Este informe no está disponible en español.

CARIBBEAN BUSINESS

Local drug manufacturing reached $102.3 billion in 2004

Net earnings of six out of eight companies lower this year

MARIALBA MARTINEZ

March 3, 2005
Copyright © 2005 CARIBBEAN BUSINESS. All Rights Reserved.

Seven out of eight pharmaceutical drug companies whose financial performance was followed by CARIBBEAN BUSINESS in 2004 increased their sales, but six out of eight didn’t increase net earnings over 2003 levels.

An analysis of 2004 sales of pharmaceutical drugs manufactured in Puerto Rico by Abbott Laboratories, Amgen, Bristol-Myers Squibb Co., Eli-Lilly & Co., Merck & Co., Pfizer Inc., Schering-Plough Corp., and Wyeth during 2004 reached $102.3 billion, or 66% of global sales of $155.4 billion. In 2003, product sales of locally manufactured products were $82.4 billion, or 59% of global sales of $139.8 billion.

What’s more, the earnings-to-sales growth for the eight companies analyzed averaged 18%, reflecting an 8% increase from $25.9 billion in 2003 to $28 billion reported in 2004. The year’s top-selling product was Pfizer’s Lipitor, racking up $17.7 billion in sales. A distant second was the company’s Norvasc ($9.2 billion), followed by Bristol-Myers Squibb’s Plavix ($7.2 billion). Trailing fourth in 2004 product sales was Eli Lilly & Co.’s Zyprexa ($4.3 billion), tied in fifth place with Pfizer’s Neurontin and Wyeth’s Effexor at $2.7 billion, with Amgen’s Epoge on their heels at $2.4 billion.

Increasing sales wasn’t pharmaceutical companies’ only concern in 2004. The industry last year faced unprecedented scrutiny from several angles, such as criminal and regulatory investigations for its sales practices, drug safety procedures, and manufacturing practices. Even the U.S. Food & Drug Administration (FDA) was criticized for its drug review and approval processes and its inability to identify potential problems with certain pharmaceutical drugs, which raised concerns about their therapeutic value.

Public dissatisfaction with the FDA has also been growing since March 2004 when Commissioner Mark McClellan left the agency to head the Medicare / Medicaid programs. On Feb. 14 President Bush designated Lester M. Crawford acting FDA commissioner.

Arthritis pain medications withdrawn

Last year, the pharmaceutical industry worldwide underwent one of its most difficult times. On Sept. 30, blockbuster arthritis pain medication and Cox-2 inhibitor Vioxx, produced by Merck & Co. in Puerto Rico, was "voluntarily" pulled from the market by the company, giving way to an estimated $750 million loss in revenue and additional $18 billion in legal defense fees.

Vioxx was withdrawn after the data safety monitoring board overseeing a long-term study of the drug recommended halting the study because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking the drug compared to patients receiving a placebo. The study was being done with patients at risk of developing recurrent colon polyps.

Pfizer’s own Cox-2 inhibitors Celebrex and Bextra, also manufactured in Puerto Rico and whose sales combined with those of Vioxx reached an annual $6 billion, were also affected by the Vioxx study findings. However, instead of withdrawing the two drugs from the market, the company chose to defend them, citing their different compositions and the results of studies indicating they presented no potential health risks.

On Feb. 18, a team of physicians met with Merck and Pfizer representatives to discuss clinical findings on the three drugs, which resulted in a reprieve for their use in medical treatments, with recommendation that drug labels contain warnings about their potential to increase the risk of heart attacks and strokes. The team also banned consumer advertising for the drugs and required prescriptions for the drugs to include a warning about the risks related to their use.

Companies have also faced or concluded respective formal criminal and regulatory investigations by the U.S. Attorney’s Office and the Securities & Exchange Commission (SEC). Bristol-Myers Squibb was forced to defend itself from charges that, to grow its revenue, the company provided incentives to wholesalers who purchased excessive amounts of some BMS drugs. The company agreed to pay $150 million for the alleged accounting fraud. However, a federal Justice Department criminal probe is still ongoing.

Bristol-Myers Squibb also settled a $300 million class-action lawsuit filed by shareholders against the company’s avid support of biotech company ImClone and $2 billion investment in its cancer drug Erbitux. A criminal case brought by the SEC against ImClone CEO Sam Waksal and home-style expert Martha Stewart, for lying and conspiring to obstruct an investigation into the 2001 sale of ImClone stock right before the share price dropped due to bad company news, resulted in guilty verdicts and prison sentences for both.

Since 1997 global pharmaceutical and biotechnology giant Wyeth has been battling class-action and individual lawsuits by former users of the diet drugs Pondimin and Redux (popularly known as the fen-phen combination) claiming to have suffered heart-valve damage caused by the drugs. To date, the company has set aside $16.6 billion in a legal trust fund and recently added $1.3 billion to cover legal settlements with about 41,600 former fen-phen users. Last week, Wyeth revealed the Court of Common Pleas of Philadelphia had decided in favor of the firm in the case of Geri McMurdie vs. Wyeth for alleged heart-valve injury from the use of Pondimin, a drug once marketed by the company. Rulings are pending on three other cases tried with the McMurdie case.

