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The Pulse of the Pharmaceutical Industry

Pfizer: A Giant Stumbles

Written by: | | Dated: Wednesday, October 1st, 2014

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Best-Selling Products

Lyrica $4,595 $4,158
Prevnar family $3,974 $4,117
Enbrel $3,774 $3,737
Celebrex $2,918 $2,719
Lipitor $2,315 $3,948
Viagra $1,881 $2,051
Zyvox $1,353 $1,345
Norvasc $1,229 $1,349
Sutent $1,204 $1,236
Premarin family $1,092 $1,073
BeneFix $832 $775
Vfend $775 $754
Genotropin $772 $832
Pristiq $698 $630
Chantix/Champix $648 $670
Refacto AF, Xyntha $602 $584
Xalatan, Xalacom $589 $806
Detrol, Detrol LA $562 $761

All sales are in millions of dollars.


Financial Performance

  2013 2012
Revenue $51,584 $54,657
Net income $22,003 $14,570
EPS $3.19 $1.94
R&D expense $6,678 $7,482
  1H 14 1H 13
Revenue $24,126 $25,383
Net income $5,241 $16,845
EPS $0.81 $2.34
R&D expense $3,382 $3,240

In millions of dollars, except for EPS



For Pfizer, 2013 was about trying to maintain its momentum and sticking to the priorities and strategies put into place three years ago to address R&D productivity and create greater shareholder value. “The actions we take and business decisions we make across every market continue to be guided by four strategic imperatives,” says CEO Ian Read. “They are: improving the performance of our innovative core, making the right capital allocation decisions, earning greater respect from society, and creating a culture of ownership among our colleagues.”

And in 2014, Pfizer attempted another strategy to create shareholder value: by offering to buy rival AstraZeneca (see profile on page 28). Despite the assiduous attempts to court the company, the offer was refused by AstraZeneca’s board. In the aftermath of the merger attempt, the U.K. Takeover Panel created new rules that would allow the Panel to seek a court order if it believes there’s a risk a buyer won’t stick to its promises to retain jobs after a merger, and to closely monitor their implementation. There had been Parlimentary hearings on the proposed deal for concerns about whether Pfizer actually would keep R&D jobs in the United Kingdom.

Executives say the company has transformed the ways it discovers, develops, and commercializes new medicines. In 2013, Pfizer launched Xeljanz, an oral therapy for rheumatoid arthritis, and with Bristol-Myers Squibb Co., Eliquis, a new approach to stroke prevention.

In February 2014, the company launched Duavee, a novel therapy for relief of moderate-to-severe hot flashes associated with menopause, and to prevent osteoporosis following menopause. “These medicines are part of a new wave of therapies taking shape in our R&D pipeline,” Read says. “We continued to focus our research on the therapeutic areas that we believe have the greatest scientific and commercial potential. Today our pipeline is the strongest it has been in recent years.”

To sharpen its focus on maximizing growth, Pfizer started 2014 with a new commercial operating structure with three global commercial businesses. The Global Innovative Pharmaceutical business is focused on branded medicines. The Global Established Pharmaceutical business has opportunities in developed and emerging markets. This business has a diverse portfolio of medicines that are no longer patent protected or are close to losing their patent protection. The Vaccines, Oncology and Consumer Healthcare business comprises three separate, distinct businesses, each of which has the potential for steady growth worldwide, executives say.

Additionally, Pfizer generated $17.3 billion in after-tax value through the separation of Zoetis, its animal health business.

Financial Performance

“Our financial and operational performance was strong in 2013,” Read says. “We met or exceeded every element of our financial guidance due in large measure to the strong operational achievements of the business.”

Pfizer saw growth in some of its branded pharmaceuticals, including Lyrica and Celebrex in the United States and Enbrel outside of North America, and solid revenue growth by several businesses, including 29 percent operational growth in oncology.

Efforts at controlling expenses yielded year-over-year operational savings in adjusted R&D and selling, informational, and administrative expenses of about $1 billion, executives say. Almost $23 billion was returned to shareholders in share repurchases and dividends in 2013 – bringing the total cash returned to shareholders over the last three years to about $53 billion.

In 2013, Pfizer’s sales were $51.58 billion, 5.6 percent less than in 2012. The operational decrease was primarily the result of the continued erosion of branded Lipitor (atorvastatin) in the United States, developed Europe, and certain other developed markets accounting for about $1.7 billion; the loss of exclusivity for Geodon in March 2012 in the United States, accounting for about $130 million); other product losses of exclusivity of about $1.3 billion; and the ongoing expiration of the Spiriva collaboration in certain countries accounting for about $475 million.

