Staff Writer

A pipeline update issued Tuesday by Pfizer Inc. did not seem to reflect major changes disclosed in a recent internal memo, which was leaked to the Wall Street Journal and posted online by Forbes.com. The memo stated that Pfizer is moving away from cardiovascular disease, among other indications. Yet in the "official" pipeline update, more than 10 of the 88 programs listed in Phase I or Phase II trials were for indications listed in the memo as discontinued.

A spokesperson for the New York-based pharma declined to comment on the memo but said the company likely will discuss its pipeline in its upcoming third-quarter earnings conference call.

Specifically, the memo stated that, after several months of review, Pfizer has decided to focus its research and development efforts on six "higher priority" areas: Alzheimer's disease, diabetes, inflammation/immunology, oncology, pain and psychoses (schizophrenia).

Pfizer's emphasis on Alzheimer's disease is evidenced by its recent $725 million deal for Medivation Inc.'s Phase III drug Dimebon. (See BioWorld Today, Sept. 4, 2008).

The big pharma has been active in oncology deal-making, too, partnering with Avant Immunotherapeutics Inc. (now Celldex Therapeutics Inc.) and acquiring Serenex Inc. and Coley Pharmaceutical Group Inc. (See BioWorld Today, Nov. 19, 2007, March 4, 2008 and April 18, 2008.)

Pfizer publicly stated that it devotes more than 22 percent of its total research and development budget to oncology. That heavy emphasis has led many to wonder if the big pharma could be reprioritizing its pipeline in advance of a very big oncology acquisition. Several analysts have speculated that Pfizer could be the unnamed large pharmaceutical company that offered to acquire ImClone Systems Inc. for $70 per share, topping a previous offer by Bristol-Myers Squibb Co. (See BioWorld Today, Sept. 11, 2008.)

Pfizer's spokesperson declined to comment on business development activities.

In addition to Pfizer's top areas of focus, the memo stated that varying levels of investment will continue in seven areas: asthma, chronic obstructive pulmonary disorder, genitourinary conditions, infectious diseases, smoking cessation, thrombosis and transplant. Ophthalmology is "still under discussion," according to the memo. But 10 indications are getting the axe: anemia, atherosclerosis/hyperlipidemia, bone health, gastrointestinal disorders, heart failure, liver fibrosis, muscle conditions, obesity, disease-modifying approaches to osteoarthritis and peripheral arterial disease.

The move away from cardiovascular-related conditions comes as Pfizer braces itself for the looming patent expiration of blockbuster cholesterol-lowering drug Lipitor (atorvastatin). Hopes for potential backup drug torcetrapib fizzled when a Phase III trial turned up higher death rates. (See BioWorld Today, Dec. 23, 2003, and Dec. 5, 2006.)

For biotech companies, Pfizer's decision to exit cardiovascular and other indications may bring some benefits. The memo stated that "some colleagues will be displaced," which indicates that a little Pfizer talent may soon be up for grabs.

Additionally, the memo indicated that discontinued programs may be available for out-licensing. When questioned, Pfizer's spokesperson referred to the Wall Street Journal article in which Martin Mackay, Pfizer's president of global research and development, said the company still sees value in its halted programs and will seek partners for some of the compounds.

Pfizer's memo said the changes in strategic direction will not affect marketed products, launches planned within the next three years or the Phase III portfolio.

Of the 114 clinical-stage programs listed in Pfizer's official pipeline update on Tuesday, only one was in registration: osteoporosis drug Fablyn (lasofoxifene), which is partnered with Ligand Pharmaceuticals Inc. A decision is expected this month. (See BioWorld Today, Sept. 9, 2008.)

The antibiotic dalbavancin, which Pfizer gained in its $1.9 billion buyout of Vicuron Pharmaceuticals Inc., regressed to Phase III after receiving an approvable letter. (See BioWorld Today, June 17, 2005.)

Yet Pfizer said in its press release that it is targeting 15 to 20 regulatory submissions between 2010 and 1012.

The big pharma has 24 programs in Phase III trials, many of which are new indications or new formulations of existing drugs like cancer drug Sutent (sunitinib malate) and pain drug Lyrica (pregabalin).

Other Phase III drugs include PF-1228305 (Thelin) for pulmonary hypertension, which Pfizer acquired through its $195 million buyout of Encysive Pharmaceuticals Inc.; cancer drugs CP-751871 and axitinib; fibromyalgia drug esreboxetine; and anxiety drug PD-332334. (See BioWorld Today, Feb. 21, 2008.)

Pfizer also is moving forward in Phase III with obesity drug CP-945598 and cardiovascular drug apixaban.

Altogether, Pfizer said 31 programs advanced into the next stage of development since its last update in February, while 12 were discontinued and two moved backward.

In addition to dalbavancin, the other backward mover was CTLA-4 antagonist tremelimumab, which remains in Phase II after a Phase III melanoma trial was halted.

Seven Phase I programs were halted, including PF-4603629 for diabetes, PF-446687 for female sexual health, PF-3274167 for incontinence, PF-3475952 and PF-755616 for rheumatoid arthritis, PD-325901 for cancer and PF-738502 for fibromyalgia.

The other five halted programs were in Phase II and included UK-432097 for chronic obstructive pulmonary disease, CP-195543 and maraviroc for rheumatoid arthritis, esreboxetine for pain and PF-3187207 for glaucoma, which had been partnered with NicOx SA.