Amylin - Zwei mögliche Blockbuster-Zulassungen im Frühjahr!!! - 500 Beiträge pro Seite

[blb]

Was haltet ihr von der Aktie? Ende März sowie Ende April stehen hier zwei FDA-Entscheidungen an, beides mögliche Blockbuster gegen Diabetes Typ 1 und 2! Marketcap von Amylin zwar schon stolze 2 Milliarden, trotzdem ist hier meiner Meinung nach noch einiges drin!

Meinungen?

[Buddah]

wie heisst es so schön:Verkaufe Deine Hoffnung! Kaufe Deine Angst!


zugegeben ich kannte die Firma nicht...denke aber,dass der Kurs wohl oder übel von den FDA-Entscheidungen abhängt...und auf eine Zulassung zu spekulieren halte ich für sehr gefährlich...
was haben die denn noch so in der pipeline?
mfg B.

[Buddah]

BRADBURY, DANIEL COO 01/05/2005 Form 4 AS IN (1,000) $22.660 9,581

GRAHAM, GINGER L. CEO 01/04/2005 Form 4 Option OE D 30,000 $7.125 105,600

BARON, ALAIN D. SR VP 01/03/2005 Form 4 AS D (934) $23.392 5,954

BARON, ALAIN D. SR VP 01/03/2005 Form 4 Option OE D 934 $7.188 6,888

GREENE, HOWARD E. JR. DIR 01/03/2005 Form 4 AS IN (3,846) $23.464 1,930,286

KOLTERMAN, ORVILLE G. SR VP 01/03/2005 Form 4 Option OE D 3,000 $0.313 97,410

KOLTERMAN, ORVILLE G. SR VP 01/03/2005 Form 4 AS D (3,000) $23.630 94,410

FOLETTA, MARK G. CFO 12/31/2004 Form 4 AS D (3,000) $23.500 19,262

FOLETTA, MARK G. CFO 12/31/2004 Form 4 Option OE D 3,000 $5.730 22,262

ROWLAND, LLOYD VP 12/30/2004 Form 4 AS D (2,500) $23.470 8,730

ROWLAND, LLOYD VP 12/30/2004 Form 4 Option OE D 2,500 $5.590 11,230

COOK, JOSEPH C. JR CB 12/27/2004 Form 4 JB D 3,000 $23.500 1,011,478

COOK, JOSEPH C. JR CB 12/27/2004 Form 4 JS IN (15,000) $23.500 113,303

BROWN, MARTIN R. SR VP 12/21/2004 Form 4 Option OE D 10,000 $5.730 149,274

COOK, JOSEPH C. JR CB 12/20/2004 Form 4 JS IN (2,449) $22.450 128,303

COOK, JOSEPH C. JR CB 12/20/2004 Form 4 Option OE IN 10,000 $5.500 130,752

GREENE, HOWARD E. JR. DIR 12/20/2004 Form 4 AS IN (3,846) $22.732 1,934,132

ROWLAND, LLOYD GEN CNSL 12/15/2004 Form 4 Option OE D 2,500 $5.590 11,230

BROWN, MARTIN R. SR VP 12/14/2004 Form 4 AS D (4,000) $22.164 139,274

DATA, JOANN L. SR VP 12/14/2004 Form 4 Option OE D 13,125 $5.730 75,363

Relation Codes
COO - Chief Operating Officer
CEO - Chief Executive Officer
SR VP - Senior Vice President
DIR - Director
CFO - Chief Fincl Officer
VP - Vice President
CB - Chairman
GEN CNSL - General Counsel
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Trans Type Codes
AS - Automatic Sell
OE - Option Exercise
JB - Acquisition (Non Open Market)
JS - Disposition (Non Open Market)
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Ownership Type Codes
IN - Indirect
D - Direct

http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&symbol=AM…

sieht aus als würden da welche Kasse machen...

[blb]

Homepage: www.amylin.com

Es handelt sich um folgende zwei Medikamente mit einem Marktpotenzial von jeweils 1 Milliarde $ (geschätzt):

SYMLIN® (pramlintide acetate)

SYMLIN® is a unique injectable product candidate intended for the treatment of patients with type 1 diabetes and insulin-using patients with type 2 diabetes. Other than insulin and insulin analogues, SYMLIN® is the first potential treatment addressing glucose control for patients with type 1 diabetes that has completed Phase 3 clinical trials since the discovery of insulin over 80 years ago. In clinical studies, SYMLIN® has demonstrated improvements in blood glucose control in people treated with insulin alone, or insulin plus one or more oral medications, without causing a weight increase.

Scientific Overview

SYMLIN® is a synthetic version of the human hormone, amylin. It is the first member of a new class of therapeutic medications known as amylinomimetic agents, or amylin receptor agonists. Amylinomimetic agents mimic the actions of the hormone amylin and have demonstrated activity in blood glucose regulation. Amylin is made in and secreted from the same cells in the pancreas that make and secrete insulin. These pancreatic cells are called beta cells. In normal physiology, amylin complements the actions of insulin, and these two hormones work together with another pancreatic hormone, glucagon, to maintain normal glucose concentrations. Along with insulin, amylin concentrations normally increase and glucagon levels decrease after meals.

In people with type 1 diabetes, insulin and amylin concentrations are extremely low or undetectable and do not increase after meals, and conversely, glucagon levels tend to rise after meals. In people with type 2 diabetes whose disease has progressed to the point where they need insulin therapy, the normal post-meal increase in insulin and amylin concentrations also fails to occur, and glucagon levels also are inappropriately elevated in the post-meal period. These hormonal abnormalities contribute significantly to the disturbance of glucose metabolism in the context of a meal. Replacement of insulin alone, the current therapy, cannot replace amylin’s actions nor can insulin normalize post-meal glucagon concentrations.

Clinical Trials

More than 5,000 patients have been treated with SYMLIN. Amylin has completed six Phase 3 clinical trials with various doses of SYMLIN® as well as numerous Phase 2 and Phase 1 trials. Additionally, the company has completed long-term open-label safety trials and open-label extensions of the Phase 3 clinical trials to assess long-term effects of SYMLIN®. Phase 3 trials have shown a statistically significant reduction in A1C levels for both type 1 and insulin-using type 2 patients. Data from short-term clinical trials involving both type 1 and insulin-using type 2 diabetes patients showed that SYMLIN®, as an adjunct to insulin, can:

prevent the abnormal rise in glucagon after meals;
slow the rate of gastric emptying; and
reduce the range of after-meal variations in blood glucose levels.
Across all of long-term Phase 3 SYMLIN® clinical trials, patients with type 1 and type 2 diabetes receiving the recommended dosage of SYMLIN®, in addition to their existing diabetes therapy, achieved an average additional reduction in A1C of 0.3% and 0.4%, respectively, at the end of 26 weeks (compared to patients using insulin with placebo). In these studies, patients with type 2 diabetes who were treated with SYMLIN® lost an average of 3.3 pounds during the trial period, while patients with type 2 diabetes in the control group gained an average of 0.7 pounds. Trial participants with type 1 diabetes who received the recommended dose of SYMLIN lost an average of 2.4 pounds at the end of 26 weeks, while those patients receiving insulin and placebo gained an average of 1.5 pounds.

In the two most recent SYMLIN® Phase 3 clinical trials, each of which lasted 52 weeks, patients with type 1 and type 2 diabetes receiving the recommended dosage of SYMLIN® in addition to their existing diabetes therapy achieved an average additional reduction in A1C levels of 0.4% and 0.6% respectively (compared to patients using insulin with placebo). In these trials, patients with type 2 diabetes treated with SYMLIN lost an average of 3.1 pounds during the trial period, while patients with type 2 diabetes in the control group gained an average of 1.5 pounds. Trial participants with type 1 diabetes who were overweight upon trial entry and who received the recommended dose of SYMLIN lost an average of 3.5 pounds during the trial period, while patients receiving insulin and placebo gained an average of 3.5 pounds.