There were also decreased government purchases of the Prevnar family of products and Enbrel in certain emerging markets, accounting for about $160 million; and lower revenue from generic atorvastatin, about $145 million.

In the first half of 2014, Pfizer sales were $24.13 billion, 5 percent less than in the first half of 2013. Pfizer executives attributed the decrease primarily to the loss of exclusivity and subsequent launch of multi-source generic competition for Detrol LA in the United States in January 2014, Viagra in most major European markets in June 2013, as well as Aricept in Canada during December 2013. Additionally, the joint-promotion collaboration for Spiriva has terminated in most countries, including the United States in April 2014, or has entered its final year in other major markets. Per the terms of the collaboration agreement with BoehringerIngelheim GmbH, this has resulted in a decline in Pfizer’s share of Spiriva sales.

Pfizer’s net profit in 2013 rose to $22 billion in 2013, 51 percent more than in 2012. This can be attributed to the sale of the Zoetis animal health business in June 2013, and the company recognized a gain of about $10.3 billion, net of tax. 2013 earnings per share were $3.19, 64.4 percent more than in 2012. In the first half of 2014, net profit was $5.24 billion, 69 percent less than in first-half 2013. Earnings per share were 81 cents, 65.4 percent less than in first-half 2013. The decrease reflects the lack of income from the divested Zoetis business in 2013.

Pfizer spent $6.68 billion on R&D in 2013, 5.8 percent less than the previous year. In the first half of 2014, the company spent $3.38 billion on R&D, 4.4 percent more than in first-half 2013.

Pfizer’s best-selling product in 2013 was Lyrica, which generated sales of $4.6 billion, 10.5 percent more than in 2012. In the first half of 2014, Lyrica sales were $2.47 billion, 12 percent more than in first-half 2013.

The second top-selling product was the Prevnar family of vaccines. The product line recorded sales of $3.97 billion, 3.5 percent less than in 2012. First-half 2014 Prevnar sales were $2.02 billion, 6.8 percent more than in the same period of 2013.

Pfizer’s third top product in sales in 2013 was the rheumatoid arthritis drug Enbrel, which produced sales of $3.77 billion for the company, about the same as in 2012. Pfizer markets the drug outside the United States and Canada. In the first half of 2014, Enbrel sales were $1.89 billion, 2.9 percent more than the first half of 2013.

The fourth top-selling product for Pfizer in 2013 was the arthritis drug Celebrex, which recorded sales of $2.92 billion, 7.3 percent more than in the previous year. First-half 2014 sales were $1.34 billion, 1.3 percent more than in the same period last year.

No. 5 among Pfizer’s best sellers was the cholesterol reducer Lipitor, which lost U.S. and EU exclusivity in 2011. Sales declined 41.4 percent to $2.32 billion. First-half 2014 sales were $1 billion, 14.6 percent less than in first-half 2013.

Pfizer’s sixth best-selling product in 2013 was Viagra, which started losing exclusivity that year. Sales declined to $1.88 billion, 8.3 percent less than in 2012. First-half 2014 sales were $801 million, 15.2 percent less than the same period in 2013.

The seventh best-selling product for Pfizer in 2013 was the antibiotic Zyvox, which produced sales of $1.35 billion, about the same as in 2012. First-half 2014 sales were $669 million, 2.8 percent less than in first-half 2013.

No. 8 for Pfizer in 2013 was Norvasc. The blood pressure medicine generated sales of $1.23 billion, 8.9 percent less than in 2012. In the first half of 2014, the drug recorded $560 million in sales, 8.8 percent less than the same time last year.

No. 9 in 2013 sales was the cancer drug Sutent, which recorded sales of $1.2 billion, 2.6 percent less than in 2012. In the first half of 2014, Sutent sales were $578 million, 5.9 percent less than in first-half 2013.

The 10th best-selling product for Pfizer was the Premarin family of hormone replacement products. Sales in 2013 increased 1.8 percent to $1.09 billion. First-half 2013 sales were $522 million, about 1 percent more than in first-half 2013.

BeneFix, the hemophilia B product, was the company’s 11th best-selling drug in 2013. Sales grew 7.4 percent to $832 million. For the first half of 2014, sales amounted to$428 million, 5.4 percent more than first-half 2013.

The antifungal Vfend was the 12th top-selling drug for Pfizer in 2013, generating sales of $775 million. 2.8 percent more than in 2012. The first half of 2014 saw sales of $398 million, 9.3 percent more than in the same period last year.

