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2009: The Year That Was For Pfizer

(RTTNews) – True to expectations, Jeffrey Kindler, the CEO of Pfizer Inc. (PFE | Quote | %20%20%20%20%20%20PFE%20|%20%20%20%20%20%20%20Quote%20|%20%20%20%20%20%20%20Chart%20|%20%20%20%20%20%20%20News%20|%20%20%20%20%20%20%20PowerRating“);”>Chart | News | PowerRating), scripted a new playbook for the drug giant in 2009, accelerating the process of transformation by clinching the largest pharmaceutical deal in nearly a decade.

The acquisition of Wyeth for $68 billion earlier this year represents a major move by Pfizer to plug the impending holes in its balance sheet when patents covering some of its key drugs expire in the next few years. Between 2010 and 2012, drugs that make up 42% of Pfizer’s pharmaceutical revenue, are slated to lose patent protection.

Let’s take a look at some of the Pfizer news that made headlines this year.

The Mega Deal

Though Pfizer is not new to mega deals, Kindler was dubious of such mega mergers till last year. He preferred only bolt-on or product acquisitions to major acquisitions. However, the craving for new sources of revenue and the inability of the company’s near-term pipeline to make up the slack when its blockbusters lose patent exclusivity made Kindler adopt the mega-merger strategy this year and acquire Wyeth.

Wyeth has a promising pipeline as well as a number of blockbusters in its arsenal, including rheumatoid arthritis drug Enbrel, jointly marketed with Amgen (AMGN | Quote | Chart | News | PowerRating), pneumonia vaccine Prevnar, antidepressant Effexor, nutritional products, intravenous antibiotic Zosyn and the hormone replacement therapy Premarin family of drugs. Enbrel topped $3 billion in total sales, Effexor raked in worldwide revenue of $3.93 billion, while Prevnar notched up sales of $2.72 billion in 2008.

As mentioned above, drugs that make up 42% of Pfizer’s pharmaceutical revenue, are slated to lose patent protection between 2010 and 2012. The drugs going off-patent include Aricept, Lipitor, Viagra, Detrol, Geodon and Xalatan. Lipitor alone accounted for 28% of Pfizer’s pharmaceutical sales last year.

Pfizer’s revenue in 2008 was $48.3 billion, while Wyeth’s revenue for the year totaled $22.8 billion. With highly complementary businesses, the combined company has a diverse product portfolio that includes 17 products with more than $1 billion each in annual revenue. It is expected that no drug will account for more than 10% of the combined company’s revenue in 2012.

The combination also brings together a robust pipeline of biopharmaceutical research and development projects, including programs in diabetes, inflammation/immunology, oncology and pain, as well as significant opportunities in Wyeth’s Alzheimer’s disease pipeline.

Pfizer completed the acquisition of Wyeth in October, nine months after the companies inked a definitive merger agreement. The acquisition is expected to be accretive to Pfizer’s adjusted earnings per share in the second full year after closing and yield cost savings of about $4 billion to be fully realized by the third year after closing.

No doubt, the acquisition of Wyeth will provide a more diversified portfolio and alleviate Pfizer’s sales decline, but this will not be the panacea for the threat caused by the raft of patent expirations, according to research firm Datamonitor. Wyeth also faces looming patent expiration on its key drug Effexor XR. The depression drug, which notched up $3.93 billion in sales last year, is slated to lose patent exclusivity in 2010.

However, as the company gets rid of operational overlap, the deep cost cuts will see the combined company delivering profit growth.

For 2009, Pfizer now expects reported earnings to range between $1.45 and $1.50 per share and adjusted earnings to range between $2.00 and $2.05 per share. Previously, the company was anticipating reported earnings to range between $1.30 and $1.45 per share and adjusted earnings to range between $1.90 and $2.00 per share. The company now expects reported revenues in the range of $49 billion-$50 billion, up from its prior forecast of $45 billion-$46 billion. The revised guidance reflects the completion of the Wyeth transaction.

Cost-cutting measures in full gear

Pfizer has been in restructuring mode since 2005 and has retained its focus on cutting costs, including outsourcing and offshoring to ease the pressure on its topline.

