Pain Therapeutics - Interessante Pipeline - 500 Beiträge pro Seite

[blb]

Kürzel: PTIE

[blb]

[blb]

Pain Therapeutics Announces Second Quarter 2005 Financial Results
TUESDAY, JULY 26, 2005 7:30 AM
- PR Newswire

SOUTH SAN FRANCISCO, Calif., July 26, 2005 /PRNewswire-FirstCall via COMTEX/ -- Pain Therapeutics, Inc. (PTIE) , a biopharmaceutical company, announced financial results for the three and six months ended June 30, 2005.

The net loss for the quarter ended June 30, 2005 was $10.2 million, or $0.23 per share, compared to a net loss of $9.1 million, or $0.26 per share, in the second quarter of 2004. The net loss for the six months ended June 30, 2005 was $18.8 million, or $0.43 per share, compared to a net loss of $19.2 million, or $0.54 per share, for the same period in 2004.

Cash, cash equivalents and marketable securities were $81.7 million at June 30, 2005.

"We completed our written milestones once again on-time and on-budget this quarter," said Remi Barbier, president and chief executive officer. "These included staying within budget while continuing to conduct Phase III programs with Oxytrex(TM), Remoxy(TM) and PTI-901. We believe we remain on-track to announce top-line results with these three drug candidates before the close of 2005."

Research and development expenses for the second quarter of 2005 increased to $9.5 million from $8.2 million for the same three-month period in 2004. Research and development expenses for the six months ended June 30, 2005 were $17.6 million, compared to $17.7 million for the same period in 2004. The increase in research and development expenses for the second quarter was primarily due to the timing of the Phase III clinical trials and other development activities with Oxytrex, Remoxy and PTI-901.

General and administrative expenses for the second quarter of 2005 were $1.1 million, approximately the same as the comparable period in 2004. General and administrative expenses for the six months ended June 30, 2005 increased to $2.2 million from $2.0 million for the same period in 2004.

No Change to Financial Outlook

Pain Therapeutics continues to expect cash requirements for 2005 to be approximately $40 million, plus or minus 10 percent. The Company also continues to expect the net loss for 2005 to be approximately $41 million, plus or minus 10 percent. The net loss for 2005 is expected to be higher than the cash requirements primarily due to non-cash expenses included in the net loss.

Upcoming Clinical Announcements

We continue to expect to make the following clinical announcements in the second half of 2005:

Drug Candidate Patient Population Expected Announcement
Oxytrex Osteoarthritic Pain - Phase III Report top-line
results
PTI-901 Irritable Bowel Syndrome - P.III Report top-line
results in
women
Remoxy Severe Chronic Pain - P.III Report top-line
results
Remoxy Severe Chronic Pain - P.III Initiate second Phase
III

About Pain Therapeutics, Inc.


We are a biopharmaceutical company that develops novel drugs. Our drug candidates target severe chronic pain, such as low-back pain or pain due to osteoarthritis or irritable bowel syndrome. We have three unique drug candidates in clinical development: Oxytrex, Remoxy and PTI-901, all of which are in Phase III clinical trials. We believe the target market for our three drug candidates exceeds $3 billion per year. We own commercial rights to our drug candidates. For more information please visit our website at www.paintrials.com.

Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). PTI disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company`s clinical development of its drug candidates, the Company`s expected cash requirements in 2005 and through late-stage development of its drug candidates, the Company`s net loss for 2005, the potential benefits of the Company`s drug candidates and the size of the potential market for the Company`s products. Such statements are based on management`s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company`s drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company`s drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company`s intellectual property or trade secrets, the Company`s ability to obtain additional financing if necessary and unanticipated research and development and other costs. For further information regarding these and other risks related to the Company`s business, investors should consult the Company`s filings with the Securities and Exchange Commission.

PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)

Three Months Ended Six Months Ended
June 30, June 30,
2005 2004 2005 2004
Operating expenses (1):
Research and development $9,518 $8,181 $17,640 $17,677
General and administrative 1,139 1,106 2,177 2,044
Total operating expenses 10,657 9,287 19,817 19,721
Operating loss (10,657) (9,287) (19,817) (19,721)
Other income:
Interest income 475 221 1,046 491
Net loss $(10,182) $(9,066) $(18,771) $(19,230)

Basic and diluted loss
per common share $(0.23) $(0.26) $(0.43) $(0.54)

Weighted-average shares
used in computing basic and
diluted loss per
common share 43,744 35,499 43,704 35,463

(1) Included in research and development and general and administrative
expenses are stock based compensation expenses of $123 thousand and $259
thousand for the three months ended June 30, 2005 and 2004, respectively,
and $90 thousand and $312 thousand for the six months ended June 30, 2005
and 2004, respectively.


PAIN THERAPEUTICS, INC.
(A Development Stage Enterprise)
CONDENSED BALANCE SHEETS
(in thousands)

June 30, December 31,
2005 2004(2)
(Unaudited)
Assets
Current assets:
Cash, cash equivalents and marketable
securities $81,650 $99,397
Prepaid expenses 35 259
Total current assets 81,685 99,656
Property and equipment, net 1,430 1,461
Other assets 75 75
Total assets $83,190 $101,192
Liabilities and stockholders` equity
Current liabilities:
Accounts payable $ 1,006 $877
Accrued development expense 6,919 6,358
Accrued compensation and benefits 188 415
Other accrued liabilities 140 146
Total liabilities 8,253 7,796
Stockholders` equity:
Common stock 44 44
Additional paid-in-capital 206,160 205,920
Accumulated other comprehensive loss (472) (544)
Deficit accumulated during the development
stage (130,795) (112,024)
Total stockholders` equity 74,937 93,396
Total liabilities and stockholders` equity $83,190 $101,192

(2) Derived from audited financial statements.


