Genzyme

Sanofi Genzyme
Fully Owned Subsidiary
Industry Biotechnology
Founded Boston, Massachusetts (1981)
Headquarters Cambridge, Massachusetts, United States
Key people
 David Meeker, MD
Products Cerezyme
Fabrazyme
Synvisc
Renagel
More Complete Product List
Revenue US $4.61 billion (2007 calendar)[1]
IncreaseUS $581 million (2007 calendar)[1]
IncreaseUS $421 million (2007 calendar)[1]
Number of employees
 12,000 (2010)
Parent Sanofi
Website sanofigenzyme.com

Sanofi Genzyme is an American biotechnology company based in Cambridge, Massachusetts. Since its acquisition in 2011, Genzyme has been a fully owned subsidiary of Sanofi. In 2010, Genzyme was the world’s third-largest biotechnology company which employed more than 11,000 people around the world. As a subsidiary of Sanofi, Genzyme has a presence in approximately 65 countries, including 17 manufacturing facilities and 9 genetic-testing laboratories. Its products are also sold in 90 countries. In 2007, Genzyme generated $3.8 billion in revenue with more than 25 products in the market. In 2006 and 2007, Genzyme was named one of Fortune Magazine’s “100 Best Companies to Work for”. The company donated $83 million worth of products worldwide; in 2006, it made $11 million in cash donations. In 2005, Genzyme was awarded the National Medal of Technology, the highest level of honor awarded by the president of the United States to America’s leading innovators.[2]

History

The company was started by Sheridan Snyder and George M. Whitesides in 1981.[3] 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.[4] Blair was a technician at the New England Enzyme Center at Tufts Medical School.[4]

Genzyme's first office was an old clothing warehouse adjacent to Tufts Medical School.[4]

Henry Termeer joined Genzyme as its president in 1983 and worked to redirect the company, which by this time had reached a valuation of US$100,000,000, from its focus on diagnostic enzymes to modified enzymes for use as human therapeutics.[5]

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 and expert in Gaucher's disease, to include Brian in the clinical trial of Ceredase along with the other seven patients who were all adults.[6] 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[5]

In 1985, Termeer became the company's Chief executive officer (CEO) and in 1986, he took the company public.[5]

Following the approval and success of Ceredase, Genzyme became devoted to finding drugs, involving recombinant human enzymes [5] that would treat enzyme deficiency conditions that were essential to human survival and which usually afflict a very small percentage of the world’s population. Drugs used to treat such conditions are considered to be “orphan drugs.”

Genzyme acquired several of Impath's laboratories and cancer-testing technologies in May 2004, after Impath sought Chapter 11 bankruptcy protection.[7]

In 2010, the year before the company's acquisition by Sanofi-Aventis, Genzyme had more than US$400,000,000 in net income on revenue of $4 billion and was the fourth-largest American biopharmaceutical company.[5] By this time, enzyme therapies accounted for about 40% of revenues, a portfolio managed by the "Personalized Genetic Health" unit, the largest of five operating units.[5]

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 FDA approved was Ceredase, a drug for treating Gaucher disease. Ceredase was eventually replaced by Cerezyme, which, at a cost of $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 treatment of dialysis patients, and Fabrazyme, used to treat patients with Fabry's disease. Other products in development are Tolevamer for Clostridium difficile colitis 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, majority of shareholders voted to approve Genzyme's acquisition.[8] In 2007, CEO, President, and Board Chairman Henri Termeer, earned a salary of $2.5 million, and non-cash compensation worth $129 million.[9]

In 2010, Genzyme launched a kidney medication for the Irish market from its Waterford base which it had set up nine years previously.[10]

Contamination incidents

The troubled Genzyme plant in Allston, Massachusetts

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.[11]

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.[12]

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.[13]

Products

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.[14]

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.[15]

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.[16]

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.[16]

References

  1. 1 2 3 Yahoo!Finance. "Income Statement for Genzyme". Yahoo!. Retrieved March 16, 2007.
  2. ↑ "The National Medal of Technology Recipients 2005 Laureates". The National Medal of Technology and Innovation. United States Patent and Trademark Office. February 19, 2009. Retrieved February 26, 2009.
  3. ↑ Michael Rosenwald (August 2010). "Can Nanotechnology Save Lives?". Smithsonian Magazine. Retrieved August 16, 2012.
  4. 1 2 3 Bruce Morgan (April 12, 2012), A Flair for the Business of Medicine: Genzyme founder Henry Blair started his career working as a technician at Tufts medical school, Tufts Now, retrieved July 17, 2015
  5. 1 2 3 4 5 6 Glick, J. Leslie (1 September 2015). "Innovation Strategies". Genetic Engineering & Biotechnology News. p. 11.
  6. ↑ Michael Margolis (nd), Awareness First Step Toward Treating Gaucher: article by TV Producer and Gaucher Patient, Mr. Michael Margolis, retrieved July 17, 2015
  7. ↑ Craig M. Douglas (May 8, 2004). "Genzyme scoops Impath for $215M: New assets will be merged into Westborough genetic testing unit". Milford Daily News. Archived from the original on November 5, 2012.
  8. ↑ Associated Press (October 22, 2007). "Genzyme Claims Victory in Prolonged Bid for Bioenvision". International Herald Tribune (France). Retrieved November 10, 2007.
  9. ↑ Forbes (December 2007). "Henri Termeer Profile". Henri Teemer profile. Retrieved July 10, 2008.
  10. ↑ "New kidney disease medication launched". RTÉ. February 12, 2010. Retrieved February 12, 2010.
  11. ↑ Angelo DePalma (April 15, 2010). "Viral Safety Methods for Manufacturing". Genetic Engineering & Biotechnology News (GEN). 30 (8).
  12. ↑ Steel, rubber, found in some genzyme drugs. Reuters. November 13, 2009
  13. ↑ "With A Life-Saving Medicine In Short Supply, Patients Want Patent Broken". npr.org. August 4, 2010.
  14. ↑ Genzyme Corp. "Client Profile: Summary" Check |url= value (help), Center for Responsive Politics, 2008
  15. ↑ Regan, James (February 3, 2011). "Sanofi could announce Genzyme deal next week – report". Reuters.
  16. 1 2 Stempel, Jonathan. "Sanofi's Genzyme pays $32.59 million in criminal Seprafilm case". Reuters. Retrieved 10 September 2015.
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