Amylin Pharmaceuticals Inc. (AMLN)

[mlkrborn]

AMYLIN DROPS to$7.94:
WASHINGTON/LOS ANGELES, Nov 4 (Reuters) - Shares of Amylin Pharmaceuticals
Inc lost more than a quarter of their value on Tuesday after the biotech company
said U.S. regulators rejected data for an experimental version of its diabetes
drug Byetta.
Amylin is developing a long-acting version of the injectable drug, known
as exenatide LAR, with Alkermes Inc and Eli Lilly and Co. San Diego-based Amylin
last month agreed to supply the drug to distributor Lilly.
But the U.S. Food and Drug Administration was not convinced that versions
of the drug used in clinical trials and produced at Alkermes' manufacturing
facility were equal to versions made at Amylin's larger Ohio facility, Amylin
and Alkermes said in filings with the U.S. Securities and Exchanges Commission.
The news brings into question Amylin's target for filing a new drug
application for the extended release drug by mid-2009, and several analysts
lowered their price targets for the stock.
Bank of America analyst William Ho reduced his 12-month price target for
Amylin shares to $9 from $28 and said he does not expect the compound to reach
the market until 2011.

[surf1944]

Amylin, Elli Lilly tout diabetes drug over Merck
Tuesday September 9, 9:16 am ET
Amylin Pharmaceuticals, Eli Lilly tout Byetta post-meal effectiveness over Merck's Januvia

Amylin has been a good short over the past month, maybe time to cover and go long!

NEW YORK (AP) -- Amylin Pharmaceuticals Inc. and Eli Lilly & Co. said Tuesday their diabetes drug Byetta worked better at reducing blood-sugar levels following a meal compared with Merck & Co.'s Januvia.

The results, based on a a four-week study, were released at the European Association for the Study of Diabetes's annual meeting in Rome, where there has been a flurry of data and posturing by rivals trying to gain an advantage in the competitive diabetes treatment market.

Byetta, which was launched in 2005, is a twice-daily injection and member of a class of treatments known as GLP-1 drugs. Merck's Januvia is part of the DPP-IV inhibitor class and is a pill taken once a day.

Whitehouse Station, N.J.-based Merck also touted a series of studies Tuesday showcasing the effectiveness of Januvia. The company said Januvia in combination with the treatment metformin was effective and well-tolerated after two years of treatment.

Both products treat Type 2 diabetes by helping the body better use the insulin it already produces. In Type 2 diabetics, the body produces enough insulin but does not use it effectively. Byetta, however, has come under fire recently after the company announced a series of deaths related to pancreatitis.

San Diego-based Amylin and Indianapolis-based Eli Lilly also sell the drug with Alkermes Inc., and the companies are developing a long-acting version, called Exenatide LAR. It would be taken once a week.

In this most recent study, Amylin and Eli Lilly said patients taking Byetta had significant improvements in their blood-sugar levels two hours after eating, compared with patients taking Januvia.

"There has been some confusion in the marketplace about the therapeutic differences between Byetta and Januvia, and data from this first head-to-head study showed a clear difference in the mechanisms of action and resultant short-term clinical effects between these two agents," Dr. Ralph DeFronzo, an investigator on the clinical trial, said in a statement released by Amylin and Eli Lilly.

DeFronzo is a professor of medicine and chief of the diabetes division at the University of Texas Health Science Center in San Antonio.

Representatives at Merck were not immediately available for comment Tuesday morning.

[surf1944]

Ahead of the Bell: Amylin drops on Byetta deaths
Wednesday August 27, 8:29 am ET
Amylin falls after report of 4 new Byetta deaths, which analysts say could erode sales

NEW YORK (AP) -- Shares of Amylin Pharmaceuticals Inc. dropped in premarket trading Wednesday after the drug developer and its partner Eli Lilly & Co. reported four new deaths of patients who had taken their diabetes drug Byetta.

Analysts said the report is likely to hurt growth in Byetta prescriptions, and could also damage prospects for the companies' next-generation diabetes drug, which they plan to begin selling next year.

In premarket trading, Amylin shares dropped $3.54, or 13 percent, to $23.70. The stock has ranged from $23.75 to $51.10 over the past year.

Late Tuesday, Amylin and Lilly said four patients who took Byetta had died of pancreatitis. The Food and Drug Administration reported two similar deaths last week, although the new patients each had complicating medical conditions. The FDA is planning a stronger warning for Byetta's label.

Robert W. Baird analyst Thomas Russo downgraded Amylin shares to "Neutral" from "Outperform" on the news, and lowered his share price target to $27 from $37.

Citi Investment Research analyst John Boris said the label changes will hurt prescriptions in the second half of 2008. He added that safety concerns, greater competition and decreasing growth in prescriptions could cause sales to miss expectations.

The analysts noted that the link between Byetta and pancreatitis has not been proved. Meg Malloy of Goldman Sachs said most of the patients had other problems that can cause the condition, and diabetes patients already face a greater-than-average risk for the disease.

[surf1944]

Lilly, Amylin Disclose More Cases of Byetta-Related Pancreatitis
Posted by Shirley S. Wang

ByettaLast week, the FDA said it had received reports of six new cases of pancreatitis – including two deaths – associated with the diabetes drug Byetta. Today, Amylin and Eli Lilly said that they had reported four additional deaths to the agency as well, which the FDA hasn’t yet made public.

The companies, which co-market the drug, chose to disclose the additional information in order to “provide context” about each of the cases, because the medical community appeared confused by the information last week, Amylin President and Chief Executive Daniel Bradbury told the Health Blog.

Another reason might be to reassure investors. Byetta, co-marketed by the companies, already has a label reflecting its association with severe inflammation of the pancreas. But the FDA says it’s working on a stronger label for the drug that includes forms of pancreatitis that involve bleeding and cell death. Both companies’ stock dipped following the news last week, though Amylin’s was particularly hard hit, plunging as much as 22% since the FDA announcement before recovering somewhat.

In the four cases brought forward by the companies today, it’s not clear whether the patients were taking Byetta at the time of deaths. And the deaths are “not directly attributable to pancreatitis in any way”, Orville Kolterman, Amylin’s senior vice president of R&D, told us. For instance, one patient appeared to die from a relapse of leukemia two months after having pancreatitis. Also, patients with Type II diabetes have a greater risk of pancreatitis than healthy people to begin with, said Kolterman.

Analysts say the bigger picture issue is whether these safety concerns might affect the long-acting version of the medicine the companies are currently developing. The question “is whether the FDA, from a regulatory standpoint, will require longer term study of” the long-acting version, Barbara Ryan of Deutsche Bank told the Health Blog. “Rather than a short half-life, you’re going to have a longer term product. So if you get in trouble, it’s [in the body] for a longer period of time.”

[surf1944]

12:28PM Amylin Pharms, Lilly's Byetta linked to 6 pancreatitis cases (AMLN) 33.16 -1.11 : Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis. FDA is working with the maker of Byetta, Amylin Pharmaceuticals, to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis. (LLY)

[surf1944]

Amylin Pharmaceuticals, Inc. Q2 2008 Earnings Call Transcript

http://seekingalpha.com/article/86075-amylin-pharmaceuticals-inc-q2-2008-earnings-call-transcript?source=yahoo

[surf1944]

Sector Snap: Diabetes drug developers
Thursday July 3, 11:34 am ET
Regulatory proposal could mean longer, costlier drug studies for diabetes drug developers

NEW YORK (AP) -- Proposals for tougher heart-risk studies on new Type 2 diabetes drugs weighed heavy on shares of Amylin Pharmaceuticals Inc. and Novo Nordisk AS Thursday, since stricter regulations could mean longer, more costly clinical trials.

On Wednesday, advisers to the Food and Drug Administration voted 14 to 2 that all new diabetes drugs should undergo longer studies to assess heart-problem risks. The advisers made the vote less than a year after the FDA was criticized for not adding a heart-risk warning to the label of U.K.-based GlaxoSmithKline's Avandia until last November. That drug was approved in 1999.

The agency still has to adopt the proposals, but it usually follows the advice of its advisers. Nearly 24 million Americans have Type 2 diabetes, which can lead to kidney failure, blindness and heart disease.

Shares of San Diego-based Amylin fell 99 cents, or 3.9 percent, to $24.52 in midday trading. The company and Indianapolis-based partner Eli Lilly & Co. make Byetta, a twice-daily treatment. At issue for them is the development of a once-weekly version of the drug called LAR exenatide, which also involves partner Alkermes Inc., based in Cambridge, Mass.

Analysts don't foresee any delays with LAR's approval, citing studies that show it reduces blood pressure, along with the body of evidence for its marketed predecessor, Byetta. Timing of the FDA's decision on the safety proposals could also be a factor.

"It may be difficult for the FDA to implement formal action in time to impact the approval of LAR or liraglutide, underscored by the widely conflicting views on trial designs at the panel," said Piper Jaffray analyst Thomas Wei, in a note to investors late Wednesday.

Eli Lilly shares rose 47 cents to $46.56 while Alkermes shares fell 6 cents to $12.47.

Liraglutide is being developed by Danish drug maker Novo Nordisk as a once-daily diabetes treatment and is being viewed as a potentially tough competitor for Byetta. The same timing issue could also be advantageous for Novo, which recently asked the FDA for approval on Liraglutide.

Novo shares fell $2.17, or 3.3 percent, to $63.85.

