AMLN

Amylin Pharmaceuticals Inc.

NASDAQ

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AMLN

Amylin Pharmaceuticals Inc.

NASDAQ

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surf1944

04/26/12 8:28 AM

Post #161

Re: #157: @surf1944 - 8:13AM Amylin Pharma: Carl Icahn confirms that he

7:13AM Amylin Pharma beats by $0.04, misses on revs (AMLN) 26.20 : Reports Q1 (Mar) loss of $0.23 per share, $0.04 better than the Capital IQ Consensus Estimate of ($0.27); revenues rose 0.7% year/year to $153.7 mln vs the $161.66 mln consensus. The increase in non-GAAP operating loss reflects investments to support the U.S. launch of BYDUREON (exenatide extended-release for injectable suspension)... While still early, we have seen a positive uptake of BYDUREON in the U.S. and Europe, and are pleased with the execution of our U.S. commercial launch... We have also made important progress against our other corporate priorities during the quarter. The recently expanded use of BYETTA with insulin glargine in the U.S. and Europe enables patients to achieve better glycemic control, without weight gain or an increased risk of hypoglycemia. In addition, we recently completed the Biologics License Application submission to the FDA for the use of metreleptin to treat diabetes and/or hypertriglyceridemia in pediatric and adult patients with rare forms of lipodystrophy and are excited to advance this drug for patients who currently have such limited treatment options."

Penny Roger$

04/26/12 5:59 AM

Post #160

Re: #159: @Penny Roger$ - ~ Thursday! $AMLN ~ Q1 Earnings posted, pending

Penny Roger$

04/26/12 5:59 AM

Post #159

~ Thursday! $AMLN ~ Q1 Earnings posted, pending or coming soon! In Charts and Links Below!

~ $AMLN ~ Earnings expected on Thursday *
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One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.

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~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=AMLN+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=AMLN
Finviz: http://finviz.com/quote.ashx?t=AMLN
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*If the earnings date is in error please ignore error. I do my best.

north40000

04/25/12 2:33 PM

Post #158

Re: #157: @surf1944 - 8:13AM Amylin Pharma: Carl Icahn confirms that he

Icahn Issues Statement Regarding Amylin Pharmaceuticals

NEW YORK, April 25, 2012 /PRNewswire via COMTEX/ -- Carl C. Icahn today
announced that his affiliates had voluntarily dismissed their lawsuit against
Amylin Pharmaceuticals which had sought an extension of the deadline to nominate
directors at the 2012 annual meeting of shareholders. Mr. Icahn released the
following statement:

The decision to discontinue our lawsuit seeking to extend the director
nomination deadline was the result of discussions I had with Daniel Bradbury,
Amylin's chief executive officer, that we agreed would not be publicly
disclosed.

Mr. Icahn reiterated that he continues to strongly believe that the company
should be sold at this time.

surf1944

04/04/12 9:25 AM

Post #157

Re: #153: @surf1944 - Amilyn Soars on News of Spurned Bristol-Myers Bid

8:13AM Amylin Pharma: Carl Icahn confirms that he has issued an Open Letter to the Board of Directors of AMLN says 'believes any decision not to pursue a sale of the company at this time is a huge mistake' (AMLN) 24.11 : Icahn stated "As one of Amylin's largest shareholders, I find it reprehensible that the Board of Directors has still not acknowledged or denied the media reports regarding its rejection of a $22 per share takeover offer from Bristol-Myers Squibb (BMY). To this day, shareholders would not have known about this opportunity had the story not been leaked to the press. Still more egregious is the fact that, in the face of this reported $22 offer, the Board approved both (i) the public offering of 10% of the company at an assumed price of $15.62 per share on March 8th, without disclosing the Bristol-Myers offer in the registration statement that Amylin filed with the SEC..These actions make absolutely no sense to me in light of a Bristol-Myers bid and have served to substantially dilute shareholders who owned the stock when these actions were taken. I believe any decision not to pursue a sale of the company at this time is a huge mistake... I believe these nominees have been a positive force for change, but apparently their influence has not been enough to keep this Board from mishandling a Bristol-Myers proposal. In light of the failings mentioned above, it seems to me that the current Board is still dysfunctional and is not operating in a manner that enhances shareholder value... number of analysts in the investment community agree that the company faces daunting prospects in fully realizing the value of its products as an independent firm....Further, we delivered to Amylin on Tuesday a demand under Section 220 of the Delaware General Corporation Law for copies of Amylin's books and records, so that we may examine the circumstances surrounding the reported Bristol-Myers Squibb proposal and the stock offering and option grants following the date of the reported bid. These are matters that, in my opinion, shareholders are entitled to fully understand...In my view, a proxy contest at this time would be a costly distraction -- but I would not shy away from that possibility if I felt that the Board was not pursuing seriously the opportunity to sell the company.

mlkrborn

03/28/12 1:39 PM

Post #154

History repeating? First down from 20 to 10 than sale @$22. Sme argue it is a rip off deal.

1. Amylin shares rocket up on report of $3.5B buyout offer by Bristol-Myers
By John Carroll

Shares of Amylin Pharmaceuticals ($AMLN) rocketed up 45% this morning, fueled by a report by Bloomberg that the Bydureon developer had turned a cold shoulder to a $22 per share buyout offer from Bristol-Myers Squibb ($BMY), putting the value on this new potential pearl at $3.5 billion.

Amylin has had an eventful schedule over the past year. First it sued its longtime partner Eli Lilly ($LLY) after Lilly forged a marketing pact with rival Boehringer, then it executed an expensive divorce from the pharma giant. Soon after, the FDA delivered on a long-awaited approval for Bydureon, the once-weekly successor to the Byetta franchise. Now Meg Tirrell and Jeffrey McCracken, quoting sources close to the deal, report that Amylin rejected Bristol-Myers offer to pay a 43% premium to buy the company--a deal that would register as the largest in a string of 19 BMS acquisitions over the past five years.

As Bloomberg notes, Amylin has been seeing its revenue from Byetta shrink as Novo's ($NVO) Victoza muscled into its market share. And it's been looking for a global partner who can step into Eli Lilly's shoes outside the U.S. But none of that persuaded Amylin to warm up to Bristol-Myers' offer. BMS hasn't been back in touch since it was rejected by Amylin.

Amylin struck a $1.6 billion deal to end its relationship with Lilly. That included a $250 million upfront and a $1.2 billion share of the Bydureon revenue. The FDA's approval came soon after the two companies split up.

