Tag Archive | "Celebrex"

Phase III osteoarthritis pain trial is a winner for Pfizer

Tags: , , , , , ,


Pfizer ran the table in a late-stage study of tanezumab, a protein inhibitor that the pharma giant is touting as a leading contender to go on to become the world’s first approved biologic for pain.

The pharma giant recruited 690 patients for the trial who suffered from chronic knee pain from osteoarthritis but were either unable to take an NSAID pain therapy or its Cox-2 inhibitor Celebrex or didn’t benefit sufficiently from the meds. Patients in all three dose groups–2.5 mg, 5 mg and 10 mg–reported a statistically significant reduction in pain compared with a placebo, according to Reuters. And the patients also demonstrated a significant improvement in physical function as well as higher scores for feeling better than before therapy. The Phase III study results are being presented at the European League Against Rheumatism meeting in Rome.

“What we’ve seen so far in terms of Phase II trials and this first Phase III trial has impressed upon us that this drug has some extraordinary efficacy benefits,” study leader Mark Brown tells Reuters.

Pfizer has high hopes for tanezumab, an antibody that was selected as one of its top drug prospects during a pipeline review in the spring of 2009. The antibody targets nerve growth factor and had already registered promising data in mid-stage trials. The fresh set of positive data is good news for Xoma, which licensed antibody technology used in developing the tanezumab program and stands to earn royalties in the event of an approval.

Source: FierceBiotech

Popularity: 2% [?]

Supremes refuse to spike Pfizer securities case

Tags: , , , ,


The U.S. Supreme Court backed another set of pharma investors trying to sue a drugmaker about its handling of a big drug safety issue. This time, it’s Pfizer that appealed to the Supremes for relief from a securities lawsuit–and lost. The high court rejected Pfizer’s appeal, allowing the securities-fraud suit to proceed.

It marks the second time in in as many weeks that the court made way for a securities suit against Big Pharma; just last week, the Supremes allowed an investor suit against Merck over Vioxx safety. In the Pfizer case, the drug in question is Celebrex, a cousin to Vioxx: Both drugs belong to the Cox-2 inhibitor class.

The legal issues were similar as well. Like Merck, Pfizer had argued that the plaintiffs missed the two-year statute of limitations. And as in the Merck case, the court determined that the lawsuit was filed within two years of the first public evidence of possible fraud. Pfizer’s appeal had been on hold pending a decision in the Merck case.

The Pfizer plaintiffs allege that the company’s Pharmacia unit withheld full data from a study showing that using Celebrex was no safer than less expensive drugs.

Source: FiercePharma

Popularity: 2% [?]

Top 10 drugs from new Merck, new Pfizer

Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , ,


The Associated Press has put out a helpful list of Merck’s top-selling drugs for the fourth quarter, now that it has merged with Schering-Plough. So we thought we’d take a look at the other megamerger–Pfizer and Wyeth–and Merck’s list, too. The names on both lists are familiar, and you’ll notice that each list includes some drugs brought in by the respective mergers. Here’s Pfizer’s list to start:

  • Lipitor, cholesterol drug, $3.175 billion, a 1 percent increase over the same period last year;
  • Lyrica, for fibromyalgia and nerve pain, $820 million, a 17 percent increase;
  • Celebrex, an arthritis pain drug, $669 million, up 1 percent;
  • Viagra, erectile dysfunction, $549 million, up 9 percent;
  • Xalatan/Xalacom, eye pressure, $499 million, up 10 percent;
  • Norvasc, for high blood pressure, $486 million, down 10 percent;
  • Zyvox, antibiotic, $330 million, up 16 percent;
  • Detrol/Detrol LA, overactive bladder, $309 million, down 1 percent;
  • Sutent, cancer treatment, $293 million, up 33 percent; and
  • Geodon/Zeldox, antipsychotics, $289 million, up 5 percent.                 Now, here’s the Merck version, from the AP (percentages ours):
  • Singulair, Asthma/Allergies, $1.26 billion, up more than 12 percent;
  • Cozaar/Hyzaar, high blood pressure, $955 million, up about 8 percent;
  • Januvia/Janumet, diabetes, $760 million, up close to 43 percent;
  • Remicade, rheumatoid arthritis, $635 million, up about 29 percent;
  • Zetia, cholesterol, $614 million, up 10 percent;
  • Vytorin, cholesterol, $577 million, up roughly 2 percent;
  • Temodar, cancer treatment, $292 million, up close to 21 percent;
  • Nasonex, allergies, $286 million, up about 2 percent;
  • Fosamax, osteoporosis, $285 million, down 10 percent; and
  • Gardasil, HPV vaccine, $277 million, down 3 percent.