No. 13 for Pfizer in 2013 was the growth hormone Genotropin, which posted sales of $772 million, 7.2 percent less than in 2012. First-half 2014 sales were $360 million, 7 percent less than the first-half 2013 total.

The menopausal drug Pristiq generated sales of $698 million in 2013, making it Pfizer’s 14th best-selling product. Pristiq sales grew 10.8 percent from 2012. First-half 2014 sales were $370 million, 7.9 percent more than same-time 2013.

The 15th top-selling product for Pfizer in 2013 was Chantix/Champix. The smoking-cessation therapy posted $648 million in sales, 3.3 percent less than in 2012. During the first half of 2014, sales were $317 million, 4.5 percent less than in first-half 2013.

Pfizer’s 16th best-selling product franchise were the hemophilia treatments ReFacto and Xyntha, which generated $602 million in sales, 3.1 percent more than in 2012. In first-half 2014, sales were $316 million, 10.9 percent more than in the first half of last year.

No. 17 in sales was Xalatan and Xalacom, for the treatment of intraocular eye pressure. The product posted $589 million in 2013, 26.9 percent less than in 2012. First-half 2014 sales were $247 million, 16 percent less than in the same period of last year.

The 18th top-selling product line for Pfizer during 2013 consisted of the overactive bladder drugs Detrol and Detrol LA, which recorded $562 million, 26 percent less than in 2012. Sales in the first half of 2014 amounted to $94 million, 69 percent less than in the first half of 2014, affected by multi-source generic erosion in the United States.

Pfizer And Astrazeneca

Over the years, Pfizer has engaged in a series of acquisitions to expand the company and add shareholder value. There was the merger with Warner-Lambert in 2000, the merger with Pharmacia in 2003, and the merger with Wyeth in 2009. Pfizer made a smaller acquisition with the purchase of King Pharmaceuticals in 2010. And in 2014, Pfizer looked to merge with another of its large rivals, AstraZeneca.

News that Pfizer was interested in acquiring AstraZeneca broke in April. According to AstraZeneca (see profile on page 28), talks actually were initiated in 2013, but no formal offer was made. Over the next month, Pfizer made four offers to AstraZeneca’s board, the final one made on May 16. Pfizer sent a letter to the chairman of AstraZeneca setting forth the terms of an improved proposal with an indicative value of £53.50, comprising 1.845 shares in the combined entity and 2,157 pence per AstraZeneca share. AstraZeneca’s board responded by saying the proposal substantially undervalues the company and was unwilling to accept a price close to Pfizer’s £53.50 proposal. Under the terms of the final proposal AstraZeneca shareholders would have received, for each AstraZeneca share, 1.747 shares in the combined entity and 2,476 pence in cash, representing an indicative value of £55.00 ($92.53) per share.

“We believe our proposal is compelling for AstraZeneca’s shareholders and that a Pfizer-AstraZeneca combination is in the best interests of all stakeholders,” Read says. “We are excited at the opportunity to create a scientific powerhouse, delivering great benefits to patients and science in the UK and across the globe. We stand by our unprecedented commitments to the UK Government. We believe that the benefits to all stakeholders can only be maximized through cooperative engagement between both companies.”

Read went to London to testify before Parliament about Pfizer’s intentions for AstraZeneca. In a letter to Prime Minister David Cameron, Read stated that Pfizer would complete the construction of the planned AstraZeneca Cambridge campus; base key scientific leadership in the U.K. who would lead all European and certain global R&D functions based in Cambridge; employ a minimum of 20 percent of the combined company’s total R&D workforce in the United Kingdom going forward; locate manufacturing operations of the combined company in the United Kingdom; base the combined company’s European business HQ in the United Kingdom; base the combined company’s EU Regulatory HQ in the United Kingdom; invite at least two AstraZeneca board members to join the board of the new company; and to hold, “as appropriate,” board meetings in the United Kingdom “and participate meaningfully in the UK commercial, economic, and social community.”

“Clearly, predictability and stability in the local and global commercial environment, as well as the UK government’s efforts to maintain incentives for investment, are important factors to enable success,” Read says. “We make these commitments for a minimum of five years, recognizing our ability, consistent with our fiduciary duties, to adjust these obligations should circumstances significantly change.”

Despite these promises, the UK government’s reception to the proposed merger was negative. Business Secretary Vince Cable vowed not to let Pfizer use the United Kingdom as a tax haven. Former AstraZeneca Chief Executive Sir David Barnes told the BBC in an interview that he feared that Pfizer would “act like a praying mantis” and “suck the lifeblood” out of AstraZeneca.