Meanwhile, shares of Januvia-maker Merck & Co. rose 58 cents to $38.65. The drug brought in $667.5 million for the Whitehouse Station, N.J.-based company in 2007. It is already in a good position, said Lazard Capital Markets analyst Matthew Osborne.

"When asked to impose tougher standards on already approved drugs, panel members mentioned Merck's Januvia and Amylin's Byetta as examples of drugs that posed the least risk," he said in a note to investors Thursday.

Competitors to Januvia include alogliptin, being developed by Japan-based Takeda Pharmaceuticals. New York-based Bristol-Myers Squibb Co. and London-based AstraZeneca are developing their drug saxaglaptin. Bristol shares rose 12 cents to $20.70 while American Depository Shares of AstraZeneca rose $1.63, or 3.7 percent, to $45.74.
http://biz.yahoo.com/ap/080703/sector_snap_diabetes_drugs.html?.v=1

[surf1944]

Icahn reports increased stake in Amylin Pharma
Thursday May 22, 6:24 pm ET
Carl Icahn raises stake in Amylin Pharmaceuticals; is in talks with management

NEW YORK (AP) -- Billionaire investor Carl Icahn on Thursday reported raising his stake in biotech Amylin Pharmaceuticals Inc. and said he is in discussions with management about ways to maximize product sales and development.

In a filing with the Securities and Exchange Commission, Icahn reported owning about 9 million shares, including shares underlying call options, representing a 6.5 percent stake based on 137.1 million shares outstanding as of April 21.

Previously, Icahn reported holding 6.3 million shares of the San Diego-based biopharmaceutical company.

According to the filing, Icahn has recently held discussions with the company's management, and plans to have further conversations about ways to enhance shareholder value.

Amylin shares lost 4 cents to close at $30.96. Shares slipped 6 cents to $30.90 in aftermarket electronic trading.

2nd item on AMLN

Ahead of the Bell: Alkermes
Friday May 23, 8:04 am ET
Alkermes gives weak forecast, but analysts are pleased with new Risperdal Consta pact

NEW YORK (AP) -- Analysts said Friday that they were disappointed with Alkermes Inc.'s fiscal fourth-quarter results and outlook, but they found promise in a new drug development pact with Johnson & Johnson.

The Cambridge, Mass., company swung to a loss in its fiscal fourth quarter, and said it expects to lose money in fiscal 2009. Alkermes will eliminate jobs and close a facility because its partner Eli Lilly & Co. chose to end development of an inhaled insulin drug. Analysts had expected the company to turn a profit for the year.

Alkermes also said it will partner with Johnson & Johnson to develop a once-per-month version of the schizophrenia drug Risperdal Consta. A twice-monthly version is sold by Johnson & Johnson and is the source of most of Alkermes' revenue.

Johnson & Johnson has been developing a rival one-per-month schizophrenia drug, Paliperidone palmitate, with Elan Corp. PLC. Analysts have expressed concern about palmitate's safety and effectiveness, and Jim Reddoch said the new agreement with Alkermes may indicate problems with palmitate.

Soleil Securities analyst Noelle Tune said the deal is a "significant positive for Alkermes," outweighing its disappointing forecast.

Baird analyst Lawrence Neibor downgraded the stock to "Neutral" from "Outperform," however, and cut his price target to $12 per share from $24. He said Alkermes is expecting weak sales of Consta, and some of its expenses will no longer be covered by Lilly.

He added that the diabetes drug candidate Exenatide LAR, which Alkermes is developing with Lilly and Amylin Pharmaceuticals Inc., "is too far from approval to help."

[surf1944]

Icahn holds stake in Amylin, drops Macy's and CSX

NEW YORK (AP) - Billionaire investor Carl Icahn reported a new stake in
Amylin Pharmaceuticals Inc. as of March 31 but no longer owned shares of
department store chain Macy's Inc. and railroad operator CSX Corp., according to
a quarterly regulatory filing Thursday.
In the Securities and Exchange Commission filing, Icahn reported holding 6.3
million shares of Amylin, a San Diego-based biopharmaceutical company. The
investor had reported stakes in Macy's and CSX and in his fourth-quarter
regulatory filing but did not report holdings in this most recent report.
He also no longer holds shares of insurance provider Unum Group, Canadian
energy company Compton Petroleum Corp. and insurance and investment manager
Lincoln National Corp.
In addition, Icahn no longer reported owning a stake in "Grand Theft Auto"
publisher Take-Two Interactive Software Inc. Electronic Arts Inc. made a $2
billion offer to buy the video game publisher in February. The bid expires
Friday. Take-Two has said the price is too low.
The investor also reported boosting his stakes in Biogen Idec Inc., Enzon
Pharmaceuticals Inc., Forestar Real Estate Group Inc., Guaranty Financial Group
Inc. and Motorola Inc. during the quarter. He reduced his holdings in Perry
Ellis International Inc., J.C. Penney Co. and Williams Cos.

[surf1944]

Premium for Amylin Not Warranted
Tuesday April 22, 2:09 pm ET
By Jason Napodano, CFA

Sales of Byetta have disappointed over the past several quarters. Specially, the first quarter 2008 was very weak, albeit in part due to wholesaler de-stocking. However, the Amylin Pharmaceuticals, Inc. (NasdaqGS: AMLN - News) story is tied to the success or failure of phase III potential blockbuster, exenatide LAR. Data on LAR from the DURATION-1 was presented in October 2007. We classified the data as good, but not great. Additional data from the DURATION program is expected in 2009.

At this time the valuation on Amylin is not attractive. The stock is trading at 21x our 2012 EPS estimate well above the peer-group at 10x and that estimate assumes LAR posts sales over $1.5 billion. In the meantime, there are few catalysts and operating expenses are soaring. Amylin currently trades at 21x our 2012 EPS estimate of $1.31.

The 2012 multiple is a 100% premium to the large-cap pharma / biotechnology peer-group average of 10x 2012 EPS. The peer-group consists of several large-cap bellwethers including Eli Lilly & Co. (NYSE: LLY - News)(8x), Merck & Co., Inc. (NYSE: MRK - News)(7x), Genentech, Inc. (NYSE: DNA - News)(9x), Amgen, Inc. (NasdaqGS: AMGN - News)(6x), Biogen Idec, Inc. (NasdaqGS: BIIB - News)(11x), Gilead Sciences, Inc. (NasdaqGS: GILD - News)(12x), Celgene Corp. (NasdaqGS: CELG - News)(13x), and Genzyme Corp. (NasdaqGS: GENZ - News)(11x).

We believe this premium by Amylin is not warranted given significant questions that surround the future growth of Byetta. As we have noted above, sales of Byetta are not yet to a level that generates profitability, and we see little chance to reach profitability until the LAR product launches in 2010. And, even with $1.6 billion in LAR sales in 2012 and a 15% tax rate Amylin's operating margin of only 10% is about half that of the peer-group. We are still at a level where we believe the name is substantially over-valued. We see far better and cheaper opportunities in biotech today. We would avoid the name. Our target is $25.

[surf1944]

Eastbourne Capital Management trying to get the shorts running:

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

[surf1944]

Amylin spent $198,000 lobbying in the first quarter
Friday May 9, 11:40 am ET
Amylin Pharmaceuticals spent $198,000 lobbying the federal government in first quarter

WASHINGTON (AP) -- Amylin Pharmaceuticals Inc. spent $198,000 lobbying the federal government on prescription drug issues in the first quarter of 2008.

The San Diego, Calif.-based company lobbied on legislation affecting the Medicare prescription drug benefit for seniors and a bill that would require drug companies to disclose gifts given to doctors to help promote pharmaceuticals.

Amylin also lobbied Congress on a bill aimed at updating the U.S. patent system. High-tech companies support the bill that passed the House last year, saying it would cut down on frivolous patent-infringement lawsuits. But the pharmaceutical industry has argued it will weaken patent protections on drugs by reducing infringement penalties. The bill has stalled in the Senate.

The company disclosed its lobbying expenses in a form filed online on April 16 by the Senate's public records office.

Under a federal law enacted in 1995, lobbyists are required to disclose activities that could influence members of the executive and legislative branches. Lobbyists are required to disclose how much they spent in the first six months of the year.

[surf1944]

Amylin Pharmaceuticals Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment in Obesity
Monday May 5, 5:00 pm ET
Preclinical findings of amylin/leptin synergy and translational Phase 2A clinical results published online today in Proceedings of the National Academy of Sciences of the United States of America

SAN DIEGO, May 5 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN - News) today announced the initiation of a Phase 2B clinical study evaluating various dosing combinations of pramlintide, an analog of the natural hormone amylin, and recombinant human leptin (r-metHuLeptin; metreleptin) for the treatment of obesity. The objective of this dose-ranging study is to support dose selection for Phase 3, and to inform the ongoing development of a convenient delivery system for this combination regimen. The six-month, randomized, double-blind, placebo-controlled multi-center study will enroll approximately 600 overweight and obese subjects and is expected to complete in mid-2009.

"There is a tremendous medical need and market demand for a weight loss product that meets both safety and efficacy expectations of patients and physicians, and we believe that our integrated neurohormonal approach to obesity holds great promise for achieving this profile," stated Christian Weyer, M.D., Vice President of Clinical Research, Amylin Pharmaceuticals. "Building upon the positive results of our translational research program published today in PNAS, and the extensive clinical experience with both pramlintide and metreleptin as monotherapies, the newly initiated Phase 2B study will bring us one step closer to our goal of offering obese individuals a safe and effective therapy that results in meaningful weight loss."

