235 E. 42nd Street
New York, NY 10017
Phone: 212-733-2323
Website: pfizer.com

 

Best-Selling Products

PRODUCT 2014 Sales 2013 Sales
Lyrica $5,168 $4,595
Prevnar family $4,464 $3,974
Enbrel $3,850 $3,774
Celebrex $2,699 $2,918
Lipitor $2,061 $2,315
Viagra $1,685 $1,881
Zyvox $1,352 $1,353
Sutent $1,174 $1,204
Norvasc $1,112 $1,229
Premarin family $1,076 $1,092
BeneFIX $856 $832
Vfend $765 $775
Pristiq $737 $698
Genotropin $723 $772
Chantix/Champix $647 $648
Refacto AF, Xyntha $631 $602

All sales are in millions of dollars.

 

Financial Performance

  2014 2013
Revenue $49,605 $51,584
Net income $9,135 $22,003
EPS $1.42 $3.19
R&D expense $8,393 $6,678
  1H 15 1H 14
Revenue $22,717 $24,126
Net income $5,002 $5,241
EPS $0.80 $0.81
R&D expense $3,609 $3,326

In millions of dollars, except for EPS

 

 

Pfizer is in the fourth year of the transformation of its R&D approach, and according to CEO Ian Read, the company achieved its financial and pipeline goals for 2014.

“Our notable results this year include achieving or surpassing all of our 2014 financial goals,” Read says. “Pfizer today has a strengthened R&D pipeline; a leaner, more efficient organization; a better reputation; and a stronger corporate culture, as measured by independent surveys. Our colleagues are highly focused on innovation and operational excellence and are demonstrating a global growth mindset so that we can better meet the needs of patients.”

According to Read, Pfizer either achieved or surpassed all elements of the company’s 2014 financial guidance, including guidance for revenues, cost of sales as a percentage of revenue, selling, informational and administrative expenses, R&D expenses, and earnings per share.

“We returned nearly $12 billion to shareholders through share repurchases and dividends,” he says. “Thisbrings the cash returned to shareholders over the past four years to more than $64 billion. Over this same period Pfizer’s stock price has appreciated 78 percent.”

In December 2014, the company announced an increase in its quarterly dividend of about 8 percent, continuing the string of consecutive dividend announcements. “We achieved these strong financial results while simultaneously operating in a new commercial structure consisting of two distinct businesses: an Innovative Products business and an Established Products business,” Read says.

The Innovative Products business comprises two operating segments: the Global Innovative Pharmaceutical (GIP) segment and the Global Vaccines, Oncology and Consumer Healthcare (VOC) segment. The Established Products business consists of the Global Established Pharmaceutical (GEP) segment.

In 2014, the GEP business comprised more than half of Pfizer’s revenue, accounted for a large part of the company’s cash flow and operationally increased revenues in the Emerging Markets by 6 percent year-over-year. Business development continued to be an enabler of Pfizer’s strategy, and the company further strengthened its GEP business through the acquisition of InnoPharma, a privately held pharmaceutical development company. “This acquisition provides innovative growth opportunities for our sterile injectables portfolio and increased the size of our sterile injectables business to 73 products,” Read says.

To further support and grow this business, in February 2015 Pfizer announced an agreement to acquire Hospira, a leading provider of injectable drugs and infusion technologies and a global leader in biosimilars.

“Hospira is an excellent strategic fit and is expected to accelerate the growth trajectory of the GEP business and to make us a top-tier player in highly attractive and growing market segments,” Read says.

The acquisition was completed in September, and was expected to be immediately accretive to adjusted diluted earnings per share upon closing, with a 10-cent to 12-cent accretion to adjusted diluted EPS expected in the first full year after close with additional accretion anticipated thereafter.

“We will continue to evaluate all potential deals against a set of strategic priorities that include using our capital efficiently in ways that create meaningful shareholder value, that have the potential for near-term solid value creation, that strengthen our individual businesses, and that enhance our leadership position in areas that are most attractive to the core of our business.” Read says.

