Pain Therapeutics mit 3 Medikamenten in Phase III - 500 Beiträge pro Seite

[cyberhai]

Hier die Pipeline:



Aktuelle MK: 302.59 Mio. Dollar

Hier die letzte Mitteilung:

Pain Therapeutics` Remoxy Reduces Pain
Friday September 9, 9:25 am ET
Pain Therapeutics` Remoxy Shown to Reduce Arthritis Pain in Late-Stage Clinical Trial

SOUTH SAN FRANCISCO, Calif. (AP) -- Biopharmaceutical company Pain Therapeutics Inc. said Friday that its Remoxy painkiller significantly reduced arthritis pain in patients enrolled in a late-stage clinical trial.

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Pain Therapeutics shares surged 62 cents, or 9.5 percent, to $7.15 in premarket activity. A year ago, the stock traded at a high of $8.39, but then dipped to a 52-week low of $4.78 in early April.

Remoxy is intended to be an abuse-resistant version of Purdue Pharma LP`s Oxycontin. The company`s version of oxycodone, the active ingredient in Oxycontin, is a sticky, highly viscous mass that is difficult to snort or inject. Also, when placed in alcohol, Remoxy only releases a small amount of its oxycodone active ingredient.

In a Phase III trial, the company found Remoxy relieved pain in osteoarthritic patients by a significant amount compared with patients given placebo. The company plans to conduct an additional Phase III study before submitting a new drug application with the FDA.

Side effects of the drug were typical of chronic opiate use: nausea, dizziness, itching and sedation.

Der Chart:



Was haltet Ihr von der Aktie?

Gruß Cyberhai

[Glück]

Hm, warum wurden die von Rodman & Renshaw im Juli downgegrated

Drei x Phase III ist eigentlich geil

[cyberhai]

Hallo Glück,

ich halte von 95 % der sogenannten Analysten gar nichts mehr. Schau doch z.B. mal bei Viropharma (wo ich seit ca. 2 Euro dabei bin), da hat Global Insider Investing am 16.08.05 bei 10 Dollar zum glattstellen geraten, anschließend ging die Aktie bis 17 Dollar hoch.

Außerdem gibt Rodman & Renshaw keinen Grund für die Rückstufung auf "market perform" an.

Gruß Cyberhai

[blb]

Sehr interessanter Wert, wir haben ihn im Depot...

[cyberhai]

Bin auch bereits investiert. Ich mache grundsätzlich immer einen Thread bei einer Aktie auf, wenn noch keiner da ist, damit ich selber den Überblick über meine Investments behalte und nicht extra eine Excel-Datei oder ähnliches für die Daten anlegen muss.

Gruß Cyberhai

[blb]

Kein Problem!

Schönes Wochenende!

[cyberhai]

PAIN THERAPEUTICS (RT-ECN)
Symbol: PTIE
Last Trade: 7.12 4:05PM ET
After Hours Change: Up 0.81 (12.84%)
Today`s Change: Up 0.77 (12.13%)
Bid: 6.03
Ask: 6.60

Im Oktober 2 Insiderkäufe über Aktienoptionen:

10-Oct-05 FRIEDMANN, NADAV
Chief Operating Officer 15,000 Direct Option Exercise at $2 per share. $30,000
5-Oct-05 FRIEDMANN, NADAV
Chief Operating Officer 10,000 Direct Option Exercise at $2 per share. $20,000

Normalerweise wird bei einem solchen schnellen möglichen Gewinn (hier das 3-fache vom Einsatz) schnell verkauft, dies ist hier nicht der Fall, was ich als sehr positiv werte.

Gruß Cyberhai

[nort_de]

Derzeit bietet sich meiner Meinung ein guter Einstieg in Pain Therapeutics. Der Kurs bewegt sich derzeit mit 10% unterhalb des 50/100 Tage Durchschnittes. Diese Differenz sollte nach der Korrektur im BioTech Segment zügig geschlossen werden. Eine stabile Unterstützung sollte die 6$ Marke bieten.

[nort_de]

Es tut sich was:

28.10.2005 13:38
Pain Therapeutics Provides Oxytrex(TM) Update

SOUTH SAN FRANCISCO, Calif., Oct. 28 /PRNewswire-FirstCall/ -- Pain Therapeutics (Nachrichten), Inc. , a biopharmaceutical company, today provided an update on its progress with its Phase III clinical program for Oxytrex. Oxytrex (oral oxycodone + ultra-low-dose naltrexone) is an investigational drug in late-stage clinical development for the treatment of moderate-to-severe chronic pain.

"We remain on-track to announce Phase III study results with Oxytrex by early December," said Remi Barbier, Pain Therapeutics` president and chief executive officer. "The Phase III data remains blinded and we are clearly excited to begin clinical and statistical analysis of this data. We also believe it`s important to articulate a clear set of expectations about the pending results."

What Is Our Phase III Clinical Strategy For Oxytrex?

Pain Therapeutics is developing Oxytrex to treat patients with moderate-to-severe chronic pain. The FDA has indicated that Oxytrex is eligible for broad-label approval if its safety and efficacy are demonstrated in two pivotal studies in chronic pain populations.

What Was The Design Of The First Phase III Study For Oxytrex?

The first Phase III study enrolled over 700 patients with severe low-back pain. This randomized, double-blind, multi-center U.S. study was designed to compare the safety and efficacy of a variable dose of Oxytrex versus oxycodone or placebo. Patient enrollment was completed in September 2004 and Phase III results were announced in March 2005.

What Were Clinical Results Of The First Phase III Study?

Among other benefits, Oxytrex patients reported a significant reduction in physical dependence and withdrawal effects (p<0.01) in the first 24 hours following cessation of prolonged, high-dose therapy compared to patients on oxycodone, as measured on the Short Opioid Withdrawal Scale.

What Is The Design Of The Second Phase III Study For Oxytrex?

The second Phase III study was initiated in the U.S. in March 2004 and is fully enrolled. Approximately 750 patients with moderate-to-severe osteoarthritic pain were enrolled in this randomized, double-blind, multi-center study. This second Phase III study is designed to compare the safety and efficacy of a fixed dose of Oxytrex versus oxycodone or placebo.

What Is The Dose For The Second Phase III Study?

Patients receive a fixed daily dose of drug (20 mg or 40mg) or matching placebo for 12 weeks. Following a washout period, patients are randomized to one of six arms, each arm enrolling 150 patients except as noted: Oxytrex 10mg BID; Oxytrex 20mg BID; Oxytrex 10mg QID; oxycodone 10mg QID; ultra-low-dose naltrexone alone (N=75); or placebo (N=75).

What Is The Primary Endpoint For The Second Phase III Study?

The final analysis plan for this study was submitted to the FDA in early October. In this study, the prospectively defined primary endpoint is reduction of physical dependence and withdrawal effects in the first 24 hours following cessation therapy, as measured on the Short Opioid Withdrawal Scale, between patients receiving Oxytrex 20mg BID and oxycodone 10mg QID (i.e., patients in both of these arms received a total dose of 40mg of drug per day).

