Describe, from a regulatory standpoint, the rise and fall of a biotech firm. It can be any firm, but preferably a US firm. In your description, give a brief history, describe the main product(s) and what ultimately led to the firms demise.
The Rise and Fall of Genzyme:
Genzyme was a biotech company founded in 1986. It went onto become the third largest biotech company in the world until it was acquired in 2011 by Sanofi. Genzyme as a company had focused on six areas of medicine:
1. lysosomal storage diseases,
2. renal disease,
4. transplant and immune diseases,
6. genetics and diagnostics
The acquisition of Genzyme was bought on by a drop in sales resulting from quality control troubles at some of its facilities. Before we describe these quality control failures, we would like to present a history of Genzyme:
1981 - The company was founded by Sheridan Snyder and scientist Henry Blair. The initial focus was on enzyme deficiency disorders and orphan drugs. After one year of operations, Genzyme had $2.2 million in revenue. Genzyme struggled until 1983, when Henri Termeer became company chairman at Genzyme. Termeer steered the company towards a new pathway. Under Termeer, Genzyme crafted a niche strategy focusing on less glamorous products that could be sold readily.
1986 - After expanding their research and development activities, the company executives decided to go public. By switching from private to public ownership, Genzyme was able to raise some capital to further fund their work. The initial public offering was 2.8 million shares at approximately $10 per share. This raised over 28 million dollars for the company to further expand their research and development.
1992-1994 - During this period, Genzyme developed Cerezyme. The drug was eventually approved by the FDA in 1994. Cerezyme is an orphan drug for the treatment of Gaucher's disease. Gaucher's disease is a genetic disease in which a fatty substance (lipid) accumulates in cells and certain organs. Gaucher's disease is the most common of the lysosomal storage diseases and became one of the flagship products at Genzyme.
1994-1996 - Genzyme diversified their portfolio of drug products and even went on to work on surgical-based treatments. Genzyme through acquisition of another company called BioSurface Technology developed Carticel, which is a cartilage repair technique also known as autologus cell implantation. Carticel was licensed by FDA in 1996.
2001-2003 - Another flagship product, ...
This solution is approximately 1200 words (about 6 double-spaced pages) including six references. The solution describes a biotech company Genzyme and how it was eventually taken over by Sanofi. The solution provides a brief history of the company and then looks at the circumstances involved with Genzyme failing to meet certain regulations.