inhale - 500 Beiträge pro Seite

[frank55]

Inhale Therapeutics,habe aus dem Fernsehen erfahren,dass der Templetonbiotechfond Inhale als seine grösste Position gewichtet hat.Schaut euch mal den Chart an,er ist sehr vielversprechend

[frank55]

Inhale ist in der Atemwegserkrankungsforschung tätig,hat 3-5 Medikamente in der Pipeline,die aber erst in den nächsten Jahren auf den Markt kommen dürften.

[Glückspfennig]

Eine Meldung die Inhale Therapeutical mittelfristig eventuell Auftrieb verleihen könnte.

Studie: Inhalation von Insulin ebenso effektiv wie Spritzen

London (dpa)- Mehrere Spritzen pro Tag könnten für Diabetes-Kranke bald der Vergangenheit angehören. Das belegt eine neue Studie mit 73 Patienten, die das britische Fachblatt "The Lancet" in seiner neuesten Ausgabe (Bd.357, S.324 u. 331) veröffentlicht. Amerikanische Ärzte um Jay Skyler von der Universität von Miami zeigten darin, dass zumindest die täglichen Spritzen vor Mahlzeiten durch eine Inhalation von Insulin ersetzt werden können.

Ein Teil der Probanden atmeten tagsüber an Stelle der üblichen Injektionen das nötige Insulin mit Hilfe eines Inhalator ein. Die anderen erhielten es auf herkömmliche Art über Spritzen. Alle Patienten bekamen am Abend eine Injektion des Stoffes, der den gestörten Zuckerstoffwechsel reguliert. Nach 12 Wochen bei ständiger Messung des Blutzuckers und Regulation der angewandten Dosen fanden die Forscher keine Unterschiede im Wohlbefinden und in den Zuckerwerten der beiden Patientengruppen.

Die Methode hatte nach Ansicht der Wissenschaftler keinerlei Nebenwirkungen und beeinträchtigte die Lungen nicht. Edwin Gale von der Universität Bristol (Großbritanien) bestätigt in "The Lancet" die Bedeutung der Ergebnisse, hält die Anzahl der untersuchten Patienten aber für noch zu klein für ein abschließendes Urteil. Bereits seit längerem arbeiten Forscher an neuen, weniger belastenden Methoden, das Insulin zu verabreichen. Dabei erscheint die Inhalationsmethode zurzeit am aussichtsreichsten. erst im vergangenen Dezember berichtete das Diabetes-Forschungszentrum der Universität Düsseldorf von guten Erfahrungen mit dieser Methode.
Quelle: dpa 021350 Feb 01

Hoffnung keimt auf, denn der Betrieb für die Produktion dieser Insulinform wird soweit ich weiß mittlerweile in Frankfurt zurzeit errichtet von Aventis (Hoechst), die ihrerseits Partnerschaften mit Inhale Therapeutical unterhalten.

Gruß
Glückspfennig

[mp7]

Inhale jetzt kaufen?


Hat jemand ne Meinung?

Danke

[puhvogel]

Was kurzfristig passiert: Keine Ahnung.
Nur hab ich einen sehr grossen Widerwillen gegen die Methode, Insulin zu inhalieren. Die Lunge ist von der Natur aus für den Gasaustausch konzipiert worden und nicht für die Inkooperation von Proteinen.
Es stellte sich oft heraus, dass wenn Forscher die Natur mit künstlichen Gedankenmodellen überlisten wollte, plötzlich Nebenwirkungen auftraten oder das Produkt bald wirkungslos wurde.
Es gibt wohlgemerkt keine Langzeitdaten und es würde mich nicht überraschen, wenn inhlaierbares Insulin auf die Dauer zu Veränderungen der Lungenphysiologie führen wird.
Höhere Insulinantikörperraten haben sie schon gemessen.
Und oral einzunehmendes Insulin ist auch nicht mehr undenkbar.
Alles nur meine persönliche Meinung.

[puhvogel]

FDA lässt erkennen, dass es die Nebenwirkungen besser erforscht haben möchte.

Inhale stock falls on Pfizer comments
NEW YORK, July 17 (Reuters) - Shares of Inhale Therapeutic Systems Inc. (NasdaqNM:INHL - news) fell sharply on Tuesday after partner Pfizer Inc. (NYSE:PFE - news) said it may delay filing for approval of an inhaled form of insulin being developed by the firms. Shares of Inhale fell $3.63, or 18.23 percent, to $16.28 on Nasdaq in midday trading.
Although Pfizer said the submission of an application is still planned for later this year, it could be postponed.
``If additional data are required, as now appears likely, the filing schedule will be revised,`` Pfizer said of its discussions with regulators. Shares of Inhale fell 22 percent on June 25 after clinical trials showed that the diabetes product, called Exubera, provoked the formation of antibodies against it in some patients taking the drug in clinical trials. ``The FDA and other regulatory agencies are working closely with us to enable presentation of a comprehensive data package that should maximize the full potential of Exubera in treating patients with diabetes,`` Pfizer said in its second-quarter earnings statement.