Why Is Physical Dependence The Primary Endpoint?

Physical dependence is an expected effect of prolonged opioid therapy. Physicians and patients often associate physical dependence with addiction and avoid opioid painkillers altogether. Patients who appropriately use opioid painkillers may find it inescapable to discontinue drug use. Based on highly encouraging Phase III study results and a unique mechanism of action, we believe Oxytrex may be developed as a novel painkiller with minimal physical dependence, among other benefits.

What Is The Secondary Endpoint For The Second Phase III Study?

One of the principle secondary endpoints in this study is non-inferior analgesic efficacy of Oxytrex 20mg BID versus oxycodone 10mg QID. That is, patients in both of these arms received a total dose of 40mg of drug per day and must report at least equal analgesia.

Are Study Results Still Blinded?

This study remains blinded. All clinical data will remain blinded until the last patient`s data is entered into the database and the database is locked. Study results will be announced after the data is unblinded and results are analyzed according to the pre-defined statistical analysis plan.

What Are Next Steps Assuming Positive Phase III Results?

Following the release of data, we plan to discuss NDA requirements for Oxytrex with the FDA. We believe this meeting may occur in Q1 2006. In 2006, we would also continue to enroll patients in an on-going open-label safety study, commence pre-commercialization activities and conduct other needed activities.

What About Other Clinical Announcements?

In addition to announcing Phase III results with Oxytrex this quarter, Pain Therapeutics remains on-track to announce in December results of a Phase III study with PTI-901 in 600 women with Irritable Bowel Syndrome.

About Oxytrex

Oxytrex is a unique oral painkiller that preferentially inhibits an excitatory effect of opioid receptors. This excitatory effect is believed to counteract analgesia (pain relief) and cause tolerance. Its inhibition enhances pain relief and minimizes opioid tolerance. We believe Oxytrex represents the first new mechanism of action by an opiate drug since morphine was discovered over 100 years ago.

We are developing Oxytrex to treat moderate-to-severe chronic pain, such as osteoarthritic pain or low-back pain. We believe Oxytrex could be an effective substitute for oxycodone, a leading opioid painkiller, with U.S. sales of nearly $2 billion for the 12-months ending August 2005, according to IMS Health data. We own all commercial rights to Oxytrex.

About Pain Therapeutics, Inc.

Pain Therapeutics is an emerging biopharmaceutical company that develops novel drugs. Our 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(TM), Oxytrex and PTI-901.

For more information please visit our website (http://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 and scope of the Company`s clinical development of Oxytrex, the Company`s anticipated discussions with the FDA, the potential benefits of Oxytrex and the Company`s drug candidates and the size of the potential market of the Company`s products, including Oxytrex. 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 Oxytrex and the Company`s drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company`s drug candidates, including Oxytrex, that could slow or prevent clinical development, 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.

[nort_de]

PAIN THERAPEUTICS wurde am 26.10 im Aktionär mit einem KS 10 Euro empfohlen. Es wird ein Marktpotential von bis 3 Milliarden Dollar gesehen (Für die 3 Phase 3 Kandidaten). Derzeitige MK beträgt 280 Mio. $

[cyberhai]

Der Chief Operating Officer hält 170.000 Aktien, davon hat er im Oktober 25.000 Stück per Option gekauft, bisher hat er keine einzige Aktie verkauft.

Der Chief Executive Officer hält über 8 Mio Aktien und hat ebenfalls noch keine einzige verkauft.

Das stimmt mich ebenfalls positiv

Gruß Cyberhai

[nort_de]

In einem Monat sollten die Ergebnisse kommen, noch vor NVAX ;-)

[nort_de]

Weitere Inseider-Aktivitäten vom Chief Medical and Operating Officer:
http://phx.corporate-ir.net/phoenix.zhtml?c=120834&p=irol-SE…

[nort_de]

Der Chief Operating Officer hält 170.000 Aktien, davon hat er im Oktober 25.000 Stück per Option gekauft, bisher hat er keine einzige Aktie verkauft.

Somit hält er jetzt 195.000 Aktien und hat im Oktober 50.000 gekauft.

[cyberhai]

nort_de, bist Du auch in Novavax?

[nort_de]

war, die SLs haben gegriffen. Im Moment warte ich ab, bis sich der Kurs erholt. Den NVAX-Fall sollen doch andere aufhalten. Im Moment ist NVAX ein riskanter Spielball (meiner Meinung)... Steht aber weiterhin auf meiner Watchlist, da es Anf. 06 interessanter wird. Richtig spannend wird es aber, wenn die Zugvögel im Frühjahr wieder nach Europa kommen!

[cyberhai]

Ja, Novavax ist sicher riskant, fundamental sieht es bei Pain mit 3 Phase III-Kandidaten besser aus. Wenn ich nochmals cash frei habe, werde ich hier nochmals aufstocken.

Gruß Cyberhai

[nort_de]

ohhh ja das solltest Du. Wenn es nur zu 50% mit den Produkten so läuft wie geplant, dann ist `07 das Unternehmen deutlich in den schwarzen Zahlen. Also ist es im Moment ein lächerlicher Einstiegskurs.

[nort_de]

Der BLACK BEAR OFFSHORE MASTER FUND besitzt nun ca. 10% der Aktien. http://phx.corporate-ir.net/phoenix.zhtml?c=120834&p=irol-se…

[nort_de]

Pain Therapeutics to Present at the CIBC Healthcare Conference

SOUTH SAN FRANCISCO, Nov. 2 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, today announced that Remi Barbier, president and chief executive officer, will present at the CIBC World Markets Annual Healthcare Conference in New York on Wednesday, November 9th at 1:30 p.m. Eastern Time.

An audio webcast of the live presentation will be open to all on the Pain Therapeutics web site, www.paintrials.com. A replay will also be available after the live event through November 23, 2005.

About Pain Therapeutics, Inc.

Pain Therapeutics is an emerging biopharmaceutical company that develops novel drugs. Our 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(TM), Oxytrex(TM) and PTI-901.

[nort_de]

Pain Therapeutics Announces Third Quarter 2005 Financial Results

SOUTH SAN FRANCISCO, Calif., Nov 02, 2005 /PRNewswire-FirstCall via COMTEX News Network/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, today reported financial results for the three and nine months ended September 30, 2005.

The net loss for the quarter ended September 30, 2005 was $8.8 million, or $0.20 per share, compared to a net loss of $9.2 million, or $0.26 per share in the third quarter of 2004. The net loss for the nine months ended September 30, 2005 was $27.5 million, or $0.63 per share, compared to a net loss of $28.5 million, or $0.80 per share for the nine months ended September 30, 2004.

Cash, cash equivalents and marketable securities totaled $71.5 million at September 30, 2005.

