Amylin Pharmaceuticals Inc. (AMLN)

[gym gravity]

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

[surf1944]

Amylin Pharms AMLN Caris & Company Buy $27

[surf1944]

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]

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]

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
Symbol Price Change
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]

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

[surf1944]

Amylin Pharmaceuticals(AMLN), Alkermes(ALKS) and Eli Lilly(LLY)
Drug/indication: Bydureon for diabetes
Approval decision date: Oct. 22
This is the second FDA review cycle for Bydureon, a once-weekly injectable drug for diabetes.

http://www.thestreet.com/story/10784106/8/13-drugs-facing-fda-approval-decisions.html

[surf1944]

Amylin Pharmaceuticals to Present at the Goldman Sachs 31st Annual Global Healthcare Conference

http://finance.yahoo.com/news/Amylin-Pharmaceuticals-to-prnews-2297297702.html?x=0&.v=1

[Volume]

What do you think the FDA response will be next week? I have a good feeling it will be Class 1.

[surf1944]

Amylin Pharms AMLN Wedbush Neutral $20

[surf1944]

5:00PM Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON (AMLN) 20.54 -0.31 : Amylin Pharmaceuticals (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS) announced that the companies have submitted their reply to a complete response letter issued last month by the FDA after review of the New Drug Application submission for BYDUREON (exenatide for extended-release injectable suspension). In accordance with its guidelines, the FDA is expected to classify the complete response as a Class 1 or Class 2 resubmission, and also provide the companies with an updated Prescription Drug User Fee Act target action date within the next two weeks. The companies' reply addresses requests from the FDA primarily related to finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy and clarification of existing manufacturing processes.

[surf1944]

7:03AM Amylin Pharms beats by $0.02, misses on revs (AMLN) 21.75 : Reports GAAP Q1 (Mar) loss of $0.27 per share, $0.02 better than the Thomson Reuters consensus of ($0.29); revenues fell 3.3% year/year to $174 mln vs the $187.8 mln consensus. Net product sales of $172.3 million for the quarter ended March 31, 2010 include $149.8 million for BYETTA (exenatide) injection and $22.5 million for SYMLIN (pramlintide acetate) injection. This compares to net product sales of $179.3 million, consisting of $157.7 million for BYETTA and $21.6 million for SYMLIN for the same period in 2009. BYDUREON response to FDA will be submitted this week BYDUREON marketing authorization application submitted to the european medicines agency. "With the submission of our BYDUREON response this week, we are preparing to make this revolutionary treatment option available this year to the millions of patients living with type 2 diabetes. We remain focused on driving revenue from our currently marketed products, BYETTA and SYMLIN, and continue to exercise financial discipline so that we remain on track to generate sustainable positive operating cash flow by year end."

[surf1944]

Amylin Pharms AMLN Piper Jaffray Neutral $26

[surf1944]

6:15AM Amylin Pharma, Eli Lilly and Alkermes receive complete response letter from FDA for exenatide once weekly submission (AMLN) 20.26 : Co, Eli Lilly (LLY) and Alkermes (ALKS) announce that the FDA has issued a complete response letter regarding the New Drug Application for BYDUREON. In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy and clarification of existing manufacturing processes. The complete response letter does not contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility. All of those observations have been addressed.

[LOCKUSA]

holding 3000 shares.

[ToysInTheAttic]

Amylin (AMLN) Falls On Reports of Inappropriate Quality Control at Ohio Plant
10:46 am ET 03/12/2010- StreetInsider
Shares of Amylin (Nasdaq: AMLN) are taking a hit on reports from Bloomberg the FDA said the company's Ohio plant had inappropriate quality control.

The company is waiting for an expected FDA decision on Byetta today.

[safleyc]

can you post or post link?!

[ToysInTheAttic]

fda quality control issues news

[ToysInTheAttic]

amln just fell out of bed...news?

[TxAgTailgater]

I'm excited... going to be a long weekend if we get the positive news this afternoon.

[safleyc]

morning everyone...big day today! most all signs i am seeing are pointing north, if anyone comes across info stating otherwise i would love to see it..i would be a liar if i said i was not a little nervous still ha!

[safleyc]

Yep...all signs pointing to a thumbs up for tomorrows meeting!!!! (knock on wood)

[TxAgTailgater]

Looking good here. Expecting to see $30 plus based off what I am seeing from analysts.

[safleyc]

CNBC just gave us a thumbs up for tomorrow..thus explaining the jump

[Bobby1010]

Assumes they believe in positive outcome obviously...no?

[Bobby1010]

Really on the fence here...feels like a coin toss.

