INSMED: MILLIARDENMARKT DIABETES, u.a.... - 500 Beiträge pro Seite

[therman]

Hi,
Die Behandlung von Diabetes is ein Milliardenmarkt, der
noch weiter wachsen wird. Durch die ungesunde Ernährung
haben zum Beispiel sogar viele Jugendliche ein sogenanne
"Altersdiabetes".

Insmed, INSM, hat ausgezeichnete Chancen ein Bigplayer
im Bereich Diabetes zu werden.
Der Therapieansatz ist einzigartig.

http://www.insmed.com/

Insmed Reports Results from Nine Months of SomatoKine Therapy for a Patient with Extreme Insulin Resistance at the 43rd Meeting of the European Society of Pediatric Endocrinology
Monday September 13, 11:21 am ET
Results Show Lowered HbA1c From 7.6% to 6.1%


RICHMOND, Va.--(BUSINESS WIRE)--Sept. 13, 2004-- Insmed Incorporated (NASDAQ: INSM - News) today reported on results from a nine-month analysis of therapy with SomatoKine® (rhIGF-I/rhIGFBP-3 (mecasermin rinfibate) for a patient with Leprechaunism, the most extreme form of insulin resistance. The nine-month analysis demonstrated substantial improvements in growth, metabolic control, and neurological development. Of significant importance, the patient has surpassed the average expected life-span for Leprechaunism, and continues to receive therapy to date. No adverse effects related to SomatoKine treatment were observed.

The results from the nine-month analysis were presented at the 43rd Annual Meeting of the European Society of Pediatric Endocrinology (ESPE) by Marc De Kerdanet, M.D. of the University Center Hospital, Rennes, France and Andreas Sommer, Ph.D., Insmed`s Chief Scientific Officer.

The patient, referred to as Rennes-1, was a 4-month old female diagnosed with Leprechaunism. The diagnosis was confirmed by identification of two mutations in the insulin receptor gene. Prior to treatment, the patient had extremely high insulin levels (5490uU/mL), severe growth retardation (-3.3 SDS in height; -3.4 SDS in BMI), and poor blood sugar control.

After nine-months of treatment with SomatoKine®, the following observations were made:

1. IGF-I levels were restored within normal range,

2. HbA1c, a primary measure of blood sugar control, was reduced

from 7.6% to 6.1%,

3. Circulating mean insulin levels were reduced 742% from

5490uU/mL to 652uU/mL,

4. Standard height deviation improved from -3.3 to -2.2 SDS, Body

Mass Index (BMI) improved from -3.4 SDS to -1.7 SDS,

5. No adverse effects related to SomatoKine treatment were

observed.

The abstract is available on Insmed`s corporate website, www.insmed.com.

About Leprechaunism

Leprechaunism is characterized by extreme insulin resistance associated with a genetically defective insulin receptor resulting in hyperinsulinemia, uncontrolled glycemic variation, failure to thrive and short life expectancy. Leprechaunism is the most severe form of insulin resistance amongst a group of extreme insulin resistance syndromes that include Type A syndrome, Rabson-Mendenhall syndrome and type B syndrome.

More on SomatoKine® (rhIGF-I/rhIGFBP-3)

Insmed`s rhIGF-I/rhIGFBP-3 is a proprietary delivery composition of insulin-like growth factor-I (IGF-I). The novel compound is administered as a subcutaneous injection, which can restore IGF levels to physiological relevant levels. In diabetic subjects, administration of rhIGF-I/rhIGFBP-3 demonstrated a significant improvement in blood sugar control and a significant reduction in daily insulin use. Following severe burn injury, in both children and adults, administration of rhIGF-I/rhIGFBP-3 demonstrated a significant improvement in muscle protein synthesis and a significant reduction in the inflammatory response associated with the trauma. In recovery from hip fractures, administration of rhIGF-I/rhIGFBP-3 has demonstrated a significant improvement in functional recovery and bone mineral density. rhIGF-I/rhIGFBP-3 is currently in a pivotal Phase III clinical trial for the treatment of Growth Hormone Insensitivity Syndrome (GHIS).

About Insmed

Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com.

[therman]

News:

Insmed Receives European Orphan Drug Designation for SomatoKine for the Treatment of Extreme Insulin Resistance; Company to Initiate Clinial Trial in Type A Insulin Resistance
Monday October 25, 6:01 pm ET


RICHMOND, Va., Oct. 25 /PRNewswire-FirstCall/ -- Insmed Incorporated (Nasdaq: INSM - News) today announced that the Committee for Orphan Medicinal Products of the European Agency for the Evaluation of Medicinal Products (EMEA) has approved the Company`s application for orphan drug designation in Europe for SomatoKine®, for the treatment of extreme insulin resistance. In December 2003, Insmed reported that the Office of Orphan Products Development of the Food and Drug Administration has approved the Company`s application for orphan drug designation in the United States for SomatoKine®, for the treatment of extreme insulin resistance. The European orphan drug designation may provide Insmed ten years of market exclusivity in Europe upon SomatoKine® approval for this indication. The United States orphan drug designation may provide Insmed seven years of market exclusivity upon SomatoKine® approval for this indication. There is currently no approved treatment available for patients with extreme insulin resistance in Europe or the United States. Insmed plans to initiate a Phase II clinical trial in patients with Type A insulin resistance later this year.
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Efficacy of SomatoKine in an Extreme Insulin Resistant Patient:

In September Insmed reported on results from a nine-month analysis of therapy with SomatoKine® (rhIGF-I/rhIGFBP-3) (mecasermin rinfibate) for a patient with Leprechaunism, the most extreme form of insulin resistance. The nine-month analysis demonstrated substantial improvements in growth, metabolic control, and neurological development. Of significant importance, the patient surpassed the average expected life-span for Leprechaunism, and continues to receive therapy to date.

More on Extreme Insulin Resistance

Syndromes of Extreme Insulin Resistance appear to result from genetic defects in the insulin receptor or insulin action pathways. In addition to insulin resistance and glucose intolerance or overt diabetes, these syndromes share a number of common features including variable degrees of hyperandrogenism, hirsutism, and dysmorphic features.

[BrauchGeld]

Hi therman

Ich bin sowieso schon dabei.In 12 wochen etwa soll auch das NDA eingereicht werden.Also mittelfristig sieht es sowieso gut aus bei Insmed.
Hoffentlich schafft Insmed heute den sprung über die 2$ dann könnte es weiter aufwärts gehen.

Auf gute Kurse

Gruss
B.M.

[therman]

Hi BrauchGeld,


freut mich für Dich, dass Du dabei bist.

Ich denke wir werden noch viel Freude an INSM haben

Aber es braucht Geduld und gute Nerven, denn es wird
weiterhin volatil bleiben, denke ich, doch es lohnt sich,
denn das Potential ist enorm.

therman

[therman]

Hi,

bei INSM gibt es zur Zeit eine sehr gute Gelegenheit zum
Einsteigen bzw. aufstocken.
Auf Grund einer Kapitalerhöhung ist der Kurs gestern
um über 20% eingebrochen.

Habe heute bei 1,30 $ zugegriffen und meinen Bestand
verdoppelt. Durchschnittlicher KK: 1,65$.

Auf Grund folgender heutiger Nachricht hat sich der
Kurs jetzt stabilisiert.
Demnächst wird wohl der Start der Phase III bekanntgegeben,
was den Kurs wohl nach oben treiben wird.

News:

Insmed Announces Expansion of Patent Portfolio in the Treatment of Diabetes; New European Patent Granted for SomatoKine
RICHMOND, Va., Nov 9, 2004 (BUSINESS WIRE) -- Insmed Incorporated (NASDAQ: INSM) today announced issuance by the European Patent Organization of patent EP1183042 entitled "Methods for Treating Diabetes", covering the use of SomatoKine(R) (rhIGF-I/rhIGFBP-3) for the treatment of diabetes mellitus, including type 1 diabetes, type 2 diabetes and insulin resistant diabetes such as Type A insulin resistance. This European patent corresponds to the Company`s United States patent US 6,040,292 also entitled "Methods for Treating Diabetes". According to the World Health Organization (WHO), approximately 170 million people have diabetes worldwide, and that this number may double by the year 2025. WHO estimates that there are 33 million patients in Europe with theses conditions and an additional 18 million patients in the United States.

"This patent is important to further strengthen our expansive intellectual property position surrounding our novel IGF-I replacement therapy, SomatoKine(R)," commented Philip J. Young, Chief Business Officer and Executive Vice President. "This new patent complements our United States patent covering the same patient types. Based on data we have generated to date, we believe SomatoKine(R) has the potential to enhance the treatment of diabetes as well as insulin resistant conditions."

Over the past several years Insmed has conducted four Phase II clinical trials with SomatoKine in type 1 and type 2 diabetes patients demonstrating SomatoKine can significantly reduce daily insulin consumption, improve blood sugar and control improve insulin sensitivity. Insmed is preparing to initiate an additional clinical trial in Europe in Type A insulin resistance, one of the most severe forms of insulin resistance.

David Clemmons, M.D., Chief of Endocrinology, University of North Carolina School of Medicine added, "SomatoKine may prove to be a very useful addition for the management of diabetic patient who cannot achieve adequate blood sugar control. Clearly physicians need new therapies to add to their diabetic patients` regimen to help control the growing epidemic of diabetes and the resulting complications."

There is an extensive unmet medical need for a therapy that can improve blood sugar control and improve insulin sensitivity. Diabetes is one of the most common diseases in the world and is the leading cause of blindness, end-stage kidney disease, and due to nerve damage caused by excessive blood sugar; diabetes is the leading cause of non-traumatic amputations. Good blood sugar control can delay the onset and progression of these complications.

More on rhIGF-I/rhIGFBP-3, SomatoKine(R)

Insmed`s SomatoKine(R) is a proprietary delivery composition of insulin-like growth factor-I (IGF-I). The novel compound is administered as a subcutaneous injection, which can restore IGF levels to physiological relevant levels. SomatoKine(R) is currently in a pivotal Phase III clinical trial for the treatment of Growth Hormone Insensitivity Syndrome (GHIS). On July 20, Insmed provided the results from a six-month data analysis of the ongoing pivotal Phase III GHIS clinical trial showing a statistically significant increase (p<0.0001) in height velocity in children receiving SomatoKine(R) as a once-daily injection. In diabetic subjects, administration of SomatoKine(R) has demonstrated a significant improvement in blood sugar control and a significant reduction in daily insulin use. Following severe burn injury, in both children and adults, administration of SomatoKine(R) has demonstrated a significant improvement in muscle protein synthesis and a significant reduction in the inflammatory response associated with the trauma. In recovery from hip fractures, administration of SomatoKine(R) has demonstrated a significant improvement in functional recovery and bone mineral density

[therman]

Hi ,

der Kurs hat sich anscheinend stabilisiert und es
geht wieder aufwärts.

Die Kapitalerhöhung:

10-Nov-2004

Entry Material Agreement, Sale of Equity, Other Events, Financial Statements and Exhib



Item 1.01. Entry into a Material Definitive Agreement.
On November 8, 2004, Insmed Incorporated (the "Company" or "Insmed") raised approximately $8.7 million in gross proceeds from a private offering of its shares of Common Stock, $0.01 par value (the "Common Stock") and warrants to purchase Common Stock (the "Warrants") (the "Private Offering"). Wells Fargo Securities, LLC acted as the placement agent for the Company. The Company will pay Wells Fargo Securities, LLC $572,720 in fees and expenses. This Private Offering is described in more detail under Item 3.02 of this Current Report on Form 8-K. In connection with the Private Offering, the Company entered into the following agreements:

• Stock and Warrant Purchase Agreements, dated as of November 5, 2004, between the Company and each of the 14 institutional and accredited investors purchasing Common Stock and Warrants (the "Purchase Agreements"). Pursuant to the Purchase Agreements, the Company has agreed to file a registration statement on Form S-3 (or another appropriate form) with the Securities and Exchange Commission within 10 days after the first business day following the closing of the Private Offering, registering the Common Stock purchased and issued in connection with the Private Offering and the Common Stock issuable upon the exercise of the Warrants purchased and issued in connection with the Private Offering. Insmed has also agreed to use its best efforts to have the registration statement declared effective within 60 days from the filing of the registration statement.

• Warrants, dated as of November 5, 2004, to purchase up to 3,227,775 shares of Common Stock from the Company. These Warrants are exercisable on or after May 5, 2005, have an exercise price of $2.00 per share and will expire if not exercised on or prior to November 5, 2009.

The foregoing is a summary of the terms of the Stock and Warrant Purchase Agreement and the Warrants and does not purport to be complete and is qualified in its entirety by reference to the full text of the form of Stock and Warrant Purchase Agreement, including the form of Warrant, which is attached hereto as Exhibit 10.1.

[BrauchGeld]

Hi

Endlich ist die 2$ marke geknackt und das mit sehr hohen volumen.
Wenn jetzt noch das NDA filing kommt dann könnte es eventuell einen schönen ruck für die Aktie geben.
Hoffen wir mal das beste.

Gruss
B.M.

[therman]

Hi BG,

die nächsten kurzfristigen Widerstände sind bei 2,5
und 3 $.
die 2$ dienen jetzt als Unterstützung.

Mein Kursziel für nächstes Jahr: mindestens ca. 4$
Da liegt auch ein mittelfristiger stärkerer Widerstand.


Gruss therman

[BrauchGeld]

Hi

Einfach herrlich wie die Aktie steigt .
Hey therman kannst Du was zu der Patentstreitigkeit mit Tercica sagen ?

Tercica Files Patent Infringement Suit Against Insmed Incorporated and Avecia Limited
Monday December 20, 8:32 am ET


SOUTH SAN FRANCISCO, Calif., Dec. 20 /PRNewswire-FirstCall/ -- Tercica, Inc. (Nasdaq: TRCA - News) announced today the filing of a suit for patent infringement in the High Court of Justice (Chancery Division Patents Court) in the United Kingdom against Insmed Incorporated of Glen Allen, Virginia and Avecia Limited of the United Kingdom. In the suit, Tercica is seeking an injunction, damages and declaratory relief.
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The suit alleges that by making, using, and selling the SomatoKine® product for the treatment of Growth Hormone Insensitivity Syndrome (GHIS) in the United Kingdom, the companies infringe a European (UK) patent under which Tercica holds an exclusive license. SomatoKine® is a complex of insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3).

"Tercica`s patent portfolio consists of a broad range of patents covering both IGF-1 as well as the combination of IGF-1 and IGFBP-3," said Stephen N. Rosenfield, Tercica`s Senior Vice President of Legal Affairs and General Counsel. "This case relates to the infringement of one of our patents for combining IGF-1 and IGFBP-3 for the treatment of short stature, and on October 18, 2004, we sent our first letter demanding that the infringing activities be stopped in the United Kingdom."

On December 17, 2004, Tercica sent a letter to Insmed demanding that Insmed immediately cease and desist from any activity in the United States that constitutes an infringement of Tercica`s patent rights under three issued U.S. patents.

Tercica, Inc. is a biopharmaceutical company focused on the development and commercialization of rhIGF-1 for the treatment of short stature, diabetes and other endocrine system disorders. For further information on Tercica and Primary IGFD, please visit


Gruss
B.M.

[BrauchGeld]

therman wenn es so weiter geht könnten wir die 4$ schon ende des jahres sehen.
ja ich merke schon ich bin wieder etwas zu euphorisch.
Ist für mich sowieso ne langfristige sache.

Gruss
B.M.

[therman]

Hi BG,

zu der Patentstreitigkeit kann ich nichts sagen, da ich
keine weitergehende Infos habe.

Der Kursverlauf ist sehr erfreulich, aber ich denke,
eine Konsolidierung zwischen 2,5 und 2$ ist durchaus
wahrscheinlich.

Gruss therman

[therman]

Hi,
Neuigkeiten zum Patentstreit:
Insmeds CEO Geoffrey Allan ist überzeugt, dass die Ansprüche,
die Tercica anmeldet unbegründett sind.



Insmed Incorporated Released the Following Statement in Response to a Press Release Made Yesterday by Tercica, Inc.
RICHMOND, Va., Dec 21, 2004 (BUSINESS WIRE) -- Insmed Incorporated (Nasdaq: INSM) has been informed that on December 20, 2004 Tercica Inc. brought legal action in the United Kingdom against Insmed Incorporated and its contract manufacturer, Avecia Limited, challenging Insmed`s right to make, use and sell its proprietary IGF- replacement hormone, SomatoKine(R), in the United Kingdom.

In addition, Insmed has received a cease and desist letter from Tercica, dated December 17, 2004, regarding certain activities Insmed is conducting in the Unites States. In response to these events, Insmed`s Chief Executive Officer, Geoffrey Allan, stated today: "We believe that Tercica`s allegations are without merit and intend to vigorously defend our position and right to make SomatoKine(R)". The action announced yesterday by Tercica is not expected to delay the filing of Insmed`s NDA for the treatment of GHIS (growth hormone insensitivity syndrome) with SomatoKine(R).

[therman]

Hi,

wie erwartet läuft nun die Konsolidierung.

Nachfolgend die Meinung eines amerikanischen Börsendienstes:

Our diabetes home-run stock

At ChangeWave, we are tracking a variety of companies in the diabetes industry, and this company is one of the most promising aggressive names.

The idea behind this pick is simple. These guys own the patented intellectual property for a hormone replacement therapy helps control diabetes almost like magic.

The market for hormone replacement therapies is huge, with growth hormones representing a billion dollar market and insulin being a $2 billion-plus sector.

This company owns the "key" to safely deliver insulin-like proteins that can greatly improve life quality (and even mean the difference between life and death). Management believes -- and our Research Alliance concurs -- that their compound, called SomatoKine , has a $1 billion annual market potential.

Why?

Simply put, this compound helps diabetics reduce their use of insulin -- dramatically in some cases. That`s an incredible breakthrough in the treatment of this dread disease.

What`s more, this drug recently received "orphan drug designation" as a treatment for extreme insulin resistance. This gives the compound preferential treatment. And it`s the first step to the FDA approval for ALL diabetics -- and that, my friend, is the promised land.

Keep in mind that this play is aggressive and volatile. But the reward I`m seeking is equally exciting.