News of the $3.5 billion bid quickly seized the attention of Wall Street analysts, who began to debate just what Amylin is worth. Its value has a lot to do with its prospects for Bydureon, of course, and as Adam Feuerstein at TheStreet notes, if the board is turning down a $22 offer, they must have a strong belief that they can go on to register blockbuster sales. But if Bristol can't prevail, adds Feuerstein, the likes of Takeda, GlaxosmithKline and AstraZeneca just might step in.

- here's the story from Bloomberg
- here's the report from TheStreet

surf1944

03/28/12 11:54 AM

Post #153

Re: #152: @surf1944 - Amylin Pharma AMLN Canaccord Genuity Sell $12

Amilyn Soars on News of Spurned Bristol-Myers Bid

March 28, 2012, 10:01 A.M. ET

By Avi Salzman

Amilyn (AMLN) jumped 41% in early trading after a Bloomberg report said the drugmaker had rejected a $3.5 billion offer from Bristol-Myers Squibb (BMY) earlier this year. BMY proposed the deal in a letter to Amilyn, which makes diabetes drug Bydureon, but the board rejected it last month. It would have been worth $22 a share, which is 43% higher than Tuesday’s closing price, two sources told Bloomberg. Spokespeople for the companies declined to comment.

Bristol-Myers has relied on an acquisition strategy as some of its top drugs have lost patent protection.

Amylin Pharma AMLN Canaccord Genuity Sell $12(this anal-list looks like a monkey)

surf1944

03/26/12 8:52 AM

Post #152

Re: #151: @surf1944 - 9:03AM Amylin Pharma announces pricing of public offering

Amylin Pharma AMLN Canaccord Genuity Sell $12

surf1944

03/08/12 10:32 AM

Post #151

Re: #150: @surf1944 - 7:55AM Amylin Pharma and Eli Lilly receive CHMP

9:03AM Amylin Pharma announces pricing of public offering of 13 mln shares of common stock; gross proceeds expected to be ~$203.1 mln (AMLN) 16.17 :

surf1944

02/17/12 8:32 AM

Post #150

Re: #136: @surf1944 - Amylin Pharmaceuticals, Inc. (AMLN)

7:55AM Amylin Pharma and Eli Lilly receive CHMP recommendation of approval for Byetta for use with basal insulin (AMLN) 18.07 : Amylin Pharmaceuticals and Eli Lilly (LLY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion in the European Union for the expanded use of BYETTA (exenatide twice-daily) as an add-on therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents. The CHMP's decision is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. The Commission usually decides on CHMP recommendations within two to three months.

WID

02/10/12 3:44 PM

Post #149

Musings on Amylin-inVentiv Deal

I revisited the Amylin-inVentiv Deal and thought that it might imply something:

Why AMLN does not create a sale force for Bydureon if the company want to make big $$$ on this blockbuster drug?

Why AMLN said in the agreement that it can notify inVentiv 60 days in advance to terminate the deal if necessary?

The deal at the time when the drug received FDA approval tell me that AMLN wants to sell the company to a big pharma that may have a well established diabetes sale force; thus AMLN does not have to layoff new hires for Bydureon commercial.

I think that AMLN will be taken over in the next 12 to 24 months.

What do you think?

All the best!
WID

Pyckstocks

02/07/12 9:44 AM

Post #148

~ AMLN~ Jefferies believes Amylin's 2012 guidance suggests upside to its Exenatide sales estimates. The firm upped its price target for shares post the company's Q4 results and keeps a Buy rating on the stock. Up $1.13

equity8

02/03/12 1:09 PM

Post #147

"Alkermes earned $0.3 million in royalty revenues from type II diabetes treatment Bydureon" - Positive sign for Amylon EU revenues so far. http://www.zacks.com/stock/news/69054/Revenues+Skyrocket+at+Merged+Alkermes

Docsfixinit

01/30/12 10:32 AM

Post #146

Recent insider buys

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Docsfixinit

01/30/12 10:15 AM

Post #145

Testing RESISTANCE !!!!!!!!!!!!

shankapotamus

01/29/12 3:07 PM

Post #144

Re: #143: @Docsfixinit - $27.00 !!!!!!!!!!!

$AMLN chart opinion: http://blog.chartmystock.com/2012/01/29/amln-amylin-fda-approval-sends-price-up-in-ah-trading.aspx

Docsfixinit

01/28/12 3:08 PM

Post #143

Re: #76: @surf1944 - Amylin Pharms AMLN Citigroup upgraded from Hold to

$27.00 !!!!!!!!!!!

Docsfixinit

01/27/12 5:59 PM

Post #142

I have 4 family members with type 2 diabetes ,,,,you have no idea of hoe much this means to us !!!!!!!!!!!!!!

Docsfixinit

01/27/12 5:57 PM

Post #141

FDA Approves BYDUREON(TM) -- The First and Only Once-Weekly Treatment for Type 2 Diabetes

Last update: 1/27/2012 3:39:00 PM

Provides Glycemic Control in a Once-Weekly Dose

SAN DIEGO and DUBLIN, Jan. 27, 2012 /PRNewswire via COMTEX/ -- Amylin Pharmaceuticals, Inc. (AMLN) and Alkermes plc (ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved BYDUREON(TM) (exenatide extended-release for injectable suspension) - the first once-weekly treatment for type 2 diabetes. BYDUREON is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. BYDUREON will be available in pharmacies nationwide in February.

To view the multimedia assets associated with this release, please visit:

"With BYDUREON, U.S. physicians and patients can now choose a therapy that offers continuous blood sugar control in just one dose per week," said John Buse, M.D., Ph.D., professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control."

The approval of BYDUREON (pronounced by-DUR-ee-on) was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with BYDUREON resulted in improvements in glycemic control with just one dose per week. The approval was also based on clinical experience with BYETTAÂ® (exenatide) injection, a twice-daily form of exenatide that has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide. BYDUREON uses Alkermes' proprietary technology for long-acting medications to provide a controlled release of exenatide.

"As the first and only once-weekly diabetes treatment, BYDUREON represents an important milestone in Amylin's promise to bring to market innovative therapies to help improve the lives of people with type 2 diabetes," said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. "BYDUREON builds upon the proven benefits of BYETTA, offering significant improvements in glycemic control in a single weekly dose."

In the DURATION-5 head-to-head clinical study, after 24 weeks of treatment, patients taking once-weekly BYDUREON experienced a statistically superior reduction in A1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for patients taking BYETTA. A1C is a measure of average blood sugar over three months. Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking BYDUREON and 3.0 pounds for patients taking BYETTA (weight loss was a secondary endpoint).The most frequently reported adverse event in both groups was nausea, reported less frequently by BYDUREON users (14 percent) than by BYETTA users (35 percent). Other common treatment-emergent adverse events in the BYDUREON group included diarrhea, upper respiratory tract infection and injection site nodules. There were no major hypoglycemic events.