[surf1944]

A huge short position should help the long cause for some time:

Average Volume (3 month)3: 3,976,780
Average Volume (10 day)3: 5,664,790
Shares Outstanding5: 141.74M
Float: 141.16M
% Held by Insiders1: 11.37%
% Held by Institutions1: 80.80%
Shares Short (as of 26-Feb-10)3: 15.93M
Short Ratio (as of 26-Feb-10)3: 4.2
Short % of Float (as of 26-Feb-10)3: 35.30%
Shares Short (prior month)3: 16.26M

[Kenticus Maximus]

Look at the pre-market. Looks like some anticipation going on. I got in yesterday--I hope I don't jinx us.

[surf1944]

Amylin Pharms AMLN Merriman started with a Buy today

[rebelpenny]

http://www.biohorizon.com/2010/03/amylin-lilly-and-alkermes-await-fda-decision-on-byetta-for-diabetes/

[surf1944]

Amylin Pharms AMLN Jefferies & Co Buy $27 to $30

[braden]

Awww geeez,I almost bought in today....Maybe I wait a bit.

[techno53]

Do you know how Amylin's FDA audit went? What was the out come?Thanks..

[surf1944]

Amylin Pharms AMLN Jesup & Lamont Buy $26

[surf1944]

Amylin Pharms AMLN Credit Suisse Outperform $28

[techno53]

Does anyone know how Amylin's FDA audit went in November 09?

[surf1944]

Amylin Pharms AMLN Citigroup upgraded from Hold to Buy $14 to $27

[Volume]

Barchart.com says.. 100% - Buy

http://quote.barchart.com/texpert.asp?sym=AMLN&code=BSTK

[Volume]

Amylin Pharmaceuticals to Present at J.P. Morgan Healthcare Conference


Amylin Pharmaceuticals to Present at J.P. Morgan Healthcare Conference

Press Release Source: Amylin Pharmaceuticals, Inc. On Monday January 4, 2010, 4:15 pm EST

SAN DIEGO, Jan. 4, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) will be presenting at the J.P. Morgan Healthcare Conference in San Francisco on Monday, January 11, 2010 at 6:30 p.m. ET / 3:30 p.m. PT. Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals, will provide a corporate overview.



The live presentation and break-out session will be webcast, and a recording will be made available following the event. The webcast and recording will be accessible through Amylin's corporate Web site, located at www.amylin.com. To access the live webcast, please log on to Amylin's site approximately fifteen minutes prior to the presentation to register and download any necessary audio software.



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 about Amylin Pharmaceuticals is available at www.amylin.com.

[mlkrborn]

mylin Falls as Analyst Says FDA Wants Byetta Study (Update3)
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By Rob Waters

Dec. 23 (Bloomberg) -- Amylin Pharmaceuticals Inc. fell the most in more than eight months in Nasdaq trading after a Citigroup analyst said U.S. drug regulators are requiring more studies of the diabetes drug Byetta to assess its safety.

San Diego-based Amylin and Indianapolis-based Eli Lilly & Co., which co-market the drug, announced Oct. 30 that the Food and Drug Administration had cleared the drug for use as standalone therapy for Type 2 diabetics and that prescribing information would warn about the risk of pancreatitis, an inflamed pancreas, in patients with severe kidney disease. That statement didn’t say the FDA wanted more studies.

Citigroup analyst Yaron Werber said today in a note to investors that he had obtained a copy of the FDA’s approval letter and that the agency was requiring animal and human studies aimed at clarifying the risk of pancreatitis posed by the drug. A statement e-mailed by Lilly and Amylin today said most of the requested studies are under way and have shown no increased risk of pancreatitis in patients taking Byetta.

“The FDA considers post-marketing reports of acute pancreatitis (fatal and non-fatal hemorrhagic or necrotizing pancreatitis), acute renal failure and thyroid neoplasms as ‘new safety information’ and is requiring Amylin to conduct additional studies,” Werber said in his note.

Amylin dropped $1.48, or 9.6 percent, to $13.97 at 4 p.m. in Nasdaq Stock Market composite trading, the most since April 2. The shares have gained 29 percent this year.

Option Trading

Trading of bearish Amylin options jumped to a 15-month high as investors boosted bets that the shares will keep slumping over the next month. More than 31,400 put options giving the right to sell shares changed hands, about 14 times the four-week average and triple the number of calls to buy the stock. The most active were January $12.50 puts, which rose 146 percent to 37 cents and accounted for about a quarter of all put volume.