Research and development expenses for the third quarter of 2005 decreased to $8.1 million from $8.5 million for the same three-month period in 2004. Research and development expenses for the nine months ended September 30, 2005 decreased to $25.8 million from $26.2 million for the same nine-month period in 2004. The decrease in research and development expenses was primarily related to the completion of the Phase III studies with Oxytrex(TM), Remoxy(TM) and PTI-901.

General and administrative expenses for the third quarter of 2005 increased to $1.1 million from $0.9 million for the same period in 2004. General and administrative expenses for the nine months ended September 30, 2005 increased to $3.3 million from $2.9 million for the same period in 2004.

[nort_de]

Der CFO langt jetzt auch zu und hält 16,971 Anteile.

Der COO hat sich auch noch bedient und besitzt nun 199,121 Anteile.

Die News über den Ausgang der Phase 3 sollten bald kommen. Evtl. schon am 9.11.05

[cyberhai]

Alles klar, hoffen wir das Beste

Gruß Cyberhai

[nort_de]

Pain Therapeutics, Inc. to Present at the
CIBC Healthcare Conference (Live)
11/09/05 at 1:30 p.m. ET (siehe Homepage)

[nort_de]

kann ich auch nicht verstehenhttp://ragingbull.lycos.com/mboard/boards.cgi?board=PTIE&rea…

[nort_de]

http://finance.yahoo.com/q/sa?s=ptie

[nort_de]

und die einkäufe gehen weiter:

http://phx.corporate-ir.net/phoenix.zhtml?c=120834&p=irol-SE…

[nort_de]

Herzlichen Glückwunsch an alle die dabei sind!!!! FRA liegt im Moment bei 40% im Plus. Hat sich schon seit einiger Zeit abgezeichnet.


Pain Therapeutics and King Pharmaceuticals Enter Into Strategic Alliance to Develop and Commercialize Remoxy(TM)

Transaction Positions Abuse-resistant Opioid Painkillers as a Major New Class
of Drugs

SOUTH SAN FRANCISCO, Calif., Nov. 10 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE) announced today it has entered into a strategic alliance with King Pharmaceuticals, Inc. (NYSE: KG) 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."

The value of this alliance could exceed $400 million, plus royalties. 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 & 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 (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 www.kingpharm.com and www.paintrials.com.

About Pain Therapeutics, Inc.

Pain Therapeutics is an emerging biopharmaceutical company that develops novel drugs. Our 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 our website (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 (www.kingpharm.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 opioid 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 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.

[cyberhai]

Das warten hat sich gelohnt

Gruß Cyberhai

[nort_de]

auf 3stockonfire gefunden:





Press Release Source: DURECT Corporation


DURECT Corporation Announces Positive Phase III Clinical Results for Remoxy, a Novel Oral Pain Medication using the ORADUR(TM) Gel-Cap
Friday September 9, 7:30 am ET


CUPERTINO, Calif., Sept. 9 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX - News), an emerging specialty pharmaceutical company, announced today that Pain Therapeutics, Inc. has achieved positive Phase III clinical results for Remoxy(TM), a novel long-acting, abuse-deterrent oral formulation of oxycodone based on DURECT`s ORADUR(TM) technology being developed under license from DURECT.


(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )

"These results represent a significant milestone for our ORADUR franchise and we are very pleased with the rapid progress by which this partnered program has advanced into late stage clinical development. Thus far, these clinical results reinforce our belief that products developed with our ORADUR sustained release oral gel-cap technology may offer a variety of benefits, including the potential to reduce abuse when compared to current long-acting dosage forms that are on the market today," stated James E. Brown, DVM, President and CEO of DURECT. "We continue working to expanding our relationships with a number of pharmaceutical companies to develop additional innovative sustained release oral gel-cap products that utilize select opioids and other potentially abused active agents."

Phase III Study Design and Results

The randomized, double-blinded study was designed to compare the safety and efficacy of Remoxy against placebo in osteoarthritic patients with moderate-to-severe chronic pain. Over 209 patients were enrolled 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. The results announced by Pain Therapeutics demonstrated a statistically significant percent decrease in pain scores for patients using Remoxy as compared to placebo, as measured by a standard Likert Pain Scale. Patients also reported a statistically significant difference in quality of life using Remoxy as compared to placebo, as measured by as measured by a standard SF-12 Health Survey and in patients` self- reported Quality of Analgesia. No drug-related safety issues were noted in the study, and as expected opioid-related adverse events (including nausea/vomiting, dizziness, pruritis (itching) and somnolence/sedation) and drop-out rates were higher in the Remoxy arm compared to placebo. Pain Therapeutics intends to initiate a second Phase III registration study by year-end 2005.

Remoxy draws upon the unique characteristics of the ORADUR sustained released oral gel-cap technology. Products based on the ORADUR technology can take the form of an easy to swallow gelatin capsule that uses a high-viscosity base component, SABER(TM) or sucrose acetate isobutyrate (SAIB), to provide controlled release of active ingredients for a period of from 12 to 24 hours of drug delivery. Oral dosage forms based on the ORADUR gel-cap may also have the added benefit of being less prone to abuse than other controlled release dosage forms on the market today. ORADUR-based products can be manufactured by a simple process using conventional methods making them readily scalable. These properties have the potential to make ORADUR-based products an

attractive option for pharmaceutical companies that seek to develop tamper and abuse resistant oral products.

About Remoxy

Remoxy is an oral, long-acting oxycodone capsule under development by Pain Therapeutics, Inc. that incorporates several abuse-deterrent properties and offers the convenience of twice-a-day dosing. Remoxy is formulated with DURECT Corporation`s ORADUR technology under a joint development and license agreement. Oxycodone is also the active drug ingredient in OxyContin, a brand name narcotic painkiller with annual sales exceeding $1.9 billion. ORADUR is a patented technology based on sucrose acetate isobutyrate, a high-viscosity, biodegradable liquid matrix that forms the basis for a number of different injectible depot and oral gel-cap drug candidates, including Remoxy. Under the terms of the license agreement between Pain Therapeutics and DURECT, Pain Therapeutics has exclusive worldwide rights to develop and to commercialize Remoxy and certain other opioid drugs formulated with DURECT`s ORADUR technology. DURECT is reimbursed for formulation and other work performed under its agreement with Pain Therapeutics, and will receive milestone payments based on the achievement of certain technical, clinical or regulatory milestones, in addition to receiving royalties on product sales.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies that treat chronic debilitating diseases and enable biotechnology products. These platform technologies include the SABER(TM) Delivery System (a patented and versatile depot injectable useful for protein and small molecule delivery), the ORADUR(TM) sustained release oral gel-cap technology (an oral sustained release technology with several potential abuse deterrent properties), the DURIN(TM) Biodegradable Implant (drug-loaded implant system), the TRANSDUR(TM) transdermal technology and the MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system). DURECT also collaborates with pharmaceutical companies to develop and commercialize proprietary and enhanced pharmaceutical products based on its technologies. DURECT has five disclosed on-going development programs of which four are in collaboration with pharmaceutical partners. Additional information about DURECT is available at http://www.durect.com.

