Pfizer, as part of its ongoing efforts to reinvent its R&D model, is aiming to accelerate product development under a new leadership team and establish a significant presence in biotechnology with a new facility devoted to "bioinnovation."

The company made several announcements Oct. 4 regarding its R&D programs, including the promotion of Global R&D VP Martin Mackay to president of the division and the launch of a new standalone facility in San Francisco that will focus solely on biotherapeutics.

Mackay succeeds John LaMattina, who announced in May that he would retire after 30 years with the company.

The announcement is the latest development in the evolution of Pfizer R&D; in January, as part of a larger restructuring effort, the firm announced it would reorganize R&D operations to focus on key therapeutic areas (¹ Also see "Pfizer’s Manufacturing Cost-Cutting May Leave Little Capacity For Growth" - Pink Sheet, 29 January, 2007., p. 3).

The company also decided to redeploy projects to major research centers including: Groton, Conn. (antibacterials, cardiovascular/metabolic and neuronscience); La Jolla, Calif. (oncology and ophthalmology research); St. Louis (inflammation and biotherapeutics); and Sandwich, U.K. (allergy/respiratory, antivirals, genitourinary/sexual health and pain).

Advancing R&D is vital to sustaining performance at Pfizer, which is facing the expected loss of exclusivity of its biggest selling product, Lipitor (atorvastatin), in March 2010.

The past 12 months have proved difficult for the world's biggest pharma company - and its new chief executive - including, among other disappointments, a high profile pipeline failure when the firm discontinued torcetrapib, which it had hoped would fill the void left by Lipitor (² Also see "Pfizer’s Lipitor Extension Shot Down By Failure Of Torcetrapib Silver Bullet" - Pink Sheet, 11 December, 2006., p. 3).

In succeeding the veteran LaMattina, Mackay inherits the largest Phase II portfolio in Pfizer's history, but also an increasing urgency to bring those projects to market to replace the loss of sales from other drug patent expirations.

Mackay is hitting the ground running with a five-point plan designed to maximize the contribution of R&D to Pfizer's growth.

One of the firm's major goals down the line is to "become a top-tier company in biotherapeutics" - a goal shared by many of the big pharma companies, which are seeking to diversify their portfolios with lucrative biologics and harness biotech innovation.

To that end, Pfizer will "aggressively advance the 25 pre-clinical and clinical programs already in its development pipeline, as well as a range of external opportunities, including those developed by the new biotherapeutics and bioinnovation center."

The new San Francisco facility will focus on priority areas such as oncology, immunology and pain.

The center will serve as a standalone entity but will collaborate with Mackay's R&D operation, Pfizer explained. The center will be headed by former Renovis CEO Corey Goodman, who will report directly to Pfizer CEO Jeffrey Kindler and become a member of the firm's Executive Leadership Team.

The creation of an independent unit, and the decision to open it in Genentech's backyard, certainly signals that Pfizer is serious about expanding its foothold in the biotech arena.

It also suggests that the firm, which has frequently been criticized for its scale, is trying to tap into the entrepreneurial spirit of the smaller, more independent biotech model.

The new biotech center has a "unique structure to discover, license and acquire more new product candidates that we can put into development," Kindler stated in a news release.

"With this strategy, we are leveraging Pfizer's excellence in drug discovery and development by complementing it with a distinct, California-based enterprise led by world-class scientists charged with discovering and bringing in new compounds," he added.

"With our collaborative and entrepreneurial model, we will be in the best position to find promising new targets, technologies and tools externally, to discover them organically, and to leverage them with the scale and know-how of [Pfizer Global R&D] so as to turn them into potential new medicines," Goodman said.

"While we will be focused on biotherapeutics, we will look for any innovative technology in any area that will help develop new medicines."

In addition, the center's location in the middle of the California biotech and venture capital community will enable the company to "attract outstanding scientific talent, to seek collaborations, and to build incubators at this very exciting time for biological discovery."

Another goal is to "aggressively advance" the firm's late stage portfolio. The R&D division also will seek to bring to market as quickly as possible Phase II and Phase III compounds, "and add value through label enhancements, line extensions, additional indications and product combinations."

In a recent pipeline update, Pfizer said that with 47 programs in Phase II development, the company is on target to reach its goal of tripling its Phase III portfolio by 2009 and introducing four new products a year beginning in 2011.

As part of that effort, the company has hired Merck exec Briggs Morrison as Senior VP for Clinical Development, responsible for clinical development of all compounds in Pfizer's portfolio.

Pfizer will separately seek to "invest in the best opportunities."

The company has already been reviewing the disease areas in which it conducts research and development.

"Given the critical need to deliver new and valuable products from our pipeline as fast as possible, I will immediately embark on a systematic review of all of our R&D investments to ensure that we prioritize allocation of funds to our most promising programs," Mackay said.

The research team "will work closely with Pfizer Business Development to secure the best external opportunities in targeted areas through acquisitions, licensing and development, joint venture and alliances and other collaborative agreements," the firm added.

That may include agreements with other big pharmas, as well as smaller companies. Pfizer inked a deal with Bristol-Myers Squibb worth $1 billion earlier this year to develop drugs for metabolic disorders (³ Also see "Bristol’s Pfizer, AstraZeneca Deals Could Add Up To $2 Billion To R&D Budget" - Pink Sheet, 30 April, 2007., p. 4).

Mackay also plans to ramp up Pfizer's R&D productivity, now that the redeployment of R&D projects and staff is complete and plans to accelerate its late-stage pipeline are in place.

"We can, and will, dramatically raise the bar on ... productivity and establish crystal-clear accountability for meeting our goals," he maintained.

"We will move from periodic restructurings to a much more systematic approach of continuous improvement that will put us in the best position to accelerate our productivity gains and speed new medicines to the market."

The final part of Mackay's plan is to "pursue the best science" outside of Pfizer, seeking ways to collaborate with biotech, academic and biomedical communities.

Pfizer cited its five-year research collaboration with Scripps Research Institute and the establishment of a biotech incubator at its La Jolla, Calif., facility as an example (⁴ Also see "Pfizer R&D Emphasizes M&A; Deal Structure, Integration To Be More Flexible" - Pink Sheet, 4 December, 2006., p. 5).

"Our incubator is already bearing fruit in terms of new pre-clinical candidates and research tools," Mackay said.

"We are looking to create more such partnerships and incubators, and we look forward to working closely with our new biotherapeutics and bioinnovation center to create additional alliances and incubators in California and elsewhere," he added.

R&D is just one area Pfizer has looked to revamp since Kindler took over in mid-2006. The company's January restructuring announcement also included plans to streamline manufacturing operations.

Pfizer said it would close manufacturing sites in Brooklyn, N.Y., and Omaha, Neb., and seek to sell a third site in Feucht, Germany.

Once that effort is complete, Pfizer's in-house manufacturing capacity will support approximately $48 billion in sales, or $1 billion at each of its remaining 48 manufacturing sites.

- Brooke McManus (b.mcmanus@elsevier.com)

Pfizer Promotes Global R&D VP Mackay To Head Unit, Opens Biotech Center

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