For 2014, Pfizer generated revenue of $49.61 billion, 3.8 percent less than in 2013. The decrease in revenue is attributed to the expiration of the co-promotion term of the collaboration agreement for Enbrel in the United States and Canada; the loss of exclusivity and subsequent multi-source generic competition for Detrol LA, Celebrex, and Geodon in the United States, Viagra in most major European markets, and Aricept and Lyrica in Canada, and certain other products; the continued erosion of branded Lipitor in the United States and most other developed markets due to generic competition; the operational decline of certain products, including Norvasc, Effexor, atorvastatin, Metaxalone, Zosyn/Tazocin, Ziprasidone, Genotropin, Tygacil, Centrum, Advil and Vfend; and the ongoing termination of the Spiriva collaboration in certain countries.

Net income was $9.14 billion, compared with $22 billion in 2013. Diluted earnings per share were $1.42 compared with $3.19 the previous year. The difference between net income and earnings per share is due to that fact that in 2013, Pfizer sold off its animal health business, Zoetis, and recognized a gain of approximately $10.3 billion, net of tax.

Executives attribute the decrease in revenue to an operational decrease of $1.1 billion, or 2 percent, and the unfavorable impact of foreign exchange of $912 million, or 2 percent.

For the first half of 2015, the company reported revenue of $22.72 billion, 5.8 percent less than in the first half of 2014. Net income was reported at $5 billion, 4.6 percent less than in first-half 2014. Diluted EPS came to 80 cents, 1 cent less than in the same period last year.

“Our second-quarter and year-to-date financial performance is the result of continued business momentum, driven by solid execution of recent product launches in our Innovative Products business, notably Ibrance and Prevnar 13 in adults in the U.S., along with continued growth from Eliquis and Xeljanz, increased focus on and support of growth initiatives within our Established Products business as well as shareholder-friendly capital allocation,” Read says. “I continue to see both of our businesses as highly focused, well managed and competitively positioned in their key markets.”

When first-half results were announced, Pfizer raised the midpoint of its 2015 financial guidance range for reported revenue by $500 million and the midpoint of its guidance range for adjusted diluted earnings per share by 4 cents.

Product performance

Pfizer executives were very satisfied with product sales in 2014. “During the year we saw growth in several branded pharmaceuticals from the Innovative Products business, including double-digit growth in both Lyrica and the Prevnar franchise, a more than 50 percent increase in Xalkori sales, and we successfully launched Nexium 24HR, the largest brand to switch from prescription only to over-the-counter in U.S. history,” Read noted.

Pfizer’s top-selling product in 2014 was the neuropathic pain agent Lyrica. The product achieved sales of $5.17 billion, 12.5 percent more than in 2013. In the U.S., revenues increased 18% in 2014 compared to 2013, driven by price increases as well as increased investment in effective direct-to-consumer advertising combined with strong field force performance and the recent promotional launch of new data demonstrating efficacy in treating fibromyalgia patients receiving antidepressants for their co-morbid depression, despite continued competition from generic versions of competitive medicines.

Internationally, Lyrica operational revenues increased 11 percent in 2014, compared to 2013, with the growth due to a focus on enhancing diagnosis and treatment rates of neuropathic back pain, and expediting the identification and appropriate treatment of generalized anxiety disorder in the European Union, physician education regarding neuropathic pain and fibromyalgia in Japan, and an effective direct-to-consumer campaign to increase awareness in Japan. In addition, growth was driven by gaining reimbursement in Australia and an effective multichannel direct-to-consumer campaign driving an increase in visits to physicians. Foreign exchange had a unfavorable impact on international revenues of 3 percent in 2014, compared to 2013.

In the first half of 2015, Lyrica generated sales of $2.41 billion, 2.4 percent less than in the same period last year. Lyrica sales in certain countries of the European Union were affected by generic competition.

Pfizer’s second-best-selling drug franchise during 2014 was the Prevnar/Prevenar family of products. The pneumococcal vaccines generated $4.46 billion, 12.3 percent more than in 2013. In the United States, revenue for Prevnar 13 increased 19 percent in 2014, compared to 2013, mainly due to government purchasing patterns and price increases, and increased demand, primarily driven by additional market penetration for Prevnar 13 in adults. Internationally, operational revenues for the Prevenar family of products increased 10 percent in 2014, compared to 2013, primarily reflecting increased shipments associated with the Global Alliance for Vaccines and Immunization as well as the timing of government purchases and the favorable impact of Pfizer’s inclusion in additional national immunization programs, both in various emerging markets.