SOURCE Pain Therapeutics, Inc.

Christi Waarich, Senior Manager of Investor Relations of Pain Therapeutics, Inc., or
[e-mail], or [phone]; or media, Carney Duntsch of Burns
McClellan, [phone], for Pain Therapeutics, Inc.


http://www.prnewswire.com


Copyright (C) 2005 PR Newswire. All rights reserved. ********************************************************************** As of Friday, 07-22-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 07-13-2005 for PTIE @ $5.97. (C) 2005 Comtex News Network, Inc. All rights reserved.

[blb]

We continue to expect to make the following clinical announcements in the second half of 2005:

Drug Candidate Patient Population Expected Announcement

Oxytrex Osteoarthritic Pain - Phase III Report top-line
results
PTI-901 Irritable Bowel Syndrome - P.III Report top-line
results in
women
Remoxy Severe Chronic Pain - P.III Report top-line
results
Remoxy Severe Chronic Pain - P.III Initiate second Phase
III

[puhvogel]

Ich dachte erst, die sind ein IPO, dann stelle ich fest, dass die in der 2000er Euphorie emittiert wurden. Peinlich, dass ich die noch nicht kenne.

@blb: Du hast Recht, die sind wirklich spannend, mit so einer so breiten marktnahen Pipeline und 270 Mio. $ Marktkapitalisierung. Ich fuchse mich dann mal in die Technologie und das Konkurrenzumfeld ein.
http://www.paintrials.com/

[puhvogel]

Zur Technologie:
Alle Phase 3 Medikamente ähneln sich stark vom Wirkmechanismus, nur die Zielgruppe variiert. Hauptvorteil nach Angabe von Pain Th. wären die fehlende Gewöhnung an Opiate bzw. geringe Suchtgefahr.

Sollten sich Komplikationen in Form von besonderen Nebenwirkungen bei einer Studie ergeben, so ist die auch bei den anderen Phase3-Medikamenten zu erwarten. Zwar hat Pain Th. schon eine Phase 3 Studie 2004 veröffentlicht, nur habe ich schon mehr als einmal erlebt, dass die wichtigsten Nebenwirkungen dabei verschwiegen werden, bis sie dann bei der FDA-Zulassung plötzlich vom Himmel fallen. Oxytrex und Remoxys Verkaufargumente sind ja aber gerade das verbesserte Nebenwirkungsprofil, hier darf also nichts schieflaufen.

An Opiat-Medikamente gibt es wohl eine ganz große Menge auf dem Markt. Ich zitiere mal aus http://www.painfoundation.org/page.asp?file=QandA/SideEffect… :

While morphine is the most common type of opioid today, and perhaps the oldest type of opioid, physicians in the 21st century have discovered many new opioid type drugs to fight pain. These drugs include hydromorphone (Dilaudid), oxycodone (Oxycontin and Percocet), methadone, meperidine (Demerol) and fentanyl (Duragesic), just to name a few. These drugs come in various forms, such as pills, intravenous form (which means it is given into a vein in the arm or hand), an intramuscular route (which means it is injected by a needle into a muscle) or by a topical patch (which means it seeps through the skin into the bloodstream by a patch that is placed on the skin).


Sprich: Das Umfeld ist hoch kompetetiv, mit jeder Menge generischer Konkurrenz, aber z.T. auch hochprofitabel: Nehmen wir mal Duragesic: Das war ein echter Blockbuster von JNJ, bis die Patente 2003 dafür ausliefen. Sind die Ergebnisse überzeugend , dann sehe ich Pain Th. als Übernahmekandidat für die großen Pharmas, denen kontinuierlich die Umsatzträger ausgehen. Zu Duragesic wäre noch anzumerken, dass JNJ seit kurzem eine Untersuchung anhängen hat, ob 120 Todesfälle auf die Fehlanwendung von Durogesic zurückzuführen ist.
http://www.rheuma-online.de/phorum/showthread.php?p=149824
Implizit bedeutet das aber auch, es wäre Platz für gute Konkurrenz.

Der Verkaufserfolg von Oxytrex und Remoxy hängt IMHO also maßgeblich davon ab , ob deren Nebenwirkungsprofil gut genug ist. Die FDA wird da nach Vioxx und vielleicht nun auch Durogesic doppelt so genau hinschauen.
Nachfrage auf der Patientenseite wäre wohl da, wie man aus dem zweiten Link gut herauslesen kann. Allerdings meinte jemand in dem Forum auch:
Das Problem ist derzeit das die Kassen bei Verschreibungspflichtigen Opiaten Stress machen weil diese der Meinung sind es könnten auch andere Medis Verordnet werden z.B. Valeron, Tilidin etc. Diese kann man überhaupt nicht mit Durogesic vergleichen,nur war mein Rheumadoc wohl anderer Meinung

Was mich zur Zeit noch stört, dass Nebenwirkungen Adaption/Suchtgefahr im ersten Link noch nicht mal erwähnt werden, komisch...

Blb, da hast Du schon einen interessanten, aber auch ziemlich komplexen Wert herausgekramt. Ich bleibe mal am Ball und werde mir wohl auch einen Posten ins Depot holen, denn wenn es ganz gut läuft kann sich das Ding verzehnfachen. Um aber ehrlich zu bleiben, den Markt der Schmerzmittel überblicke ich noch nicht mal ansatzweise, nur werden dort auch enorme Summen umgesetzt!!