[erkilein]

@puhvogel
an welchen wert hast du in dem posting vom 7.7. gedacht? (insulin als tabletten)
was anderes als endorex?

[gholzbauer]

als Alternativen zu Inhale fallen mir ein:

Endorex DOR (Insulin per Pille)
Helix Biopharma HBP.TO (Insulin per Pflaster)
Aradigm ARDM (inhalierbares Insulin, s. Text unten)
evtl. Roesch ? (nadelloses Spritzsystem)
Alkermes ALKS (inhalierbares Insulin)
Generex GNBT (orales Spray)

s. auch http://www.biospace.com/ct/list_indication.cfm
unter "Diabetes" usw.

INHL kamen heute verdächtig glimpflich davon mit -8%. Es sollte mich nicht wundern, wenn sie in nächster Zeit weiter nachgeben. ARDM und die anderen könnten die nächsten Tage dagegen von Empfehlungen profitieren.

----------------------------------------

Drug Delay Has Inhale Gasping and a Rival Catching Up
By Adam Feuerstein
Staff Reporter
7/17/01 6:57 PM ET



Sometimes you have to take one for the team. Inhale Therapeutic (INHL:Nasdaq - news - commentary) was sporting a black eye Tuesday after partner Pfizer (PFE:NYSE - news - commentary) acknowledged a delay in the development of Exubera, the highly anticipated and experimental inhaled diabetes drug produced by the two companies and a third partner, Aventis (AVE:NYSE ADR - news - commentary).


The delay could also mean good news for a rival inhaled diabetes drug from Aradigm (ARDM:Nasdaq - news - commentary) and partner Novo Nordisk (NVO:NYSE ADR - news - commentary).

Pfizer is the world`s largest drug maker, so a major setback for a single drug -- Exubera is now likely a full year behind schedule -- barely causes a ripple of concern. Pfizer shares closed up 71 cents to $38.58 Tuesday, bolstered by strong-second quarter earnings.

But Inhale -- tiny by comparison -- is feeling the pain. Shares of the San Carlos, Calif.-based biotech firm dropped $1.64, or 8.2%, to $18.27 Tuesday, recovering slightly from earlier in the day, when shares were off almost 20%. The company`s stock has now fallen almost 35% since concerns about Exubera first surfaced at the end of June.

An Old Story

In some respect, Exubera`s delay is an old story -- blame it on persnickety regulators at the Food and Drug Administration, who are turning downright miserly when it comes to approving new drugs. Pfizer was expected to push Exubera to the agency for approval by the end of the year. But early Tuesday, the drug maker said conversations with FDA regulators put that timing in jeopardy and that additional testing might be required. In typical big-pharma fashion, Pfizer executives refused to offer any more details.

But later Tuesday, Inhale Chairman Robert Chess acknowledged that Exubera isn`t likely to be filed with the FDA until the second half of next year. And in true team fashion, he insisted that the delay was actually a good thing.

"Given that the FDA is being picky about filings, Pfizer and Aventis are taking the right course of action. What`s important is when the product is approved, not when it`s filed; a strong filing will increase our chances for approval," he says.

In other words, here`s a steak for that eye, Bob; thanks for being a team player.

Most Wall Street insiders were not surprised by today`s news. Last month, Pfizer, Inhale and Aventis reported mixed results from late-stage testing of the drug, which is a first-of-its-kind dry insulin powder inhaled into the lungs using a special device. Exubera is supposed to replace traditional insulin injections.

At a medical conference last month, the companies said that Exubera patients were four times more likely to develop antibodies against their insulin than those taking injected insulin. Antibodies are proteins that the body creates to destroy foreign invaders, which led some analysts to suggest that Exubera`s effectiveness might diminish over time.

This troubling news followed an earlier disclosure from Aventis that one patient in a 1,000-patient Exubera study suffered from scarring of the lungs.

Robertson Stephens analyst Robert Hazlett downgraded Inhale to market outperform from buy Tuesday, after previously advising clients that Exubera`s launch was going to be delayed based on the mixed test results. Hazlett`s firm has a banking relationship with Inhale.