In long-term SYMLIN clinical trials of 26 or 52 weeks, the addition of SYMLIN® did not adversely affect patients’ lipids or blood pressure. The most commonly occurring side effects in the SYMLIN® trials have been nausea, anorexia and vomiting, which were generally mild to moderate in intensity, were dose related, occurred early in treatment and generally dissipated over time.

In April 2002, after consultation with the FDA, Amylin initiated a seven-month dose titration study of SYMLIN focused on safety involving approximately 300 subjects with type 1 diabetes. The data from this study indicated that initiation of SYMLIN® therapy using a dose-titration protocol reduced the impact of nausea and that SYMLIN® was associated with a positive effect on post-meal glucose. The data also showed a reduction in A1C at 16 weeks consistent with the non-inferiority objective for the study. As shown in previous pivotal studies, the SYMLIN® treated subjects used less insulin and had a reduction in weight, and the control group used more insulin and gained weight.

SYMLIN dose titration also reduced the incidence of severe hypoglycemia during the initiation phase of this study compared to earlier pivotal trials. The rate of severe hypoglycemia observed is consistent with that seen in the landmark Diabetes Control and Complication Trials. Approximately 75% of the SYMLIN® treated subjects progressed to the highest trial dose of 60 micrograms, in accordance with the protocol, and experienced a similar rate of severe hypoglycemia to the control group during the titration period. Doses of SYMLIN higher than 30 micrograms were not well tolerated by approximately 25% of subjects. This group experienced higher rates of nausea with initiation of therapy and subsequently experienced higher rates of hypoglycemia. Most of the 30 microgram dose subjects chose to continue in the study and experienced reductions in both post-meal glucose and A1C. Conclusions cannot be drawn with respect to severe hypoglycemia until data is available from the full seven months of treatment.

Regulatory Status

In December 2000, Amylin submitted a New Drug Application, or NDA, for SYMLIN® to the FDA. In October 2001, the company received a letter from the FDA stating that SYMLIN® was approvable for marketing in the United States, as an adjunctive therapy with insulin, for the treatment of type 1 and insulin-using type 2 diabetes patients, subject to satisfactory results from additional clinical trials. In April 2002, Amylin commenced the seven-month dose titration study, and in March 2003 all patients completed the study. The company also completed four smaller trials to clarify suggested prescribing information. Based on the approvable letter from the FDA, Amylin believes that efficacy for SYMLIN® has been established. As a result, the dose titration study employed a “non-inferiority” design to permit evaluation of the results without having to demonstrate statistically significant differences in efficacy between the SYMLIN® and placebo treatment groups. While focusing principally on safety, however, Amylin expects the FDA will want the safety of SYMLIN® to be established without giving up improvements in glucose control or other important parameters of diabetes management. Amylin submitted an NDA amendment for SYMLIN in June of 2003 and received a second approvable letter in December 2003. Discussions are underway with the FDA to identify specific requirements for approval.

Amylin submitted a Marketing Authorization Application, or MAA, for SYMLIN® to the European regulatory authorities in May 2001. In October 2002, following consultation with the European Committee for Proprietary Medicinal Products, Amylin determined that additional information would be required for approval of SYMLIN in Europe. The European centralized regulatory procedure provides no mechanism for adding new information to an application in progress; therefore, Amylin withdrew the MAA for SYMLIN®. The company is engaging in further discussions with European regulatory authorities and other regulatory experts to clarify regulatory alternatives and requirements for SYMLIN®.

In August 2001, Amylin submitted an application for SYMLIN® to regulatory authorities in Switzerland (Swissmedic). Amylin submitted interim summary data from the SYMLIN® dose titration trial and study reports from four smaller studies at the request of the Swiss authorities in March 2003. The interim summary was performed with concurrence from the FDA, and the FDA received a copy of the Swiss submission. In January 2004, Amylin withdrew the regulatory application after receiving correspondence from the Swissmedic indicating that SYMLIN® could not be approved for marketing in Switzerland based on data received to date. The Swiss regulatory procedure does not allow for another supplemental submission of data at this stage. The revision in Amylin’s Swiss regulatory strategy for SYMLIN® does not affect regulatory strategies being pursued in the U.S.

Target Market

The primary patient population focus for SYMLIN® is people with diabetes who use insulin. This target population currently has limited therapeutic options. Patients with type 1 diabetes have complete beta cell deficiency and must use insulin to sustain life or undergo islet transplant therapy, which, in some cases, can temporarily render them insulin-independent. Patients with type 2 diabetes who have progressed to insulin therapy have typically exhausted other therapeutic options for improved blood glucose control due to advanced beta cell dysfunction. Amylin estimates that this group is made up of approximately 4.5 million people in the United States based on published and proprietary estimates. Within this population group, the company estimates that approximately one million people have type 1 diabetes, and the remaining 3.5 million have type 2 diabetes. SYMLIN® is an injectable product and Amylin plans to market it in syringe/vial form and a pen/cartridge system similar to those currently marketed with newer insulin preparations.

[blb]

Exenatide - (synthetic exendin-4)

Exenatide is a first-in-class drug candidate for the treatment of type 2 diabetes. Exenatide is initially being developed to improve glucose control in patients with type 2 diabetes who are not using insulin and are not achieving target levels with diet and oral medications.

In September 2002 Amylin announced a global agreement with Eli Lilly and Company to collaborate on the development and commercialization of exenatide.

Scientific Overview

Exenatide is a potent 39-amino acid peptide that exhibits several anti-diabetic, or glucose lowering, actions. It is the first member of a new class of therapeutic medications known as incretin mimetic agents. Exenatide (synthetic exendin-4) is being investigated for its potential to address important unmet medical needs of many people with type 2 diabetes. Clinical trials suggest that exenatide treatment decreases blood glucose toward target levels and is associated with weight loss. The effects on glucose control seen with exenatide treatment are likely due to several actions that are similar to those of the naturally occurring incretin hormone GLP-1. These actions include stimulating the body’s ability to produce insulin in response to elevated levels of blood glucose, inhibiting the release of glucagon following meals and slowing the rate at which nutrients are absorbed into the bloodstream. In animal studies exenatide administration resulted in preservation and formation of new beta cells, the insulin-producing cells in the pancreas, which fail as type 2 diabetes progresses.

Clinical Trials

A small Phase 2 clinical trial of exenatide completed in 1999 in people with type 2 diabetes showed statistically significant reductions in post-meal glucose concentrations, post-meal increases in glucagon concentrations and reductions in the rate of nutrient release from the stomach. Patients also reported sensations of fullness and satiety following exenatide administration. In another Phase 2 clinical trial completed in 1999, the blood glucose concentration during the first five hours following a standardized meal was reduced on average by 34% in participants that were treated with exenatide (compared to participants that were treated with placebo). In addition to lowering post-meal glucose concentrations, exenatide has also been shown to suppress post-meal elevations in serum triglyceride concentrations in people with type 2 diabetes. Elevations in post-meal triglycerides appear to be an independent risk factor for cardiovascular mortality.

In June 2001, Amylin announced the results of a Phase 2 clinical trial designed to examine the effect of exenatide on glucose control in over 100 subjects with type 2 diabetes who were not achieving adequate blood glucose control with their current oral medications. In this 28-day trial, patients treated with exenatide, together with their current oral medications, experienced statistically significant lowering of A1C levels by 0.7% to 1.1%, compared to the average reductions experienced by patients treated with their current oral medications and placebo of 0.3%. Moreover, 90% of patients treated with exenatide together with their current oral medications experienced reductions in A1C levels of greater than or equal to 0.5%, compared to 33% of patients treated with their current oral medications and placebo. It is important to note that this was a 28 day study and that A1C measures average blood glucose concentrations over a 3-4 month period.

In these clinical trials, exenatide was well tolerated. The majority of reported adverse events in the trials were judged to be mild or moderate in intensity. These events included nausea, which was the most common adverse event, and to a much lesser extent, vomiting. To better understand how to minimize nausea, Amylin performed a Phase 2 dose-escalation trial in which patients achieved a target dose either gradually or suddenly. The data indicated that patients who gradually increased their dose of exenatide had a clinically meaningful reduction in the incidence of nausea over patients who did not receive a gradual dose increase.