BYDUREON has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of BYDUREON outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma. As part of the REMS, Amylin has established a communication plan for healthcare professionals to help minimize these risks. In addition, Amylin will fulfill a number of post-marketing requirements to further assess the impact of BYDUREON on medullary thyroid cancer and cardiovascular disease. More information will be available at .

BYDUREON is provided in a straightforward single-dose tray so that patients can self-administer the once-weekly subcutaneous injection. In the DURATION clinical studies, the delivery system was well accepted by patients and physicians.

Docsfixinit

01/27/12 5:27 PM

Post #140

ALMN
Shares Outstanding 137,241,585 a/o Jul 25, 2008
Float Not Available
Authorized Shares Not Available
Par Value 0.001

Docsfixinit

01/27/12 5:26 PM

Post #139

http://finance.yahoo.com/news/FDA-Approves-BYDUREON-The-prnews-2702238983.html?x=0

Docsfixinit

01/27/12 4:52 PM

Post #138

BIG NEWS BYDUREON™ once a week diabetes drug
get it while it's still cheap

oregon 1

01/27/12 2:45 PM

Post #137

Re: #136: @surf1944 - Amylin Pharmaceuticals, Inc. (AMLN)

APPROVED

surf1944

01/27/12 1:05 PM

Post #136

Re: #135: @surf1944 - Avg Vol (3 month)3: 1,961,420

Amylin Pharmaceuticals, Inc. (AMLN)
Amylin is a biopharmaceutical company. The company currently focuses upon the discovery, development, and commercialization of drug candidates for the treatment of diabetes, and obesity.

FDA Pending News
On January 28, Amylin will attempt to begin the process in selling BYDUREON within the United States. The company has a pending FDA Prescription Drug User Fee Act (PDUFA) decision for the drug as a proposed treatment for type 2 diabetes. This is a resubission of a New Drug Application (NDA) for BYDUREON.

I believe the New Drug Application for BYDUREON will be approved based upon the January 9, 2012 Amylin Pharmaceuticals Inc at J.P. Morgan Global Healthcare Conference presentation.

Action
I am only trying to earn some option premium with a tight leash on maximum loss. I am long AMLN Feb 2012 10.000 calls (AMLN120218C00010000) and short the AMLN Feb 2012 9.000 call s (AMLN120218C00009000) for a 60 cent credit per contract. My maximum loss is 40 cents per contract.

http://seekingalpha.com/article/321945-fda-pending-catalysts-for-5-biotechs?source=yahoo

surf1944

11/30/11 3:12 PM

Post #135

Re: #133: @surf1944 - 7:10AM Amylin Pharma, Eli Lilly (LLY), and Alkermes

Avg Vol (3 month)3: 1,961,420
Avg Vol (10 day)3: 1,609,350
Shares Outstanding5: 146.28M
Float: 131.26M
% Held by Insiders1: 0.36%
% Held by Institutions1: 93.00%
Shares Short (as of Nov 15, 2011)3: 9.12M
Short Ratio (as of Nov 15, 2011)3: 3.10
Short % of Float (as of Nov 15, 2011)3: 9.00%
Shares Short (prior month)3: 6.14M

mlkrborn

11/08/11 1:39 PM

Post #134

AMLN $9.60 with "Blockbuster breakup: Amylin buys out Lilly's exenatide rights in $1.6B deal
By John Carroll FierceBiotech
The decade-long union of Amylin ($AMLN) and Eli Lilly ($LLY) on the diabetes front ended in a blockbuster breakup today, with Amylin agreeing to pay Lilly $250 million upfront and up to $1.2 billion from the sales of exenatide products in exchange for full rights to the drug and its successors.

The divorce was presented today as an amicable ending to a long and fruitful partnership, but Amylin has been acting anything but amicably over the course of the year. The biotech filed suit against Eli Lilly earlier this year after the pharma giant joined forces with Boehringer Ingelheim, a rival in the diabetes field, on Trajenta. Today's agreement also ends the litigation.

Under the terms of the deal, Amylin will hand over a $1.2 billion secured note to Lilly, paying it off with the sales revenue from exenatide products. But if the FDA still hasn't approved the once-weekly injectable Bydureon--the successor to Byetta--by mid-2014, then the revenue sharing deal will terminate and Lilly's share of the sales revenue will shrink from 15% to 8%. FDA approval of a once-monthly version of the drug, now in mid-stage development, would trigger a $150 million milestone payment. Transitioning worldwide commercialization and development of new exenatide products starts in the U.S. at the end of this month then rolls around the globe by the end of 2013.

"Lilly remains confident that the resubmission package for Bydureon has addressed the requirements outlined by the FDA and looks forward to Amylin achieving the alliance's long-held goal of making Bydureon available to patients in the U.S.," said Enrique Conterno, president of Lilly Diabetes. "Looking forward, Lilly Diabetes remains committed to providing a comprehensive portfolio of diabetes treatment options for patients through our currently marketed products and robust clinical pipeline."

Alkermes, which has a royalty stake in the success of Bydureon, will evidently stay with Amylin now that the two big partners have severed their union."
source: FierceBiotech

surf1944

09/12/11 8:13 AM

Post #133

Re: #132: @surf1944 - 1. AMYLIN PHARMACEUTICALS INC (AMLN): AMLN recently traded

7:10AM Amylin Pharma, Eli Lilly (LLY), and Alkermes (ALKS) announced positive analyses from the DURATION-3 and -4 trials (AMLN) 10.63 : Cos announced that patients treated with the investigational medication BYDUREON experienced significant improvements in select cardiovascular risk factors, in comparison to patients who received commonly prescribed diabetes treatments. The analyses showed that patients receiving BYDUREON for the treatment of type 2 diabetes experienced improvements in composite endpoints related to body weight, abnormal blood pressure and abnormal lipid levels.

surf1944

09/05/11 10:47 PM

Post #132

Re: #131: @surf1944 - 7:39AM Amylin Pharma misses by $0.04, reports revs

1. AMYLIN PHARMACEUTICALS INC (AMLN): AMLN recently traded at $10.11 and lost 49.2% during the past 12 months. The stock has a market cap of $1.5 billion. Icahn had $164 million invested in AMLN shares. Steven Cohen’s Sac Capital Advisors and Christopher Medlock James’ Partner Fund Management also have relatively small positions in AMLN.