Byetta, a twice-daily injection, has been sold since April 2005 for patients taking other diabetes medications. In August 2008, the FDA and Amylin announced six patients taking Byetta had died from pancreatitis. A safety alert was issued by the FDA and Amylin said no evidence directly linked the drug to the deaths.

The companies, in their statement today, said they had been planning to conduct some of the studies requested by the FDA since pancreatitis emerged as a potential safety problem in 2007.

‘No Increased Risk’

“A well-powered, completed epidemiological study has shown no increased risk of pancreatitis in patients taking Byetta compared to patients taking other antidiabetic medications,” company spokeswoman Alice Izzo said in the statement. “This has been confirmed by an additional large epidemiological study utilizing a different database and different methodology.”

Amylin’s revenue from Byetta fell 5 percent to $171 million in the third quarter compared with the same period a year earlier, the company said Oct. 20 in a statement. Amylin and Lilly have been trying to gain U.S. approval for a once-weekly version of the medicine.

To contact the reporter on this story: Rob Waters in San Francisco at [e-mail].

[surf1944]

Amylin Pharms AMLN Jefferies & Co started with a
Buy $22

[surf1944]

2:53PM Amylin Pharms: FDA confirms Byetta label revised to include safety information on possible kidney problems (AMLN) 12.04 +1.00 : The U.S. Food and Drug Administration acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes. From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Nearly 7 million prescriptions for Byetta were dispensed between April 2005 and September 2008. The 78 cases represent a small percentage of the total number of patients using the drug to control blood sugar (glucose) levels. The most common side effects associated with Byetta include nausea, vomiting, and diarrhea. These side effects may have contributed to the development of altered kidney function. Kidney malfunction can result in a build-up of waste products in the blood, leading to serious illness or life-threatening conditions... Byetta is manufactured by San Diego-based Amylin Pharmaceuticals... See 14:18 prior comment.

[surf1944]

3:32PM Amylin Pharms and Eli Lilly and Company issue statement on FDA's BYETTA injection update (AMLN) 12.17 +1.13 : Amylin Pharmaceuticals and Eli Lilly (LLY) issued the following statement in response to the FDA update on BYETTA (exenatide) injection. "The FDA update issued today aligns with the BYETTA label approved last week. The current label reflects our understanding of post-marketing reports of renal events and provides physicians with updated guidance about appropriate use in patients with renal conditions. There is no evidence from preclinical and clinical studies that BYETTA has any direct toxic effect on the kidney... Post-marketing reports of serious changes in renal function have been rare and usually complicated by other factors that could have contributed to the kidney problems. It is also important to note that diabetes is the leading cause of kidney failure. Information about use of BYETTA in patients with impaired renal function was included in the initial product label in 2005 and was updated in 2007."

[surf1944]

Amylin signs weight-loss drug deal with Takeda
Amylin Pharmaceuticals signs weight-loss drug deal with Takeda potentially worth over $1B

On 3:58 pm EST, Monday November 2, 2009

Companies:Amylin Pharmaceuticals, Inc.Arena Pharmaceuticals, Inc.Orexigen Therapeutics, Inc.
NEW YORK (AP) -- Amylin Pharmaceuticals Inc. says it could potentially receive more than $1 billion from a partnership with Japan's Takeda Pharmaceutical Co. on potential weight-loss treatments.

Company shares climbed nearly 10 percent in trading Monday, despite an announcement that government regulators strengthened warning labels on company's diabetes treatment Byetta.

The Food and Drug Administration highlighted bolstered language about kidney damage on the drug's labeling.

Amylin, based in San Diego, said late Sunday it will receive $75 million upfront from Takeda and said future payments for development and achieving commercial milestones could top $1 billion.

The deal includes two potential weight-loss treatments, a pramlintide-metreleptin combination and davalintide. Both potential drugs are in midstage, or Phase II, clinical development. In July, Amylin said pramlintide-metreleptin prompted an average weight loss of 22 pounds, or 11 percent of patients' body weight, during a midstage study.

The deal also includes additional compounds from both companies research programs. Aside from milestone payments, Amylin is also eligible for royalties on global sales.

Its shares rose $1.07, or 9.7 percent, to $12.11 in afternoon trading.

Amylin is responsible for developing potential products through midstage development, while Takeda will take over late-stage development, along with all development activities outside the U.S.

Amylin estimates it will be responsible for 20 percent of development costs for obtaining approval for products in the U.S.

Leerink Swann Research analyst Dr. Joshua Schimmer reaffirmed a "Market Perform" rating for Amylin, saying the obesity drug deal will help reduce future expenses. He said Amylin costs for obesity drugs represented about 13 percent of second-quarter research and development costs.