Sir David told the BBC that tax was “one of the key drivers” behind the Pfizer offer for AstraZeneca, rather than a long-term commitment to research and development.

“That is a very narrow basis on which to base such a massive task,” Sir David told the BBC. “The risk is that the past history of Pfizer has shown that they tend to extract destructive synergies, they have done that in the past. I have a great concern that they will act like a praying mantis and suck the lifeblood out of their prey.”

Even as UK officials were expressing opposition to the merger, US officials were making their concerns loudly. In a statement, U.S. Senator Carl Levin, D-Mich., chairman of the Senate Armed Services Committee and the Senate Permanent Subcommittee on Investigations, released a statement today on corporate inversions. “I’ve long been concerned about inversions – companies moving offshore on paper, for tax purposes, while the management and operations remain in the United States,” Levin says. “It’s become increasingly clear that a loophole in our tax laws allowing these inversions threatens to devastate federal tax receipts. We have to close that loophole. I am talking to my colleagues about legislation to close the loophole, which I intend to introduce soon. Companies that exploit this loophole benefit from the protections and services the federal government provides, including patent protection, research and development tax credits, national security and more; they shouldn’t be allowed to shift their tax burden onto others.”

The governors of Delaware and Maryland, Jack Markell and Martin O’Malley, where AstraZeneca has many employees, also had concerns about the impact of the merger and issued a joint statement.

AstraZeneca employs about 3,100 people in Maryland and about 2,600 people in Delaware, prompting the two governors to seek answers about the company’s potential future in the two states.

“We are concerned because, despite our requests, we have received no corresponding assurances about retaining jobs and research and development in our states,” the governors said. “Our concern is exacerbated by Pfizer’s history of closing U.S. research facilities, including sites in Michigan and Illinois, after closing on previous corporate transactions. It is also concerning that Pfizer is seeking to complete an acquisition involving jobs supporting thousands of families in our states in order to achieve tax advantages.

“While we understand your desire to operate efficiently, relocating your corporate and tax residence outside of the United States is not only detrimental to the United States, but potentially comes at a direct cost to our states and our constituents.”

Pfizer’s efforts quickly came to nothing. By May 19, the deal had been refused.

“We continue to believe that our final proposal was compelling and represented full value for AstraZeneca based on the information that was available to us,” Read says. “As we said from the start, the pursuit of this transaction was a potential enhancement to our existing strategy. We will continue our focus on the execution of our plans, bringing forth new treatments to meet patients’ needs and remaining responsible stewards of our shareholders’ capital.”

Potentially under UK law, Pfizer could try and make another concerted bid for AstraZeneca in November 2014.

Acquisitions And Collaborations

Undaunted after the AstraZeneca deal petered out, Pfizer made other arrangements. In July, the company announced a deal to acquire InnoPharma Inc. Under the terms of the agreement, Pfizer will acquire InnoPharma for an upfront cash payment of $225 million, with up to $135 million of contingent milestone payments.

InnoPharma’s portfolio includes 10 generic products approved by the FDA. The company also has a pipeline of 19 products filed with FDA and more than 30 injectable and ophthalmic products under development. The company seeks to develop novel formulations of existing drugs, including hard-to-make products such as those that require complex manufacturing capabilities or have bio-equivalency challenges, in areas such as cancer and central nervous disorders.

Executives say the acquisition expands Pfizer’s sterile injectables portfolio to 73 products. Pfizer Injectables is part of the Global Established Pharma business and includes the manufacturing, production and sale of human pharmaceutical and surgiceutical products. The active sterile injectable portfolio consists of 44 products with more than 190 presentations in the United States The expanded portfolio of 73 products will include currently marketed medicines as well as products filed with the FDA.

The closing of the transaction was expected to occur during the third quarter of 2014.

Later on in July, Pfizer announced that it had entered into a definitive agreement to acquire Baxter International Inc.’s portfolio of marketed vaccines for $635 million. As part of the transaction, Pfizer will also acquire a portion of Baxter’s facility in Orth, Austria, where these vaccines are manufactured.

Baxter’s portfolio of marketed vaccines consists of NeisVac-C and FSME-IMMUN/TicoVac. NeisVac-C is a vaccine that helps protect against meningitis caused by group C meningococcal meningitis (MenC). FSME-IMMUN/TicoVac is a vaccine that helps protect against tick-borne encephalitis, an infection of the brain, which is transmitted by the bite of ticks infected with the TBE-virus. FSME-IMMUN/TicoVac is approved in 30 countries and has been marketed for more than 30 years with about 120 million doses produced since 1976.