[mischa30]

Kaum zu glauben welche Spinner es so gibt

Tissue engineering

www.emforum.de/modules.php?name=eBoard&file=viewthread&tid=115&page=1

[derschweizer]

@mischa30

Junge du nervst, was soll das zugemülle sämlicher Threads

[therman]

Hi,

Statement von Insmed zu den Angriffen von Tercica:

Insmed Incorporated Released the Following Statement in Response to Recent Actions by Tercica, Inc.
RICHMOND, Va., Dec 30, 2004 (BUSINESS WIRE) -- Insmed Incorporated (Nasdaq: INSM): On December 23, 2004, Tercica Inc. and its licensor, Genentech, filed a lawsuit in the U.S. District Court for Northern California against Insmed challenging Insmed`s right to commercialize its proprietary IGF-I replacement hormone, SomatoKine(R), in the United States and seeking damages for alleged patent infringement by Insmed`s predecessor, Celtrix, of certain patents licensed to Tercica. Tercica also filed a lawsuit in the United Kingdom against Insmed and its contract manufacturer, Avecia, that was announced last week. In response to these events, Insmed`s Chief Executive Officer, Geoffrey Allan, stated today: "As we stated last week, we believe that these allegations are without merit and intend to vigorously defend our position and right to make SomatoKine(R). Our position has been and remains that we do not believe we infringe these patents in either the United States or the United Kingdom."

therman

[therman]

News:

Insmed Completes New Drug Application -NDA- for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome; Conference Call Scheduled for 11:00 am January 5, 2005
RICHMOND, Va., Dec 31, 2004 (BUSINESS WIRE) -- Insmed Incorporated (Nasdaq: INSM) announced that it has completed the New Drug Application (NDA) to seek regulatory approval of SomatoKine(R) (Mecasermin rinfabate) for the treatment of growth hormone insensitivity syndrome. The Company will submit the NDA before market open on Monday, January 3, 2005.

"The completion of the NDA for SomatoKine represents a great achievement for the Company. An NDA is a huge undertaking for a small company like Insmed and we have made every effort to ensure we have a submission of the highest quality. This important milestone is evidence of our continuing commitment to develop medicines for patients with unmet medical needs," said Geoffrey Allan, Ph.D., President and CEO of Insmed Incorporated.

Conference Call

Insmed will host a conference call on Wednesday, January 5, at 11:00 a.m. Eastern Time (10:00 a.m. Central Time) to provide an update on recent corporate events and planned activities for 2005. To participate in the conference call dial 800-479-9001(domestic) or 719-457-2618 (international). The call will be webcast live through Insmed`s corporate website: www.insmed.com.

A telephonic replay of the call will be available for one week at 888-203-1112 (domestic) or 719-457-0820 (international), passcode: 238426. A web replay of the call will be available through the corporate website beginning at 1:00 p.m.

[therman]

Insmed Submits New Drug Application -NDA- to Seek Regulatory Approval of SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome
RICHMOND, Va., Jan 3, 2005 (BUSINESS WIRE) -- Insmed Incorporated (Nasdaq: INSM) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of SomatoKine(R) (mecasermin rinfabate) for the treatment of growth hormone insensitivity syndrome (GHIS). The application includes safety and efficacy results from Insmed`s prospective, multicenter, Phase III clinical trial with SomatoKine conducted in patients with growth hormone insensitivity syndrome. SomatoKine is Insmed`s proprietary insulin-like growth factor I (IGF-I) therapy, composed of recombinant human IGF-I and IGF binding protein 3 (rhIGF-I/rhIGFBP-3 complex).

"The submission of the NDA for SomatoKine represents a great achievement for the Company, highlighting our efforts to bring the first specific treatment for children with this disease. We believe that SomatoKine is a breakthrough therapeutic agent and that it will become the standard of care for treating GHIS," said Geoffrey Allan, Ph.D., President and CEO of Insmed Incorporated.

SomatoKine has already received orphan drug designation for the GHIS indication. Orphan drug designation is conferred upon investigational products by the FDA for indications that affect fewer than 200,000 people in the United States. The GHIS indication encompasses a variety of genetic and acquired conditions in which the action of growth hormone (GH) is absent or severely attenuated, resulting in low serum levels of IGF-I. Because IGF-I is the primary mediator of the growth-promoting actions of GH, replacement therapy in children with GHIS using SomatoKine is intended to bypass the blockade of GH action and improve longitudinal growth.

Conference Call

Insmed will host a conference call on Wednesday, January 5, at 11:00 a.m. Eastern Time (10:00 a.m. Central Time) to provide an update on recent corporate events and planned activities for 2005. To participate in the conference call, dial 800-479-9001(domestic) or 719-457-2618 (international). The call will be webcast live through Insmed`s corporate website: www.insmed.com. A telephonic replay of the call will be available for one week at 888-203-1112 (domestic) or 719-457-0820 (international), passcode: 238426. A web replay of the call will be available through the corporate website beginning at 1:00 p.m. Wednesday.

[BrauchGeld]

Hi

Hier eine etwas ältere analyse von Rodman :

NAVDEEP S. JAIKARIA, RODMAN & RENSHAW

“On November 17, 2003, we initiated coverage of INSM shares with a Market Outperform rating and 12-month price target of $8 (30x our 2007 EPS estimate of $0.68 discounted annually at 35%). Insmed Incorporated (Nasdaq: INSM) is a biopharmaceutical company developing recombinant human insulin-like growth factor-I (rhIGF-I) in combination with recombinant human IGF-I binding protein –3 (rhIGFBP-3) for the treatment of various endocrine disorders. The equimolar complex of rhIGF-I and rhIGFBP-3 is designated as rhIGF-I/rhIGFBP-3 or SomatoKine and is in a Phase III pivotal trial in children with growth hormone insensitive syndrome (GHIS). SomatoKine is also in Phase II trials for severe burn injury, hip fracture in osteoporotic patients, and severe insulin resistant Type 1 and Type 2 diabetes mellitus. Pharmacia’s free IGF-I went through all phases of clinical development and was shown to be efficacious for the treatment of growth retardation in children with GHIS. The drug was approved in Europe. However, Pharmacia never marketed the product. No other IGF-I drug is currently approved and marketed and GHIS remains an unmet medical need. We believe INSM’s pivotal Phase III trial of SomatoKine in children with GHIS has a high probability of success because (a) free IGF-1 is effective and (b)apharmacokinetic study has established that once daily subcutaneous administration of SomatoKine is equally effective as a twice-daily subcutaneous injection free IGF-I in elevating serum IGF-I level in patients which in turn restores IGF-I functions in vivo. We expect SomatoKine to be approved and launched in 2005 and project sales of $7.8 million in 2005, $44.7 million in 2006 and $140.4 million in 2007. Physicians thought leaders find SomatoKine to be promising and once approved, to find significant off-label use in the general GHIS population, in late-stage diabetic patients with severe insulin resistance, in patients with severe burn injury, and in osteoporotic patients suffering from hip facture. INSM`s pipeline also consists of rhIGFBP-3 in early clinical development as an anti-cancer therapeutic agent for a variety of tumor types. We consider INSM shares, at a technology value of around $80 million, to be significantly undervalued compared to its peers. We reiterate our Outperform rating for INSM shares. Our 12-month target price remains unchanged at $8.00.” (February 11, 2004)

Gruss
B.M.

[Daibler]

Kurssturz!

[therman]

Hi,

Heute geht es sehr volatil zu bei INSM.

Ich denke dies ist ein Pullback zum überwundenen
Widerstand bei 1,80 $.
Die sollten allerdings halten.
Tagesschluß abwarten.
Seit 16.12.04 bildet sich ein kurzfristiger Abwärtstrend
in Form einer Flagge.
Die 1,80 stellen heute die untere Begrenzung dieses
Kanals dar.

Bis jetzt ist diese Flagge als bullish zu bewerten.

therman

[BrauchGeld]

Associated Press
Insmed to Get Fast SomatoKine FDA Review
Wednesday April 13, 12:15 pm ET
Insmed Is Granted Priority Review From FDA for Its SomatoKine Growth Hormone


RICHMOND, Va. (AP) -- Insmed Inc. said Wednesday that the Food and Drug Administration granted the biopharmaceutical company priority review for its growth hormone SomatoKine.
Insmed shares rose 28 cents, or 31.8 percent, to $1.16 in midday trading on the Nasdaq.

ADVERTISEMENT


A priority review designation normally cuts the FDA review time for a product to about six months from than the standard ten months. The company said the agency accepted its application for the treatment March 10. The FDA told Insmed that it expects to make a decision by July 3.

SomatoKine already has an orphan drug designation from the agency. An orphan drug is one that treats conditions affecting fewer than 200,000 patients in the United States. Companies making the drug are given incentives such as seven years marketing exclusivity, development grants and tax breaks.

The treatment is a combination of insulin-like growth factor-1 and insulin-like growth factor binding protein-3. The company is looking for an indication to treat Growth Hormone Insensitivity Syndrome.

In December, biotech companies Tercica Inc. and Genentech Inc. sued Insmed over its efforts to commercialize the product, alleging the infringement of two U.S. patents licensed to Tercica in the United States. Insmed filed a motion to dismiss the suit in February.

[[KERN]Codex]

sehr interessant!

[Schuhbert]

Hi,

ist noch jemand in Insmed investiert ?

Gestern ist die Aktie um über 30% eingebrochen.
..konnte auf Annhieb keinen plausiblen Grund finden.
Weis jemand mehr ?

[blb]

Ein Konkurrenzprodukt von Tercica wurde zugelassen. Es wird in diversen Foren diskutiert, ob aufgrund dessen Orphan Drug Status das Medikament von Insmed überhaupt noch zugelassen werden darf. Ich hab die auf der Watchlist, am 3. Oktober kommt die Entscheidung.

[blb]

Press Release Source: Insmed Incorporated

Insmed Receives Approvable Letter for iPlex(TM)
Tuesday September 27, 6:55 pm ET
Conference Call Tomorrow at 8:00am EST

RICHMOND, Va.--(BUSINESS WIRE)--Sept. 27, 2005--Insmed Incorporated (NASDAQ-NMS: INSM - News; NASDAQ: INSM - News) announced today the receipt of an Approvable Letter from United States Food and Drug Administration (FDA) for iPlex(TM) (rhIGF-I/rhIGFBP-3) (Mecasermin rinfibate), for the treatment of children with growth failure who suffer from Severe Primary IGF-1 deficiency (Primary IGFD). Previously Insmed referred to its primary indication as Growth Hormone Insensitivity Syndrome (GHIS). Based on FDA input GHIS is now referred to as Severe Primary IGFD. iPlex is the new worldwide trade name for Insmed`s proprietary combination of rhIGF-I/rhIGFBP-3 which was previously called SomatoKine.

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click here
The Approvable Letter Insmed received is an official notification that the FDA has completed the review of the iPlex New Drug Application (NDA) and has found the application to be sufficiently complete for full approval pending the submission of additional information primarily regarding the Chemistry, Manufacturing and Controls (CMC) section of the application. FDA is not requiring the Company to conduct additional preclinical or clinical trials. FDA has informed Insmed that they are still considering iPlex`s orphan exclusivity status.

"The Company plans to rapidly respond to these questions and work with the Agency to resolve all outstanding issues. I look forward to the completion of our work with the FDA so that we may bring this product to the clinic, and provide caregivers with this important therapeutic option for their patients", added Geoffrey Allan, Ph.D., President and Chief Executive Officer of Insmed.

"Based on my experience with therapies for a variety of growth disorders, it is clear that the pediatric endocrine community will welcome this alternative therapy. Throughout the clinical development program, iPlex therapy has demonstrated a very favorable safety profile, in addition to the robust growth response," commented Kenneth Attie, M.D. Chief Medical Officer for Insmed.

Conference Call at 8:00am

Insmed management will host a conference call at 8:00am ET, September 28, 2005. To participate in the conference call, dial 800-811-8824 (domestic) or 913-981-4903 (international). The call will be webcast live through Insmed`s corporate website: www.insmed.com. A telephonic replay of the call will be available for one week at 888-203-1112 (domestic) or 719-457-0820 (international) Passcode: 2242133 A web replay of the call will be available through the corporate website beginning at 10:00 a.m.

About Insmed Incorporated

Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com.

Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding planned clinical trial design, our regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, the company may lack financial resources to complete development of product candidates, the FDA may interpret the results of our studies differently than we have, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the company`s filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release. For further information with respect to factors that could cause actual results to differ from expectations, reference is made to reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and Insmed disclaims any intention or responsibility for updating predictions or financial guidance contained in this release.
Contact:

Insmed Incorporated
Baxter Phillips, III, 804-565-3041
Fax: [phone]
[e-mail]


Source: Insmed Incorporated

[therman]

Bin in INSM nach wie vor investiert und denke dass INSM langfristig ganz enormes Potential hat.
Die gute Nachricht über den Approvable Letter for iPlex(TM)wird einen shortsqeeze auslösen.
Short am 15. September waren: 2,315,046 Aktien

Vorbörslich jetzt bei 1,55.

Werde weiter zukaufen.

therman

FDA has informed Insmed that they are still considering iPlex`s orphan exclusivity status

[blb]

Die Entscheidung über Somatokine steht am 3. Oktober an soweit ich weiß...

[therman]

Hi,

News:

Insemd clarifies FDA approval letter on iPlex
Thu Sep 29, 2005 07:00 AM ET
NEW YORK, Sept 29 (Reuters) - Insemd Inc. INSM, said on Thursday the U.S. Food and Drug Administration has not yet decided whether the recent approval and granting of orphan exclusivity for Mecasermin for severe primary IGF-1 deficiency will block the approval of iPlex.
Insmed said Tuesday the FDA had asked for more data before the agency clears the company to apply for final approval on a growth therapy for children.



Insmed Says Drug Increased Growth Speed
Thursday September 29, 6:24 pm ET
Insmed Says Its Experimental IPlex Drug Increased Growth Speed in Study; Shares Rise

RICHMOND, Va. (AP) -- Insmed Inc. said Thursday preliminary data from an ongoing study showed that its experimental drug significantly increased the speed at which children with a severe hormone deficiency grew taller.

Insmed`s stock starting sinking early in the day after the company issued a carefully worded statement clarifying the status of its request for exclusive "orphan drug" selling rights from the Food and Drug Administration.

The statement said that regulators have not yet decided if the drug -- a growth hormone called iPlex -- will be blocked from such exclusivity by the recent approval of a similar therapy.

The FDA uses orphan drug status, which carries seven years of exclusive selling rights, to motivate companies to develop treatments for rare diseases.

On Wednesday, Insmed said iPlex received an "approvable" letter from the FDA stating that its therapy would be cleared following the submission of certain additional data. At that point, the company said only that the FDA was still considering iPlex`s request for exclusive selling rights as an "orphan" drug.

Competitor Tercica Inc. received FDA approval and orphan drug exclusivity for its similar growth hormone, Increlex, earlier this month. It was approved to treat children with a severe deficiency of a hormone called IGF-1, the same indication that Insmed is now seeking.

[blb]

Sorry, war ein Fehler von mir, SomatoKine wurde ja umbenannt...

iPlex is the new worldwide trade name for Insmed`s proprietary combination of rhIGF-I/rhIGFBP-3 which was previously called SomatoKine.

Grüße
blb

[toriol]

So Gap ist vorbildlich geschlossen worden. Auf zur 2$-Marke. Dort werden wir als nächstes Abprallen.

Mögen die Nachrichten dem Chart entsprechen

[toriol]

so hier noch die News, damit das chartbild auch bestätigt wird.

Insmed Submits Response to FDA Approvable Letter for iPlex



RICHMOND, Va., Oct. 17 /PRNewswire-FirstCall/ -- Insmed Incorporated (Nasdaq: INSM) announced today that it has submitted its response to the Approvable Letter received from United States Food and Drug Administration (FDA) for iPlex(TM) (rhIGF-I/rhIGFBP-3) (Mecasermin rinfibate), for the treatment of children with growth failure who suffer from Severe Primary IGF-1 deficiency (Primary IGFD).

In September 2005, the FDA issued an Approvable Letter indicating that the FDA has completed the review of the iPlex NDA and has found the application to be sufficiently complete for full approval pending the submission of additional information primarily regarding the Chemistry, Manufacturing and Controls (CMC) section of the application. The Company believes that its response addresses all issues noted in the Approvable Letter. FDA is not requiring the Company to conduct additional preclinical or clinical trials. The Company looks forward to working with the Agency as they continue the evaluation of the iPlex New Drug Application (NDA).

About Insmed Incorporated

Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit http://www.insmed.com.

Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding planned clinical trial design, our regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, the company may lack financial resources to complete development of product candidates, the FDA may interpret the results of our studies differently than we have, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the company`s filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release. For further information with respect to factors that could cause actual results to differ from expectations, reference is made to reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and Insmed disclaims any intention or responsibility for updating predictions or financial guidance contained in this release.

SOURCE Insmed Incorporated
-0- 10/17/2005
/CONTACT: Baxter Phillips, III of Insmed Incorporated, [phone],
Fax: [phone], [e-mail]/
/Web site: http://www.insmed.com /
(INSM)

CO: Insmed Incorporated
ST: Virginia
IN: BIO HEA MTC
SU: FDA

LD
-- NYM272 --
5073 10/17/200516:00 EDThttp://www.prnewswire.com

[toriol]

so ein Ausbruch steht bevor...hoffentlich nach oben.

[toriol]

Ausbruch??
Z.Z. bei 1.3 US-Dollar.

Das sollte als Signal reichen.....
damit wären die 3 Kursziele von der Richtung her bestätigt. Alles eine Frage der Zeit....und die vergeht ja bekanntlich sehr schnell

[toriol]

nachbörslich ask auf 1,39US-Dollar

es darf weiter gehen....

einmal Alleinunterhalter - man das fetzt.

[toriol]

comdirect:
Bid: 0,01
Ask: 9000

das ist doch mal eine Spanne.

[toriol]

Da man bearbeitete Bilder nicht hochladen kann (Wallstreet, das wäre doch mal eine Verbesserung wert) hier nun als Text:
1.KZ: 1,5 US-Dollar
2.KZ: 1,85
3.KZ: 2,5

[toriol]

So vorbildlich zur Ausbruchsstelle zurückgekehrt. Da wir auf Tageshoch geschlossen haben, sag ich mal, das war´s mit der Korrektur. Ab gen Norden.
Ansonsten wäre noch Potential die 1,2-1,25 eine Woche lang anzuschauen,um anschliessend Dampf zu machen.

nächstes Updat folgt. Es spricht aber auch aufgrund der Nachrichtenseite eher für ein jetzigen Ausbruch. Die guten Nachrichten der (hoffentlichen) Zulassung am 12.12.05 müssen ja laut "Börsengesetz" vorweggenommen werden.

toriol

[toriol]

Und nun die Wettervorhersage:

Es bleibt sonnig

[Macrocosmonaut [Blogger]]

Klären Sie mich bitte mal auf über die vermeintliche Zulassung am 12.12.

Worum geht es da?

Denn charttechnisch ist die Aktie derzeit eher überkauft und weist zudem Verkaufsignale auf - was aber natürlich bei einem FDA-approval hinfällig wäre. Meinen Sie heirbrei rhIGF-1?

Oder handelt es sch um den Patentrechtstreit mit Tercica?

Info wäre nett, da sie den Wert ja schon seit enormer Zeit verfolgen.

MfG.

M.

[Macrocosmonaut [Blogger]]

Im übrigen hat der Wert mittlerweile sich in 3 Monaten verdoppelt - charttechnisch sehe ich durchaus nochmal Kurse bis 1.20/1.25 US$.

Das Handelssignalö kommt erst oberhalb von 1.50 US$ (Tagesschlusskurs).

