Pfizer is emphasizing a diversified approach, focusing on both small molecules and biotech products, as it attempts to regain investor confidence in the company's growth potential.

"Small molecules are still clearly a priority for us, but today we also are emerging as an innovation leader in other areas, areas like biologics and oncology, areas that have not traditionally been associated with Pfizer," Global R&D President John LaMattina said during an investor meeting Feb. 10 in New York.

Pfizer has established a foothold in biologics that ranks the drug maker roughly eighth on the global stage and encompasses sales expected to reach $1.4 bil. in 2006.

Pfizer, however, has set its sights on becoming one of the top five producers of biologics, LaMattina announced.

"We are targeting to triple our biologics revenues by the year 2010, which would place us as high as number four," he said.

Pfizer has transformed its biologic R&D program from a single initiative in 1996 to 36 programs today, LaMattina said.

The firm's biologics portfolio includes marketed products like the human growth hormone Genotropin , the wet age-related macular degeneration therapy Macugen , and the most recent addition, the inhaled insulin Exubera .

All three of those products, however, came to Pfizer through acquisitions and partnerships: Genotropin was inherited from Pharmacia, Macugen originated from a marketing and development agreement with Eyetech, and Exubera comes from a partnership with Nektar.

CEO Hank McKinnell foreshadowed Pfizer's plans to step up its biotech M&A efforts during an analyst meeting in April, where he indicated that the firm would be doing more biotech deals in the coming year (¹ [A#00670160008], p. 11).

Pfizer began expanding its biotechnology capability through acquisitions in 2004 with the purchase of Esperion for $1.3 bil. The firm has since gone on to strengthen its position with other additions like Indun and Vicuron.

Convincing investors that Pfizer is suited up and ready to compete - and maintain its pharma leadership - in a field that has changed dramatically over the past decade was the primary aim of the Feb. 10 financial meeting.

The presentation follows several months of highs and lows for Pfizer investors - including a slowdown in the cholesterol market, an unexpected change in earnings guidance, and a significant drop in market cap (² Also see "Pfizer’s Product Parachute? Firm Could See Rally Around New Approvals" - Pink Sheet, 30 January, 2006., p. 27).

During the meeting, the company outlined its growth drivers for 2006 through 2008, including plans for building in-line medicines, enhancing R&D and strengthening productivity initiatives.

In addition to biologics, the "next generation" Pfizer will focus on its emerging oncology portfolio, building on treatments like Camptosar and Sutent , LaMattina noted.

One potential near-term oncologic in development is ticilimumab, a CTLA4 monoclonal antibody that has shown efficacy in the treatment of metastatic melanoma. Currently in Phase III clinical trials, ticilimumab is targeted for regulatory filing in 2007.

ProMune , a receptor 9 agonist under development in partnership with Coley Pharmaceuticals, also is in Phase III development. ProMune is being studied for the treatment of solid tumors, including breast cancer and non-small cell lung cancer.

"Falling behind our advanced development candidates in [the] mid- and early-stage pipeline, we have 22 other oncology programs," LaMattina said.

They include products in Phase II research such as a second-generation Sutent product, an MEK1 inhibitor, VEGFR TK inhibitor, ErbB2 TK inhibitor and a PARP inhibitor.

"The 21st century Pfizer is a blend of the old and new," LaMattina said, pointing to the company's pipeline in small molecule drugs as well.

The company currently has 152 new molecular entities in development, including six in registration, five in late-stage and 30 in mid-stage. Eighty-three enhancement projects are also underway.

"Despite major changes in our R&D organization in the last year and despite spending 4% less in 2005, our pipeline is 8% larger then it was at the end of 2004," LaMattina said.

Pfizer expects to spend $7.8 bil. on R&D in 2006, up from $7.4 bil. in 2005. The firm announced an R&D efficiency program in mid-2005, with the aim of doubling productivity without a commensurate increase in cost (³ Also see "Pfizer Cutting Cost Of R&D Under Efficiency Program; Output To Double" - Pink Sheet, 25 July, 2005., p. 18).

With two recent approvals (Exubera and Sutent) and up to six products pending or slated for filing in 2006, Pfizer may be entering a recovery phase after a year in which the firm had no novel drug approvals.

The drug maker is close to achieving one research goal set by McKinnell in 2001--filing 20 NDAs in the five-year period ending in 2006. The company has so far submitted 17 NDAs for review and has another two submissions - maraviroc for HIV/AIDS and an undisclosed potential licensing candidate - planned for filing in 2006, according to LaMattina.

"We are confident that we will reach 19 filings, but the 20th might prove elusive," the exec said.

Although Pfizer is nearing completion of that goal, two of the filings - Oporia and parecoxib - were deemed "not approvable" by FDA.

The company received "not approvable" letters in September for both Oporia (lasofoxifene) for osteoporosis prevention, and the injectable COX-2 inhibitor parecoxib, marketed as Dynastat in Europe.

"We are disappointed by this, but we are continuing to develop both," LaMattina said.

Two ongoing Phase III studies evaluating Oporia will further strengthen the risk/benefit profile of the drug, he maintained.

The 8,500-person PEARL (postmenopausal evaluation and risk reduction with lasofoxifene) and 500-patient CARL (comparison of raloxifene, lasofoxifene and placebo) trials will reinforce the superiority of Oporia versus raloxifene, the exec said.

"These results, coupled with the addition of thousands of patients to the safety database, should greatly enhance the risk-benefit equation for Oporia," he said. "We are hopeful that this will convince the FDA of the value of this compound to women with osteoporosis."

With parecoxib, Pfizer said it is continuing discussions with FDA to determine an approval pathway for the agent, which is approved for marketing in over 30 countries.

Upcoming approvals anticipated by the company include two anti-infectives expected to clear FDA in the first half of the year, Eraxis (anidulafungin) for the treatment of esophageal candidiasis, and Zeven (dalbavancin) for the treatment of complicated skin and soft tissue infections caused by gram-positive bacteria.

Pfizer gained both candidates through the acquisition of Vicuron last year, and both drugs have received "approvable" letters from FDA. Pfizer is anticipating approval of Eraxis in the first quarter and Zeven in the second, LaMattina said.

Approval of the smoking cessation drug Champix and the insomnia drug indiplon also are anticipated, with user fee dates in May.

Rounding out the year, Pfizer plans to file the CCR5 inhibitor maraviroc for the treatment of HIV in treatment-experienced patients by the end of 2006.

The drug is currently in Phase III trials and has demonstrated antiviral potency comparable to best-in-class protease inhibitors and non-nucleoside reverse transcriptase inhibitors, according to Pfizer.

Filings slated for 2007 include the torcetrapib/atorvastatin combination for atherosclerosis, asenapene for schizophrenia and bipolar mania and the oncologic ticilimumab.

In the longer term pipeline, Pfizer said it is also working to develop a follow on to Exubera. The company received approval for the inhaled insulin for the treatment of type 1 and type 2 diabetes Jan. 27 (⁴ Also see "Exubera Lung Test Will Be Advised Until More Data Is Collected, FDA Says" - Pink Sheet, 30 January, 2006., p. 3).

Revenue from new products will be key to Pfizer's performance this year. In terms of current products, for 2006 Pfizer said it expects sales of Lipitor to exceed $13 bil., Celebrex sales to top $2 bil. and Lyrica sales over $900 mil.

The company predicted that consolidated 2006 revenues would be flat compared to 2005, as new products offset revenue declines stemming from exclusivity losses. Revenue growth is expected to resume in 2007, the firm said.

Pfizer Sets Sights On Becoming Top Five Biologics Player By 2010

More from Archive

More from Pink Sheet