[blb]

Danke für dein Feedback, puhvogel. Soweit ich dich richtig verstanden habe, wäre somit die erste Bekanntgabe von Phase III Ergebnissen gleichzeitig auch richtungsweisend für die anderen 2 Medikamente in der Pipeline. Dürfte noch ein spannendes zweites Halbjahr werden. Falls sich Leute im Forum befinden, die sich mit der biologischen Materie näher auskennen, bin ich immer dankbar. Ich schau bei Biotechs hauptsächlich nach einer möglichst vielversprechenden Pipeline, niedriger Bewertung und einer ausreichenden Cashbasis. Dass das noch lange nicht ausreicht, um beurteilen zu können, ob ein Medikament erfolgreich sein wird, ist natürlich klar.

Ich habe leider keine Pharmazie studiert...
Im übrigen wurde der Wert hier anderweitig schon angesprochen, auch in diversen anderen Foren. Ist also definitiv nicht meine Entdeckung.

Grüße
blb

[Keinporschefahrer]

Behaupten die nicht auch, daß die Medikamente besser wirken würden? Bei manchen Menschen sprechen Opiate ja nicht an. Na ja, ist schon lange her, daß ich mir die ins Deopt gelegt habe.

Derartige Investments sind eh Zockerei - aber so lange die Bewertung eine Verzehnfachung im Erfolgsfall rechtfertigen würde, kann man ruhig mal ein paar Euro setzen.

[puhvogel]

hi blb, das ist im Prinzip ja auch mein Ansatz, wobei ich noch eine Vorliebe für (mit Grund) niedergeknüppelte Werte habe, wozu PTIE ja eigentlich nicht gehört. 270 Millionen $ sind zwar gegenüber einer Millennium Pharmac. billig, aber da krepeln ne ganze Menge kleine Biotechs mit interessanten Entwiclungen herum, die noch mal nur ein Fünftel dieser 270 Millionen kosten:

Je länger ich mich damit beschäftige, desto mehr zweifle ich allerdings , ob selbst ein nicht-spezialisierter Pharmazeut einen Überblick über den Analgetica-Markt haben kann. Ich zitiere mal den Neuroinvestor aus einer etwas älteren 2003er Ausgabe:

NeuroInvestment today announced the release of its March issue. The issues focuses upon new approaches to the pharmacotherapy of severe, nociceptive pain. Such pain is epitomized by the intractable pain endured by many cancer patients, but extends far beyond that category, Pain is the most frequent reason for physician visits, and produces an enormous market, with US sales for prescription pain medications exceeding $9 billion annually. Opiate-derived drugs have been a mainstay in this area, but involve significant side effects and the risks of dependency and abuse. [....]

Among the programs included in this review are:

1) combination opiate drugs such as are under development by Pain Therapeutics (PTIE - news) and Endo

2) novel twists on the opiate them being developed by Adolor (ADLR - news), CeNeS, ConjuChem

3) Specific calcium channel blockers, such as Elan`s (ELN - news) ziconotide, and oral compounds from NeuroMed

4) Next-generation ion channel blockers, such as the conopeptide analogs being developed by Cognetix

5) the expanding range of cannabinoid modulators and their analogs, from Pharmos), GW Pharmaceuticals, and Organix

6) Muscarinic and nicotinic modulators from Acadia, Abbott, and Targacept

7) Capsaicin formulations from NeurogesX, histamine modulators from ReNeuron

8) Genomics research by Biofrontera, Ionix, and NeuroTargets

9) the improved anesthetic prodrug being developed by Guilford (GLFD - news)
_________________________________________________________
Wichtig ist dabei auch das Zitat combination opiate drugs such as are under development by Pain Therapeutics (PTIE - news). Irgendwo habe ich auch aufgeschnappt, dass man auch schon jetzt Opiate wie oxycodone mit naltrexone (beide Präparate sind bereits zugelassen) in Kombi verschrieben werden (sogenannte off-label), wenn für die Patienten die Wirkung der Opiate nachlässt.
Diese private Internetseite deutet genau darauf hin.
http://www.lowdosenaltrexone.org/#When_will_LDN_be_approved

blb: Nimm meine Aussagen nicht ganz Ernst, weil ich noch mitten in der Recherche bin und andere Felder weitaus besser kenne. Aber ich habe dieses Wochenende endlich etwas Zeit (Strohwitwer ), insofern kann ich mich mal in was Neues einarbeiten.

Mir ist zB noch nicht ganz klar, ob PTIEs Oxytrex letztendlich eine Oxycodone/Naltrexone-Kombi ist, insofern muß ich meinen Eindruck, hinter Oxytrex, Remoxy und PTI-901 steht im Wesentlichen dieselbe Technolgie, zurücknehmen!

[puhvogel]

Behaupten die nicht auch, daß die Medikamente besser wirken würden? Bei manchen Menschen sprechen Opiate ja nicht an.

Die verwenden auch nur handelsübliche Opiate, ich vermute ja das Opiat Oxycodone (Handelsnamen wie Oxycontin, Percocet, Percodan und Tylox), mischen die aber mit dem Opiat-Antagonisten Naltrexone (wird bei Heroinabhängigen eingesetzt), um sowohl einen Gewöhnungseffekt an die eingesetzten Opiate als auch um den Missbrauch zu verhindern.

Hier haben wir keine Neuentwicklung vor uns, sondern ein Mischung zweier etablierter Wirkstoffe, die synergistisch zusammenarbeiten sollen, obwohl sie eigentlich Antagonisten sind!