The Prevnar family outsold Lyrica during the first six months of 2015. First-half 2015 sales of Prevnar/Prevenar were $2.81 billion, 38.7 percent more than in first-half 2014. Prevnar 13 revenue in the United States increased 87 percent during the second quarter of 2015, primarily driven by continued strong uptake among adults. International revenue increased 25 percent operationally, driven by Prevenar 13, which grew 10 percent operationally, primarily reflecting increased shipments associated with Gavi, the Vaccine Alliance, the favorable impact of Prevenar’s inclusion in additional national immunization programs in certain emerging markets compared with the year-ago quarter, as well as the inclusion in second-quarter 2015 of revenues associated with the acquisition of Baxter’s portfolio of marketed vaccines in Europe.

The third best-selling product for Pfizer in 2014 was the rheumatoid arthritis drug Enbrel, which the company markets outside the United States and Canada under a deal with Amgen Inc. Sales of the product were recorded at $3.85 billion, 2 percent more than in 2013. Executives say results were favorably impacted by continued market leadership in rheumatoid arthritis. First-half sales of the drug were $1.58 billion, 16.4 percent less than in first-half 2014.

Celebrex was the fourth-highest-selling product for Pfizer in 2014, with sales of $2.7 billion, 7.5 percent less than in the previous year. First-half 2015 sales were $428 million compared with $1.39 billion in the same period last year, due to loss of U.S. exclusivity in December 2014 and the rise of generic competition.

Lipitor was Pfizer’s fifth best-selling product in 2014, at $2.06 billion, 11 percent less than in 2013. In the first half of 2015, Lipitor sales were $950 million, 5 percent less than in first-half 2014. The cholesterol-reducing product is continuing to be affected by generic competition in all markets.

Sixth in 2014 sales was the erectile dysfunction drug Viagra, at $1.69 billion, 10.4 percent less than in 2013. First-half 2015 sales of the drug were $843 million, 5.2 percent more than in first-half 2014.

The seventh best-selling drug for Pfizer in 2014 was the antibiotic Zyvox, with sales of $1.35 billion, about the same as the previous year. First-half 2015 sales were $530 million, a 21 percent decrease due to loss of U.S. exclusivity.

No. 8 for Pfizer in 2014 sales was the cancer drug Sutent, which generated $1.17 billion, 2.5 percent less than in 2013. During the first half of 2015, Sutent sales were $536 million, 7 percent less than in the same period last year.

The hypertension agent Norvasc was the ninth best-selling drug in sales for Pfizer in 2014. The drug made $1.11 billion, 9.5 percent less than in 2013, reflecting, among other factors, generic erosion in Japan, partially offset by strong volume growth in China. Foreign exchange had an unfavorable impact of 4 percent in 2014, compared to 2013. For first-half 2015, Norvasc sales were $503 million, 10.2 percent less than in the same period last year.

No. 10 for Pfizer in 2014 was the Premarin family of hormone replacement therapies. Sales were $1.08 billion, 1.5 percent less than in 2013. The Premarin line had sales of $491 million during January-June 2015, 5.9 percent less than in first-half 2014.

The antihemophilic factor (recombinant) BeneFIX was the 11th highest-selling product line for Pfizer in 2014, generating $856 million, 2.8 percent more than in 2013. The drug had sales of $366 million in first-half 2015, 14.5 percent less than in the same period in 2014.

Vfend, for fungal infections, was the company’s 12th best-selling product in 2014, recording $756 million, 2.5 percent less than in 2013. Vfend sales in first-half 2015 were $345 million, 13 percent less than in first-half 2014.

The No. 13 drug in sales for Pfizer in 2014 was Pristiq, for treating major depressive disorder. Pristiq sales were $737 million, 5.6 percent more than in 2013. First-half 2015 sales were $338 million, 8.6 percent less than in the first half of last year.

The growth hormone Genotropin had sales of $723 million in 2014, 6.3 percent less than the previous year, making it Pfizer’s 14th best-selling product. Sales in the first half of this year were $306 million, 15 percent less than in the same period of 2014.