Since 2005, Pfizer has significantly reduced its workforce. According to the company’s quarterly filing with the SEC, from June 2005 through September 27, 2009, it terminated 26,300 of its employees and has expensed employee termination costs of $5.35 billion.

In tandem with its merger with Wyeth, Pfizer is in the process of laying off 15% of the combined company’s workforce. That includes the 10% workforce reduction announced earlier this year. In the first nine months of 2009, the company reduced its workforce by approximately 6,500 employees. The company’s aggressive belt-tightening measures are expected to generate significant cost reductions for the combined company.

Pfizer anticipates achieving total annual cost savings of about $6 billion by the end of 2012. The targeted savings include $2 billion in net cost reductions from Pfizer cost-reduction initiatives, of which about $950 million has been achieved through September 27, 2009, and an additional $4 billion in expected synergies related to the integration of Wyeth.

The Neurontin Controversy

There are about 1,200 lawsuits over Pfizer’s off-label marketing of Neurontin. While the drug was originally approved by the FDA as an add-on treatment for partial epileptic seizures in 1993 and for the management of post-herpetic neuralgia in 2002, Pfizer has been marketing it to treat multiple conditions including mood swings and arthritis. In 2004, Pfizer paid $430 million in fine to settle civil and criminal charges of promoting Neurontin for unapproved uses.

The first lawsuit against Pfizer, in regard to Neurontin came to trial in July of this year. The suit was filed by the family of Susan Bulger, a 39-year-old woman who committed suicide in 2004. Bulger had been prescribed Neurontin for arthritis, an off-label use, and was taking the drug for two years. However, after just one day of testimony, Bulger’s family dropped the case against Pfizer after an anonymous donor offered to set up a trust for the deceased woman’s 10-year old daughter.

A review of Neurontin trial results published by Kay Dickersin last month in the New England Journal of Medicine, accuses Pfizer of manipulating the trial data for various unapproved indications. The author Kay Dickersin was an expert witness in the trial. Pfizer, which has disputed the findings of the article, said the review published in the journal was “derived from a report created for litigation and coauthored by plaintiffs’ expert witness, who was hired to produce opinions to support plaintiffs’ arguments.”

Though the first case involving Neurontin has been dismissed, this legal tangle is far from over. However, Pfizer firmly believes that there is no scientific evidence to prove that Neurontin causes suicidal behavior.

The basic U.S. patents relating to Neurontin expired in 1994 and 2000. However, in April 2000, a U.S. patent was granted relating to stable pharmaceutical compositions of Neurontin containing low levels of lactam impurity. This patent expires in 2017.

Neurontin, which once fetched $2 billion in sales for Pfizer, began to face generic competition in the U.S. in the latter half of 2004. Subsequently, the pharma giant launched its own generic version of Neurontin in the U.S. through its Greenstone Ltd. generic pharmaceutical subsidiary. In 2008, the global sales of Neurontin totaled $387 million, a decline of 10% from 2007. For the nine months ended September 2009, Neurontin sales declined 18% to $242 million from the comparable period a year before.

Major legal settlements

Pfizer, which is no stranger to legal tussles, got itself cleared of some of the legal issues this year by settling with the plaintiffs. After all, legal beagle Kindler knows that closure of significant legal matters will only help his company to enhance its focus on discovering, developing and delivering innovative medicines.

On July 30, Pfizer settled the long drawn-out lawsuit with Kano State government in Nigeria related to the company’s 1996 study of antibiotic drug Trovan.

The suit filed by authorities in Kano accused Pfizer of administering the untested and unapproved antibiotic called Trovan to children during a meningitis epidemic in 1996, resulting in the deaths of an unspecified number of children and leaving others deaf, paralyzed, blind or brain-damaged.

According to the lawsuit, Pfizer did not obtain consent from the children’s families before enrolling the children in the ill-fated trial. The suit also accused Pfizer of conducting the study of Trovan despite knowing the life-threatening side effects of the drug and being well aware that it was unfit for human use. However, Pfizer has denied any wrongdoing or liability in connection with the 1996 study.

Under the terms of the settlement, Pfizer agreed to pay $30 million over a period of two years to support health initiatives designated by Kano State and to reimburse Kano State for $10 million in legal costs associated with the litigation.

