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[dottore]

MAP Pharmaceuticals' Analysis of Positive Phase 3 LEVADEX(TM) Data To Be Presented in Late-Breaking Session at 14th Congress of the International Headache Society
-- Analysis Shows Potential of LEVADEX to Treat a Broad Spectrum of Migraine --
-- Company to Host Webcast on Monday, September 14th at 7:15 a.m. ET --

MOUNTAIN VIEW, Calif., Sept 10, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced today that it will present analysis of data from the efficacy portion of the first Phase 3 trial of its novel LEVADEX(TM) orally inhaled migraine therapy, currently in development, at the 14th Congress of the International Headache Society. Data from this Phase 3 trial show the potential of LEVADEX to be effective in treating acute migraine as well as a broad spectrum of migraine, including migraine subpopulations that are often resistant to current therapies such as triptans, migraine with moderate and severe pain, migraine with nausea and vomiting and migraine with and without aura.

"A majority of patients are dissatisfied with their current migraine treatment due in part to inconsistent response, high rates of recurrence of the migraine attack within 24 hours and slow onset of action,"

said Stewart Tepper, M.D., Director of Research for the Center for Headache and Pain, Cleveland Clinic. "Based on these Phase 3 data, LEVADEX has the potential to provide rapid and sustained pain relief, along with a favorable tolerability profile. In addition, LEVADEX showed efficacy in a broad spectrum of migraine subpopulations that are often unresponsive to current migraine therapies."

As previously reported, LEVADEX met all four co-primary endpoints, as well as a number of secondary endpoints, in the first of two Phase 3 clinical trials. The four co-primary endpoints at two hours were:

-- pain relief (p<0.0001);
-- phonophobia free (p<0.0001);
-- photophobia free (p<0.0001); and

-- nausea free (p=0.02).

Results from the post-hoc analyses reported today found that LEVADEX also was effective compared to placebo in treating migraine:

-- in patients with or without allodynia;
-- at any time during the migraine attack, regardless of how long patients
had waited to treat a migraine;
-- that occurs in the early morning, also known as "morning
migraine";
-- in severely disabled and non disabled patients, as defined by a HIT-6
score;
-- with severe as well as moderate intensity of baseline pain;
-- with severe intensity of pain, providing pain relief at 10 minutes; and

-- with and without nausea, vomiting and aura.

Additional LEVADEX data from the Phase 3 trial showed rapid and sustained efficacy in treating migraine with:

-- pain relief at 10 minutes (p=0.16) and time to pain relief at 30 minutes
(p=0.03);
-- sustained pain relief from two to 24 hours in 44 percent of patients
compared to 20 percent for placebo (p<0.0001);
-- sustained pain relief from two to 48 hours in 36 percent of patients
compared to 17 percent for placebo (p<0.0001, unadjusted for
multiplicity); and

-- sustained pain free from two to 24 hours in 23 percent of patients
compared to 7 percent for placebo, and from two to 48 hours in 18
percent of patients compared to 6 percent for placebo (p<0.0001 for
both timepoints, unadjusted for multiplicity).

There were no drug-related serious adverse events reported in the trial. LEVADEX was well tolerated, with the most common adverse event reported being medication aftertaste at six percent, with two percent of patients receiving placebo also reporting medication aftertaste. The next most common adverse event was nausea at five percent, compared with two percent for placebo. Symptoms or sensitivities typically associated with commonly used triptan migraine treatments, such as chest discomfort (one percent) or chest pain (0 percent), were rare and comparable to placebo. There were no decreases in lung function, as measured by spirometry, between the active and placebo groups.

"These sub-analyses further heighten our enthusiasm for LEVADEX and its potential to help the many patients who suffer from the debilitating effects of migraine, including the potential to provide benefit to a number of significant subpopulations of migraine patients who are not well served by currently available therapies," said Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals. "We look forward to continuing development of LEVADEX and initiating a confirmatory Phase 3 trial in the first quarter of 2010."

LEVADEX data are being presented in a late-breaking oral platform presentation titled "LEVADEX(TM), a novel orally inhaled treatment for acute migraine: efficacy and tolerability results of a Phase 3 study" on Saturday, September 12, 2009 at the 14th Congress of the International Headache Society in Philadelphia, PA by clinical trial investigator Stephen Silberstein, M.D., F.A.C.P., director of the Jefferson Headache Center, and professor in the Department of Neurology at Jefferson Medical College of Thomas Jefferson University. In addition, three poster presentations titled 1) "Efficacy and tolerability of MAP0004, a novel inhaled therapy, in treating acute migraine", 2) "Efficacy evaluation of LEVADEX(TM) (previously MAP0004) in treating resistant migraine including migraine with allodynia, migraine treated late in its cycle, morning migraine and disabling migraine" and 3) "Efficacy evaluation of LEVADEX(TM) (previously MAP0004) in treating a broad spectrum of acute migraine attacks including patients using triptans and patients not using triptans" will be available for review at the conference.

Webcast Information

MAP Pharmaceuticals will host a webcast on Monday, September 14, 2009 at 7:15 a.m. ET to review the data presented at the 14th Congress of the International Headache Society. The webcast will be accessible in the Investor Relations section of the company's website at www.mappharma.com.