In September 2001, Amylin announced that another Phase 2 clinical trial indicated that exenatide stimulated insulin secretion and lowered the elevated fasting blood glucose concentrations in people with type 2 diabetes after an overnight fast.

Amylin commenced a Phase 3 program for exenatide in December 2001. The Phase 3 program includes three pivotal trials.

In all three studies, patients are randomized into three groups, two on exenatide and one on placebo. Those on active drugs receive an introductory 5 microgram dose for one month, given by subcutaneous injection twice a day at breakfast and dinner, followed by six-months of exposure to doses of either 5 micrograms or 10 micrograms given twice a day.

The first pivotal study was designed to evaluate the effects of exenatide in people with type 2 diabetes not achieving target blood glucose concentrations using metformin alone prior to entering the study. Metformin is one of several available oral therapies for the treatment of type 2 diabetes. The second pivotal trial is evaluating the effects of exenatide on patients not achieving target blood glucose concentrations using sulfonylureas alone. Sulfonylureas are another form of oral therapy for the treatment of type 2 diabetes. The third of the three Phase 3 pivotal trials is evaluating the effects of exenatide on patients who are currently not achieving target blood glucose concentrations using a combination of metformin and sulfonylureas. All of the treatment groups in each of the three Phase 3 clinical trials are continuing to use their current therapies of oral medications.

In August 2002, Amylin commenced an open-label clinical study using a similar protocol to the Phase 3 pivotal trials. This study includes patients not achieving target blood glucose concentrations using metformin, sulfonylureas or both metformin and sulfonylureas. In August 2003, 105 patients in this ongoing open-label study showed mean reductions in A1C of 1.3% at the end of six months. At the end of six months, 44% of these participants had lowered their A1C to the treatment goal of less than or equal to 7% set by the American Diabetes Association. In this trial, the effect of exenatide on A1C appears unaltered by the formation of antibodies. The most common adverse event reported was mild to moderate nausea, consistent with previous exenatide clinical studies. Participants maintain their current diabetes treatment regimens for the duration of the trial. Subjects received an introductory 5-microgram dose for four weeks by subcutaneous injection twice a day at breakfast and dinner. After four weeks, the dose was increased to 10 micrograms twice a day.

In November 2003, Amylin reported positive results from the final Phase3 pivotal study of exenatide (synthetic exendin-4), marking the conclusion of the long-term human clinical trials required for regulatory submission to the FDA. All three pivotal studies met the primary glucose control endpoint as measured by hemoglobin A1c (A1C). The average reduction in A1C across the Phase 3 program in patients completing the studies on the highest dose of exenatide (10 micrograms twice daily) was approximately one percent. Additionally, approximately 40 percent of these patients achieved A1C measurements of 7 percent or less. On average, subjects in the Phase 3 program on the highest dose of exenatide also showed statistically significant reductions in body weight of approximately two kilograms. The most common adverse event was mild to moderate, transient nausea.

Regulatory Status

Amylin filed an Investigational New Drug Application, or IND, for exenatide in January 1999 prior to the initiation of clinical trials. The successful completion of exenatide`s phase 3 pivotal studies was announced in November 2003. A New Drug Application (NDA) is planned for submission to the FDA mid-2004.

Target Market

The initial patient focus for exenatide is patients with type 2 diabetes who are not using insulin and are not achieving target blood glucose concentrations with diet plus metformin and/or sulfonylureas. The current therapeutic steps available to this patient population are additional oral medications, the addition of insulin to the oral agent regimen or insulin therapy alone. These approaches are often not very successful and are usually associated with inconvenience and side effects, particularly weight gain. Amylin estimates this population of people with diabetes who were using oral medications as of 2001 to be 11.9 million in the United States, France, Germany, Italy, Japan, Spain and the United Kingdom, which comprise the seven largest pharmaceutical markets worldwide, of which an estimated 5.9 million people are in the United States. Amylin currently plans to market exenatide in an injectable pen/cartridge delivery system, subject to receiving the necessary regulatory approvals.

[blb]

Amylin Pharmaceuticals Provides Update On Clinical Development Programs
SUNDAY, DECEMBER 05, 2004 11:00 PM
- PR Newswire

SAN DIEGO, Dec 5, 2004 /PRNewswire-FirstCall via COMTEX/ -- Amylin Pharmaceuticals, Inc. (AMLN) today presented an update on its clinical development programs at a reception webcast from San Diego, CA. Included in the presentation were new data from its pramlintide (AC137) obesity program and details of a Phase 2 study recently initiated in its AC2592 development program for congestive heart failure. The successful completion of the AC137 study and initiation of the AC2592 study mark the achievement of all of the Company`s stated development milestones for 2004.

Amylin discussed results from its recently completed study in obese subjects evaluating the safety and tolerability of the drug candidate pramlintide (AC137). In the study, obese subjects were able to tolerate higher doses of pramlintide than those previously studied, and achieved clinically and statistically significant weight loss. Approximately 90% of subjects receiving pramlintide were able to progress to the highest dose of 240 micrograms three times a day. Consistent with previous observations, the most common side effect observed with pramlintide compared to placebo was mild, transient nausea.

This blinded, placebo-controlled study included 204 obese subjects, 160 without diabetes and 44 with non-insulin-treated type 2 diabetes. After a 1-week placebo lead-in period, study participants received pramlintide or placebo three times a day before meals and were asked to maintain their usual diet and exercise routines. During a 4-week dose-escalation period, subjects increased study medication to their highest tolerated dose, or a maximum of 240 micrograms three times a day. Following this dose-escalation period, subjects continued with their maintenance dose for 12 weeks. Pramlintide- treated subjects completing the 16-week active treatment period experienced progressive weight loss with an approximate 3.6% (3.5 kg) average reduction in body weight compared to placebo (p<0.0001). Thirty-one percent of pramlintide recipients completing active treatment achieved a 5% or greater weight loss compared to 2% of placebo recipients (p<0.0001).

"The results of this study improve our understanding of the safety and tolerability profile of pramlintide at higher doses than those used in previous studies of patients with type 1 or insulin-treated type 2 diabetes," said Orville Kolterman, MD, Senior Vice President, Clinical Affairs of Amylin. "In addition, we`ve learned that weight loss can be seen in obese subjects with and without diabetes."

Pramlintide is the active ingredient in SYMLIN(R) (pramlintide acetate) injection, which is being developed by Amylin. SYMLIN(R) is currently under review by the FDA for the treatment of type 1 and insulin-using type 2 diabetes with an action date of March 20, 2005.

Amylin also discussed details of a recently initiated Phase 2 study of AC2592, under investigation for the treatment of congestive heart failure. This program utilizes continuous infusion of glucagon-like peptide 1 (GLP-1), a naturally occurring hormone produced in the gut. This double-blind, placebo-controlled study will include approximately 180 subjects, and will test two doses of AC2592. The primary endpoint of this study will be peak oxygen consumption. The secondary endpoints will include various measures of quality of life and cardiac function.

In addition, Amylin provided an update on the ongoing open-label extensions of the exenatide pivotal studies. Data from these studies demonstrate sustained reductions in both blood sugar, as measured by A1C, and body weight through 18 months of treatment. The most common adverse event reported in clinical studies of exenatide has been mild to moderate nausea which occurred most frequently early in the studies. No new safety or tolerability signals have been observed in subjects completing 18 months of treatment. Exenatide is the first potential therapy in a new class of drugs under investigation for the treatment of type 2 diabetes known as incretin mimetics. Exenatide is currently under review by the FDA with an action date of April 30, 2005.

A recording of today`s webcast is accessible through Amylin`s corporate website, located at http://www.amylin.com.

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. Further information on Amylin Pharmaceuticals and its pipeline in metabolism is available at http://www.amylin.com.

