AMLN - comments?

[jiesen]

good news for AMLN

http://biz.yahoo.com/ap/080610/amylin_exenatide_lar.html?.v=1

Amylin posts solid results for once-weekly Byetta
Tuesday June 10, 9:12 am ET
Amylin says once-weekly Byetta lowers sugar better than twice-daily version

SAN FRANCISCO (AP) -- Amylin Pharmaceuticals Inc. late Monday said that a once-weekly version of its diabetes drug Byetta lowered blood sugar in patients more than Byetta, which is taken twice daily, though shares were down early Tuesday.

Amylin shares shed 14 cents to $26.70 in premarket trading.The drug candidate, known as Exenatide LAR, lowered glucose levels by 1.9 percent over 30 weeks, compared with a 1.5 percent reduction for Byetta over the same period.
Amylin added that at 52 weeks, Exenatide LAR patients saw the reduction maintained at 2 percent. In addition, patients who switched to Exenatide LAR after 30 weeks of Byetta also had a blood sugar reduction of 2 percent over a year.
In addition, Exenatide LAR patients saw an average weight loss of 9.5 pounds over the year.
Eli Lilly and Co. and Alkermes Inc. are partners on Exenatide LAR.
Amylin shares have been hammered in recent days as Danish competitor Novo Nordisk A/S presented head-to-head data on its late-stage type 2 diabetes drug liraglutide, showing it lowered blood sugar better than Byetta. Liraglutide is given once daily.
Exenatide LAR also has competition among once-weekly treatments. Switzerland-based Roche AG said Tuesday that it presented midstage data at the American Diabetes Association annual meeting on its drug taspoglutide demonstrating a lowering of glucose levels and weight loss after eight weeks. As a result, Roche said it is moving the drug into late-stage trials in the second half of the year.
Novo Nordisk shares lost $1.91, or nearly 3 percent, to $65.12 in premarket trading.

[jiesen]

Interesting post from AMLN msg board:

http://www1.investorvillage.com/smbd.asp?mb=2885&mn=35986&pt=msg&mid=3386035

Msg: 35986 of 36084 11/5/2007 9:14:53 PM Author: briang60

Why I am not worried

We have seen this bs before. I think that most of us are just pissed that we KNEW we would get slammed again when the good LAR news was released but still just hung on. What encourages me though is the massive effort that goes into keeping the share price down. The crap that is pawned off as analysis is ridiculous. Lets review a few.

1. One injection a day(lirg.) is much better than twice a day, however, one injection a week vs. one a day means nothing.

2. Patients who take Byetta have reported pancreatitis, this is very bad. Hey! But the numbers show that the incidence of pancreatitis is actually LOWER for those on Byetta than the general population of diabetics, so this should be good, right? "No, were you not listening, patients on Byetta have reported pancreatitis!"
"But at a lower rate ,right?"
""All we are at liberty to disclose is that patients on Byetta have reported pancreatitis."

3.The time line for Exenatide Lar is highly in doubt and many delays are probable, but Lirg. will have zero delays. After all, Lirg. has no history as an approved drug and Lar is just a better version of an old already approved drug. We view this as a positive for Lirg.

4. Due to the assured delays of Lar and the prompt approval of Lirg. Lar will be behind Lirg. by 6-9 months and this is a HUGE advantage, however, the 3+ year head start of Byetta bid over Lirg. is of no consequence.

5. Exenatide Lar ONLY reduced A1C by 1.9% as compared to Byetta BID of 1.5%. We really needed the difference to be much larger. After all, 25% of patients on Lar FAILED to reach the 7% goal of the ADA.
"But 75% reached the goal, no treatment has ever had that % reach 7% or below."
"We prefer to state that 25% FAILED to reach the 7% goal."

I am sure there are more examples and I am also sure that some of my examples may not be completely accurate, but you get the general idea. Someone really wants to keep the price down and our shares. Mine still are not for sale. I have the long term view. I still think the science and the best therapy will win out.