Vorm gedankenlosen Umgang mit Naltrexone wird gewarnt, aber Schmerz ist definitiv keine Autoimmunerkrankung.
http://www.amsel.de/ms/index.php?kategorie=medizin&cnr=32&an…

Btw: Ich bin es nicht gewohnt, in Jahresberichten Karikaturen zu lesen.

[puhvogel]

Meine Fresse, das gesamte Feld der Opiate ist ja aktuell gewaltig im Bewegung.
http://www.sacbee.com/24hour/jobs/story/2530600p-10905259c.h…

Der Missbrauch von Oxycodone nimmt wohl in den USA solch ein Ausmaß an, dass Pain mit seiner Langzeit-Variante des Oxycodones (Remoxy) auch echte Marktchancen hätte.

[puhvogel]

1.Feststellung: In Oxytrex ist tatsächlich oxycodone enthalten:
Aus dem J Pain. 2005 Jun;6(6):392-9 .

Adding Ultra Low-Dose Naltrexone to Oxycodone Enhances and Prolongs Anesthesia; A Randomized Controlled Trial of Oxytrex

Oxytrex is a novel drug that combines oxycodone with ultralow-dose naltrexone, an opioid antagonist. Ultralow-dose opioid antagonists have been demonstrated to enhance and prolong opiate analgesia and alleviate opioid tolerance and withdrawal in rodents. This 3-week, Phase II clinical trial assessed safety and analgesic efficacy of Oxytrex in patients with moderate to severe pain from osteoarthritis. Patients with a pain score > or =5 received placebo, oxycodone 4 times a day (qid), Oxytrex qid, or Oxytrex twice a day (bid). All active treatment groups received the same total daily dose and dose escalation of oxycodone starting at 10 and ending at 40 mg/day. Importantly, the Oxytrex bid group received a lower daily dose of naltrexone than Oxytrex qid (0.002 vs 0.004 mg/day). Oxytrex bid produced a 39% reduction in pain intensity, which was significantly greater than that of placebo (P < .001), oxycodone qid (P = .006), and Oxytrex qid (P = .003). Oxytrex bid was also superior to placebo in quality of analgesia (P = .002), duration of pain control each day (P = .05), patients` global assessments (P = .04), and the Western Ontario and MacMaster Universities Osteoarthritis Index total score (P = .03). The incidence of side effects was comparable between active treatments. In this Phase II dose-ranging study, Oxytrex bid demonstrated greater pain relief with a more convenient dosing schedule compared to oxycodone qid. PERSPECTIVE: Preclinical data have shown ultralow-dose opioid antagonists to enhance and prolong opioid analgesia while reducing analgesic tolerance and physical dependence. Recent molecular pharmacology data show a mechanism of action to be the prevention of aberrant G protein coupling by opioid receptors that underlies opioid tolerance and dependence.

2.Feststellung:
Die erste Phase 3 Studie haben sie veröffentlicht. Was mir so überhaupt nicht schmeckt ist die riesige Zahl der Dropouts. Da muß mal recherchieren, ob die bei vergleichbaren Studien auch so hoch waren und in diesem Fall die FDA das so akzeptiert hat.


Pain Therapeutics Announces Positive Oxytrex Phase III Results
Statistically Significant Results in Patients With Low-back Pain
SOUTH SAN FRANCISCO, Calif., March 24, 2005 -- Pain Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, today reported clinical results from the first of two Phase III trials with Oxytrex, a novel oral opioid painkiller.

In this Phase III study of 719 patients with severe chronic low-back pain, Oxytrex patients reported over 50% less symptoms of physical dependence and withdrawal effects (p<0.01) after cessation of prolonged, high-dose opioid therapy compared to patients on oxycodone. Oxytrex patients reported equal pain relief to patients on oxycodone and about 20% less overall opioid-related side-effects during treatment, including less somnolence (p<0.05), less pruritus (p<0.05) and 44% less moderate-to-severe constipation (p<0.05).

"This is the first time a large, rigorous trial shows a meaningful improvement in physical dependence," said Lynn Webster, MD, lead investigator on this study, medical director of Lifetree Clinical Research & Pain Clinic in Salt Lake City, board certified physician in pain management and anesthesiology and a specialist in addiction medicine. "Physical dependence is a predictable effect of prolonged opioid therapy. Physicians or patients often associate physical dependence with addiction and avoid opioid painkillers altogether. Many recreational drug users who become hooked on opioids due to physical dependence find it inescapable to discontinue drug use. I think a new drug that provides pain relief yet curbs dependency stands to gain rapid acceptance in the medical community."

"Drug safety continues to dominate the public health agenda, especially with chronic drug treatments," said Remi Barbier, president and chief executive officer of Pain Therapeutics. "The oxycodone market is about $2 billion in size and represents over 10 million scripts per year. Will a broad swath of this market adopt a new drug that offers less physical dependence, less side-effects or lower dosing requirements? We believe so and that`s why we`re excited about our Phase III results."

"We plan to discuss an NDA strategy for Oxytrex with the FDA in late 2005 after unblinding results of our second Phase III trial," added Nadav Friedmann, PhD, MD, chief operating and medical officer at Pain Therapeutics.

Pain Therapeutics plans to submit trial results at the World Congress on Pain (Australia), August 21-26. Management also plans to present at the Smith Barney Citigroup 2005 Healthcare Conference in Washington, DC on Wednesday, March 30, and at the 2005 CIBC World Markets Annual Biotechnology Conference in New York, Monday, April 4, followed by a non-deal roadshow with institutional investors in the upcoming weeks.