In June, Pfizer and Cellectis announced that they have entered into a global strategic collaboration to develop Chimeric Antigen Receptor T-cell (CAR-T) immunotherapies in the field of oncology directed at select targets. Cellectis’ CAR-T platform technology provides a proprietary, allogeneic approach (using engineered T-cells from a single donor for use in multiple patients) to developing CAR-T therapies that is distinct from other autologous approaches (engineering a patient’s own T-cells to target tumor cells).

Under the terms of the agreement, Pfizer has exclusive rights to pursue development and commercialization of CAR-T therapies, in the field of oncology, directed at a total of 15 targets selected by Pfizer. Both companies will work together on preclinical research and Pfizer will be responsible for the development and potential commercialization of any CAR-T therapies for the Pfizer-selected targets. In addition, the agreement provides for a total of 12 targets selected by Cellectis. Both companies will work together on preclinical research on four Cellectis-selected targets and Cellectis will work independently on eight additional targets. Cellectis will be responsible for clinical development and commercialization of CAR-T therapeutics for the Cellectis-selected targets. Pfizer has right of first refusal to the four Cellectis-selected targets.

Cellectis will receive an upfront payment of $80 million, as well as funding for research and development costs associated with Pfizer-selected targets and the four Cellectis-selected targets within the collaboration. Cellectis is eligible to receive development, regulatory and commercial milestone payments of up to $185 million per Pfizer product. Cellectis is also eligible to receive tiered royalties on net sales of any products that are commercialized by Pfizer.

Additionally, Pfizer will be entering into an equity agreement to purchase about 10 percent of the Cellectis capital through newly issued shares at €9.25 per share, pending Cellectis shareholder approval. Cellectis expects to open a site in the United States to work more closely with scientists at Pfizer.

“This leading immuno-oncology collaboration aimed at delivering immunotherapies is built upon Cellectis’ advanced genome editing and cell engineering capability and Pfizer’s cutting-edge biotherapeutic cancer therapy platform,” says Mikael Dolsten, M.D., Ph.D., president of R&D at Pfizer. “Combining the innovation and scientific expertise of Cellectis with Pfizer’s deep oncology and immunology experience creates a world-class partnership designed to deliver a new generation of CAR-T immunotherapies for cancer patients with urgent medical needs.”

In August, Pfizer announced an agreement with Merck (see profile on page 48) to explore the therapeutic potential of the combination of Pfizer’s crizotinib (marketed as Xalkori) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer. The financial terms of the agreement were not disclosed.

“This collaboration between Pfizer and Merck is just one example of the willingness of sponsors to work together in an effort to accelerate progress against some of the most difficult-to-treat cancers,” says Dr. Mace Rothenberg, senior VP of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “Understanding the effects of combining one drug, Xalkori, which inhibits an abnormally activated enzyme in patients with ALK-positive metastatic lung cancer, with the investigational drug, pembrolizumab, which harnesses the body’s immune system to fight cancer, is vital if we are to continue to advance the care of lung cancer patients.”

This multi-center, open-label clinical study is expected to begin in 2015. Pfizer will conduct the study.

Pipeline Development

In the area of inflammation and immunology, Pfizer has a number of Phase II and Phase III studies under way to leverage the science behind Xeljanz and other novel investigational therapies that target the root causes of a number of immune diseases where new and more effective therapies are greatly needed, including ulcerative colitis, Crohn’s disease, psoriasis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and lupus. Xeljanz was approved in November 2012 for the treatment of rheumatoid arthritis.

In 2013, Pfizer moved into Phase III trials for bococizumab, a new monoclonal antibody aimed at lowering LDL cholesterol, and ertugliflozin, for the treatment of type 2 diabetes, through a collaboration with Merck. Among other medicines in development are additional indications for Eliquis in preventing venous thromboembolism in orthopedic patients in the United States, and VTE treatment in the United States and Europe, with partner Bristol-Myers Squibb; and a novel compound for diabetic nephropathy. The two companies presented new data about Eliquis at the ESC Congress 2014 in early September.

In August, FDA approved the supplemental new drug application for Eliquis to treat deep-vein thrombosis and pulmonary embolism, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as venous thromboembolism.

The company also has several medicines in early development for diabetes that have potential as monotherapies or combination treatments.