http://seekingalpha.com/article/287348-carl-icahn-s-long-term-holdings?source=yahoo

surf1944

07/26/11 8:13 AM

Post #131

Re: #130: @surf1944 - Amylin, Alkermes say diabetes drug safe for heart

7:39AM Amylin Pharma misses by $0.04, reports revs in-line (AMLN) 13.30 : Reports Q2 (Jun) loss of $0.21 per share, excluding items, $0.04 worse than the Capital IQ Consensus Estimate of ($0.17); revenues rose 2.1% year/year to $158.1 mln vs the $157.1 mln consensus.

surf1944

07/08/11 11:11 AM

Post #130

Re: #129: @surf1944 - http://www.secform4.com/insider-trading/881464.htm

Amylin, Alkermes say diabetes drug safe for heart
Amylin and partners say weekly diabetes injection does not affect heart activity

On Thursday July 7, 2011, 6:55 pm EDT

WASHINGTON (AP) -- Shares of Amylin and Alkermes Inc. climbed Thursday after the companies said their once-per-week diabetes medication appears safe for the heart, addressing concerns that delayed its federal review last year.

The drug, Bydureon, is designed to be a next-generation version of the twice-daily injection Byetta, which is currently marketed by Amylin and Eli Lilly & Co. Inc. Alkermes, based in Waltham, Mass., created the technology that gradually releases the drug over the course of a week.

The Food and Drug Administration declined approval for Bydureon in October, saying more information on its effect on the heart was needed.

The companies said a 75-patient study of Bydureon showed it did not interfere with the electrical activity of the heart even at high doses, a key safety measure in drug trials.

"We are confident in these results and will continue to work toward making Bydureon available to patients in the U.S. as soon as possible," said Christian Weyer, senior vice president at Amylin Pharmaceuticals.

Bydureon is part of a new wave of diabetes treatments designed to treat the rising epidemic of the disease in the U.S. However, the FDA has raised safety standards for such treatments after GlaxoSmithKline's blockbuster diabetes pill Avandia was linked to heart attack risks.

New drugs that have already reached the market include Merck & Co.'s Januvia and Bristol-Myers Squibb Co. and AstraZeneca's Onglyza. Those drugs are technically in a different class from Bydureon but work with the same goal of controlling blood sugar levels.

Regulators for the European Union approved Bydureon last month.

Lilly is based in Indianapolis, and Amylin is headquartered in San Diego.

Shares of Amylin Pharmaceuticals Inc. rose $1.44, or 10.5 percent, to $15.15 in afterhours trading. Alkermes tacked on $1.17, or 6 percent, to $20.40. Lilly was unchanged.

surf1944

07/04/11 11:12 AM

Post #129

Re: #128: @surf1944 - Once-Monthly Exenatide Improved Glucose Control in Patients with

http://www.secform4.com/insider-trading/881464.htm

surf1944

07/04/11 11:11 AM

Post #128

Re: #127: @surf1944 - The Diabetes Trade: Why We Like Amylin

Once-Monthly Exenatide Improved Glucose Control in Patients with Type 2 Diabetes: Phase 2 Study Results Presented at ADA 2011
Majority of Patients Reached the ADA Treatment Target for Glycemic Control

Follow these stocks
Press Release Source: Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc. On Friday June 24, 2011, 5:00 pm EDT

SAN DIEGO, June 24, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN - News), Eli Lilly and Company (NYSE:LLY - News) and Alkermes, Inc. (Nasdaq:ALKS - News) today announced additional results from a phase 2 study of an investigational, once-monthly injectable suspension formulation of exenatide which showed substantial improvements in glycemic control, including reductions in A1C and fasting plasma glucose, with modest weight loss. These findings will be presented in a late breaking poster session at the 71st Scientific Sessions of the American Diabetes Association on Sunday, June 26 from 12-2 p.m. PDT.

The 121-patient study assessed the efficacy, safety and tolerability of three different doses (5 mg, 8 mg and 11 mg) of exenatide once monthly, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist. After 20 weeks of treatment (total of five injections), patients receiving exenatide once monthly experienced average improvements in A1C (a measure of average blood sugar over three months) from baseline of 1.3 percentage points for the 5 mg and 8 mg doses and 1.5 percentage points for the 11 mg dose. In addition, 50 percent of those treated with the 5 mg dose, 57 percent treated with the 8 mg dose and 70 percent treated with the 11 mg dose achieved an A1C of less than 7 percent, the ADA-recommended target for good glucose control. Patients also lost a modest amount of weight (0.9 pounds with the 8 mg dose and 2.4 pounds with the 5 mg and 11 mg doses), although exenatide once monthly is not being studied as a weight-loss product. Fasting plasma glucose was improved with all doses, with reductions of 25 mg/dL with the 5 mg dose, 30 mg/dL with the 8 mg dose and 49 mg/dL with the 11 mg dose. The mean pharmacokinetic profile showed all three exenatide once monthly doses resulted in steady-state exenatide plasma levels within the known therapeutic range.

As a reference arm, the study also included patients receiving BYDUREON™ (exenatide extended-release for injectable suspension), another investigational form of exenatide that is dosed once-weekly. Results for A1C, fasting glucose and weight in the exenatide once monthly treatment arms were generally comparable to those seen in the BYDUREON reference arm. Patients receiving BYDUREON experienced reductions in A1C (1.5 percentage points), fasting plasma glucose (34 mg/dL) and weight (3.1 pounds) compared to baseline.

"Our exenatide suspension program builds upon our extensive experience and knowledge gained throughout the development of BYETTA and BYDUREON, and suggests promise in harnessing the therapeutic potential of continuous GLP-1 agonism in a monthly dose," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "We are committed to expanding the treatment options available to patients living with type 2 diabetes through the continued investigation of additional formulations of exenatide."

More than 90 percent of patients completed the study. The most common adverse events within the exenatide once monthly treatment groups were headache (17-27 percent) and nausea (17-23 percent). Headache (30 percent) and diarrhea (27 percent) were most common among the BYDUREON group. No major or minor hypoglycemia was reported in the study. The duration of adverse events was generally similar between treatment groups.

Exenatide once monthly is an investigational, extended-release formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which is given twice daily. Exenatide once monthly is based on the same microsphere technology used in BYDUREON. BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension, an investigational medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON received marketing authorization in the European Union earlier this month.

Study Design

This phase 2, randomized, open-label, dose-ranging study included 121 adults with type 2 diabetes (baseline A1C: 8.6 percent for BYDUREON and 8.4-8.5 percent for exenatide once monthly) who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, Actos® (pioglitazone) or both. Subjects were randomized to receive either 2 mg weekly subcutaneous injections of BYDUREON or subcutaneous injections of exenatide once monthly at a low (5 mg), medium (8 mg) or high (11 mg) dose administered once every four weeks for 20 weeks.

