Amylin Pharmaceuticals

Last updated
Amylin Pharmaceuticals, Inc.
Type Subsidiary
NASDAQ: AMLN
Industry Biotechnology
Founded1987;37 years ago (1987)
Defunct2014 (2014)
FateAcquired by Bristol-Myers Squibb and AstraZeneca
Headquarters San Diego, California, United States
Key people
Daniel M. Bradbury [1]
ProductsSymlin (pramlintide)
Byetta (exenatide)
Bydureon (exenatide long-acting release)
RevenueDecrease2.svg US$651 million (2011) [2]
Decrease2.svg US$−543 million (2011) [2]
Total assets Increase2.svg US$1.87 billion (2011) [2]
Total equity Decrease2.svg US$−139 million (2011) [2]
Number of employees
1,300 (2011) [2]
Subsidiaries Amylin Ohio LLC

Amylin Pharmaceuticals, Inc. is a biopharmaceutical founded in 1987 that was based in San Diego, California. The company was engaged in the discovery, development, and commercialization of drug candidates for the treatment of diabetes, obesity, and other diseases. Amylin produced three drugs: Symlin (pramlintide acetate), Byetta (exenatide) and Bydureon (exenatide extended release).

Contents

History

1987–1992: Founding and IPO

In 1987, Amylin Pharmaceuticals was co-founded by Howard E. Greene Jr., former CEO of San Diego biotech pioneer Hybridtech, to develop a treatment for diabetes from a synthetic analog of amylin. [3] Amylin was discovered by researchers at Oxford University earlier that year. [4] Greene served as CEO from 1987 to 1996. Amylin completed its IPO in 1992.[ citation needed ]

1992–1998: Invention of Pramlintide and partnership with Johnson & Johnson

Amylin, in its natural form, is sticky, clumping on needles and forming little rocks[ clarification needed ] in the pancreas. To create a synthetic version that was more reliable and easy to work with, researchers at Amylin Pharmaceuticals altered amino acids in the molecule. The result was a new drug named pramlintide. [5]

In 1995, Amylin Pharmactietucals signed an agreement with Johnson & Johnson's LifeScan division to further develop pramlintide. [6] A Phase II study made public in January 1997 showed that pramlintide was safe to mix with leading short-acting and intermediate-acting commercial insulin products, with preliminary results suggesting it might improve glycemic control. [7]

Initial Phase III trial results released in August 1997 demonstrated statistically significant results for type 1 (juvenile-onset) diabetes, helping modestly to improve glucose control without increasing the risk of hypoglycemia (low blood sugar) while also improving weight and cholesterol levels. In patients with adult-onset type 2 diabetes, pramlintide showed significant benefits at six months but not after 12 months. [8] In March 1998, seven months before the next trial data were due, Johnson & Johnson terminated its partnership with Amylin.[ citation needed ]

1998–2005: New Leadership, struggle to launch Pramlintide, and development of Byetta

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, 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 moving through the regulatory pipeline. [4]

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. [9] 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. [10] In March 2005, Symlin was approved by the FDA for use in diabetics who have difficulty maintaining glycemic control. [11]

Byetta (Exenatide)

In October 1996, Dr. John Eng licensed to Amylin exendin-4, a peptide he had isolated in the venom of a Gila monster. [12] Exendin-4 is similar to the human gut hormone GLP-1, which is responsible for regulating insulin and glucagon release. [13] Unlike human GLP-1, however, exendin-4 has a half-life of several hours, making it a much better drug candidate. [12] 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. [14] In May 2005, Byetta (commercial name for exenatide) was approved in the United States. [15]

2005–2009: Development of Bydureon and proxy battle

2011–2012: End of collaboration with Eli Lilly and acquisition

In July 2012, Bristol-Myers Squibb announced it would acquire Amylin Pharmaceuticals for $5.3 billion. [16] As part of the acquisition, AstraZeneca made a $3.4 billion cash payment to make Amylin a wholly owned subsidiary within the existing BMS/AZ joint venture in diabetes. [17] 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. [18] [19]

