5200 Old Orchard Road
[Searle's] mission is to bring to the market innovative, value-added healthcare products that satisfy unmet medical needs.
Skokie, Illinois-based G.D. Searle & Co. is a mid-sized pharmaceutical firm owned entirely by chemical producer Monsanto Company. Searle concentrates on developing, manufacturing, and marketing pharmaceuticals in five main areas: arthritis, insomnia, cancer, cardiovascular disease, and women's reproductive health. Its top-selling product is the arthritis drug Celebrex, which was introduced in early 1999 and became the most successful pharmaceutical launch in U.S. history, with 19 million prescriptions written in the first 12 months. Over its more than 100-year history, Searle has developed a number of well-known products, including the laxative Metamucil, motion-sickness treatment Dramamine, the first birth control 'pill,' high-blood-pressure medication Aldactone, and the artificial sweetener aspartame (brand name NutraSweet). Four generations of the Searle family guided the company through much of its development. In October 1985 Monsanto acquired Searle, which then operated as a wholly owned subsidiary. In December 1999 Monsanto agreed to a merger with Pharmacia & Upjohn Inc., a development that signalled the likely end of Searle's existence as an operating company.
Gideon D. Searle founded his namesake company in 1888 in Omaha, Nebraska. Searle was a young druggist who decided to become a full-time pharmaceutical manufacturer. In 1890 he relocated the company to the corner of Ohio and Wells streets in Chicago. He formally incorporated his venture as G.D. Searle & Co. on April 10, 1908. Initially the small firm sold a wide variety of products to doctors throughout the Midwest who dispensed medications directly to their patients rather than sending them to a drugstore. Claude Howard Searle, son of Gideon and a practicing physician, took over as president of the company following his father's death in 1917.
Under Claude Searle's leadership, the company continued his father's marketing strategy but--like other pharmaceutical companies who saw their supply of drugs from Germany cut off with the start of World War I--also began to emphasize research and development in the late 1910s and 1920s. During the latter decade Searle developed an American version of a European treatment for syphilis. Aminophyllian, a treatment for cardiac and respiratory disorders, was introduced in 1930.
Helping to steer the company through the difficult environment of the Great Depression was John G. Searle, son of Claude, who became general manager in 1931, then president and CEO in 1936. John Searle reduced the company's product line to highly specialized and profitable items, with a particular emphasis on filling niches left by other pharmaceutical firms.
An early example of the new strategy was the 1934 introduction of Metamucil, the first effective but nonirritating laxative. Metamucil went on the become the top selling laxative in the United States. In 1941 company headquarters were moved to Skokie, a northern Chicago suburb. Eight years later, one of Searle's most successful products--Dramamine, the first motion-sickness pill--was discovered. In 1966 Dramamine remained a leader in motion-sickness medications; by the 1980s the drug had become a household staple. Also successfully introduced in the years following World War II was a treatment for peptic ulcers. During the 1950s Searle began an international expansion, which took the company into Europe, Latin America, Asia, and Africa.
1960s: The 'Pill' and Diversification
The company's reputation as a manufacturer of quality drugs corresponded to its growing profits. Increasing sales by $1 million to $2 million annually, the company had sales of $37 million by 1960. Searle's former successes, however, offered no indication of the large profits to come with the introduction of one of the most revolutionary drugs of the decade--an oral contraceptive. Under the direction of Dr. Albert L. Raymond, head of Searle's research department since the 1930s, pioneering work with synthetic hormones in 1951 led to Searle's development of Enovid, the first contraceptive of its kind to reach the market. Within four years of the introduction of 'the pill' in 1960, Searle's sales increased 135 percent to $87 million, with a 38 percent return on stockholder's equity. Moreover, almost half of the company's $73 million in total assets existed in cash and marketable securities, long-term debts were virtually nonexistent, and Searle stock traded at 34 times earnings.