[toriol]

Das mit den 1,2-1,25$ schrieb ich ja auch, wäre wahrscheinlich nicht mal ungesund.

zum 12.12. es ging um die Neuzulassung. Im Juni/Juli wurde der Erstantrag (ich hoffe ich liege richtig) abgegeben, dann kamen Korrekturwünsche seitens der FDA. Diesen wurde entsprochen, und nun soll bis zum 12.12. der Entscheid fallen. müsste auch in einr News drinnengestanden haben: siehe unten)

Charttechnisch: schau dir mal den 5-Jahreschart an. Bildschöner gehts nicht. ;-) deswegen sehe ich kurzfristig auch eher Potential nach oben. Zumal ich sowieso nicht tageweise denke.

Hoffe, das stimmt so alles.

http://www.nasdaq.com/aspxcontent/NewsStory.aspx?cpath=20051…[/url]

[toriol]

Vielleicht noch ein Nachtrag:

wenn ich mir den langfristchart anschaue, dann wird eine gewisse Formation erst bei ca. 5-7 US-$ geschlossen.
Naja träumen darf man ja wohl noch.

Allerdings haben wir mit dem Ausbruch neulich entscheidende "Arbeit" geleistet, und einen Abwärtstrend gebrochen.
Hoffen wir, dass die Charttechnik auch weiterhin bei insmed sich so schön vorhersagen lässt.

Dass ich die Aktie schon länger betrachte ist gut - seit ca. 4 Jahren. Bin mal rein und raus. Denke aber, dass der Wert sobald ein Produkt auf dem Markt ist, enormes Potential hat. Sollen die Leute sich an McDonalds tot fressen.

[toriol]

also mir würde auch ein Ausbruch ohne Schlusskurs reichen. Ist sicher mit Schlusskurs besser, aber meiner Meinung nach nicht zwingend. Da die Charttechnik sowieso auf OHLC-Charts basiert.

toriol

[toriol]

Nachbörslich:
Bid: 1,46
Ask: 1,48
Das wären wieder mal "neue Höchststände"

Und in Frankfurt werden auch Unsummen in Insmed zu horränten Preisen ausgegeben.

[Macrocosmonaut [Blogger]]

Also der Abwärtstrend ist nach wioe vor voll intakt und ein Handelsiganl liegt auch nicht vor.

Der Kurs kann bei Verzögerung der Zulassung ioder gar im negativen Fall sich glatt halbieren und auf 0.79 US$ fallen.

Wie gesgat ein Bruch des Abwärtstrendes liegt bisher nicht vor und charttechnisch notiern wir auserhalb der rechnerischen Normalzone.

Derzeit keine Posiotion - konservative Anlageentscheidung.

Einstieg entweder bei 0.79 oder stopp buy bei Tages/Wochenschluss oberhalb der letzten Bewegungshochs.

Reaktiosnsrisiko ist deutlich angestiegen.

MfG.

M.

[toriol]

Also ich denke (abgesehen von Erdbeben oder Nichtzulassung) geht hier gar nichts runter auf 80 cent. Das käme einem Bruch des "kurzfristigen" Aufwärtstrend gleich. Und das ist mehr als unwahrscheinlich. Aber wir werden sehen. ich bin ja auch kein Hellseher, sondern nur Charttechniker; aber das hat bisher bei Insmed ganz gut funktioniert.

toriol

[toriol]

so, erstes Kursziel erreicht: 1,5US$


nun ja der Rest sollte nur eine Frage der Zeit sein. die 1,5 greifen wir jetzt zum 3. Mal an. Irgendwann fällt jede Mauer.
das nächste Kursziel ist bei 1,85US-$

toriol

[therman]

Charttechnisch sieht INSM sehr gut aus:

Die 50EMA täglich und wöchentlich nach oben überwunden.

Bei Zulassung wird es über kurz oder lang eine Kursvervielfachung geben. jmo

therman

[toriol]

Richtig! Das "5-Jahres-W" wird erst bei 5-7 US-$ abgeschlossen sein. Man kann ja auch mal eine kleine Rechnung aufstellen:

Diabethesmarkt:
Nehmen wir an Insmed hat einen Blockbuster = 1Mrd. US$ Umsatz

Biotech/Pharma-Margen: ca. 25-30% = 250Mio Gewinn
Anzahl Aktien: ca. 50 Mio

Fazit: 250Mio/50Mio = 5 $

D.h. wenn die Zulassung kommt, dann sollten die 5$ auch aus fundamentaler Sicht kommen. Ich bin vor Jahren mal auf den Wert gestossen, weil es damals wohl eins der einzigen Unternehmen war, die gegen Insulinresistenz forschen (lt. Aktionär). Wenn das noch stimmt, hätten sie nicht mal grosse Konkurrenz. Gibt es hier einen "Mediziner" oder einen gut Informierten, der das bestätigen kann oder Quellen kennt?
toriol

[toriol]

übrigens ist das Volumen seit Dezember deutlich höher als sonst... wahrscheinlich wollen immer mehr verkaufen....ähm....

[toriol]

nachbörslich:
Bid: 1,47
Ask: 1,55

noch Fragen?

[blb]

Sorry toriol, aber was du hier teilweise schreibst lässt mir die Haare zu Berge stehen.

Fakt ist, dass vor einigen Wochen ein Konkurrenzprodukt von Tercica zugelassen wurde. Somit haben wir bei dieser Indikation also schon einen Konkurrenten. Insmed ist eine sehr kleine spekulative Biotechfirma. Vieles hängt hier jetzt erstmal an der Zulassung am Montag.

Bei einem Scheitern rechne ich mit Kursverlusten von 50% und höher, ebenso sind bei Erfolg Kursgewinne in die andere Richtung möglich. Hier aber von einem Selbstläufer zu sprechen, ist definitv falsch.

Ich persönlich rechne zwar mit einer Zulassung am Montag, ob der Orphan Drug Status gewährt wird, wird ebenfalls interessant werden. Das Orderbuch der letzten Tage sieht auch eher nach Zulassung aus.

Fazit: Das Ganze ist eine Hopp oder Topp-Angelegenheit. Das sollte man hier schonmal deutlich machen!

Schönen Abend
blb

[toriol]

na endlich: es kommt wieder Leben in die Bude!

wegen den Haaren, da empfehle ich Dir einen Kamm. manchmal hilft das. Ok Spass beiseite.

Das mit Tercica stimmt. Habe ja auch gefargt, ob es jemand besser weiss. Bin in den ganzen News nicht so drin, da es für mich mehr ein top denn ein hop ist. Die Ergebnisse der ganzen Vorstudien waren ziehmlich klar.

Und zum Schluss handel ich zu 90% nach Charttechnik. Und die sagt mir, dass es eine Zulassung geben wird. *indieGlaskugelschau*
Das Ganze ist für mich eine Art Nachweis, ob die Charttechnik funktioniert oder nicht.

Also: Hop oder Top, das ist hier die Frage.

toriol

PS: ein weiterer Wert, der sehr schön auf die Charttechnik reagiert ist Macmin. Da ist im Moment und bis auf weiteres Polen offen.

[blb]

@toriol: Ich befasse mich schon längerer Zeit mit Biotechs und habe Insmed vor kurzem in einem anderen Forum empfohlen, allerdings mit dem klaren Hinweis, dass hier alles von der Zulassung abhängt.

Du schreibst in etwas, nur eine Nichtzulassung kann den Kurs vom Steigen abhalten! Ja aber darum geht es doch!!! Du kannst doch nicht behaupten, wenn eine Aktie charttechnisch gut aus sieht, ist eine Zulassung so gut wie sicher. Sieh dir mal die Charts von Biogen und Elan vor dem Absturz an. Nichs ist im vornherein sicher!

Wenn du Insmed benutzen willst, um deine charttechnische Strategie zu überprüfen, ist das o.k.! Aber ohne fundamentale Kenntnisse hast du bei Bios nur eine geringe Chance auf Kursgewinne und vorprogammiert ist bei der Chartanalyse gar nichts. Starke externe Einflüsse wie Scheitern in den klinischen Studien haben hier extremen Einfluss auf den Kurs und sind vorher absolut nicht erkennbar (siehe Medigene im Juni/Juli).

Ich wünsche dir natürlich viel Erfolg, das Orderbuch sah die letzten Tage wirklich eher pro Zulassung aus.

Aber nochmal an alle anderen, auch wenn es wohl schon zu spät ist: Dieses Teil ist hochspekulativ!

Grüße
blb

[DR.DIAMOND]

INSMED INC Quick Quote: INSM 1.46 (+0.03)




Market Pulse Announces Its Hot Stock Alerts for Friday, Dec. 9, 2005: XKEM, AAPL, INSM, JDSU
12/9/05

NOTE TO EDITORS: The Following Is an Investment Opinion Being Issued
by Market Pulse.

ATLANTA, GA, Dec 09, 2005 (MARKET WIRE via COMTEX) --
Market Pulse is pleased to introduce our featured stock, Xechem International Inc. (OTC BB: XKEM), to the investment community! Xechem International is new to Market Pulse and is poised to become a significant player in the biopharmaceutical industry! XKEM just had excellent news out in a press release before today`s opening bell announcing that it has acquired the exclusive, worldwide licensing rights to a new five-membered hetercyclic anti-sickling compound from Virginia Commonwealth University, Richmond, VA! This could be great news for investors! Other notable stocks that should be watched because they look great lately from a fundamental and technical perspective include:

Apple Computer Inc. (NASDAQ: AAPL) : Market Outperform

Insmed Inc. (NASDAQ: INSM) : Attractive

[toriol]

Also, es hat noch nicht wirklich viel zu sagen, aber comdirect gibt vorbörslich folgendes an:
BID: 1.38
ASK: 2.05

Weiss jemand, ob die Zulassungsmeldung eher nachbörslich oder vorbörslich kommt?

toriol

[blb]

Ist wirklich sauspannend!!!

Wers live mitverfolgen will: www.level2quotes.com

[BrauchGeld]

Super Nachrichten für Insmed

Hab leider zu früh verkauft egal man kann nicht überall dabei sein.
Glückwunsch an alle investierten aktie ist über 50% im plus.


FDA Approves Insmed`s Orphan Drug, IPLEX, for the Treatment of Severe Primary IGF-1 Deficiency
Monday December 12, 5:05 pm ET
The First Once-Daily Therapy for the Treatment of Severe Primary IFG-1 Deficiency


RICHMOND, Va.--(BUSINESS WIRE)--Dec. 12, 2005--Insmed Incorporated (NASDAQ: INSM - News) announced today the United States Food and Drug Administration (FDA) approved IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. As an orphan drug, IPLEX is entitled to seven years of marketing exclusivity for the treatment of Primary IGFD.


"We are very pleased IPLEX was approved, making IPLEX the only approved once-daily IGF-1 replacement therapy available to treat children with severe short stature," stated Geoffrey Allan, Ph.D., President and Chief Executive Officer of Insmed. "Today marks the beginning of a new treatment paradigm for treating children with Primary IGFD. I am grateful to all who have made this drug approval possible. This is also an exciting transition for Insmed as we now begin to focus on the commercialization of IPLEX, which we expect to launch during the second quarter of calendar year 2006."

Andreas Sommer, Ph.D., Chief Scientific Officer of Insmed added, "This event marks the end of a long road and two decades of hard work by hundreds of dedicated people. I`m thrilled that our visionary efforts have now culminated in making available a novel therapeutic composition for the treatment of children who suffer from Primary IGFD."

"It is gratifying to see that a Company who cares for the needs of patients has developed a needed therapy that allows physicians to treat children with Primary IGFD. From my experience in treating these types of patients, IPLEX therapy has produced improvements in growth rates while providing an excellent safety profile" said Louis Underwood, M.D., Professor of Pediatrics, University of North Carolina, Chapel Hill, and a Principal Investigator and a member of Insmed`s Pivotal Trial Steering Committee. Dr. Underwood is a world renowned Pediatric Endocrinologist who pioneered the early use of GH and IGF-1.

[blb]

Nachbörslich 60% rauf, Glückwunsch allen Investierten!

Hab nur ne kleine Position!

Gute Nacht!
blb

[therman]

Geduld zahlt sich aus.
Ich bleibe weiter investiert in INSM, werde noch zukaufen.
Dies ist erst der Anfang.

Durch die Zulassung und 7-jähriges exclusives Vermarktungsrecht Kursziel ca. 6$.

Die Pipeline von INSM ist vielversprechend.

Langfristig ein Kursvervielfacher, langfristiges Kursziel 20 bis 30 $, m.E.

therman

[toriol]

So, zweites Kursziel ist auch erreicht.
Kurzentschlossene können ja auf einen Rückschlag auf die 1,5-1,6US$ hoffen und zocken (immerhin sollte das Gap schon geschlossen werden)Aber das ist heiss.

Frage an die Kundigen:
Hat Insmed nicht vor Jahren mal eine Kooperation mit einem europäischen Unternehmen zur Produktion eines möglichen Medikaments geschlossen?
Wenn ich wieder falsch liege, werde ich mir umgehend einen Kamm besorgen.

[therman]

Hi,

habe heute nochmal nachgekauft zu 1,63$.

Möglicherweise geht es noch etwas weiter nach unten kurzfristig.

therman

[[KERN]Codex]

#55 von blb 10.12.05 09:40:48 Beitrag Nr.: 19.229.219

biib/eln

haben tysabri selbstständig vom markt nehmen lassen.. da es einen todesfall wegen einem virus im gehirn gab der sich wegen der immunsupression breitmachen konnte

hab insmed auch im blick..

[blb]

Absolut richtig! Die Frage ist aber doch, ob man das im Chart vorher ersehen konnte. Genau das meine ich mit negativen externen Effekten. Meiner Meinung nach hilft da Charttechnik gar nichts. Ich bin zwar ein absoluter Chartfreak, das muss ich gestehen, manchmal schau ich drauf wohl sogar zuviel, aber auch Charttechnik hat ihre Grenzen...

Schade, dass der Kurs heute so abgebröckelt ist. Hab einen Teil verkauft, der Rest ist noch drin!

Gute Nacht!
blb

[Senti018]

Buy on bad News?

Tercica Files Unfair Business Practices Lawsuit Against Insmed Incorporated

07.12.2005, 00:00:00

[blb]

@Senti018:

Die Meldung ist doch schon uralt.

Sorry für das Deutsch in meinem letzten Posting, es war schon sehr spät...

Grüße
blb

[therman]

Das erste Upgrade.
Ich denke es werden noch mehr kommen.
Die Bewertung von Lazard ist sehr konservativ.

DECEMBER 1 3 , 2 0 0 5
LAZARD CAPITAL MARKETS , LLC
30 ROCKEFELLER PLAZA
NEW YORK, NY 10020
INSMED (INSM)
BIOTECHNOLOGY RATING: BUY PRICE: $1.44 PRICE TARGET: $4.00
INSM: iPlex gains approval and orphan exclusivity; increasing target to $4.00
Last night, Insmed’s iPlex gained approval and orphan exclusivity for the treatment of growth failure in children
with severe primary IGF-1 deficiency, placing it in direct competition with Tercica’s (TRCA-$9.90, SELL)
Increlex, which was approved in August 2005
The Office of Orphan Products Development decided iPlex was a different drug for purposes of granting orphan exclusivity
Insmed has identified key sales personnel and is ready to expand its commercial operations for a mid-2006 launch
Labeling advantages for iPlex, besides a once-daily dosing regimen, may include the lack of a requirement for a
meal or snack 20 minutes to be given before or after each injection, as is the case with Increlex
In speaking with pediatric endocrinologists, they indicate that iPlex’s dosing advantage alone renders this drug
their exclusive choice for the initial indication of severe primary IGF-1 deficiency. We assume that iPlex and
Increlex will face more formidable competition for children with idiopathic short stature, where we have modeled
low penetration rates
Preliminary injunction suits filed by Tercica will likely ensue with little consequence to Insmed, in our view
We arrive at our new 12-month price target of $4.00 price by applying a 5.6 enterprise value-to-revenue multiple to
our new 2008 iPlex sales estimate of $119 M, discounted two years at 25%, including fully diluted shares of 109.5
million, which assumes a financing in 2006
Risks to our thesis include a delayed launch for iPlex or faster-than-anticipated launch of Increlex.

[therman]

Upgrade von Lazard auf 4 Dollar

Lzard geht davon aus, dass Insmed demnächst ca. 50 Millionen Aktien verkauft um Geld zu schöpfen, deshalb nur 4 Dollar als Kursziel.
Werden keine neue Aktien herausgegeben entspräche das einem Kursziel von 8 Dollar.

Teil 2:

iPlex gains approval and orphan exclusivity for severe primary IGF-1 deficiency. Last night, Insmed’s iPlex
gained approval and orphan exclusivity for the treatment of growth failure in children with severe primary IGF-1
deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth
hormone. This approval is similar to Tercica’s Increlex, which was approved in August 2005. The Office of Orphan
Products Development ultimately decided iPlex was a “different drug” for purposes of orphan exclusivity by invoking
the clinical superiority claim, although this apparently is not clarified in the approval letter received by Insmed.
Besides dosing, iPlex may offer other labeling advantages: iPlex’s once-daily injection is a distinct advantage
over Increlex’s twice-daily injections and while it appears iPlex’s label is similar to Increlex’s in terms of the
addressable patient population (-3 SD in IGF-1 levels and growth velocity), iPlex may not have to be administered 20
minutes before or after a snack or meal, as is the case with Increlex. This advantage may prove insignificant to dosing
alone, as pediatric endocrinologists with whom we spoke leading up to iPlex’s approval, if given a choice between
once-daily and twice-daily regimens, almost exclusively chose the once-daily regimen.
Rev up the commercial operations: With an approved product in hand, Insmed can now prepare in earnest for the
commercial launch of iPlex and we understand leading up to last night’s approval that key sales personnel where
already identified. We assume upon final labeling and printing that commercial scale up is sufficient to launch iPlex by
mid-2006.
Raising our price target to $4.00 from $2.50 based on new 2008 iPlex revenue estimates. We assume iPlex is
priced to parity with Increlex at an annual wholesaler acquisition cost of therapy for the initial indication of $23,000
per child, but that Insmed may be justified in charging a premium. Based on the majority of pediatric
endocrinologists with whom we speak who suggest that for the initial indication of severe primary IGF-1 deficiency,
they would almost exclusively use iPlex over Increlex, we have modeled iPlex revenues of $7.7 million for 2006, $54
M for 2007 and $119 M for 2008.
The biotechnology group currently trades at a mean enterprise value of 5.6 times 2007 revenues. Applying the 5.6
multiple to projected 2008 iPlex sales of $119 million, discounted two years at 25% and including fully diluted shares
of 109.5 million (assuming a financing in 2006), we arrive at our 12-month price target of $4.00.
Assume Tercica won’t sit back. Court filings including preliminary injunctions are likely to follow from Tercica but
with little consequence to Insmed, in our view. In January 2006, Insmed and Tercica are scheduled for private
mediation in the U.S. District of Northern California, where we assume both parties will continue to “agree to
disagree” and that the trial will proceed to a court hearing scheduled for November 2006. We believe the case will
come down to the manufacturing of IGF-1 and, in reviewing the discovery documents, that Insmed can claim noninfringement
and that a settlement prior to the court trial is unlikely.

