The company states:
By "Challenging Science," Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialization of novel therapies for metabolic diseases.
Amylin's approach and dedication are rooted in the belief that they will be "Changing Lives" for millions of people - not only with the drugs currently in late-stage development, but also with their pipeline of future therapies.
Amylin explained their new product, which the FDA has approved for people with Type 1 and Type 2 Diabetes who use insulin injections to manage their disease, as follows:
SYMLIN is a synthetic version of human amylin, a naturally occurring hormone that is made by the same pancreatic cells that produce insulin.
In patients with Type 1 Diabetes, these cells malfunction and do not adequately produce either insulin or amylin.
Volatile blood sugar levels can increase the likelihood of long-term diabetes complications such as kidney failure, nerve damage, blindness, amputation and cardiovascular disease.
Clinical studies demonstrated that SYMLIN, a self-administered injection given prior to meals, helps patients achieve lower blood glucose (sugar) after meals, leading to less fluctuation during the day, and better long-term glucose control (A1C) compared to patients taking insulin alone.
In these studies, patients used less mealtime insulin and also had a reduction in body weight compared to patients taking insulin alone.
SYMLIN was studied in over 5,300 individuals in the clinical program that led to approval.
No testing has been done yet, however, on children.
SYMLIN has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with Type 1, or juvenile diabetes, the company said.
The drug's label strongly warns that Symlin's use raises the risk that blood sugar will drop too low, which can cause loss of consciousness.
According to iControlDiabetes.com:
Insulin Therapy needs to be individualized to custom-fit the lifestyle of each and every individual who uses insulin to control his or her diabetes.
In nondiabetic individuals, amylin is cosecreted along with insulin and plays a very important role in glucose regulation.
Amylin is completely absent in people with Type 1 Diabetes and ineffective in people with Type 2 Diabetes in a remarkably similar fashion to the abnormalities seen with insulin.
Symlin helps to keep the sugar levels from getting too high immediately after meals and too low several hours after eating.
Symlin works via several different mechanisms.
It regulates nutrient delivery to the stomach, which helps prevent postmeal hyperglycemia and may help store glucose in the liver that can be released when the blood sugar starts to get too low, thus avoiding severe hypoglycemia.
Symlin also suppresses the appetite center in the brain, and a very significant finding in the clinical trials is that the people who took Symlin consistently lost weight and improved their blood sugar at the same time. This finding is truly unique because normally, when blood sugar control is improved with pills and/or insulin, weight gain is inevitable because the fat and muscle cells of the body are now properly utilizing all of the sugar that was spilling out in the urine. The bottom line is that Symlin is a natural hormone in an identical fashion to insulin, and I am all for replacing what is supposed to be in our bodies in the first place.
Ginger L. Graham, President and CEO of Amylin Pharmaceuticals, Inc. said:
The approval of SYMLIN, a first-in-class therapy, is a major milestone for Amylin Pharmaceuticals.
It is the result of 18 years of research in diabetes.
This extensive development program has resulted in prescribing information for SYMLIN that we believe is an excellent tool to introduce SYMLIN to the diabetes community.
Robert E. Ratner, MD, an investigator for SYMLIN clinical studies and Vice President for Scientific Affairs at MedStar Research Institute and Professor of Medicine at the Georgetown University Medical School said:
SYMLIN provides a new option for many patients who, despite their best efforts with insulin therapy, continue to struggle to achieve their glucose control targets.
These patients often experience weight gain and continued high blood sugar after meals.
The science behind SYMLIN has improved our understanding of the physiology of diabetes and has provided a welcome new tool for insulin users.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines.
The company's first product, SYMLIN(R) (pramlintide acetate) injection is an antihyperglycemic drug for use in patients with diabetes treated with insulin.
A New Drug Application for SYMLIN was submitted to the FDA in June 2003. The FDA approved SYMLIN on March 16th 2005.
The company's second compound, exenatide, is under review at the FDA for improved glucose control for people with type 2 diabetes.
In May 2000, Amylin signed an agreement with Alkermes, Inc. for the development and manufacturing of an injectable sustained release formulation of exenatide. This development program utilizes Alkermes' patented, FDA approved and proprietary Medisorb® injectable sustained release drug delivery technology. Based upon results obtained from initial feasibility studies, the goal of the work under this agreement is to develop a sustained release formulation of exenatide for the treatment of type 2 diabetes.
In September 2002, Amylin announced a global agreement with Eli Lilly and Company to collaborate on the development and commercialization of exenatide (synthetic exendin-4).
Eli Lilly and Amylin are working together to codevelop and co-commercialize exenatide.
According to a Bear Stearns research analyst, exenatide is expected to be approved for the treatment of patients with Type 2 Diabetes ahead of the April 30 PDUFA [Prescription Drug User Fee Act] date.
Building on its experience in the diabetes field, the Company is also developing candidates for cardiovascular disease and obesity by utilizing its research experience with the metabolic properties common to all three conditions.
Amylin Pharmaceuticals was founded in 1987 on the discovery of a hormone, amylin, produced by the same beta cells of the pancreas that make insulin.
Since then, Amylin has built a strong foundation on research and development.
Amylin's scientists are primarily focused on investigating the potential utility of new peptide hormone candidates. The company has amassed significant research and clinical expertise in metabolic medicine including the areas of diabetes, obesity and cardiovascular disease.
