QUOTE AND NEWS
MedPage Today  Jul 27  Comment 
(MedPage Today) -- The cellular regulatory system known as autophagy appeared to play a key role in preventing type 2 diabetes by protecting insulin-secreting beta cells from the accumulation of toxic amylin oligomers, researchers reported.
StreetInsider.com  Jun 25  Comment 
Visit StreetInsider.com at http://www.streetinsider.com/Corporate+News/Flamel+Technologies+%28FLML%29+Reports+Successful+Preclinical+Testing+of+Exenatide/9611773.html for the full story.
MedPage Today  Mar 3  Comment 
(MedPage Today) -- The FDA has approved a new means of delivery for weekly exenatide (Bydureon) - a pen formulation - for patients with type 2 diabetes.
Benzinga  Dec 10  Comment 
Oramed Pharmaceuticals (NASDAQ: ORMP) announced today that it has received allowance for a key patent from the Israeli Patent Office. The patent, entitled "Methods and Compositions for Oral Administration of Exenatide," covers oral exenatide...
MedPage Today  Oct 9  Comment 
(MedPage Today) -- The GLP-1 agonist exenatide (Byetta, Bydureon) may temper the cardiovascular risks associated with rosigltiazone (Avandia), possibly via its effects on a clotting pathway, a database study suggests.
MedPage Today  Aug 14  Comment 
(MedPage Today) -- The GLP-1 agonist exenatide (Byetta) used in type 2 diabetes may have metabolic effects on patients with type 1 disease, researchers found.
FierceBiotech  Jun 22  Comment 
CHICAGO--Eli Lilly has highlighted upbeat data from three late-stage studies of its experimental drug dulaglutide, showing that the drug provided better blood-sugar control than Bristol-Myers Squibb's Byetta, Merck's Januvia and metformin. 
MarketWatch  Jun 10  Comment 
Robert Ramnarine, who was involved with evaluating potential acquisition targets for Bristol-Myers Squibb, admitted to illicit gains from trading in stock options of several of the pharmaceutical company’s targets.
FiercePharma  May 31  Comment 
Inconclusive data, confounding variables, as-yet-unreplicated results--they're all reasons critics have dismissed a link between incretin mimetics, a class of diabetes drugs including blockbusters Januvia and Byetta, and pancreatic cancer.
FiercePharma  Apr 4  Comment 
Bristol-Myers Squibb is rolling up the Amylin tent in San Diego. After buying the smaller drugmaker last year, Bristol-Myers plans to shut down its former headquarters and lay off at least 400 workers. Bristol-Myers ($BMY) says it plans to move...




 

Amylin Pharmaceuticals (NASDAQ: AMLN) is a pharmaceutical company that produces drugs to treat diabetes and obesity. The company currently has two type II diabetes drugs on the market: Simylin and Byetta. The latter is responsible for approximately 90% of the company's sales and is unique in that it promotes moderate weight loss; other diabetes drugs often have the opposite affect. Amylin is poised to take advantage of the rapidly growing market for diabetes and obesity drugs.

There are an estimated 21 million people in the United States with diabetes,[1] and over 30% of the U.S. population is currently eligible for obesity treatment. To augment its chances of success, Amylin has teamed up with pharma giant Eli Lilly and Company (LLY) to market the Byetta domestically and internationally.

Company Overview

Amylin makes its money from the sale of biopharmaceutical products. Currently it has two products on the market: Byetta, a joint diabetes venture with Eli Lilly and Company (LLY), and Symlin, also a diabetes medication. Currently Byetta sales are 10x those of Symlin. This is probably due in part to the fact that Eli Lilly has partnered with AMLN to market the drug both domestically and internationally. That said Amylin is applying for additional patents that would expand the therapeutic uses of Symlin and hopefully increase sales. It is important to note that the company has yet to achieve a profitable year. Because of the long lead time needed to develop drugs and the huge R&D costs, Amylin will need several years of profitable sales to recoup its costs.

Business Financials

In 2009, AMLN earned a total of $758 million in total revenues. This was a decline from its 2008 total revenues of $840 million. However, despite the decrease in revenues, AMLN was able to improve its net income. Between 2008 and 2009, AMLN decreased its net loss from $315 million in 2008 to a net loss of $186 million in 2009.[2]

Key Trends and Forces

Obesity and Diabetes

Amylin's two main products focus on diabetes treatment. A rise in obesity has led to increased cases of diabetes in the U.S.; roughly 30% of the U.S. population is currently eligible for anti-obesity treatment. Roughly 7% of the US population currently has diabetes, and this number is rapidly increasing. The aging US population will likely result in even more cases of diabetes, as the prevalence of diabetes increases among older individuals.[3] Byetta, one of Amylin's two drugs for diabetes, also aids weight loss, an effect most other diabetes medications do not have. Amylin should benefit from the rapidly expanding market for its products.

Research and Development

Amylin is currently developing products in its two therapeutic areas of diabetes and obesity. The first is Exenatide LAR, a medication derived from Byetta and currently in clinical trials. The second, a treatment for obesity, derives from the active ingredients in Symlin. These developmental drugs, however, are not "new" as much as derivatives of current medications. Amylin is looking at other hormonal treatments for obesity, but in general its pipeline is very limited. Unlike larger pharmaceutical companies that may be developing several hundred drugs at a time, Amylin is working on at most five.

Patent Expiration

While Amylin's drugs have only recently hit the market, patent life for pharmaceutical products is very short. After the patent on the drugs expires generic drugs (Biogenerics and Biosimilars) are often introduced. Generic drugs can drive down the price of Amylin's drugs significantly.

International Expansion

Amylin teamed up with Eli Lilly and Company (LLY) in producing Byetta, and the two have successfully sought approval for the medication in the EU. The US population is not the only aging population, and there is a market for diabetes medications in other countries as well. Therefore, this partnership has the potential to make a large impact on AMLN's future earnings.

Competition

AMLN is unique relative to its competitors in that it promotes moderate weight loss. Most other drugs either result in very limited weight loss or worse, weight gain. Amylin, also reduces insulin resistance, a major problem caused by type II diabetes. Amylin's primary disadvantage is that its products are injectable whereas many new drugs are taken orally. In general, oral drugs are more palatable for patients. Doctors are also more likely to prescribe an oral therapy like Merck's Januvia because of its greater ease of use. Amylin is also much smaller than its competitors.

  • Novartis AG (NVS): markets Starlix for treatment of type 2 diabetes.
  • AstraZeneca (AZN): currently developing saxagliptin for diabetes.
  • GlaxoSmithKline (GSK): produces Avandia, a huge diabetes medication that recently was linked to cardiovascular risks.
  • Eli Lilly and Company (LLY): sells Actos, an oral diabetes medication in addition to its collaboration with Amylin on Byetta.
  • Merck (MRK): manufactures Januvia, which was launched in 2006 and is a direct competitor to Byetta. Byetta, however, has shown more benefits in weight-loss than Januvia, and it increase insulin levels more effectively than Januvia.

Notes

  1. Juvenile Research Foundation International
  2. AMLN 10-K 2009 Item 6 Pg. 43
  3. http://apps.nccd.cdc.gov/ddtstrs/template/ndfs_2005.pdf
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