NOTE: SABER(TM), ORADUR(TM), DURIN(TM), TRANSDUR(TM) and MICRODUR(TM) are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT`s products in development, anticipated product benefits and clinical trial plans are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT`s ability to complete the design, development, and manufacturing process development of the product candidate and obtain approvals from regulatory agencies to manufacture the product candidate, as well as Pain Therapeutics` ability to initiate, enroll and complete clinical trials and obtain product approvals from regulatory agencies to commercialize the product candidate, and marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT`s Quarterly Report on Form 10-Q for the quarter ended June 30, 2005 filed with the SEC on August 4, 2005 under the heading "Factors that may affect future results."





Pain Therapeutics` Remoxy Reduces Pain
Friday September 9, 10:08 am ET
Pain Therapeutics` Remoxy Shown to Reduce Arthritis Pain in Late-Stage Clinical Trial


SOUTH SAN FRANCISCO, Calif. (AP) -- Biopharmaceutical company Pain Therapeutics Inc. said Friday that its Remoxy painkiller significantly reduced arthritis pain in patients enrolled in a late-stage clinical trial.


Pain Therapeutics shares surged 37 cents, or 5.7 percent, to $6.90 in morning trading on the Nasdaq. A year ago, the stock traded at a high of $8.39, but then dipped to a 52-week low of $4.78 in early April.

In a Phase III trial, the company found Remoxy relieved pain in osteoarthritic patients by a significant amount compared with patients given placebo. Side effects of the drug were typical of chronic opiate use: nausea, dizziness, itching and sedation. The company plans to begin an additional Phase III study by the end of the year before submitting a new drug application with the FDA.

Remoxy is intended to be an abuse-resistant version of Purdue Pharma LP`s Oxycontin. The company`s version of oxycodone, the active ingredient in Oxycontin, is a sticky, highly viscous mass that is difficult to snort or inject. Also, when placed in alcohol, Remoxy only releases a small amount of its oxycodone active ingredient.

The abuse-resistant formulation was developed using technology licensed from Cupertino, Calif.-based specialty drug maker Durect Corp. Durect saw the clinical trial results as a validation of its Oradur sustained release oral gel-cap technology. Shares of Durect were also up on the results, rising 28 cents, or 4.1 percent, to $7.04 in morning trading on the Nasdaq.

[nort_de]

das ist nur ein kleiner vorgeschmack. noch sind zwei kandidaten in der pipe und die vermarktung hat noch gar nicht begonnen Und die weiteren $150 Prämie möchte man sich ja auch noch holen. Entspricht überigens knapp der MK (Stand gestern :laugh

[nort_de]

die insiderkäufe muss man sich auf der zunge zergehen lassen:

http://www.secform4.com/insider/showhistory.php?symbol=ptie

[BrauchGeld]

Hallo

Hab meine Ptie aktien verkauft und weitere Durect Corp.(Drrx) aktien gekauft.
Ptie ist eine gute aktie aber kurzfristig sehe ich bei Durect viel mehr potential.
Übrigens auch Durect ist an Remoxy beteiligt.

[nort_de]

hallo brauchgeld,

habe ich schon gelesen. ich persänlich bleibe bei ptie, da noch zwei weitere kandidaten vermarktet werden müssen und der bonus für den ersten kandidaten auch noch abgeholt werden muss. erst dann denke ich über einen verkauf nach

nort

[nort_de]

Motley Fool
Portfolio Pain Relief
Thursday November 10, 4:39 pm ET
By W.D. Crotty

Are you looking for a small drug development company with three drugs in phase 3 trials? If so, take a look at Pain Therapeutics (Nasdaq: PTIE - News).

ADVERTISEMENT
click here
The company`s stock is the largest percentage gainer on the Nasdaq -- up an astounding 48.9% at Thursday`s high. The reason: Pain Therapeutics is forming a strategic alliance with King Pharmaceuticals (NYSE: KG - News) to develop and commercialize Remoxy (long-acting oral oxycodone) and other abuse-resistant opioid painkillers. Positive phase 3 test results were announced for Remoxy in September.

Painkiller oxycodone has come under attack because drug abusers can grind the pills or dissolve them in high-proof alcohol to get a quick, powerful high. Remoxy and its "sticky, high viscosity" make the capsule formulation nearly impossible to abuse. Even so, the drug`s target market is a $1.9 billion-a-year opportunity in the U.S. alone.

King obviously likes that potential. It`s making an up-front payment of $150 million in cash. That`s a wad of greenbacks for a company that, at Wednesday`s close, had an enterprise value (market capitalization minus cash) of $207 million.

Based on milestone payments, Pain Therapeutics can earn another $150 million for Remoxy and other abuse-resistant opioid drugs. Better yet, King is responsible for all R&D expenses related to the alliance , which could total $100 million. Remoxy enters phase 3 trials in January 2006.

Another drug in the pipeline is Oxytrex. Fellow Fool contributor David Nierengarten covered its phase 3 trial results earlier this year. This product is targeted as a substitute for oxycodone, with fewer side effects. If approved, it will clearly offer a viable alternative to today`s generic oxycodone medication.

Pain Therapeutics` third drug undergoing phase 3 trials targets irritable bowel syndrome, a $1 billion market in the U.S. alone. Results from the first U.S. test are expected by the end of 2005.

.....

Bestellt schon mal jemand die Musikanlage? Die Party geht nch dieses Jahr ab

[cyberhai]

Schön für uns (etwas Schadenfreude muss sein):

King Pharmaceuticals: Aktie bricht nach Downgrade ein
Leser des Artikels: 23

Die Aktie des US-Pharmakonzern King Pharmaceuticals Inc. (ISIN US4955821081/ WKN 911091) muss im Freitagshandel einen Kurseinbruch hinnehmen. Auslöser ist die Herabstufung der Aktie durch das Investmenthaus J.P. Morgan.

Die Analysten hatten die Aktie heute von "neutral" auf "underweight" herabgestuft. Als Grund hierfür wurde der gestrige Deal mit Pain Therapeutics genannt. Hierbei geht es um das Medikament Remoxy. Der Deal ist aus Analystensicht mit 400 Mio. Dollar äußerst teuer.

Erst am Mittwoch hatte der Konzern für das dritte Quartal einen Gewinn nach einem Vorjahresverlust ausgewiesen. Der Nettogewinn belief sich im dritten Quartal auf 121,9 Mio. Dollar bzw. 50 Cents pro Aktie, nach einem Fehlbetrag von 8 Mio. Dollar bzw. 3 Cents pro Aktie im Vorjahr. Vor Einmaleffekten lag der Gewinn bei 52 Cents pro Aktie. Der Umsatz kletterte im dritten Quartal um 31 Prozent auf 518 Mio. Dollar.

