Amylin Pharmaceuticals is a biopharmaceutical company based in

San Diego San Diego ( , ; ) is a city on the Pacific Ocean coast of Southern California located immediately adjacent to the Mexico–United States border. With a 2020 population of 1,386,932, it is the eighth most populous city in the United States ...

, CA, that was founded in 1987. The company was engaged in the discovery, development and commercialization of drug candidates for the treatment of

diabetes Diabetes, also known as diabetes mellitus, is a group of metabolic disorders characterized by a high blood sugar level (hyperglycemia) over a prolonged period of time. Symptoms often include frequent urination, increased thirst and increased ap ...

obesity Obesity is a medical condition, sometimes considered a disease, in which excess body fat has accumulated to such an extent that it may negatively affect health. People are classified as obese when their body mass index (BMI)—a person's ...

and other diseases. Amylin produced three drugs: Symlin ( pramlintide acetate), Byetta (

exenatide Exenatide, sold under the brand name Byetta and Bydureon among others, is a medication used to treat diabetes mellitus type 2. It is used together with diet, exercise, and potentially other antidiabetic medication. It is a treatment option after ...

) and Bydureon (exenatide extended-release).

History

1987-1992: Founding and IPO

In 1987, Amylin Pharmaceuticals was co-founded by Howard E. Greene Jr., former CEO of

biotech pioneer Hybridtech, to develop a treatment for

from a synthetic analog of

amylin Amylin, or islet amyloid polypeptide (IAPP), is a 37-residue peptide hormone. It is co-secreted with insulin from the pancreatic β-cells in the ratio of approximately 100:1 (insulin:amylin). Amylin plays a role in glycemic regulation by slow ...

. Amylin was discovered by researchers at Oxford University earlier that year. Greene served as CEO from 1987 to 1996. Amylin completed its IPO in 1992.

1992 - 1998: Invention of Pramlintide & Partnership with Johnson & Johnson

Amylin, in its natural form, is sticky—it clumps on needles and forms little rocks in the pancreas. Researchers first had to create a synthetic version that they could work with more easily and reliably. The inventors at Amylin Pharmaceuticals—Laura Gaeta, Howard Jones, and Elisabeth Albrecht—altered amino acids in the molecule and created a new drug named pramlintide. In 1995, Amylin Pharmactietucals signed an agreement with

Johnson & Johnson Johnson & Johnson (J&J) is an American multinational corporation founded in 1886 that develops medical devices, pharmaceuticals, and consumer packaged goods. Its common stock is a component of the Dow Jones Industrial Average and the company ...

's LifeScan division to further develop pramlintide. A Phase II study made public in January 1997 showed pramlintide was safe to mix with leading short-acting and intermediate-acting commercial insulin products, with preliminary results suggesting it might improve glucose control. Initial Phase III trial results released in August 1997 showed pramlintide did show statistically significant results for type 1 (juvenile-onset) diabetes, helping modestly to improve glucose control without increasing the risk of

hypoglycemia Hypoglycemia, also called low blood sugar, is a fall in blood sugar to levels below normal, typically below 70 mg/dL (3.9 mmol/L). Whipple's triad is used to properly identify hypoglycemic episodes. It is defined as blood glucose belo ...

(low blood sugar) while also improving weight and cholesterol levels. But adult-onset type 2 diabetes affects far more people than type 1, and pramlintide showed significant benefits only at 6 months but not after 12 months. In March 1998, seven months before the next trial data were due, J&J discontinued its partnership with Amylin.

1998 - 2005: New Leadership, Struggle to Launch Pramlintide (Symlin), Development of Byetta (Exenatide)

Joseph C. Cook Jr., a 28-year veteran at Eli Lilly & Co. and an Amylin board member since 1994, came out of retirement in 1998 to help the company recover its footing, taking the title of chief executive officer. Cook reduced the company's workforce by 75 percent to conserve cash and raised capital from investors to keep Symlin (pramlintide's commercial name) moving through the regulatory pipeline.