Source: FiercePharma

Popularity: 6% [?]

Feds Accuse Doc of Faking Research On Pfizer & Merck Drugs

Tags: , , , , , ,


It looks like Scott Reuben, the Massachusetts anesthesiologist said to have used phony research data in 21 published papers, has reached a plea deal with the feds.

Federal prosecutors accused Reuben of health-care fraud for allegedly faking data that suggested after-surgery benefits from painkillers including Merck’s Vioxx and Pfizer’s Bextra and Celebrex, the Justice Department said yesterday. The Justice announcement said he faces as much as a 10-year sentence and a $250,000 fine.

[ad]

But the Associated Press said Reuben, the former chief of acute pain at Baystate Medical Center in Springfield, has agreed to plead guilty in exchange for prosecutors recommending a more lenient sentence. The sentence would also reportedly include forfeiting assets of at least $50,000 that Reuben received for the allegedly phony research. The Republican, a Springfield newspaper, said Reuben has signed a plea agreement under which he must pay $420,000 in restitution to pharmaceutical companies.

Reuben is accused with taking pharma money for doing research, then fabricating results and getting studies published in anesthesiology journals.The tale began to unravel last year as Baystate said it found Reuben had faked data and the Boston U.S. attorney began looking into the case.

Reuben’s attorney has said in the past his client cooperated with the hospital review and expressed regret. The lawyer didn’t immediately return a call for comment after Thursday’s federal complaint, the AP said.

Source: The Wall Street Journal

Popularity: 3% [?]

Pfizer earnings beat the Street. Beating future hurdles will be tougher

Tags: , , , , , , , , , , , ,


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.

[ad]

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.

[ad]

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

Popularity: 5% [?]

FDA warns drugmakers over “misleading” Internet ads

Tags: , , , , , , , , , , , , , , , , , , , , ,


According to documents posted to the FDA’s website, the agency sent warning letters to 14 drugmakers regarding “misleading” Internet advertisements that appear as sponsored links following search engine queries. The regulator, which said that the ads were misleading because they do not include information about risks related to the products, ordered the companies to remove the ads.

[ad]

Pfizer was warned about six products, including Celebrex and Chantix. A spokesperson for the company said that the drugmaker will re-evaluate its use of sponsored links to conform to agency guidelines. Meanwhile, sanofi-aventis received a letter regarding its ads for Plavix in which the agency stated that “by omitting the most serious and frequently occurring risks associated with Plavix, the sponsored links misleadingly suggest that [the compound] is safer than has been demonstrated.” Sanofi-aventis did not comment on the news.

Biogen Idec was warned over the promotion of its multiple sclerosis drug Tysabri. The FDA noted that the ads “make representations and/or suggestions about the efficacy of Tysabri, but fail to communicate any risk information associated with the use of the product.” The regulator added that the drugmaker’s “casual approach to Tysabri treatment is extraordinary in light of the potentially lethal risks of the drug and the stringent controls over its distribution.” A Biogen Idec spokesperson commented that “we take our responsibility to communicate appropriately about the risks and benefits of our products seriously” and indicated that the company was working with the FDA to resolve the problem.

Cephalon also received a warning letter concerning ads for pain drug Fentora which, according to the FDA, do not include information about potentially fatal side effects in patients who are not accustomed to potent narcotics. Cephalon spokesperson Candace Steele commented that the company “removed the links within hours of receiving the letter,” adding that “we had believed that the use of the sponsored links to our medication websites was compliant with industry standards and FDA regulations.”

Johnson & Johnson, GlaxoSmithKline, Novartis, Eli Lilly, Merck & Co., Bayer, Roche, Genentech, Boehringer Ingelheim, and Forest also received letters. In all, ads for 48 products were cited by the FDA in its letters to drugmakers. Rita Chappelle, a spokesperson for the agency, said that the regulator looked at the ads as part of its routine monitoring of website advertising. She also noted that 19 of the treatments cited in the letters carry a boxed warning and that some of the promotional materials expanded the uses of the drugs beyond those for which they are approved.