About Diabetes

Diabetes affects nearly 26 million people in the U.S. and an estimated 285 million adults worldwide.(i)(ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs more than $174 billion per year in direct and indirect medical expenses.(iii)

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.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi)(vii)

surf1944

07/04/11 11:10 AM

Post #127

Re: #126: @surf1944 - http://www.nasdaq.com/asp/holdings.asp?symbol=AMLN&selected=AMLN&FormType=Instit

The Diabetes Trade: Why We Like Amylin

In my recent manifesto about diabetes, I briefly touched upon Amylin Pharmaceuticals (AMLN). As most readers are aware, Amylin focuses the majority of its R&D on drugs for type 2 diabetes and obesity.

We believe that Amylin's pipeline could fit in with well with that of several large pharmaceuticals. Many drug companies have been cutting back on R&D and intend to make further cuts in the upcoming years. It all boils down to a risk-reward dynamic. Big pharma may determine that it is more cost effective to look elsewhere for future products rather than to try to keep developing them on their own. Amylin’s current drugs are Symlin, used to treat both type 1 and type 2 diabetes, and Byetta, which treats just type 2 diabetes.

Byetta is Amylin's flagship drug, and comprises more than 80% of its revenues. The only problem is that Byetta is expected to come off patent in 2013. Amylin is currently developing other versions of Byetta. These phase II and phase III trials are determining if the efficacy of the drug can be used in alternative delivery and dosing methods, respectively. The revamped Byetta line in the later trial stages should most likely win approval based on the fact that they are reformulated versions of existing drugs.

There are several large pharmas that may have an interest in Amylin. We believe that Eli Lilly (LLY), a current partner, is the most likely winner. Of the other companies interested, including Merck (MRK) and Pfizer (PFE), Pfizer is perhaps the more likely candidate, having recently been losing market share to two of the largest diabetes drug manufacturers, Sanofi-Aventis (SNY) and Novo Nordisk (NVO). Amylin's pipeline could give Pfizer much need market share in the diabetes sector of the industry. Pfizer has only one type 2 diabetes drug in phase II trials; the other nine are all in phase I.

Amylin’s market cap is around $2 billion and the stock trades for around $13 dollars a share. Revenues have declined 12% year over year, as other diabetes drugs have eaten into Amylin’s market share. Any type deal that involves a small biotech-pharma is always risky, and trials may have to progress further before another company is comfortable enough to pull the trigger. Carl Icahn's 10% stake in Amylin is another question mark that merits consideration. As an activist shareholder, his letter to the board was not unexpected to say the least. If Mr. Icahn has his way, he will either get the new management that he is seeking or will convince the powers that be to sell some or all of the company, thus unlocking Amylin's value.

There is little clarity on how this will ultimately shake out. Either way, Amylin will undergo a changing environment. We feel that between its precision execution on cost-cutting and the likelihood of approval on its new delivery methods for Byetta, Amylin could see $20 - $22 representing full value for the stock - a far cry from its all time high of $53.25 in August of 2007, but still a nice return from here.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

http://seekingalpha.com/article/277351-the-diabetes-trade-why-we-like-amylin?source=yahoo

surf1944

07/04/11 11:09 AM

Post #126

Re: #123: @surf1944 - 8:02AM Amylin Pharma and Takeda voluntarily suspend clinical

http://www.nasdaq.com/asp/holdings.asp?symbol=AMLN&selected=AMLN&FormType=Institutional

trade2much

04/15/11 6:28 PM

Post #125

Re: #124: @BobStockguy - Picked up this from a news blast this morning

Bob... this could be a good play for a while the "expert committee" in the EU recommended approval for this type2 diabetes drug. The regulatory committee has a habit of going with the committee's recommendations and my mid to end Jun we should get an approval imo. If so this should be a big deal for AMLN. Type 2 diabetes patients now have to do injections daily into their stomach etc, this is supposed to make that now weekly if approved. I can't think too many wouldn't opt for this as a result.

BobStockguy

04/15/11 9:45 AM

Post #124

Picked up this from a news blast this morning
Stock Pop Alert !News (AMLN) on the run. Bullish
(SHAR) alert trading at 15 day high

AMLN NEWS LINK : http://www.alphatrade.com/news/stories/AM/2011-04-15/BIZ/201104150725BIZWIRE_USPR_____BW5427.html

surf1944

03/16/11 10:46 AM

Post #123

Re: #122: @surf1944 - 8:01AM Amylin Pharma, Eli Lilly (LLY) and Alkermes

8:02AM Amylin Pharma and Takeda voluntarily suspend clinical activities in obesity trial (AMLN) 11.03 : Co and Takeda Pharmaceutical announced that they have suspended clinical activities in an ongoing Phase 2 study examining the safety and effectiveness of the investigational combination therapy pramlintide/metreleptin for the treatment of obesity. The clinical study was voluntarily halted to investigate a new antibody-related laboratory finding with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity.

surf1944

03/10/11 1:04 PM

Post #122

Re: #112: @surf1944 - Amylin Pharms AMLN Caris & Company Buy $27

8:01AM Amylin Pharma, Eli Lilly (LLY) and Alkermes (ALKS) announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes (AMLN) 11.34 : AMLN, LLY, and ALKS announce positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes. After 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3-1.5 percentage points from baseline. In the once-weekly BYDUREON treatment arm, the reduction was 1.5 percentage points. A1C is a measure of average blood sugar over three months. More than 90% of patients overall completed the study. The most common adverse events among the exenatide once monthly treatment groups were headache and nausea. Headache and diarrhea were most common among the once-weekly BYDUREON group. No major or minor hypoglycemia was reported in the study.

Blutribe

10/24/10 12:20 PM

Post #121

Bloomberg article...possible buyout??....Lilly's Diabetes Setbacks May Spur Shopping Spree Beyond Amylin
By Catherine Larkin - Oct 22, 2010 4:18 PM ET

Eli Lilly CEO John Lechleiter

John Lechleiter, chairman, president, and chief executive officer of Eli Lilly & Co. Photographer: Jeff Kowalsky/Bloomberg

Eli Lilly & Co., under pressure to gain new products after setbacks this week with two diabetes drugs, may try to acquire its partner Amylin Pharmaceuticals Inc. or covet companies with more approved products.