Die Aktie von King Pharmaceuticals verliert derzeit an der NYSE 8,35 Prozent auf 14,82 Dollar


Gruß Cyberhai (der sich etwas ärgert, dass es letzte Woche nicht mehr zum Nachkauf gereicht hat )

[nort_de]

Ja, der Deal wundert mich auch etwas. PTIE kommt da sehr gut weg. Bei einem Medikament, bei dem der MArkt auf 1,3 Mrd. $ geschätzt wird, können bei PTIE gleich von Anfang an 300 Mio $ einfliessen. Danach noch die Beteiligung am Umsatz und keinerlei Ausgaben mehr für RD.... TOP Management bei PTIE scheint mir

P.S. Habe ein Tag zuvor schon nachgedacht, ob es der richtige Zeitpunkt war. Jaaaaaa er war es!!!

[nort_de]

sieht ja schön aus:

http://quotes.barchart.com/texpert.asp?sym=ptie

Und Institutionelle wurden wohl überrascht

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=…

[cyberhai]

Ja, sieht alles sehr gut aus

Die Instis werden jetzt langsam wach...

Solange kein Insider (aus dem Unternehmen) in großem Stiel verkauft, sehe ich keinen Handlungsbedarf.

Gruß + eine gute nächste Handelswoche

Cyberhai

[nort_de]

14.11.2005 08:07
Pain Therapeutics Inc.: market perform (Rodman & Renshaw)
Rating-Update:

Die Analysten von Rodman&Renshaw stufen die Aktie von Pain Therapeutics (Nachrichten) (ISIN US69562K1007/ WKN 938335) von "market underperform" auf "market perform" hoch.
Analyse-Datum: 14.11.2005

[nort_de]

und noch ein paar die aufwachen....

Die Analysten von Needham & Co stufen die Aktie von Pain Therapeutics (ISIN US69562K1007/ WKN 938335) unverändert mit "strong buy" ein. Das Kursziel sei von 10 auf 13 USD angehoben worden.

[cyberhai]

Das sind vom jetzigen Kurs 50 %

[nort_de]

[posting]18.793.804 von cyberhai am 14.11.05 21:46:39[/posting]also auf zu den 100

[cyberhai]

Bin aktuell mit genau 43 % im Plus

[nort_de]

[posting]18.794.192 von cyberhai am 14.11.05 22:11:30[/posting]+45,70

[nort_de]

comments vom yahoo-board:

Oxy P3 results are a binary event and their is always selling in front of such an event. The nervous nellies always get-out. $15+ when positive Oxy news hots the street.

It too far away from here for me to have the balls to put it up for public abuse 8-)

Suffice it to say that I think the sp without either of those two programs should be a min of $16.


Forgetting about Remoxy for a second,whats your "wild ass guess" on the stock price if results of Oxytrex AND PT901 are positive?? (my guess is $12-$15 but Im predjudiced as own alot of January and April calls!!!LOL)
JERR

[nort_de]

schööööönes grün:

http://quotes.barchart.com/texpert.asp?sym=ptie

[nort_de]

im yahoo board formieren sie sich:

Oxytrex and PTI clinical results coming in December. The results of these two drugs will validate the success of the Remoxy deal with KING. I think PTIE is a $15 stock by the end of the year. It is very possible we see a similar deal with either of those two drugs. We already did great with REMOXY, anyone selling PTIE at these levels will be very sorry in December.

wird zeit zuzulegen

[cyberhai]

So schnell sind die Gewinne wieder weg:

UPDATE 1-Pain Therapeutics` shares drop after study
Tue Nov 22, 2005 10:18 AM ET
(Recasts; adds share price, details)

NEW YORK, Nov 22 (Reuters) - Shares of Pain Therapeutics Inc. (PTIE.O: Quote, Profile, Research) fell more than 21 percent after the company said on Tuesday a late-stage clinical trial of its Oxytrex drug failed to reach statistical significance for the primary goal because too many people dropped out of the trial.

The company, which is testing Oxytrex as an alternative painkiller to the narcotic oxycodone, said it anticipated that up to 40 percent of patients would drop out before completing the study`s three-month treatment period.

In the trial of more than 775 patients with moderate-to-severe osteoarthritis pain, Oxytrex reduced physical dependency by 28 percent compared with an equivalent dose of oxycodone, but this result did not reach statistical significance, the company said.

The trial met its secondary goal, as patients on Oxytrex reported slightly better pain relief than those on oxycodone.

"We are highly encouraged by the promise of the science, however, in today`s trial we believe the signal was lost in the noise," the company`s chief operating and medical officer, Nadav Friedmann, said in a statement.

Shares of Pain Therapeutics fell $1.87 to $6.64 in morning trading on the Nasdaq.

[nort_de]

[posting]18.940.641 von cyberhai am 22.11.05 16:36:49[/posting]Ja und ich schau mir es erstmal von der Seitenlinie an... hmmm

[nort_de]

selten so einen chart gesehen

[Plaste]

Hallo Leute,
also wenn ich das richtig Lese haben Sie für 2006 ca 200 Mio Cash und eine Cashburnrate von 15.
Mal im ernst, das ist ja nix, was beunruhigen sollte. Weiterhin haben Sie 3 Produkte in Phase III. Sollte das eine nicht gleich zugelassen werden (wie so eben geschehen), ist das auch noch nicht das Ende.
Ich auf jeden Fall bin gerade mit einer größeren Position eingestiegen.

mfg Plaste
PS: ja, toller Chart, den beobachte ich schon seit Wochen


Pain Therap: Oxytrex Data Not Statistically Significant-2-


11-22-05 11:12 AM EST

Pain Therapeutics` Oxytrex study met its secondary endpoint concerning pain- relief effectiveness. The company said Oxytrex was non-inferior to oxycodone, a generic pain medication.

Oxytrex patients reported slightly better pain relief than oxycodone patients and significantly better analgesia than placebo patients, the company said. Analgesia refers to a state when a person doesn`t feel pain even though he is fully conscious.

Pain Therapeutics said the clinical news doesn`t impede the closing of the King Pharmaceuticals Inc. (KG) alliance. The deal is scheduled to close this year, subject to antitrust and other regulatory reviews.

On Nov. 10, Pain Therapeutics and King Pharmaceuticals agreed to jointly develop and market Pain Therapeutics` investigational drug Remoxy and other abuse-resistant painkillers.

Pain Therapeutics expects to start 2006 with more than $200 million of cash, thanks to proceeds from the King Pharmaceuticals alliance. Pain Therapeutics also expects its preliminary net cash burn rate for 2006 will come in under $15 million.

Company Web site: http://www.paintrials.com

-Eamon Beltran; Dow Jones Newswires; 201-938-5400; [e-mail]

(END) Dow Jones Newswires

11-22-051112ET

Copyright (c) 2005 Dow Jones & Company, Inc.