Notwithstanding three stock offerings between the years 1950 and 1966, the Searle family maintained a 46 percent share of their namesake enterprise. Upon John G. Searle's death in January 1978, the family had become one of Chicago's wealthiest, with an estimated net worth of $250 million. John Searle's descendants were not only destined to become wealthy men, but his two sons would eventually assume positions of company leadership. Interestingly enough, however, in early 1963 a proposed merger between G.D. Searle and Abbott Laboratories, arranged by the two companies' presidents, was said to be inspired by John Searle's lack of confidence in his offsprings' business acumen. The golfing partners arrived at a tentative agreement over drinks in Chicago's exclusive Old Elm golf club. According to the arrangement, no plans were made to include top management positions for John Searle's sons.
The proposed merger never occurred. One explanation cited John Searle's realization that the amount of bickering on the golf course between him and Abbott's George Cain was an indication of how poorly they would get along as business partners. A more likely explanation pointed to the complications arising from the younger Searles's sizable holdings in the merged company. At any rate, John Searle went into semiretirement during 1966 in the wake of the aborted merger; he assumed the title of chairman and his two sons moved into executive positions. William L. Searle became vice-president of marketing while his older brother, Daniel Searle, a Harvard Business School graduate, succeeded his father as president with the additional title of chief operating officer. Daniel now inherited the leadership of one of the most profitable pharmaceutical companies in the industry.
Yet even before the leadership had changed, a number of industry developments foreshadowed an era of growing problems. Competition from other manufacturers producing birth-control pills, including Upjohn and Johnson & Johnson, reduced Searle's share of the market. Furthermore, a concern about side effects associated with oral contraceptives slowed management's decision to increase production and prolonged the Food & Drug Administration's market approval of Searle's Ovulen, a second-generation contraceptive. Finally, the increasing cost of research, coupled with its unpredictable results, meant that company scientists were unable to bring to fruition a new product line. By 1965 earnings decreased to $23.2 million, down from $24.2 million the previous year; while industry competitors posted net profit increases of 19.4 percent, Searle's dropped 4.4 percent.
It was under these circumstances that Daniel Searle initiated an ill-fated policy of acquisition. Purchasing a dozen small companies with a wide variety of products, including nuclear instrumentation, medical electronics, and veterinary and agricultural products, Searle diversified into unfamiliar waters. While industry competitors made similar purchases outside the business of ethical drugs, few companies were less fortunate in their choices. By 1977 Searle reported a $95 million write-off; sales had increased to $844 million, but return on equity dropped from 50 percent to 11 percent. The acquisitions outside the area of pharmaceuticals accounted for 57 percent of sales but only 13 percent of profits, and G.D. Searle's profitability decreased sharply.
In addition to a new generation of family executives, 1966 brought Dr. Raymond's tenure as director of the research department to an end. Dr. Thomas P. Carney, former director of research at Eli Lilly, succeeded Raymond as head of the Searle laboratories. Carney's background in both chemical engineering and organic chemistry, as well as his success in developing profitable agricultural chemicals for Lilly, promised to facilitate the development of new innovative drugs for Searle. Aldactone and Aldactazide, two diuretics used in the treatment of hypertension, and Flagyl, a drug to cure reproductive tract infections, awaited and received FDA approval.
1970s and Early 1980s: Publicity Woes and the Battle over Aspartame
By 1971 an estimated 80 percent of company profits resulted from sales of pharmaceuticals other than oral contraceptives. The previous year's profits had actually risen 12 percent, but only on the company's ability to use its Puerto Rican operations as a tax shelter; while profits before taxes actually fell $5 million, Searle's tax bill was reduced by $9 million. Long-term debt was now reported at $49 million.
By 1973 sales of Aldactone and Aldactazide alone contributed 18 percent of annual revenues, surpassing sales generated from the birth control pill for the first time. Research expenditures at Searle laboratories increased 33 percent and led to the development of a new artificial sweetener, aspartame. Aspartame's unique structure resulted from the combination of two naturally occurring amino acids. While the company awaited approval to market the product as a food additive, production was planned using the expertise of Ajinomoto Co., Inc., a Japanese company experienced in the manufacture of amino acids. With cyclamates removed from the market and questions circulating about the safety of saccharin, Searle's new product represented the possibility of a large market share. In addition to developing the sweetener, the company moved into new areas of birth control. A copper intrauterine contraceptive was introduced in England and awaited market approval in the United States.