Brian

[jiesen]

Reposting from the POTW thread

This post really belongs here:
Quote:
Originally Posted by New-born baby
Jiesen,
Whatever happened to AMLN? Looking short to $36 on this once high flier.

AMLN is getting taken down hard on good news. Just like it did when Byetta and Symlin were approved. Stock tanked from $25 to 15 (or something like that) and it provided me a great entry at $20.

http://biz.yahoo.com/prnews/071031/law097.html?.v=101

Now it's the same thing, imo. Byetta LAR (Long-acting release version) clinical data just came in, says it's better than Byetta, and so someone is dropping the price... perhaps trying to exit a big short, or buy a big piece of the company on the cheap.

AMLN is a bargain at $41, but that doesn't mean it won't go to $30 before taking off again.

Sales will pick up with Byetta LAR, but it will take a couple of years. Approval is still not guaranteed, but it should happen in 2009. With once per week injections, instead of twice daily, there will be little excuse left for doctors not to prescribe it. Plus, it works better at controlling glucose levels! Many people using Byetta now are reducing, or even eliminating their need for insulin injections. I don't think the competing drugs (Januvia) are able to do the same.

The reason Januvia is outselling Byetta now is mostly the inconvenience of the injections vs the convenience of Januvia's pill form, but also because of the weight of MRK's marketing machine. When people wise up and realize which drug actually performs better, the sales will finally reflect it.

I still think AMLN is a great stock to own, and still own my $20 shares. However, LJPC offers a much greater opportunity for weekly triple-digit gains, which is what I'm hoping to get here (one of these days). When positive Riquent results are announced (and they should be someday soon) the stock has the potential to jump from $4 to $40 in a month, week, or even a day. I would hate to be out of LJPC on that day...

[jiesen]

Symlin was approved by FDA in a new package this week.

It wasn't in the news, but it's posted on the FDA site... AMLN received an approval for a package change for Symlin.

from:

http://www.fda.gov/cder/whatsnew.htm

September 27, 2007

• New and Generic Drug Approvals
  • Abilify (aripiprazole) Intramuscular Injection, Otsuka, Labeling Revision
  • Abilify (aripiprazole) DISCMELT, Otsuka, Labeling Revision
  • Abilify (aripiprazole) Oral Solution, Otsuka, Labeling Revision
  • Abilify (aripiprazole) Tablets, Otsuka, Labeling Revision
  • Albuterol Sulfate Inhalation Solution, Watson Labs, Approval
  • Gabapentin Capsules, Hikma Pharma, Approval
  • KALETRA (lopinavir/ritonavir) Tablets, Abbott Labs, Labeling Revision
  • KALETRA (lopinavir/ritonavir) Oral Solution, Abbott Labs, Labeling Revision
  • Methimazole Tablets, Caraco Pharma, Approval
  • Symlin (pramlintide acetate) Injection, Amylin Pharma, Package Change
  • Zebeta (bisoprolol fumarate) Tablets, Duramed Pharma, Labeling Revision
  • Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets, Duramed Pharma, Labeling Revision
• PDUFA Information: Notice to Applicants Submitting NDAs/BLAs to CDER/CBER for Fiscal Year 2008

[jiesen]

Byetta works better than Lantus

which means that more people will be buying the stuff!

from:
http://biz.yahoo.com/ap/070921/amyli...over.html?.v=1

AP
Amylin Shares Rise on Study Claim
Friday September 21, 12:12 pm ET
Amylin Pharmaceuticals Shares Rise on Study Claim Comparing Byetta With Competitor

NEW YORK (AP) -- Shares of Amylin Pharmaceuticals Inc. jumped Friday after the company and its partner Eli Lilly & Co. cited a study claiming its diabetes drug Byetta is more effective than Sanofi-Aventis' Lantus.

