Genzyme

1980s: Early history The company was started by Sheridan Snyder and George M. Whitesides in 1981. Genzyme's scientific founder was Henry Blair who had a contract with the National Institutes of Health (NIH) to produce modified enzymes for the NIH to test in clinical trials. Blair was a technician at the New England Enzyme Center at Tufts Medical School. Henri Termeer joined Genzyme as its president in 1983 and worked to redirect the company, which by this time had reached a valuation of $100 million, from its focus on diagnostic enzymes to modified enzymes for use as human therapeutics. In 1984, Robin Berman, MD, who volunteered at the NIH, had a three-year-old son Brian, who had Gaucher's disease. He was scheduled for a spleen removal but his mother pleaded with Roscoe Brady, MD, an expert in Gaucher's disease, to include Brian in the clinical trial of Ceredase along with the other seven patients who were all adults. This trial ultimately failed due to use of too low a dose of the enzyme, but Ceredase went on to "become the company's most important product line", receiving FDA approval in 1991 In August 2003, the company acquired SangStat Medical Corp. and its principal anti-organ rejection drug named Thymoglobulin for $600 million. In 2004, the company acquired Ilex Oncology Inc. Genzyme acquired several of Impath's laboratories and cancer-testing technologies in May 2004, after Impath sought Chapter 11 bankruptcy protection. In 2005, the company acquired Bone Care International Inc for $600 million. In 2007, the company agreed to acquire Bioenvision for $345 million, motivated by the potential of the leukemia treatment clofarabine. In 2010, the year before the company's acquisition by Sanofi-Aventis, Genzyme had more than $400 million on net income on revenue of $4 billion and was the fourth-largest American biopharmaceutical company. In 2011, Sanofi acquired the company for $20.1 billion. Acquisition history The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list): }} ==Operations==

Genzyme focuses on six areas of medicine relating to lysosomal storage diseases, renal disease, orthopedics, transplant and immune diseases, oncology, genetics, and diagnostics. The first orphan drug for Genzyme that the FDA approved was Ceredase, a drug for treating Gaucher disease. Ceredase was eventually replaced by Cerezyme, which, for $200,000 per patient annually for life, currently accounts for approximately 30% of Genzyme's revenue. Other important drugs made by Genzyme are Renagel, used in the treatment of dialysis patients, and Fabrazyme, used to treat patients with Fabry's disease. Other products in development are Tolevamer for Clostridioides difficile infection and Campath for Chronic lymphocytic leukemia. Genzyme had a sub-license from Bioenvision to market clofarabine in North America. On May 29, 2007, Genzyme made a tender offer to purchase Bioenvision for $5.60 per share. On October 27, 2007, most shareholders voted to approve Genzyme's acquisition. In 2007, CEO, President, and Board Chairman Henri Termeer, earned a salary of $2.5 million, and non-cash compensation worth $129 million. In 2010, Genzyme launched a kidney medication for the Irish market from its Waterford base which it had set up nine years previously.{{cite web | date = February 12, 2010 | url =http://www.rte.ie/news/2010/0212/genzyme.html | title = New kidney disease medication launched| publisher = RTÉ Manufacturing Sites: Allston MA USA; Geel Belgium; Framingham, MA, USA; Haverhill, Suffolk UK; Waterford, Munster Ireland; ==Contamination incidents==

In June 2009, Genzyme's Allston, Massachusetts plant was shut down to correct a viral contamination (Vesivirus 2117). A similar event had occurred in 2008 at the Geel, Belgium facilities. By April 2010, it had restarted operation at diminished capacity. In November 2009, fragments of stainless steel, rubber, and fiber-like material were discovered in some of Genzyme's drugs. The FDA found these materials in Cerezyme, Genzyme's treatment for Gaucher disease, a rare genetic disorder that can lead to life-threatening organ damage. The FDA is permitting the drug to stay in the market, due to a lack of adverse events, and a critical need for the product. Supplies of Fabrazyme, Genzyme's treatment for Fabry disease, have been rationed to one-third the recommended dose prompting patients to file a petition asking for a license to produce Fabrazyme by other manufacturers to make up the deficit under the Bayh–Dole Act. ==Products==

• Aldurazyme • Alprolix • Aubagio • Cablivi • Cerdelga • Cerezyme • Clolar • Dupixent • Elitek • Eloctate • Eloxatin • Fabrazyme • Jevtana • Kevzara • Lemtrada • Libtayo • Lumizyme • Sarclisa • Taxotere • Zaltrap ==Lobbying==

Genzyme has spent more than $8.2 million on lobbying from 2007 to 2009. In 2009 alone, it had 10 different organizations with a total of 49 lobbyists working on its behalf. ==Takeover bid==

On August 30, 2010, Sanofi announced a bid to acquire Genzyme for $18.5 billion. The deal was later rejected by the board of Genzyme. On February 16, 2011, Sanofi declared the full acquisition of Genzyme for $20.1 billion. ==Lawsuit over marketing of Seprafilm==

In September 2015, Genzyme accepted responsibility and agreed to pay $32.59 million over U.S. charges against its marketing of the adhesion barrier product Seprafilm. Genzyme's sales representatives had been instructing surgeons on how to create a "slurry" using Seprafilm for use during laparoscopic surgeries. This use of Seprafilm is not FDA-approved. Genzyme had also reached a $22.28 million civil agreement pertaining to marketing of Seprafilm in December 2013. Genzyme was claimed to be in violation of the federal False Claims Act. ==References==