Amylin Pharmaceuticals, Inc., a biopharmaceutical company, engages in the discovery, development and commercialization of medicines for diabetes, obesity and other diseases.
Marketed Products
BYETTA (exenatide) injection
The company has developed and gained approval for BYETTA (exenatide) injection to treat diabetes. BYETTA has also been approved in the European Union. BYETTA is the approved medicine in a new class of compounds called incretin mimetics. It is approved as an adjunctive therapy to improve glycemic control in patients with type 2 diabetes who have not achieved gylcemic control and who are taking metformin, sulfonylurea and/or a thiazolidinediene (TZD), the three most common oral therapies for type 2 diabetes.
BYETTA provides self-regulating glucose control by augmenting the body’s natural physiologic processes, allowing the body to respond to blood glucose changes as they occur.
In June 2006, the company entered into an agreement with Nastech Pharmaceutical Company to develop a nasal spray formulation of exenatide. The company and Nastech would jointly develop the nasal spray formulation using Nastech’s proprietary nasal delivery technology. It has the responsibility for the development program, including clinical, non-clinical and regulatory activities, and Nastech would focus on drug delivery and chemistry, and manufacturing and controls activities. It has also submitted an Investigational New Drug Application (IND), to the United States Food and Drug Administration (FDA) for a human feasibility study for nasal exenatide.
SYMLIN (pramlintide acetate) injection
SYMLIN is the approved medicine in a new class of compounds called amylinomimetics. The company began selling SYMLIN in the United States in April 2005 as adjunctive therapy to mealtime insulin to treat diabetes. SYMLIN is the FDA-approved medication addressing glucose control for patients with type 1 diabetes. The company owns 100% of the global rights to SYMLIN. SYMLIN is indicated for use in adults with type 2 or type 1 diabetes to control blood sugar. SYMLIN is used with insulin and has been associated with a risk of insulin-induced severe hypoglycemia.
Lilly Collaboration
The company entered into a collaboration agreement with Lilly for the global development and commercialization of exenatide, including both the twice-daily version, BYETTA, and sustained-release formulations, such as exenatide LAR.
Research and Development
Product Pipeline Programs
The company has late-stage development programs in the therapeutic areas of diabetes and obesity and multiple early-stage programs in diabetes and obesity.
Diabetes
Exenatide LAR: Exenatide LAR is the company’s late stage development program in diabetes. Exenatide is the active ingredient in BYETTA and is combined with proprietary technology developed by the company and its partner, Alkermes, for a sustained release delivery of exenatide. The company has an agreement with Alkermes for the development, manufacture and commercialization of exenatide LAR and this program is included in its collaboration agreement with Lilly. It is working with Lilly and Alkermes to develop a formulation that enables a once-a-week administration of exenatide for the treatment of type 2 diabetes.
In March 2006, the company initiated a long-term comparator clinical study of exenatide LAR in patients with type 2 diabetes.
Obesity
Treatment of Obesity with Pramlintide: The company is developing pramlintide acetate, the active ingredient in SYMLIN, as a potential treatment of obesity. The company completed Phase 2 study in February 2006.
Integrated Neurohormonal Therapy for Obesity (INTO)
Pramlintide
The company is conducting a clinical study using pramlintide in combination with approved oral obesity agents, phentermine and sibutramine. This Phase 2b study is designed to replicate preclinical data. It is also conducting a clinical study using pramlintide in combination with leptin. It is also studying pramlintide in combination with PYY 3-36. The company is conducting a fourth clinical study to evaluate a second-generation amylinomimetic designed to have anti-obesity properties. In 2006, the company submitted an IND application to the FDA for this Phase 1 drug candidate.
Leptin
In 2006, the company acquired the rights to the leptin molecular franchise and program from Amgen, Inc. (Amgen). Leptin is a naturally occurring protein hormone secreted by fat cells. The company completed pre-clinical study for leptin.
PYY 3-36
The company is developing PYY 3-36 as a drug candidate for the potential treatment of obesity.
Partnerships
The company has partnered with PsychoGenics, Inc. to form Psylin Neurosciences, Inc. (Psylin), a company that would focus on the discovery and development of peptide hormones for treatment of psychiatric indications.
In-Licensing Activities
The company licenses or acquires rights to compounds, drug candidates and technologies that have been developed outside of Amylin. In addition to acquiring the rights to the leptin molecular franchise and program from Amgen, in 2006, the company in-licensed intellectual property and other rights to glucose-dependent insulinotropic polypeptide (GIP) agonists from Diabetica, Ltd. In 2005, the company acquired the chemical ligation technology and intellectual property from Gryphon Therapeutics, Inc.
BioSeek Inc. is signing a joint research collaboration agreement with Amylin Pharmaceuticals Inc. that would focus on the discovery and development of novel peptide therapeutics for inflammatory conditions.
Suppliers
BYETTA: The company obtains exenatide, the active ingredient contained in BYETTA, from Bachem California (Bachem), and Mallinckrodt, Inc. (Mallinckrodt), pursuant to long-term agreements with each company. The company has long-term agreements with Wockhardt UK (Holdings), Ltd. (Wockhardt), and Baxter Pharmaceutical Solutions LLC, a subsidiary of Baxter, Inc. (Baxter), to supply it the dosage form of exenatide in cartridges. The company has a long-term agreement with Lilly to supply pens for delivery of BYETTA in cartridges.
SYMLIN: The company obtains pramlintide acetate, the active ingredient contained in SYMLIN, from Bachem and Lonza, Ltd. (Lonza), pursuant to long-term agreements with each company. The company has a long-term contract with Baxter for the dosage form of SYMLIN in vials. It also has an agreement with Wockhardt for the dosage form of SYMLIN in cartridges. It has a long-term agreement with Ypsomed AG to supply pen components for the delivery of SYMLIN in cartridges. The company also has a long-term agreement with Hollister-Stier for the assembly of the SYMLIN pen components and cartridges.
Exenatide LAR: Under the terms of the company’s development and license agreement with Alkermes, the company is responsible for manufacturing the once-weekly dosing formulation of exenatide LAR for commercial sale. Alkermes would transfer to the company its technology for manufacturing the once-weekly formulation of exenatide LAR and would supply it with the polymer materials required for the commercial manufacture of exenatide LAR.
Competition
The company’s major competitors include AstraZeneca, Bristol-Myers Squibb Company, GlaxoSmithKline, Lilly, Merck & Co., Novartis AG, Novo Nordisk, Pfizer, Sanofi-Aventis and Takeda Pharmaceuticals. Its competitors who market oral medicines for the treatment of obesity include Hoffmann-LaRoche, and Abbott Laboratories.
History
Amylin Pharmaceuticals, Inc. was in 1987.