San Diego-based Amylin and Indianapolis-based Eli Lilly said a one-year study showed that Byetta was more effective in treating type 2 diabetes and patients lost weight. The companies said patients taking Lantus gained weight. The results were presented at the 43rd Annual Meeting of the European Association for the Study of Diabetes in Amsterdam. It involved 69 people.Shares of Amylin rose $1.64, or 3.4 percent, to $49.68 in midday trading. The stock has traded between $35.55 and $53.25 over the last 52 weeks. Shares of Eli Lilly rose 77 cents to $57.85 and shares of Paris-based Sanofi-Aventis fell 40 cents to $42.70.

"We think these results bode well for the upcoming Byetta monotherapy results--expected in the fourth quarter--in early-stage patients as this study clearly demonstrates Byetta's efficacy in earlier-stage patients," wrote FBR Research analyst Jim Reddoch, in a note to investors.
He said positive study results from the monotherapy results could add an additional 8 million eligible patients to Byetta's current total of about 5 million. He reaffirmed a "Outperform" rating on the stock and $62 price target.

[jiesen]

Byetta scrips up this week to 58k

AMLN continues to make steady progress in Byetta sales, setting a new weekly record of 58269 scrips for Byetta. Check out the sales data:

http://members.cox.net/mystock/Amylin.htm

As the scrip #'s go up, so must the stock... and remember, we still have all of Europe to service, then there's Byetta LAR, nasal delivery, and weight loss claims, and the list goes on!

[billyjoe]

Jiesen,
A friend of mine who had juvenile diabetes had shocking weight gains and losses. It was sad. His wife also had diabetes. They married young at about 19 knowing they didn't have much time. They made it a little past their 40's. I went to their wedding and their funerals.

--------------billyjoe

[jiesen]

Delta Burke on Diabetes

Jiesen,
Remember all the controversy over Delta Burke's weight gain when "Designing Women" was a major TV show? They threatened firing her. Did it turn out that diabetes was the cause ?

--------------billyjoe

That very well could be:

http://www.investorvillage.com/smbd.asp?mb=2885&mn=20354&pt=msg&mid=1688241

Caregiving: Delta Burke on diabetes

By ALEX CUKAN
UPI Health Correspondent ALBANY, N.Y., March 16 (UPI) -- Actress and diabetic Delta Burke, perhaps best known for her role as straight-talking Suzanne Sugarbaker on the TV show "Designing Women" (1986-1993), says now she wants to so some straight-talking on diabetes management.

"By addressing diabetes head on, I'm in better control of my blood sugar, and I'm able to pursue my love of acting," said Burke, who recently appeared in ABC's "Boston Legal."

"Let's talk about proper eating, let's talk about ways to increase activity and let's talk about how medication can play an important role," she said.
The stage, screen and film actress -- and the wife of actor Gerald McRaney -- leads the Let's Talk campaign, which sheds light on the importance of managing diabetes. The campaign begins Saturday in Boston at the New England Spring Flower Show and continues to 10 U.S. cities throughout the summer. At most events, attendees will hear firsthand from Burke about her experience with type 2 diabetes.

About 10 years ago Burke was diagnosed with type 2 diabetes at the same time she was a caregiver to her mother, who was being treated for breast cancer.

"I was feeling funny the last couple of years (before the diagnosis) and I was going to doctors. They thought I might have something like Epstein-Barr (virus)," Burke told UPI's Caregiving.
Finally, one doctor did some testing and diagnosed type 2 diabetes. Burke didn't need insulin, but she did need medication and was told to exercise and watch her diet.

Did Burke's caregiving and the stress of her mother's illness have anything to do with her diabetes?

Virginia Valentine, a certified diabetes educator who will be available to talk one-on-one with attendees at the Let's Talk campaign, says Burke's diabetes may have been hastened by her caregiver stress.

"For many people who have a genetic predisposition to diabetes, stress (makes) it harder to manage a healthier lifestyle and may be a trigger. But it might have happened later as well," Valentine told Caregiving.