STUDY ABSTRACT

Phase III Design

This randomized, double-blind, placebo and active-controlled trial was conducted in multiple U.S. centers in ambulatory patients with persistent, moderate-to-severe low-back pain. After signing an informed consent form, all patients (N = 719) began a 4-10 day washout period. After the washout period, patients with severe pain scores (. 5 out of 10) were randomized to one of four treatment groups for dose titration: Oxytrex-QID (N=206), Oxytrex-BID (N=206), oxycodone-QID (N=206); or placebo (N=101). (Note: QID refers to four-times-a-day; BID refers to twice-a-day).

Treatment Period

During a six-week titration period, patients were dose-escalated with up to 80 mg of Oxytrex, oxycodone or placebo. Dose escalation stopped when patients reported adequate pain relief (< 2 out of 10) or an unacceptable level of opioid related side-effects. At that point the dose was fixed and patients continued their opioid therapy at that dose for a period of three months. The actual dose titration schedule was: 10 mg/day in week one; 20 mg/day week two; 30 mg/day week three; 40 mg/day week four; 60 mg/day week five; or 80 mg/day week six. Patients in the oxycodone group only received oxycodone. Patients in the Oxytrex groups received oxycodone formulated with ultra-low-dose naltrexone. Oxytrex-QID patients received a total daily dose of 4 nanograms of ultra-low-dose naltrexone; Oxytrex-BID patients received a total daily dose of 2 nanograms of ultra-low-dose naltrexone. Rescue medication was not allowed at any time during the study.

Evaluations

The primary and secondary endpoints were prospectively defined as superiority of Oxytrex to oxycodone. Pain intensity was measured on the Likert Pain Scale (0 = no pain; 10 = worst imaginable pain). Patients recorded their pain scores and side-effects in a daily diary immediately before their bedtime dose. Patients also visited the clinic initially each week and then every fortnight during the fixed dose period. Physical dependence is an expected response to prolonged opioid use and is characterized by a series of well-known clinical symptoms when opioid use is abruptly discontinued. At the conclusion of the study, patients were evaluated for opioid withdrawal effects using the Short Opiate Withdrawal Scale (SOWS).

Summary of Trial Results

Baseline. All patients reported similar baseline pain scores (7.3-7.7 out of 10).


Pain Scores. All drug groups separated from placebo (p<0.01). The oxycodone and Oxytrex groups all reported equal pain relief during the study (about 45% mean reduction in pain intensity from baseline).


Drug Dose. Patients in both Oxytrex groups required substantially less opioid drug dose (35 mg per day) to achieve equal pain relief compared to patients in the oxycodone group (39 mg per day) (p<0.05).


Side-effects. Opioid-related side-effects were about 20% lower overall in the Oxytrex-BID group compared to the oxycodone group. Oxytrex-BID patients reported 44% less moderate-to-severe constipation compared to the oxycodone group through the treatment period (p<0.05). Somnolence and pruritus were also both significantly lower in the Oxytrex-BID group (p<0.05) compared to the oxycodone group.


Physical Dependence/Withdrawal. The Oxytrex-BID group reported substantially lower mean SOWS scores (1.2) than patients in the oxycodone group (2.6) in the first 24 hours following drug discontinuation (p<0.01). This large difference in scores (>50%) reflects milder withdrawal events in the Oxytrex-BID group and more severe dependency and withdrawal effects in the oxycodone group.


Dose Frequency. Oxytrex-BID provided pain relief on par with oxycodone-QID without the use of a slow-release formulation. (Oxycodone has a peak effect within two hours of dosing and a clinical duration of action of 3-6 hours due to its short (2 to 4 hour) half-life in plasma. As a result, it is typically prescribed four-times-a-day for round-the-clock pain relief; slow-release formulation can provide more convenient forms of dosing, such as twice-a-day).


Drop-outs. As expected, the overall dropout rate was high (about 50%) due to the inclusion of a large placebo group (N= 101) and the length and complexity of the study. As expected, placebo patients dropped out earlier and more often than the drug groups.

[puhvogel]

Hmm, noch ein Punkt der mir nicht gefällt:
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

Oben in der Zusammenfassung der Ergebnisse, so wie sie Pain Th. im Juni veröffentlicht in einem Journal haben, steht:
The primary and secondary endpoints were prospectively defined as superiority of Oxytrex to oxycodone

In welchem Kriterium sich die Überlegenheit konkret äußern sollte, sagen die einem leider nicht, sie zählen eigentlich nur einige statistisch signifikante Unterschiede auf. Nun soll ich also alte Veröffentlichungen suchen, um das genau herauszufinden.
Die ursprünglich im März publizierte Meldung der Phase 3 Daten, ist scheinbar gar nicht mehr auf der PTIE-Homepage auffindbar.
Dort heißt es lakonisch unter den 2005 Milestones:Report Results of First Phase III Study (March)

Ich habe eben den primären Endpunkt der Studie gefunden:
http://www.biospace.com/ccis/news_story.cfm?StoryID=13121320…
In this study, Oxytrex(TM) was superior to oxycodone (p=0.006) and to placebo (p<0.001) in reducing severe osteoarthritic pain during a 21-day treatment period.
....
The primary endpoint in this study is analgesic efficacy and will be measured using the same industry-wide standard metrics of pain that the Company used in its Phase II studies, such as pain reduction and global assessment.