Amylin has a distinguished Board of Directors including one of the company's co-founders, Howard E. "Ted" Greene, Jr.
Ted served as a director of the company since Amylin's inception in September 1987. From September 1987 to July 1996, he served as Amylin's Chief Executive Officer. Greene is an entrepreneur who has participated in the founding and/or management of eleven medical technology companies over two decades, including three companies for which he served as chief executive officer. Greene received an M.B.A. from Harvard University.
This week Greene said:
We never lost faith in Symlin.
But what scared us to death was the fear that we were going to lose the company.
While their "saving" investor Allen Andersson is not a formal member of the board of directors, their co-founder remains on the Board along with Joseph C. Cook, Jr. (Chairman of the Board), Ginger L. Graham (President and CEO), Vaughn D. Bryson (President of Life Science Advisors), Terrance H. Gregg (retired President, Medtronic MiniMed), Jay S. Skyler, MD (Professor of Medicine, Pediatrics and Psychology, University of Miami), Joseph P. Sullivan (Chairman of the Board of Advisors, RAND Health), Thomas R. Testman (retired Managing Partner, Ernst & Young LLP) and James N. Wilson (Chairman of the Board, Corcept Therapeutics).
Mr. Cook, who had been brought in as chief executive to save the company, recalled that he did not know what to think when a man he had never met called the company to say he was interested in Symlin because his daughter had diabetes.
Mr. Cook recalled:
I thanked him for his words of encouragement.
But then Allen said, 'No, I'm serious. I'm interested in putting some of my money where my mouth is.'
Mr. Cook flew to Bethesda, Maryland to have dinner with Mr. Andersson at an Italian restaurant near his home. The two discussed the drug by drawing scientific graphs on the paper tablecloth.
Mr. Cook left with Mr. Andersson's $6 million offer in hand.
With that he was able to round up an additional $9 million from other directors or supporters of the company, including Donald H. Rumsfeld, who as secretary of defense is no longer on the board.
Further information on Amylin and its pipeline in metabolism is available at:
For more information about SYMLIN go to:
Diabetes is a large and growing market in the United States, affecting over 18 million Americans and growing at three times the rate of population growth.
Approximately 4.5 million patients with diabetes use insulin.
Diabetes is the sixth leading cause of death in the United States.
Diabetes is a complex metabolic disease manifesting with a defect in the beta cells in the pancreas, resulting in a deficiency of both insulin and amylin secretion.
Poor control of blood sugar may result in severe long-term complications such as kidney failure, nerve damage, blindness, amputation and cardiovascular disease.
About Allen Andersson
As reported by Andrew Pollock today in The New York Times:
Mr. Andersson's daughter was found to have diabetes in 1988, when she was 4 years old. Andersson said he stumbled upon references to Symlin in the mid-1990's. He thought it might ameliorate the wild swings in her blood glucose levels. On seven occasions, he said, Rachel's blood sugar dropped too low while she was asleep, causing her to fall onto the floor, moaning.
When you hear that sound, you know your child has two hours to live if you don't do something quick," he said. Mr. Andersson said he tried to get Rachel into a clinical trial of Symlin, but the drug was not being tested in children.
While Wall Street had written off Symlin, Mr. Andersson thought the drug would help his daughter Rachel.
"I loved the medicine and the market hated it," he said.
"We had an actual shutdown plan already mapped out," Joseph C. Cook Jr., the chairman of Amylin, recalled in an interview. "If Allen hadn't brought the money forward, there would have been no other choice."
Andersson's action ended up being good not only for Amylin and diabetics, but also for him.
Mr. Andersson invested $6 million at a time when Amylin's stock was selling for about $1.
He later invested $28 million at prices of $5 and $12 a share, he said.
This week, when the stock closed at $21.06, Mr. Andersson's Amylin holdings, which account for the bulk of his wealth, were worth nearly $200 million.
Today, he is Amylin's largest shareholder, with nine million shares, a 9.7 percent stake, according to the company's most recent proxy statement, from last April.
Mr. Andersson, 60, who served in the Peace Corps in Honduras in the 1960's, has been plowing some of his new fortune into his Riecken Foundation, a charity he named for his wife's parents.
Riecken has built more than 20 libraries in remote villages in Honduras and Guatemala.
Mr. Andersson also has an investment company, Paperboy Ventures, that is backing start-up companies developing electric motors, information technology and medical products.
Any profits from those investments, he said, will eventually also go to promote education and democracy in Central America.
Meanwhile, Rachel Andersson is now a 20-year-old junior at Pomona College in California. She began taking Symlin two years ago as part of a clinical trial.
"It improves her life," Mr. Andersson said.
As for Amylin, "I feel such a deep bond with those people."
I can't help but wonder how many companies have great products in the pipeline that will never make it to market because their creators could not find an angel like Allen Andersson.
Mr. Andersson you are a hero.
As the mother of two children with Type 1 Diabetes and as the founder of BioSpace.com, I am thrilled to hear your story, Amylin's triumph and the diabetic world's future benefit -- thanks to SYMLIN.
Thank you to the FDA.
Congratulations to everyone at Amylin Pharmaceuticals, especially those who never gave up believing!
Long live Amylin and San Diego's greater biotechnology and pharmaceutical community, Biotech Beach.
Inspire & Be Inspired.
Here's to healthy, adventuresome, soulful "in range" living!
~ Jennifer Carolyn King, Rugged Elegant Living