[therman]

Durch diesen link kann man die Ergebnisse bei Diabetes im klinische Versuch sehen.
Eine Versuchsreihe in Phase I wird bei Krebs getestet.

http://www.insmed.com/secondary.asp?title=Clinical%20Trials&…

[Senti018]

In der USA zieht der Kurs schon wieder kräftig an!

9.76% Kursgewinn!!!

[blb]

Wenn die Lazard-Prognose von 54 Millionen $ für 2007 aufgeht, dann ist Anschnallen angesagt. Insmed ist aktuell nichtmal 100 Millionen $ wert!

[therman]

Hi,

die Konvertierung der Warrants und die damit verbundenen Spielchen ist offensichtlich beendet.
Heute "normale" Umsätze in USA.

therman

[Senti018]

Warum steigt der Kurs in Germany nicht bzw. warum wird hier so wenig gehandelt? Normal müßte er sich doch nach den Vorgaben aus der USA richten oder?

[toriol]

Nun ja, ersehen schon, aber gegen solche Unternehmensmeldungen ist man natürlich speziell im Pharma/Biotech bereich nicht immer gewappnet. Aber, ich habe es halt schon öfters erlebt, dass man auch die Nachricht vorwegnehmen konnte. Und dann fragt man sich schon, was zuerst da war, die Henne oder das Ei.

Aber egal, interessant finde ich v.a. die Kursreaktion von Tercica.

Jedenfalls haben wir nun ein ziehmlich deutliches langfristiges Signal gesetzt. Wir sollten jetzt noch mal zw. 2 und 2,5$ etwas ringen, bevor es abgeht. Dazu wären dann aber schon noch Verkaufszahlen bzw. Verkaufsvorbereitungen notwendig.
Und ich wiederhole meine Frage noch mal: Gab es da nicht eine Kooperation mit einem Produzenten??? Bzw. Weiss jemand wie das ablaufen soll? Wann können die ersten Medikamente auf den Markt "geworfen" werden?

Toriol

[Senti018]

USA

Last Price
1.8300

Percent Change
+3.39%
+2.81 (AH)

Last Order Time
18:07:37.093

[whyso]

nur ein kleine Lesezeichen....
Sonntagsgrüße sendet Euch,
Whyso

[therman]

Bericht über Insmed im Forbes USA

das könnte den Kurs beflügeln

Forbes (12-19-2005 7:00a.m.)
Insmed (nasdaq: INSM - news - people ) rose 10% last Tuesday, after the tiny biotechnology firm announced U.S. Food and Drug Administration approval of IPLEX, a human growth hormone for short-statured children. The drug was also granted orphan-drug status, which allows Insmed to retain market exclusivity for seven years. Shares of Tercica (nasdaq: TRCA - news - people ), which has a similar drug, fell 29% on the news. Lazard Capital Markets analyst Matthew Osborne downgraded Tercica to "sell" from "hold" on Tuesday. "Tercica`s Increlex is at a distinct disadvantage to IPLEX for the initial indication of severe primary IGF-1 deficiency based on our discussions with endocrinologists, whom on dosing alone, almost exclusively choose IPLEX`s once daily regimen over Increlex`s twice-daily regimen ," the analyst said.

[toriol]

Allerdings, das ist ein entscheidender Vorteil.
Auf das sich die jahrelange Forschung auch auf Jahre auszahlt. Und das nicht nur für die Patienten.

[whyso]

ich denke um die 1,30€ sind sie wieder interessant...

[toriol]

Warum sprichst Du in Euro und zeigst den Chart in Dollar??? Das verlangt ja schon fast einen Hochschulabschluss.

[whyso]

[posting]19.338.583 von toriol am 19.12.05 16:37:36[/posting]Tja, so wird heutzutage eben gehandelt...
Man tradet die sicher kommende pariatät die zwei Währungen mit im Kurs.

Oder glaubst du wirklich das unsere Handel in Europa die Amerikaner überhaupt beeindrücken kann?

Good trades & steady hands wünscht dir/Euch,
Whyso

[toriol]

Also mal abgesehen davon, dass ich langfristig auch von einer parität ausgehe, hoffe ich, dass sich die Amis nicht bedrücken lassen , vielleicht beindrucken, aber egal...

[whyso]

Maybe english is better?
If you liked it at $1,80, you should love it at $ 1.40...
Whyso

[toriol]

1,4$??? Sportliches Ziel.

Aber Vorsicht, die 1,5$ werden ein ansprechender Widerstand sein. Immerhin sind wir 3 mal gegen diese Wand gelaufen. Das Gap ist sehr klein welches geschlossen werden muss. alles andere darf meinetwegen auch nur intraday passieren.

einen schönen Abend und esst schön über Feiertage.

[toriol]

So, das Gap ist geschlossen. von der reinen Charttechnik, könnten wir wieder.

[toriol]

das meinte ich mit zocken. Den heutigen Tag könnte man schon als Intradayreversal gelten lassen

So, eins meiner Kursziele ist noch offen - die 2,5US$
sollten die jetzt kommen?
Aber das weiss nur Gott und 10 andere.

toriol

[Senti018]

Name
Insmed Inc

Last Price
1.8700

Net Change
+0.1500

Shares Matched
161,634

Orders Entered
778

Last Match Time
11:05:46.439
Market
NM

Previous Close
1.7200

Percent Change
+8.72%

Shares Entered
541,361

Open Orders
63

Last Order Time
11:05:47.548

[Senti018]

BUY ORDERS

SHARES PRICE

6,400 1.8800
2,200 1.8700
2,200 1.8600
7,200 1.8500
700 1.8400
200 1.8300
2,700 1.8200
1,800 1.8100
2,000 1.8000
1,000 1.7900

45 Buy Orders



SELL ORDERS

SHARES PRICE

100 1.8900
9,400 1.9000
200 1.9100
200 1.9200
200 1.9300
200 1.9400
200 1.9500
2,900 2.0000
1,500 2.3200
7,750 5.0000

21 Sell Orders

[Senti018]

Name
Insmed Inc

Last Price
1.9000
Net Change
+0.1800

Shares Matched
271,003

Orders Entered
1,085

Last Match Time
11:16:43.062
Market
NM

Previous Close
1.7200

Percent Change
+10.47%
Shares Entered
688,525

Open Orders
53

Last Order Time
11:16:54.008

[toriol]

Also jetzt noch Mal so ordentlich über 2Dollar schliessen und der nächste Sprung lässt uns auf 2,5 landen.

Wie heisst es jetzt so schön: einen guten Rutsch (nach oben) uns allen!

[Runcaly]

Hallo, zusammen !
Bin seit dem FDA-Approval bei INSMED investiert. Einstiegskurs 1,76 €. Habe mich mittlerweile über dieses Unternehmen informiert und sehe sehr gute Aussichten hier Geld zu machen. Potential ist reichlich vorhanden, denke aber auch, das sie einen großen Teil an Aktien noch auf dem Markt werfen werden, um das Marketing zu finanzieren. Fragt sich nur, wann sie das machen?

[toriol]

Also, mal etwas positiv gesponnen. Das Medikament ist sehr gut, und hat gegenüber der Konkurrenz entscheidende Vorteile (siehe eine der letzten News) Wozu dann noch Werbung? Schau Dir Roche und Tamiflu an. Die können die Marketingabteilung für das Medikament einstampfen.

Aber zurück zur Charttechnik.Bind gespannt wie ein Flitzbogen. Ähnlich gespannt ist auch Insmed. Der Chart sieht gut aus.
Hoffen wir, dass es weiter geht.

toriol

[Runcaly]

Ist klar. Hab mich etwas unklar ausgedrückt. Mit Marketing meinte ich die ganze Vertriebsphase, also auch Produktion, Vertriebswege usw.
Ansonsten sind frohe Erwartungen wie zu Weihnachten angesagt.

[therman]

INSM steigt heute über den 2$ Widerstand.

Kurzfristiges Ziel 4 - 6$.

Nächster Widerstand 2,5$

[Senti018]

Name
Insmed Inc

Last Price
2.2000

Net Change
+0.2300

Shares Matched
526,110

Orders Entered
3,427

Last Match Time
12:35:01.743
Market
NM

Previous Close
1.9700

Percent Change
+11.68%

Shares Entered
1,658,087

Open Orders
94

Last Order Time
12:35:12.130

[blb]

Die 4-6$ würde ich eher als Jahresziel sehen, aber der Chart sieht wirklich hervorragend aus!

Grüße
blb

[toriol]

Also die 4-6$ in Ehren, aber ich würde die auch eher im Jahres- oder wenigstens Halbjahreschart sehen.

Zumal: der Widerstand um die 2,5$ bis vielleicht 2,7$ ist sehr dick. Daran sollten wir schon ne Weile zu knaubeln haben. Zumindest um einiges länger als an der 1,85$.

Ausserdem kommt bei 2,5$ noch eine psychologische Marke ins Spiel. Seit dem Ausbruch um die 1,2 - 1,25 sind es dann exakt 100% Gewinn. Ein Grund für einige, erstmal Kasse zu machen.

Also bei aller Liebe, die vorhergesagten 2,5 sollten schon noch kommen, aber das wir gleich bis 4 durchstarten halte ich für eher unwahrscheinlich. Ich lasse mich aber auch gern eines besseren belehren.

Toriol

[[KERN]Codex]

Sieht gut aus

[therman]

Hi toriol und blb,

Ihr habt natürlich recht.
Kurzfristig bedeutet für mich im Verlauf der nächsten Monate.
Langfristig = mehrere Jahre halte ich Kurse von über 20$ für wahrscheinlich.

therman

[blb]

@therman: Die Einführung des Medikamentes ist für das 2. Quartal geplant. Eine Studie von Lazard rechnet dieses Jahr noch mit Umsätzen von 7 Millionen $, nächstes Jahr mit rund 50 Millionen $ und 2008 mit über 100 Millionen $. Auf Basus der Schätzungen für 2007 halte ich 4$-6$ dieses Jahr deshalb absolut für möglich, wir hätten dann ein 2007er KUV von 4-6, für Bios absolut im Rahmen. Allerdings muss man wohl mit einer Kapitalerhöhung rechnen, das wurde hier aber schon angesprochen. Ich würde aktuell keine Stücke verkaufen, eher in Schwäche nachkaufen.

Grüße
blb

[blb]

U. of Rochester Initiates Phase 2 Clinical Trial of Insmed`s iPlex for the Treatment of Myotonic Muscular Dystrophy; Trial Funded by NIH and MDA Grants
WEDNESDAY, JANUARY 04, 2006 10:56 AM
- BusinessWire

RICHMOND, Va. & ROCHESTER, N.Y. & TUCSON, Ariz., Jan 04, 2006 (BUSINESS WIRE) -- -- Insmed Incorporated (INSM) , a Richmond, Va., biotechnology company, the University of Rochester School of Medicine, and the Muscular Dystrophy Association (MDA) announced today the initiation of a Phase 2 clinical study investigating the use of iPlex(TM) (mecasermin rinfabate (rDNA origin) injection), a once-daily IGF-1 therapy, for the treatment of myotonic muscular dystrophy (MMD), the most common form of adult muscular dystrophy.

iPlex is a proprietary drug product for the delivery of recombinant insulin-like growth factor 1 (IGF-1). It is administered as a preformed complex with a recombinant form of its natural binding protein, insulin-like growth factor binding protein 3 (rhIGFBP-3). The novel compound is administered as a once-daily subcutaneous injection, which can restore and maintain IGF-1 levels to physiologically relevant levels. (The original name of the Insmed compound was SomatoKine.)

It has been known for decades that MMD patients do not respond normally to insulin. Recent research has identified an abnormality in an insulin receptor protein as the underlying cause and IGF-1 as a potential remedy.

Myotonic dystrophy affects an estimated 40,000 individuals in the United States and causes progressive muscle wasting and weakness in the hands, forearms, legs, neck and face. It often involves many other systemic effects, including endocrine abnormalities, especially with respect to insulin, a regulator of blood sugar (glucose); neurological changes, including excessive sleepiness and apathy; cataracts, usually requiring surgical excision; gastrointestinal problems; and cardiac rhythm abnormalities, often requiring pacemaker insertion.

The disease can lead to severe disability, and death can result from respiratory muscle weakness or fatal cardiac dysrhythmias.

At present, there is no treatment to reverse the muscle weakness or wasting or the defective insulin utilization in MMD.

"For decades we have studied various potential therapies for patients afflicted with myotonic dystrophy," stated Richard T. Moxley, III, M.D., Professor of Neurology and Pediatrics at the University of Rochester and the Principal Investigator in the Phase II trial. "This study is based on preliminary clinical data demonstrating IGF-1`s ability to restore or preserve muscle strength as well as improve glucose control. We are optimistic that iPlex given once daily will be effective and well tolerated in these patients."

The Phase 2 study of iPlex to investigate the safety and tolerability of once-daily subcutaneous injections of iPlex in patients with MMD will involve two sequential studies each involving 15 patients. The first study is a 24-week, dose-escalation study of iPlex to identify an optimal dose for the subsequent 24-week, fixed-dose study. Both studies will evaluate a number of safety parameters in a prospective manner, as well as several key efficacy measures such as muscle mass and strength.

Kenneth M. Attie, M.D., Chief Medical Officer of Insmed, added, "Myotonic dystrophy is an example of a serious disease, characterized by muscle wasting and insulin resistance, for which iPlex may be an ideal therapeutic intervention. We are very pleased that NIH has endorsed Dr. Moxley`s protocol and that NIH and MDA are supporting this important clinical trial. Insmed is committed to working with the University of Rochester to advance the study of iPlex for this devastating disease."

The University of Rochester, designated by the National Institutes of Health (NIH) as one of several "centers of excellence" for muscular dystrophy research, is receiving up to $1 million per year for five years in federal NIH funding and up to $500,000 per year for three years from MDA, for a total of up to $6.5 million, to identify potential muscular dystrophy therapies.

Robert Ross, President and CEO of MDA, added, "With the compassionate support of the American people, MDA, together with the NIH, is very proud to support the research being conducted by Dr. Moxley as he continues the lifesaving mission of finding a treatment for those with myotonic dystrophy."

About Myotonic Muscular Dystrophy

Myotonic muscular dystrophy (also known as myotonic dystrophy, dystrophia myotonica or Steinert`s disease, and abbreviated MMD, MyD, or DM) is the most common type of adult muscular dystrophy, which affects 1 in 8000 individuals (approximately 40,000 people in the United States). Two genetic abnormalities have been identified that are responsible for myotonic dystrophy types 1 and 2 (DM-1, DM-2). Myotonic dystrophy patients develop progressive muscle wasting and weakness in the hands, forearms, legs, neck and face, as well as cataracts and cardiac arrhythmias, and eventually can become totally disabled, dying usually from respiratory or cardiac failure. At present, there is no treatment to reverse most of these symptoms. Previous preclinical and human studies have demonstrated that IGF-I therapy may be an effective treatment for myotonic muscular dystrophy(1,2). For more information about MMD, please visit www.mdausa.org.

About The Muscular Dystrophy Association

MDA is a voluntary health agency -- a dedicated partnership between scientists and concerned citizens aimed at conquering neuromuscular diseases that affect more than a million Americans. MDA combats neuromuscular diseases through programs of worldwide research, comprehensive medical and community services, and far-reaching professional and public health education. MDA is the world`s largest non-governmental sponsor of research seeking the causes of and effective treatments for neuromuscular diseases, sponsoring some 400 research projects annually.

About Insmed Incorporated

Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com.

1. Furlin D, Marette A, Puymirat J. Insulin-Like Growth Factor I Circumvents Defective Insulin Action in Human Myotonic Dystrophy Skeletal Muscle Cells. Endocrinology. 1999; 140:4244-4250.

2. Vlachopapadopoulou E, Zachwieja JJ, Gertner JM, Manzione D, Bier DM, Matthew DE, Slonim AE. Metabolic and Clinical Response to Recombinant Human Insulin-Like Growth Factor I in Myotonic Dystrophy-A Clinical Research Center Study. J Clin Endocrinol Metab. 1995; 80:3715-3723.

Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements regarding expected financial position, results of operations, cash flows, dividends, financing plans, business strategies, operating efficiencies or synergies, budgets, capital and other expenditures, competitive positions, growth opportunities for existing or proposed products or services, plans and objectives of management, demand for new pharmaceutical products, market trends in the pharmaceutical business, inflation and various economic and business trends. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed, the company may lack financial resources to complete development of product candidates, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the company`s filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release.

SOURCE: Insmed Incorporated

Insmed Incorporated
Baxter Phillips, III, 804-565-3041
[e-mail]
or
Muscular Dystrophy Association
Bob Mackle, Director of Public Information, 520-529-5317
[e-mail]
or
University of Rochester School of Medicine
Tom Rickey, 585-275-7954


Copyright (C) 2006 Business Wire. All rights reserved.

[toriol]

Also mit 2,45$ haben wir die 2,5 nicht ganz erreicht, ich denke trotzdem dass hier erstmal Sense ist.

Ich rechne noch mit Kursen knapp unter 2$.

Schaun wir mal.
euch ein schönes Wochenende
toriol

[toriol]

Also mit einem Schlusskurs von 2,2$ haben wir ein neues "Tief"
Sollte also weiter abwärtsgehen. Zumal sich die Indikatoren auch mal erholen wollen.

Ich bleibe bei meiner Vorhersage. Einstiegskurse zw. 1,85 und 1,95. Wer dann schon wieder will.

toriol

[whyso]

Ist Insmed mit Vertex zu vergleichen?

[blb]

Das Ding rennt und rennt....

@whyso: Ist natürlich nicht vergleichbar. Vertex hat Blockbusterpotenzial in der Pipeline und ist Milliarden schwer. Aber INSM ist auf einem guten Weg und immer noch sehr günstig zu haben. Analystenschätzungen findest du weiter unten. Chartechnisch bleib ich bei meinen 3,5-4$ dieses Jahr. Können auch mehr werden mal sehn...

Grüße
blb

[amorphis]

Insmed gefällt mir...glaub ich bin evtl schon morgen mit an board!

[[KERN]Codex]

erinnert mich eher an mologen

[blb]

Schachsinn, im 2. Quartal haben die ihr Produkt auf dem Markt und dann gehts erst richtig los. Das Produkt ist besser als die Konkurrenz von Tercica.

Mologen lebt aktuell nur von der Phantasie möglicher Abschlüsse, die immer wieder angekündigt wurden. Bis jetzt ist dahin nichts passiert und ich bleib bei denen skeptisch.

Nochmal die Umsatzschätzungen für INSM von Lazard:

We assume iPlex is priced to parity with Increlex at an annual wholesaler acquisition cost of therapy for the initial indication of $23,000
per child, but that Insmed may be justified in charging a premium. Based on the majority of pediatric
endocrinologists with whom we speak who suggest that for the initial indication of severe primary IGF-1 deficiency,
they would almost exclusively use iPlex over Increlex, we have modeled iPlex revenues of $7.7 million for 2006, $54
M for 2007 and $119 M for 2008.
The biotechnology group currently trades at a mean enterprise value of 5.6 times 2007 revenues. Applying the 5.6
multiple to projected 2008 iPlex sales of $119 million, discounted two years at 25% and including fully diluted shares
of 109.5 million (assuming a financing in 2006), we arrive at our 12-month price target of $4.00.