Pfizer’s 15th best-selling drug in 2014 was the smoking cessation drug Chantix/Champix. Sales were $647 million, about the same as in 2013. In the first half of 2015, sales were $332 million, 5 percent more than in first-half 2014.

The hemophilia products ReFacto AF and Xyntha were Pfizer’s 16th best-selling product line in 2014, with sales of $631 million, 4.8 percent more than in 2013. First-half 2015 sales were $262 million, 17 percent less than in the same period of 2014.

Read says newly launched products from the company’s Innovative Products business did well in 2014, with Eliquis gaining significant momentum worldwide. Although the drug, which was jointly developed and is promoted with Bristol-Myers Squibb, was launched third in the novel oral anticoagulant class, executives say Eliquis is winning share among cardiologists and is moving toward a leading position in the new-to-brand share among all prescribers in several markets, including the United States and Japan.

And executives say the rheumatoid arthritis drug Xeljanz now ranks No. 3 among rheumatologists in the new-to-brand prescription share of self-administered rheumatoid arthritis therapies and is on track to become No. 33 new-to-brand overall in the United States.

Recent product approvals and pipeline updates

“Innovation is at the heart of Pfizer,” Read says. “We are now four years into transforming our approach to biopharmaceutical R&D. The mark of our progress is an R&D pipeline that is matched to a set of important medical needs and poised with the potential to provide a steady flow of new therapies starting in a few years. We’ve built a range of assets across six therapeutic areas and also biosimilars that have strong scientific and commercial potential.”

During 2014, Eliquis received approval for new indications in the United States and in the European Union. First approved for reducing the risk of blood clots and stroke in certain patients with atrial fibrillation, Eliquis is now cleared in the United States and the European Union for treating blood clots in the veins of the legs or lungs, and in reducing the risk of their reoccurrence. In the United States, Eliquis was further approved to lessen the risk of blood clots in patients following hip or knee replacement surgery.

Despite the widespread acceptance of statins such as Lipitor, millions of patients still have trouble managing cholesterol, either because statin therapy does not work for them, or because they need additional help beyond statins. Pfizer is now into Phase III development for bococizumab, a monoclonal antibody that is a new approach to lowering LDL cholesterol and reducing cardiovascular events for patients in need of improved cholesterol management. Two large cardiovascular outcomes trials for bococizumab are under way, designed to include the broadest range of high-risk patients, compared with other clinical programs offered by competitors.

In addition, through collaboration with Merck & Co., Pfizer is moving ahead with its entry into a new class of diabetes treatments called SGLT2 inhibitors. The compound, ertugliflozin, is being studied as both a standalone treatment and in combination with Merck’s Januvia and metformin.

Cancer is the second leading cause of death in the United States and executives say Pfizer has rapidly expanded its portfolio of approved cancer treatments, aimed at some of the most prevalent, difficult-to-treat cancers.

In February 2015, the U.S. Food and Drug Administration gave accelerated approval of Ibrance for metastatic breast cancer patients. Ibrance is available to be prescribed as a treatment for postmenopausal women with ER+, HER2-, advanced disease and is the first new medicine approved for this group of patients in a decade. “Ibrance may change the treatment paradigm in the U.S., and we are pursuing approvals in other major markets,” Read says. Ibrance is also being studied for early-stage breast cancer as well as for a range of other tumors, including lung, head, and neck, and pancreatic cancers.

In May 2015, Pfizer announced study results demonstrating palbociclib in combination with fulvestrant was superior to treatment with a standard of care, fulvestrant, by significantly extending progression-free survival (PFS) in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed during or after endocrine therapy. Results from the Phase 3 PALOMA-3 study were presented as a late-breaker at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2015. The PALOMA-3 study met its primary endpoint of PFS at the interim analysis and was stopped early in April 2015 due to efficacy based on an assessment by an independent data monitoring committee. Benefit was demonstrated across all pre-specified subgroups, including both pre/perimenopausal and postmenopausal patients.

Pfizer plans to submit a supplemental new drug application to FDA in fourth-quarter 2015 for potential inclusion of data from the PALOMA-3 study in the U.S. label. Additionally, Pfizer intends to file a marketing authorization application for palbociclib with the European Medicines Agency in third-quarter 2015. The planned EMA submission will include data from the PALOMA-1 study, which evaluated palbociclib plus letrozole in women with estrogen receptor positive, HER2- locally advanced or newly diagnosed metastatic breast cancer, as well as data from the PALOMA-3 study.