Pfizer has also agreed to establish a Healthcare/Meningitis Fund from which study participants can receive financial support. The maximum amount that could be disbursed by the Fund is $35 million, but the final amount will depend on the total number of valid claims submitted.

In turn, Kano State agreed to dismiss both the civil and criminal Trovan-related cases it filed against Pfizer and various individuals.

Yet another lawsuit that Pfizer resolved this year is a multi-billion dollar settlement and the largest healthcare fraud settlement in the history of the Department of Justice. Pleading guilty to a felony crime in off-label promotional practices for painkiller Bextra, which was withdrawn from the market in 2005 over safety concerns, and fraudulent marketing of anti-psychotic drug Geodon, antibiotic Zyvox and anti-epileptic drug Lyrica, Pfizer on September 2 announced it agreed to pay $2.3 billion in fines to settle federal criminal and civil charges against it. The fine was already factored into the fourth-quarter earnings of 2008 and no additional charges are expected to be carried over.

In October, the drug giant entered into an agreement with drugmaker Mylan Inc. (MYL | Quote | Chart | News | PowerRating) related to a generic version of Vfend (voriconazole), an antifungal agent. In the same month last year, Matrix Laboratories Ltd., the India-based subsidiary of Mylan, challenged Pfizer’s patents for its Vfend tablets, 50 mg and 200 mg, with the filing of its Abbreviated New Drug Application.

However, Pfizer did not file a lawsuit against Matrix within the statutory 45-day time period. Now that Pfizer has entered into an agreement with Mylan, the generic drugmaker will have the right to market voriconazole tablets in the U.S. in the first quarter of 2011. The details of the agreement with Mylan were not disclosed. Vfend logged in sales of $743 million in 2008 and $555 million for the nine months ended September 2009.

Not out of legal woods…

Though Pfizer has settled some of its long-standing legal issues, it is not completely out of the legal woods. In addition to its own legal hassles, Pfizer also has to resolve Wyeth’s legal woes inherited through the acquisition.

Wyeth’s hormone replacement therapy drugs, Premarin and Prempro touted as “magic bullets” are indicated for the relief of hot flashes and night sweats, associated with menopause. After the U.S. government’s Women’s Health Initiative study found that healthy postmenopausal women enrolled in the study who were treated with the hormone replacement therapy drugs, Premarin and Prempro had increased risk of invasive breast cancer, stroke and blood clots, Wyeth came under fire. The study, which was to continue until 2005, came to an abrupt halt in early June 2002. However, the drugs continue to be in the market.

Wyeth faces lawsuits from more than 10,000 women who claim that the company’s hormone-replacement therapy drugs Premarin and Prempro caused breast cancer.

In the trial related to hormone-replacement therapy drugs, two verdicts were announced this year, and Wyeth, now a division of Pfizer, has been ordered to pay $103 million in punitive damages in the two cases.

Wyeth has not set aside any legal reserve for dealing with the hormone replacement therapy litigation and settlements.

Regulatory Approvals

Pfizer spends more than $7 billion annually on research and development. Last year, the company abandoned its research projects related to heart disease, obesity and bone health to focus on lucrative fields like cancer and Alzheimer’s.

According to the company’s latest pipeline update, the areas of focus include allergy & respiratory; cardiovascular, metabolic and endocrine diseases; gastrointestinal; genitourinary; infectious diseases; inflammation; neuroscience; oncology; ophthalmology and pain.

The following are few of Pfizer’s drugs that won regulatory approval this year.

A Double Treat

It was a double treat from the FDA for Pfizer on November 20, as the drug giant won approval for two of its drugs the same day.

Pfizer’s antipsychotic Geodon won expanded FDA approval for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults.

The drug is already FDA-approved as a monotherapy in the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia.

Since the FDA approval of Geodon in February 2001, nearly 2 million adult patients have been treated with this drug. Unlike other antipsychotics, Geodon is not associated with weight gain. The drug raked in global sales of $1 billion last year and $713 million for the nine months ended September 30, 2009.