Since 2000, Schering-Plough has paid $502 million in fines to the FDA for quality control violations at their manufacturing plants in both Puerto Rico and New Jersey, as well as for violations to the SEC Regulation FD, the Fair Disclosure & Foreign Corrupt Practices Act (FCPA). In July, the company was fined $291.9 million after an investigation of the company’s managed-care division by the U.S. Attorney’s Office for the Eastern District of Pennsylvania and the U.S. Department of Justice.

Global Drug Sales of Pharmaceutical Manufacturers in Puerto Rico

2003 vs. 2004
In billions of dollars

Company: Sales 2003 / Sales 2004 / % Change / Earnings 2003 / Earnings 2004 / % Change

Brand: Sales 2003 / Sales 2004 / % Change

Abbott: $17.3 / $19.7 / 13.8% / $2.753 / $3.24 / 17.5%

Biaxin: $0.538 / $1.183 / 119.9%

Depakote: 0.886 / 1.027 / 15.9%

Synthroid: 0.565 / 0.689 / 21.9%

Amgen: 8.4 / 10.6 / 26.3% / 3.148 / 0.7 / -76.2%

Epogen: 2.435 / 2.601 / 6.8%

Aranesp: 1.544 / 2.473 / 60.2%

Neulasta: 1.255 / 1.740 / 38.6%

Neupogen: 1.267 / 1.175 / -7.3%

BMS: 18.7 / 19.4 / 3.9% / 4.7 / 4.4 / -5.6%

Plavix: 7.160 / 7.740 / 8.1%

Pravachol: 2.467 / 3.327 / 34.9%

Glucophage XR: 0.118 / 0.068 / -42.4%

Avapro: 0.757 / 0.930 / 22.9%

Sustiva: 1.253 / 1.581 / 26.2%

Glucovance: 0.424 / 0.169 / -60.1%

Zerit: 0.354 / 0.272 / -23.2%

Eli Lilly: 12.6 / 13.9 / 10.1% / 2.6 / 1.8 / -29.3%

Zyprexa: 4.277 / 4.420 / 3.3%

Evista: 0.922 / 1.013 / 9.9%

Prozac: 0.645 / 0.559 / -13.3%

Merck: 22.5 / 22.9 / 2.0% / 6.8 / 5.8 / -14.9%

Zocor: 1.214 / 5.197 / 328.1%

Fosamax: 0.650 / 3.160 / 386.2%

Cozaar/Hyzaar: 0.690 / 2.824 / 309.3%

Vioxx: 0.731 / 1.489 / 103.7%

Proscar: 0.168 / 0.733 / 336.3%

Propecia: 0.640 / 0.270 / -57.8%

Pfizer: 44.7 / 52.5 / 17.4% / 3.9 / 11.4 / 190.6%

Lipitor: 16.008 / 17.682 / 10.5%

Norvasc: 9.231 / 10.862 / 17.7%

Zoloft: 3.118 / 3.361 / 7.8%

Celebrex: 1.883 / 3.302 / 75.4%

Neurontin: 2.702 / 2.723 / 0.8%

Zithromax: 2.010 / 1.851 / -7.9%

Viagra: 1.879 / 1.678 / -10.7%

Zyrtec: 1.338 / 1.287 / -3.8%

Geodon: 0.353 / 0.467 / 32.3%

Diflucan: 1.176 / 0.945 / -19.6%

Bextra: 0.687 / 1.286 / 87.2%

Detrol: 0.544 / 0.904 / 66.2%

Accupril/Accuretic: 0.706 / 0.665 / -5.8%

Cardura: 0.594 / 0.628 / 5.7%

Alliance*: 0.759 / 0.721 / -5.0%

Xanax: 0.238 / 0.378 / 58.8%

Aricept: 0.254 / 0.308 / 21.3%

Relpax: 0.085 / 0.169 / 98.8%

Schering-Plough: 8.3 / 8.3 / -0.7% / -0.1 / -0.9 / -929.3%

Clarinex: 0.694 / 0.692 / -0.3%

Zetia**: 0.600 / 1.000 / 66.7%

Rebetol: 0.639 / 0.287 / -55.1%

Wyeth: 7.4 / 8.2 / 10.8% / 2.1 / 1.6 / -23.8%

Effexor***: 2.690 / 3.300 / 22.7%

Protonix***: 1.500 / 1.600 / 6.7%

Premarin***: 1.160 / 0.800 / -31.0%

Zosyn/Tazocyn***: 0.640 / 0.760 / 18.8%

2003 Sales: $139.8 billion

2004 Sales: $155.4 billion

2003 Sales of Products Manufactured in Puerto Rico: $82.4 billion or 59% of global sales

2004 Sales of Products Manufactured in Puerto Rico: $102.30 billion or 66% of global sales

2003 Earnings: $25.9 billion

2004 Earnings: $28.0 billion

*Alliance includes Aricept, Spiriva, and Rebif as well as sales of Celebrex and Bextra prior to Pharmacia acquisition.

**Estimated sales

***2003 key-product final sales figures weren’t available. Estimates based on percentage change supplied in 2004.

Source: CARIBBEAN BUSINESS analysis

This Caribbean Business article appears courtesy of Casiano Communications.
For further information, please contact:

CARIBBEAN BUSINESS Archive

or

www.casiano.com

Self-Determination Legislation | Puerto Rico Herald Home
Newsstand | Puerto Rico | U.S. Government | Archives
Search | Mailing List | Contact Us | Feedback