Merck KGaA and Pfizer announced in April 2015 the initiation and first patient treated in a Phase III study designed to assess the efficacy and safety of the investigational cancer immunotherapy avelumab, compared with docetaxel, in patients with stage IIIb/IV NSCLC who have experienced disease progression after receiving a prior platinum-containing doublet therapy. The Phase III study is an open-label, multicenter, 1:1 randomized clinical trial where patients with stage IIIb/IV NSCLC are receiving either avelumab or docetaxel, regardless of programmed death-ligand 1 (PD-L1) status.

About 650 patients will participate across 290 sites in more than 30 countries in North America, South America, Asia, Africa and Europe. The study is part of the JAVELIN clinical trial program for avelumab.

Pfizer continues to invest in the science behind Xalkori, its treatment for certain kinds of lung cancer not associated with smoking. Pfizer announced in April 2015 that Xalkori received breakthrough therapy designation by the FDA for the potential treatment of patients with ROS1-positive non-small cell lung cancer. Occurring in approximately 1 percent of NSCLC cases, ROS1-positive NSCLC represents a particular molecular subgroup of NSCLC. Xalkori currently is approved in the United States for the treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by a FDA-approved test. Pfizer will work closely with the FDA on the development of Xalkori for ROS1-positive NSCLC and provide the information needed to support a potential regulatory submission.

Executives say the company is building its expertise and creating an industry-leading program in immuno-oncology, with the goal of treatments that focus the patient’s own immune system on an invading cancer. Through a partnership with Germany’s Merck KGaA, Pfizer has accelerated its work in immuno-oncology by more than two years and given both companies a solid opportunity to participate in the next wave of potential cancer therapies.

“With this and other collaborations – with Cellectis on CAR-T technology that harnesses T-cells to fight cancer, and with iTeos Therapeutics for the development of small-molecule immuno-oncology agents supplementing our home-grown expertise – we believe we are poised to lead in the fight against cancer,” Read says.

In the area of inflammation, Pfizer has a Phase III study to evaluate Xeljanz in ulcerative colitis, and Phase II programs in Crohn’s disease, topical psoriasis, atopic dermatitis, and ankylosing spondylitis. During 2014, Pfizer announced positive results from Phase III clinical studies using Xeljanz to treat moderate-to-severe psoriasis, and the FDA has accepted for review an application for this indication.

In the areas of neuroscience and pain, Pfizer has a number of biologicals and small-molecule candidates in early development for treating dementias, including a new approach to Alzheimer’s that may improve how nerve cells signal each other inside the brain. The company is also developing a compound, already designated as an orphan drug by the FDA, that may prove useful in treating Huntington’s disease, and promising early-stage research aimed at developing a dopamine modulator useful against Parkinson’s disease that could provide longer-lasting motor benefits for people suffering from Parkinson’s compared to existing treatments.

For chronic pain, in 2014 the FDA approved an updated label for Embeda, an extended-release morphine that the company has relaunched, to reflect properties that are proven to reduce the potential for abuse.
In addition, early this year the FDA accepted for review the application for a marketing authorization in the United States for ALO-02, an extended-release oxycodone hydrochloride medicine that is designed to reduce abuse.

A few examples of the company’s work in the rare diseases area include myostatin, entering Phase II for Duchenne muscular dystrophy; tafamidis, in Phase III trials for adults with symptomatic transthyretin cardiomyopathy; and rivipansel, which is being developed through a licensing agreement with GlycoMimetics for vaso-occlusive crises of sickle cell disease.

Pfizer announced in June 2015 that the first patient has been enrolled in the RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study, a Phase III clinical trial assessing the efficacy and safety of rivipansel for the treatment of vaso-occlusive crisis in hospitalized individuals with sickle cell disease who are 6 years of age or older. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study is expected to enroll at least 350 people. Rivipansel has received orphan drug and fast-track status from the FDA, and this study is being conducted under a special protocol assessment, in agreement with the FDA.