The FDA stated in its letters that it is seeking a response from the drugmakers by April 9.

Source: FirstWord

Popularity: 6% [?]

Researcher accused of allegedly fabricating studies of pain-relief drugs

Tags: , , , , , , , , , , , , , , , , , , , ,


An anaesthesiologist is accused of allegedly fabricating data in at least 21 studies concerning the benefits of pain drugs such as Pfizer’s Celebrex (celecoxib), Lyrica (pregabalin), Bextra (valdecoxib) and Neurontin (gabapentin); Merck & Co.’s Vioxx (rofecoxib); as well as Wyeth’s antidepressant Effexor XR (venlafaxine). The allegations involve studies published in medical journals since at least 1996, according to information from the hospital where the researcher was employed.

[ad]

The Baystate Medical Center has asked medical journals to retract the 21 studies, some of which included positive findings for Pfizer’s and Merck’s drugs. Research summaries by the doctor, Scott Reuben, also showed favourable data for Effexor XR as a pain treatment, and he is reported to have suggested to the FDA that the use of some pain drugs he studied should not be restricted, based on his own data for safety and efficacy.

The chief academic officer of the hospital, Hal Jenson, explained that during a routine review of Reuben’s research summaries last May, physicians discovered that the research conducted was not approved by an internal hospital review board. In many cases, “there was no clinical trial because there were no patients,” Jenson remarked, adding that Reuben “was solely responsible for the fabrication of data.” Reuben is on indefinite leave from his position, Baystate indicated.

Pfizer stated that it was “not involved in the conduct of any of these independent studies or in the interpretation or publication of the study results.” The drugmaker underwrote some of Reuben’s research between 2002 and 2007 for drugs that include Celebrex, Lyrica and Neurontin, and he was a member of Pfizer’s speakers bureau. Company spokesperson Sally Beatty noted that Reuben’s data were not included in clinical trials that led to the FDA approval of Celebrex and Lyrica for pain indications.

In further reactions to the news, Wyeth indicated that it was not aware of having any financial ties to Reuben; a spokesperson for the FDA was unaware of the matter; and no comment was available from Merck. Steven Shafer, editor in chief of the journal Anesthesia & Analgesia, which published ten of Reuben’s falsified papers, stated that there are “millions of patients worldwide, where postoperative pain management has been affected by the research findings of Dr. Reuben.”

Source: FirstWord

Popularity: 6% [?]

Pfizer, Wyeth Both Braced For Expiration Of Patents On Big Drugs

Tags: , , , , , , , , , , , , , , , , , , , , , , , , , ,


A look at Pfizer Inc.’s pharmaceutical sales last year suggests one major reason for its offer to buy Wyeth Pharmaceuticals for $68 billion: sagging revenues from its current drug offerings.

Last year’s overall pharmaceutical sales were off $250 million, or about 1 percent, from the year before, according to Pfizer’s unaudited year-end report. Wyeth, on the other hand, reported an increase in revenues of about 2 percent, or more than $400 million.

Still, both drug companies face a near-term problem with expiring patents on some of their leading compounds.

[ad]

For Pfizer, the elephant in the room is Lipitor, the leading medicine in the world, which will be subject to generic competition in 2011, taking a huge bite out of sales numbers that totaled $12.4 billion last year, or more than a quarter of the company’s revenues. Pfizer acquired Lipitor when it bought out Warner-Lambert for $90 billion nine years ago.

”It’s the world’s biggest drug ever,” said health care analyst Les Funtleyder of Miller Tabak & Co. in New York. “No one drug is going to replace it.”

Yet Lipitor isn’t the only problem for Pfizer: Analysts project that about half of the company’s drug sales would dry up because of patent expirations if the company’s research and development operation, headquartered in New London, doesn’t find replacements in the next five years.

Wyeth also has its drug-development issues, with two top compounds facing patent expirations: depression medication Effexor in 2010 and heartburn drug Protonix in 2011. Meanwhile, a promising new Alzheimer’s vaccine that Wyeth has been developing with Elan Pharmaceuticals has been slowed by unexpected results from a clinical trial, and the FDA last year denied two of the company’s other drug candidates.

”R&D is not linear,” said Funtleyder. “More money does not necessarily equal more drugs. There are those eureka moments. It’s cyclical.”