Millions of Americans with type 2 diabetes do not get diagnosed, especially without regular doctor visits, "so it creeps up a little bit at the time," Valentine said.

Burke, whose only relative with diabetes was her father's mother, said she had always watched what she ate. In fact, sometimes she didn't eat at all.
In 1974, after high school, Burke won the Miss Florida title. When she became an actress, she says she was hypoglycemic, sometimes passing out, and at the time she didn't realize her excessively low blood sugar might have something to do with her spiking blood sugar later in life.

"I wish I had had more information back then," Burke said. "There was always so much pressure to be thin, I was size 6 and when I got to Hollywood I was told to lose weight. Sometimes I would not eat for seven days, but by the time I was in my 30s I couldn't do that kind of thing anymore."

In fact, Burke's devotion to dieting may have only added to her problem. There have been several studies that show that dieting is linked to greater weight gain over time among adolescents.

Burke's weight gain did not go unnoticed, but she received her first Emmy nomination for best actress in her role as Sugarbaker for the episode "They Shoot Fat Women, Don't They?" in which Burke's character attended her 15-year high school reunion and got her feelings hurt after hearing disparaging remarks about her weight.


"At that time I took my medicine and paid attention to what I was eating -- I had given up things like sugar and white flour long ago -- but my blood sugar was still spiking," Burke said. "My doctors said I needed to get a better hold on my blood sugar or I would end up on insulin. Then I got really strict with my diet and lost 20 pounds -- I only ate meat, vegetables and fruit."

However, Burke said she later still had blood sugar "jumping all over the place."

In Los Angeles, a doctor mentioned a new kind of drug to Burke: incretin mimetics, which worked quickly to keep her blood sugar in a normal range.
Incretin mimetics are a new class of drugs that exhibit many of the same effects as the human incretin hormone glucagon, which improves blood sugar after food intake and works in concert on the stomach, liver, pancreas and brain. [Glucagon is a pancreatic hormone secreted by alpha-cells. ...war]
"This is a special, totally unique drug based on a natural hormone, which 20 years ago was unknown," Valentine said.

-- Alex Cukan is an award-winning journalist, but she has also been a caregiver since she was a teenager. UPI welcomes comments and questions about this column. E-mail: [email protected]

http://www.upi.com/ConsumerHealthDaily/caregiving_delta_burke_on_diabetes/20070316-122748-5977r/

[billyjoe]

Jiesen,
Remember all the controversy over Delta Burke's weight gain when "Designing Women" was a major TV show? They threatened firing her. Did it turn out that diabetes was the cause ?

--------------billyjoe

[jiesen]

This just in: (Europe) Patent application for Amylin's #2 drug, Symlin

USE OF AMYLIN AND AMYLIN AGONISTS AS CARDIOPROTECTIVE OR MYOPROTECTIVE AGENTS

http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=WO2007014051&F=0

[0001] USE OF AMYLIN AND AMYLIN AGONISTS AS CARDIOPROTECTIVE OR

[0002] MYOPROTECTIVE AGENTS

[0003] FIELD OF THE INVENTION

[0004] [0001] The present invention relates to the medical field and in particular to the area of heart disease, diseases that affect the heart and cardiovascular system, and the skeletal system.

[0005] BACKGROUND OF THE INVENTION

[0006] [0002] It has been stated that cardiovascular disease is by far the leading cause of morbidity and mortality in the developed world. By the year 2020, it is predicted that acute coronary occlusion will be the major cause of death in the world. Therefore, despite much time, money and effort that has been expended to understand, treat and prevent various cardiac and cardiovascular diseases, there continues to be a need for greater understanding of the diseases and effective options for treating them.