With Amylin, Lilly would gain full control of the diabetes drug Byetta and a longer-acting version called Bydureon delayed Oct. 19 by U.S. regulators, said Seamus Fernandez, a Leerink Swann & Co. analyst. Lilly might try to acquire Cephalon Inc. or Endo Pharmaceuticals Inc. to expand its painkiller business, said Bill Tanner, an analyst at Lazard Capital Markets.

By 2013, Lilly loses patents on medicines responsible for almost half its revenue. The Bydureon rejection, which stalled a new revenue source for at least two years, was compounded Oct. 20 when the company halted tests on a second experimental diabetes medicine because it wasn’t effective. Lilly Chief Executive Officer John Lechleiter yesterday ruled out “large- scale combinations” while expressing interest in smaller deals.

“An outright acquisition of Amylin certainly could make sense” if Lilly thinks Bydureon will be approved, Fernandez said in a telephone interview from Boston. Amylin, based in San Diego, lost half its market value on Oct. 20 after the Food and Drug Administration requested a study of Bydureon’s effect on heart rhythm.

Amylin fell 18 cents, or 1.6 percent, to $11.30 at 4 p.m. in Nasdaq Stock Market composite trading, after a 46 percent plunge on Oct. 20. Indianapolis-based Lilly fell 10 cents to $35.40 in New York Stock Exchange composite trading.

40 Percent Premium

The average premium paid in the last 12 months for acquisitions of U.S. medical and biotechnology companies was 40 percent, according to data compiled by Bloomberg. That suggests Amylin may have cost $2.3 billion yesterday, excluding debt, compared with $3.4 billion before shares plunged this week. Lilly had $5.16 billion in cash to make deals as of June.

Other diabetes-drug developers led by Pfizer Inc. and Sanofi-Aventis SA, may also pursue Amylin at its bargain price, Fernandez said. Ray Kerins, a spokesman for New York-based Pfizer, the world’s largest drugmaker, didn’t return calls for comment. Jean-Marc Podvin, a spokesman for Paris-based Sanofi, said he doesn’t comment on market rumors.

“We are very satisfied with our current relationship with Amylin and their management team,” Mark Taylor, a Lilly spokesman, said yesterday in an e-mail.

Shareholder Value

“Executing our current business strategy, including working with the FDA to bring Bydureon to patients as quickly as possible, is the best way to increase value for our shareholders,” said Alice Izzo, an Amylin spokeswoman, in an e- mail.

While there is risk Amylin may be the target of an opportunistic acquirer, it’s not likely the company would solicit offers, said Howard E. Greene Jr., a co-founder who resigned from the board last year, in an Oct. 20 telephone interview.

“Whenever the stock gets whacked, you have to assume that some people are going to sharpen their pencils,” Greene said. “Two things happen: shareholders are mad, and companies with bundles of cash are standing on the sidelines, waiting for an opportunity.”

Lilly paid an undisclosed amount in July to buy closely held Alnara Pharmaceuticals Inc., the maker of a drug for pancreatic insufficiency. Lilly also said in March that it would pay an undisclosed amount to buy European rights to certain animal drugs from Pfizer and a manufacturing plant in Ireland.

‘Fundamental Strategy’

“Our fundamental strategy remains intact,” Lechleiter said during a conference call yesterday. “We’re not interested in large-scale combinations. I think there are many other opportunities that I think we could consider along the lines of several that we have done this year.”

Lechleiter’s plan to stick to small purchases or licensing deals won’t give investors much confidence, said Barbara Ryan, an analyst with Deutsche Bank in New York, in a telephone interview.

“A lot of those companies will just be adding to the pipeline and they’re not going to be something that the market will accrue much value to on Lilly,” Ryan said.

United Therapeutics Corp. may also be a good fit because Lilly has an 11 percent stake and the two companies are partnered on Adcirca, a lung treatment made from the ingredient in Lilly’s impotence pill Cialis, according to Fernandez. Forest Laboratories Inc. would be another option to complement Lilly’s research in antidepressants and arthritis medicines, he said.

‘Takeover Target’

“It is not our expectation that we’re an imminent takeover target for Eli Lilly,” said Andrew Fisher, a spokesman for Silver Spring, Maryland-based United Therapeutics, in a telephone interview. The 2008 Cialis marketing agreement prevents Lilly from attempting a takeover before 2014, he said.

Cephalon doesn’t comment on rumor or speculation, said Candace Steele, a spokeswoman for the Frazer, Pennsylvania-based company. Kevin Wiggins, of Chadds Ford, Pennsylvania-based Endo, also declined to comment as a matter of company policy. Frank Murdolo, a spokesman for New York-based Forest, didn’t return a telephone message for comment.

The patent expires next year for Lilly’s top-selling antipsychotic Zyprexa, which brought in $4.92 billion last year. Generic copies of the antidepressant Cymbalta and insulin product Humalog may be introduced in 2013. Had Bydureon been approved this week, it could have generated sales of $420 million next year, said Phil Nadeau, an analyst with Cowen & Co. in New York.

Tanner, of Lazard, estimates a fair price for Amylin would be as much as $15 a share, or about $2.16 billion based on 143.7 million shares outstanding as of June. He said Bydureon sales will be limited because there are at least six competing diabetes drugs in development -- including one from Lilly -- as well as one approved product, Novo Nordisk S/A’s Victoza.

“The chances that this drug makes it to market are probably pretty high, but you’re looking at almost two years from now,” Tanner said. “If it didn’t make it, then somebody would have massively overpaid for Amylin.”

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

mlkrborn

10/20/10 10:45 AM

Post #119

SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., Oct 19, 2010 /PRNewswire via COMTEX/ -- Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM) (exenatide extended-release for injectable suspension).

In the complete response letter the FDA requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. The tQT protocol will be agreed to by the FDA prior to study initiation. Additionally, the FDA has now requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON. This letter did not cite any manufacturing processes referenced in the FDA's March 15 complete response letter. REMS and product labeling discussions will continue following submission of the additional data.

The companies' goal is to submit their reply to the complete response letter by the end of 2011, pending discussions with the FDA. Based on the requirements for additional data, this will likely be considered a Class 2 resubmission requiring a six-month review.

"We are committed to working closely with the FDA to resolve the issues raised in the complete response letter so that BYDUREON can be approved, and we can make this important treatment available to patients with type 2 diabetes as quickly as possible," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "We remain confident in BYDUREON based on the extensive exenatide database, including more than seven years of clinical experience with BYETTA, the twice-daily form of exenatide that is available in more than 60 countries worldwide."

BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA(R) (exenatide) injection. BYETTA has been available in the U.S. since June 2005 and is used in more than 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.

