Pfizer ‘invests to win’

NEW YORK—The end of 2009 and dawn of 2010 saw Pfizer signingmultiple collaboration deals with small pharmaceutical research andbiotechnology companies as the inevitable effects—namely, thousands of jobcuts—of last year's merger with Wyeth began to set in.

Providing an update to its pipeline for the first time sincethe close of the Wyeth transaction in October, Pfizer on Jan. 27 announced arefocused drug development pipeline of 133 programs from Phase I toregistration and identified what it has dubbed six "Invest to Win" areas ofresearch where it sees the most commercial opportunity: oncology, pain,inflammation, Alzheimer's disease, psychoses and diabetes. The retooledpipeline involves an investment in vaccines and biologics, "reflective ofPfizer's goal of becoming a top-tier biotherapeutics company by 2015," thepharma giant said in a statement.

"This pipeline of investigational medicines represents thestrong future of Pfizer," stated Martin Mackay, head of Pfizer global researchand development. "Since the closing of the Wyeth transaction late last year, wehave made strategic decisions about our R&D resources, global footprint andhigh-priority projects. Our focus now turns to delivery of these healthsolutions for patients around the world."

Notably, most of Pfizer's recent deals involve partners inother countries. In one of several deals announced in the last month, Pfizerwill collaborate with Compugen Ltd., a genomics-based drug and diagnosticdiscovery company based in Tel Aviv, Israel, on therapeutic peptide productcandidates for three undisclosed drug targets of interest to Pfizer. Pfizerwill fund the research, which is expected to take a few months, and then havethe right to exercise options for worldwide exclusive milestone androyalty-bearing licenses to develop and commercialize the selected productcandidates or further optimize them to obtain final potent, selective productcandidates with favorable pharmacokinetic properties. Specific financial dealswere not disclosed.

"The deal provides important validation of Compugen'spredictive discovery platforms, including at least one platform that has yet tobe disclosed," says Anat Cohen-Dayag, president and co-CEO of Compugen, whichalso has research deals with Medarex, Merck, Merck-Serono, Roche and Bayer Schering."The discovery process is funded, and if successful, the peptide therapeuticcandidates could result in substantial milestone and royalty payments toCompugen."

In a second deal, Pfizer and Strides Arcolab, a Bangalore,India-based manufacturer of finished dosage forms with an emphasis on sterileinjectables, will commercialize off-patent sterile injectable and oral productsin the United States. These finished dosage form products will be licensed andsupplied by Strides and Onco Laboratories Ltd., and Onco Therapies Ltd., twojoint ventures between Strides and Aspen, South Africa, in which each has a 50percent ownership interest. The financial terms of the supply agreement werenot disclosed.

The collaboration is expected to deliver 40 off-patentproducts, many of which are oncology therapeutics, to healthcare providers andpatients in the U.S. The first of the products commercialized under thiscollaboration is expected to launch in 2010.

"Both Strides and Pfizer share values needed for success inthe market—that of innovation and differentiation," says Arun Kumar, founderand managing director of Strides Arcolab. "In addition, we also havesynergistic strengths with Pfizer's solid commercial infrastructure and ourhigh-quality manufacturing and R&D capabilities. And finally and moreimportantly, 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 theworld's leading biopharmaceutical company and has a stated objective of beingamong the top five injectable players in the U.S. markets."

Kumar says the collaboration is "game-changing andtransformational" for Strides Arcolab.

"It fits into our strategy of being a niche pharmaceuticalplayer with a focus on sterile injectables," Kumar adds. "It also enhances ourability to reach a larger base of customers and patients in need of qualitytreatment options, and we are very excited about the potential that thispartnership offers."

In another deal with an overseas company, Pfizer extended amaster services agreement with Banaglore, India's TCG Lifesciences, a researchservices and informatics company. TCG will provide Pfizer with integratedresearch services in the field of discovery chemistry, focusing on areas suchas synthesis of monomer and templates, medicinal chemistry and parallelmedicinal chemistry to "enhance Pfizers drug discovery pipeline and shortendevelopment timelines," according to the company.