In December 2013, AstraZeneca 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. [20] [21]

On February 4, 2014, the U.S. FDA approved Myalept (metreleptin), an analog of human leptin, [22] as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. [23] Metraleptin was originally developed at Amylin Pharmaceuticals. [24] In November 2014, Aegerion Pharmaceuticals made a $325 million cash payment to AstraZeneca to acquire and commercialize metreleptin. [25]

Related Research Articles

Drugs used in diabetes treat diabetes mellitus by decreasing the glucose level in the blood. With the exception of insulin, most GLP receptor agonists, and pramlintide, all are administered orally and are thus also called oral hypoglycemic agents or oral antihyperglycemic agents. There are different classes of hypoglycemic drugs, and their selection depends on the nature of diabetes, age, and situation of the person, as well as other factors.

<span class="mw-page-title-main">AstraZeneca</span> British pharmaceutical company

AstraZeneca plc is an Anglo-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 including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. It has been involved in developing the Oxford–AstraZeneca COVID-19 vaccine.

<span class="mw-page-title-main">Bristol Myers Squibb</span> American pharmaceutical company

The Bristol-Myers Squibb Company, doing business as Bristol Myers Squibb (BMS), is an American multinational pharmaceutical company. Headquartered in Princeton, New Jersey, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the Fortune 500 list of the largest U.S. corporations. For fiscal 2022, it had a total revenue of $46.2 billion.

Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France. Originally, the corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004, Sanofi-Synthélabo merged with Aventis and renamed to Sanofi-Aventis, which were each the product of several previous mergers. It changed its name back to Sanofi in May 2011. The company is a component of the Euro Stoxx 50 stock market index.

<span class="mw-page-title-main">Stavudine</span> Chemical compound

Stavudine (d4T), sold under the brand name Zerit among others, is an antiretroviral medication used to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for prevention after a needlestick injury or other potential exposure. However, it is not a first-line treatment. It is given by mouth.

<span class="mw-page-title-main">Amylin</span> Peptide hormone that plays a role in glycemic regulation

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 slowing gastric emptying and promoting satiety, thereby preventing post-prandial spikes in blood glucose levels.

<span class="mw-page-title-main">Biocon</span> Indian multinational biopharmaceutical company

Biocon Limited is an Indian biopharmaceutical company based in Bangalore. It was founded by Kiran Mazumdar-Shaw in 1978. The company manufactures generic active pharmaceutical ingredients (APIs) that are sold in approximately 120 countries, including the United States and Europe. It also manufactures novel biologics as well as biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon's biosimilar products are also sold in both bulk and formulation forms in several emerging markets.

<span class="mw-page-title-main">Pramlintide</span> Diabetes medication

Pramlintide is an injectable amylin analogue drug for diabetes, developed by Amylin Pharmaceuticals. Pramlintide is sold as an acetate salt.

<span class="mw-page-title-main">Celgene</span> American biopharmaceutical company

Celgene Corporation is a pharmaceutical company that makes cancer and immunology drugs. Its major product is Revlimid (lenalidomide), which is used in the treatment of multiple myeloma, and also in certain anemias. The company is incorporated in Delaware, headquartered in Summit, New Jersey, and a subsidiary of Bristol Myers Squibb (BMS).

<span class="mw-page-title-main">Exenatide</span> Medication

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 metformin and sulfonylureas. It is given by injection under the skin twice daily or once weekly.

<span class="mw-page-title-main">Saxagliptin</span> Chemical compound

Saxagliptin, sold under the brand name Onglyza, is an oral hypoglycemic of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Early development was solely by Bristol-Myers Squibb; in 2007 AstraZeneca joined with Bristol-Myers Squibb to co-develop the final compound and collaborate on the marketing of the drug.