Pain May Equal Rival`s Gain

But Inhale`s pain might be Aradigm`s gain. The Hayward, Calif.-based biotech firm is partnered with Danish drug maker Novo Nordisk on a rival product dubbed the AERx insulin delivery system. Novo, the world`s largest maker of insulin, is experimenting with an Aradigm-engineered device that diabetics use to take a mist form of liquid insulin into the lungs.

Last month, the two companies released positive results from midstage testing of the system. Late-stage testing is expected to start later this year.

"Exubera looks like it will be delayed for at least a year, which put a big dent in its lead over Aradigm and Novo," says Matt Kaplan, biotech analyst at Punk Ziegel.

Kaplan, who rates Aradigm a buy, says the company and partner Novo will also benefit because they can devise a late-stage testing program that will sidestep the FDA concerns that are now delaying Exubera.

"You can make the argument that Aradigm and Novo might be able to design a testing program that expedites the product`s approval because they`ll learn from Pfizer`s mistakes," he says. Kaplan`s firm doesn`t have a banking relationship with Aradigm or Novo, and he has no rating on Inhale or Pfizer.

And investors might want to give Aradigm a try, based solely on the company`s relatively cheap valuation. At $5.40 a share, the company sports a lightweight $104 million market cap. The company`s shares are trading at just above its 52-week low of $4.19 a share, and well off the year high of $27.44.

By comparison, Inhale, even with its recent selloff and efforts to diversify its portfolio beyond Exubera, is still valued at just under $1 billion. At that valuation, Inhale trades at a pricey 16 times 2001 sales of $61 million. Inhale is expected to lose $1.44 a share this year.

[erkilein]

danke

[puhvogel]

Ich bin da nicht wirklich auf dem laufenden, aber orales Insulin ist grundsätzlich nicht ausgeschlossen. gholz hat die jetzigen Player detailliert dargestellt.
http://www2.varsity.utoronto.ca/groups/varsity/archives/121/…
Komisch, dass Rösch so wenig Erfolg bisher hat.

[gholzbauer]

Ein paar Player als Link.
http://finance.yahoo.com/q?s=inhl+alks+dor+hbp.to+ardm+gnbt+…

Wen sollte man noch hinzufügen?

[erkilein]

schaut euch das mal bitte an:

ID Biomedical (NASDAQ:IDBE)
by: Sir_Holler 07/15/01 02:33 am
Msg: 550 of 554

Hello,

I am an investor from the ID Biomedical(NASDAQ:IDBE) message board. I just `ran into` this company, and so I`m just stopping by.

The recognition of the importance of alternative delivery technologies for vaccines, by the financial markets, may be just around the corner. This, as Aviron legitimizes nasal delivery with its FluMist product. In just a couple of weeks, in fact, Aviron goes before the FDA where its application for approval is to be reviewed; then, hopefully, comes sales. This is an exciting time for this field, and many new empires can be expected to be built.

Concerning ID Biomedical, it recently took over, or merged, with Intellivax whose technology is listed in the following excerpt from an Endorex filing:

From Endorex`s 10QSB Filing(Date: 05/14/2001):

"Our competitors in the vaccine delivery field include: Aviron, which is developing a nasal flu vaccine that is in Phase III clinical trials, Intellivax, which is in Phase I and II trials with an intranasal flu vaccine and another major vaccine, specialized biotechnology firms, universities, and governmental agencies."


There isn`t that much competition listed is there? ID Biomedical has recently announced its intentions to potential allies with regards to potential strategic alliances. I would anticipate deals within the coming months demonstrating industry interest.

ID Biomedical`s technology uses a purified piece of a bacterium that can make its way through the mucosa, until it is recognized by the immune system. Just like the Trojan horse of ole, guess what is `tucked inside` the purified protein? You got it, the antigen that is required to stimulate an immune response to a given infectious disease. This is a significantly proven technology already as well. ID Biomedical has two shigella vaccines in phase II that have already passed FDA, phase I, safety trials; and a flu vaccine currently in phase I producing promising results. The NIH in their review of the vaccine field ranked the shigella results as `promising`. ID Biomedicals technology is both a nasal, and oral, delivery system. Its current products in trials are nasal.

Good luck with Endorex!

Sir_Holler

[mp7]

was meint ihr,jetzt kaufen?

52 wochen tief!
mfg

[gholzbauer]

In the pipeline: Exubera

Inhaled insulin expected to be a blockbuster; FDA may need more data

August 16, 2001: 1:49 p.m. ET


NEW YORK (CNNfn) - Inhaled insulin, a drug which could make life easier for many of the 100 million diabetics worldwide by replacing injections, was expected this year. But with regulators likely to request more data, the makers of the most advanced version of inhaled insulin, and their potential customers, are waiting to inhale.

