to Pfizer's research," said Rick Connell, vice president and head of external research solutions at Pfizer, in a statement. "Through our strong relationships with leading Asian CROs, such as TCG Lifesciences, we are able to tap into their scientific talent pool to further the success of our research programs."
Back on U.S. soil, Pfizer's interest in pursuing the tremendous promise and potential of stem cell and regenerative medicine research is at the heart of a deal with Athersys Inc., a clinical stage biopharmaceutical company located in Cleveland, Ohio. Under the companies' agreement, announced Dec. 21, they will develop Athersys' investigational stem cell therapy, MultiStem, for the treatment of inflammatory bowel disease (IBD). Athersys will receive an upfront cash payment of $6 million from Pfizer, as well as research funding and support during the initial phase of the collaboration. Athersys is also eligible to receive milestone payments of up to $105 million upon the successful achievement of certain development, regulatory and commercial milestones.
The pact is not Athersys' first experience working with Pfizer. For about the past 10 years, Athersys has provided validated drug targets to Pfizer—as well as Bristol-Myers Squibb—using its Random Activation of Gene Expression (RAGE) technology, which can be used to express validated protein drug targets from virtually every gene in the human genome without having to clone cDNA molecules.
In the companies' new partnership, they seek to control the underlying causes of IBD—rather than the symptoms, as most current therapies do— using MultiStem, a patented and proprietary cell therapy product consisting of a special class of stem cells that are obtained from the bone marrow of healthy, consenting adult donors, and which have the demonstrated ability to produce a range of factors, as well as form multiple cell types.
"IBD is a pretty significant condition and encompasses several different subsets of conditions, many of which are very serious," says Dr. Gil Van Bokkelen, chairman and CEO of Athersys. "There are small-molecule drugs in use clinically to try to control the symptoms and severity of these diseases, and some biologic agents are being used as kind of a second-line therapy to treat people who have become resistant to those drugs. Many patients also undergo surgery to remove damaged and affected areas, but that doesn't acknowledge the origin of their condition. In many instances, the disease comes back later and affects other parts of the bowel. We believe there is more opportunity to effectively control the underlying causes of disease, not just the symptoms of disease."
MultiStem is also in development by Athersys for several other conditions, including acute myocardial infarction, bone marrow transplant support and ischemic stroke, notes Van Bokkelen.
"I think Pfizer sees this agreement as an important cornerstone of what it wants to do in the stem cell and regenerative medicine field," he says. "I don't want to speak for Pfizer, but I do think it is fair to say that their interest in this area extends well beyond the boundaries of what we have started, and their interest in regenerative medicine is very broad."
Athersys' stated commitment to bringing safer and more effective drugs to market also likely made it an attractive partner for Pfizer, as Big Pharma companies find themselves under intense scrutiny for drug safety and efficacy, Van Bokkelen adds.
"We have similarly high standards for what we need to see in our safety and efficacy profiles," he says. "Our commitment is to develop best-in-class products. Pfizer, in many instances, may not have been first to market on some key drugs, but their drugs were developed with a better safety and efficacy profile. We don't care as much about being first as bringing the safest and most effective drugs to market. We think that is something that is very appealing to a large pharma like Pfizer because they see we are not taking shortcuts—something you don't always see in smaller sized organizations."
Pfizer also announced an antibody discovery collaboration with Adimab Inc. of Lebanon, N.H., and a strategic alliance with Ensemble Discovery of Cambridge, Mass., to "discover and develop drug candidates of a novel class against a number of high-value pharmaceutical targets."
Of course, the Wyeth merger and subsequent restructuring involve something less positive for the research community. In early January, Pfizer announced it will cut about 1,200 jobs, while Merck will eliminate 500 positions. Pfizer said the layoffs were part of the combined 20,000 jobs cuts both companies disclosed they would make when the merger closed.
Despite widespread fear and uncertainty in the research community, the stocks of both companies have suffered little in the midst of this news. Following the announcement of job cuts, Pfizer shares rose 18 cents to $18.86, while Merck shares rose 4 cents to $37.74.