Aktuelle Marketcap INSM: Gerade einmal 135 Millionen $

Grüße
blb

[therman]

HI,

sieht so aus als ob INSM doch schneller nach oben ausbricht.

Möglicherweise heute 3 Dollar.

Möglicherweise sind wir schneller bei 3 und 4$
als ich gedacht habe.

Übrigens GNTA ist gerade am ausbrechen.

therman

[therman]

Schlusskurs 2,59$

Ich denke es ist nicht ratsam mit INSM jetzt kurzfristig zu traden.
Der Schub in die 4 bis 5 Dollar kann sehr schnell gehen.
Ich rechne damit in den nächsten Wochen.

Eine kurzfristige Schwäche wäre ein sehr gute Kaufgelegenheit, darauf spekulieren würde ich jedoch nicht.

Im Bereich 4 bis 5 Dollar werde ich einen Teilverkauf in Erwägung ziehen.

therman

[whyso]

[posting]19.660.949 von blb am 11.01.06 19:04:10[/posting]Vielen Dank für dein Antwort blb,

Ich finde die Firma auch im höchste Maße von Interesse, denke allerdings das sie etwas "Luft" aus der jüngsten Kursverlauf rauslassen müssen um weiterhin beständig anzusteigen.

Ich warte dieser Gelegenheit geduldig abwarten, & hoffe dich demnächst in die Reihen der neuen Investoren hier bald wieder begrüßen zu dürfen!

Beste Grüße & good trading,
Whyso

[therman]

PHARMACOKINETIC STUDIES OF rhIGF-I/rhIGFBP-3 COMPLEX ADMINISTERED TO PATIENTS WITH GROWTH HORMONE INSENSITIVITY SYNDROME.

Camacho-Hubner C, Rose S, Preece MA, Sleevi M, Storr HL, Miraki-Moud F, Minuto F, Frystyk J, Rogol A, Allan G, Sommer A, Savage MO.

Department of Endocrinology, William Harvey Research Institute, Queen Mary, University of London, UK, Department of Paediatrics, Birmingham Heartland Hospital, Birmingham, UK, Biochemistry, Endocrinology and Metabolism Unit, Institute of Child Health, London, UK, Insmed Incorporated, Glen Allen, VA, USA, Department of Endocrinology and Metabolism and Centre of Excellence for Biomedical Research, University of Genoa, Italy and Medical Research Laboratories and Medical Department, Norrebrogade, Aarhus University Hospital, Aarhus, Denmark.

Context: Growth Hormone Insensitivity Syndrome (GHIS), Laron syndrome, is characterized by severe short stature, high serum GH and very low serum IGF-I and IGFBP-3 levels associated with a genetic defect of the GH receptor. Recombinant human (rh) IGF-I treatment at doses of 80-120 microg/kg given sc. twice daily is effective in promoting growth in these patients. We have investigated a newly developed drug rhIGF-I/rhIGFBP-3, a 1:1 molar complex of rhIGF-I and rhIGFBP-3. Objectives: The objectives of the study were to determine IGF-I pharmacokinetics following the administration of rhIGF-I/rhIGFBP-3 in adolescents with GHIS and to evaluate its safety and tolerability. Design: This was an open labeled clinical study. Setting: The study was conducted in a general pediatric ward of a university teaching hospital. Participants: Four patients (1F, 3M) mean age 14.9 yr, mean height SDS -4.9 and confirmed molecular diagnosis of GHIS agreed to participate in the study. Intervention: RhIGF-I/rhIGFBP-3 was administered in a single sc. injection at 0.5 and 1.0 mg/kg/dose (equivalent to 100 microg/kg and 200 microg/kg of rhIGF-I) after breakfast with a two-day interval between doses. Results: IGF-I levels reached maximum between 19 +/- 8.3 h and 15 +/- 6.2 h for the low and high doses, respectively. The IGF-I circulating levels obtained with the low dose and the high dose were similar, although a discrete dose-dependent increase in circulating IGF-I levels was observed. The IGF-I half-life in 4 subjects after a dose of 0.5 mg/kg rhIGF-I/rhIGFBP-3 was estimated to be 21+/- ?4 h. There were no acute adverse events reported and all blood glucose measurements were normal Conclusion: These data demonstrated that rhIGF-I/rhIGFBP-3 complex was effective in increasing levels of circulating total and free IGF-I into the normal range for a 24-h period after a single sc administration in patients with GHIS and that administration of rhIGF-I/rhIGFBP-3 was safe and well tolerated.

[whyso]

http://www.americanbulls.com/StockPage.asp?CompanyTicker=INS…
Any comments?
Whyso

[therman]

INSM hat auf wöchentlicher Basis ein Kaufsignal erzeugt,
das immer noch intakt ist.

Auf täglicher Basis steht es neutral.
Ein Verkaufssignal deutet sich an, ist aber nicht bestätigt - könnte eine Falle sein.

Fazit: Halten

[therman]

HI,

das angedeutete Verkaufssignal durch das black spinning top wird heute nicht bestätigt also weiterhin halten oder zukaufen.

Mit einem Pullback bis 2,50$ ist eventuell nochmal zu rechnen, das wäre eine gute Kaufgelegenheit.

Das Buy-Signal bleibt voll intakt.

http://bigcharts.marketwatch.com/javachart/javachart.asp?sym…

therman

[Senti018]

INSM - INSMED INC (NASDAQ)

Date Open High Low Last Change Volume % Change
01/17/06 2.60 2.77 2.57 2.75 +0.16 2418200 +6.18 %

[therman]

INSM

hat die 2,5 locker genommen und geht heute sogar über 3 Dollar.

Das geht schneller als gedacht aber erhofft.

Es ist noch zu früh um zu verkaufen.

Weiter halten, die shorts kommen ins schwitzen.

therman

[amorphis]

jepp...bin zwar nicht drin...weil ich alles auf gnta gepackt habe... hatte den richtigen riecher...shit!naja...aber...liegst aus meiner sicht völlig richtig...der wert ist "very hot"...würd auch drin bleiben...

[therman]

Ich möchte auf einen sehr interessanten Wert hinweisen,
der meines Erachtens riesiges Potential hat.

GlobeTel Communications Corp. (GTE)

Infos im thread:

Thread: GTE - Globetel Communications Corp - Megachance

therman

[therman]

Hi,

hier noch zwei Aktien, die gerade am ausbrechen sind und das Potential haben sich in den nächsten Wochen zu vervielfachen.

Nanophase NANX
Nanogen NGEN



therman

[therman]

Heute zur Zeit plus 17%.

Bei einem Kurs von 3,22$

hat INSM eine Marktkapitalisierung von ca.: 175Mill. Dollar.

Alleine die kürzlich erfolgte Zulassung vo iplex würde einen weitaus höheren Kurs rechtfertigen.

Und INSM hat noch weitere heisse Eisen im Feuer.
Gute Nachrichten von den anderen Produkten in der Pipeline
kann den Preis zusätzlich sehr schnell deutlich hochtreiben.

therman

[[KERN]Codex]

Echt der Hammer

[kobv]

[posting]19.774.828 von therman am 18.01.06 20:59:39[/posting]Meinst Du die 4 ist bald drin?
Grüße kobv

[therman]

[posting]19.776.138 von kobv am 18.01.06 22:31:56[/posting]Mit 4 bis 5 Dollar rechne ich in den nächsten Wochen.

Eigentlich wäre jetzt mal eine Konsolidierung fällig.
Die kann bis 2,9 - 2,5 gehen.
Kurse um 2,5 $ wäre eine sehr gute Nachkaufgelegenheit.

Es kann aber auch schneller nach oben gehen.

Eine entsprechende Nachricht und wir sind sofort bei4$.

therman

[blb]

Auf jeden Fall dabeibleiben! Man hat hier wirklich die Chance bei einer völligen Neubewertung mal dabei zu sein. Wir haben die Aktie zu 1,26$ ins Musterdepot gekauft und werden sie auch nicht so schnell verkaufen!

Grüße an alle INSM-Fans und solche, die es noch werden!
blb

Großes Kursziel für mich ist wirklichd er Bereich 4$! Spätestens da erwartet ich eine größere Korrektur. Wer sich aber den Langfristchart näher ansieht, wird merken, dass da noch deutlich mehr drin ist!

[whyso]

Nur schade das sie so eng gehandelt werden hierzulande in good old BRD...man siehts heute recht deutlich, 100 stk verkauft und das bewirkt -8% ...das ist mir GNTA z.Zt lieber rein von Volumina her.

Viel Glück & auf ein weiterhin bombigen Performanz mit INSM!
Whyso

[blb]

@whyso: Man kann doch auch ohne Probleme über jeden deutschen Broker direkt in den USA handeln...

Bei so marktengen Werten macht Deutschland auf jeden Fall keinen Sinn. Ich hab zusätzlich noch ein Depot bei Interactive Brokers, kann ich nur empfehlen!

Grüße
blb

[therman]

[posting]19.783.389 von whyso am 19.01.06 12:50:55[/posting]HI whyso und blb,

ich handle INSM genauso wie GNTA direkt an der Börse in USA. Alle anderen Us Werte übrigens auch.
Da braucht man sich um geringe Umsätze keine Sorge machen.

Gruß
therman

[therman]

Konsolidierung bei INSM ist eingeleitet.

Die Frage ist wie lange dauert sie und wie stark wird sie ausfallen.

Unterstützungsbereiche sind.
1. ca. 2,9 bis 3 Dollar
2. ca. 2,5 bis 2,4 Dollar.

Die 2,90$ wurde gerade angetestet.

Könnte nochmal eine gute Kaufgelegenheit werden.

therman

[therman]

Die Konsolidierung bei INSM geht heute weiter.
Unterstützung bietet heute die 10Tageslinie, die bei ca.2,6$ verläuft.

Mal sehen ob der Bereich um 2,5$ hält.

Ich halte INSM weiterhin und werde noch zukaufen.

therman

[therman]

INSM
hat auf täglicher Basis ein deutliches Verkaufssignal erzeugt.

Auf wöchentlicher Basis hat sich ein schwaches Verkaufsignal ergeben, das nicht sehr aussagekräftig ist, und bestätigt werden muss.

Ich rechne damit, dass der Bereich 2,4 bis 2,5 angetestet wird, eventuell sogar der Bereich um 2 Dollar.


therman

[therman]

Bis jetzt hält die 2,5-2,4 Marke.

habe gestern bei 2,41 nochmal nachgekauft.

rein charttechnisch steht es momentan auf abwarten.

In anbetracht der fundamentalen situation ist es für mich ein klarer kauf.

dass INSM weiterhin volatil bleiben wird ist sehr wahrscheinlich, dies eröffnet jedoch auch tradinmöglichkeiten.

therman

[therman]

INSM

testet heute weiter den bereich um 2,5 - 2,4 Dollar.

Unterstützung bietet in diesem Bereich die 20 SMA täglich und ein horizontale Unterstützungslinie.

weiter abwarten.

therman

[therman]

INSM

hat ein Verkaufssignal erzeugt auf wöchentlicher und täglicher Basis, Kerzenanalyse, Unterstützung bietet zur Zeit der Bereich 2,5 und die 20-EMA-linie-täglich.

Habe am Freitag einen Teil zu 2,72Dollar verkauft, den ich billger wieder zurückkaufen möchte.

Durch entsprechende Nachrichten kann der Kurs jedoch auch sehr schnell nach oben gehen.

therman

[kobv]

[posting]19.953.690 von therman am 30.01.06 09:28:05[/posting]Unterstützung bei 2.35 oder gehts noch tiefer?
Grüße kobv

[miristegal]

[posting]19.953.690 von therman am 30.01.06 09:28:05[/posting]gehst du nur nach chart , oder berücksichst du auch andere
aspekte? Ich schätze deine beiträge , also nicht als angriff verstehen!!!
so wie ich es verstanden habe , sprechen sie eine krankensparte von 40 000 in USA . das ist aber verdammt wenig
um ein wirkliches potenzial zu haben, geld zu verdienen.
das menschliche lassen wir hier aussen vor. wir wollen doch alle hier geld an der börse verdienen

Bilden Sie 8-K für INSMED Inc.

24-Jan-2006

Verkauf von Billigkeit


Nicht registrierte Verkäufe des Einzelteils 3,02 der Dividendenpapiere

Zwischen Januar 17, 2006 und Januar 24, 2006, empfing Insmed, das enthalten wurde, Nachrichten von den Haltern seiner 5,5% umwandelbaren Anmerkungen passendes 2008 - 2010 wählend, um die Menge mit $4.175.000 Direktionen umwandelbare Anmerkungen in 3.223.927 Anteile von Stammaktien mit dem Umrechnungssatz von einem Anteil von Stammaktien für jede $1,295 in der Hauptmenge der umwandelbaren Anmerkungen freiwillig umzuwandeln. Die Firma empfing auch $3.310.735 von den Ermächtigungsübungen, die 2.434.364 Anteile der Stammaktien ergaben, die zu einem Übungspreis von $1,36 herausgegeben wurden. Die Zahl Anteilen gab gemäß der Umwandlung der umwandelbaren Anmerkungen und der Übung der Ermächtigungen seit Januar 13, 2006, das Datum von Insmeds letztem Report unter Einzelteil 3,02 heraus, überstiegen 1% von Insmeds hervorragenden Stammaktien an Januar 18, 2006.

Die Stammaktien gaben nach der Umwandlung der umwandelbaren Anmerkungen heraus und die Ermächtigungen wurden im Vertrauen nach den Befreiungen von den Ausrichtungsanforderungen der Sicherheitstat von 1933 herausgegeben, wie geändert, zur Verfügung gestellt für innen
Alle Abschnitt 3(a)(9) und Abschnitt 4(2) davon und ist, die z.Z. für Weiterverkauf durch die Halter gemäß Ausrichtungsaussage Insmeds auf Form S-3 eingeordnet mit den Aktien und der Austauschkommission an August 8, 2005 registriert werden (die "Ausrichtungsaussage").

Nach den Umwandlungen, die oben beschrieben wurden, blieb die Menge mit $6.013.000 Direktionen der umwandelbaren Anmerkungen hervorragend. Zusätzlich weil sicher der umwandelbaren Anmerkungen vor dem März 1 umgewandelt wurden, gab vierteljährliche 2006 Zinszahlung, die Firma zusätzliche 24.068 Anteile von Stammaktien für die eingebüßte Bargeldzinszahlung zu einem Konvertierungskurs von $1,295 heraus. Eine Zusammenfassung der Bezeichnungen der Kabriolettanmerkungen und der Ermächtigungen, einschließlich der Umwandlungseigenschaften und der Zinszahlungen der umwandelbaren Anmerkungen wurde vorher in in der Ausrichtungsaussage und Insmeds gegenwärtigen dem Report auf Form 8-K eingeordnet mit den Aktien und der Austauschkommission an März 16, 2005 zur Verfügung gestellt (der "gegenwärtige Report"). Die Formen der umwandelbaren Anmerkungen und der Ermächtigungen wurden auf einem gegenwärtigen Report eingeordnet mit der sek an März 16, 2005 eingeordnet. Die Ausrichtungsaussage, der gegenwärtige Report, die Formen der umwandelbaren Anmerkungen und die Ermächtigungen werden jede hierin durch Hinweis enthalten.


ist zwar eine google übersetzung aber , kann einer
die aussichten hier auf dieser basis reinstellen?

@kobv
deine anleger strategie würde ich gerne kennenlernen.
auch per BM.

MFG

[blb]

@miristegal: Das, was du hier reingestellt hast, bedeutet nicht anderes als dass die Leute ihre Convertibles teilweise in Aktien umgewandelt haben. Gab zwei Meldungen an die SEC! Im nächsten Quartalsbericht dürfte es dann genauer ersichtlich sein, wieviel da jetzt von den Convertibles auf der Passivseite noch übrig ist.

Grüße
blb

[blb]

Zum Marktpotenial des Medikaments:

Lazard rechnet in 2006 mit 7 Millionen ,in 2007 mit rund 50 Millionen und in 2008 mit rund 100 Millionen $ Umsatz für Insmed. Andere Schätzungen habe ich nicht vorliegen.

Grüße
blb

[therman]

hi mistregal,

die kauf und verkaufsignale sind rein charttechnisch.

ich bin vom langfristigen potential überzeugt,

denn die kürzlich erteilte zulassung ist erst der anfang.

INSM hat eine pipeline , die weitaus höhere umsätze verspricht, es wird jedoch noch ein paar jahre dauern bis diese wirklichkeit werden.

habe gestern bei 2,37 einen teil der bei 2,71 verkauften aktien zurückgekauft.
der kurs kann durchaus kurzfristig noch tiefer gehen, dann werde ich den rest zurückkaufen.

therman

[therman]

INSM
sieht heute gut aus .
möglicherweise kann ich nicht mehr unter 2,5 zurückkaufen, macht nichts.

wenn sich der kurs so hält liefert INSM heute ein Kaufsignal im tageschart.

warten wir´s ab.

therman

[therman]

INSM

hat gestern ein Kaufsignal geliefert.
die letzten zwei kerzen bilden ein bullish harami pattern, das auf einen trendwechsel hindeutet.
dieses signal ist nicht sehr stark und bedarf der bestätigung.
mal sehen ob dies heute bestätigt wird.

therman

[therman]

Das bullishe harami pattern wurde gestern nicht bestätigt.

Es bleibt noch der heutige Tag, um das pattern zu bestätigen.

therman

[toriol]

Die Korrektur war notwendig, unabhängig von Tageskerzen. Der 5Jahreschart im Wochenzyklus war mehr als übergekauft.
ich sehe immernoch kurse um 2$, eher etwas tiefer.

aber mal sehen... auf jeden Fall ist langsam wieder acht auf Einstiegskurse zu geben.

toriol

[therman]

[posting]20.020.613 von toriol am 02.02.06 22:53:27[/posting]das leichte Kaufsignal auf Kerzenanalyse wurde nicht bestätigt.

INSM steht für mich charttechnisch auf abwarten.
Kurse um die 2$ halte ich ebenfalls für möglich.

Trotzdem habe ich einen weiteren Teil meiner bei 2,71$ verkauften Aktien gestern bei 2,29 zurückgekauft, da ich langfristig von INSM überzeugt bin.

Wenn es weiter runtergeht werde ich den Rest zurückkaufen. Wenn ich nicht um die 2$ herum kaufen kann, kaufe ich den Rest bei einem bestätigten Kaufsignal zurück.

therman

[blb]

Für mich sieht der Chart stark nach einem Bullkeil aus, mal abwarten...

Grüße
blb

[therman]

[posting]20.023.499 von blb am 03.02.06 09:25:48[/posting]Hi blb,

den bullishen keil sehe ich auch so.