The July 1981 FDA approval of aspartame's use as a table top sweetener, as well as a food additive in a number of items, resulted in a minor victory for Searle. Sugar prices had recently tripled and the market for low calorie products began expanding significantly. Furthermore, aspartame lacked the bitter aftertaste of saccharin and eliminated 95.5 percent of the calories of sugar. Yet several disadvantages in the new product caused industry analysts to remain cautious in their assessment of aspartame's future. The projected cost for the new sweetener was many times greater than that of saccharin, and its short shelf life--it lost its sweetness after several months&mdash′ecluded any speedy acceptance in the profitable soft drink market. Bottlers would resort to a more stable, less expensive product before they would turn to aspartame. Nevertheless, Searle persevered in the test marketing of Equal, the consumer brand name for its new product.
Despite such hopeful products emerging from Searle laboratories, many industry analysts remained skeptical about the company's future. Diluted earnings, resulting in part from the company's numerous acquisitions, aspartame's unclear future, and the expiration of a number of important patents all contributed to this attitude. Yet, apart from these problems, Searle management could never have been prepared for the series of blows dealt them in a televised hearing involving an FDA challenge to their reputation. In July 1975 a Senate subcommittee on health, headed by Edward Kennedy, sought to investigate allegations about questionable research surrounding the safety of both Aldactone and Flagyl. A 1972 article in the Journal of the National Cancer Institute, with the support of numerous subsequent independent studies, cited an increased incidence of lung tumors in mice treated with Flagyl. Similar cancer risks, not evident in Searle's research data, appeared in tests of Aldactone.
While conceding that 'clerical errors' had occurred, Searle categorically denied any suppression of lab tests. The company did embark on a public relations campaign to improve its image of social responsibility. The price of company stock, however, dropped from around $25 to $15 per share as analysts estimated that sales of Flagyl, Aldactone, and Aldactazide would be reduced by half its previous volume. With a new strategy of public relations, Searle's problems were hardly over. In December 1975, in an unprecedented move, the FDA suspended permission to market aspartame based on an audit of Searle's new drug applications filed since 1968.
The FDA actions resulted in more delays than actual damage. While labels warning about cancer risks appeared on the investigated products, sales for Aldactone and Aldactazide actually rose 24 percent on the last quarter of 1975; Flagyl's increased 12 percent. Aspartame remained under investigation, only to receive market approval six years later. The $29 million already invested in its production was left in abeyance.
While the assault on Searle's corporate integrity marred the company's public image, internal problems threatened to disrupt its very operations. By 1977 money borrowed in the United States against the $420 million saved in the Puerto Rican tax shelter translated into an interest payment of $24 million; earnings from this same tax haven amounted to only $17 million. This, in turn, had some effect on overall company earnings so that shares gaining $1.56 in 1975 gained only $.57 in 1977.
To remedy the situation, an outsider was called in to assume control of the company. Donald H. Rumsfeld, a former congressman, presidential aide, and defense secretary, agreed in 1975 to step in as president and chief executive officer, thus ending four generations of family management. Daniel Searle, who advanced to chairman, had met Rumsfeld 15 years earlier and supported him in his congressional election bid. Their friendship gave impetus to Rumsfeld's midlife career change. While refusing to state he had given up public life for good, the accomplished politician rose to the challenge of correcting the company's numerous problems.
Searle's turnabout was almost immediate. By repatriating Puerto Rican dollars, bringing in new staff, selling unprofitable divisions, and announcing a massive write-off, Rumsfeld cleared the way for major changes in the company. From 1977 to 1983 Searle divested businesses with aggregate sales of almost $500 million. An optical retailing business, under the name Vision Centers, represented a profitable new subsidiary; it had been acquired as part of a 1973 merger with Will Ross. In 1978 this retailer of eyeware contributed $91 million; a five-year estimate placed contributions at $400 million. While long-term debt now stood at $350 million, Vision Center's profits were necessary to improve the company's performance.