This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. The company`s actual results could differ materially from those forward-looking statements discussed in this press release due to a number of risks and uncertainties, including risks and uncertainties that current or future clinical trials will confirm the results referred to in this release or the AC2592 study will conclude when planned; risks and uncertainties that exenatide and/or SYMLIN may not be approved by the FDA or that approval, if any, may be withheld, delayed and/or limited; risks and uncertainties in the FDA`s review process generally; risks and uncertainties inherent in the drug discovery and development process; and uncertainties regarding the company`s ongoing clinical studies of its drug candidates, including exenatide, pramlintide and AC2592. These and additional risks and uncertainties are described more fully in the Company`s recently filed registration statement on Form S-3 under the heading "Risks Related to Our Business" and our other recently filed SEC documents. Amylin undertakes no duty to update these forward-looking statements.

SOURCE Amylin Pharmaceuticals, Inc.

Mark G. Foletta, Vice President, Finance and Chief Financial
Officer, [phone]


http://www.amylin.com


Copyright (C) 2004 PR Newswire. All rights reserved.

[blb]

Hier noch Analystenschätzungen von Comdirect:

Verzehnfachung des Umsatzes innerhalb zwei Jahren, beide Zulassungen wohl vorausgesetzt...

2006e 2005e 2004



Umsatz 392,57 Mio. 164,11 Mio. 35,20 Mio.
EbitDa 0,00 0,00 -121,07 Mio.
EBIT 1,13 Mio. -112,35 Mio. -159,15 Mio.
Gewinn je Aktie -- -- --
KGV -- -- --
KCV -- -- --
Dividende je Aktie 0,00 0,00 0,00
Dividendenrendite 0,00% 0,00% 0,00%
Cashflow je Aktie -- -- --
Nettovermögen je Aktie -- -- 0,31
Nettoverschuldung * 0,00 0,00 0,00

Trifft dies ein halte ich eine Verdopplung der Marktkapitalisierung auf 4 Milliarden $ für möglich. Wird nur ein Medikament zugelassen, wär wohl immer noch einiges drin.

Was sagen die Experten?

Grüße
blb

[Buddah]

@blb
warum verkaufen die insider???

mfg B.

[blb]

@Buddah: Gute Frage! Natürlich würde das gegen eine Zulassung sprechen.

Ich hab jetzt nochmal ein bißchen recherchiert. Also Symlin nimmt anscheinend schon den dritten Anlauf für eine Zulassung. Das Marktpotenzial sehen Analysten hier doch nicht so hoch, wohl eher ein paar Millionen $! Bei Exenatide dagegen hab ich schon Schätzungen bis 1,5 Milliarden $ gelesen. Amylin teilt sich die Forschungskosten mit EliLilly hier 50:50 und wird dann auch 50% der Gewinne bekommen. Persönlich halte ich die Zulassung für Exenatide für wahrscheinlicher, man könnte also die erste Entscheidung abwarten und evtl. danach (auch nach einem möglichen Kursrutsch) einsteigen!

Vielleicht sind ja hier doch noch einige tiefer in der Materie drin. Würd mich über Postings freuen!

Grüße
blb (der überlegt sich ne kleine Position zuzulegen)

[blb]

Sollte natürlich "ein paar hundert Millionen" heißen...

[blb]

Symlin wurde heute zugelassen!

Amylin Pharmaceuticals Announces FDA Approval of SYMLIN(R) for Insulin-Using Type 2 and Type 1 Diabetes
WEDNESDAY, MARCH 16, 2005 5:00 PM
- PR Newswire


SAN DIEGO, March 16, 2005 /PRNewswire-FirstCall via COMTEX/ -- Amylin Pharmaceuticals, Inc. (AMLN) today announced that the U.S. Food and Drug Administration (FDA) has approved SYMLIN(R) (pramlintide acetate) injection to be used in conjunction with insulin to treat diabetes. SYMLIN is to be used at mealtime in patients with type 2 or type 1 diabetes who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN will be commercially available in approximately 90 days.

"The approval of SYMLIN, a first-in-class therapy, is a major milestone for Amylin Pharmaceuticals. It is the result of 18 years of research in diabetes," said Ginger L. Graham, President and CEO of Amylin Pharmaceuticals, Inc. "This extensive development program has resulted in prescribing information for SYMLIN that we believe is an excellent tool to introduce SYMLIN to the diabetes community."

Clinical studies demonstrate that SYMLIN, a self-administered injection given prior to meals, helps patients achieve lower blood glucose (sugar) after meals, leading to less fluctuation during the day, and better long-term glucose control (A1C) compared to patients taking insulin alone. In these studies, patients used less mealtime insulin and also had a reduction in body weight compared to patients taking insulin alone. SYMLIN was studied in over 5300 individuals in the clinical program that led to approval.

"SYMLIN provides a new option for many patients who, despite their best efforts with insulin therapy, continue to struggle to achieve their glucose control targets. These patients often experience weight gain and continued high blood sugar after meals," said Robert E. Ratner, MD, an investigator for SYMLIN clinical studies, Vice President for Scientific Affairs, MedStar Research Institute and Professor of Medicine at the Georgetown University Medical School. "The science behind SYMLIN has improved our understanding of the physiology of diabetes and has provided a welcome new tool for insulin users."

Important Safety Information

SYMLIN is not intended for all patients with diabetes. SYMLIN is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with SYMLIN use occurs, it is seen within three hours following a SYMLIN injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk. This information is highlighted in a boxed warning in the SYMLIN prescribing information for healthcare professionals and in a medication guide for patients, which will be distributed by pharmacists.

Other adverse events commonly observed with SYMLIN when co-administered with insulin were mostly gastrointestinal in nature, including nausea, which was the most frequently reported. The incidence of nausea was higher at the beginning of SYMLIN treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when SYMLIN is gradually increased to the recommended doses.

Amylin will provide educational programs for physicians, diabetes care teams, and patients to help ensure appropriate administration and patient selection. In addition, the company plans to conduct a small pediatric study and a two-year open-label study to evaluate SYMLIN use in clinical practice and assess the effectiveness of its education programs.

About SYMLIN

SYMLIN is an antihyperglycemic drug for use in patients with diabetes treated with insulin. SYMLIN is a synthetic analog of human amylin, a naturally occurring hormone that is made in the beta cells of the pancreas, the same cells that make insulin. In patients with type 2 diabetes who use insulin, and in patients with type 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals. The use of SYMLIN contributes to glucose control after meals.

Healthcare professionals and people with diabetes may obtain more information, including the complete prescribing information and the medication guide, at www.SYMLIN.com.

About Diabetes

Diabetes is a large and growing market in the United States, affecting over 18 million Americans and growing at three times the rate of population growth. Approximately 4.5 million patients with diabetes use insulin. Diabetes is the sixth leading cause of death in the United States.

Diabetes is a complex metabolic disease manifesting with a defect in the beta cells in the pancreas, resulting in a deficiency of both insulin and amylin secretion. Poor control of blood sugar may result in severe long-term complications such as kidney failure, nerve damage, blindness, amputation and cardiovascular disease.

Webcast Announcement

Amylin Pharmaceuticals will webcast a conference call to discuss the SYMLIN approval and commercialization plans on Thursday, March 17, 2005 at 8:30 a.m. ET (5:30 a.m. PT). Ginger L. Graham, President and Chief Executive Officer of Amylin Pharmaceuticals, will lead the call.

The call will be webcast live through Amylin`s corporate website, and a recording will be made available following the close of the call. To access the webcast, please log on to www.amylin.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. A recording will be available by phone for 24 hours beginning approximately one hour after the close of the call and can be accessed at 888-286-8010 (domestic) or 617-801-6888 (international), passcode 17581369.

About Amylin Pharmaceuticals

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. The company`s first product, SYMLIN(R) (pramlintide acetate) injection is an antihyperglycemic drug for use in patients with diabetes treated with insulin. The company`s second compound, exenatide, is under review at the FDA for improved glucose control for people with type 2 diabetes. Further information on Amylin and its pipeline in metabolism is available at www.amylin.com.