[0007] [0003] Cardiac and cardiovascular diseases include left ventricular hypertrophy, coronary artery disease, essential hypertension, acute hypertensive emergency, cardiomyopathy, heart insufficiency, exercise tolerance, chronic heart failure, arrhythmia, cardiac dysrhythmia, syncopy, atheroschlerosis, mild chronic heart failure, angina pectoris, cardiac bypass reocclusion, intermittent claudication (atheroschlerosis oblitterens), diastolic dysfunction and systolic dysfuntion. [0004] Abnormal Na+/K+-ATPase enzyme, or sodium pump, activity has been postulated to be involved in the pathophysiology of several diseases, including cardiac and cardiovascular diseases, among others. These complex effects may be related to the role of the pump in controlling the cellular ingress of other molecules.

[0008] [0005] The Na+/K+-ATPase enzyme is a membrane protein responsible for establishing an electrochemical gradient of Na+ and K+ ions across the plasma membrane of mammalian cells. The ion gradient formed by this enzyme is necessary for the active transport of essential nutrients into the cells, for regulation of osmotic balance and cell volume, and for maintaining the resting membrane potential in excitable cells. The Na+/K+-ATPase enzyme is the only known receptor for cardiac glycosides such as digitalis. The tight conservation of the digitalis binding site over many phyla, among other observations, suggests the existence of endogenous sodium pump inhibitors (SPIs) in mammals as well. These hypothetical mammalian inhibitors would be involved in modulating the activity of the sodium pump, and might be involved in vivo sodium homeostasis.

[0009] [0006] There are at least 3 isoforms of each the [alpha]- and [beta]-subunits of Na+/K+-ATPase. These are distributed in a tissue-specific manner, and show different functional characteristics (e.g., different affinities to Na+ or cardiac glycosides). Acute effects of numerous hormones on Na+/K+-ATPase appear to be receptor mediated, and hence dependent upon the existence of the relevant receptors in tissues of interest. Receptor distribution is highly tissue specific, so various tissues may not respond similarly to a particular hormone. [0007] It is generally understood that transmembrane sodium and potassium gradients across cells represent stored electrochemical potential, the release of which powers impulse propagation in excitable tissues such as nerves and muscles, including heart muscle. This potential is established in an energy-consuming Na+/K+ exchange whereby Na+ is pumped out of cells and K+ is pumped into cells via a transporter, Na+/K+-ATPase. [0008] Compounds such as calcitonin gene related peptide and intermedin have been purported to have an effect on the heart. Gennari et al. 1990, concludes that CGRP improves myocardial contractility in patients with congestive heart. WO 2004/048547 describes intermedin (AFP-6) and lists its potential use as a hypotensive agent, as a cardioprotective agent, in the regulation of gastrointestinal motility, and in stimulating the release of prolactin, e.g. as an aid in fertilization, lactation, pre-term labor, and the like.

[0010] [0009] Amylin

[0011] [0010] Human amylin is a 37 amino acid peptide hormone that is co-secreted with insulin from pancreatic [beta]-cells in response to nutrient stimuli. Human amylin has the following amino acid sequence:

[0012] Lys-Cys-Asn-Thr-Ala-Thr-Cys-Ala-Thr-GlnArg-Leu-Ala-Asn-Phe-Leu-Val-His-Ser-Ser-Asn-Asn- Phe-Gly-Ala-ne-Leu-Ser-Ser-Thr-Asn-Val-Gly-Ser-Asn-Thr-Tyr (SEQ ID NO:1). [0011] Amylin is believed to regulate gastric emptying, and suppress glucagon secretion and food intake, thus regulating the rate of glucose appearance in the circulation. It appears to complement the actions of insulin, which regulates the rate of glucose disappearance from the circulation and its uptake by peripheral tissues. These actions are supported by experimental findings in rodents and humans, which indicate that amylin complements the effects of insulin in postprandial glucose control by at least three independent mechanisms, all of which affect the rate of glucose appearance. [0012] First, amylin suppresses postprandial glucagon secretion. Compared to healthy adults, patients with type 1 diabetes have no circulating amylin and patients with type 2 diabetes have diminished postprandial amylin concentrations. Furthermore, infusion of an amylin specific monoclonal antibody, which bound circulating amylin, again resulted in greatly elevated glucagon concentrations relative to controls. Both of these results point to a physiological role of endogenous amylin in the regulation of postprandial glucagon secretion. Second, amylin slows gastrointestinal motility and gastric emptying. Finally, intrahypothalamic injections of rat amylin were shown to reduce feeding in rats and alter neurotransmitter metabolism in the hypothalamus. In certain studies, food intake was significantly reduced for up to eight hours following the intrahypothalamic injection of rat amylin and rat CGRP. [0013] In human trials, an amylin analog, pramlintide, has been shown to reduce weight or weight gain. Amylin may be beneficial in treating metabolic conditions such as diabetes and obesity. Amylin may also be used to treat pain, bone disorders, gastritis, to modulate lipids, in particular triglycerides, or to affect body composition such as the preferential loss of fat and sparing of lean tissue. [0014] It has now surprisingly been found that amylin and its agonists may have a cardioprotective, myoprotective effect, or both.