The cycle has been running against major pharmaceutical companies for some time now, and Pfizer has become a poster child for those who believe major R&D investments don’t necessarily guarantee a better drug pipeline. An article on Forbes.com Tuesday, typical of the skepticism regarding the Wyeth deal, noted that in the past decade “Pfizer has launched only one medicine with annual sales surpassing $1 billion, despite plowing more than $60 billion into research and development.”

Indeed, even Pfizer’s one blockbuster drug, Lyrica, traces its roots to Warner-Lambert. Other Pfizer best-sellers include arthritis treatment Celebrex, overactive bladder medication Detrol and cancer compound Sutent, all of which came out of the purchase of Pharmacia in 2003.

Sutent, Detrol, Celebrex and Lyrica are all performing relatively well for Pfizer – particularly the pain medication Lyrica, which showed a sales increase of more than 40 percent last year, launching it into the No. 2 position among the company’s top sellers.

But several other drugs counted on to help shoulder the burden of Lipitor’s loss showed weakness, and Pfizer’s older pharmaceutical pipeline is beginning to show cracks.

”Pfizer is in the most desperate state of anyone in the industry in terms of patent expirations,” Standard & Poor’s analyst Herman Saftlas told Business Week magazine.

As an example, blood pressure medication Norvasc, which once accounted for 10 percent of Pfizer’s bottom line, lost a quarter of its sales last year compared to the year before after facing generic competition for the first time in 2007. And cancer compound Camptosar, which went off patent last year, saw 42 percent of its sales dry up last year.

Other negative performers last year included Chantix, the once-ballyhooed anti-smoking drug that lost its luster in the United States after it was tied to concerns about suicidal thoughts; pain medication Neurontin, which got bad press when Pfizer was accused of suppressing studies showing the drug didn’t help with diabetic nerve pain; and Diflucan, an older anti-fungal drug whose patents expired some time ago.

Pfizer also lost more than $250 million in sales with the patent expiration of Zyrtec, an allergy medication.

On the plus side, psychiatric medication Geodon and antibiotic Zyvox reached $1 billion in sales last year, while erectile dysfunction pill Viagra, still going strong after 10 years on the market, neared the $2 billion mark. But Pfizer’s biggest rising star, on a percentage basis, was cancer drug Sutent, which finished with nearly $850 million in sales, 46 percent more than last year.

Pfizer will need more compounds like Sutent, a chemotherapy drug expected to gain more traction with an aging population of baby boomers. But analysts said there appear to be few if any blockbusters in Pfizer’s pipeline to make a dent in the loss of Lipitor – a situation that caused Forbes.com to headline an article on the Wyeth deal “Big Pharma’s Death Spiral.”

”It’s not necessarily a death spiral, but you have to have new drugs,” said analyst Funtleyder.

Pfizer seems to be staking its biggest hopes on Alzheimer’s disease medicines, including bapineuzumab, which Wyeth has partnered with Elan Pharmaceuticals on and is currently in late-stage trials. It’s unclear, however, whether the partnership will continue once Pfizer takes over Wyeth.

Pfizer has its own Alzheimer’s pipeline, but its current top medication, Aricept, loses patent protection at the end of next year. Pfizer had five Alzheimer’s drugs in development, but its acquisition of Wyeth would triple that total.

”If Wyeth delivers on Alzheimer’s, it will be all worthwhile,” said Funtleyder. “Who knows? Maybe drug development will go into an up cycle, and it will be good to be big.”

Source: TheDay.com

Popularity: 10% [?]

Pfizer announces more job cuts, 90-percent drop in 4Q earnings

Tags: , , , , , , , , , , ,


Pfizer on Monday announced new cost-cutting measures that will entail a 10-percent reduction in its workforce, or more than 8000 jobs, as well as the closure of five manufacturing sites. The company also reported that fourth-quarter earnings dropped 90 percent to $266 million compared to the prior-year period, due in part to a $2.3-billion charge to settle investigations on past marketing practices involving Bextra. The settlement, which requires the approval of a federal judge, is the largest amount paid by a drugmaker to resolve alleged off-label marketing.

[ad]

In regards to workforce reductions, company spokesperson Ray Kerins stated that the job cuts, which will affect most departments, including sales, R&D, and administration, would begin in the first quarter and be completed by 2011. The drugmaker did not specify which manufacturing sites it would shut down. Pfizer’s Chief Financial Officer Frank D’Amelio predicted the latest cost-cutting measures will “achieve anticipated incremental savings of approximately $3 billion by the end of 2011.”