In 2014, Pfizer helped form the Rare Disease Consortium – with agreements between certain U.K. universities and academic health centers and the company – bringing together a range of skills and technologies needed to speed up the flow of potential new therapies. Pfizer also expanded its rare disease R&D abilities through an agreement with Spark Therapeutics to investigate a gene therapy approach for hemophilia B. If successful, such an approach would actually replace genes that are not working properly.

In addition, in late 2014, Pfizer entered into an agreement with Opko Health to jointly develop and commercialize a long-acting human growth hormone for patients with adult and pediatric growth hormone deficiency. This has the potential to be the first innovation in growth hormone therapies in 20 years.
Pfizer experienced success in the vaccines area in 2014, when Trumenba was approved by the FDA to prevent invasive disease caused by Group B meningitis in people aged 10 through 25 years.

There was progress in other preventive vaccines, including one now in Phase II development against Staphylococcus aureus, a leading cause of serious healthcare-associated infections, resulting in a substantial burden to healthcare systems. There is no licensed vaccine available to prevent this disease. The Staphylococcus aureus vaccine has “fast track” status by the FDA. In July 2015, Pfizer announced enrollment of the first patient in a Phase IIb clinical trial for the vaccine in adults undergoing elective spinal fusion surgery. The purpose of the study, named STRIVE (STaphylococcus aureus SuRgical Inpatient Vaccine Efficacy), is to evaluate the safety and efficacy of the vaccine to determine if it prevents postoperative invasive S. aureus infections in patients undergoing elective spinal surgery. The trial is expected to enroll about 2,600 patients with final results expected in 2017.

In July 2015, Pfizer announced that the company’s Clostridium difficile vaccine candidate, PF-06425090, is in a new Phase II study to evaluate the safety, tolerability, and immunogenicity of its investigational C. difficile vaccine in healthy adults 65 to 85 years of age. The trial is expected to enroll approximately 850 patients with final results expected in 2017. PF-06425090 was granted fast track designation by the FDA in August 2014.

In addition to positive internal developments, the company also broadened its vaccines portfolio with two acquisitions. In 2014, Pfizer acquired Baxter International’s marketed vaccines, including one that helps protect against diseases caused by Group C meningitis. The Baxter acquisition also provides the company with a second vaccine that helps protect against tick-borne encephalitis.

Early in 2015, Pfizer acquired a controlling interest in Swiss-based Redvax. This gives the company access to a promising vaccine in early-stage development for human cytomegalovirus, a virus present in most people but potentially dangerous if passed from a newly infected mother to her newborn.

Along with new vaccines, the company continues to invest in clinical studies to expand the value of its marketed portfolio, including Prevnar 13. Early in 2014, Pfizer announced that a landmark study called CAPiTA (for Community-Acquired Pneumonia Immunization Trial in Adults) demonstrated the value of vaccinating adults aged 65 and over against pneumococcal disease. As a result, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to recommend Prevnar 13 for this older patient population, one of the fastest-growing cohorts in the U.S.

An emerging area of innovation for Pfizer is biosimilars, highly similar versions of approved and authorized biological medicines. “We have built one of the leading biosimilars pipelines in our industry, with a strong focus on cancer treatments and auto-immune disorders,” Read says. The company now has five biosimilars in development, with Phase III trials under way in therapies for metastatic breast cancer, follicular lymphoma, and rheumatoid arthritis. The company is striving to become one of the world’s leading providers of biosimilars, a market expected to approach $20 billion in 2020.

“Pfizer is suited to lead in this business segment as we have the scientific and manufacturing expertise to engineer and produce these complex, large-molecules in the quantities needed and to the quality standards required,” Read says.

In July 2015, Pfizer began dosing patients in a multinational Phase III clinical trial of PF-06410293, a potential biosimilar to Humira (adalimumab). The Phase III clinical trial will evaluate the efficacy, safety, and immunogenicity of PF-06410293 plus methotrexate and adalimumab sourced from the European Union plus methotrexate in subjects with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate monotherapy.

As of May 2015, Pfizer began dosing patients in a multinational Phase III clinical trial of PF-06439535, a potential biosimilar to Avastin (bevacizumab). The Phase III clinical trial will evaluate the efficacy and safety of PF-06439535 plus paclitaxel and carboplatin against Avastin sourced from the EU plus paclitaxel and carboplatin by comparing the best confirmed objective response rate by week 19 in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.