Als Endergebnis die speziellen Phase III Studie steht dann plötzlich:The oxycodone and Oxytrex groups all reported equal pain relief during the study (about 45% mean reduction in pain intensity from baseline).

Ich bleibe dann doch mal lieber draußen.

[blb]

Pain Therapeutics Announces Positive Phase III Results
FRIDAY, SEPTEMBER 09, 2005 7:30 AM
- PR Newswire

SOUTH SAN FRANCISCO, Calif., Sept 09, 2005 /PRNewswire-FirstCall via COMTEX/ -- Pain Therapeutics, Inc., (PTIE) a biopharmaceutical company, today reported positive Phase III results with Remoxy, an abuse-resistant form of long-acting oxycodone.

In this study, the safety and efficacy of Remoxy was compared against placebo in osteoarthritic patients with moderate-to-severe chronic pain. This Phase III study design was randomized, double-blinded and enrolled 209 patients in over 20 U.S. clinical sites. Patients were treated with Remoxy 20 mg or matching placebo twice daily over a 4-week study period. Patient demographics and baseline pain scores were similar in both arms.

The primary objective of this study was to evaluate pain relief. Results demonstrated a statistically significant difference (p<0.05) between Remoxy and placebo in the study`s primary endpoint: percent decrease in pain scores from baseline to final study visit, measured with a standard Likert Pain Scale.

The secondary objective of this study was to evaluate patients` quality of life. Results demonstrated statistically significant differences (p<0.05) between Remoxy and placebo in each component of the WOMACTM Osteoarthritis Index, in physical function measured by a standard SF-12(R) Health Survey and in patients` self-reported Quality of Analgesia.

"We`re delighted to announce these positive Phase III study results with Remoxy," said Remi Barbier, president and chief executive officer. "These positive data allow us to forge ahead with Remoxy`s clinical development. We also believe these data open doors to various commercial options for Remoxy, such as launching this drug by ourselves or with a pharmaceutical firm that shares our vision of the market potential for this drug."

No drug-related safety issues were noted in this study. As expected, opioid-related adverse events were higher in the Remoxy arm compared to the placebo arm. Adverse events typically associated with chronic opioid use include nausea/vomiting, dizziness, pruritus (itching), and somnolence/sedation. Also as expected, the patient drop-out rate was higher in the Remoxy arm (35%) compared to the placebo arm (24%). Patients in the Remoxy arm dropped mainly due to opioid-related adverse events. Patients in the placebo arm dropped mainly due to lack of efficacy.

Pain Therapeutics` next step with Remoxy is to conduct a large, pivotal Phase III registration study that can support a New Drug Application under an FDA filing strategy known as 505(b)(2). The Company expects to initiate this study by year-end 2005.

About Oxycodone Abuse

Oxycodone is a strong opioid painkiller and is the active drug ingredient in Remoxy. Oxycodone is also the active drug ingredient in Oxycontin(R), a brand name drug with sales of nearly $2 billion in 2004. Long-acting versions of oxycodone are widely used to treat moderate-to-severe chronic pain. However, drug abusers can easily extract oxycodone from Oxycontin(R) tablets (and all other marketed versions of long-acting oxycodone) in order to induce a quick and powerful euphoric high. Abusers of long-acting oxycodone risk respiratory depression, which can be fatal, and opioid addiction. According to government data, oxycodone abuse resulted in over 20,000 visits to emergency rooms and hundreds of deaths in 2002. Please visit the U.S. Drug Enforcement Administration`s website ( www.usdoj.gov/dea ) for more information.

About Remoxy

Remoxy is an investigational drug candidate to treat severe chronic pain. The FDA has not yet evaluated the merits, safety or efficacy of Remoxy. We are developing this drug as an abuse-resistant alternative to marketed forms of long-acting oxycodone. Remoxy has a sticky, high-viscosity mass that resists injection or snorting. Published data show that freezing, crushing or submerging Remoxy in high-proof alcohol for hours at a time releases just a fraction of oxycodone compared to Oxycontin(R) at time points when abusers presumably expect to get high. We believe these collective properties of Remoxy may deter recreational abuse or accidental patient misuse of long acting oxycodone.

About Pain Therapeutics, Inc.

We are a biopharmaceutical company that develops novel drugs. Our drug candidates target severe chronic pain, such as low-back pain or pain due to osteoarthritis or irritable bowel syndrome. We have three unique drug candidates in clinical development: OxytrexTM, Remoxy and PTI-901, all of which are in Phase III clinical trials. We believe the target market for our three drug candidates exceeds $3 billion per year. We own commercial rights to our drug candidates.

Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). PTI disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company`s clinical development for commercialization of Remoxy, the potential benefits of Remoxy and the Company`s drug candidates and the size of the potential market for the Company`s products, including Remoxy. Such statements are based on management`s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company`s drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company`s drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company`s intellectual property or trade secrets, the Company`s ability to obtain additional financing if necessary and unanticipated research and development and other costs. For further information regarding these and other risks related to the Company`s business, investors should consult the Company`s filings with the Securities and Exchange Commission.

SOURCE Pain Therapeutics, Inc.

Christi Waarich, Senior Manager of Investor Relations of Pain Therapeutics, Inc.,
[phone], or [e-mail], or Carney Duntsch of Burns McClellan,
[phone], for Pain Therapeutics, Inc.


http://www.prnewswire.com


Copyright (C) 2005 PR Newswire. All rights reserved. ********************************************************************** As of Monday, 09-05-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 07-13-2005 for PTIE @ $5.97. (C) 2005 Comtex News Network, Inc. All rights reserved.