The Phase 2B study will include a broad range of overweight and obese subjects (body mass index 27 to 45 kg/m2) and will compare various pramlintide/metreleptin combination regimens with each compound alone and with placebo.

PNAS Publication

Also today, comprehensive preclinical findings of amylin/leptin synergy, along with positive results of a translational Phase 2A clinical study were published online in PNAS, Proceedings of the National Academy of Sciences of the United States of America, in a scientific paper entitled, "Leptin Responsiveness Restored by Amylin Agonism in Diet-Induced Obesity: Evidence from Non-Clinical and Clinical Studies."

"Leptin is a fundamentally important hormone in energy metabolism with a unique role in inducing fat-specific weight loss and in preventing weight loss counterregulation," remarked Steven Smith, M.D., Professor and Assistant Associate Director of Clinical Research, Endocrinology Laboratory at the Pennington Biomedical Research Center. "The intriguing and important findings published today constitute a strong scientific basis for the development of peptide hormone combinations, and provide renewed hope of harnessing the therapeutic potential of leptin as part of an integrated neurohormonal approach to obesity pharmacotherapy."

The scientific studies included in the PNAS publication provide preclinical and clinical evidence that leptin responsiveness is at least partially restored by amylin agonism. In several independent experiments in diet-induced obese rats, co-administration of amylin, together with leptin, resulted in synergistic reductions in food intake (up to 45%) and body weight (up to 15%), effects considerably greater than with leptin or amylin treatment alone. Importantly, weight loss with amylin/leptin treatment was fat-specific, and not accompanied by a reduction in lean mass. Neurohistological studies provided important insights into the neurobiological basis of amylin/leptin synergy. Finally, the translational clinical research confirmed that findings in the non-clinical experiments are relevant to human obesity and suggest that metreleptin may be an effective partner to pramlintide in the treatment of obesity.

The full paper, published in the May 5, 2008 early edition of PNAS, is available online at http://www.pnas.org/. PNAS is one of the world's most prestigious multidisciplinary scientific journals.

[amylinterry]

Eastbourne trying to Buy 20% of the company

Wellington Fidelity and Marisco(13%) round out the big 4

Short Interest is very high

Amylin should beat the estimates for the quarter thanks in part to slowly rising scripts and a 6% price increase.

A move to file by years end is the next Question that needs to be asked. The FDA MAY let them do it or ask for a bioequivilancy test ( 6 mos) delay

[drluck]

start look this

[drluck]

soros here

[jjmack71]

Most have gone to investorvillage.com.
I prefer this site, but whomever started the migration was evidently not aware of this site.

[howlongtoretire]

Any Yahoo castaways here?

Anyone know where people have gone?

[SeriousMoney]

Amylin Pharmaceuticals, Inc. Earnings Conference Call (Q2 2006)
Scheduled to start Mon, Jul 24, 2006, 5:00 pm Eastern

http://biz.yahoo.com/cc/1/69781.html

[SeriousMoney]

Amylin: Byetta sales set for bumpy ride
By Staff Writer, 13th April 2006
Pharmaceutical Business Review

Given that physicians expect to increase their use of Amylin's diabetes drug Byetta over the next two years, the product is expected to generate US sales of $336.1 million in 2006 and $555 million in 2007. However, oral rivals look set to take market share from Byetta thereafter, before a once-weekly formulation of the drug, expected in 2009 or later, can help the franchise recover.

Based on favorable reports from surveyed physicians on Byetta's efficacy and comfort with its safety profile, physicians are expected to increasingly prescribe Byetta over the next two years. On average, they currently prescribe the drug to 34% of patients who fail oral therapies, and plan to increase this to 48% in two years' time. Byetta's US sales are therefore forecast to reach $336.1 million in 2006 and $555 million in 2007.

Although the treatment's price and its cumbersome twice-daily injection delivery method are significant barriers to uptake, Byetta's potential for weight loss acts as a key incentive for patients.

Nevertheless, competition from oral formulation rivals is set to increase from late 2006 onwards. Merck's Januvia and Novartis' Galvus, both DPP-IV inhibitors, are expected to launch in late 2006 and early 2007, respectively, and look set to be the first of several competitors to Byetta. Due to their oral formulation, 70% of surveyed physicians expect DPP-IV inhibitors to reduce Byetta usage, in spite of their questionable efficacy and a lack of weight loss benefit.

Furthermore, it is also possible that novel anti-obesity agents, specifically Sanofi-Aventis' Acomplia, will impact physicians' use of Byetta. Rather than competing directly, such agents may increase the competitive threat of other oral drugs, by eliminating the power of Byetta's weight loss advantage.

As a result of these threats, Byetta's US sales for 2008 are forecast to see a modest rise, to reach $580.4 million.

To combat this, Amylin, Eli Lilly and Alkermes are working to develop a long-acting release formulation of Byetta. Clinical trials are being conducted with a once-weekly formulation, and the feasibility of a once-monthly formulation is also being explored.

A once-weekly formulation, anticipated to launch in 2009 or later, would greatly help the franchise recover from its flat 2008 sales forecast. However, faced with up to two years of anticipated declining market share prior to its launch, the ramp-up in revenue may be slower than Wall Street expects.

http://www.pharmaceutical-business-review.com/article_feature.asp?guid=D608CA2E-DE4E-4BB0-9988-66FEE...

[SeriousMoney]

Something sweet in AMLN Annual Report? http://finance.yahoo.com/q?s=AMLN

[SeriousMoney]

Amylin Shares May Hit $100 In 3 To 5 Years
Forbes.com, Peter Kang, 04.07.06, 10:11 AM ET

Morgan Stanley raised the price target on Amylin Pharmaceuticals to $52 from $42, citing strong sales for diabetes drug Byetta.

The analyst lifted the forecasted first-quarter and 2006 U.S. sales of Byetta to $75 million and $383 million, respectively, from $65 million and $348 million, citing current prescription trends and a recent price increase.

"We believe the stock could reach the low $50s with solid data at the American Diabetes Association meeting in June and continued growth trends," the analyst wrote in a Thursday note. "Performance in the second half of 2006 may be more muted as the stock trades on sentiment surrounding the DPP-IV inhibitors."

Harr maintained an "overweight" rating on the stock.

"Long-term, we continue to believe that Amylin could reach $80 to $100 over the next three to five years if Byetta LAR potential approaches our mega-blockbuster beliefs," he said.

Byetta is co-marketed by Eli Lilly. The companies, along with Alkermes, are developing a long-acting version of Byetta.

Elsewhere in the sector, Harr has "overweight" ratings on ImClone Systems, Regeneron Pharmaceuticals, Threshold Pharmaceuticals and ZymoGenetics, among others.

http://www.forbes.com/markets/economy/2006/04/07/amyln-byetta-0407markets03.html

[SeriousMoney]

Amylin's Byetta Sales May Lead To Q1 Upside
Forbes.com, Peter Kang, 03.30.06, 3:02 PM ET

Friedman, Billings, Ramsey raised the price target on Amylin Pharmaceuticals and said prescription trends for diabetes drug Byetta may lead to earnings upside in the first quarter.

Research analyst Jim Reddoch raised the Byetta sales estimate for the first quarter to $77 million from $60 million, citing recent sales data and positive feedback from physicians.

Byetta, co-marketed by Amylin and Eli Lilly, comes in a pre-filled pen containing 60 doses. "Doctors say they have been surprised at patients' willingness to use the pen, that it seems to lack insulin's stigma," the analyst said.

"Our increased estimates are based on both increased sales potential for Byetta, as well as continued positive sentiment among clinicians towards the drug."

The firm raised the price target on Amylin shares to $60 from $50 and maintained an "outperform" rating. "Recent doctor commentary makes us more bullish," said Reddoch. "Also, Amylin's top line will grow 36% from 2006 to 2011, a premium growth rate justifying a premium multiple."

Looking ahead, the FBR analyst said the American Diabetes Association meeting will be a key event for the stock as Amylin will present new data on Byetta as well as the experimental long-acting version, exenatide LAR.

http://www.forbes.com/markets/equities/2006/03/30/amyln-pharmaceuticals-0330markets14.html

[SeriousMoney]

Amylin Pharma Raises $441.4 Million
AP, Thursday March 30, 6:56 am ET

Amylin Pharmaceuticals Raises Proceeds of $441.4 Million in Public Stock Offering


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

SAN DIEGO (AP) -- Biopharmaceutical company Amylin Pharmaceuticals Inc. said Thursday a public offering of 10 million shares at $46.50 each raised net proceeds of about $441.4 million.

The company has granted underwriters an overallotment option to purchase up to an additional 1.5 million shares.

Amylin, which develops therapies to treat diabetes and associates disorders, said in a regulatory filing it plans to use proceeds to commercialize approved products, fund the development of drug candidates, increase research and development and for other general corporate purposes.

Morgan Stanley & Co. is the sole bookrunning and co-lead manager for the offering, Goldman Sachs & Co. is co-lead manager, and co-managers are Bear Stearns & Co. and Lehman Brothers Inc.

