Jacki and Jet Li had a plan to star a movie together earlier in 2002. Not sure about it now. I watched only Jacki movie.
More on venom news.
signonsandiego.com
Lizard venom the basis of possible blockbuster
By Terri Somers
UNION-TRIBUNE STAFF WRITER
April 30, 2005
San Diego's Amylin Pharmaceuticals won government approval yesterday to market a potential blockbuster diabetes drug derived from the spit of the poisonous Gila monster lizard.
The Food and Drug Administration gave the go-ahead for doctors to begin prescribing the drug exenatide to people with type 2 diabetes who have not had success taking oral medications to control the disease.
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The drug, which aims to postpone or prevent the need for insulin injections, will be sold under the brand name Byetta and is expected to be on the market June 1. Using insulin is a complicated daily regimen and can vary depending on diet and activity level.
The FDA went even further than Amylin and its development partner Eli Lilly had hoped and also said it would consider approving Byetta for use as a stand-alone therapy if the companies send regulators data to support it.
"When the FDA offers to give you more than you asked for, that is definitely a good thing," said John McCamant, editor of the Medical Technology Stock Letter.
But the good news was not reflected in Amylin's share price, which dropped to a two-year low yesterday. The stock traded as low as $16.01 before bouncing back to $17.70 a share in after-hours trading.
McCamant said the decline was a result of a misinterpretation of the FDA's news by "unsophisticated manipulators," as opposed to serious investors.
Byetta, which type 2 diabetics would take twice daily with an injection pen, has the potential to serve a $2 billion market that continues to expand as Americans' waistlines bulge, McCamant said.
People with type 2, or adult onset diabetes, either don't properly process or don't produce enough insulin, a hormone that helps cells process blood sugar. The progressive disease affects about 90 percent of the 18.2 million diabetics in the United States, according to the American Diabetes Association. About 80 percent of type 2 diabetics are obese.
McCamant said investors might have been confused when the FDA asked for more data on patients who take only Byetta. That request came in what the industry calls an approvable letter, which can be seen as bad news when it requires the company to submit more data before it can get any approval.
In this case, however, the extra data could enable Amylin to market the drug to a larger market than its application covered.
Previously, Amylin received an approvable letter for its first drug, Symlin. And it took the company another four years before it was able to satisfy the FDA and win approval for Symlin on March 16.
Symlin helps diabetics already using insulin to gain better control of their blood sugar, particularly after a meal. The market for that drug is an estimated $300 million.
The Symlin development and regulatory approval process taught Amylin some lessons that the company used to shorten the development of Byetta, chief executive Ginger Graham said.
"The wish of every early stage pharmaceutical company is to have more than one product," Graham said. But the pathway is so long and expensive that many never achieve that goal, she said.
The Symlin development process and approval allowed Amylin to set up the infrastructure it needs, such as a sales force and a call center to record problems and answer questions once the drug is distributed to a wide market, she said.
It will also help the company with something it needs to support other drugs it has in development: revenue, she said.
"This is a validation of the company's science and its commitment to the pursuit of a unique approach to diabetes treatment," Graham said.
Byetta is the first product approved in a new class of drugs known to mimic GLP-1, a hormone that stimulates insulin secretion so the body can process blood sugar after a meal.
The drug is a synthetic version of a hormone in the venom of the endangered Gila monster lizard, which lives in the Southwest and Mexican desert. In 1996, Amylin licensed the right to the Gila monster hormone discovery from Dr. John Eng, an endocrinologist working at the Bronx Veterans Affairs Medical Center in New York.
Byetta is better than synthetic forms of the human body's GLP-1 hormone because it stays in the bloodstream for hours before breaking down, said Dr. David Kendall of the American Diabetes Center in Minneapolis.
"This is like a smart bomb for diabetes," said Kendall, who was chief investigator on Amylin's pivotal human trial.
The hormone seems to know when blood sugar is low and there is no need to stimulate insulin production, he said. This helps diabetics avoid a dangerous and sometimes fatal condition of hypoglycemia, or low blood sugar, he said.
In response to low blood sugar, the body produces glucagon to regulate itself. Byetta's active ingredient shuts off the body's glucagon production when the blood sugar is at normal levels, Kendall said.
It also slows down the rate at which food travels through the gut, increasing satiety, he said. Many people who have been taking the drug for 82 weeks experienced an average and maintained weight loss of about 10 pounds, a very positive side effect when dealing with a disease so closely linked to obesity, Kendall said.
All the clinical trials showed Byetta helped patients keep steady, long-term control of their blood sugar levels, which is a very important indicator the doctors watch when treating diabetics, Kendall said.
"I think the approval will affirm Amylin's position as a leader in diabetes research and its understanding of the basic fundamental physiology that is related to diabetes and obesity," Amylin Chairman Joseph Cook said.
Since the drug is the first in its class, it will take time to educate physicians, said Yaron Werber, an analyst with Smith Barney Citigroup.
It will probably compete directly with Lantus, a once-a-week insulin injection that has been on the market for five years, Werber said.
Byetta has the potential to become a blockbuster when its second generation, once-a-week injection, is introduced, he said. Now in phase 2 clinical trials, the long-acting version is expected to hit the market in late 2008 or early 2009, he said.
McCamant, of the Medical Technology Stock Letter, was more enthusiastic about the adoption of the drug's use.
"If I was a health care provider and I had to pay for the care of the growing number of type 2 diabetics for the rest of their life, I'd want to force them to take this medication," he said. "This drug is going to save significant dollars in health care costs."
In 2002, Eli Lilly & Co. agreed pay up to $325 million to help Amylin finish the drug's development. Amylin will now receive a $30 million milestone payment from Lilly for the approval.
The two companies will promote Byetta in the United States and split the profits evenly. Lilly will pursue regulatory clearance outside the United States and market the drug if approved, keeping 80 percent of those profits.
In preparation for the launch of Byetta, Graham said, Amylin has been hiring a nationwide sales force that will include more than 300 people. |