"A high-quality and flexible working model is critical toPfizer's research," said Rick Connell, vice president and head of externalresearch solutions at Pfizer, in a statement. "Through our strong relationshipswith leading Asian CROs, such as TCG Lifesciences, we are able to tap intotheir scientific talent pool to further the success of our research programs."

Back on U.S. soil, Pfizer's interest in pursuing thetremendous promise and potential of stem cell and regenerative medicineresearch is at the heart of a deal with Athersys Inc., a clinical stagebiopharmaceutical company located in Cleveland, Ohio. Under the companies'agreement, announced Dec. 21, they will develop Athersys' investigational stemcell therapy, MultiStem, for the treatment of inflammatory bowel disease (IBD).Athersys will receive an upfront cash payment of $6 million from Pfizer, aswell as research funding and support during the initial phase of thecollaboration. Athersys is also eligible to receive milestone payments of up to$105 million upon the successful achievement of certain development, regulatoryand commercial milestones.

The pact is not Athersys' first experience working withPfizer. For about the past 10 years, Athersys has provided validated drugtargets to Pfizer—as well as Bristol-Myers Squibb—using its Random Activationof Gene Expression (RAGE) technology, which can be used to express validatedprotein drug targets from virtually every gene in the human genome withouthaving to clone cDNA molecules.

In the companies' new partnership, they seek to control the underlyingcauses of IBD—rather than the symptoms, as most current therapies do— usingMultiStem, a patented and proprietary cell therapy product consisting of aspecial class of stem cells that are obtained from the bone marrow of healthy,consenting adult donors, and which have the demonstrated ability to produce arange of factors, as well as form multiple cell types.

"IBD is a pretty significant condition and encompassesseveral different subsets of conditions, many of which are very serious," saysDr. Gil Van Bokkelen, chairman and CEO of Athersys. "There are small-moleculedrugs in use clinically to try to control the symptoms and severity of thesediseases, and some biologic agents are being used as kind of a second-linetherapy to treat people who have become resistant to those drugs. Many patientsalso undergo surgery to remove damaged and affected areas, but that doesn'tacknowledge the origin of their condition. In many instances, the disease comesback later and affects other parts of the bowel. We believe there is moreopportunity to effectively control the underlying causes of disease, not justthe symptoms of disease."

MultiStem is also in development by Athersys for severalother conditions, including acute myocardial infarction, bone marrow transplantsupport and ischemic stroke, notes Van Bokkelen.

"I think Pfizer sees this agreement as an importantcornerstone of what it wants to do in the stem cell and regenerative medicinefield," he says. "I don't want to speak for Pfizer, but I do think it is fairto say that their interest in this area extends well beyond the boundaries ofwhat we have started, and their interest in regenerative medicine is verybroad."

Athersys' stated commitment to bringing safer and moreeffective drugs to market also likely made it an attractive partner for Pfizer,as Big Pharma companies find themselves under intense scrutiny for drug safetyand efficacy, Van Bokkelen adds.

"We have similarly high standards for what we need to see inour safety and efficacy profiles," he says. "Our commitment is to developbest-in-class products. Pfizer, in many instances, may not have been first tomarket on some key drugs, but their drugs were developed with a better safetyand efficacy profile. We don't care as much about being first as bringing thesafest and most effective drugs to market. We think that is something that isvery appealing to a large pharma like Pfizer because they see we are not takingshortcuts—something you don't always see in smaller sized organizations."

Pfizer also announced an antibody discovery collaborationwith Adimab Inc. of Lebanon, N.H., and a strategic alliance with EnsembleDiscovery of Cambridge, Mass., to "discover and develop drug candidates of anovel class against a number of high-value pharmaceutical targets."

Of course, the Wyeth merger and subsequent restructuringinvolve something less positive for the research community. In early January,Pfizer announced it will cut about 1,200 jobs, while Merck will eliminate 500positions. Pfizer said the layoffs were part of the combined 20,000 jobs cutsboth companies disclosed they would make when the merger closed.

Despite widespread fear and uncertainty in theresearch community, the stocks of both companies have suffered little in themidst of this news. Following the announcement of job cuts, Pfizer shares rose18 cents to $18.86, while Merck shares rose 4 cents to $37.74.