Safe Harbor/Forward Looking Statements

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 SYMLIN may not prove to be an important new therapeutic option, SYMLIN may not be commercially available in 90 days, SYMLIN may be affected by unexpected new data or technical issues, or that exenatide may not be approved by the FDA or that approval, if any, may be withheld, delayed and/or limited. The potential for SYMLIN may also be affected by reimbursement and pricing decisions, the pace of market acceptance, and any issues related to manufacturing and supply. These and additional risks and uncertainties are described more fully in the Company`s recently filed Form 10-K under the heading "Risks Related to Our Business". Amylin undertakes no duty to update these forward-looking statements.

SOURCE Amylin Pharmaceuticals

investors, Alice Bahner, Executive Director, Investor Relations, ext. 7272, or media
Eric Shearin, Sr. Manager, Corporate Communications, ext. 7177, both of Amylin
Pharmaceuticals, Inc., [phone]


http://www.prnewswire.com


Copyright (C) 2005 PR Newswire. All rights reserved.

[blb]

Ende April kommt dann Entscheidung Nummer 2...

[blb]

Medikament Nummer 2 wurde heute ebenfalls zugelassen ,der Kurs sinkt jedoch! Kann mir das irgendjemand erklären?

Lilly-Amylin Diabetes Drug Wins FDA Approval

By Althea Chang
TheStreet.com Staff Reporter
4/29/2005 12:12 PM EDT
Click here for more stories by Althea Chang


Eli Lilly (LLY:NYSE - commentary - research) and partner Amylin Pharmaceuticals (AMLN:Nasdaq - commentary - research) announced approval of a new diabetes drug that the companies say will be in pharmacies by June.

The Food and Drug Administration approved the Byetta injection as an adjunctive therapy for type 2 diabetes for patients who have not been able to control blood sugar levels using common oral diabetes drugs. The FDA says the drug is also approvable as a stand-alone therapy.




Byetta, chemically known as exenatide, is the first drug approved from the class of incretin mimetics drugs, which work by stimulating insulin secretion, lowering blood-sugar levels after meals and while fasting. The drug restores the insulin secretion response in the pancreas, which is lost in patients with type 2 diabetes.

"Often, current treatments do not provide adequate blood-sugar control leaving patients and caregivers frustrated," says Ginger Graham, Amylin Pharmaceuticals` CEO. "Byetta, a first-in-class medicine, is a new therapy for those who are not able to effectively control their blood sugar with their current oral medications."

Eli Lilly shares were recently down 9 cents, or 0.2%, to $57.91. Amylin shares sank $1.77, or 9.7%, to $16.41.

[blb]

Mittlerweile sind beide Medikamente erhältlich. Kurs zieht an!

[blb]

Die Situation bei Amylin mal auf den Punkt gebracht:

Diabetes-Firma hat es geschafft, doch der Kurs fällt

Von Daniel Wilhelmi

Es ist Dienstag und damit ist beim Profit-Radar der Tisch mit Biotech- und Nanotechspeisen angerichtet. Erinnern Sie sich? Letzten Dienstag schrieb ich Ihnen, dass ich derzeit eine Aktie recherchiere, die vom Markt völlig falsch bewertet wird. Nun, ich halte mein Wort: In dieser und der nächsten Ausgabe des Profit-Radar wird sich alles um das amerikanische Biotech-Unternehmen Amylin (AMLN-Nasdaq) drehen.

Fangen wir von vorne an. Amylin ist einer der wenigen übrig gebliebenen Biotechs der 1. Stunde, ist aber bei der breiten Anlegermasse wesentlich unbekannter als Unternehmen wie Vertex (VRTX-Nasdaq) oder Protein Design Labs (PDLI-Nasdaq).

Amylin ist auf Diabetes spezialisiert, besitzt eine umfangreiche und aussichtsreiche Produktpipeline und ist wie die meisten Biotechs noch hoch defizitär. Seit Jahren forscht man an 2 Diabetes-Medikamenten namens Symlin und Exenatide. Nun, nach Jahren der Forschung und typischen Rückschlägen (Symlin wurde 2 Mal von der amerikanischen Gesundheitsbehörde FDA mit der Bitte um mehr Studiendaten zurückgewiesen) sollte es in diesem Frühling so weit sein. Beide Wirkstoffe standen bei der FDA auf der Prüfungsliste.

Volle Produktpipeline, doch die Anleger wollen davon nichts wissen

Zum Jahresanfang stand der Aktienkurs von Amylin knapp unter 24,00 US$. Dann der Knaller: Amylin erhielt von der FDA nicht nur die Zulassung für 1 Medikament, sondern gleich sowohl für das umstrittene Symlin als auch Exenatide. Das sind sensationelle News für das Biotech-Unternehmen.

Der Kurs muss vor Freude durch die Decke gehen, richtig? Falsch. Der Aktienkurs ist gestern auf ein neues Jahrestief gefallen! Von seinen Jahreshöchstkursen bei 24,95 US$ am 10. Januar hat die Aktie von Amylin sage und schreibe 38,47% verloren.

Moment mal. OBWOHL das Unternehmen die Zulassung für 2 Medikamente erhalten hat, ist Amylin jetzt knapp 40% weniger wert als im Januar, als noch völlig ungewiss war, ob diese Medikamente überhaupt auf den Markt kommen? Zumindest müsste der Aktienkurs ja auf dem Januar-Niveau notieren, da sich die Unternehmenslage nicht verschlechtert hat. Und das Gegenteil ist ja sogar der Fall: Die Unternehmenslage hat sich dramatisch verbessert. Die Reaktion des Marktes ist doch komplett unlogisch.


Amylin jetzt weniger wert als vor FDA-Entscheidung

Es gibt einige Erklärungen für das Missfallen der Anleger an Amylin. So stellt sich immer mehr heraus, das Symlin wohl nie das Riesen-Medikament werden wird, wovon man früher ausging. Stattdessen wird es nur für Spitzenumsätze im Bereich von 200 Mio. US$ gut sein. Aber das würde einen gleich bleibenden Aktienkurs rechtfertigen, denn immerhin wird Amylin jetzt Umsätze von 100 bis 200 Mio. US$ erzielen, die es im Januar noch nicht gab.

Bei Byetta, wie der Marketing-Name von Exenatide nun lauten wird, war es die Enttäuschung, dass Byetta nicht als Einzeltherapie zugelassen wurde, sondern nur als Zusatzanwendung mit den bekannten Diabetes-Präparaten Metformin und Sulfonylurea eingesetzt werden wird. Das Verrückte: Etwas anderes hatte das Management nie beabsichtigt.

Für eine weitere Zulassung für eine Einzelanwendung, die dann tatsächlich das große Umsatzpotenzial in sich birgt, wird noch eine zusätzliche Phase-III-Studie von Nöten sein. Da macht es aus unternehmerischer Sicht wesentlich mehr Sinn, Byetta erst einmal als Zusatzmittel (für die Kontrolle des Blutzuckerspiegels) auf den Markt zu bringen, und so schon einmal Umsätze zu erzielen, während man weiterforscht.

Short-Seller drücken künstlich die Kurse

Trotzdem ist die Aktie gestern auf ein neues Jahrestief gefallen. Warum? Aus den USA höre ich dafür nur die 2 Worte, die jedem Long-Anleger den Angstschweiß auf die Stirn treiben: ?Short-Seller?. Tatsächlich haben nach meinen Quellen einige Hedge Fonds verschiedene Aktien ausgewählt und prügeln auf diese Werte ein wie die Klitschkos.

Unter diesen Werten befinden sich übrigens interessanterweise überdurchschnittlich viele Biotechs. So habe ich erfahren, dass zum Beispiel auch die beliebte Millennium Pharmaceuticals (MLNM-Nasdaq) auf der Abschussliste steht. Doch da sich bei Amylin im Gegensatz zu einigen der anderen Firmen die fundamentale Lage deutlich verbessert hat, bietet sich hier eine interessante Chance, auf die ich morgen an gleicher Stelle im Detail eingehen werde.


Hier kaufen Insider!