By 1981 Searle reported the second highest profit margin among 30 leading U.S. drug firms. Furthermore, an FDA announcement ended aspartame's years-old struggle to win market approval. Rumsfeld's revitalization of the research department through the infusion of $100 million promised a new line of pharmaceuticals from anti-ulcer medication to treatments for herpes. An aggressive policy of licensing and joint ventures generated income to supplement the research costs. Long-term debt was reduced to $89 million as the renamed Pearle Vision Centers moved to the top of the optical retailing business.
In 1983 a 39 percent drop in earnings during the first quarter prompted a decision to sell the eyecare subsidiary. In September 1983 Searle sold 55 percent of Pearle to the public through an IPO; two years later, the remaining stake was sold to GrandMet USA, Inc., a unit of U.K. food and alcohol giant Grand Metropolitan PLC. It was hoped that income generated from the sale would help improve pharmaceutical research which had not produced an extremely lucrative 'blockbuster' drug in several years. Drug research, however, did not bring the sought after profits; instead, industry analysts were surprised as sales of aspartame reached record-breaking figures. As a tabletop sweetener and a food additive in cold cereals and dry drink mixes, sales between 1981 and 1982 increased from $13 million to $74 million. As the product was ready to enter into the immensely profitable soft drink market, Searle invested $25 million to expand production in the United States. Once Searle received the expanded FDA approval in 1983, carbonated drink companies lined up to secure contracts. By the end of 1983 virtually all major bottlers became Searle customers, and with the marketing plan to print the consumer name on all products using the sweetener, NutraSweet became a household name.
Despite this expansion after 17 years of testing, fears of aspartame's side effects were not completely dispelled. One study noted changes in behavior after large quantities of carbohydrates and aspartame had been ingested. Woodrow Monte, director of the Food Sciences & Nutrition Laboratory at Arizona State University, along with several consumer groups, challenged NutraSweet's safety by pointing to its production at high temperatures of methanol, a compound associated with poisoning. The FDA reasserted aspartame's safety by pointing to the existence of methanol in fruit juices.
While sales of aspartame reached $336 million in 1983, the continuing question of its safety was not the only issue to concern Searle management. The sweetener's patent was scheduled to expire in 1987; forthcoming competition threatened the sales figure. Even more disturbing was the lack of new pharmaceuticals. One observer facetiously predicted that the company, like its new campaign to sweeten sodas exclusively with NutraSweet as opposed to a combination with saccharin, was in danger of itself becoming 100 percent NutraSweet.
As sales of NutraSweet edged towards maximum market potential the Searle family, still holding a 34 percent interest, announced a decision to liquidate part of their stake. Industry analysts, noting the timing of this announcement, predicted that the family could collect as much as $75 per share. Four months after the announcement, not one company had tendered an offer. The financial burden of running NutraSweet's huge operations, as well as an Internal Revenue Service investigation into allegedly deficient taxes paid by the Puerto Rican subsidiary, deterred potential suitors. Liability for the contested taxes was estimated at $381 million.
1985-2000: The Monsanto Era
Only two months later, the announcement to withdraw the offer to sell Searle seemed to indicate a new effort to remain independent. The company purchased 7.5 million of the Searle family shares, reducing their holdings to 21 percent. Rumsfeld succeeded Daniel as chairman, which further solidified independent management. No sooner had these events taken place than Monsanto Co., a chemical firm, announced it planned to purchase Searle for an agreed-upon $2.7 billion. For Monsanto the acquisition represented an end to its long search for an ethical drug company that could generate the income necessary to boost its maturing agricultural chemical products. Monsanto also hoped to benefit from Searle's experienced marketing and sales staff, its biotechnological expertise, and the attractive market potential of new products like the antiulcer drug, Cytotec. Following the completion of the acquisition in October 1985, Searle became a wholly owned subsidiary of Monsanto.