Amylin Pharmaceuticals has about 111.5 million shares outstanding. Shares of the company closed Wednesday at $46.86 on the Nasdaq.

http://biz.yahoo.com/ap/060330/amylin_pharma_stock_offer.html?.v=1

[SeriousMoney]

Amylin Launches Study of Diabetes Drug
AP, Friday March 24, 10:03 am ET

Amylin Launches 30-Week Study of Long Acting, Extended-Release Version of Diabetes Drug Byetta



INDIANAPOLIS (AP) -- Amylin Pharmaceuticals Inc. said Friday it started a 30-week clinical study of a long-acting version of its Byetta diabetes drug.

The San Diego-based drugmaker is working with Eli Lilly & Co. and Alkermes Inc. on the study, which aims to see if using extended-release Byetta once a week is at least as effective as the already approved twice-daily treatment. Byetta initially received regulatory approval in April as an add-on treatment for Type 2 diabetes.

The three pharmaceutical firms, which have discussed the study with the Food and Drug Administration, intend to use the safety and effectiveness data as support for a new drug application.

Amylin shares rose 73 cents to $45.40 in morning trading on the Nasdaq, while Alkermes shares gained 33 cents to $24.39. Meanwhile, shares of Eli Lilly added 46 cents to $58.50 on the New York Stock Exchange.

http://biz.yahoo.com/ap/060324/amylin_study.html?.v=1

[SeriousMoney]

William Blair & Company Initiates Coverage of Amylin Pharmaceuticals, Inc. With Market Perform Rating

CHICAGO, March 21 /PRNewswire/ -- William Blair & Company initiated research coverage of Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) ($46.32) with a Market Perform rating and company profile of Aggressive Growth.

San Diego-based Amylin is focused on the discovery and development of products to treat metabolic disorders -- diabetes in particular.

Analyst John Sonnier estimated that the company would generate revenue of $362 million in 2006, $625 million in 2007, and $866 million in 2008.

"We believe that Amylin is one of the highest-quality midcap biotechnology companies," Sonnier said. "The combination of two first-in-class FDA-approved drugs (Byetta and Symlin), strong management, significant pipeline growth potential, a strong balance sheet, and a partnership with Eli Lilly
distinguishes Amylin among its peers, in our view."

"We expect GLP-1-related therapies to reshape the management of diabetes," he added. "GLP-1 has proved to be a unique metabolic target for managing type 2 diabetes, and Byetta is the first approved GLP-1 analog. The launch of Byetta has been, and should continue to be, the most significant driver of value in Amylin shares. Notably, the biological action of GLP-1 is either directly or indirectly associated with a significant number of drugs in clinical development."

William Blair & Company, L.L.C. ( http://www.williamblair.com ) is a Chicago-based investment firm offering investment banking, asset management, equity research, institutional and private brokerage, and private capital to individual, institutional, and issuing clients. Since 1935, we have been committed to helping clients achieve their financial objectives. William Blair & Company has offices in Chicago, Hartford, London, San Francisco, Tokyo,
Vaduz, and Zurich.

William Blair & Company, L.L.C. has received compensation for investment banking services from the company within the past 12 months, or expects to receive or intends to seek compensation for investment banking services in the next 3 months.

William Blair & Company, L.L.C. is a market maker in the security of this company and may have a long or short position.

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/03-21-2006/0004324327&...

[SeriousMoney]

Local firms win state development grants
Cincinnati Business Courier - 11:35 AM EST Tuesday

A biomedical company planning a Butler County facility and a Cincinnati chemical firm were two of the 12 businesses and municipalities to divide more than $11.5 million in Ohio Department of Development grants.

Gov. Bob Taft on Monday announced the awards, which assist companies in creating and retaining jobs in Ohio.

Amylin Ohio LLC, a subsidiary of Amylin Pharmaceuticals in San Diego, was awarded a $100,000 business development grant to buy machinery and equipment for a manufacturing plant it will build in West Chester. The company has acquired a 150,000-square-foot building on 26 acres, where it will produce pharmaceuticals. The $70 million project is expected to create 52 jobs during its first three years of operation.

http://cincinnati.bizjournals.com/cincinnati/stories/2006/03/13/daily18.html

[SeriousMoney]

Byetta Treats Diabetes And Helps Patient Lose Weight Too
MedicalNewsToday.com, 13 Mar 2006

Diabetics' use of Byetta (Amylin Pharmaceuticals) has boomed since the glucose-regulating prescription drug was introduced last year as the first in a class of medicines for type 2 diabetes called incretin mimetics.

The big appeal?

Many people not only have better regulation of their blood sugar, but they lose weight, too.

UAB endocrinologist Fernando Ovalle, M.D., said, “Byetta slows down the gastrointestinal transit time and therefore makes people feel full after eating. The biggest side effect may be nausea, but it's usually transient.”

The injectable drug also facilitates insulin production in response to a meal and helps suppress glucagon levels. UAB doctors participated in some of the clinical studies of the drug and use it in clinics.

http://www.medicalnewstoday.com/medicalnews.php?newsid=39375#

[SeriousMoney]

Amylin Pharmaceuticals "outperform," target price raised - update
Tuesday, February 28, 2006 2:29:23 AM ET
Piper Jaffray



NEW YORK, February 28 (newratings.com) - Analysts at Piper Jaffray maintain their "outperform" rating on Amylin Pharmaceuticals (AMLN.NAS). The target price has been raised from $50 to $52.

In a research note published yesterday, the analysts mention that a recent survey on the current prescribers indicates that the adoption of the company’s Byetta drug is expected to increase by 140% over the next one year. The survey reflects that there is a possibility of Amylin Pharmaceuticals posting 4Q06 drug sales ahead of the estimates and the consensus by 25%-30%, the analysts say.

http://www.newratings.com/analyst_news/article_1216114.html

[SeriousMoney]

Amylin and Eli Lilly seek expanded diabetes approval
By Staff Writer, 3rd March 2006
Pharmaceutical Business Review Online

Amylin Pharmaceuticals and Eli Lilly and Company have submitted a supplemental new drug application to the FDA for the expanded use of their diabetes medication Byetta injection.

The companies are specifically seeking approval for use of their drug as an add-on therapy to a common class of oral diabetes medications called thiazolidinediones, or TZDs, for the treatment of people with type 2 diabetes who are not achieving acceptable blood sugar control.

The drug is already approved as an add-on therapy for treatment of people not achieving acceptable blood sugar control despite using the commonly prescribed diabetes medications metformin, a sulfonylurea or a combination of both.

Byetta is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics and exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to regulate blood sugar.

http://www.pharmaceutical-business-review.com/article_news.asp?guid=82BD5B14-A917-4776-ABAE-DA623A54...

[SeriousMoney]

Getting Even More Bullish On Byetta
Peter Kang, 02.27.06, 1:23 PM ET
Forbes.com

Piper Jaffray raised the price target on Amylin Pharmaceuticals and said a recent physician survey indicates sales growth for diabetes treatment Byetta may be tracking above current Wall Street sentiment.

"Overall, physicians reported their Byetta usage will grow by 140% over the next 12 months," wrote Piper Jaffray analyst Thomas Wei.

"Our survey suggests roughly 25% to 30% potential upside to our prior estimate of $91 million and the Street consensus of $96 million for the fourth quarter 2006."

The pharmaceutical analyst raised the price target on Amylin shares to $52 from $50 and lifted the 2006 Byetta sales estimate to $331 million from $306 million.

The Piper Jaffray survey was sent to more than 500 endocrinologists and general practitioners with 115 responses.

Currently, endocrinologists and other specialists are more likely to prescribe the drug; Wei noted that sales growth could be even higher than projected by the survey as general practitioners become more comfortable prescribing Byetta.

"Endocrinologists were the major driving force behind adoption, with 95% of them with at least one Byetta patient vs. only 19% of GPs," he said.

The analyst has an "outperform" rating on the stock, which is one of Piper Jaffray's top mid-cap sector picks.

A long-acting form of Byetta is currently being developed by Amylin, Eli Lilly and Alkermes.

http://www.forbes.com/markets/commodities/2006/02/27/amylin-byetta-0227markets09.html

[SeriousMoney]

AMYLIN (AMLN) - Toby 2/23/06

Amylin released data that showed its pramlintide helped obese patients lose weight. In a 16-week trial, 408 patients lost an average of 8.4 pounds to 13.4 pounds (the average loss is 6.2 pounds) and in general experienced progressive weight loss during the 16 weeks. In the weight-loss arena this is very good data and let me remind you, Amylin's two new diabetes drugs are the only diabetes treatments on the market that induce weightloss -- other treatments create weight gain.

[SeriousMoney]

Amylin Pharmaceuticals to Present at Citigroup Healthcare Conference
INVESTMENT BANKING HEALTH-CARE CONFERENCES
PharmaLive, February 22, 2006

SAN DIEGO, February 22, 2006 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. will be presenting at the Citigroup Healthcare Conference on Tuesday, February 28, 2006 at 8:35 a.m. ET in Washington, DC. Mark Foletta, VP, Finance and Chief Financial Officer of Amylin Pharmaceuticals, will be providing a corporate overview.

The live presentation will be webcast, and a recording will be made available following the event. The webcast and recording will be accessible through Amylin's corporate website, located at http://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.

Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic diseases through the discovery, development and commercialization of innovative, cost-effective medicines.