Von Daniel Wilhelmi

Biotech: Amylin, Teil 2: Ein Short-Squeeze steht bevor

Dies ist der 2. Teil über das amerikanische Biotech-Unternehmen. Amylin Pharmaceuticals (AMYLN-Nasdaq). Ich will hier nicht noch einmal detailliert auf alle Fakten von gestern eingehen. Die können Sie ja problemlos im Profit-Radar nachlesen.

Die Situation ist folgende: Amylin (aktuelle Marktkapitalisierung ca. 1,6 Mrd. US$) hat nach Jahren der defizitären Forschung in 2005 endlich den Sprung vom forschenden Biotech-Unternehmen zum wirtschaftenden Biotech-Unternehmen geschafft.

Im 1. Quartal 2005 hat man die Zulassung für 2 Medikamente erhalten. Zudem verfügt man über eine äußerst zukunftsträchtige und gut diversifizierte Forschungspipeline mit 5 weiteren Präparaten (3 in Phase II und 2 in Phase I). Dabei hat man seine Forschung neben Diabetes auf die ebenfalls hoch lukrative Indikationsfelder Fettleibigkeit und Herz-Kreislauf-Erkrankungen ausgedehnt. Das Unternehmen schreibt zwar noch dicke Verluste, und wird dies auch noch in den nächsten Jahren tun, aber der Grundstein für einen wirtschaftlichen Erfolg ist gelegt.

Hedge Fonds manipulieren noch den Kurs

Trotzdem ist der Aktienkurs diesem Jahr um knapp 40% eingebrochen. Dafür gibt es keine logische Erklärung, denn die fundamentale Lage hat sich nach den beiden Zulassungen dramatisch verbessert. Die Kursverluste wären angebracht, wenn eines oder beide Mittel abgelehnt worden wären. Aber sie wurden ja zugelassen.

Die einzige andere logische Erklärung für den Kursverfall ist, dass die Amylin-Aktie im Vorfeld (bei Kursen um 24,00 US$) überbewertet war. Aber Studien die ich gelesen habe, bestätigen die Annahme nicht. So hat das Investmenthaus Bear Stearns den fairen Wert von Amylin nach den Zulassungen auf 25,00 US$ taxiert.

Fazit: Der Markt bewertet diese Aktie falsch. Wie Sie vom gestrigen Profit Radar wissen, sind es Hedge Fonds, die den Kurs von Amylin als Short-Seller nach unten treiben. Inzwischen ist das Short-Interest von Amylin auf astronomische 15,76% angewachsen. Das ist ein Niveau, das sie sonst nur bei Pleite-Kandidaten finden, und davon ist Amylin nach den Zulassungen und einer soliden Cash-Position meilenweit entfernt.

Und genau diese Situation bietet gewieften Anlegern spannende Chancen. Denn wenn Hedge Fonds Aktien manipulieren, bedeutet dies, dass diese Werte wieder zu ihrer wahren Bewertung zurückkehren, sobald sich die Hedge Fonds ein anderes Opfer suchen.

Wenn die Shorties aussteigen, wird Kurs explodieren

Das wird auch bei Amylin so sein, wo die fundamental verbesserte Lage ja klar gegen ein Short-Engagement spricht. Das deutet auf einen mächtigen Short-Squeeze hin. Eines der lukrativsten Szenarien an der Börse, bei denen Sie sehr schnell sehr viel Geld verdienen können. Denn wenn der Kurs anfängt, nach oben zu drehen, und sich die guten Fundamentaldaten durchsetzen, dann müssen sich immer mehr Short-Seller Hals über Kopf eindecken. In Panik kaufen sie die leer verkauften Aktien am Markt zurück, egal zu welchem Preis. Die Kurse explodieren.

Für den Aktien Trader (www.investor-verlag.de/produkte/at) warten wir nur auf das Einstiegssignal. Aber es gibt noch einen weiteren Punkt, der Amylin besonders spannend macht: Die Insider. Keiner kennt eine Firma besser als das Management. Deshalb ist es wichtig, das Anlageverhalten der Firmeninsider genau zu beobachten. Wenn diese plötzlich in Massen ihre Papiere auf den Markt werfen, müssen bei Ihnen die Alarmglocken angehen. Bei Amylin erleben wir derzeit genau das Gegenteil. Auf dem niedrigen Niveau kaufen die Manager von Amylin aggressiv eigene Aktien. Und wer weiß besser über den wahren Wert von Amylin Bescheid, als das Management.

Insider kaufen massiv Amylin-Aktien

Im Mai haben die Insider bei Amylin für satte 841.351 US$ Aktien des eigenen Unternehmens über den Aktienmarkt gekauft. Bedenken Sie: Die müssen das nicht tun. Die können ihr Geld in alle nur erdenklichen Anlageformen investieren, aber sie kaufen sich bei Amylin ein. Das tun sie nur, weil sie den fairen Wert von Amylin deutlich über den aktuellen Kursen sehen.

Dabei bekommen Sie die Aktie von Amylin aktuell sogar noch billiger als die Insider. Die haben durchschnittlich 16,76 US$ gezahlt. Erst am 10. Mai kaufte der Vizeprädident Craig Eberhard noch Amylin-Papiere im Wert von 199,525 US$ für 17,35 US$. Aktuell notiert Amylin bei 15,05 US$. Setzen Sie Amylin deshalb unbedingt auf Ihre Watchlist. Zu einem Kauf ist es jetzt noch zu früh. Aber wenn der richtige Moment gekommen ist und der Short-Squeeze startet, gibt es hier richtig viel Geld zu verdienen.

Have a successful day.


Ihr Daniel Wilhelmi

Quelle: www.wissen-fuer-investoren.de

[blb]

Sieht sehr gut aus! Schade, dass das hier keinen interessiert!

[Binnochdrin]

Hallo blb,
danke für die Infos, das alles interessiert mich mächtig.
Ich habe mir schon ein paar Stücke von Amylin gekauft.
Klingt alles sehr vielversprechend und der Kurs hat ja auch schon nach oben gedreht.
Viele Grüße
Binnochdrin

[Aktientrader62]

Bin bei 12,80 Euro eingestiegen 30.Prozent im Mai heißt für mich aussteigen. Grund RSI ist mir zu hoch gelaufen steige lieber um die 15,00 Euro noch mal ein.

[Aktientrader62]

Merrill Lynch stuft AMLN heute auf neutral.

[blb]

AMLN läuft sehr gut zur Zeit. Die Aktie ist kurz davor den langfristigen Abwärtstrend zu brechen. Darüber wär erstmal Luft bis 24$, danach bis zum Hoch bei 30$. Ob das im ersten Versuch gelingt, ist allerdings fraglich. Fundamental interessant sind sicherlich die nächsten Quartalszahlen mit den ersten Prognosen für die Verkäufe der beiden am Markt erhältlichen Diabetes-Medikamente.

Hier ist sehr schön die 5-wellige Abwärtsbewegung zu sehen, die nach der EW-Theorie abgeschlossen ist.

[Aktientrader62]

Ich mußte fast 2. Monate warten bis Amylin wieder Richtung 15,00 Euro ging. Bei 15,17 Euro hab ich sie dann bekommen. Die letzten zwei Tage ging Amylin durch die Decke. Heute geht der Spass weiter es müssen sehr gute Zahlen anstehen. Das hier welche im Vorfeld kaufen. Kursziele liegen bei 30,00 bis 40,00 Dollar ?? So billig werden wir sie vielleicht nicht mehr sehen unter 17,00 Euro kann man noch einsteigen der den Zug verpasst hat !!

Tschau
Aktientrader62

[blb]

Wer Details braucht:

http://library.corporate-ir.net/library/10/101/101911/items/…

[blb]

Vor den Zahlen gab es heute eine derbe Abstufung...