Pfizer also received FDA approval for the intravenous formulation of Revatio for the continued treatment of patients with pulmonary arterial hypertension who are currently prescribed Revatio Tablets but who are temporarily unable to take oral medication.

Pulmonary arterial hypertension is a rare, progressive disease that affects an estimated 100,000 men and women worldwide. This incurable disease is characterized by continuous high blood pressure in the pulmonary arteries, often leading to heart failure and premature death.

Revatio Tablets were approved by the FDA in June 2005 and by the European Medicines Agency, or EMEA, in November 2005. Revatio contains the same active ingredient as Viagra, which is used to treat erectile dysfunction (impotence). Pfizer doesn’t break out Revatio sales when reporting its quarterly results, so there are no specific numbers on the drug’s sales.

The first canine cancer drug

All these years, veterinarians had to rely on human oncology drugs without knowledge of how safe or effective they would be for dogs. Cancer treatments used in animals are used in an “extra-label” manner as allowed by the Animal Medicinal Drug Use Clarification Act of 1994. However, dog owners, in consultation with their veterinarian, now have an option for treatment of their dog’s cancer.

On June 3, the FDA approved Palladia (toceranib phosphate), the first drug developed specifically for the treatment of cancer in dogs. According to the Morris Animal Foundation, which is dedicated to funding animal health research, 1 in 4 dogs die of cancer. About 1.2 million new canine cancer cases are reported in the U.S. every year. The product is expected to be available for purchase in early 2010.

U.K.’s NICE becomes nice to Sutent

Reversing its earlier stance, the United Kingdom’s NICE (National Institute for Health and Clinical Excellence), which evaluates the cost-effectiveness of medications, recommended reimbursement for kidney cancer drug Sutent as a second-line treatment for patients with advanced gastrointestinal stromal tumor.

The decision of NICE gives hope to patients with gastrointestinal stromal tumors who develop resistance to Imatinib (Novartis’ (NVS) Gleevec), according to Pfizer. It is estimated that about 7,000 people in the U.K. are diagnosed with kidney cancer every year and that 3,600 patients are eligible to receive Sutent since they have an advanced form of the disease.

Last year, NICE rejected four kidney cancer drugs including Sutent for the treatment of advanced and/or metastatic forms of renal cell carcinoma within the National Health Service due to financial considerations.

In international markets, the sales growth of Sutent continues to outpace its growth in the U.S. In 2008, Sutent’s annual sales in the U.S. were up a mere 7% to $254 million, while international sales of the drug rose 72% to $593 million. In the third-quarter ended September 30, 2009 Sutent generated U.S. sales of $192 million, an increase of 2% over the comparable quarter last year, while international sales of the drug totaled $479 million, an increase of 9% over the year-ago quarter.

Old Drug, New use

Pfizer remains committed to expand its HIV drug Selzentry’s current indications. The company is seeking approval of Selzentry in treatment of adult patients with CCR5-tropic HIV-1 virus as part of combination therapy.

In October, an FDA panel recommended the expanded use of Selzentry in treatment-naïve patients. The FDA is scheduled to make a final decision in the coming months.

Selzentry was granted accelerated approval in August 2007 and full approval in November 2008 by the FDA for use in patients with resistant HIV strains or who do not respond favorably to multiple antiretrovirals.

According to AIDS Healthcare Foundation, Selzentry’s price has increased 10% since its approval in 2007 two years ago to $13,767 per-patient per year. If approved for the expanded use, Selzentry would become the most-expensive first-line AIDS drug.

A shot at vaccines

For Pfizer, vaccine innovation is a key strategic priority and an expression of its vision to broaden and diversify its global product portfolio.

On November 18, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 10 to 1 recommending Prevnar 13 for the prevention of invasive pneumococcal disease in infants and young children. The FDA is scheduled to make a final decision on Prevnar 13 on December 30, 2009.

In late September, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for Prevenar 13. A final decision is expected by European regulatory authorities in December. Additionally, the vaccine is being studied in global phase-III clinical trials for the prevention of pneumococcal disease in adults, with regulatory submissions expected in 2010.

Prevnar 13 targets thirteen strains of bacteria known as streptococcus pneumoniae, while Prevnar, which has been in the market since 2000, targets only seven strains of bacteria. Prevnar is Wyeth’s second top-selling drug and had global sales of about $2.7 billion last year.