Copyright (C) 2005 Dow Jones & Company, Inc. All Rights Reserved.

Quelle: http://news.morningstar.com/news/DJ/M11/D22/200511221112DOWJ…

[cyberhai]

Im Aktionär war heute ein kurzer Bericht. Raten jetzt zumindest einen Teil der Gewinne zu realisieren- da wussten die noch nichts vom heutigen Desaster. Kursziel ist 10 Euro. Urspr. Empfehlungskurs war 5,19 Euro am 20.10.05.

Gruß Cyberhai

[Plaste]

Pain Therapeutics Rebounds on Upgrade
Wednesday November 23, 1:53 pm ET
Pain Therapeutics Stock Rebounds Slightly on Analyst Upgrade Following Failure of Study

NEW YORK (AP) -- Shares of Pain Therapeutics Inc. rebounded slightly Wednesday from a Tuesday sell-off after Citigroup upgraded the drug maker when its stock fell below the investment firm`s target price.


Pain Therapeutics shares rose 35 cents, or 5.1 percent, to $7.25 in afternoon trading on the Nasdaq, after closing down 19 percent on Tuesday. Over the past 52 weeks, shares have traded between $4.78 and $9.45.

Shares plummeted after the South San Francisco, Calif.-based company announced its clinical trial of painkiller Oxytrex against oxycodone, the active ingredient in OxyContin, and a placebo did not succeed in significantly lowering addiction levels by at least 25 percent. While researchers found that Oxytrex was 28 percent less addictive, too many subjects had dropped out of the study to make these results statistically significant.

Citigroup analyst Andrew Swanson upgraded Pain Therapeutics to "Hold" from "Sell" as shares fell below his target price of $7.50.

However, Swanson said he does not expect that the Oxytrex news will have any effect on the company`s recent licensing deal for painkiller Remoxy with King Pharmaceuticals.

Earlier in the month, King agreed to an upfront payment of $150 million in cash, up to $150 million in cash in milestone payments and up to $100 million in research and development funds for the sticky, abuse-resistant form of oxycodone.



Quelle: http://biz.yahoo.com/ap/051123/pain_therapeutics_upgrade.htm…

[puhvogel]

Ihr habt Glück, dass die Geschäftsleitung von King nicht Studien interpretieren kann und wohl offenabr auch keinen kennt, der das kann.

[Plaste]

@ puhvogel,
das liegt evtl. daran, daß PAIN 3 Produkte in Phase III hat!

[puhvogel]

Na jetzt sind es nur noch 2.

Ich muss aber meinen Fehler korrigieren.

King hat sich beim missbrauchssicheren (?) Opiat Remoxy eingekauft, nicht beim nun toten Oxytrex.
Aber auch bei der Remoxy Studie aus dem September-Studie hast Du eine deutlich höhere Aussteigerquote im Remoxy-Arm.
Mir wäre das zu riskant zu investieren, King offenbar nicht. Die Story dahinter, zunehmender Missbrauch von Opiaten medizinschen Ursprungs, ist aber zugegeben sehr spannend.

Aber was soll es: Der Kurs steht heute höher als im September, und nichts anderes zählt für Euch!

[blb]

@puhvogel: Das Medikament ist noch nicht endgültig gescheitert, ich finde, man sollte da mal abwarten. So dämlich sind die bei King sicher auch nicht!

Grüße
blb

[Plaste]

@ puhvogel,

aber Du hast schon recht. Die Anlage in PAIN ist halt sehr spekulativ. Vor allen Dingen heißen 3 Phase 3 Medikamente nicht, daß auch 1 davon zugelassen wird.
Es kann genau so sein, daß kein einziges zugelassen wird.
Wobei ich davon ausgehe, das King nicht einfach so investiert!

mfg Plaste

[Plaste]

noch was:

Trial results blow for Pain Therapeutics
Pain Therapeutics has announced that results from its 775-patient phase III trial in patients with osteoarthritic pain did not reach statistical significance, sending shares in the company down by over 20%.

23 Nov 2005, 17:41 GMT - Although the drug candidate, Oxytrex, did reduce physical dependency by 28% compared to an equivalent dose of oxycodone this result did not reach statistical significance due to high drop-out rates in all study arms.

The company anticipated that up to 40% of patients would drop-out before completing the study`s three-month treatment period. Actual drop-out rates were 48% to 60% in the drug arms and 37% in the placebo arm. The number of patients completing the study was lower than expected and, given the statistical rigor of the study design, statistical significance was not reached in the primary endpoint.

"We are highly encouraged by the promise of the science, however, in today`s trial we believe the signal was lost in the noise," stated Dr Nadav Friedmann, chief operating and medical officer at Pain Therapeutics.

Quelle: http://www.pharmaceutical-business-review.com/article_news.a…

[blb]

@Plaste: Rein statistisch gesehen, ist die Wahrscheinlichkeit einer Zulassung in Phase III höher als die einer Nicht-Zulassung. Bei drei Medikamenten seh ich deshalb das Gesamtrisiko als relativ niedrig an. Nicht vergessen, sie haben 5$ Cash pro Aktie, das gibts fast nie bei Bios!

Grüße
blb

[Plaste]

29.11.2005 03:02
Pain Therapeutics Reports Oxytrex(TM) Results From a Large Trial in Patients With Moderate-to-Severe Osteoarthritic Pain

SOUTH SAN FRANCISCO, Calif., Nov. 22 /PRNewswire-FirstCall/ -- Pain Therapeutics (Nachrichten), Inc. , a biopharmaceutical company, today announced results of a 775-patient Phase III trial with Oxytrex, an investigational drug candidate. The pre-defined primary endpoint was reduction in physical dependency, as measured by SOWS. The Company expected Oxytrex to reduce physical dependency by 25% or more. In this trial, Oxytrex reduced physical dependency by 28% compared to an equivalent dose of oxycodone but this result did not reach statistical significance due to high drop-out rates in all study arms.

Nadav Friedmann, PhD, MD, Chief Operating and Medical Officer at Pain Therapeutics, stated, "This is the second of two large trials designed to examine opioid-related physical dependency. We see a consistent and positive clinical response in the two trials. We are highly encouraged by the promise of the science, however, in today`s trial we believe the signal was lost in the noise. There are ways to design clinical trials that overcome the statistical limitations imposed by very high drop-out rates. We expect to discuss these methodologies with the FDA in early 2006."

Pain Therapeutics anticipated that up to 40% of patients would drop-out before completing the study`s three-month treatment period. Actual drop-out rates were 48% to 60% in the drug arms and 37% in the placebo arm. The number of patients completing the study was lower than expected and, given the statistical rigor of the study design, statistical significance was not reached in the primary endpoint.

"We believe the weight of all evidence, including prior clinical and non-clinical data, continues to favor Oxytrex over oxycodone," said Remi Barbier, President&CEO of Pain Therapeutics. "We remain steadfast to the Oxytrex program and its ability to reduce physical dependency."