About LEVADEX(TM)

LEVADEX orally inhaled migraine therapy is a novel migraine therapy candidate in Phase 3 development. Patients administer LEVADEX themselves using the company's proprietary TEMPO(R) inhaler. LEVADEX is designed to be differentiated from existing migraine treatments. It is a novel formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines. Based on clinical results, the company believes that LEVADEX has the potential to provide both fast onset of action and sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy.

LEVADEX is designed to incorporate the multiple beneficial mechanisms of action that allow DHE to block initiation of migraine, limit pain, reduce inflammation and stop a migraine at any point in the migraine cycle. Based on research to date, including the FREEDOM-301 trial, which was the first Phase 3 trial of LEVADEX, the company believes the unique pharmacokinetic profile of LEVADEX has the potential to effectively treat migraine, while minimizing the side effects commonly seen with DHE and other currently available medicines.

[tradepunk]

Antwort auf Beitrag Nr.: 37.963.649 von dottore am 11.09.09 16:11:32

International Headache Society Wat es nich alles gibt!

Aber einem Entwickler von Arzneimitteln gegen Kopfschmerzen würde ich keine allzu großen Chancen geben. Gute Mittelchen dagegen wachsen schließlich an jedem einigermaßen sonnigen Plätzchen! Kann also im Prinzip Jeder "entwickeln"!

[dottore]

Antwort auf Beitrag Nr.: 37.965.063 von tradepunk am 11.09.09 18:53:28

da hast du wohl recht, gegen Kopfschmerzen schon, aber gegen Migräne eben nicht. Und die Triptane helfen oft, wo Aspirin und Co nicht helfen. Es kommt häufig vor, dass bei einem Patienten ein Triptan hilft und ein anderes nicht. Wir wissen nicht arum. Jedenfalls erhöht man nicht die Dosis, sondern versucht ein anderes Triptan. Ich habe selbst schon Patienten gehabt, denen kein Triptan helfen konnte, oder nach einigen Stunden der Schmerz und die vegetativen Erscheinungen durchbrachen.
In diesen Fällen wäre ein neues Medikament allemal ein Fortschritt.

PS: Obwohl bei der Akupunktur die Wirkung wesentlich auf den fälschlicherweise als Placebo bezeichneten Effekt zurück zu führen ist, konnte ich Patienten damit gut helfen. Vorteil den Verdienst hatte ich und nicht die Pharmafirma

[tradepunk]

Antwort auf Beitrag Nr.: 37.965.393 von dottore am 11.09.09 19:49:56

Natürlich darfst Du als Arzt (oder Heilpraktiker?) Deinen Patienten offiziell keine solche Behandlung empfehlen. Aber genau das zeigt ja auch, woher der Wind bei dieser verlogenen Prohibition weht. Wenn jeder einfach seine eigenen Heilkräuter anwenden würde, könnten die entsprechenden Pharmas ja nichts verdienen (und mögl. auch versteuern)! Es gibt Studien, nach denen man rd. 1/3 der herkömmlichen Medikamente durch Naturprodukte, speziell Marihuana, ersetzen könnte. Und z.B. gegen die Übelkeit während einer Chemotherapie gibt es nunmal definitiv kein anderes wirksames Mittel als THC. Hier (und beim Glaukom) geht es in der Forschung mittlerweile nur noch darum, wie man das Kraut in andere, möglichst Nebenwirkungs- (sprich Rausch-) freie Dareichungsformen verpacken kann.

Marihuana wurde in Wirklichkeit schon tausende von Jahren benutzt aufgrund seiner gut bekannten medizinischen Qualitäten. Ein Auszug dieser Qualitäten ist veröffentlicht im Buch "Marihuana: Die verbotene Medizin" Grinspoon (1993), welcher die folgenden klinischen Krankheiten und Störungen auflistet, wo Marihuana sich als hilfreich erwiesen hat:

* Uebelkeit als Folge von Chemotherapie bei Krebspatienten
* Glaukom ("Grüner Star")
* Epilepsie
* Multiple Sklerose
* Paraplegie und Tetraplegie
* Aids
* Chronische Schmerzen
* Migräne
* Fieber
* Menstruationskrämpfe und Geburtsschmerzen
* Depression und andere Stimmungsstörungen

http://archiv.hanflobby.de/archiv/maripharm-marihuana-als-me…

Deine Threads zu diversen Pharmas finde ich hochinteressant. Mach weiter so! Z.B. mit dieser GENova-Story werde ich mich auch mal beschäftigen.

LG + ein schönes WE,

tradepunk

[dottore]

jedenfalls wäre es mir als Arzt nur recht, wenn ich ein zuverlässig wirkendes Medikament für meine MigränePatienten hätte.
- auch wenn ich dann meine Akupunktur nicht mehr verkaufen kann

[dottore]

reagiert er Kurs in USA doch noch!
Ich dachte schon, ich wäre da auf em falschen Dampfer, dabei bin ich nur zu ungeduldig.
Also ich hätte aber nicht nur früher mit einer Reaktion gerechnet, sondern auch mit 20 %