Along with Searle's attractive qualities, Monsanto also accepted the drug company's tax dispute liabilities. What the new parent company did not expect, however, was to become embroiled in a new controversy. Searle's Copper 7, the most widely used intrauterine contraceptive device (IUD), was suddenly accused of causing pelvic infections and infertility. Even more disturbing was a major business magazine's disclosure that the company distorted information surrounding the IUD's safety. The final version of the company's lab results did not state that some cells in the test monkeys developed 'premalignant transformations,' but only referred to cell modification. Similarly, Searle's human test results may not have accurately reported the rate of pelvic inflammatory disease developed by users. On January 3, 1986, facing 305 pending lawsuits out of a total 775 claims, Searle withdrew the Copper 7 from the market. While continuing to defend the product's safety, the company acted to preempt growing litigation costs; Searle's defense had already cost $1.5 million. The specter of events surrounding the Dalkon Shield, an IUD manufactured by A.H. Robins, undoubtedly expedited Searle's removal of the IUD from the market. Litigation costs surrounding alleged infections and ailments suffered by users of the Dalkon Shield eventually caused A.H. Robins to seek protection under Chapter 11 of the Bankruptcy Code.
The Copper 7 crisis continued to unfold in the late 1980s, as hundreds of new claims--including shareholders charging the company with failing to inform them of the IUD suits--were filed against Searle. Although a jury ordered Searle to pay $8.2 million for damages related to the Copper 7 IUD in 1988, the company appealed the decision.
Apparently undaunted by the ongoing litigation, Monsanto established a new strategy for Searle, combining research and development goals with performance objectives, and promoting those efforts with aggressive marketing initiatives. By the mid-1990s, the company planned to average one important new product introduction each year, annual sales of $3 billion, and a standing among the world's top 15 drug companies. Monsanto also turned Searle into a pure pharmaceutical company, placing Searle's artificial sweetener business into a separate subsidiary called the NutraSweet Company.
Launched in 1987, Searle's 'Patient Promise' marketing program made it the first pharmaceutical firm in America to extend refunds on any of its products that proved ineffective. The program successfully promoted Searle's blood pressure treatment, Calan SR, to the leading position among such 'calcium channel blockers.' By 1990, the drug had captured one-fifth of that market in spite of competition from at least three similar medicines, and had become Searle's leading product. According to an article published in Forbes magazine that year, Calan SR was the catalyst that changed Searle's financial losses into profits.
Searle countered burgeoning governmental and popular criticism of the U.S. pharmaceutical industry with a separate special public relations campaign. The company's 'Rx Partners' program set up interviews wherein top executives of pharmaceutical firms could offer their perspectives on such divisive issues as pricing, marketing, and research and development.
Led by Sheldon G. Gilgore in the early 1990s, Searle underwent an admittedly 'difficult' restructuring in 1992, as the company fought to achieve consistent profitability. The reorganization focused on three primary areas: rationalizing capacity; consolidating global research and development efforts; and reducing the administrative workforce by nearly 2,000 employees. Savings from this effort helped make possible a massive $305 million investment in research and development (20 percent of sales). Although Calan SR was still Searle's leading product, by this time it had lost its patent protection and was under competition from generics. Pinning its future on new patented drugs, Searle launched three products in 1993: Daypro and Arthrotec, two nonsteroidal anti-inflammatory drugs (NSAIDs) specially formulated for treatment of arthritis, and Ambien, an insomnia treatment. Daypro became Searle's first product to exceed over $100 million in sales within the first year of its U.S. introduction. Heavy investment in research and development put several promising drugs in Searle's pipeline as well.
In late 1994 Richard U. De Schutter, a 20-year Monsanto veteran, was named CEO of Searle. Philip Needleman became head of Searle R & D. Over the next several years, the focus of Needleman's R & D efforts would be in five main areas: arthritis, insomnia, cancer, cardiovascular disease, and women's reproductive health. Searle entered the last of these fields in 1995 when it purchased Roche Holding Ltd.'s Syntex women's healthcare product line for $250 million. In addition to focusing the company's research more narrowly, Needleman also instituted a ruthless policy of quickly ending research on a new drug if it failed an early acid test. In this way--given that Searle was a relatively small pharmaceutical firm--he was able to save precious resources.