In quarterly results, Pfizer said that pharmaceutical sales declined 4 percent, reaching $11.2 billion. Lipitor sales fell to $3.1 billion, down 8 percent from the year-ago period. Revenue for Lyrica gained 25 percent to $702 million, in part due to increased use of the drug in fibromyalgia, the company said. Celebrex sales rose to $664 million, up 4 percent from year-ago results, while Sutent recorded a 21-percent increase in sales to $220 million. Revenue for Chantix dropped 36 percent to $180 million because of continued negative impact of changes to the drug’s US label.

Total revenue during the quarter, which fell 4 percent to $12.3 billion, was negatively affected by the loss of patent exclusivity for Zyrtec and Camptosar in the US, as well as generic competition for Norvasc in certain Asian markets. For the full-year, Lipitor sales slipped 2 percent to $12.4 billion versus 2007, while Lyrica surged 41 percent to $2.6 billion. Overall, Pfizer reported that earnings and revenue were largely flat, compared with 2007, at $8.1 billion and $48.3 billion, respectively.

Going forward, Pfizer lowered its earnings guidance to $1.85 to $1.95 per share, falling short of consensus estimates that had predicted profit of at least $2.49 per share for 2009.

Source: FirstWord

Popularity: 5% [?]

Pfizer in Talks to Buy Wyeth

Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,


Pfizer Inc. is in talks to acquire rival drug maker Wyeth in a deal that could be valued at more than $60 billion, said people familiar with the matter.

A combination of these two U.S. pharmaceutical giants would redraw the boundaries of the global drug industry, which has suffered from flagging product development and high fixed costs. It would also represent a high-stakes gambit for Pfizer, which has been stung in the past by expensive acquisitions.

The two sides have been in discussions for months and a deal isn’t imminent, the people said. Given recent market volatility and overall economic uncertainty, the talks are especially fragile and could collapse, the people warned.

[ad]

Pfizer spokesman Raymond F. Kerins Jr. said the company doesn’t comment on “market rumors and speculation.” A Wyeth spokesman said, “We don’t comment on marketplace rumor.”

Joining New York-based Pfizer and Madison, N.J.-based Wyeth would create a behemoth with combined revenue of about $75 billion and a line of blockbuster drugs including Pfizer’s cholesterol drug Lipitor and Wyeth’s pediatric vaccine Prevnar.

Pfizer, the world’s largest drug maker by revenue, would likely use a combination of cash and stock for the acquisition. Details on price haven’t been worked out, but Wyeth has a market capitalization of about $52 billion and premiums in the sector have averaged just over 20%. That would put the value of the deal at well over $60 billion.

If completed, a deal could create billions in cost savings through the combination of back-office operations, research and development, sales and manufacturing. Like other major pharmaceutical companies, Pfizer and Wyeth face the looming expiration of patents on their most lucrative products as well as intense competition from makers of generic drugs. In addition, a tougher regulatory environment in the U.S. and overseas has made it more difficult to win approval for new treatments, forcing companies to narrow their research focus.

Those realities have prompted calls for industry consolidation from the investment community. For years, companies have withstood pressure to merge, hoping that new discoveries would allow them to maintain independence. But with drugs generating an estimated $30 billion in sales losing patent protection over the next several years, many analysts have been saying industry consolidation is inevitable.

Unlike other sectors of the economy, the pharmaceutical industry has historically been buffered from downturns because patients typically don’t stop seeking treatment for major ailments. While there are growing signs that this recession has triggered a decline in prescription-drug consumption among cash-strapped consumers, major companies nonetheless have streams of cash they can use for acquisitions.

Pfizer alone had more than $27 billion in cash and equivalents on its balance sheet at the end of 2008, Goldman Sachs estimated in a recent note to investors. Analysts believe that most of that money is outside the U.S. and Pfizer would suffer a tax hit if the company repatriated the funds. Many in the industry have been waiting to see what Pfizer does before pursuing deals of their own.

Pfizer posted revenue of $48.4 billion and a profit of $8.1 billion in 2007, the most recent year for which data are available. Wyeth’s revenue totaled $22.4 billion and its profit $4.6 billion in 2007.

The stocks of both companies have held up fairly well over the past year compared with the rest of the market. Pfizer’s shares have fallen about 23% while Wyeth’s stock is down 7.5%. The S&P 500 is off 37% over the same period.