Es sollte eigentlich ein Ausbruch nach oben erfolgen.

therman

[cyberhai]

Insmed Incorporated Files Shelf Registration Statement
Friday February 3, 5:25 pm ET

GLEN ALLEN, Va.--(BUSINESS WIRE)--Feb. 3, 2006--Insmed Incorporated (Nasdaq: INSM - News) has filed a shelf registration statement with the Securities and Exchange Commission (SEC) that when declared effective by the SEC would allow Insmed to sell up to $75,000,000 of its common stock, preferred stock or warrants for common or preferred stock. Insmed may sell these securities in one or more separate offerings in amounts, at prices and on terms to be determined at the time of such offer or offerings. This shelf registration statement is intended to give Insmed flexibility to take advantage of financing opportunities when and if deemed appropriate by the Company. Insmed expects to use the proceeds from any of these offerings for general corporate purposes, including expanding commercial and marketing efforts; increasing working capital; funding capital and clinical development expenditures; acquiring new products or technologies; and making other investments.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell, or the solicitation of, an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

[therman]

[posting]20.039.105 von cyberhai am 04.02.06 09:34:19[/posting]Bin gespannt, was für Reaktionen diese Meldung auslösen wird.

Ein deutlicher Kursrückgang wäre ein gute Gelegenheit aufzustocken.

therman

[cyberhai]

Nachbörslich bereits unter Druck, stimmt - könnte eine gute Nachkaufgelegenheit geben:

Symbol: INSM
Last Trade: 2.19 Feb 3
After Hours Change: Down 0.14 (6.01%)
Today`s Change: Down 0.18 (7.59%)
Bid: 0.75
Ask: 2.32

Gruß Cyberhai

[therman]

der letze nachbörsliche kurs war: 2,33 $.

http://bigcharts.marketwatch.com/javachart/javachart.asp?sym…

mit einem heftigen kurzfristigen kursrückgang sollte man rechnen. werde diesen nutzen zum aufstocken, wenn er kommt.

therman

[therman]

INSM verliert heute 7,8% auf 2,15$

bewegt sich weiter in einem bullishen keil.

habe heute bei 2,12$ aufgestockt.
die unterstützung bei 2,14 hat heute gehalten.
nächste unterstützung ist 2,03$.

zusätzlich unterstützung geben die 50ema linie bei ca. 2,02$ und die unterkante des bullishen keils bei ca. 2 $.

mal sehen ob die unterstützungen halten.

marktkapitalisierung zum jetzigen kurs 117mill ohne die neuen aktien - plus 75mill durch neue aktien/warrants = ca:200mill mit den neuen aktien.
bei den umsätzen, die zu erwarten sind ein günstiger einstiegskurs.

nachdem die finanzierung durch ist hat INSM genügend geld - ca. 90mill.$ - um seine forschungen durchzuführen - sehr positiv.

spätestens nach abschluss der finanzierungsmaßnahme wird es meiner meinung anch wieder aufwärts gehen.

therman

[blb]

@therman: Man muss auch abwarten, wieviel von den 75 Millionen sie auch tatsächlich gleich nutzen werden. Außerdem ist es nicht unwichtig wo der Kurs dann da steht.
Also die Prognose von Lazard mit 4$ hatte schon Kapitalmaßnahmen berücksichtigt und ich bleibe ebenfalls dabei. Haben sie deshalb nach unglücklichem Ausstoppen fürs Musterdepot zurückgakuft!

Gute Nacht!
blb

[cyberhai]

Bin bei 2,11 aus Steuergründen ausgestiegen und dann kam ich mit Mühe und Not bei 2,13 wieder rein...

Gruß + einen schönen Tag

Cyberhai

[therman]

Die letzten zwei Kerzen bilden ein:
Bullish Meeting Lines Pattern

dies ist ein leichtes Kaufsignal und deutet auf einen
möglichen trendwechsel hin.

Dieses Signal ist nicht sehr stark und bedarf der bestätigung.

@blb : stimme Dir zu

Ich halte meine Aktien weiter.

therman

[Runcaly]

Hallo, guten Morgen,
haben bisher in Frankfurt über Cortal Consors geordert. Da auch die Möglichkeit besteht hier direkt in US zu ordern, möchte ich das demnächst probieren. Muß ich was beachten? Wer hilft mir?
Danke.

[therman]

[posting]20.094.958 von Runcaly am 08.02.06 11:23:38[/posting]Auf jeden Fall ein Limit eingeben.

therman

[cyberhai]

[posting]20.094.958 von Runcaly am 08.02.06 11:23:38[/posting]All or none oder ähnliches bei Orderzusatz anwählen, damit keine Teilausführungen erfolgen - das kann teuer werden. Das Limit leicht über den aktuellen Kurs setzen, damit einer auch genau Deine gewünschte Aktienzahl verkauft bzw. wenn Du es sowieso eilig hast...

Gruß Cyberhai

[Runcaly]

Danke für die Tipps.

[therman]

Das Kauf-signal wurde gestern bestätigt.

INSM steht damit im Tageschart auf kaufen - kerzenanalyse.

therman

[therman]

Den widerstand bei 2,5Dollar hat INSM noch nicht wieder überwinden können.

Mal sehen ob dieser Widerstand zu einer Konsolidierung führt oder ob er schnell überwunden wird.

therman

[therman]

Bei INSM gehts wieder aufwärts.

habe nochmal nachgelegt.

Kaufsignal wurde bestätigt.

Auf zu neuen Höhen.

therman

[therman]

Insmed setzt seinen Anstieg weiter fort.

Weiter halten.

therman

[[KERN]Codex]

Bin auch wieder dabei, sieht super aus

[therman]

[posting]20.440.223 von [KERN]Codex am 01.03.06 12:15:08[/posting]ja, das sieht sehr gut aus,INSM überwindet heute den widerstand bei 2,5$.

auf zu neuen höhen.

therman

[therman]

Durch den Verkauf von den 20Mill. Aktien könnte der Kurs kurzfristig gedrückt werden.
Durch den Verkauf hat INSM jedoch dann genügend in der Kasse um den Marktstart von IPLEX erfolgreich durchzuführen, der in Kürze erfolgen wird.
INSM wird IPLEX weltweit vermarkten und arbeitet mit Hochdruck an einer schnellen und erfolgreichen Vermarktung.

News:
http://biz.yahoo.com/bw/060306/20060306005590.html?.v=1

Insmed Incorporated Announces Proposed Public Offering of Common Stock
Monday March 6, 7:21 am ET


RICHMOND, Va.--(BUSINESS WIRE)--March 6, 2006--Insmed (NASDAQ: INSM - News) announced today that it has filed a preliminary prospectus supplement relating to an offering of 20,000,000 shares of its common stock pursuant to a Form S-3 shelf registration statement filed last month with the U.S. Securities and Exchange Commission. Insmed will also grant the underwriters in the offering an option to purchase up to 3,000,000 additional shares of common stock to cover over-allotments, if any. All of the shares are being sold by Insmed.

[therman]

habe die günstigen kurse zum nachkaufen genützt.

therman

[toriol]

Bin mal gespannt. Charttechnisch waren das bei 2$ neue "Tiefststände". Demnach müsste es schon noch bis 1,8$ gehen. Mal sehen, wann ein Einstieg wieder lohnt.

toriol

[therman]

[posting]20.685.810 von toriol am 14.03.06 22:14:59[/posting]Habe bei 1,99$ nochmal zugekauft.

Mag sein, dass es noch bis 1,8$ runtergeht, das kann man nicht ausschließen.

Aber schon die Preise um 2 Dollar halte ich für ein Geschenk, langfristig gesehen.

therman

[blb]

Im 2. Quartal kommt das Medikament auf den Markt, Insmed bleibt ein klarer Kauf!

Grüße
blb

[toriol]

So, ich bin wieder am Start bei Insmed. Auf zu 4$. Charttechnisch sollten wir langsam die Wende sehen. Fundamental sowieso...


toriol

[toriol]

übrigens haben wir kurz unter 2,5$ ein Gap zu schliessen.
Mögen die Spiele beginnen. Bin ja bei 1,9$ wieder rein.
auf eine grüne Woche

toriol

[toriol]

so, das waren die 1,8$

und nun aber schluss mit abwärts....

[toriol]

Zugegeben damit habe ich nicht gerechnet, aber wie sind bilderbuchreif bei 1,64$ abgeprallt. jetzt sollte es relativ zügig richtung 3$ (und weiter) gehen.

also wer noch nicht wieder drin ist, sollte sich es bald überlegen, dann rollt der Zug wieder.

toriol

[toriol]

bilden wir gerade ein kleines W aus, damit wir auch in Formatin steigen? wir können ja nicht einfach so nach oben gehen, alles schön ordentlich... ;-)

die Tage sind gezählt....

toriol

[toriol]

So die langfristindikatoren sind seit "langem" beide wieder im Grünen Bereich.
Fazit: KAUFEN!

Zur Formation habe ich ja mein Senf schon dazugegeben. Das W wird bildschön, und absichern könnte man sich auch gut, wer denn nicht darauf vertraut.

max. 2 Wochen und wir sind mindestens bei 2$ (als Anfang...)

gute nacht
Toriol

[toriol]

So, die 2$ gabs heute als Intraday. "Vorhersage" erfüllt. das war aber nur die Ansage des nun kommenden Aufwärtstrend bis zu 3-4$.

Auf grüne Wochen...schliesslich ist Frühling

toriol

[amorphis]

Pre-Market (RT-ECN): 1.76 Up 0.22 (14.29%)

Press Release Source: Insmed Incorporated

INSMED Announces IPLEX(TM) Availability Nationwide for Children with Severe Short Stature
Thursday May 25, 8:05 am ET
IPLEX Launch Marked By The First Product Shipments To Patients in States Across the Country

RICHMOND, Va.--(BUSINESS WIRE)--May 25, 2006--Insmed Incorporated (NASDAQ:INSM - News) announced today the nationwide availability of IPLEX(TM) (mecasermin rinfabate (rDNA origin). IPLEX was approved as an orphan drug by the Food and Drug Administration in December 2005 for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. IPLEX is the only once-daily IGF-I replacement therapy available for the treatment of severe primary IGFD.

"Insmed is very pleased to provide this novel therapeutic protein complex for the treatment of children who suffer from severe primary IGFD," said Philip J. Young, CBO. "It has been a 20-year journey for the many researchers involved in the development of IPLEX, and we are very gratified to finally have the opportunity to provide the only once-daily IGF-I therapy to patients in the United States. It is with great pleasure that we announce that on May 24, 2006 the first US patients with Primary IGFD began receiving IPLEX."

Primary IGFD is a distinct diagnosis of short stature and is believed to affect as many as 30,000 children in the United States. A subset of these patients is classified as having Severe Primary IGFD, which is estimated to affect 6,000 children. Severe Primary IGFD is a genetic or acquired condition in which patients do not generate sufficient quantities of IGF-I due to defects in the GH receptor/IGF-I pathway. In addition to the growth failure, Severe Primary IGFD can be associated with psychosocial problems. The early recognition and proper treatment of Severe Primary IGFD is critical in helping patients normalize growth and metabolic function.

"Numerous areas of the growth process remained a mystery for many years," said Mary Andrews, Executive Director of the MAGIC Foundation. "Now, thanks to the hard work of the researchers at Insmed, growth is better understood. It is so exciting to know that a new and convenient therapy is available for the many children with adequate levels of growth hormone who are not growing normally."

"As long time advocates for the diagnosis and treatment of children with growth issues, we recognize the importance of new and innovative approaches. We are pleased to welcome Insmed's debut into the field of pediatric growth therapy," adds Patricia D. Costa, Executive Director of the Human Growth Foundation.

IPLEX became available starting May 24 through a nationwide distribution system called PlexPoint(TM). PlexPoint is a single point of contact system for patients, payers and healthcare providers. PlexPoint can be accessed by calling 866-GO-IPLEX (866-464-7539) or on the web at www.go-IPLEX.com. The PlexPoint system is designed to provide the highest level of customer service to all stakeholders in the therapeutic decision-making and treatment processes. This system has been designed to provide flexibility and support to the payers, physicians, distributors and patients by allowing them to customize the distribution process to meet their individual needs.

More About IPLEX

Much of the data to support the FDA's approval last December were recently presented at the Pediatric Academic Societies' (PAS) 2006 Annual Meeting in San Francisco, California. At 12 months the ongoing study demonstrated significant, dose-dependent increases in growth rate. The investigators reported that the mean height velocity for the dose group titrated with up to 2 mg/kg/day increased from 2.0 cm/year pre-treatment to 8.3 cm/year during treatment. Children with genetic and acquired forms of GH insensitivity or IGFD appeared to respond equally well to treatment.

The once-daily dosing regimen used in the study was associated with a high compliance rate of 95% of injections taken. The safety profile of IPLEX proved favorable as instances of low blood sugar (hypoglycemia) were mostly mild and asymptomatic. Patients with severe GH insensitivity have a predisposition to hypoglycemia without treatment. Of the subjects enrolled in the study, 28% reported a history of hypoglycemia prior to treatment. This was similar to the proportion of subjects (31%) who experienced at least one incidence of hypoglycemia during the first year of treatment with IPLEX.

In the study, no patients discontinued IPLEX due to a related adverse event. Two patients had papilledema (one with a blocked pre-existing ventriculo-peritoneal shunt and one asymptomatic). No instances of facial nerve paralysis were reported. As is common with protein therapeutics, antibodies to the protein complex were detected in most patients, but were not associated with growth attenuation or adverse effects.

IPLEX is also being investigated for various other indications with unmet medical needs, including extreme insulin resistance, myotonic muscular dystrophy and HIV Associated Adipose Redistribution Syndrome (HARS) and short stature in children with Primary IGFD associated with Noonan Syndrome.

[Berti78]

Hallo Leute..

verfolge die Aktie auch schon länger. Hat jemand etwas neues zu der Aktie nach dem Bericht der letzten Tage? Aktie ist zwar
stark volatil aber ohne nenneswerte Fakten.

[toriol]

So, endlich wurde der Abwärtstrend nach oben gebrochen. Auch wenn wir noch mal einen Rücksetzer bekommen sollten, sollte es danach doch deutlich nach oben gehen. Das Kursziel bis August bleibt bei 3$.
Das wären wiedermal knappe 100%

toriol

[HSM]

Servus allerseits


Aus "Der Aktionär" - Mehr aus der aktuellen Ausgabe siehe Thread: ► Der Aktionär Empfehlungen Ausgabe 28/2006 ◄


Insmed ist unterbewertet, Mutige vor, 100 % Chance, für risikobereite Anleger, limitiert ordern, Kursziel 2,50 Euro.

[toriol]

Antwort auf Beitrag Nr.: 22.406.737 von HSM am 04.07.06 13:44:55

wohl der Grund für den fulminanten absturz heute....

TRCA/INSM: Court Rules Insmed Infringed Patent Claims

Tercica, Inc. (TRCA) announced the U.S. District Court for the Northern District of California issued rulings on summary judgment and claim construction in Tercica's patent infringement litigation against defendants Insmed Incorporated, Celtrix Pharmaceuticals, Inc. and Insmed Therapeutic Proteins, Inc. In the case, Tercica has alleged that the defendants have infringed and are infringing three patents. The Court granted both of Tercica's motions for partial summary judgment. The Court ruled that Insmed's process for making IPLEX(TM) infringes three claims of the patent. The Court also denied four of Insmed's five motions for summary judgment.

[toriol]

Antwort auf Beitrag Nr.: 22.422.839 von toriol am 05.07.06 18:33:04

Ich weiss, man kann auch aus jeden Absturz noch was positives ziehen, aber ich habe mir den Chart gerade noch mal angeschaut und bin auf was gestossen. Und zwar den 5 jährigen langfristigsten Aufwärtstrend.

Soll Heissen, wenn der nicht hält, dann fangen wir von vorne an, ansonsten könnten die 1,2$ dann auch mal der Boden sein.

Hoffen wir das beste. Immerhin haben wir noch ein Gap bei ca. 1,5$ zu schliessen.

Gute Nacht

toriol

[toriol]

Die Hoffnung stirbt zuletzt.

aber sehen meine Augen da ein kleines W???
Dieses W könnte endlich das Gap bei 1,5 zumachen. Zeit wird's.

Wir werden sehen, auf jeden Fall hat der Dollar ganz gut gehalten.

toriol

[toriol]

es riecht nach Ausbruch. Zumindest sieht es stark danach aus, als ob wir in Kürze das Gap bei 1,5$ schliessen werden.

Aufiiii.
toriol

[toriol]

Doppeltop oder rechtwinkliges Dreieck?
Sprich:
Brechen wir erst aus, schliessen das Gap und kommen dann noch mal runter oder gehen wir erst nochmal runter, bilden ein W und schliessen dann das Gap.

Ich persönlich tendiere eher zum Dreieck, da es selten so schön ist wie hier. Wenn das so ist, dann ist der Ausbruch in unmittelbarer Nähe.

wir werden sehen
toriol

[toriol]

Antwort auf Beitrag Nr.: 23.341.362 von toriol am 07.08.06 14:42:20

sehr schön und abgeprallt. W startklar. Kursziel zum schliessen des W liegt bei ca. 1,70$.

Aktuell bei 1,12$

Aufiii - LOS!!!

toriol

[toriol]

irgendwie klappt das Vorhersagen bei nanogen wesentlich besser.

aber ich bleibe dabei, der Ausbruch (nach oben oder unten) kommt!

Wir haben jetzt hier eine ähnliche Situation wie bei Nanogen. Nur dass der zweite Boden 1 cent tiefer lag als der erste. Das wird aber erstmal irgnoriert. Im positiven Fall war der kurze Rückgang die letzten Tage die Bestätigen des zweiten Bodens. Im negativen Fall fällt die Aktie sowieso ins Bodenlose. Aber: Der Wiederstand zwischen 1 und 1,2$ ist verdammt stark. Daher glaube ich mehr an einen Ausbruch nach oben.

Loooooooooooosssssss, steig endlich.

toriol

[toriol]

Antwort auf Beitrag Nr.: 23.622.083 von toriol am 26.08.06 13:52:04

typisch. wenn man die Hoffnung schon beinahe aufgegeben hat, knallt es. Aber ich glaube wir noch ein Gap. Auf jeden Fall haben wir die seitliche Bewegung nach oben durchbrochen.Zurück Gap schliessen und dann hooooooooch!?

toriol

[toriol]

Antwort auf Beitrag Nr.: 23.725.553 von toriol am 01.09.06 20:55:28

lang hats gedauert. aber irgendwann muss es ja so kommen. der langfristchart sieht fein aus. endlich wieder mal was los bei insmed

toriol

[cyberhai]

Antwort auf Beitrag Nr.: 25.573.814 von toriol am 21.11.06 20:33:22

Ja, wurde langsam Zeit, bin auch seit ein paar Tagen investiert

Anscheinend hat diese Nachricht für den Startschuss genügt:

http://biz.yahoo.com/bw/061121/20061121005134.html?.v=1

Gruß Cyberhai

[stotinka]

Antwort auf Beitrag Nr.: 25.574.485 von cyberhai am 21.11.06 20:45:06

Hallo

Bin schon seit Jahren INSMED treu wird Zeit das es mal
Bewegung in Richtung Norden gibt.Kann man die Mitteilung
auch in deutsch bekommen?