[Glück]

[posting]17.635.188 von puhvogel am 21.08.05 22:45:19[/posting]Aber danke für die Mühe, kam mal ganz anders rüber wie vieles Andere hier !!!!!

[blb]

Der nächste Volltreffer! Heute ist Zahltag!

King Pharmaceuticals and Pain Therapeutics Enter Into Strategic Alliance to Develop and Commercialize Remoxy(TM)
THURSDAY, NOVEMBER 10, 2005 8:03 AM
- PR Newswire

BRISTOL, Tenn., Nov 10, 2005 /PRNewswire-FirstCall via COMTEX/ -- King Pharmaceuticals, Inc. (KG) announced today it has entered into a strategic alliance with Pain Therapeutics, Inc. (PTIE) to develop and commercialize Remoxy and other abuse-resistant opioid painkillers. Remoxy (long-acting oral oxycodone) is an investigational drug in late-stage clinical development by Pain Therapeutics for the treatment of moderate-to-severe chronic pain.

Brian Markison, president and chief executive officer of King Pharmaceuticals, stated, "This alliance is the culmination of an extensive screening process for late-stage development opportunities in the pain market. We have strong capabilities in the neuroscience space and have focused our licensing efforts toward the unmet medical needs in today`s evolving pain market. The technologies at Pain Therapeutics rose to the top of our list of the most attractive opportunities in this market." Mr. Markison emphasized, "Today`s announcement underscores King`s commitment to form strategic alliances with companies at the forefront of drug development. We are confident our alliance with Pain Therapeutics adds considerable strength to King`s pipeline and positions both companies for solid long-term growth."

"We see this alliance as a winning combination of commercial expertise and unique technology," said Remi Barbier, president and chief executive officer of Pain Therapeutics. "King has enjoyed considerable success in commercializing neuroscience drugs, while our track record is in drug development. By pooling expertise, we aim to position abuse-resistant opioid painkillers, such as Remoxy, as a new class of drugs in the biopharmaceutical industry. We are confident the capabilities and incentives of King and Pain Therapeutics are aligned to achieve this goal."

Under the terms of the agreement, King will make an upfront payment of $150 million in cash to Pain Therapeutics. Pain Therapeutics could also receive additional milestone payments of up to $150 million in cash based on the successful clinical and regulatory development of Remoxy and other abuse- resistant opioid products. This amount includes a $15 million cash payment upon acceptance of a regulatory filing for Remoxy and an additional $15 million upon its approval. King is responsible for all R&D expenses related to this alliance, which could total $100 million.

Brian Markison added, "Our primary research indicates that safe and appropriate use of opioid painkillers is a major concern among physicians, patients, managed care and regulatory agencies. Remoxy addresses this concern, while at the same time its technical foundation serves as a platform to develop a pipeline of other abuse-resistant opioid painkillers. Our vision is to create a large market opportunity around this platform to complement our existing neuroscience portfolio."

About Remoxy

Remoxy is being developed as an abuse-resistant version of long-acting oxycodone. It is intended to meet the needs of physicians who appropriately prescribe opioid painkillers and who seek to minimize risks of drug diversion, abuse or accidental patient misuse. Remoxy has a sticky, high-viscosity mass that resists injection or snorting. Published data show that freezing, crushing or submerging Remoxy in high-proof alcohol for hours at a time releases just a fraction of oxycodone compared to Oxycontin(R) at time points when abusers presumably expect to get high. The companies believe these and other physical properties of Remoxy may deter recreational abuse or accidental patient misuse of long acting oxycodone. The U.S. Food and Drug Administration (FDA) has not yet evaluated the merits, safety or efficacy of Remoxy.

Pain Therapeutics is currently designing a pivotal Phase III study with Remoxy in patients with severe chronic pain. This randomized, placebo- controlled Phase III clinical trial will enroll 400 patients with moderate-to- severe chronic pain in multiple U.S. clinical sites. This trial is expected to begin in January 2006 and to be completed by December 2006. If this Phase III clinical trial is successful, a New Drug Application for Remoxy could be filed with the FDA in 2007.

About the Agreement

Pain Therapeutics and King will form a joint operating committee to oversee drug development and commercialization strategies for the alliance. Pain Therapeutics will retain sole control of drug development activities through Phase II. The companies will jointly manage Phase III and New Drug Application submissions in the U.S. King will have this responsibility outside the U.S. Upon regulatory approval, King will assume sole control and worldwide responsibility to exclusively commercialize Remoxy and other abuse- resistant opioid drugs. Pain Therapeutics retains all development and commercial rights in Australia and New Zealand.

King will record net sales of all products and pay Pain Therapeutics a 20% royalty, except as to the first $1 billion in cumulative net sales, which royalty is set at 15%. King is also responsible for the payment of third- party royalty obligations of Pain Therapeutics related to this alliance.

The agreement is subject to customary regulatory approvals, including antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act.

About Pain Management and Oxycodone Abuse

Over 50 million people are affected by severe chronic pain in the United States. Due to the aging population, better physician training in pain management and other factors, opioid sales are rising and are expected to exceed $7 billion in 2009 according to Frost and Sullivan.

Oxycodone is a leading opioid used in the treatment of moderate-to-severe pain, with U.S. sales of nearly $2 billion for the 12-months ending August 2005, according to IMS Health data. Oxycodone is also the active drug ingredient in Remoxy and in the branded product Oxycontin(R). Drug abusers can easily extract oxycodone from Oxycontin(R) tablets in order to induce a quick and powerful euphoric high. Oxycodone abusers risk respiratory depression, which can be fatal, and opioid addiction. According to government data, oxycodone abuse resulted in over 20,000 visits to emergency rooms and hundreds of deaths in 2002. Please visit the U.S. Drug Enforcement Administration`s website (http://www.usdoj.gov/dea) for more information.