Amylin Pharmaceuticals Reports Second Quarter Financial Results
THURSDAY, AUGUST 04, 2005 4:01 PM
- PR Newswire

SAN DIEGO, Aug 04, 2005 /PRNewswire-FirstCall via COMTEX/ -- Amylin Pharmaceuticals, Inc. (AMLN) today reported financial results for the quarter and the six months ended June 30, 2005. The Company reported total revenue of $46.8 million for the second quarter, which included the Company`s first net product sales of $8.7 million. Net loss was $26.6 million or $0.26 per share for the quarter.

"In the first few weeks of the launch of Amylin`s two new first-in-class products, physician interest in both BYETTA and SYMLIN is very high," said Ginger L. Graham, Amylin`s President and Chief Executive Officer. "We shipped both products ahead of schedule and have fully staffed our field organization. Our focus will continue to be on the implementation of our commercialization strategy."

Net product sales of $8.7 million include sales of $7.5 million for BYETTA(TM) (exenatide) injection, a first-in-class therapy for type 2 diabetes, and $1.2 million for SYMLIN(R) (pramlintide acetate) injection, a first-in-class diabetes therapy that is used with mealtime insulin. Net product sales consist of shipments of BYETTA and SYMLIN to the Company`s wholesale customers, net of allowances for discounts, distribution fees and returns.

Revenue under collaborative agreements increased to $38.1 million for the quarter ended June 30, 2005, from $7.6 million for the same period in 2004. For the six months ended June 30, 2005, revenue under collaborative agreements increased to $42.4 million, from $14.2 million for the same period in 2004. The increase primarily reflects the recognition of $35 million in milestone payments from Eli Lilly and Company earned in connection with the regulatory approval and commercial launch of BYETTA in the United States during the second quarter of 2005.

Cost of goods sold was $1.5 million for both the quarter and six months ended June 30, 2005, and consists of costs associated with the manufacture of BYETTA and SYMLIN.

Research and development expenses decreased to $26.7 million for the quarter ended June 30, 2005, compared to $29.9 million for the same period in 2004. For the six months ended June 30, 2004, research and development expenses decreased to $54.1 million compared to $57.4 million for the same period in 2004. The reduction in research and development expenses in the current periods primarily reflects reduced development expenses for BYETTA, partially offset by increased expenditures for the Company`s Phase 2 programs in obesity, diabetes and cardiovascular disease and early stage research activities, as compared to the same periods in 2004.

Selling, general and administrative expenses for the quarter ended June 30, 2005, were $42.3 million compared to $15.7 million for the same period in 2004. For the six months ended June 30, 2005, selling, general and administrative expenses were $62.4 million compared to $31.8 million for the same period in 2004. The expected increase in the current periods reflects execution of the Company`s plans to expand its commercial capabilities and business infrastructure to support the recent launches of BYETTA and SYMLIN in the United States. This expansion included the addition of over 300 field personnel, expanded medical education programs for both medicines, and establishment of customer service capabilities.

In connection with net product sales for BYETTA, the Company also recorded collaborative profit sharing of $2.9 million in the second quarter.

Net loss was $26.6 million, or $0.26 per share, for the three months ended June 30, 2005, compared to a net loss of $39.4 million, or $0.42 per share, for the same period in 2004. For the six months ended June 30, 2005, net loss was $70.2 million, or $0.68 per share, compared to a net loss of $76.7 million, or $0.82 per share, for the same period in 2004.

Operating activities used approximately $81.0 million of cash in the first half of 2005, compared to $88.1 million for the same period in 2004. At June 30, 2005, the Company held cash, cash equivalents and short-term investments of approximately $401 million.

Second Quarter Highlights
* Amylin and its collaboration partner Lilly received approval for and
launched BYETTA in the United States. BYETTA is indicated for people
with type 2 diabetes who have inadequate glucose control with
metformin, sulfonylureas, or both.
* Amylin also launched SYMLIN, indicated for people with type 1 or type
2 diabetes who use mealtime insulin.
* To support the launch of these two new first-in-class diabetes
products, Amylin recruited, hired, and trained over 300 additional
field personnel.
* The Company had a significant commercial and research presence at the
American Diabetes Association annual meeting, the premier diabetes
meeting for the medical community, launching physician education
programs and presenting 12 abstracts in oral and poster presentations.
* Amylin presented data from a 16-week Phase 2 obesity study of
pramlintide (AC137) at the European Congress on Obesity showing
statistically significant, progressive weight loss of 3.6 percent (3.5
kilograms) compared to placebo, with no evidence of a plateau in
effect at 16 weeks. A new Phase 2 dose-ranging study of pramlintide
for obesity is now fully enrolled.
* Amylin completed enrollment for a Phase 2 multiple-dose study of the
once weekly LAR formulation of BYETTA. Amylin expects to announce
results from the study by the end of 2005.

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/or SYMLIN may not prove to be important new therapeutic options or may be affected by unexpected new data or technical issues; that the Company may not be able to effectively launch BYETTA and/or SYMLIN; that current or future clinical trials will not replicate previous trial results or will not conclude when planned; that our drug candidates may not receive regulatory approval; and risks and uncertainties inherent in the drug discovery and development 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/or SYMLIN. These and additional risks and uncertainties are described more fully in the Company`s most recently filed SEC documents, including its Annual Report on Form 10-K for the year ending December 31, 2004. Amylin undertakes no duty to update these forward-looking statements.

CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)

Quarter Six months
ended June 30, ended June 30,
2005 2004 2005 2004
Revenues:
Net product sales $8,652 $-- $8,652 $--
Revenue under
collaborative
agreements 38,114 7,559 42,376 14,248
Total revenues 46,766 7,559 51,028 14,248

Costs and expenses:
Cost of goods sold 1,522 -- 1,522 --
Research and development 26,661 29,932 54,129 57,389
Selling, general and
administrative 42,315 15,691 62,386 31,779
Collaborative profit
sharing 2,866 -- 2,866 --
Total costs and expenses 73,364 45,623 120,903 89,168

Operating loss (26,598) (38,064) (69,875) (74,920)

Interest income
(expense), net 4 (1,363) (323) (1,780)

Net loss $(26,594) $(39,427) $(70,198) (76,700)

Net loss per share - basic
and diluted $(0.26) $(0.42) $(0.68) $(0.82)

Shares used in computing
net loss per share -
basic and diluted 104,100 93,889 102,790 93,864




CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

June 30, December 31,
2005 2004
Assets
Current assets:
Cash and cash equivalents $64,966 $60,583
Short-term investments 336,026 233,173
Accounts receivable, net 10,530 --
Receivables from collaborative partners 257 5,770
Inventories 23,430 15,676
Other current assets 15,695 9,156
Property and equipment, net 24,859 20,739
Other assets 11,581 12,703
Total assets $487,344 $357,800

Liabilities and stockholders` equity (deficit)
Accounts payable, accrued expenses and other
current liabilities $46,162 $37,651
Current portion of deferred revenue 4,286 4,286
Other liabilities, net of current portion 9,132 7,290
Deferred revenue, net of current portion 13,800 20,943
Convertible senior notes 375,000 375,000
Stockholders` equity (deficit) 38,964 (87,370)
Total liabilities and stockholders`
equity (deficit) $487,344 $357,800



CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

Six Months Ended
June 30,
2005 2004
Operating activities:
Net loss $(70,198) $(76,700)
Adjustments to reconcile net loss to cash
used for operating activities:
Non-cash expenses 5,447 3,192
Working capital changes (16,205) (14,625)
Net cash used for operating activities (80,956) (88,133)

Investing activities:
Purchases, sales and maturities of short-term
investments, net (102,760) (94,699)
Purchases of equipment and increase in
patents, net (7,882) (7,607)
Net cash used for investing activities (110,642) (102,306)

Financing activities:
Proceeds from issuance of common stock, net 195,988 3,498
Proceeds from issuance of convertible
senior notes -- 193,642
Principal payments on notes payable and
capital leases (7) (6)
Net cash provided by financing activities 195,981 197,134

Increase (decrease) in cash and cash equivalents 4,383 6,695

Cash and cash equivalents at beginning of period 60,583 76,615
Cash and cash equivalents at end of period 64,966 $83,310


SOURCE Amylin Pharmaceuticals, Inc.