Combining major drug companies doesn’t solve the industry’s short-term need for new drugs, but it would allow the industry to slash research-and-development spending, which accounts for nearly 20% of sales at many companies.

With more scale, drug companies would also be better positioned to acquire biotech companies, which many believe will be a source of future treatments. Many pharmaceutical companies have already begun to buy or strike drug-development deals with smaller biotech firms. While promising in the long term, such deals tend to bring too little revenues and profits in the short term to make up for the loss of blockbuster drugs.

Since Jeffrey B. Kindler took Pfizer’s helm in 2006, there have been rumors he would seek a major acquisition. Pfizer has been battling generic competition for some of its top drugs, while its best-selling drug, Lipitor, which accounts for one-fourth of its revenue, loses patent protection in 2011. It has had trouble bringing new products to market.

Mr. Kindler has been cutting costs, firing more than 15,000 employees since January 2007. A person familiar with the matter say Pfizer is planning to cut as many as 2,400 sales-force jobs in the first quarter of 2009. The chief executive has also been revamping drug-research efforts, shuttering laboratories and selling manufacturing plants.

Investors and analysts have grown increasingly frustrated that these steps aren’t enough to return Pfizer to the kind of profitability that made it a stock-market star in the 1990s and early 2000s. Since Mr. Kindler took over, Pfizer stock is down 34%, compared with a drop of 20% for the Dow Jones Wilshire Pharmaceuticals Index.

Critics have lambasted Pfizer’s 2006 sale of its consumer business, which included the Listerine, Visine and Lubriderm brands, as well as nonprescription drugs Sudafed and Nicorette. That unit is now helping its buyer, Johnson & Johnson, weather problems in its own prescription drug business.

Of big drug makers, Pfizer in particular has been built through big acquisitions. It gained full control of Lipitor after a $116 billion takeover of Warner-Lambert Co. in 2000. But Pfizer’s deal-making history also suggests the pitfalls of what analysts say is a reliance on big takeovers over strong in-house research and smart licensing.

Pfizer bought Pharmacia in 2003 largely for painkiller Celebrex, but sales plunged after a rival drug, Vioxx, was withdrawn in 2004 over heart risks.

“The record of big mergers and acquisitions in big pharma has just not been good. There’s just been an enormous amount of shareholder wealth destroyed,” said Gary Pisano, a Harvard Business School professor who has written about the issue.

Wyeth has had struggles of its own in the past year or two, with sales of its new antidepressant Pristiq taking off slowly and a plunge in sales of heartburn drug Protonix after generic competition came sooner than expected. Midstage trial data of an Alzheimer’s drug the company is developing with Elan Corp. have also disappointed some investors.

Nonetheless, analysts have named Wyeth as a likely target because the company has products and businesses that complement Pfizer’s lineup. It’s not clear what role Wyeth CEO Bernard Poussot would play in the combined company.

Wyeth has already established a foothold in biotechnology. The company has had strong success with Prevnar, its pediatric pneumococcal vaccine, which brought in $2.11 billion in sales in the first nine months of 2008, a 12% increase over the year-earlier period. The company’s pipeline includes a new version, Prevnar-13, that is designed to offer enhanced protection against pneumococcal disease. Another strong biotechnology seller in Wyeth’s portfolio is the anti-inflammatory biologic Enbrel, which Wyeth co-markets with Amgen Inc.

Wyeth also would bring with it an animal-health business and consumer-health unit whose brands include Advil, Robitussin and ChapStick. Those businesses would help offset the cyclicality and risks of the drug business.

In the absence of big merger deals, pharmaceutical companies have tried to buy time by slashing costs. Most notably, the industry has eliminated about 15,000 sales jobs since pharmaceutical sales-rep ranks reached a peak of about 105,000 in the first quarter of 2006, according to ZS Associates, a sales and marketing consulting firm.

Consultants say the industry still hasn’t cut costs nearly enough, and analysts have increased the pressure on executives like Mr. Kindler. Investors are especially keen on acquisitions from cash-rich pharmaceuticals companies now that values of smaller companies have shrunk.

“There is no major payday in R&D coming in the next several years, and the personal makeovers will not be enough,” Deutsche Bank analyst Barbara Ryan wrote in a recent note to investors.

Source: The Wall Street Journal

Popularity: 11% [?]

Site Sponsors