The NDA for BYDUREON was submitted in May 2009 and is based on data that include the DURATION-1 head-to-head clinical study, safety data from DURATION-2 and more than seven years of clinical experience with BYETTA. The agency issued a complete response letter to the companies in March 2010 and in May 2010 classified the companies' first complete response as a Class 2 resubmission with a PDUFA action date of October 22, 2010.

Amylin to Host Investor Conference Call

Amylin will host a conference call to discuss the complete response letter for BYDUREON at 4 p.m. PT on Oct. 19. Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals, will lead the call.

The call will be webcast live through Amylin's corporate website and a recording will be made available following the close of the call. To access the webcast, please log on to approximately 15 minutes prior to the call to register, download and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling (800) 857-5738 begin_of_the_skype_highlighting (800) 857-5738 end_of_the_skype_highlighting (U.S./Canada) or (415) 228-4970 begin_of_the_skype_highlighting (415) 228-4970 end_of_the_skype_highlighting (international), conference access code 7487145. A replay of the call will also be available by phone beginning approximately two hours after the close of the call and can be accessed at (866) 375-1047 begin_of_the_skype_highlighting (866) 375-1047 end_of_the_skype_highlighting (U.S./Canada) or (203) 369-0288 begin_of_the_skype_highlighting (203) 369-0288 end_of_the_skype_highlighting (international).

mlkrborn

10/20/10 10:39 AM

Post #118

Amylin Pharmaceuticals Announces Third Quarter Product Revenues; Quarterly Update Conference Call Canceled
Date : 10/19/2010 @ 7:06PM
Source : PR Newswire
Stock : Amylin Pharmaceuticals (MM) (AMLN)
Quote : 10.17 -10.32 (-50.37%) @ 7:22AM

Amylin Pharmaceuticals Announces Third Quarter Product Revenues; Quarterly Update Conference Call Canceled
Amylin Pharmaceuticals (MM) (NASDAQ:AMLN)
Intraday Stock Chart

Today : Wednesday 20 October 2010
Click Here for more Amylin Pharmaceuticals (MM) Charts.

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that unaudited net product sales for the quarter ended September 30, 2010 were $154.0 million. Unaudited net product sales for the quarter include $132.4 million for BYETTA® (exanatide) injection and $21.6 million for SYMLIN® (pramlintide acetate) injection. This compares to net product sales of $192.9 million consisting of $171.1 million for BYETTA and $21.8 million for SYMLIN for the same period in 2009. Amylin plans to report full financial results for the quarter and nine months ended September 30, 2010 within the next few weeks pending its assessment of the potential financial impact of the U.S. Food and Drug Administration complete response letter regarding BYDUREON™ (exenatide extended-release for injectable suspension).

Amylin also announced that the previously announced quarterly update conference call, originally scheduled for Wednesday, October 20, 2010 at 5:00 p.m. ET/2:00 p.m. PT., has been canceled.

About Amylin Pharmaceuticals

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California. Further information on Amylin Pharmaceuticals is available at www.amylin.com.

SOURCE Amylin Pharmaceuticals, Inc.

mlkrborn

10/20/10 10:15 AM

Post #117

AMLN: Down $10 to $10.
By Val Brickates Kennedy

NVO AMLN ALKS LLY

BOSTON (MarketWatch) -- Shares of Danish drug maker Novo Nordisk A/S /quotes/comstock/13*!nvo/quotes/nls/nvo (NVO 100.51, +9.52, +10.46%) jumped 10% in premarket trading Wednesday, the day after U.S. regulators declined to approve a hotly-anticipated diabetes medication called Bydureon that posed a competitive threat to Novo's diabetes drug franchise. Novo shares had been trading substantially lower recently in anticipation of a U.S. approval for the product. Bydureon was co-developed by Amylin Pharmaceuticals /quotes/comstock/15*!amln/quotes/nls/amln (AMLN 10.12, -10.37, -50.61%) , Alkermes Inc. /quotes/comstock/15*!alks/quotes/nls/alks (ALKS 10.35, -4.15, -28.62%) and Eli Lilly & Co. /quotes/comstock/13*!lly/quotes/nls/lly (LLY 35.62, -1.83, -4.89%) .

Volume

09/25/10 6:03 PM

Post #115

Deutsche Bank Maintains a 'Buy' on Amylin Pharmaceuticals #AMLN#; Thinking Long-Term: Bydureon a Likely Blockbuster

September 24, 2010 8:06 AM EDT

Deutsche Bank maintains a 'Buy' on Amylin Pharmaceuticals (Nasdaq: AMLN), PT $27.

Deutsche analyst says, "Amylin is awaiting approval of its long-acting diabetes drug, Bydureon, which is a GLP-1 agonist. This class of drugs is used after oral therapy before insulin. Street controversy has focused not on IF Bydureon will be approved (Oct 22 is FDA PDUFA date), but how BIG peak sales will be. Our analysis suggests peak sales of Bydureon of $1.4B in '14 and $3B by '20 in the U.S. alone. We rate the stock a Buy because we believe Bydureon sales will be greater than street expectations."

"NY Times reported a potential sale of Amylin in ’09. We view Amylin as a possible acquisition candidate for a large pharma company with a diabetes sales force. Acquirer could extract significant SG&A and R&D synergies. Our M&A analysis indicates Lilly (NYSE: ELY) and Takeda make most sense with M&A value at $43-$44/share."

To see all the upgrades/downgrades on shares of AMLN, visit our Analyst Ratings page.

The 52-wk trading range is $11.01 - 24.21.

Volume

09/22/10 8:31 PM

Post #114

Re: #113: @gym gravity - AMLN looking good... I intend to sell half

Rumor: Amylin spikes up on renewed takeover speculation

On The Fly: Rumor Buzz
Market speculation today includes Amylin Pharmaceuticals (AMLN) which is said to be holding talks with Eli Lilly & Co. (LLY) for as much as $32 per share...Brocade Communications Systems (BRCD), up nearly 8%, is reportedly in talks with IBM (IBM) for $7.50 per share...DISH Network Corp. (DISH) is rumored to be acquiring TiVo (TIVO)...Banco Santander, S.A. (STD) is speculated again to be considering a bid for M&T Bank Corp. (MTB)...Semiconductor company Cree (CREE) is again the subject of takeover speculation. Last week Siemens (SI) was rumored to be considering a bid. :theflyonthewall