By 1996 earnings for Searle were a healthy $200 million on sales of $2 billion. By this time, annual sales of both Daypro and Ambien were nearing the $300 million mark. Sales increased to $2.4 billion in 1997. During the following year, Monsanto reached an agreement with American Home Products Corporation on a $35 billion merger. Combining the research laboratories of Searle and American Home would have created a pharmaceutical entity on a par with the industry's leaders, Pfizer Inc. and Merck & Co., Inc. But late in 1998 Monsanto and American Home called off the merger, having failed to agree on a number of major issues.
On December 31, 1998--soon after the merger's demise--the FDA approved a new Searle drug, Celebrex, for the treatment of arthritis pain and inflammation. This was the first of a new category of pain drugs, dubbed Cox-2 inhibitors, to be approved. Cox-2, an enzyme present in various diseases, was blocked by the new drugs. As a treatment for arthritis, Celebrex was noted for being effective and for not irritating the stomach. Searle partnered with Pfizer for the global marketing and distribution of Celebrex. Launched in the United States in February 1999, Celebrex became the most successful pharmaceutical launch in U.S. history, with 19 million prescriptions written in the first 12 months; sales during 1999 alone exceeded $1.4 billion. With 43 million Americans suffering from arthritis, and hundreds of millions worldwide, sales of Celebrex were predicted to reach $3 billion annually by 2002. The development of rival Cox-2 inhibitors, however, had the potential to dampen sales of the blockbuster new drug. In December 1999 the FDA approved Celebrex for a second use, that of treating a particular genetic disease that almost always results in colorectal cancer.
Also in December 1999 Monsanto and Pharmacia & Upjohn Inc., a major pharmaceutical company based in Peapack, New Jersey, announced an agreement to merge via a deal initially valued at $27 billion. The merger would create a new company, to be called Pharmacia Corporation, which would be one of the global giants in pharmaceuticals with annual sales of $17 billion and an annual pharmaceutical R & D budget of more than $2 billion. Within the new company, Monsanto's agricultural operations would be deemphasized, with a partial IPO planned for the unit, which would retain the Monsanto name. Searle, meantime, would no longer exist as a separate company, but its name would be retained to designate one of Pharmacia's sales divisions. It thus appeared that the firm known as G.D. Searle & Co. would end its history soon after introducing its most successful product ever.
Principal Subsidiaries: Continental Pharma Inc. (Belgium); Searle do Brasil Ltda. (Brazil); Searle PRC (China); Searle European Inc. (Czech Republic); Sanitas, a.s. (Czech Republic); Heumann Pharma GmbH (Germany); Searle Vianex (Greece); Searle Hong Kong Ltd.; Searle & Co. Ltd. (Ireland); Searle Malaysia Sdn. Bhd.; Searle de Mexico S.A. de C.V.; Searle (Nederland) B.V. (Netherlands); Searle Philippines Inc.; Searle Farmaceutical Ltda. (Portugal); Searle & Co. (Puerto Rico); Searle (South Africa) PTY, Ltd.; Searle Ciba-Geigy Korea, Ltd. (South Korea); Searle Iberica S.A. (Spain); Searle S.A. (Switzerland); Searle Pharma Ltd. (Taiwan); Searle U-Liang Co., Ltd. (Taiwan); Searle Thailand Ltd.; Searle de Venezuela, C.A.
Principal Competitors: Alpharma Inc.; AstraZeneca PLC; Biomatrix, Inc.; Bristol-Myers Squibb Company; Centocor, Inc.; Cypress Bioscience, Inc.; Hi-Tech Pharmacal Co., Inc.; IVAX Corporation; Merck & Co., Inc.; Novartis AG; Sanofi-Synthelabo; Schering AG; SmithKline Beecham plc.