[0013] SUMMARY OF THE INVENTION

...

[jiesen]

Delta Burke to Americans: Let's Talk about Managing Diabetes

http://biz.yahoo.com/prnews/070314/nyw010.html?.v=83

Delta Burke to Americans: Let's Talk about Managing Diabetes
Wednesday March 14, 7:00 am ET

- BYETTA(R) Let's Talk campaign features meet-and-greet with experts to help people manage type 2 diabetes through a more active, healthy lifestyle

-
SAN DIEGO and INDIANAPOLIS, March 14 /PRNewswire/ -- Stage, screen and film actress Delta Burke is leading the BYETTA Let's Talk campaign, sponsored by Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN - News) and Eli Lilly and Company (NYSE: LLY - News). The BYETTA Let's Talk campaign is designed to educate people with type 2 diabetes about the importance of leading a healthy, active lifestyle, including taking the right medications. To learn more about the campaign, type 2 diabetes and BYETTA, log on to www.ByettaLetsTalk.com.

Did you know that there are more than 20 million Americans who have diabetes -- the majority of whom are diagnosed with type 2 diabetes? That's enough people to fill all 31 professional football stadiums nearly 10 times! People who have type 2 diabetes either do not produce enough insulin and/or the cells in the body do not respond normally to insulin. Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people. "I was diagnosed with type 2 diabetes at the age of 41," said Ms. Burke, who has recently appeared on the ABC television show "Boston Legal." "I want to get people talking about better management of this disease. By addressing diabetes head on, I'm in better control of my blood sugar, and I'm able to pursue my love of acting. So let's talk about proper eating, let's talk about ways to increase activity, and let's talk about how medication can play an important role. For me, adding BYETTA has made a real difference, and I am excited to have the opportunity to share my story with others who live with type 2 diabetes."
The BYETTA Let's Talk campaign will launch in Boston on March 17 at the New England Spring Flower Show. Over the summer, the campaign will visit 10 cities throughout the United States. At most events, attendees will hear firsthand from Delta Burke about her experience with type 2 diabetes and how BYETTA helps her manage the disease. Other exciting components to the campaign include:

-- Chris Smith, The Diabetic Chef, will be sharing recipes of and
preparing healthy, delicious dishes.
-- Nikki Kimbrough, fitness trainer from Bally Total Fitness,
demonstrating easy ways to incorporate physical activity into your
daily life.
-- Virginia Valentine, a certified diabetes educator, will be available to
talk one-on-one with attendees about the disease and BYETTA®
(exenatide) injection as a treatment option.
-- Booth giveaways including FlashCarbs flashcards that help people with
type 2 diabetes count carbohydrates.

"As a certified diabetes educator and someone with type 2 diabetes, I know what it takes to manage diabetes successfully. Every day, I talk with people with diabetes about leading a healthy, active lifestyle and taking the right medications," said certified diabetes educator Virginia Valentine, who will accompany Ms. Burke during the BYETTA Let's Talk campaign. "This campaign is designed to reach people with type 2 diabetes who may not know the best way to control their condition!"
For more information about the campaign, type 2 diabetes and BYETTA® (exenatide) injection, and for a list of campaign events and dates, go to www.ByettaLetsTalk.com.