<span class="mw-page-title-main">Dapagliflozin</span> Diabetes medication

Dapagliflozin, sold under the brand names Farxiga (US) and Forxiga (EU) among others, is a medication used to treat type 2 diabetes. It is also used to treat adults with heart failure and chronic kidney disease.

<span class="mw-page-title-main">Insulin lispro</span> Rapid-acting insuline analog

Insulin lispro, sold under the brand name Humalog among others, is a modified type of medical insulin used to treat type 1 and type 2 diabetes. It is used by injection under the skin or within an insulin pump. Onset of effects typically occurs within 30 minutes and lasts about 5 hours. Often a longer-acting insulin like insulin NPH is also needed.

<span class="mw-page-title-main">Muraglitazar</span> Chemical compound

Muraglitazar is a dual peroxisome proliferator-activated receptor agonist with affinity to PPARα and PPARγ.

Glucagon-like peptide-1 (GLP-1) receptor agonists, also known as GLP-1 analogs, GLP-1DAs or incretin mimetics, are a class of drugs that reduce blood sugar and energy intake by activating the GLP-1 receptor. They mimic the actions of the endogenous incretin hormone GLP-1 that is released by the gut after eating.

Acquired generalized lipodystrophy is a rare skin condition that appears during childhood or adolescence, characterized by fat loss affecting large areas of the body, particularly the face, arms, and legs. There are 4 types of lipodystrophy based on its onset and areas affected: acquired or inherited, and generalized or partial. Both acquired or inherited lipodystrophy present as loss of adipose tissues, in the absence of nutritional deprivation. The near-total loss of subcutaneous adipose tissue is termed generalized lipodystrophy while the selective loss of adipose tissues is denoted as partial lipodystrophy. Thus, as the name suggests, AGL is a near-total deficiency of adipose tissues in the body that is developed later in life. It is an extremely rare disease that only about 100 cases are reported worldwide. There are three main etiologies of AGL suspected: autoimmune, panniculitis-associated, or idiopathic. After its onset, the disease progresses over a few days, weeks, months, or even in years. Clinical presentations of AGL are similar to other lipodystrophies, including metabolic complications and hypoleptinemia. Treatments are also similar and mainly supportive for symptomatic alleviation. Although HIV- or drug-induced lipodystrophy are a type of acquired lipodystrophy, its origin is very specific and distinct hence is usually not discussed with AGL.

<span class="mw-page-title-main">Insulin degludec</span> Ultralong-acting basal insulin analogue

Insulin degludec (INN/USAN) is an ultralong-acting basal insulin analogue that was developed by Novo Nordisk under the brand name Tresiba. It is administered via subcutaneous injection once daily to help control the blood sugar level of those with diabetes. It has a duration of action that lasts up to 42 hours, making it a once-daily basal insulin, that is one that provides a base insulin level, as opposed to the fast- and short-acting bolus insulins.

Metreleptin, sold under the brand name Myalept among others, is a synthetic analog of the hormone leptin used to treat various forms of dyslipidemia. It has been approved in Japan for metabolic disorders including lipodystrophy and in the United States as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.

Dapagliflozin/saxagliptin/metformin, sold under the brand name Qternmet XR among others, is a fixed-dose combination anti-diabetic medication used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is a combination of dapagliflozin, saxagliptin, and metformin. It is taken by mouth. The drug is marketed by AstraZeneca.