Conference Call/Webcast

King Pharmaceuticals and Pain Therapeutics will jointly host a conference call and webcast for the investment community on November 10, 2005 at 10:00 a.m. ET to discuss this announcement. To participate in the conference call, please dial 877-234-1973 (within the U.S.) or 973-582-2700 (outside the U.S.) fifteen minutes prior to the start of the call. The call reference number is 6710999. A playback of the conference call will be available following the call. To access the playback, please dial 877-519-4471 (within the U.S.) or 973-341-3080 (outside the U.S.) and enter reservation number 6710999. A live webcast of the conference call will also be available online at http://www.kingpharm.com and http://www.paintrials.com.

About King Pharmaceuticals, Inc.

King, an S&P 500 Index Company, is a vertically integrated branded pharmaceutical company that employs over 2,500 people. King`s growing line of branded products includes neuroscience drugs such as Skelaxin(R) (metaxalone) and Sonata(R) (zaleplon).

King seeks to capitalize on opportunities in the pharmaceutical industry though internal development efforts, in-licensing arrangements or the acquisition of novel branded prescription drugs in attractive markets that can benefit from focused promotion, superior marketing or life-cycle management. For more information, please visit its website (http://www.kingpharm.com).

About Pain Therapeutics, Inc.

Pain Therapeutics is an emerging biopharmaceutical company that develops novel drugs. Its investigational drug candidates target different types of chronic pain, such as low-back pain, pain due to osteoarthritis or irritable bowel syndrome. Pain Therapeutics has three unique drugs in Phase III clinical development: Remoxy, Oxytrex(TM) and PTI-901. Pain Therapeutics retains worldwide commercial rights to Oxytrex and PTI-901, both of which are unaffected by this agreement. For more information please visit the Company`s website (http://www.paintrials.com).

Forward-looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect managements` current views of future events and operations, including, but not limited to, statements pertaining to the anticipated results of the strategic alliance, including its expected effect on King`s pipeline and potential for revenue growth; statements pertaining to the anticipated R&D funding by King and the number of abuse resistant opiod products to be developed under the alliance; statements pertaining to King`s regulatory, manufacturing, sales and marketing capabilities; statements pertaining to expected benefits of Remoxy or the value and future potential of the application of the Remoxy technology and the potential development and commercialization of other abuse-resistant opioid painkillers; statements pertaining to the future market opportunity for Remoxy and other opioid products utilizing the same drug delivery technology; statements pertaining to the potential for Remoxy to deter abuse and misuse of oxycodone; statements pertaining to the development of Remoxy and other abuse-resistant opioid products; statements pertaining to the filing of a New Drug Application (NDA) for Remoxy; and statements pertaining to the long-term growth potential provided each company by the alliance. Some important factors which may cause results to differ materially from such forward-looking statements include dependence on obtaining appropriate governmental approvals and consummation of the transaction; dependence on the companies` abilities to carry out their respective business plans; dependence on the successful development and commercial acceptance of Remoxy and other abuse-resistant opioid products; dependence on the companies` ability to timely file an NDA for Remoxy; dependence on the companies` abilities to obtain regulatory approvals for Remoxy; dependence on the companies` abilities to successfully manufacture Remoxy after obtaining the necessary regulatory approval; dependence on King`s ability to successfully market Remoxy; dependence on the availability and cost of raw materials; dependence on the unpredictability of the duration and results of the FDA`s review of Investigational New Drug Applications (IND), NDAs, and supplemental New Drug Applications, (sNDAs) and/or the review of other regulatory agencies worldwide; dependence on compliance with FDA and other government regulations that relate to King`s and Pain Therapeutics` respective businesses; and dependence on changes in general economic and business conditions; changes in current pricing levels; changes in federal and state laws and regulations; changes in competition; unexpected changes in technologies and technological advances; and manufacturing capacity constraints. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of King`s Form 10-K for the year ended December 31, 2004 and Form 10-Q for the third quarter ended September 30, 2005, and Pain Therapeutics` Form 10-K for the year ended December 31, 2004 and Form 10-Q for the third quarter ended September 30, 2005, which are on file with the U.S. Securities and Exchange Commission. The companies do not undertake to publicly update or revise any of their forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.

Contacts:

James E. Green, Executive Vice President, Corporate Affairs - 423-989-8125
David E. Robinson, Senior Director, Corporate Affairs - 423-989-7045

EXECUTIVE OFFICES

KING PHARMACEUTICALS, INC.
501 FIFTH STREET, BRISTOL, TENNESSEE 37620


SOURCE King Pharmaceuticals, Inc.

James E. Green, Executive Vice President of Corporate Affairs, [phone], or
David E. Robinson, Senior Director of Corporate Affairs, [phone], both of
King Pharmaceuticals


http://www.prnewswire.com


Copyright (C) 2005 PR Newswire. All rights reserved. ********************************************************************** As of Sunday, 11-06-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated an UPTREND on 11-03-2005 for KG @ $16.32. As of Sunday, 11-06-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 10-28-2005 for PTIE @ $5.95. (C) 2005 Comtex News Network, Inc. All rights reserved.

Siehe auch:

www.f-tor.de/board
http://www.stockadhoc.de/biotech_md.htm

Grüße an puhvogel und die anderen...