Symlin (Pramlintide)

In October 2001, Amylin received an approvable letter for Symlin from the FDA, requiring additional clinical data addressing concerns of severe hypoglycemia in type 1 diabetics for approval. In December 2003, the FDA issued a second approvable letter requesting further clinical data to identify a patient population and method of use for Symlin where there is no increased risk of significant hypoglycemia or where there is an added benefit that clearly counterbalances any potential for increases in episodes of hypoglycemia. In March 2005, Symlin was approved by the FDA for use in diabetics who have difficulty maintaining glycemic control.

Byetta (Exenatide)

In October 1996, Dr. John Eng licensed his discovery, exendin-4 to Amylin. Dr. Eng discovered exendin-4 in the venom of a

Gila monster The Gila monster (''Heloderma suspectum'', ) is a species of venomous lizard native to the Southwestern United States and the northwestern Mexican state of Sonora. It is a heavy, typically slow-moving reptile, up to long, and it is the only v ...

. Exendin-4 is similar to the human gut hormone

GLP-1 Glucagon-like peptide-1 (GLP-1) is a 30- or 31-amino-acid-long peptide hormone deriving from the tissue-specific posttranslational processing of the proglucagon peptide. It is produced and secreted by intestinal enteroendocrine L-cells and certa ...

, which is responsible for regulating

insulin Insulin (, from Latin ''insula'', 'island') is a peptide hormone produced by beta cells of the pancreatic islets encoded in humans by the ''INS'' gene. It is considered to be the main anabolic hormone of the body. It regulates the metabolism ...

and

glucagon Glucagon is a peptide hormone, produced by alpha cells of the pancreas. It raises concentration of glucose and fatty acids in the bloodstream, and is considered to be the main catabolic hormone of the body. It is also used as a medication to tre ...

release. Unlike human GLP-1, however, exendin-4 doesn’t degrade for hours, making it a much better candidate for a drug. Amylin developed exenatide, a synthetic version of exendin-4. In 2002, Eli Lilly signed an agreement with Amylin for $325 million to partner in development of exenatide. In May 2005, Byetta (commercial name for exenatide) was approved in the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territo ...

2005 - 2009: Development of Bydureon, Proxy Battle

2011 - 2012: End of collaboration with Eli Lilly and Acquisition

In July 2012,

Bristol-Myers Squibb The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the lar ...

announced it would acquire Amylin Pharmaceuticals for $5.3 billion. As part of the acquisition,

AstraZeneca AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas includi ...

made a $3.4 billion cash payment to make Amylin a wholly owned subsidiary within the existing BMS/AZ joint venture in diabetes. In April 2013, Bristol-Myers Squibb announced it would close Amylin's San Diego operations by the end of 2014 and merge the Amylin manufacturing facility in West Chester, Ohio and all field-based sales personnel into Bristol-Myers Squibb operations. In December 2013,

purchased the Bristol-Myers Squibb share of the diabetes joint venture, and as a result, became the sole owner of all former Amylin products and business, including the manufacturing facility in West Chester,

Ohio Ohio () is a state in the Midwestern region of the United States. Of the fifty U.S. states, it is the 34th-largest by area, and with a population of nearly 11.8 million, is the seventh-most populous and tenth-most densely populated. The sta ...

. On February 4, 2014, the U.S. FDA approved Myalept ( metreleptin), an analog of human

leptin Leptin (from Greek λεπτός ''leptos'', "thin" or "light" or "small") is a hormone predominantly made by adipose cells and enterocytes in the small intestine that helps to regulate energy balance by inhibiting hunger, which in turn dimini ...

, as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. Metraleptin was originally developed at Amylin Pharmaceuticals. In November 2014, Aegerion Pharmaceuticals made a $325 million cash payment to AstraZeneca to acquire and commercialize metreleptin.

References

External links

{{Authority control Pharmaceutical companies disestablished in 2012 Defunct pharmaceutical companies of the United States Companies based in San Diego Health care companies based in California Biotechnology companies of the United States Biotechnology companies established in 1987 Pharmaceutical companies established in 1987 Companies formerly listed on the Nasdaq Life sciences industry Biopharmaceutical companies 1992 initial public offerings 2012 mergers and acquisitions Bristol Myers Squibb AstraZeneca