[cyberhai]

Antwort auf Beitrag Nr.: 25.586.417 von stotinka am 22.11.06 10:14:12

Hallo,

leider nicht, musst ein Übersetzungsprogramm benutzen...

Gruß Cyberhai

[hedger_de]

NESW NEWS NEWS NEWS NEWS NEWS NEWS VOM 17.02.2007 !!!!

KAUFEMPFEHLUNG IN US-BÖRSENBRIEF

Buy at $ 1,23 / Sell at $ 2+
(MOMENTUM PLAY)

Volume is over 7 Million shares
52-week high $ 2,79 / low $ 0.80

..."Based off of our data, the stock is poised for a significant surge in stock price sometime over the next 1-2 months...this is definitely a stovk to keep on eye on over the coming weeks as a surge in price is highlx prohable. Be sure to buy in the dip !"

===KEINE KAUFEMFHELUNG MEINERSEITS !!!!

grüße hedger_de

[alysant]

morgen, Donnerstag, 10.5., Bekanntgabe 1. Quartal;
==================================================

durch Verkauf von 20 Mi0. zu 0.90 und Wandelanleihe (1,--) ist der Kurs unter Druck gekommen

aktuell 0.84 US-$

Könnte morgen scharf anziehen, wenn das Management einiges vom Stapel läßt !

[alysant]

Antwort auf Beitrag Nr.: 29.239.136 von alysant am 09.05.07 20:15:19

Umsatzausweitung + Verlustreduzierung

mit einigen passenden statements rechne ich mit 1.20 (US-$) kurzfristig

[alysant]

Antwort auf Beitrag Nr.: 29.252.142 von alysant am 10.05.07 15:36:15

anfangs im Plus, am Schluß im Minus

nach St. 7 Mio. Vol. rechne ich ähnlich wie bei SCLL mit einem scharfen Anstieg. Die haben kürzlich auch von 0.03 und gr. Vol. auf 0.055 angezogen.

alle Angaben in US-$
====================

[alysant]

Antwort auf Beitrag Nr.: 29.268.154 von alysant am 11.05.07 13:14:54

über 0.80

meine Meinung:

eine positive Meldung und wir sind bei 1.20 !

Ist tgl. möglich.

[alysant]

Antwort auf Beitrag Nr.: 29.275.471 von alysant am 11.05.07 20:05:59

lese gerade bei yahoo.com, daß ein insider seine Option zu 0.83 ausgeübt hat.

möglicherweise kommt in Kürze eine positive message

alles unter Vorbehalt
=====================

[alysant]

Antwort auf Beitrag Nr.: 29.275.471 von alysant am 11.05.07 20:05:59

heute high bisher 0.82

[Berni1129]

Antwort auf Beitrag Nr.: 29.304.241 von alysant am 14.05.07 17:06:30

Hallo, ich bin neu bei Insmed und wollte dich mal nach deinen Kursziel fragen? habe immer wieder beobachtet das die Aktie mal eine Rakete hinlegt und dann wieder fällt....mich würde deine Meinung dazu interesieren und über deine Prognose beim Kursverlauf!!!
mfg Bernd

[Indium]

Insmed to Present at the 2007 BIO Investor Forum on Wednesday, October 10, 2007
Wednesday October 3, 4:05 pm ET
RICHMOND, Va.--(BUSINESS WIRE)--Insmed Inc. (Nasdaq:INSM - News), a biopharmaceutical company focused on the development and approval of drugs for the treatment of metabolic diseases with unmet medical needs and the development of a comprehensive portfolio of follow on biologics, today announced that it will present at the 2007 BIO Investor Forum in San Francisco.
http://biz.yahoo.com/bw/071003/20071003006202.html?.v=1" target="_blank" rel="nofollow ugc noopener">
http://biz.yahoo.com/bw/071003/20071003006202.html?.v=1

Freitag 5.Okt 2007 +18% war das der Startschuss ???

[Indium]

Last Trade: 0.9298
Trade Time: 10:37AM ET (08.10.2007)
Change: 0.0798 (9.39%) ( PLUS! )

[Indium]

2007 BIO Investor Forum in San Francisco

http://webcastingplayer.corporate-ir.net/player/PlayerLargeS…

[Indium]

Insmed Inc Q3 results
at Reuters (Thu, Nov 8)
http://www.reuters.com/article/marketsNews/idUKWNAS156620071…


Insmed Advances Follow on Biologics Initiative
Tuesday November 13, 9:00 am ET
Completes Characterization and Scale Up Manufacturing of Two Follow On Biologics Products
Initiation of Clinical Studies Planned for First Half of 2008
http://biz.yahoo.com/bw/071113/20071113005392.html?.v=1


Dinner for One

[Indium]

HALLOOOOOO AUFWACHEN !!!

Press Release Source: Insmed Inc.
Insmed Awarded $2.1 Million by Muscular Dystrophy Association
Wednesday December 12, 9:00 am ET

RICHMOND, Va., Dec. 12 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM - News), today announced that it has been awarded a grant of $2,087,325 from the Muscular Dystrophy Association (MDA). The grant is expected to cover a substantial portion of the external costs associated with Insmed's 24-week Phase 3 enabling trial in patients with Myotonic Muscular Dystrophy (MMD).

http://biz.yahoo.com/prnews/071212/nyw026.html?.v=101

[Indium]

Press Release Source: Insmed Inc.
Insmed Completes External Assessment of Myotonic Muscular Dystrophy Market
Tuesday January 22, 8:00 am ET
Study Estimates Potential Myotonic Muscular Dystrophy Market Could be as High as $800 Million to $1.4 Billion
http://biz.yahoo.com/prnews/080122/nytu014.html?.v=101

[Indium]

Insmed Provides Update on IPLEX(TM) Expanded Access Program in Italy for the Treatment of Amyotrophic Lateral Sclerosis
Thursday January 24, 8:00 am ET
Company Received $5.2 Million in Cost Recovery from EAP in 2007
http://biz.yahoo.com/prnews/080124/nyth040.html?.v=101

[Indium]

hey indium,

könnte interassant werden:
Insmed Fourth Quarter and Full-Year 2007 Conference Call
Scheduled to start Tue, Mar 4, 2008, 8:30 am Eastern
http://biz.yahoo.com/cc/9/90649.html

gruß
indium

[Indium]

Insmed Initiates Clinical Study for Follow-on Biologic Version of Neupogen(R)
Wednesday April 16, 8:00 am ET
INS-19 Receives Regulatory Clearance
http://biz.yahoo.com/prnews/080416/nyw031.html?.v=101

[Indium]

Insmed to Present at CBI Follow-On Biologics Conference
Tuesday April 22, 8:00 am ET
http://biz.yahoo.com/prnews/080422/nytu015.html?.v=101

[Indium]

Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company
Thursday July 10, 8:00 am ET
Company Intends to Request Meeting with FDA Regarding Possible Phase III Trial Based on Human Data Demonstrating Bioequivalence of INS-19 to Neupogen(R)
http://biz.yahoo.com/prnews/080710/nyth041.html?.v=101

[Indium]

Press Release Source: Insmed
Insmed Provides Update on IPLEX(TM) Programs
Monday July 21, 8:00 am ET
-- MMD Phase 2 Trial Fully Enrolled --
-- Expanded Access Program Generates $4.9 Million in Cost Recovery During First Half of 2008 -- http://biz.yahoo.com/prnews/080721/nym061.html?.v=101

[Indium]

NASDAQ Hearing Panel Grants Insmed Request for Continued Listing on the NASDAQ Stock Market
Wednesday September 3, 8:00 am ET
Insmed must evidence a closing bid price of $1.00 or more for at least ten consecutive business days by December 15, 2008
http://biz.yahoo.com/prnews/080903/nyw055.html?.v=101

[Indium]

Insmed and Premacure Cite Study Results Demonstrating Potential Effectiveness of IPLEX(TM) in Preventing Blindness in Premature Infants
Tuesday September 23, 8:00 am ET
http://biz.yahoo.com/prnews/080923/ny34275.html?.v=1

[Indium]

Press Release Source: Insmed Inc.

Insmed Announces That NASDAQ Temporarily Suspends Minimum Bid Closing Price Rule
Tuesday October 21, 8:00 am ET

Company Postpones Special Meeting of Shareholders until further notice
RICHMOND, Va., Oct. 21 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM - News), a developer of follow-on biologics and biopharmaceuticals, today announced that on Thursday, October 16, 2008 NASDAQ issued a notice that:

Effective immediately, NASDAQ has suspended the enforcement of the rules requiring a minimum $1.00 closing bid price.
Effective immediately, NASDAQ has also suspended the enforcement of the rules requiring a minimum market value of publicly held shares (MVPHS).
NASDAQ will not take any action to delist any security for these concerns during the suspension.
The suspension will remain in effect through Friday, January 16, 2009 and the original rules will be reinstated on Tuesday, January 20, 2009.
Prior to the suspension, Insmed had been given until December 15, 2008 to evidence a closing bid price of $1.00 or more for a minimum of 10 consecutive business days to remain listed on The NASDAQ Stock Market.

As a result of the rules suspension the Special Meeting of Shareholders, planned for November 24, 2008 to seek shareholder approval of a reverse split, should the Company need it, has been postponed until further notice.

Insmed will provide further information as it becomes available from NASDAQ.


http://biz.yahoo.com/prnews/081021/ny40389.html?.v=1

[Indium]

Insmed Gains Royalty-Free Worldwide Rights for IPLEX(TM) in Connection with Potential Expanded Access ALS Programs

Monday November 10, 8:00 am ET
http://biz.yahoo.com/prnews/081110/ny44958.html?.v=1

[Eisenherz1]

Insmed and Premacure Announce European Orphan Designation for IPLEX(TM) in Retinopathy of Prematurity in Infants

RICHMOND, Va., Jan. 21 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, and Premacure AB, a biopharmaceutical company dedicated to the development of, diagnosis and prevention of complications in neonates due to premature birth, today announced that the European Medicines Agency (EMEA) has granted Premacure orphan designation for Insmed's IPLEX(TM) product, also known as mecasermin rinfabate, for the prevention of retinopathy of prematurity (ROP) in neonates of less than 32 weeks of gestational age. Premacure AB intends to initiate a phase II multicenter trial for IPLEX(TM) in the ROP indication during the second quarter of 2009.

With an orphan designation in Europe, Premacure AB is eligible for protocol assistance (scientific advice), as well as fee reductions for pre-authorization activities, including the application for marketing authorization, and inspections. Post-authorization activities, such as variations and annual fees, are also subject to fee reductions. More details on EMEA orphan drug designation incentives can be found at http://www.emea.europa.eu/htms/human/orphans/incentives.htm. The EMEA Public Summary on the IPLEX(TM) in ROP positive opinion can be found at:

http://www.emea.europa.eu/pdfs/human/comp/opinion/6385108en.…

About IPLEX(TM)

IPLEX(TM) was approved in the United States in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency (Primary IGFD). IPLEX(TM) rhIGF-I/rhIGFBP-3), is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3). The drug is also being investigated for various other indications with unmet medical needs.

About ROP

ROP is a disease of the eye that affects prematurely born babies. It is thought to be caused by disorganised growth of retinal blood vessels which may result in scarring and retinal detachment. ROP can be mild and may resolve spontaneously, but may lead to blindness in serious cases. It is one of the most common causes of visual loss in childhood and can lead to lifelong vision impairment and blindness. As such, all preterm babies are at risk for ROP, and very low birth weight is an additional risk factor.

About Premacure AB

Premacure AB, based in Uppsala, Sweden is a biopharmaceutical company dedicated to the development of diagnosis and prevention of complications in neonates due to premature birth. The first of several indications to be developed is Retinopathy of Prematurity (ROP) a retinal disease being one of the major causes of blindness in infants throughout the world. Contact: Jan Borg, CEO, [e-mail].

About Insmed

Insmed Inc. is a biopharmaceutical company with unique protein process development and manufacturing experience and a proprietary protein platform aimed at niche markets with unmet medical needs. For more information, please visit http://www.insmed.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of product candidates, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our entrance into the follow on biologics market may be unsuccessful, our common stock could be delisted from the Nasdaq Capital Market and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

Investor Relations Contact:
Brian Ritchie - FD
212-850-5683
[e-mail]

Media Contact:
Irma Gomez-Dib - FD
212-850-5761
[e-mail]

SOURCE Insmed Inc.

Source: PR Newswire (January 21, 2009 - 8:03 AM EST)

News by QuoteMedia
www.quotemedia.com

[Indium]

Insmed Sells Follow-on Biologics Platform to Merck & Co., Inc. for Gross Proceeds of $130 Million
Thursday February 12, 2009, 7:00 am EST

http://finance.yahoo.com/news/Insmed-Sells-Followon-prnews-1…

[Indium]

Insmed to Host Fourth Quarter and Full-Year 2008 Conference Call
Thursday February 26, 2009, 8:00 am EST
http://finance.yahoo.com/news/Insmed-to-Host-Fourth-Quarter-…

[Indium]

UPDATE 1-US allows Lou Gehrig's patients to try Insmed drug
Tue Mar 10, 2009 12:49pm EDT
http://www.reuters.com/article/marketsNews/idINN105261222009…

[Indium]

It's Party Time!

[dyna6]

Antwort auf Beitrag Nr.: 36.739.673 von Indium am 10.03.09 18:30:35

Hallo, kannst du mir sagen, was der Grund für den heutigen Einbruch ist

[Indium]

Antwort auf Beitrag Nr.: 36.747.556 von dyna6 am 11.03.09 17:57:37

hi dyna6,
außer den etwas enttäuschenden Zahlen gab es keinen Grund für diesen Kursrutsch (Zockerspielchen?).
http://biz.yahoo.com/prnews/090311/ny81550.html?.v=1
Je niedriger der Kurs, um so mehr shares kann INSM zurückkaufen - am 31. März fließen Merck\'s Millionen. Alternativ muss ein RS her. Finanziell gibt es keine Probleme (ca. 120 mio cash bei ca. 130 Mio shares).
Grüsse
Indium

[dyna6]

Antwort auf Beitrag Nr.: 36.752.400 von Indium am 12.03.09 13:46:19

Danke für Deine Antwort und gleich noch ne Frage hinter her. Wie schätzt du das zukünftige Potential von Insmed ein?

[Indium]

Antwort auf Beitrag Nr.: 36.754.993 von dyna6 am 12.03.09 18:30:18

da muss man sich selbst ein Bild machen!



Biogenerics platform was sold in february 2009 to Merck for 130 million US dollars (finalizes march '09)

- Total share count for Insmed: 122 million, cash per share from the deal: 1.03$ per share after taxes
( Proceeds for Insmed are 123 million US dollar AFTER taxes )
- Liabilities end of 2008 6~8million, 2.4 million in cash
- Cash burn was about 1 million per month prior to the Merck deal
- Tax los carry forward per dec '07 330 million US dollars.
- 70 staff will go with the Boulder plant to Merck (of total of 90 TOTAL staff for insmed)
- 20 staff will remain at Insmeds Richmond HQ.
- IPLEX pipeline and IP remain
- IPLEX is allready fda approved for short stature in children
- IPLEX is researched in europe in retinophathy in infants.
- IPLEX Myotonic Muscular Dystrophy IIb resuls in Q2 the latest (peak revenue estimates from 600mln-1.3bln)
- MMD iib results triggers optin from ipsen/genentech (50% of all past and future cost in return for 50% of profits)
- ALS (Lou Greg) named patient partner to be announced soon
- Still takeover candidate for Ipsen and/or Genentech


march 2008 CFO comment: (MMD trial will go to phase III in Q2, despite that...) " In the short-term, we expect to be cash neutral for the balance of 2009 as we continue moving ahead with our IPLEX programs for MMD and ALS.


Quelle: http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…

[Indium]

Insmed Announces Agreement With IDIS to Manage Expanded Access Programs for IPLEX(TM)

Monday March 30, 2009, 5:30 pm EDT

http://finance.yahoo.com/news/Insmed-Announces-Agreement-prn…

[Indium]

Insmed Completes Sale of Follow-On Biologics Platform to Merck & Co., Inc. for Gross Proceeds of $130 Million
Tuesday March 31, 2009, 5:06 pm EDT
http://finance.yahoo.com/news/Insmed-Completes-Sale-of-prnew…

[jacci]

Antwort auf Beitrag Nr.: 36.893.366 von Indium am 01.04.09 07:13:57

Interessanter Artikel über Iplex in der New York Times

http://www.nytimes.com/

[[KERN]Codex]

[[KERN]Codex]

Ich erwarte Heute +30% in den USA! Huge News are coming, das wird lecker

[[KERN]Codex]

bump!

Fetter Artikel in den Times, über IPLEX.

[[KERN]Codex]

Hier ist der Link:

Man muss aber registriert sein, deswegen stell ich den Artikel mal rein:

http://www.nytimes.com/2009/05/17/health/policy/17untested.h…

Fighting for a Last Chance at Life

Article Tools Sponsored By
By AMY HARMON
Published: May 16, 2009

VIRGINIA BEACH — As Lou Gehrig’s disease sapped Joshua Thompson of his ability to move and speak last fall, he consistently summoned one question from within the prison of his own body. “Iplex,” he asked, in a whisper that pierced his mother’s heart. “When?”

Iplex had never been tested in people with amyotrophic lateral sclerosis, the formal name for the fatal disease that had struck Joshua, 34, in late 2006. Developed for a different condition and banished from the market by a patent dispute, it was not for sale to the public anywhere in the world.

But Kathy Thompson had vowed to get it for her son. On the Internet, she had found enthusiastic reviews from A.L.S. patients who had finagled a prescription for Iplex when it was available, along with speculation by leading researchers as to why it might slow the progressive paralysis that marks the disease. And for months, as she begged and bullied biotechnology companies, members of Congress, Italian doctors and federal drug regulators, she answered Joshua the same way:

“Soon,” she said. “Soon.”

At a time when terminally ill patients have more access to medical research than ever before, and perhaps a deeper conviction in its ability to cure them, many are campaigning for the chance to be treated with drugs whose safety and effectiveness is not yet known.

But even as advances in areas like stem cells and genetics generate greater hope for experimental therapies, there is little consensus on how and when to provide them to dying patients whose lives could be prolonged, or shortened, by trying them.

Insurance companies typically do not pay for drugs that are part of a not-quite-finished scientific process. But even affluent families like the Thompsons find themselves pleading simply for the right to buy a drug, with institutions and individuals that often seem to them to have no logic — and sometimes no heart.

Doctors worry about instilling false hope and doing unnecessary harm. Companies fear damaging a drug’s chance of winning approval from the Food and Drug Administration if a patient suffers a bad reaction. The F.D.A. itself does not want patients to bypass clinical trials, which require that some participants receive a placebo to determine reliably whether a drug works.