CONTACT: Alice Bahner, Executive Director, Investor Relations of AmylinPharmaceuticals, Inc., [phone]

Web site: http://www.amylin.com/
Ticker Symbol: (NASDAQ-NMS:AMLN)

http://www.pharmalive.com/News/index.cfm?articleid=317292&categoryid=62

[SeriousMoney]

Amylin Pharmaceuticals Reports 2005 Financial Results
Newswire, February 09, 2006 4:05:00 PM ET
Fourth Quarter Net Product Sales Increase to $56 Million

SAN DIEGO, Feb. 9 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. AMLN today reported financial results for the quarter and year ended December 31, 2005. The Company reported total revenue of $63.5 million for the fourth quarter, including net product sales of $56.2 million. The net loss for the quarter ended December 31, 2005 was $67.2 million, or $0.61 per share. At December 31, 2005, the Company held cash, cash equivalents and short-term investments of approximately $443 million.

"In 2005, Amylin transformed from a research and development organization to a fully commercial enterprise, achieving $87 million in net product sales. We launched two first-in-class products, BYETTA and SYMLIN, both of which are growing in their acceptance by health care providers, patients, and payors," said Ginger L. Graham, Amylin's President and Chief Executive Officer. "As we enter 2006, demand for both products continues to accelerate, we have two compounds in late-stage development: one for diabetes and one for obesity, and expect to introduce two novel compounds into the clinic."

Quarter ended December 31, 2005

Net product sales of $56.2 million for the quarter include sales of $49.7 million for BYETTA(R) (exenatide) injection and $6.5 million for SYMLIN(R) (pramlintide acetate) injection. Net product sales consist of shipments of BYETTA and SYMLIN to the Company's wholesale distributors, net of allowances for prescription coupons, payor discounts, distribution fees and returns. Cost of goods sold was $9 million for the quarter ended December 31, 2005.

Revenue under collaborative agreements was $7.4 million for the quarter ended December 31, 2005, compared to $6.6 million for the same period in 2004.

Research and development expenses increased to $45.3 million for the quarter ended December 31, 2005, compared to $31.3 million for the same period in 2004. Increased costs are primarily associated with the development of exenatide LAR, support for commercial products and the advancement of early stage development programs.

Selling, general and administrative expenses increased to $57.1 for the quarter ended December 31, 2005, compared to $20.2 million for the same period in 2004. The increase reflects the expansion of the Company's commercial organization and business infrastructure to support the launches of BYETTA and SYMLIN in the United States during 2005. This expansion included hiring and training the Company's field force, expanded marketing, medical education, and customer service activities, and related administrative support.

Collaborative profit sharing, which represents Lilly's share of the gross margin for BYETTA, was $21.3 million for the quarter ended December 31, 2005.

Net loss was $67.2 million, or $0.61 per share, for the quarter ended December 31, 2005, compared to a net loss of $46.4 million, or $0.49 per share, for the same period in 2004.

Fourth quarter highlights
* Announced that positive results from a study of BYETTA used in addition to thiazolidinediones (TZDs) in patients with type 2 diabetes resulted in improved glucose control with over 60% of patients achieving A1C goal. Supports regulatory applications for expanded use planned for submission mid 2006.
* Purchased a facility in Ohio for the eventual commercial manufacturing of exenatide LARYear ended December 31, 2005

Total revenue for the year ended December 31, 2005 was $140.5 million. This includes net product sales of $86.7 million, consisting of $75.2 million for BYETTA and $11.5 million for SYMLIN. The net loss for 2005 was $206.8 million, or $1.96 per share.

Revenue under collaborative agreements increased to $53.8 million for the year ended December 31, 2005, compared to $34.3 million for the same period in 2004. The increase reflects the recognition of $35 million in milestone payments from Lilly earned in connection with the regulatory approval and commercial launch of BYETTA in the United States, partially offset by lower cost-sharing revenues due to lower BYETTA development expenses during 2005, as compared to 2004.

Research and development expenses increased to $132.1 million for the year ended December 31, 2005, compared to $119.6 million for 2004. The increase primarily reflects costs associated with the continued development of exenatide LAR and pramlintide for obesity, as well as increased costs associated with the Company's early stage programs, partially offset by a reduction in development expenses for BYETTA during 2005, as compared to 2004.

Selling, general and administrative expenses increased to $171.5 million for the year ended December 31, 2005, compared to $67.0 million for the same period in 2004. The increase consists primarily of costs associated with the expansion of the Company's commercial capabilities and business infrastructure to support the launches of BYETTA and SYMLIN in the United States.

Collaborative profit sharing was $31.4 million for the year ended December 31, 2005.

Net loss was $206.8 million, or $1.96 per share, for the year ended December 31, 2005, compared to $157.2 million, or $1.67 per share, for the same period in 2004.

Conference Call

Amylin will webcast its Quarterly Update Conference Call today at 5:00 p.m. ET/2:00 p.m PT. The call will be webcast live through Amylin's corporate website, and a recording will be made available following the close of the call.

Ginger L. Graham, Amylin's President and Chief Executive Officer will lead the call. During the call, the Company plans to provide supporting details underlying its fourth quarter and 2005 financial results, and information regarding key trends and assumptions for 2006 operations. For those without access to the Internet, the live call may be accessed by phone by calling [phone] (domestic) or [phone] (international), passcode 86499025. A replay of the call will also be available by phone for 24 hours beginning approximately one hour after the close of the call and can be accessed at [phone] (domestic) or [phone] (international), passcode 94895774.

About Amylin

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines.

This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. The Company's actual results could differ materially from those discussed herein due to a number of risks and uncertainties, including risks that BYETTA and SYMLIN may be affected by unexpected new data or technical issues; risks that our financial results may fluctuate significantly from quarter to quarter and may not meet market expectations; risks that our clinical trials will not commence when planned; and risks inherent in the drug development and commercialization process. Commercial and government reimbursement and pricing decisions, the pace of market acceptance and any issues related to manufacturing and supply may also affect the potential for BYETTA and SYMLIN. These and additional risks and uncertainties are described more fully in the Company's most recently filed SEC documents, including its Form 10-Qs. Amylin disclaims any obligation to update these forward-looking statements. Amylin disclaims any obligation to update any forward-looking statements.

                        AMYLIN PHARMACEUTICALS, INC. 
                     CONSOLIDATED STATEMENTS OF OPERATIONS 
                     (in thousands, except per share data) 
                                  (unaudited) 
  
                                   Three months ended        Years ended 
                                      December 31,           December 31, 
                                   2005        2004        2005       2004 
     Revenues: 
      Net product sales          $56,189         $--     $86,713        $-- 
      Revenues under 
       collaborative agreements    7,351       6,597      53,761     34,268 
     Total revenues               63,540       6,597     140,474     34,268 
     Costs and expenses: 
      Cost of goods sold           9,002          --      14,784         -- 
      Research and development    45,251      31,335     132,128    119,558 
      Selling, general and 
       administrative             57,072      20,173     171,520     66,958 
      Collaborative profit 
       sharing                    21,341          --      31,359         -- 
       Total operating expenses  132,666      51,508     349,791    186,516 
  
     Operating Loss              (69,126)    (44,911)   (209,317)  (152,248) 
     Interest income (expense), 
      net                          1,967      (1,490)      2,485     (4,909) 
  
     Net loss                   $(67,159)   $(46,401)  $(206,832) $(157,157) 
     Net loss per share - 
      basic and diluted           $(0.61)     $(0.49)     $(1.96)    $(1.67) 
     Shares used in computing 
      net loss per share - 
      basic and diluted          110,262      94,377     105,532     94,054 
 . 
                          AMYLIN PHARMACEUTICALS, INC. 
                     CONDENSED CONSOLIDATED BALANCE SHEETS 
                                 (in thousands) 
                                  (unaudited) 
                          
     December 31,                                                     2005        2004 
     Assets 
      Cash and cash equivalents                         $72,026     $60,583 
      Short-term investments                            371,397     233,173 
      Accounts receivable, net                           26,784          -- 
      Receivables from collaborative partners                --       5,770 
      Inventories                                        26,750      15,676 
      Other current assets                               17,847       9,156 
      Property and equipment, net                        42,050      20,739 
      Other assets                                       11,192      12,703 
       Total assets                                    $568,046    $357,800 
     Liabilities and stockholders' equity (deficit) 
      Accounts payable, accrued expenses and other 
       current liabilities                              $95,384     $37,651 
      Current portion of deferred revenue                 4,286       4,286 
      Other liabilities, net of current portion          12,454       7,290 
      Deferred revenue, net of current portion           11,658      20,943 
      Convertible senior notes                          375,000     375,000 
      Stockholders' equity (deficit)                     69,264     (87,370) 
       Total liabilities and stockholders' equity 
        (deficit)                                      $568,046    $357,800

http://news.moneycentral.msn.com/provider/providerarticle.asp?feed=PR&Date=20060209&ID=54936...

[SeriousMoney]

Amylin's Exenatide LAR Pricing In Half Of Stock's Value
Forbes, Peter Kang, 02.13.06, 3:20 PM ET

Merrill Lynch upgraded Amylin Pharmaceuticals to "neutral" from "sell," citing more reasonable share prices, but said it continues to be wary of risks related to experimental drug exenatide LAR.

"We remain cautious on the stock as optimism over strong Byetta sales is offset by the company's uncertainty about the clinical trials that will be required by the FDA for seeking approval of exenatide LAR, the once weekly version of Byetta, for type 2 diabetes," wrote Merrill Lynch analyst Thomas McGahren.

The analyst estimates about half of Amylin's stock price is attributed to the future success of exenatide LAR, in development with Eli Lilly (nyse: LLY - news - people ), and trades on the assumption the drug will hit the market by 2009.