In neuroscience and pain, the company’s investigational abuse deterrent formulation of oxycodone hydrochloride and naltrexone, ALO-O2, met its primary efficacy endpoint in a Phase III study of patients with moderate-to-severe chronic low back pain. The company has several new molecules in early-stage clinical development for conditions such as schizophrenia, Parkinson’s disease, Alzheimer’s disease, and Huntington’s disease.

In oncology, Pfizer continues to build a strong portfolio of potential cancer therapies, including palbociclib for breast cancer. In February 2014, Pfizer announced that a Phase II study of palbociclib had positive top-line results in patients with certain kinds of advanced breast cancer.

The company has additional studies under way of palbociclib, including two Phase III trials in advanced breast cancer, a Phase III study in advanced breast cancer sponsored by the Spanish Breast Cancer Research Group Foundation, and a Phase III trial sponsored by the German Breast Group in patients with early breast cancer at a high risk of recurrence.

Preclinical and early-phase studies are also under way to evaluate palbociclib in other tumor types, including melanoma, lung cancer, and head and neck cancer.

In August, Pfizer submitted to FDA the new drug application for palbociclib, in combination with letrozole, to treat postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase II trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.

The company has a promising early-stage oncology pipeline. Early clinical data suggest the potential of Pfizer’s smoothened protein inhibitor, or “SMO” inhibitor, to treat a range of hematologic diseases by blocking cancer cell growth and survival. Another promising early-phase asset is from the company’s immuno-oncology program, which includes investigational therapies that harness the body’s immune system to treat disease. Pfizer is studying this asset both as a single therapy and in combination with other therapies, such as Merck’s investigational anti-PD1 therapy, also an immuno-oncology agent.

In its portfolio of preventative and therapeutic vaccines, Pfizer has a vaccine that may stimulate the body to ward off the Staphylococcus aureus microbe, a common bacteria that is becoming increasingly resistant to antibiotics. The company also has a meningitis B vaccine in development and a vaccine for Clostridium difficile, one of the most difficult to treat hospital and assisted-living facility acquired infections.

In August, FDA accepted for review the biologics license application for the bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidisserogroup B in 10 through 25-year-olds. The FDA has also granted priority review designation for the BLA, providing an anticipated Prescription Drug User Fee Act (PDUFA) action date of Feb. 14, 2015.

Also in August, Pfizer received fast-track designation from FDA for the Clostridium difficile vaccine, which is in Phase II trials.

In 2013, the company advanced its pipeline assets in rare diseases, including initiating a late-stage program for tafamidis (marketed as Vyndaqel in Europe) in adults with symptomatic transthyretin cardiomyopathy, the first study of its kind for this rare, progressive and universally fatal condition. Pfizer is working with partner GlycoMimetics to advance rivipansel for treating vaso-occlusive crisis, a common and painful complication of sickle cell disease. The company has a clinical development program in Duchenne muscular dystrophy.

“We are on the right path to having a pipeline that is both robust and sustainable, offering biomedical innovations that patients and payers will value,” Read says.

Building Trust, Quality, Reach

Pfizer executives say the company has taken a leadership role in the industry concerning the access and sharing of clinical-trial results. Late in 2013, Pfizer announced a policy that simplifies and broadens access to information gathered in Pfizer-sponsored clinical trials. “While for several years we have published the results of clinical trials we file with regulators, this expanded policy enables the sharing of anonymous patient-level data from recent Pfizer-sponsored studies with qualified investigators outside the company, upon their request,” Read says. “We are also providing, in easy-to-understand language, information on clinical trial results to study participants.”

According to executives, in 2013, Pfizer’s leadership in supply-chain quality and reliability was showcased by the successful passage of track-and-trace legislation in the United States, which the company strongly supported. Executives believe that new law will help prevent counterfeit medicines from reaching patients and require that prescription drug packaging use technologies that can verify a product’s source and distribution history from production to patient use.

In 2013, Pfizer also sought to create deeper connections with people who share the company’s goal of fostering a healthy society. Pfizer continued its multi-year initiative called “Get Old,” where the company is striving to create a richer societal dialogue on aging, and increasing the public outreach of Dr. Freda Lewis-Hall, chief medical officer, to share health and medical information in ways that encourage people to take charge of their health care.

Also last year, Pfizer continued its global compliance training programs, which emphasize that every colleague is responsible for always doing the right thing and for understanding the important legal and ethical issues that affect the way the company does business.

“All Pfizer colleagues know that by doing our jobs with integrity every day, society will trust us to develop medicines that make people’s lives better,” Read says.


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