Pfizer Inc. announced the discontinuation of A4021018 (also known as ADVIGO 1018), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC). An independent Data Safety Monitoring Committee (DSMC) recommended A4021018 be stopped after concluding that the addition of figitumumab to erlotinib is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to erlotinib alone in the study population.

“As a pioneer in the IGF-1R field, we are committed to a thorough evaluation of figitumumab. We will carefully review our extensive clinical database and use this information to refine the figitumumab clinical program with the goal of identifying the right patient population in which to evaluate this compound.”

“This outcome is disappointing to us and to patients with NSCLC. Pfizer is working to thoroughly analyze all available data from the figitumumab program to better understand the compound and the IGF-1R (insulin growth factor-1 receptor) pathway,” said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit. “As a pioneer in the IGF-1R field, we are committed to a thorough evaluation of figitumumab. We will carefully review our extensive clinical database and use this information to refine the figitumumab clinical program with the goal of identifying the right patient population in which to evaluate this compound.”

The Company has notified A4021018 clinical investigators and has initiated the notification procedure for all involved regulatory agencies of the discontinuation of A4021018. Investigators have been instructed to work with all of their patients in the A4021018 study on an individual basis to determine an appropriate course of action.

In December 2009, Pfizer announced the stop of A4021016 (ADVIGO 1016), a Phase 3 study examining the effects of figitumumab as first-line treatment in patients with advanced non-adenocarcinoma NSCLC, after an analysis by the DSMC showed that addition of figitumumab to carboplatin plus paclitaxel would be unlikely to meet the primary endpoint of improved overall survival compared to paclitaxel plus carboplatin alone.

Pfizer is continuing to study figitumumab in clinical trials for the potential treatment of prostate, breast and lung cancers, and Ewing’s sarcoma.

About Non-Small Cell Lung Cancer
Lung cancer is the most common cancer worldwide. NSCLC accounts for about 85 percent of lung cancer cases and 25 to 30 percent are of squamous histology. Nearly 60 percent of NSCLC patients are diagnosed late with Stage IIIB/IV advanced disease. Despite recent advances, NSCLC remains difficult to treat, particularly in the metastatic setting.

About Figitumumab (CP-751,871)
Figitumumab, an investigational fully human monoclonal antibody, is a highly specific inhibitor of the insulin growth factor-1 receptor (IGF-1R) pathway. The IGF-1R pathway is thought to be one of the fundamental signaling pathways that leads to uncontrolled growth and survival of tumor cells, and may represent a resistance mechanism against EGFR inhibitors and other anti-cancer therapies.

About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers, including breast, lung, prostate, sarcoma, melanoma, and various hematologic cancers. Pfizer Oncology has biologics and small molecules in clinical development and more than 200 clinical trials underway.

By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for the right patient at the right time.

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Pfizer has dropped its Phase III trial evaluating figitumumab (CP-751,871) as an addition to paclitaxel and carboplatin therapy in patients with advanced nonadenocarcinoma non-small-cell lung cancer (NSCLC). The decision followed an analysis by the trial’s independent data safety monitoring committee (DSMC), which found that the treatment would be unlikely to improve overall survival.

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In September the DSMC put a halt on new patient enrolment to the study after observing an apparent increase in serious adverse events including deaths in the patient cohort randomized to receive figitumumab.

Pfizer admits that having to discontinue the trial is disappointing but says it hopes to identify a subset of NSCLC patients who would benefit from the addition of figitumumab to chemotherapy. Future trials would then target this group of patients specifically. “We remain strongly committed to the figitumumab clinical development program in NSCLC in addition to other cancers where treatment options are desparately needed,” asserts Garry Nicholson, svp and GM of Pfizer’s oncology business unit.

Figitumumab is a fully human mAb targeting the insulin growth factor-1 receptor pathway. The drug’s Phase III trial program includes an ongoing study of the antibody as an addition to erlotinib in patients with refractory, advanced nonadenocarcinoma NSCLC. Another Phase III trial being planned will assess the addition of figitumumab to cisplatin and gemcitabine as a first-line treatment for advanced NSCLC. Pfizer says that it will use data from the discontinued trial to help optimize the new Phase III study. Figitumumab is also being evaluated in clinical trials against breast and prostate cancers and Ewing’s sarcoma.

Source: GEN News

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Pfizer Inc. (PFE) sure had a busy third quarter, thanks at least partly to the ongoing process of acquiring Wyeth for $68 billion. The two officially merged on Oct. 16, creating an even larger pharmaceutical company that will likely continue to restructure for some time. So this latest quarterly report doesn’t include results from Wyeth operations, leaving investors in the dark about Wyeth’s third quarter.

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Pfizer Chairman and CEO Jeff Kindler described Pfizer’s results as “solid operational performance in an environment that continues to be challenging.” Earnings indeed were up 26 percent to $2.88 billion, or 43 cents a share, but that was mostly due to cost-cutting measures from site closures and job cuts — 1,100 during the third quarter alone. Adjusted earnings per share were 51 cents, beating estimates of 48 cents per share.

Pfizer’s third-quarter revenues declined 3 percent to $11.6 billion, but were still above analyst estimates of $11.4 billion. Executives were quick to point out that revenues suffered by approximately 5 percent due to foreign exchange conversions. Operating revenues increased 2 percent.