Remi Barbier added, "We also note that today`s clinical news does not impede the closing of our recently announced strategic alliance with King Pharmaceuticals, Inc. We expect to enter 2006 with over $200 million of cash, thanks to proceeds from this alliance. Preliminarily, we believe our net cash burn rate may be under $15 million in 2006, subject to final budget approvals."

Trial Design

Over 775 patients with moderate-to-severe osteoarthritic pain were enrolled in this randomized, double-blind, multi-center U.S. study. Patients received a fixed dose of drug (20mg or 40mg) or matching placebo for 12 weeks. Following a washout period, patients were randomized to one of six arms, each arm enrolling 150 patients except as noted: Oxytrex 10mg BID; Oxytrex 20mg BID; Oxytrex 10mg QID; oxycodone 10mg QID; ultra-low-dose naltrexone alone (N=75); or placebo (N=75).

The prospectively defined primary endpoint was reduction of physical dependence and withdrawal effects in the first 24 hours following cessation of therapy, as measured on the Short Opioid Withdrawal Scale (SOWS), between patients receiving Oxytrex 20mg BID and oxycodone 10mg QID (i.e., patients in both arms received a total daily drug dose of 40mg).

The secondary endpoint in this study was prospectively defined as non-inferior analgesic efficacy (pain relief) of Oxytrex 20mg BID versus oxycodone 10mg QID. `Non-inferior analgesic efficacy` means patients on Oxytrex had to report equal or better pain relief than patients on oxycodone.

Trial Results

In the pre-defined primary endpoint, Oxytrex patients reported 28% less clinical symptoms of physical dependence and withdrawal effects in the first 24 hours following cessation of therapy, compared to patients on oxycodone. This result did not reach statistical significance. The trial did report statistical significance in a sub-group analysis: Oxytrex reduced physical dependency by 75% (p=0.04) in patients over 50 years of age.

The study met its pre-defined secondary endpoint. During the three-month treatment period, Oxytrex was non-inferior to oxycodone. Oxytrex patients reported slightly better pain relief than oxycodone patients and significantly better analgesia than placebo patients (p<0.05). In contrast, oxycodone did not separate from placebo, given the high drop-out rate and placebo response.

Corporate Update

Pain Therapeutics` recently announced a strategic alliance with King Pharmaceuticals, Inc. to develop and commercialize Remoxy(TM), a long-acting oral oxycodone, and other abuse-resistant opioid painkillers. Terms include an upfront cash payment of $150 million to Pain Therapeutics, payable upon closing of the alliance. We believe the alliance will close in 2005, subject to anti-trust and other regulatory reviews.

Pain Therapeutics remains on-track to announce in December results of a 600-patient Phase III trial with PTI-901 in women with Irritable Bowel Syndrome.

Conference Call

Pain Therapeutics will host a conference call for the investment community on Tuesday, November 22, 2005 at 10:00 a.m. ET to discuss this announcement. To participate in the conference call, please dial 800-659-1966 (within the U.S.) or 617-614-2711 (outside the U.S.) fifteen minutes prior to the start of the call. The call reference number is 38909448. A playback of the conference call will be available following the call. To access the playback, please dial 888-286-8010 (within the U.S.) or 617-801-6888 (outside the U.S.) and enter reservation number 12338816. A webcast of the conference call will also be available online at http://www.paintrials.com/.

About Pain Therapeutics, Inc.

Pain Therapeutics is an emerging biopharmaceutical company that develops novel drugs. Our 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(TM), Oxytrex and PTI-901. For more information please visit our website: http://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 and scope of the Company`s clinical development of Oxytrex or PTI-901, the Company`s anticipated discussions with the FDA, the potential benefits of Oxytrex and the Company`s drug candidates, the Company`s cash position at the end of 2005 and the Company`s anticipated cash usage in 2006. 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 Oxytrex and the Company`s drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company`s drug candidates, including Oxytrex, that could slow or prevent clinical development, 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.


Quelle: PR Newswire

http://www.finanznachrichten.de/nachrichten-2005-11/artikel-…

[blb]

Die Threadüberschrift muss geändert werden, seit gestern sind es nur mehr 2 Medikamente:

Pain Therapeutics Terminates Drug Candidate for the Treatment of Irritable Bowel Syndrome
FRIDAY, DECEMBER 09, 2005 8:21 PM
- PR Newswire

SOUTH SAN FRANCISCO, Calif., Dec 09, 2005 /PRNewswire-FirstCall via COMTEX/ -- Pain Therapeutics, Inc. (PTIE) , a biopharmaceutical company, today announced results of a Phase III study with PTI-901, an investigational drug candidate for the treatment of irritable bowel syndrome (IBS).

This randomized, double-blinded, multi-center U.S. study compared a daily dose of PTI-901 against placebo in 600 women with documented IBS over a three-month treatment period. PTI-901 showed a favorable safety profile and patients reported statistically meaningful relief of IBS symptoms in the second month of treatment (p<0.02), but the drug did not demonstrate a meaningful benefit in the third month of treatment, which was defined as the primary endpoint. According to current regulatory standards, an experimental drug for chronic IBS needs to show efficacy at the end of a three-month treatment period.

The Company believes this study was well designed to detect any durable benefits of PTI-901 versus placebo in a large patient population with IBS. Based on the adequacy of the study itself, coupled with today`s clinical results, the Company is discontinuing all further clinical development activities with PTI-901.

"This is an opportunity to sharpen our focus on our late-stage pipeline," said Remi Barbier, president and chief executive officer of Pain Therapeutics. "We`re ready to start 2006 with a strong balance sheet, a modest cash burn rate and two lead drug candidates in Phase III clinical development. In addition, in 2006 we plan to add depth to the pipeline by announcing, with our commercial partner, Investigational New Drug applications for one or more new abuse-resistant opioid painkillers."

Pain Therapeutics expects to have over $200 million of cash at the end of 2005. The Company expects a net cash burn rate of under $15 million in 2006.

About Pain Therapeutics, Inc.

We are a biopharmaceutical company that develops novel drugs. We have two lead drug candidates in late-stage clinical trials, Remoxy(TM) and Oxytrex(TM). Both drugs are in Phase III programs and are aimed at different segments of the multi-billion dollar market to treat severe chronic pain, such as low-back pain or pain due to osteoarthritis.

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 (including the filing of additional IND applications in 2006), the potential benefits of the Company`s drug candidates, the Company`s cash position at the end of 2005 and the Company`s expected cash burn in 2006, 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) ,reaching agreement with our commercial partner on the timing, scope and content of development activities for additional drug candidates, 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.

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


http://www.prnewswire.com


Copyright (C) 2005 PR Newswire. All rights reserved. ********************************************************************** As of Monday, 12-05-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated an UPTREND on 11-10-2005 for PTIE @ $8.89. (C) 2005 Comtex News Network, Inc. All rights reserved.