Mark G. Foletta, Vice President Finance and Chief Financial Officer of Amylin
Pharmaceuticals, Inc., [phone]


http://www.prnewswire.com


Copyright (C) 2005 PR Newswire. All rights reserved. ********************************************************************** As of Sunday, 07-31-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 07-25-2005 for AMLN @ $20.61. (C) 2005 Comtex News Network, Inc. All rights reserved.

[blb]

Die Abstufung heute vor den Zahlen war eine Frechheit. Die Verkäufe sind sehr gut, 8 Millionen im ersten Verkaufsmonat. Das kann man sich nun schön hochrechnen!

Ich bin noch nicht investiert, überlege aber stark. Vielleicht kommt der Kurs nochmal zurück. Zur Zeit ist da Extremstmanipulation am Werk, man siehts auch die letzten Wochen am Kursverlauf!

Grüße
blb

[blb]

Hammer ist der Short Interest:

Short Interest: 25,870,240 (24.82%)

[blb]

Man nähert sich wieder dem langfristigen Abwärtstrend...

[blb]

Sorry, Chart vergessen...

[lopinsky]

hallo blb,
bin heute auf AMYLIN Pharma durch godemode-trader aufmerksam geworden. der einstieg ist jetz wohl nich ratsam. Aber bei einem ordentlichen Absacker, den ich Dir nicht wünsche, schon.

Gratuliere für Deine Arbeit!

Viel Erfolg!

http://www.godmode-trader.de/news.php?ida=243899&idc=65

Gruß
L.

[lopinsky]

upps,
da fehlen zwei "t" : jetzt und nicht

[blb]

War leider eine Woche in Kroatien. Der Kursverlauf spricht für sich. Muss mir das Ganze aber erstmal in Ruhe durchlesen...

[blb]

Wir hatten AMLN übrigens in unserem Musterdepot bei www.f-tor.de/board . Die Position wurde mit rund 60% Gewinn verkauft!

[blb]

Neues All-Time-High. Glückwunsch allen Investierten...

[BrauchGeld]

Hallo Zusammen

Wer bei Amylin den zug verpasst hat ,kann sich Conjuchem anschauen die besitzen ein konkurrenzprodukt in der pipeline in Phase 2b ,nur mit dem unterschied das Conjuchem 30 mal niedriger bewertet ist als Amylin.
Hier kann man von anfang an dabei sein.

Marktkap:80mio€
Kurs:1,70€
cash:19mio€

http://www.conjuchem.com/

Spekulativ aber dafür auch mit mehr als 1000% chance.

[BrauchGeld]

Conjuchem arbeitet an einem produkt das nur 2x im monat injiziert werden muss also eindeutig besser als Amylins produkt.

Vielversprechende Therapieansätze mit neuen Hormon-Analoga
Für die Diabetes-Therapie wird nach neuen Wirkstoffen geforscht. In klinischen Studien geprüft wird derzeit zum Beispiel das subkutan anwendbare Amylin-Analogon Pramlintide.

Amylin ist ein Betazell-Hormon, das unter anderem über die Hemmung der postprandialen Glukagonsekretion und eine verzögerte Magenentleerung die Abstimmung von Insulin- und Kohlenhydratwirkung verbessert. Bei Typ-1-Diabetikern fehle das Hormon völlig, sagte Dr. Tim Heise vom Profil Institut für Stoffwechselforschung in Neuss in Bremen. Bei Typ-2-Diabetikern könne im Nüchternzustand zwar der Amylin-Spiegel erhöht sein, aber die Verstärkung zu den Mahlzeiten funktioniere nicht mehr.

In Studien mit Typ-1- und Typ-2Diabetikern, die vor dem Essen Normalinsulin oder Insulin lispro injizierten, verringerte das zusätzlich subkutan applizierte Pramlintide den postprandialen Blutzucker deutlich. Zudem hatte die Substanz einen positiven Effekt auf den HbA1c-Wert: Bei Typ-2-Diabetikern, die ein Jahr lang zusätzlich zu Insulin Pramlintide oder Placebo bekamen, nahm der HbA1c um bis zu 0,7 Prozentpunkte ab, so Heise. Der Insulinbedarf sank, so daß die Patienten die Insulindosis reduzieren konnten.

Fokus auf GLP-1-Derivate mit längerer Wirkungsdauer
Ein weiterer Therapieansatz ist das injizierbare intestinale Hormon GLP-1 (Glucagon-like Peptide). Es senkt den Blutzucker, indem es die Insulinfreisetzung glukoseabhängig stimuliert. "Wenn das normale Niveau erreicht ist, hört die insulinotrope Wirkung des Peptids auf. Der Patient muß also keine Hypoglykämie fürchten", berichtete Professor Burkhard Göke von der Universität München. GLP-1 hemmt die Glucagon-Sekretion, verzögert die Magenentleerung und verringert die Nahrungsaufnahme.

Die Wirkung von GLP-1 wurde unter anderem in einer sechswöchigen Studie mit Typ-2-Diabetikern geprüft, die das Hormon über eine Pumpe kontinuierlich subkutan erhielten. Nach vier Wochen war der HbA1c um 1,3 Prozentpunkte gesunken, die Patienten hatten leicht abgenommen.

GLP-1 hat nur eine kurze Plasma-Halbwertszeit, zwei bis drei Stunden nach der Injektion ist der Effekt weg, wie Göke sagte. Daher werden mehrere Derivate mit längerer Wirkung geprüft. Dazu gehöre ein GLP-1-Derivat des Unternehmens Novo Nordisk, das mit nur einer Spritze den GLP-1Tagesbedarf abdecken könne. Die Unternehmen Lilly und Amylin Pharmaceuticals testen gemeinsam Exendin-4. Das kanadische Unternehmen ConjuChem entwickelt einen GLP-1-Agonisten, der nur zweimal im Monat injiziert werden muß. (hbr / mar)

[blb]

Kapitalerhöhung am ATH. Nicht dumm...

Amylin Pharmaceuticals Announces Public Offering of Common Stock
TUESDAY, AUGUST 30, 2005 7:30 AM
- PR Newswire

SAN DIEGO, Aug 30, 2005 /PRNewswire-FirstCall via COMTEX/ -- Amylin Pharmaceuticals, Inc. (AMLN) today announced a public offering of 5,068,138 shares of common stock at a price of $31.00 per share under shelf registration statements previously filed and declared effective by the Securities and Exchange Commission (SEC). Net proceeds to Amylin are expected to be approximately $152 million.

A prospectus supplement relating to the offering will be filed with the SEC by Amylin, and will be available along with the base prospectuses filed with the SEC in connection with the shelf registrations, on the SEC`s website at http://www.sec.gov/. Goldman, Sachs & Co. is the sole underwriter for this offering. Printed copies of the prospectus supplement and base prospectuses relating to the offering may also be obtained, when available, from Goldman, Sachs & Co. (Attn: Prospectus Department, 85 Broad Street, New York, New York 10004, Phone: [phone]).

This announcement is neither an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state. The common stock is being offered in connection with a distribution by the issuer and represents a new financing.

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

SOURCE Amylin Pharmaceuticals, Inc.

Mark G. Foletta Vice President, Finance and Chief Financial Officer of Amylin
Pharmaceuticals, Inc., [phone]


http://www.prnewswire.com


Copyright (C) 2005 PR Newswire. All rights reserved. ********************************************************************** As of Friday, 08-26-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated an UPTREND on 08-03-2005 for AMLN @ $21.42. (C) 2005 Comtex News Network, Inc. All rights reserved.

[puhvogel]

Vielleciht für amylin Besitzer ganz interessant. Momentan werden die aktuellen Standards bei DM II ganz schön gelichtet. Nimmt schon bald COX2-Hemmer Dimensionen an.
http://www.newsday.com/news/health/wire/sns-ap-diabetes-pill…

[lopinsky]

Hallo gibt es hier noch Leute sie Anteile an Amylin besitzen?

Wünsche euch schöne Weihnachten!

Gruß
L.