It’s also interesting to see the impact resulting from different health insurance systems around the world. While the economic recession has been global, sales actually grew 5 percent operationally in Europe due to mostly public health care there. In the U.S., rising unemployment meant lost health insurance and led more consumers to opt for generic drugs, if they could afford them. That led to revenues decreasing 2 percent in the U.S. Pfizer itself would be responsible for adding 20,000 people to the unemployment line by the time integration with Wyeth is complete.

The drugmaker also upped its fourth-quarter guidance to reflect Wyeth’s impact. It expects earnings per share of $1.45 to $1.50 for all of 2009, up from prior guidance of $1.30 to $1.45 per share. Pfizer is pegging revenue to be $49 billion to $50 billion, up from $45 billion to $46 billion, because Pfizer will record revenue from Wyeth’s products for only part of the fourth quarter. It will give a forecast for 2010 when it reports the current quarter in January.

“Excluding foreign exchange,” Kindler said, “our five Pharmaceutical units and Animal Health business continued to perform well enabling us to continue to meet our commitments.” Translation: Sales were down in several business divisions, with the worst decline — 12 percent — in the established-products business, which sells drugs that lost patent protection in at least one region and face generic competition (for example, Norvasc for blood pressure and Relpax for migraine).

Of course, an ongoing concern regards Pfizer’s top blockbusters that are going to face generic competition as they lose patent protection in the next few years. And that’s where the limits of cost-cutting come in. At some point, there has to be growth.

For example, Pfizer’s Lipitor cholesterol drug is selling at over $12 billion annually and is responsible for a quarter of company revenue. But it’s set to lose patent protection and face generics in 2011. And its sales have already declined 9 percent to $2.8 billion. Norvasc, Chantix anti-smoking drug (which was hit with an FDA warning recently), and a few others saw sales fall-offs in the double digits. Viagra sales dropped 8 percent, and pain drug Celebrex slid 4 percent, to name a few others. The exceptions are the Lyrica pain drug, Sutent oncology drug and Genotropic endocrine treatment. Outside the U.S., Lyrica grew 35 percent and Sutent 21 percent on a constant-dollar basis.

To offset the upcoming lost revenue from Lipitor, Pfizer decided to acquire Wyeth. On the conference call, Kindler said the deal makes Pfizer more diversified in its product portfolio with vaccines, biotechnology drugs, animal health, nutrition and consumer health-care products. Wyeth’s pipeline includes some late-stage experimental drugs in Alzheimer, oncology and pain management. The integration plans, he added, have been carefully crafted to continue the R&D, sales and marketing and manufacturing operations smoothly as well as enhance shareholders’ value. “All told, this quarter’s results show that Pfizer is on the right track. The acquisition strengthens Pfizer,” he said.

As for Pfizer’s long-term goals, management explained that greater scale brings benefits in certain markets and for large clinical trials, but it can create impediments, as in doing innovative research. Pfizer is currently organizing into smaller units that, for now, benefit from being part of a big company. But executives also said Pfizer will always look at the mix of assets with the aim of maximizing shareholder value. And if they decide it would be better to split up the company into separate, smaller, publicly traded entities, they would do so.

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After the Wyeth merger, Pfizer will have 15 percent nonpharma assets, which isn’t nearly as much as Johnson & Johnson (JNJ) and Abbott (ABT). Asked whether Pfizer intends to expand its nonpharma assets, executives said they definitely set them up to grow, not to be sold and that they look at the animal health unit — now among the world’s largest — to get bigger.

Pfizer also says its pipeline is much stronger with Wyeth and that it’s leading to more submissions for FDA approvals. The company expects at least four compounds to reach the market in 2010-2011. While it acknowledges that there are always setbacks — such as the recent one with its experimental lung-cancer compound figitumumab, where safety concerns led to a halt in patient enrollments fo a late stage clinical trial — it still experiments with a number of products, including Sutent. Oncology, especially, is a high-risk/high-reward field. Pfizer thinks it has now a robust oncology business with 22 products in development — certainly the strongest it’s been in a while.

Pfizer now needs to integrate Wyeth’s operations, deal with an approaching “patent cliff,” manage and expand its new pipeline and find more avenues for growth. Perhaps by demonstrating it can manage through tough times, it will increase investors’ confidence about its ability to do the rest.

Source: DailyFinance

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Alarmed by signs that patients in a late-stage lung cancer drug study were afflicted by a higher rate of adverse events than the volunteers in a placebo arm, Pfizer says it opted to halt enrollment until it can gain a better understanding of what is happening. The adverse events, which include deaths, were flagged by an independent monitoring board overseeing the Phase III figitumumab trial.

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As in many cancer trials, researchers were looking for an improved combo effect. In this trial, they matched figitumumab (or CP-751,871) with paclitaxel and carboplatin. Another arm was treated with paclitaxel and carboplatin. The experimental drug is an IGF-1R inhibitor, which is intended to block insulin-like growth factor. Patients already enrolled in the trial will continue to receive treatment under the supervision of their doctor. And a separate trial that matches the drug with Tarceva will continue.

For Pfizer the enrollment halt represents one more hitch among a series of problems that have
plagued its R&D efforts. Pfizer recently announced plans to merge with Wyeth in an effort to rejuvenate its pipeline work.

Source: FierceBiotech

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