AMLN - comments?

[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]

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!

[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]

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]

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]

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]

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.