"Any delays in the clinical development and launch would adversely impact the stock," he said.

Amylin (nasdaq: AMLN - news - people ) will provide an update on whether the U.S. Food and Drug Administration will allow an open label clinical trial of exenatide LAR, set to begin in the second quarter, to serve as the "line extension" registration trial.

"If not, then the clinical path for exenatide LAR will take longer, thus hurting valuation."

McGahren values Amylin stock at approximately $36 per share, assuming a 65% probability exenatide LAR launches in the April 2009 time frame with peak sales of $2 billion.

Byetta is co-marketed by Eli Lilly and was approved last April.

http://www.forbes.com/markets/2006/02/13/amylin-exenatide-0213markets10.html

[SeriousMoney]

Challenges Needle Novo Nordisk
Friday January 27, 11:34 am ET
MotleyFool.com, By Stephen D. Simpson, CFA

It looks like large and growing markets with limited competition don't quite guarantee success. A challenging year for Danish pharmaceutical company Novo Nordisk (NYSE: NVO - News) ended on a down note when the company offered uninspiring fourth-quarter numbers and softer-than-expected guidance.

The company reported that sales in the fourth quarter were up 19%, but the numbers soften up as you continue on down the income statement. Despite higher gross margins, higher selling, general, and administrative expenses and research and development expenses squeezed the operating income growth to just 4%, and net income actually shrunk by 18% relative to last year.

While sales in Novo Nordisk's diabetes care business continue to far exceed those in the biopharmaceuticals business (and grew 18% for the fourth quarter), the biopharmaceuticals business is much more profitable, and operating profits in diabetes actually shrank. All the same, Novo continues to experience strong growth in its insulin analog business (with sales up 67%) and now holds close to 40% of the U.S. insulin market.

As is always the case for stocks, the question isn't so much about "What have you done for me lately?" as it is "What are you going to do for me tomorrow?" In that respect, there are some reasons to be concerned. Novo has likely harvested a lot of the "low-hanging fruit" in the insulin analog business, and I would expect growth to start slowing.

What's more, Novo needs to get moving on the new product front. While the company says it plans to reinitiate phase 3 studies of its inhaled insulin device, I'm not sure that's the best move. The company might be better served by partnering with or buying MannKind (Nasdaq: MNKD - News) and using its device instead.

Likewise on the diabetes drug front -- the company has its own GLP-1 analog drug candidate, but it's well behind Amylin Pharmaceuticals (Nasdaq: AMLN - News), and other companies like Merck (NYSE: MRK - News), Novartis (NYSE: NVS - News), and Bristol-Myers (NYSE: BMY - News) are developing medications that, if approved, should help postpone Type 2 diabetics' dependence on insulin.

Novo Nordisk has a great fortress in its insulin business, but the barbarians are at the gate and the torches are lit. Success with new drugs and inhaled insulin would go a long way toward securing its franchise, but guidance for 2006 wasn't impressive and there are definite challenges ahead.

http://biz.yahoo.com/fool/060127/113837967218.html?.v=2

[SeriousMoney]

AMLN up 4.63% after missing estimates? http://finance.yahoo.com/q?s=AMLN

Could it have something to do with... http://www.investorshub.com/boards/read_msg.asp?message_id=9434256

[SeriousMoney]

Amylin Shares Rise on Byetta Sales
AP, Thursday January 26, 1:09 pm ET

Byetta Sales Push Amylin Pharmaceuticals Shares Higher Despite Wider-Than-Expected 4Q Loss

NEW YORK (AP) -- Amylin Pharmaceuticals Inc. shares edged higher Thursday after Eli Lilly & Co. released particularly strong sales for the diabetes therapy the drug makers developed together.

The Byetta drug, used by Type 2 diabetics to help control their blood sugar levels, was approved by the Food and Drug Administration in June. It posted fourth-quarter sales of $49 million, bringing its total since launch to $74.6 million.

Amylin, which receives 50 percent of the gross profit from Byetta, saw its shares rise 83 cents, or 2 percent, to $43.20 in afternoon trading on the Nasdaq. Lilly shares fell 17 cents to $57 on the New York Stock Exchange.

San Diego-based Amylin said earlier it will post a fourth-quarter loss of $66 million to $69 million, or 60 cents to 63 cents per share, because of higher costs that offset the Byetta revenue. Some of the increased expenses come from investment in a once-weekly formulation of Byetta.

Analysts surveyed by Thomson Financial expect a loss of 59 cents per share.

Amylin plans to release more detailed fourth-quarter results on Feb. 9. The company's third-quarter revenue totaled $25.9 million.

http://biz.yahoo.com/ap/060126/amylin_outlook.html?.v=1

[SeriousMoney]

Amylin Pharmaceuticals Announces BYETTA Revenue
PR, Thursday January 26, 6:30 am ET

Preliminary Fourth Quarter 2005 Results

SAN DIEGO, Jan. 26 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN - News) today announced that unaudited net product sales for BYETTA® (exenatide) injection for the quarter ended December 31, 2005 were approximately $49 million. BYETTA net product sales consist of shipments to the Company's wholesale customers, net of allowances for discounts, distribution fees and returns. These preliminary results are being released in conjunction with today's financial results announced by Eli Lilly and Company, Amylin's collaborative partner for BYETTA.

Amylin also announced that the unaudited net loss for the quarter ended December 31, 2005 is expected to be $66 to $69 million, or $0.60 to $0.63 per share. Amylin's fourth quarter activities included increased investment in exenatide LAR (once-weekly formulation of BYETTA) and other compounds in the Company's drug development pipeline, and increased selling, general and administrative expenses.

Amylin plans to release full financial results for the fourth quarter and year ended December 31, 2005 on Thursday, February 9, 2006, at the close of market, followed by a webcast of the Company's Quarterly Update Conference Call at 5:00 p.m. ET/2:00 p.m. PT. During the call, the Company plans to provide supporting details underlying its fourth quarter and 2005 financial results, and information regarding key trends and assumptions for 2006 operations.

About Amylin

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines.

This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. The Company's actual results could differ materially from those discussed herein due to a number of risks and uncertainties, including risks that the Company's final audited results for the fourth quarter of fiscal 2005 could differ materially from those described above as a result of the Company's customary quarterly financial closing procedures. These and additional risks and uncertainties are described more fully in the Company's most recently filed SEC documents, including its Form 10-Qs. Amylin disclaims any obligation to update these forward-looking statements.

http://biz.yahoo.com/prnews/060126/lath063.html?.v=43

[SeriousMoney]

Not a bad start, 2006!

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

[SeriousMoney]

Amylin designing trial of sustained diabetes drug
Reuters.com, Mon Jan 9, 2006 10:02 PM ET
By Deena Beasley

SAN FRANCISCO, Jan 9 (Reuters) - Amylin Pharmaceuticals Inc. (AMLN.O: Quote, Profile, Research) plans to launch this year a long-term trial of an extended release version of its diabetes drug Byetta, but is still in talks with regulators over the trial's design, the company's chief executive said on Monday.

"We don't know if this will be sufficient for a Phase 3 registration trial," said CEO Ginger Graham during an investors conference held here.

San Diego-based Amylin announced in August positive preliminary results from a 15-week study of the drug, a once-a-week injection called Exenatide LAR.

Byetta, which is given twice daily by injection, was approved by the U.S. Food and Drug Administration in April 2005 as a treatment for Type 2 diabetes in patients who no longer respond adequately to pills commonly used to control blood sugar.

Graham said the drug, which is co-marketed with Eli Lilly & Co. (LLY.N: Quote, Profile, Research) , is now the eighth most commonly prescribed drug for Type 2 diabetes.

But a large portion of prescriptions have been for refills, rather than new patients, according to prescription tracking services.

Graham said Amylin is "very pleased with the roll-out so far."

She also said the prescription figures have been skewed by several factors, including many new patient starts that are free samples.

The company is adding to its sales force next year and expects to raise the number of physicians it targets.

Graham said Amylin is also talking with the FDA about plans to launch in the first half of this year a study of Byetta as a single treatment in newly-diagnosed diabetes patients.

"It might work better if it is used earlier," said Lynn DePippo, managing partner at Sherbrook Capital Management LLC. In addition to Byetta, Amylin also sells diabetes drug Symlin for patients who are already on insulin.

Sales of the two drugs totaled $21.9 million in the third quarter of last year.

Novo Nordisk (NOVOb.CO: Quote, Profile, Research) is developing a drug in the same class as Byetta that is given by daily injection. The Danish company is expected to start a large pivotal stage trial of its drug this year, Graham said.

"We believe that the need for diabetes agents is so large -- there are hundreds of millions around the globe who need treatment," the CEO said.

Shares of Amylin rose 2.7 percent to close at $43.10 on Nasdaq.

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh53196_2006-01-10_03-02-15_n09...

[SeriousMoney]

Amylin Pharmaceuticals, Inc. Earnings Conference Call (Q4 2005)
Scheduled to start Thu, Feb 9, 2006, 5:00 pm Eastern

http://biz.yahoo.com/cc/0/63750.html

[SeriousMoney]

Amylin Pharmaceuticals Added to the NASDAQ-100 Index
PR, Monday January 9, 7:15 am ET

SAN DIEGO, Jan. 9 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN - News) announced that, effective today, it has been added to the NASDAQ-100 Index®, which is composed of the 100 largest non-financial stocks on The NASDAQ Stock Market® based on market capitalization and eligibility criteria.