Amylin October volatility at 48, November elevated at 80 into PDUFA
Amylin is recently up 2c to $20.92 on renewed takeover chatter. PDUFA date for Bydureon is October 22. October option implied volatility is at 48, November is at 80, January is at 64 versus its 26-week average of 72. About 4,661 calls (616 puts) traded in AMLN with short term speculation focused on October 22 and October 24 calls according to Track Data, suggesting traders are expecting larger price movement. :theflyonthewall.com

gym gravity

08/30/10 10:02 AM

Post #113

AMLN looking good... I intend to sell half before approval, lets see how this runs until then.

surf1944

07/14/10 9:05 AM

Post #112

Amylin Pharms AMLN Caris & Company Buy $27

surf1944

06/28/10 8:14 AM

Post #111

1:54AM Amylin Pharma: Study finds BYETTA use was not associated with increased rate of acute pancreatitis vs other antidiabetic drugs (AMLN) 19.31 : Co and Eli Lilly (LLY) announce final results from a retrospective study including more than 260,000 patients that showed the risk of acute pancreatitis among initiators of BYETTA injection was not increased compared to initiators of other antidiabetic therapies. The retrospective study used data accrued over three years from a large, geographically diverse U.S. healthcare insurance claims database to examine the risk of acute pancreatitis in more than 25,000 patients who were treated with BYETTA, relative to nearly 235,000 patients who were treated with other antidiabetes medications. Medical records from claims-identified cases of acute pancreatitis were reviewed by four gastroenterologists, blinded to drug exposure, using a standard assessment tool. In a nested case-control study based on the review, use of BYETTA was not associated with an increased rate of acute pancreatitis compared to the other antidiabetes medications, based on the adjusted odds ratio and 95% confidence interval for current, recent and past use of BYETTA.

mlkrborn

06/18/10 12:20 PM

Post #110

Re: #109: @mlkrborn - Amylin $19, Alkermes gain ground on Roche

UPDATE 3-Roche, Ipsen drug faces at least 12-18 month delay
Fri Jun 18, 2010 5:10am EDT

* Roche had previously aimed for regulatory filings in 2011

* Change in clinical trial protocols causes delay

* Follows hypersensitivity reactions in some patients

* Ipsen shares down 15 percent, Roche 2.5 percent; Novo up 3.3 percent (Adds more analyst comment, detail on Roche strategy

mlkrborn

06/18/10 12:16 PM

Post #109

Amylin $19, Alkermes gain ground on Roche drug delay
Amylin Pharmaceuticals, Alkermes shares rise as Roche diabetes drug faces FDA filing delay
ap

Related Quotes
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ALKS 12.49 +0.93
Chart for Alkermes, Inc.
AMLN 19.14 +2.62
Chart for Amylin Pharmaceuticals, Inc.
AZN 45.56 -0.23
Chart for ASTRAZENECA
BMY 25.59 -0.27
Chart for BRISTOL MYERS SQUIBB
LLY 34.61 +0.22

On Friday June 18, 2010, 10:29 am EDT

NEW YORK (AP) -- Shares of Amylin Pharmaceuticals Inc. and its partner Alkermes Inc. gained ground Friday after potential competitor Roche said it would face filing delays on a developing diabetes drug.

Amylin, Alkermes and Eli Lilly & Co. are awaiting a Food and Drug Administration decision on the once-weekly diabetes treatment Bydureon. Meanwhile, Roche said it will have to delay filing an application for taspoglutide by up to 18 months, citing safety concerns.

Shares of Amylin rose $2.72, or 16.5 percent, to $19.23 in morning trading while shares of partner Alkermes rose 97 cents, or 8.4 percent, to $12.53. Eli Lilly shares rose 15 cents to $34.54.

On Friday, Roche said it would delay filing a regulatory application because of a new risk-mitigation plan in the ongoing late-stage study of taspoglutide. The Swiss company said incidents of hypersensitivity reactions are higher than expected for the study population.

"Material delay to the filing of taspoglutide means that investor concerns here are now warranted," said Jefferies & Co. analyst Jeffrey Holford, in a note to Roche investors.

He now expects the drug to reach the market in 2014, a launch date he said was too late to matter, given the growing competition in the diabetes treatment field.

The competition includes Novo Nordisk's once-daily drug Victoza, which received FDA approval in January. Shares of Novo Nordisk rose $2.51, or 3.1 percent, to $84.30 in morning trading. Earlier shares traded at a 52-week peak of $84.55.

Bydureon is expected to be a direct competitor to Victoza, and the FDA is set to make a decision on the drug by Oct. 22. Bydureon is a long-lasting version of the twice-daily injection Byetta, which is made by Amylin and Eli Lilly.

Alkermes is contributing the long-lasting technology to once-weekly Bydureon.

Several newcomers to the diabetes drug market include the oral treatment Onglyza, made by Bristol-Myers and AstraZeneca, and Januvia, made by Merck & Co.

surf1944

06/18/10 9:03 AM

Post #108

Amylin Pharmaceuticals to Present New Data and Insights From the Company's Diabetes Programs at ADA 2010

http://finance.yahoo.com/news/Amylin-Pharmaceuticals-to-prnews-3405526697.html?x=0&.v=1

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http://finance.yahoo.com/q/pr?s=AMLN

http://www.form4oracle.com/company?cik=0000881464&ticker=amln

Amylin Pharmaceuticals, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of medicines for diabetes, obesity, and other diseases in the United States. It sells BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection for the treatment of patients with Type II diabetes. The company also has research and development programs in the therapeutic areas of diabetes and obesity, including exenatide once weekly; Nasal Exenatide, a nasal spray formulation of exenatide for diabetes; Pramlintide and PYY 3-36 for the treatment of obesity; Leptin for the treatment of obesity and lipodystrophy; Pramlintide-Metreleptin combination product candidate for overweight or obese subjects; and second generation Amylinomimetic for weight loss. It sells its products to healthcare providers, managed healthcare organizations, wholesalers and pharmacies, government purchasers, and other third-party payors. The company has collaboration agreements with Eli Lilly and Company, as well as with Alkermes, Inc. to develop exenatide once weekly for diabetes; a contract research arrangement with Kelaroo, Inc. for the commercialization of Kelaroo's SeqR technology that is used for peptide hormone identification and optimization; a joint research collaboration agreement with BioSeek, Inc. for discovery and development of novel peptide therapeutics for inflammatory conditions; and a joint research collaboration agreement with Xenome, Ltd. for discovery and development of novel peptide hormones for a range of metabolic and musculoskeletal diseases. It also has a collaboration with Pacira Pharmaceuticals, Inc. for the development of sustained release injectable products based on the DepoFoam technology platform. Amylin Pharmaceuticals was founded in 1987 and is based in San Diego, California.