On Friday, Amylin said the FDA expanded approval of Byetta as a stand-alone diabetes treatment. Previously, it was approved for use in combination with other diabetes drugs.

Schimmer said there will likely be little change in how physicians prescribe Byetta following the expanded approval, saying doctors have already been prescribing the drug off-label as a stand-alone therapy.

The FDA also strengthened warning language on Byetta, following more than 60 reports of kidney failure with the drug between April 2005 and October 2008.

While the previous label mentioned such side effects, the new language specifies that doctors should not prescribe Byetta to patients with severe kidney problems. The FDA did not put the warning in a so-called "black box," a move that could have raised safety concerns among doctors.

"In our view these developments are in line with expectations and we do not expect any impact to Byetta sales as pancreatitis was first added as a precaution on the label in October 2007," wrote Lazard Capital Markets analyst Michael O'Brien, in a note to investors.

The Amylin-Takeda deal comes amid a surge in obesity treatment research and development from the biotechnology industry. Several companies already have their potential drugs in late-stage development, setting the stage for a competitive market if each gains Food and Drug Administration approval.

In October, several companies reported positive updates to their studies at the annual scientific meeting of The Obesity Society in Washington DC.

Vivus Inc. said patients taking its potential weight-loss drug Qnexa lost about 11 percent of their body weight. Arena Pharmaceuticals Inc. said patients taking lorcaserin lost 31 percent of their excess body weight in the first year of a two-year study. Earlier this year, Orexigen Therapeutics Inc. reported results showing that Contrave patients lost more than 8 percent of their weight.

[mlkrborn]

$12 NOW AFTER DEAL with TAKEDA!
Amylin forges $1B weight-loss pact with Takeda
November 2, 2009 — 9:20am ET | By John Carroll



There's a new entry in the closely-watched race to win approval for a blockbuster new weight loss drug. Amylin Pharmaceuticals announced this morning that it struck a billion-dollar development deal with Takeda for new obesity therapies that may rival the late-stage programs pushed by Vivus, Arena Pharmaceuticals and Orexigen.

While further back in the clinical field, San Diego-based Amylin has been grabbing attention for its combination of Amgen's leptin and its diabetes drug pramlintide. Preliminary results from a trial involving 608 overweight patients demonstrated that a group of patients lost 11 percent of their body weight after taking the highest dose. The placebo group lost an average of 1.8 percent of its body weight. The most severely obese patients in the trial, though, didn't benefit as much as patients with a BMI of less than 35.

Amylin gets $75 million from Takeda upfront for the deal, along with more than a billion dollars in commercial and clinical milestone payments as well as double-digit royalties, "Both Amylin and Takeda have extensive experience in the diabetes and metabolic disease area, and this collaboration should allow us to more quickly bring promising new treatments to patients in need," said Yasuchika Hasegawa, the CEO of Takeda Pharmaceutical.


Read more: http://www.fiercebiotech.com/story/amylin-forges-1b-weight-loss-pact-takeda/2009-11-02#ixzz0VjXHAJIZ

[drolismith]

depends on when LAR will be approved to be produced and sold. If that doesn't come this year there is no way it will hit $25 this year.

[Volume]

Holding Jan10 $20 calls for 2 months now...Will we see $25 this year?

[mlkrborn]

"Recent reports of pancreatitis tied to Byetta have hurt the drug and clouded prospects of the new version, which Lilly is developing with Amylin Pharmaceuticals (AMLN.O: Quote, Profile, Research, Stock Buzz). Amylin shares rose 20 percent on news of the impending drug application.

Lilly expects three experimental cancer drugs from the ImClone deal to be in late-stage testing next year.

CEO John Lechleiter has taken bold steps in his eight months at Lilly's helm, sealing the ImClone acquisition as well as making significant risk-sharing and cost-cutting deals.

But Lechleiter offered little interest in a large pharmaceutical merger, saying Lilly's best path forward was to remain independent.

Lilly backed its long-term forecast of double-digit compound annual earnings per share growth from 2007-2011, and stuck to its 2008 forecast of $3.97 to $4.02 per share, excluding big charges from the ImClone deal.

Lilly shares rose 42 cents to $35.43 in late-afternoon trading on the New York Stock Exchange." (Reporting by Lewis Krauskopf and Ransdell Pierson; Editing by Derek Caney, Steve Orlofsky, Dave Zimmerman, Gunna Dickson, Richard Chang)

[mlkrborn]

Elly L.. CEO talks and AMLN moves up!

[mlkrborn]

NICE POP AND PULL BACK $11??