"We are pleased to be included on the NASDAQ-100 Index and listed among the top companies in the world," said Ginger L. Graham, President and CEO of Amylin Pharmaceuticals, Inc. "It is particularly meaningful following our company's successful transition to a fully commercial organization in 2005 and the market adoption of our first-in-class diabetes products BYETTA® and SYMLIN®."

Amylin has a market capitalization of $4.4 billion.

About the NASDAQ-100 Index

The NASDAQ-100 Index, launched in January 1985, is one of the most widely followed benchmarks in the world. The NASDAQ-100 Index Tracking Stock represents ownership in the NASDAQ-100 Trust. The Trust holds a portfolio of equity securities that compose the NASDAQ-100 Index and aims to provide investment results that generally correspond with the performance of the Index.

NASDAQ® is the largest electronic screen-based equity securities market in the United States. With approximately 3,200 companies, it lists more companies and, on average, trades more shares per day than any other U.S. market. It is home to companies that are leaders across all areas of business including technology, retail, communications, financial services, transportation, media and biotechnology.

About Amylin

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first- in-class medicines for diabetes, SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin is located in San Diego, California with over 1000 employees nationwide. Further information on Amylin Pharmaceuticals and its pipeline in metabolism is available at http://www.amylin.com .

http://biz.yahoo.com/prnews/060109/nym120.html?.v=27

[SeriousMoney]

Bucking The Odds at Amylin
Friday December 30, 3:58 pm ET
By Arlene Weintraub, BusinessWeek Online

At least once a day, Ginger L. Graham follows a routine that many people with diabetes know all too well: She pricks her finger and tests her blood sugar. Graham, chief executive of Amylin Pharmaceuticals Inc. (NasdaqNM:AMLN - News), does not have diabetes. But her company just launched two new drugs to treat the disease, and Graham believes that to truly understand her customers, she must live the diabetic lifestyle. "I just think we don't appreciate how hard their lives are," she says. So she watches her diet, taking notice of foods that can cause dangerous glucose swings. But it's the finger sticks that are the toughest to get used to. "I dread it," confesses Graham, 50. "It's so unpleasant."

Those daily jabs are pretty much the only pain Graham is experiencing these days. In the spring, after 18 years of regulatory setbacks and near-death experiences, San Diego-based Amylin pulled off a rare feat in biotech, scoring Food & Drug Administration approval for both its first and second products. The back-to-back wins -- which Graham celebrated by jumping into the fountain outside Amylin's headquarters -- instantly transformed the company from a pure research outfit to a player in the pharma business. And Graham, who has been CEO since 2003, found herself facing brand new challenges, from cobbling together a salesforce to gearing up for commercial manufacturing. "We needed to hire 300 people all at once," she says.

For the most part, Amylin's transition is going swimmingly. In March the company introduced Symlin, an engineered form of a human hormone that insulin-dependent diabetics can take along with insulin to smooth out dangerous fluctuations in blood sugar. Two months later, Amylin launched Byetta, a drug derived from a hormone found in the saliva of desert-dwelling Gila monsters. The injected hormone, aimed at diabetics who are not yet dependent on insulin, helps them control their blood sugar. That, in turn, could keep patients from sliding toward insulin dependency. The company is on track to report 2005 sales of $122 million, analysts estimate. Because of its frantic expansion, Amylin's loss is expected to jump 38% over 2004, to about $216 million. But analysts believe the company could turn profitable by 2008 and surpass $1 billion in annual sales the following year.

Graham already has her scientists working on an improved version of Byetta, which may have to be injected only once a week, as opposed to twice a day. And the drug may offer an additional benefit: In August the company announced that in an early clinical trial, patients taking the longer-acting drug lost an average of nine pounds.

Considering that most diabetes treatments cause patients to gain weight -- which in turn aggravates their condition -- investors were stunned. "I don't think anyone has seen such compelling data," says Kris H. Jenner, a biotech analyst for T. Rowe Price Group Inc. (NasdaqNM:TROW - News), which holds shares of Amylin. Hopes for the next generation of Byetta, which could be introduced by 2008, helped push Amylin's stock up 58% in 2005, to $39.70.

Dire Straits

There was a time when Amylin's fate seemed as precarious as that of the threatened Gila monster. In 1998, Graham was an executive at device maker Guidant Corp. (GDT) and serving on Amylin's board when the company suffered some setbacks. Johnson & Johnson (JNJ) pulled out of a key research partnership, Amylin's share price fell to 31 cents, and it was nearly delisted from the NASDAQ. Six weeks from running out of cash, the biotech stripped down from 300 employees to 37.

Amylin was in such dire straits that some board members invested their own money to keep it afloat. Graham contributed $200,000 to the cause. "I thought: 'This is somebody who puts her money where her mouth is,"' says Chief Operating Officer Daniel M. Bradbury. The company raised $33.5 million altogether, allowing it to continue studying its flagship drug Symlin, as well as Byetta, which Amylin acquired from its inventor in 1996.

Sleeping Beauty

In 2003, Graham was mulling early retirement when Amylin's board asked her to take over as CEO. She quickly abandoned the idea of spending her days riding horses and learning to play the harp her husband bought her as a retirement gift. But shortly into her tenure, Graham realized the job might be harder than she anticipated. Unexpectedly, the FDA said it wouldn't approve Symlin without more clinical trial data.
It was the second such request -- and a chilling warning that the drug might never see the light of day. On the other hand, early studies of Byetta indicated that it might be a billion-dollar drug. Graham deliberated briefly before shifting all but 20 of the 350 employees then working at Amylin over to the Byetta team.

For the many employees who had staked their careers on Symlin, the move was painful. The mood at Amylin was grim, especially for Graham, who was simultaneously mourning the death of her mother. In a pep talk to the staff, Graham explained that Symlin was like Sleeping Beauty: "She was still beautiful, but she had to go to sleep." After Symlin was approved, Graham came to work dressed as the newly awakened Sleeping Beauty and handed out hardbound copies of the fairy tale.

Graham has always had a penchant for the theatrical. As a child growing up on a chicken farm in Arkansas, she competed in local rodeos, earning the title of Arkansas High School Rodeo Queen. "I could rope a calf or tie a goat or run barrels and poles," she says. As an undergraduate at the University of Arkansas she won the 1976 state title and then competed at the national Miss Rodeo America Pageant. Her speech about Arkansas garnered her the top prize in the public-speaking portion of the contest.

Competing in the male-dominated world of rodeo prepared Graham well for her first corporate gig, selling agricultural chemicals for a division of Eli Lilly & Co. (NYSE:LLY - News). As a woman working in agriculture at that time, Graham was such an oddity that her very presence offended some customers. One of Lilly's largest buyers refused to work with Graham and called her manager to demand that the previous sales rep -- a man -- return to the account. Her manager refused, and an undaunted Graham kept calling on the customer. "I hung out there, I got to know all the staff," she says. Her stubbornness paid off: He became a loyal customer.

The normally soft-spoken and approachable Graham can turn crusty if she's not getting her way. After returning to Lilly in 1986, Graham worked in a variety of divisions, ranging from finance to pharmaceuticals to medical devices. In 1987 she managed the sale of Elizabeth Arden to Faberge for $735 million -- then the largest cosmetics deal ever. When one of the Morgan Stanley (NYSE:MWD - News) bankers dragged his feet, "she had him backed into a corner and she was screaming at him," says Michael Hunt, who worked with her on the deal. "She was holding him accountable." In the middle of the negotiations, the Black Monday market crash forced the parties to restructure the financing. Still, Graham and Hunt managed to close it at the originally agreed-upon price.

Today, Graham is facing a delicate balancing act. She has to transform Amylin into a sales-driven company without letting go of the scrappy culture that inspired those original 37 survivors to stick by two promising drugs. "How do you infuse that into all these new people who didn't go through the Valley of Death?" asks Joseph C. Cook Jr., Amylin's former CEO and now chairman of the board. "Ginger worries about that." Graham vows to continue to spend heavily on research, nurturing Amylin's experimental drugs to treat obesity and heart failure. And she spends much of her time on the road, speaking to all of the newly hired salespeople.

The rodeo-queen-turned-CEO revels in telling new recruits about Amylin's two-decade fight for survival. One of her favorite stories describes an early Amylin investor who was so determined to nurture new treatments for his diabetic daughter that he FedExed a $6.2 million personal check to the company. Graham refers to these specimens of corporate lore as "cave paintings," and at her San Diego office she surrounds herself with symbols of Amylin's history, including figurines of Gila monsters and her personal copy of Sleeping Beauty. Every day they remind her of the challenge she has taken on. "I need to transfer what was," she says, "to what we're about to become."

http://biz.yahoo.com/bizwk/051230/b3966092.html?.v=1

[SeriousMoney]

Amylin Pharmaceuticals Acquires Facility in Ohio to Manufacture Exenatide LAR
PR, Thursday December 29, 4:29 pm ET

SAN DIEGO, Dec. 29 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN - News) today announced that it has purchased an existing 150,000 square foot building and 26 acres of land in West Chester, Ohio. This acquisition completes previously announced facility expansion plans for the eventual commercial manufacturing of a long-acting release (LAR) formulation of exenatide, a product candidate in development for the treatment of type 2 diabetes. Exenatide is the active ingredient in the commercial product BYETTA® (exenatide) injection, which is used twice a day for the treatment of type 2 diabetes. The acquisition price and associated costs for the building and land were approximately $9 million.