Exubera is one the most-anticipated drugs in development and analysts said it could be a blockbuster. The drug is designed to be delivered by an inhaler at room temperature, replacing multiple daily insulin injections, and is one of the top drugs in a strong Pfizer pipeline.

No. 2 pharmaceutical company Pfizer is developing the drug with Aventis and much-smaller Inhale Therapeutic Systems.

In November 1998, Inhale struck a deal with Pfizer and Hoechst Roussel AG, now part of Aventis (AVE: down $0.85 to $75.65, Research, Estimates), to develop an inhaled insulin product, with the larger companies building an insulin manufacturing plant and providing the marketing.

Pfizer called the drug "a first-in-class product, with novel attributes and expected rapid, extensive usage" in its second-quarter earnings report last month.




But in that same report, the company said the U.S. Food and Drug Administration is likely to request more Phase III clinical data, which would mean a much longer wait for the launch of the drug.

Exubera was scheduled for launch at the end of this year, but analysts now are pointing to the end of 2002.

In June, Pfizer (PFE: down $0.12 to $41.09, Research, Estimates) said in one study that patients taking inhaled insulin were more likely to develop antibodies against the insulin than those injecting, which would reduce the long-term effectiveness of the drug.

Pfizer has not officially changed its schedule on Exubera. The company said it is still in active talks with the FDA and will make an announcement if more data is required. Analysts said it would be a big surprise if the drug was released this year, but didn`t think the delay will have too much effect on such a large company.

"I happen to believe in Exubera ultimately," said Cynthia Glass, analyst with ThinkPartners Equity. "But I didn`t think it was going to be a hop, skip and a jump with the FDA."

Glass said Pfizer is probably doing the right thing by taking its time and not trying to push too hard to meet the original Exubera schedule.

But while Pfizer has more drugs coming through its pipeline and more than $32 billion in revenue flooding in from other products, a long wait for Exubera may prove more tricky for Inhale.


Can Inhale survive the wait?

Inhale (INHL: down $0.27 to $15.50, Research, Estimates) is projected to have annual revenue of a little more than 0.2 percent the revenue of Pfizer. It also has yet to make a profit and is relying on the potential sales of Exubera.

Investors were not happy with a possible delay and the company`s stock has fallen about 22 percent since Pfizer announced the FDA may require more data.

But Glass said the company`s recent strategic acquisitions, including its July acquisition of Shearwater Corp. for about $164 million, have added products and partnerships which should help the company outlast the Exubera wait.

Michael Hurle, analyst with Leerink Swann & Co., said at the current stock price, around $15.50, and with Inhale`s assets and cash reserves of about $400 million, buyers of the stock would be getting any Exubera benefits for free.

"While the stock has been punished by what hasn`t happened with Pfizer, you`ve basically got a situation where the drain is being thrown out with the bathwater," Hurle said.

But he said that Exubera revenue isn`t just around the corner.

"I don`t think many people are holding their breath on inhaled insulin," he said.


In the Pfizer pipeline

Along with Exubera, Pfizer continues to tout the rest of its pipeline, which has 156 projects in development.

The company plans to file two other major drug applications during the next twelve months. Valdecoxib is a pain medication in the Cox-2 inhibitor class, a drug sector pioneered by Merck`s (MRK: up $0.64 to $69.54, Research, Estimates) big-selling arthritis drug Vioxx.

Pfizer also has epilepsy treatment Pregabalin scheduled for a new drug applications.

Among those drugs undergoing global regulatory review are Zeldox, a treatment for psychotic disorders, with labeling discussion ongoing with the FDA, migraine headache treatment Relpax, and Vfend, which treats serious fungal infections.

Also in the cards is Pagoclone, a drug for panic disorders which could help an estimated 60 million people. The drug is currently in Phase III clinical trials.


http://cnnfn.cnn.com/2001/08/16/companies/exubera/

[gholzbauer]

Thursday October 25, 2:19 am Eastern Time
Nordisk puts $20 mln in Aradigm
COPENHAGEN, Oct 25 (Reuters) - Danish pharmaceuticals group Novo Nordisk said on Thursday it had invested $20 million in U.S.-based medical equipment maker Aradigm Corporation (NasdaqNM:ARDM - news).

Aradigm has sold 5,665,723 shares at $3.53 per share, world leading diabetes maker Novo Nordisk said in a statement.

``Aradigm and Novo Nordisk are jointly developing a product that offers a precise and flexible system for non-invasive insulin delivery that we believe will become an important treatment option for people with diabetes,`` Novo Nordisk said.

The Danish company will retain all of its Aradigm shares for at least two years from the effective date of the agreement, it said.

The two partners are currently in phase 2 clinical trials with their diabetes management system.