Sunday, March 18, 2012


 Image: Amylin® Logo Amylin Pharmaceuticals Pulling Ahead Of Roche In Anti-Obesity Drugs?
March 18, 2012  |  about: AMLN, includes: RHHBY.PK  

Obesity is among the most common health problems in the US. More than one third of all Americans (35.7 percent) are considered obese and about 17 percent or 12.5 million young people under the age of 19 are as well. It is not just a problem of carrying around too much weight or taking up bigger space on an airplane, it can lead to many serious health problems, such as diabetes type II, colorectal cancer, breast cancer, and heart disease.
For a long time, researchers have searched for a solution to the problem of obesity. Some research has focused on surgical options, while others have focused on medications that reduce the amount of fat ingested by the body.
More recent research has focused on the hormonal mechanisms behind appetite. It is now known that a hormone is believed to play a crucial role in the development of hunger. This protein, called leptin, is produced by the white adipose tissue (fatty tissue) of the body. The more adipose tissue you have, the more leptin is produced.
Leptin acts on hormonal receptors in the hypothalamus where it counteracts neuropeptide Y, and the effect of anandamide, both of which are potent feeding stimulants. In addition, it promotes the creation of a hormone called alpha-MSH, which suppresses the appetite, causing you to eat less and to therefore lose weight.
Doctors have tried giving leptin to individuals in order to see if it would promote weight loss and reduce body fat; however, it appears that people with obesity are relatively resistant to leptin and it takes a great deal to overcome the resistance.
Another hormone that plays a role in obesity is amylin, which produced along with insulin in the islet cells of the pancreas. Amylin is important in the correction of blood sugar anomalies seen in diabetes.

Image: Amylin® LogoAmylin Pharmaceutical's Answer
Amylin Pharmaceuticals (AMLN) is active in research related to diabetes and obesity-two diseases that often go together. They already have Byetta and Bydureon on the market. Byetta has been available for several years in the management of type II diabetes and Bydureon is the first ever drug to improve glycemic control in diabetics, when given as a once-weekly injection. Both medications are designed for type II diabetes. Bydureon is a polypeptide that binds to glucagon receptors and acts as an adjunctive agent for those people with type II diabetes, who need glycemic control but don't want to be stuck with taking a pill or several pills a day for the disease.
The company also makes an analogue of the human hormone called amylin that works with insulin to reduce both blood sugar and weight in those who take the medication. The analogue, called Symlin, is effective in promoting glycemic control with those patients who have type I or type II diabetes. Symlin works much like amylin in improving the blood sugar concentrations of diabetics. In addition, those in an open-label clinical trial lost an average of 6 pounds in a six-month period of time.
Perhaps the most exciting thing to come out of this biotech is research on the development of Metreleptin, an analogue of the human neurohormone, leptin. As mentioned, it plays a big role in fat distribution and obesity. Should the analogue make it past clinical trials to be offered to the public, it will be used to treat diabetes, lipodystrophy, and, if the dose is high enough, to overcome the leptin resistance.
It is currently being studied for people with heavy build up of fat on the belly, upper back and breasts, although it may be successful in reducing fat throughout the body. Amylin also expects that it can be used in those with high triglyceride levels-a risk factor for heart disease. Metreleptin can also improve insulin resistance in diabetic patients, making for a better medication for those with metabolic syndrome-a syndrome of elevated triglycerides, type II diabetes, obesity and an elevated risk for heart disease. If approved, it would be the first therapeutic use for a leptin analogue.
Roche's Choice for Obesity Treatment
Roche (RHHBY.PK) can be compared with Amylin in that both are working on the management of obesity, although the route by which each company has approached the health problem greatly differs. While Amylin is working on the underlying mechanism of appetite and fat cells, Roche is producing a medication that binds fat in the diet.
Roche's answer is the medication Orlistat, which is also marketed as Alli or as Xenical. This medication is intended to be used along with a low fat and low calorie diet and exercise program. It is given as a capsule taken three times per day with meals that have fat in them. The medication works by binding fat in the GI tract so that the fat cannot be absorbed. It does nothing to change the amount of protein or carbohydrates in your diet and you can still consume too many calories when taking it.
Orlistat varies as to how well it works on those who are obese. If a person eats a great many calories that lacks fat, it will not help the individual lose weight. In addition, if the person fails to follow a low fat diet, fat will bind to Orlistat and will be excreted as greasy stool, which sometimes comes out unbidden. It can also cause increased gas, bloating and abdominal discomfort, especially if the medication is taken along with a high fat diet.
Comparing Roche and Amylin Pharmaceuticals
Amylin is not as far along in its research and development as Roche, which already has a product on the market for obesity. However, the focus of Amylin's research and development is on the core basis behind appetite and obesity, making in-roads in places that have not been heavily researched in the past.
Roche, on the other hand, simply has developed a fat-binding agent that has significant side effects and that doesn't work unless the patient follows a strict lifestyle change. This leads one to question whether it is the caloric restriction of the person's diet, which results in weight loss or whether it is the Orlistat.
About Amylin Pharmaceuticals
The company began its success with the creation of amylin for diabetes and expanded its research to include the unique diabetic drugs, Byetta and Bydureon. It has since further expanded to research and development of the neurochemicals basis of appetite. With its transformation around 2005 to becoming a fully integrated biopharmaceutical company, with a strong emphasis on research and development as well as manufacturing and commercialization of several quality drugs.
Can Metreleptin be the next answer for obesity and metabolic syndrome? Research is in its early phases, but the biochemistry of the product is extremely promising. Currently it looks as though it will be entering into a niche market, but as the technology and science advances it could be able to tap into the billion-dollar obesity market.
Amylin is currently trading in the mid $15 range with room to grow. They have finished a public offering recently, with gross proceeds expected to be in excess of $200 million to further commercialize Bydureon and continue with research and development. I believe the long-term potential of the company makes it one to watch.
By Amy Baldwin : seekingalpha.com
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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