Facility and process design efforts are already underway and construction is set to begin in early 2006. The facility is expected to cost up to $150 million and will be completed in phases, allowing initial use of the facility before final aspects of construction are completed in 2008.

Amylin's new facility is being designed to manufacture exenatide LAR in bulk form and finished drug product, and will also include packaging capabilities. The commercial use of this facility will depend upon successful clinical development, manufacturing scale up activities, validation and regulatory approval. The plans for the facility also include manufacturing of exenatide LAR for clinical studies at increasing scale prior to transitioning to commercial manufacturing. Alkermes, Inc. will continue to provide exenatide LAR for clinical studies.

"This new facility is strategically located near our technology partner Alkermes, which will facilitate technology transfer and allow for additional support as we move forward," said Ginger L. Graham, President and CEO of Amylin Pharmaceuticals. "We are also very pleased with the cooperation and resources available to us in Ohio and Butler County, and look forward to building relationships within the community."

About Exenatide LAR

Amylin, Eli Lilly and Company, and Alkermes Inc. are working together to develop a once weekly sustained release, subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes' proprietary Medisorb® injectable long-acting release drug delivery technology. Exenatide LAR has not been approved by the Food and Drug Administration (FDA) for marketing in the United States.

About Amylin

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin is located in San Diego, California with over 1000 employees nationwide. Further information on Amylin Pharmaceuticals and its pipeline in metabolism is available at www.amylin.com.

This press release contains forward-looking statements about Amylin. The company's actual results could differ materially from those discussed in this press release due to a number of risks and uncertainties, including that BYETTA may not prove to be an important new therapeutic option or may be affected by unexpected new data or technical issues; risks and uncertainties that current or future exenatide LAR clinical trials may not confirm previous clinical trial results; risks and uncertainties inherent in the collaboration with and dependence upon Lilly and/or Alkermes; risks that exenatide LAR may not be successfully developed or receive regulatory approval; and risks and uncertainties that Amylin will be able to complete construction, manufacturing scale up, and validation of the manufacturing facility on a timely basis and/or within its budget projections, or at all. These and additional risks and uncertainties are described more fully in the Company's SEC filings, including its Form 10-Qs. Amylin undertakes no duty to update these forward-looking statements.

http://biz.yahoo.com/prnews/051229/lath032.html?.v=41

[SeriousMoney]

Toby's latest on AMLN 12/1/05

AMYLIN (AMLN): A terrific performer and a big long-term winning company -- does this stock have legs!

* Recent Trends: Mostly up -- a very solid chart with recent gains being consolidated on somewhat lower volume. The Big Pharma analysts and mutual funds are getting into the stock and a good deal of the recent rise is from this flow of funds.

* Upside Catalysts: There are two major upside catalysts in the next six months. The first is sales data for Byetta and Symlin (another recently approved drug), and the second is more trial data and FDA application dates for the long-lasting version of Byetta. One wild card is an outright purchase of the company by partner Eli Lilly (LLY), something increasingly remote as the stock price increases.

* Downside Catalysts: Any problem with Byetta is a big problem for the stock. Also, the company could buy another firm or additional licensing rights, but it's a cash-rich company ($500 million in the bank) and might not need to issue shares for a small deal.

http://www.changewave.com/biotech/

[SeriousMoney]

Amylin Still Has Edge Over Novo Nordisk In Diabetes
Forbes.com, David Ng, 11.28.05, 2:26 PM ET

Piper Jaffray reiterated an "outperform" rating and $43 target price on Amylin Pharmaceuticals (nasdaq: AMLN - news - people ), saying the company's diabetes treatments still have the upper hand over the competing product from Novo Nordisk (nyse: NVO - news - people ).

"We believe that Amylin will continue to hold multiple competitive advantages with its Byetta franchise, including more convenient dosing frequency, timeline and first mover advantage," Piper analyst Thomas Wei wrote in a note to investors.

Novo Nordisk's liraglutide has shown "impressive" results for phase IIb trials, according to Piper. The research firm added that liraglutide has reached "the gold standard measure" for glycemic control.

"On safety, the drug appeared well tolerated, with a low 5% to 10% rate of nausea and no hypoglycemia reported," Piper said.

Novo Nordisk recently reiterated its intent to initiate a 3,800-patient, Phase III program in February 2006, according to the research firm.

Piper believes Amylin can obtain regulatory approval for its long-acting release exenatide treatment with a much smaller patient database, thus potentially beating Novo Nordisk to market.

http://www.forbes.com/markets/2005/11/28/amylin-pharmaceuticals-novo-1128markets08.html?partner=yaho...

[SeriousMoney]

Amylin Pharma Seen As A Top Small-Cap Pick
Forbes.com, David Ng, 11.16.05, 12:17 PM ET

Piper Jaffray reiterated an "outperform" rating and $43 target price on Amylin Pharmaceuticals (nasdaq: AMLN - news - people ), saying the company is "one of our top small-cap picks" based on the prospects of its diabetes treatment, Byetta.

Amylin recently announced top-line results for a Phase III study of Byetta, demonstrating a solid placebo-adjusted reduction at the 16-week time point in patients.

The company said 62% of Byetta patients compared to 16% on placebo achieved the American Diabetes Association hemoglobin standard, HbA1c, of 7% or less.

Piper said the most common adverse event was nausea, seen in 40% of Byetta patients compared to 15% on placebo, "in-line with prior studies which have shown a rate of 45% to 51%."

The research firm said Amylin could potentially expand the label for Byetta by mid-2007.

For fiscal 2006 and 2007, Piper reiterated the loss-per-share estimates on Amylin of $1.61 and 78 cents, respectively.

http://www.forbes.com/markets/2005/11/16/amylin-pharmaceuticals-earnings-1116markets09.html?partner=...

[SeriousMoney]

Novacea Announces Appointment of Daniel M. Bradbury to Board of Directors
PR, Monday November 14, 8:30 am ET

SOUTH SAN FRANCISCO, CA--(MARKET WIRE)--Nov 14, 2005 -- Novacea, Inc. announced today the appointment of Daniel M. Bradbury to the Company's Board of Directors.

Mr. Bradbury is currently Chief Operating Officer of Amylin Pharmaceuticals, Inc. (NasdaqNM:AMLN - News) and a member of the Board of Directors of Illumina, Inc. and Cerexa, Inc. Prior to joining Amylin in 1994, Mr. Bradbury spent eleven years in various international sales and marketing roles with Beecham Pharmaceuticals and SmithKline Beecham Pharmaceuticals. Mr. Bradbury holds a Pharmacy degree from Nottingham University and a Diploma in Management Studies from Harrow and Ealing Colleges of Higher Education and is a member of the Royal Pharmaceutical Society of Great Britain.

"We are delighted to announce that Dan Bradbury has accepted our invitation to join the Novacea Board of Directors," Brad Goodwin, chief executive officer of Novacea said. "With more than 20 years in the biopharmaceutical industry, he brings significant experience, intelligence and passion that will be a tremendous asset to Novacea as we move forward with the development and commercialization of our oncology product pipeline, which includes two Phase 3-ready products."

About Novacea

Novacea, Inc. is a privately held biopharmaceutical company focused on licensing, developing and commercializing novel agents to revolutionize the treatment of cancer. Novacea's in-licensed product portfolio features three clinical stage oncology therapeutics. Products ready for Phase 3 studies are DN-101, for the treatment of advanced prostate cancer, and vinorelbine oral, for the treatment of breast or lung cancer. Banoxantrone, or AQ4N, is in a Phase 1 study in advanced malignancies and a Phase 1/2 study in patients with non-Hodgkin's lymphoma or chronic lymphocytic leukemia. The Company also features a highly-experienced management team and leverages this leadership to ensure that each program fully realizes the benefits of the Company's expertise, creativity and commitment to excellence. For more information, visit www.novacea.com.

http://biz.yahoo.com/iw/051114/0100613.html

[SeriousMoney]

Sell Some Amylin to Panicked Shorts
By James J. Cramer, RealMoney.com Columnist, 8/24/2005 9:24 AM EDT

Can't figure out how some stocks get so hated. Take this Amylin (AMLN:Nasdaq) . The short position has doubled in the last few months. Doubled! All because the scrips for its new diabetes drug Byetta may not be as good as thought.

I approach Amylin totally differently from the shorts. For some reason -- I think because it is an epidemic -- I have a lot of friends who have diabetes. Any positive for them, I cheer. It's a tough disease. When Byetta hit the market, I went out hard on Amylin, saying it should be bought. The catcalls started almost immediately, and any time the stock lifted, I saw shorts trying to knock the thing down, selling it below the bid, making it heavy at every turn.

Last night, Amylin revealed that it might have a once-a-week injectible for diabetes. The shorts weren't thinking about the possibility. Today, I see them going nuts -- the stock is much higher than it was -- covering the darned thing in early morning trading. (Only crazed short-sellers buy stocks up $6.)

What should you do if you have been listening to me on Amylin? I would sell the stock, that's what I would do, at least half the position, and play with the house's money for the rest. Think about it: This injectible is something that won't hit the market for a couple of years. You have time. Sell into the shorts' panic.

But remember, any company working on diabetes is, per se, a company you should consider because the market is much more huge than most people realize. The Amylin shorts learned that today. Sobering lesson.

http://www.thestreet.com/_tscct/funds/smarter_up/10239332.html