About the BYETTA Let's Talk campaign
The BYETTA Let's Talk campaign, sponsored by Amylin Pharmaceuticals, Inc. and Eli Lilly and Company, is designed to educate people with type 2 diabetes and their caregivers about the importance of leading an active and healthy lifestyle, including taking the right medications, such as adding treatment with BYETTA, to help successfully manage type 2 diabetes. The campaign, featuring stage, screen and film actress Delta Burke, will travel to ten cities across the United States. Attendees will have an opportunity to talk with fitness experts, chefs, healthcare professionals and others with diabetes, including Ms. Burke, about diabetes management. For more information about the BYETTA Let's Talk campaign, to download recipes, watch exercise demonstrations, and read Delta's Diary, go to www.ByettaLetsTalk.com.

About BYETTA® (exenatide) injection
BYETTA is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics. BYETTA exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels. BYETTA is an add-on therapy for people currently using metformin, a sulfonylurea, or a thiazolidinedione. For full prescribing information, visit www.BYETTA.com.

About Diabetes
Diabetes affects more than 20 million in the United States and an estimated 194 million adults worldwide.(1,2) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.(3)
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(4)
Important Safety Information for BYETTA® (exenatide) injection
BYETTA improves glucose (blood sugar) control in patients with type 2 diabetes who are taking metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems with the stomach or food digestion, or those who have severe kidney disease. Before using BYETTA, patients should tell their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding. BYETTA has not been studied in children.
When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is most common when first starting BYETTA, but decreases over time in most patients. BYETTA may reduce appetite, the amount of food eaten, and body weight. No changes in dose are needed for these side effects. These are not all the side effects with BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

For complete safety profile and other important prescribing considerations, visit www.BYETTA.com.

About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes. Amylin's research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is located in San Diego, California with over 1,500 employees nationwide. For more information about Amylin and the company's diabetes products, visit www.amylin.com.
Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help health care professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For more information about Lilly's current diabetes products visit www.lillydiabetes.com.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
P-LLY

[jiesen]

AMLN news (not yet announced)

We've been expecting an approval for room-temp Byetta pens for a while (which should lead to higher sales), and the time has apparently arrived. Read the first testimony to it here:

From the IV board:

http://www1.investorvillage.com/smbd.asp?mb=2885&mn=18269&pt=msg&mid=1456862

Msg: 18269 of 18400 2/15/2007 4:16:12 PM Recs: 35 Sentiment: Buy By: nobonesaboutit

Visit with Endo today - room temp approved

Had my regular visit with my Endo's CDE today. They have over 500 patients on Byetta. The did prescribe Januvia in the beginning but their experience has not been that great. Januvia is NOT as good as Byetta in the treatment of Diabetes. The benefits of Byetta far outweigh those of Januvia so they have gone back to Byetta as their first drug of choice for their patients.

The CDE did say that about 5% of their patients did see some benefit from Januvia. Many of those, however, did not have a weight problem.

The CDE thinks most Endos will adopt their view on Byetta as well.

One piece of news was that apparently the FDA has approved a label change to room temperature for Byetta. The label says that you don't have to refrigerate the pen that you are currently using but any inventory must continue to be refrigerated. The FDA said room temperature is no higher than 77 degrees.

I would expect an announcement shortly.

[peanuts]

Jiesen - AMLN

$$$HUGE$$$ day, J, HUGE

You sees? He's a genius!!!

[peanuts]

Peanuts, are you still holding onto your AMLN? If not, it's now back above where you bought it...

you got that right, dude!!! I've been a very good boy with this stock.

Thanks again for bringing it to all of our attention

[jiesen]

This sucker is taking a nose dive this morning

Peanuts, are you still holding onto your AMLN? If not, it's now back above where you bought it...