Clinical Trial Missteps and Regulatory Knockdowns

This year, the pharma behemoth endured failure in a number of late-stage trials, raising concerns about its R&D department.

Jan.30 – Pfizer halted a phase III study of its investigational agent axitinib for the treatment of advanced pancreatic cancer following no evidence of improvement in the primary endpoint of survival in patients treated with axitinib and gemcitabine compared to gemcitabine alone. However, the company is investigating axitinib in renal cell carcinoma where it is currently in a late-stage testing for second-line treatment.

Feb.24 – Two late-stage development programs for investigational compounds esreboxetine for fibromyalgia and PD 332,334 for generalized anxiety disorder were terminated as neither was found to be better than the current standard of care. Pfizer already has an FDA-approved medicine for the treatment of fibromyalgia sold under the brand name Lyrica. The company plans to pursue expanded indication for Lyrica in the treatment of generalized anxiety disorder, a condition that overlaps with fibromyalgia.

April 2 – Pfizer’s phase III program of Sutent suffered its first blow of the year when a trial evaluating the drug for breast cancer indication had to be halted. The trial dubbed SUN 1107 evaluated single-agent Sutent versus single-agent capecitabine for the treatment of a broad range of patients with advanced breast cancer after failure of standard treatment. An independent Data Monitoring Committee found that Sutent would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival.

June 1 – The phase III program of Sutent suffered yet another blow when the company had to halt a trial dubbed SUN 1094 that evaluated Sutent plus paclitaxel versus bevacizumab plus paclitaxel for the first line treatment of patients with advanced breast cancer. The independent Data Monitoring Committee found that treatment with Sutent in combination with paclitaxel would be unable to meet the primary endpoint of superior progression-free survival (PFS | Quote | Chart | News | PowerRating) compared to the combination of bevacizumab and paclitaxel. No new safety issues were identified.

June 30 – Another late-stage trial of Sutent to bite the dust was that of the metastatic colorectal cancer study. The trial dubbed SUN 1122 evaluated Sutent plus chemotherapy drug combination FOLFIRI versus FOLFIRI alone for the first-line treatment of metastatic colorectal cancer. The independent Data Monitoring Committee found that the addition of Sutent to the chemotherapy regimen FOLFIRI would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared to FOLFIRI alone.

Oct.9 – Following recommendations of an independent safety monitoring committee, Pfizer temporarily stopped enrolling new patients in a late-stage trial dubbed Advigo 1016 that was evaluating its experimental lung-cancer compound Figitumumab. The primary objective of the trial is to determine whether the addition of Figitumumab in combination with paclitaxel and carboplatin prolonged survival in patients with non-small cell lung cancer.

An independent safety monitoring committee overseeing the study found more serious adverse events, “including fatalities, in patients who were randomized to receive figitumumab,” than in patients who didn’t receive the investigational drug. Figitumumab, with estimated sales potential of $400 million to $1.2 billion by 2015, was one of the drugs that Pfizer had been counting on to replace sales of Lipitor when it loses basic patent protection in the U.S. in March 2010. The second patent covering the calcium salt of atorvastatin, the active ingredient in Lipitor, expires in June 2011.

However, another late-stage lung cancer study testing Figitumumab in combination with Roche Holding Ltd.’s (RHHBY.PK) and OSI Pharmaceuticals Inc.’s (OSIP | Quote | Chart | News | PowerRating) Tarceva is continuing to enroll new patients, according to Pfizer.

Third time’s no charm for Fablyn

On January 16, the FDA issued a complete response letter for Pfizer’s investigational osteoporosis drug Fablyn (lasofoxifene) and sought additional information.

Last September, an FDA panel voted 9 to 3, endorsing Fabyln. Though study results of Fabyln have demonstrated its efficacy in treating osteoporosis in postmenopausal women, according to the FDA Administration advisory board briefing document, Fabyln increased the chances of cancer or stroke-related deaths. Other side effects include blood clots.

Fablyn, a selective estrogen receptor modulator, or SERM, was developed by Pfizer with the help of screening technology licensed from Ligand Pharmaceuticals Inc. (LGND | Quote | Chart | News | PowerRating).