References

  1. ↑ "Company Profile for Amylin Pharmaceuticals Inc (AMLN)" . Retrieved 2008-10-21.
  2. 1 2 3 4 5 "Form 10-K". www.sec.gov. Retrieved 2017-05-26.
  3. ↑ "Howard E. Greene Jr. - Executive Bio, Compensation History, and Contacts - Equilar Atlas". people.equilar.com. Archived from the original on 2016-08-13. Retrieved 2017-05-26.
  4. 1 2 "History of Amylin Pharmaceuticals, Inc. – FundingUniverse". www.fundinguniverse.com. Retrieved 2017-05-26.
  5. ↑ Chartrand, Sabra (1997-11-17). "Patents; Presenting amylin, which is being called the first new diabetes drug since the discovery of insulin". The New York Times. ISSN   0362-4331 . Retrieved 2017-05-26.
  6. ↑ Fisher, Lawrence M. (1995-06-22). "Amylin Gets Johnson Deal And Ends One With Glaxo". The New York Times. ISSN   0362-4331 . Retrieved 2017-05-26.
  7. ↑ Moukheiber, Zina (2000-07-24). "Roller Coasting". Forbes. Retrieved 2017-05-26.
  8. ↑ "The Motley Fool, 3/20/98: The Daily Trouble". www.fool.com. Archived from the original on 2006-03-08. Retrieved 2017-05-26.
  9. ↑ Letter, The Pharma. "Amylin to take Symlin back to clinic - Pharmaceutical industry news". www.thepharmaletter.com. Retrieved 2017-05-26.
  10. ↑ Letter, The Pharma. "Amylin's Symlin US approval on hold - Pharmaceutical industry news". www.thepharmaletter.com. Retrieved 2017-05-26.
  11. ↑ "FDA Approves Symlin for Type 1 and Type 2 Diabetes". 2005-03-18. Retrieved 2017-05-26.
  12. 1 2 "Dr. John Eng's Research Found That The Saliva Of The Gila Monster Contains A Hormone That Treats Diabetes Better Than Any Other Medicine". Diabetes In Control. A free weekly diabetes newsletter for Medical Professionals. 2007-09-18. Retrieved 2017-05-26.
  13. ↑ Garber, Alan J. (2011-05-01). "Long-Acting Glucagon-Like Peptide 1 Receptor Agonists". Diabetes Care. 34 (Supplement 2): S279–S284. doi:10.2337/dc11-s231. ISSN   0149-5992. PMC   3632193 . PMID   21525469.
  14. ↑ GELLENE, DENISE (2002-09-21). "Eli Lilly to Join Forces With Amylin". Los Angeles Times. ISSN   0458-3035 . Retrieved 2017-05-26.
  15. ↑ "Diabetes Drug Byetta Gets FDA Approval" . Retrieved 2017-05-26.
  16. ↑ Shannon Pettypiece (3 July 2012). "Bristol's Amylin Deal Heralds Acquisition Hunger". Bloomberg.com. Retrieved 21 February 2015.
  17. ↑ Pollack, Michael J. de la Merced and Andrew (30 June 2012). "Bristol-Myers in Deal for Amylin Valued at $7 Billion". DealBook. Retrieved 2017-05-25.
  18. ↑ Fikes, Bradley J. "Amylin's San Diego operations closing". sandiegouniontribune.com. Retrieved 2017-05-25.
  19. ↑ "Amylin Pharmaceuticals to Be Closed | San Diego Business Journal". www.sdbj.com. 3 April 2013. Retrieved 2017-05-25.
  20. ↑ Allison Connolly (19 December 2013). "AstraZeneca to Acquire Bristol Stake in Diabetes Venture". Bloomberg.com. Retrieved 21 February 2015.
  21. ↑ "Business as usual at Amylin plant during sale". daytondailynews. Retrieved 2017-05-25.
  22. ↑ Lipodystrophy Orphan Drug Program. Amylin Pharmaceuticals.
  23. ↑ U.S. Food and Drug Administration (25 February 2014). "FDA approves Myalept to treat rare metabolic disease". News & Events: Press Announcements. Retrieved 22 June 2015.
  24. ↑ "Amylin and Takeda Suspend Obesity Study to Consider Metreleptin Data | Xconomy". Xconomy. 2011-03-16. Retrieved 2017-05-25.
  25. ↑ "Struggling Aegerion Diversifies With Fat Disease Drug | Xconomy". Xconomy. 2014-11-06. Retrieved 2017-05-25.
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