Some patient advocates are lobbying for laws and policies that would sanction what has become known as the “compassionate use” of experimental drugs by seriously ill patients who have run out of other options. But for now, each appeal to the guardians of untested drugs is an improvisation, in which success relies on connections, determination, mercy and luck, and the hope of prevailing can sometimes eclipse the hope held out for the drug itself.

The Search for a Treatment

Kathy discovered Iplex deep in the pages of her first Google search for “A.L.S. and treatment” late one night in spring 2007, shortly after Joshua’s diagnosis.

In the daylight, she still had trouble believing that her athletic, magnetic son had the devastating disease with an unknown cause, named for the 1930s New York Yankees star whose career was cut short by it. When Joshua’s racquetball racket flew out of his hand because he could not grip it, his mother’s diagnosis was tennis elbow. When the first neurologist mentioned A.L.S., she scheduled more tests, rooting for Lyme’s disease, multiple sclerosis or even cancer.

But an A.L.S. specialist at Johns Hopkins University, Dr. Jeffrey D. Rothstein, had confirmed it. Like the 5,600 other people given the diagnosis each year in the United States, Dr. Rothstein said, Joshua would almost certainly die of the disease in two to five years.

The doctor prescribed the only drug approved for A.L.S., Rilutek, which typically prolongs life by a few months. Joshua, he said, would be eligible to participate in a clinical trial for another drug, Arimoclomol, that would start as soon as the F.D.A. gave the go-ahead. There was nothing else.

Except, maybe, Iplex.

Kathy clicked her way through online news releases, blogs and scientific journal articles. Iplex, she learned, is believed to protect the motor neurons whose death leads to paralysis in A.L.S. Some patients had persuaded their doctors to prescribe the drug when the F.D.A. approved it in late 2006 for children with growth deficiencies.

“I started on Tuesday,” Debbie Gattoni, an A.L.S. patient in New Jersey, had written on a Web discussion forum, “and on Sunday, I noticed that my right index finger, which was bent, was straightening and moving on its own.”

But almost immediately, the drug’s maker, Insmed, lost a patent infringement lawsuit to a biotechnology firm that was already selling a drug for short stature that had similar properties. Iplex , however, was thought to be more potent for treating A.L.S.

Insmed agreed to pull its drug off the market. Only the Italian Health Ministry, which had begun to distribute the drug to A.L.S. patients under a compassionate use program, could continue to buy it.

Kathy dashed off a letter to the F.D.A.

“Is there any way we can get Iplex,” she wrote, “before it is too late for my son and others like him?”

But the agency could not weigh in until Insmed agreed to make the drug available. And Insmed’s hands were tied by the settlement agreement.

Mounting Physical Needs

In late July, Joshua fell in the street near Times Square on a trip to New York with his wife, Joy, and could not get up. Joy could not lift him, and passers-by did not stop. Finally, a homeless person watching from the corner came to help.

The event was traumatic for Joshua, who was beginning to experience another symptom of the disease, too, a lack of control over his emotions. At the weekly poker game with his friends, he could no longer bluff.

As Joy helped Joshua with his mounting physical needs and cared for their son, Wyatt, who had been born two weeks after Joshua’s diagnosis, the couple pressed Kathy to explore Joshua’s medical options.

They decided he should try what seemed like the next best thing to Iplex — the drug that had triumphed over it in the patent dispute. But the first neurologist they visited refused to give him a prescription.

“This could cause hypoglycemia,” he told Joshua, warning that low blood sugar could result in seizures or brain damage.

“I’ll take my chances of hypoglycemia over laying in the gutter,” Joshua replied fiercely, but the doctor did not relent.

Kathy found another doctor to prescribe the drug, called Increlex. But she cried later when she read a blog entry by an A.L.S. patient who said he had experienced a “seismic” improvement on Iplex before it was withdrawn. The Increlex shots he was taking now felt like “trying to get drunk on cough syrup when there’s a case of bourbon locked in the closet,” he wrote.

At brunch with her long-term boyfriend, Richard Stravitz, soon after, Kathy told him she did not want to play golf that afternoon, as was their Sunday ritual. As always these days, she could think only about trying to help her son.

“I understand,” she said, “if you need to move on.”

Mr. Stravitz, a sculptor and retired chairman of the meat processing giant Boar’s Head Provisions, shook his head.

“I want to help,” he said.

Involuntary twitches known as fasciculations signaled which of Joshua’s muscles would be the next to go. His mother watched the disease spread from his right arm to his left arm to his left leg. A natural storyteller who had played toastmaster at friends’ weddings and charmed business associates with stories of his misadventures in surfing and snowboarding, Joshua began to slur his words in what is known as the “A.L.S. accent.”

Kathy, who had majored in biology before leaving college when she was pregnant with her son, ruled out traveling to Belize or China for stem cell infusions with no proven value. But she did pay $25,000 to send Joshua to a holistic health program in Arizona for a month. At the clinic, he had physical therapy and swallowed vitamin cocktails. He spent hours each day hooked to an intravenous tube to remove heavy metals from his body. But any improvement quickly dissipated on his return.

A few weeks later, the cancellation of the clinical trial that Joshua had been waiting to participate in came as a sharp blow. The F.D.A., the Thompsons were informed, wanted more animal research first.

“We have to get Iplex,” Kathy told Joshua’s father, Bruce Thompson. “I’m going to find a way.”

Divorced 20 years earlier, the Thompsons still sometimes shared holidays and vacations with Joshua and their younger son, Christopher, but they disagreed on how to approach A.L.S. Bruce had concluded there was little to be done medically. He proposed a trip to Europe, where Joshua had never been.

A hotel and restaurant developer who had been training his older son to someday take over his business empire, Bruce remodeled his guest house, where Joshua and his family had moved, to make it wheelchair accessible. And in December, tracing Joshua’s irritability and depression to the cycle of raised and dashed hopes, he admonished Kathy not to mention to their son what seemed like an impossible long shot.

“Let him live his life,” Bruce urged her in a heated conversation. “Don’t give him false hope.”

“This isn’t false hope,” Kathy retorted. “It’s real. And it’s all we have.”

Joshua did not go to Europe. But in February, he and Joy told their inner circle and that Joy was pregnant with their second child. Wyatt, the couple had decided, should have a sibling.

On hearing the unexpected news, one family friend gave Joshua a fist-bump.

“I didn’t know you could do that,” he said.

Joshua laughed.

“It seems to be the only thing that’s still working,” he replied.

‘Our Rights to Live’

Adopting the online moniker “FightingMom,” Kathy haunted Web forums devoted to the disease. At night, after working full days at her own business, which manufactures filling for quilts, she exchanged messages with several dozen patients and caregivers who came to call themselves “Team Iplex.”

“Fighting Mom,” wrote Andrea Reimers, a nurse who was pursuing Iplex for her husband, Jim. “It seems to me that there haven’t been enough cries from the A.L.S. community to demand our rights to live.”

Mrs. Reimers thought a demonstration by dying people in wheelchairs might shake up the companies holding Iplex under wraps.

Her militancy emboldened Kathy, whose letters and calls to public officials took on a more insistent tone. But everyone told her it was a corporate matter.

She also turned her attention to Italy, where the government was still spending several million dollars a year to buy Iplex for A.L.S. patients. A doctor there wrote to Kathy that she had seen “very good results in almost 50 percent” of the A.L.S. patients she had treated with Iplex over two years. Joshua and Joy were ready to move there, but the answer came back: only Italian citizens could receive Iplex through the program.

“Josh’s sadness is unbearable,” his mother wrote one night in her journal, nearly a year after her son’s diagnosis.

Unexpected encouragement came in a Mother’s Day note from her ex-husband. “You have given me some peace of mind that all potential options for Josh are being researched and acted upon,” Bruce wrote. “Thank you.”

Kathy’s boyfriend accompanied her to Insmed’s headquarters in Richmond, Va., offering to raise several million dollars to underwrite a compassionate use program for Iplex in the United States with A.L.S. patients. But the couple came away with a new understanding: F.D.A. regulations, they were told, prohibit any company from profiting on compassionate use. Even if Insmed could wriggle free of restrictions in the patent agreement, there was little financial incentive for it to invest in making the drug solely for compassionate use by A.L.S. patients.

Kathy was not surprised when weeks passed without hearing back.

Seizing an Opening

By July, Joshua could no longer lift his arms. Feeding him one evening, Kathy stifled a cry when she saw his tongue twitching as if it had large worms crawling inside it. Worse for her was the knowledge that he had felt the fasciculations, and known what they signaled: the end of swallowing, saliva control and speech.

“I can’t believe I may never hear him speak again,” she wrote in her journal.

The best hope for regenerating the long nerves that control muscle movement, Kathy knew, were stem cell therapies still in very early stages of development. But if Iplex worked as hoped, it would slow the death of those nerves, perhaps sustaining Joshua’s life long enough for a cure to come along.

That fall, a major study at the Mayo Clinic concluded that a hormone that is the active agent in Increlex and Iplex had no effect on people with A.L.S. But a leading researcher suggested that a drug like Iplex, which combined the hormone with a protein that could deliver it to cells more effectively, could have better results.

Kathy saw an opening. Genentech, the company that held the patent for Increlex, would now most likely have no market for its own drug among A.L.S. patients. Perhaps it would release Iplex from the restrictions of the patent settlement.

Aggie Wilson, the assistant who answered Kathy’s call to Genentech’s chief executive, listened to her story.

“His son keeps sitting on his lap saying ‘Hello, Dada,’ waiting for Josh to say hello,” Kathy said of Wyatt.

Ms. Wilson told Kathy that if she wrote a letter, she would personally deliver it to her boss.

Kathy did not wait for his response. The members of Team Iplex set a date for the protest: Veterans Day, at the Capitol in Washington. They let the drug companies know that dozens of news media outlets had been alerted.

Joy gave birth to a boy, Jordan, a few weeks later. And at the urging of his mother and his wife, Joshua assented to using a machine that enabled him to communicate with a speech synthesizer. A camera picks up small movements of his head as he “types” letters on a screen, tracking a reflective patch on his forehead.

Kathy and Joy watched him laboriously peck out his first words, anticipating an expression of gratitude or affection. Instead, the machine pronounced a playfully vulgar directive. Gleeful, Joshua hit the “repeat” button over and over.

The Saturday evening before the protest, Kathy found a letter in her e-mail. The competing companies had agreed to make Iplex available to A.L.S. patients worldwide on a compassionate use basis, pending the approval of the regulatory agencies.

On a crisp fall day, on the lawn outside the Capitol, Team Iplex handed out information about the disease, and celebrated. All they needed now was for their doctors to file a formal request for the drug with the F.D.A.

Safety Concerns

Joshua’s doctor at Johns Hopkins, Jeffrey Rothstein, believed there was a rational logic for why Iplex might work. But the review procedure at Hopkins, he told Kathy, could delay getting the request to the drug agency. Instead, Kathy took the stack of paperwork to her son’s local family practitioner, Dr. David L. Werwath, only to burst out crying in his office when he demurred.

He had never treated anyone with A.L.S., much less with an experimental drug.

But that evening, he called Kathy on her cellphone to tell her he had had a change of heart.

“Look, I’m a father,” he said “If it were my son or daughter, I’d be doing the same thing.”

The F.D.A. had a month to respond from the date it received Joshua’s application on Dec. 16. When Joshua asked about Iplex now, Kathy told him, “It should be any day.”

On Jan. 16, when Dr. Werwath called to tell her the application had been rejected, she stood up in disbelief.

“How could that be?” she asked, dazed.

Kathy’s friend Mrs. Reimers had received a call with the same news.

“He said they had safety concerns,” Mrs. Reimers said. “This for a drug that was approved for children!”

“Safety,” Kathy repeated. “And what, exactly, is safe about A.L.S.?”

Appealing an F.D.A. Denial

Before the F.D.A.’s decision, Kathy had spared little thought for any broader meaning of her quest for Joshua. But when she met with Richard A. Samp, a lawyer with the Washington Legal Foundation a week later, her outrage went beyond her son, and beyond Iplex.

“The F.D.A. is supposed to protect American citizens,” Kathy fumed over an iced tea in Williamsburg, Va. “How does denying dying patients access to this drug serve the common good?”

Mr. Samp had handled a lawsuit by a patient advocacy group, the Abigail Alliance, that had sought to establish a constitutional right for terminally ill patients to use experimental drugs. In the case, which the group had lost on appeal in 2007, the F.D.A. claimed that it granted “nearly all” requests for compassionate use.

They would first make an administrative appeal, Mr. Samp told Kathy, asserting that the F.D.A. had violated its own guidelines. If that failed, they could pursue litigation that might allow them to raise the constitutional question again in a federal court in Virginia.

“But,” he said carefully, “that might continue for a number of years.”

Because a lawsuit cannot continue if the plaintiff dies, Mr. Samp explained that it might require forming an organization to carry it forward.

Kathy stirred her iced tea.

“I’d like to do that,” she said finally. “This case could be important to lots of patients, even if Josh is no longer involved.”

In its follow-up letter, the F.D.A. had indicated that its chief concern was that “adequately controlled trials would become virtually impossible” if it granted requests like Joshua’s. In the appeal, Mr. Samp argued that Joshua and other A.L.S. patients, whose life expectancy was measured in months, would never have an opportunity to participate in such a trial.

Kathy had avoided telling her son that the drug agency had turned them down. His swallowing had deteriorated to the point that he choked after just two sips of an Orange Crush soda he asked his mother to bring him one night. When he finally agreed to have a feeding tube inserted in mid-February, his family viewed it as a statement that he wanted to live. But the tube also represented a new frontier in the heartbreak of A.L.S., which took away small pleasures every day, and sometimes big ones.

“How cruel can you be?” Bruce barked at his younger son, Christopher, when he unwrapped a hoagie in front of Joshua.

Mr. Samp’s foundation, a conservative public interest law firm, had agreed to work on the appeal pro bono for members of Team Iplex. Kathy tried to interest Andrea Reimers in joining her appeal. But after learning of the drug agency’s decision, Mrs. Reimers said, her husband went into respiratory distress and now could barely breathe.

He died on Valentine’s Day.

Winning a Reversal

Kathy was pouring milk for her cereal on the morning of March 10 when Dr. Werwath’s number flashed on her phone. The F.D.A. had just reversed itself, he said.

Before she could take a breath, Senator Mark Warner’s office called. E-mail bleeped in as the news seeped out.

In the weeks after the appeal, Kathy learned, the F.D.A. had reached out to Insmed. The agency had persuaded the company to run a clinical trial for Iplex with several dozen A.L.S. patients, and permitted it to recoup the hefty costs directly from participants. In the trial, some of the participants would get a placebo. That way, the F.D.A. wrote on its Web site, the next wave of A.L.S. patients would learn whether the drug was in fact beneficial or harmful.

But for now, the agency had ruled, Joshua and 12 other patients would be given Iplex outside of the trial, on a compassionate use basis, if they agreed to read all the data about the risks.

Who would pay for the drug, which Insmed said could cost $100,000 a year, was unclear.

Kathy called her daughter-in-law Joy and asked her to turn the speakerphone on. She reported the news, and smiled to hear Joy tell her that Joshua had raised his eyebrows, his sign of approval. Then she sat down at her kitchen table and gazed out at the ocean.

“Oh my gosh,” she thought for the first time. “What if it doesn’t help him?”

Dr. Werwath arrived with Joshua’s first vial of Iplex at 9:10 a.m. on Wednesday, March 25.

The doctor slipped on his gloves and showed Kathy and Joy how to extract the medicine with a needle. Then the women followed the doctor into Joshua’s bedroom and watched him give the injection, which one of them would do daily.

Joshua slept most of the day.

But when Kathy visited a few days later, her son was sitting in a reclining chair in the living room, in good spirits. They watched the end of a college basketball game together. Around 11:30 the original “Airplane” movie came on.

Joshua smiled a lot. It made her smile too.

•

EPILOGUE: In April, Joshua signaled that he felt he was swallowing better, and to Joy and Kathy he seemed to be regaining tone in his voice. But on Easter Sunday, he was rushed to the hospital with pneumonia and is still on a ventilator. He continues to take Iplex every day.

[[KERN]Codex]

pardon in der NYTimes, ich such nochmal den Link raus, wo man sieht welche Fonds kaufen.

[[KERN]Codex]

Da habe ich ihn auch schon, danke an die fire.fox Chronik:

http://www.mffais.com/insm

[[KERN]Codex]

Etwas zur Geschichte:

When is a biotech actually worth less after their drug is FDA approved? Answer: When the new drug means there is a lawsuit from Genentech (DNA). The market has already factored into Insmed’s (INSM) stock price the worse case scenario. This is a potential blockbuster drug with definitive advantages over its competition.

Here is my thesis as to why I believe it's time to go long with this stock:

a. Insmed has a once a day injectable drug approved by the FDA. It is called Iplex. The drug is a combination of igf-1 and bp3. It is approved for small indication - a treatment for very short children that aren't helped by growth hormone. It has Orphan Drug Designation.

b. Tercica (TRCA) is a company with a competing drug called Increlex. It is a free igf-1 drug that needs to be injected twice a day. It is approved for the same indication.

c. Essentially the difference between the two drugs is that in all humans there isn't a lot of free igf-1 floating around in our bodies. Almost ninety seven percent of igf-1 is packaged together with binding protein 3. Insmed worked out how to synthesize the binding protein with the igf-1.

d. The Iplex combination of igf-1 and bp3 increases the half life of the drug (from one hour to twenty four hours) and decreases the side effects. The main side effect of pure igf-1 and the combination Iplex is hypoglycemia. The difference lies in the levels which one can give the pure igf-1 as against the Iplex drug before the drugs lead to hypoglycemia.

e. In practical terms Iplex only needs to be injected once a day as against Increlex which is injected twice a day. If this drug is injected into a child for five years then the Implex drug saves 1,500 injections. Anyone who has injected a child regularly understands this competitive advantage.

f. Insmed is currently in a trial using the drug for myotonic muscular distrophy. It should work for this indication given that free igf-1 was tried many years ago, and it actually showed efficacy. However patients couldn't take the side effects. Insmed should be able to deliver even higher doses, if needed, due to the binding protein. Currently, there is nothing approved for this indication. There are about 40,000 people in the US with this condition and about the same number in Europe.

g. Insmed also has current trials using Iplex in AIDS Lypodystophy and Severe Insulin Resistance.

h. Insmed intends to begin a trial for Noonan’s syndrome and other conditions. There are 270,000 potential patients covering conditions which Insmed can target to deal with including short stature, AIDS, muscular dystrophy and noonans.

i. Two simultaneous battles are occurring between Insmed and Tercica – one in the sales field and one in the courts. Both companies are ramping up salesforces to sell their respective drugs. There is no injunction currently outstanding.

j. Infringement case bought by Genentech and Tercica against Insmed revolves around three patents. Trial before a jury is set to commence on November 6, 2006.

k. It has rarely happened that a safer drug for children would give rise to a total injunction on the product and force it to be withdrawn from the market. Most likely a royalty agreement would be reached. In the interim period, Insmed might have to pay a royalty into escrow until all appeals are completed.

c seekingalpha.com