It was Fablyn’s third go-around with the FDA. The FDA rejected Fablyn as a medicine for the prevention of post-menopausal osteoporosis in September 2005 and for the treatment of vaginal atrophy in January 2006 on concerns that the drug may lead to cancer in the lining of the uterus.

However, the drug received approval from the European Commission in March of this year for the treatment of osteoporosis in post-menopausal women at increased risk of fracture.

Late-stage pipeline

Pfizer has more than twenty phase III programs and Wyeth has more than five late-stage trials that are currently underway.

Wyeth is also conducting a late-stage trial evaluating Pristiq for the non-hormonal treatment of vasomotor symptoms associated with menopause. The FDA, which issued an approvable letter for Pristiq in July 2007, has sought additional data regarding the potential for serious adverse cardiovascular and hepatic effects associated with the use of Pristiq for the treatment of menopausal symptoms. The requested clinical trial that is underway is expected to be completed in the first half of 2010.

In the first half of 2009, Mexico and Thailand granted approvals for Pristiq for the treatment of menopausal symptoms.

Viviant is yet another Wyeth drug waiting to pass muster with the FDA. The investigational postmenopausal osteoporosis pill has been twice at the FDA altar – in December 2007 and May 2008 – only to be turned down. In its approvable letters, the regulatory agency had requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events and requested additional source documents related to Viviant.

In a recent SEC filing, Wyeth said the FDA will be convening an advisory committee to review its pending New Drug Application for Viviant. Wyeth expects the FDA-requested advisory committee meeting will be scheduled following submission of its complete response to the approvable letters, which are planned for filing later this year.

The EU trade name for Viviant is Conbriza and the drug was approved for the treatment of postmenopausal osteoporosis in women at increased risk of fracture in April of this year. The drug is expected to hit the pharmacy shelves in the EU next year.

In July, Wyeth announced new positive results from a late-stage trial of Aprela, a drug under development for menopausal symptoms and osteoporosis. An initial NDA for Aprela is expected to be filed no earlier than the first half of 2010.

In December, Pfizer made an entry into the market for orphan drugs by acquiring worldwide rights to Uplyso, an experimental drug for Gaucher’s disease, a rare genetic disorder, from Israeli biotech firm Protalix BioTherapeutics Inc. (PLX | Quote | Chart | News | PowerRating). The current standard of care for Gaucher patients is enzyme replacement therapy and Genzyme Inc. (GNZ | Quote | Chart | News | PowerRating)’s Cerezyme is currently the only approved enzyme replacement therapy for Gaucher disease. Last year, Cerezyme fetched $1.2 billion in sales for Genzyme. Protalix is close to complete a rolling New Drug Application submission for Uplyso with the FDA. The product is expected to reach the market next year.

Eyeing generic drug pie

It is no secret that Pfizer has been vying for a greater share of the generic drug market. The drug giant estimates that the global generic business is set to grow to $500 billion by 2012 from $270 billion in 2006.

Early last year, the company formed an Established Products Business Unit to execute growth strategies tailored to the unique needs of branded emerging markets (such as China, India, Brazil and Russia), branded traditional markets (such as Japan, Western Europe and South Korea), and intellectual-property-driven markets (such as the United States and Canada).

Pfizer’s global annual sales of established products are approximately $10 billion. (Established products are medicines that have lost or will soon lose patent protection).

In May, Pfizer entered into agreements with India-based Claris Lifesciences Ltd. to commercialize 15 sterile injectable medicines after the products are no longer patent protected and have lost market exclusivity in North America, Europe, Australia and New Zealand.

The same month, Pfizer expanded its agreements with Aurobindo Pharma Ltd. in India by acquiring rights to 55 solid oral dose products and 5 sterile injectable products for patients in more than 70 emerging market countries.

Closing Thoughts

Shares of Pfizer, which touched a 12-1/2 year intra-day low of $11.62 in March, have since recovered nearly 55% and currently trade around $18. As the now streamlined, more flexible and strategically grounded Pfizer gets ready to face another new year, will there be a change in investors’ ho-hum attitude towards the stock?

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