[cyberhai]

[posting]19.229.256 von blb am 10.12.05 09:46:28[/posting]Ich überlege derzeit auszusteigen, bist Du hier investiert?

Gruß Cyberhai

[BrauchGeld]

Hallo

Schlechte Nachrichten für Pain aber dafür gute für Alizyme das dürfte der aktie weiteren schub geben.
Im gegensatz zu Pain denke ich wird Alizyme erfolgreicher sein.
Sorry für die Investierten aber ich bin froh frühzeitig ausgestiegen zu sein.


Tip Update: Alizyme gets IBS go ahead

Published: 16:54 Thursday 07 July 2005
By Algernon Craig Hall, Secret Buying Correspondent

Biotech company Alizyme has got the go ahead from the Food and Drug Administration (FDA) in the US for phase III trail plans for its potential blockbuster irritable bowel syndrome (IBS) treatment.

Only a week on from a statement by Alizyme that protested about a recent share price fall the company has delivered some much desired news flow.

The IBS phase III trial will involve up to 1,700 women suffering form constipation-predominant IBS who will be treated over a 12-week period.

The trial will test whether Alizyme`s IBS drug called renzapride is more effective than a placebo in relieving the overall symptoms of the disease. The trial will also test whether the drug provides adequate relief to abdominal pain and bowel problems.

Recruitment for the trial is expected to begin in the fourth quarter of this year and if everything goes according to plan results would be available in the first half of 2007.

Chief executive Richard Palmer said: `This is a major achievement for both renzapride and the company as it takes a second product from our portfolio into phase III clinical development.`

The trial approval could also open the way for licensing deals.

[blb]

Nein cyberhai, bin nicht investiert, wir haben sie jedoch in unserem Musterdepot. Die Fantasie dürfte nun leider etwas raus sein, aufgrund der Cashbasis ist die Aktie jedoch meiner Meinung nach je nach dem wie der Rückschlag am Montag ausfällt ein Kauf.

Grüße
blb

[Buddah]

gab einen Insider Kauf:http://www.sec.gov/Archives/edgar/data/1069530/0001140888050…

[cyberhai]

[posting]19.366.864 von Buddah am 21.12.05 15:17:55[/posting]Ja, die Insiderkäufe stimmen mich insgesamt auch positiv. Sollte sich 1 Medikament mit ca. 500 Mio Umsatz durchsetzen, haben wir einen einen Verfünffacher, bei einem KUV von 3 (ist angesichts des vorhandenen cash in Höhe von 200 Mio sicher gerechtfertigt).

Gruß Cyberhai

[Plaste]

http://biz.yahoo.com/ap/060109/pain_therapeutics_mover.html



Pain Therapeutics Shares Rise on Upgrade
Monday January 9, 3:56 pm ET
Pain Therapeutics Shares Rise After Analyst Upgrade on Low Price

NEW YORK (AP) -- Shares of Pain Therapeutics Inc. rose Monday after investment firm Oppenheimer upgraded the drug maker Monday given its low price and recent cash infusion from King Pharmaceuticals Inc.

ADVERTISEMENT
Pain Therapeutics rose 69 cents, or 9.8 percent, to $7.84 in afternoon trading on the Nasdaq at nearly three times their average volume. In the past 52 weeks, shares have bounced between $4.78 and $9.45.

Oppenheimer analyst Scott R. Henry called Pain Therapeutics "too cheap to ignore" and raised his rating of the stock to "Buy" from "Neutral" with a $10 price target.

The target accounts for $5 per share in cash from a recent $150 million cash payment from King to collaborate on Remoxy, an abuse-resistant form of Purdue Pharma LP`s Oxycontin painkiller; $4 per share for continued Remoxy program payments, and $1 for other abuse resistant opiates.

The best case scenario figures a possible $16 price target where the Food and Drug Administration gives the company a clear path on how to conduct its trial to increase the likelihood of approval for Remoxy.

The analyst expects the company to begin a late-stage clinical trial on Remoxy by the second quarter with an anticipated second quarter 2008 launch.

Remoxy is a sticky, thick version of oxycodone, the active ingredient in Oxycontin, that is difficult to snort or inject for a quick high. Also, when placed in alcohol, Remoxy only releases a small amount of its oxycodone active ingredient.

King shares rose 32 cents to $18.27 on the New York Stock Exchange.

[cyberhai]

Ich bin mittlerweile nicht mehr in Pain investiert, halte den Wert aber weiterhin für kaufenswert, habe nur cash gebraucht.

Euch allen weiterhin viel Erfolg

Gruß Cyberhai

[Buddah]

ständig neue "Hochs" - wahnsinns Volumen:

Schöner Wert!

[BrauchGeld]

Cramer spricht und die anleger folgen ,ihm ist es hauptsächlich zu verdanken das die aktie steigt.


http://www.thestreet.com/_yahoo/funds/madmoneywrap/10267648.…

[nort.]

[Erbse1]

Abuse-resistant OxyContin faces hurdles
Durect is developing abuse-resistant OxyContin amid legal headwinds; patches deploying painkillers can last for days.

By Aaron Smith, CNNMoney.com staff writer
January 19 2007: 4:31 PM EST


NEW YORK (CNNMoney.com) -- Durect is developing an abuse-resistant form of the addictive painkiller OxyContin that has a good shot at being a blockbuster, but it faces a minefield of potential patent battles.

While other companies are striving to fill their pipelines with new drugs, Durect Corp. is developing new ways to ingest old drugs like OxyContin. Durect (up $0.04 to $4.49, Charts), a relatively small pharma pioneer with a market capitalization of about $400 million, is tweaking methods of drug delivery.

Purdue Pharmaceuticals' painkiller OxyContin is a pill that can be crushed into powder and snorted, a favorite form of delivery for addicts seeking to abuse the drug. (A Google search on the words "oxycontin" and "snorting" came up with 508,000 hits, as opposed to 373,000 hits for "oxycontin" alone.)

To try and reduce abuse of the painkiller, Durect is developing Remoxy, a gel cap form of OxyContin, with its partner King Pharmaceuticals (down $0.01 to $17.50, Charts). Remoxy is swallowed like the standard pill, but addicts would no longer have the option of putting it up their noses.

"[Remoxy] can't be crushed up and snorted because it's a gel cap," said Durect Chief Executive James Brown. The CEO also said that the Remoxy loses potency when combined with alcohol, unlike other painkillers, which gain potency when added to alcohol, with dangerous and sometimes fatal results.

Analysts expect Durect, based in Cupertino, Calif, to announce results of late-stage tests for Remoxy in mid-2007. The company could bring the product to market next year.

"I think the FDA will act on [Remoxy] rather quickly because OxyContin is kind of a mess for [the agency]," said Jon Hickman, analyst for MDB Capital Group.

Hickman said that Remoxy could take half of OxyContin's annual sales, because the gel cap painkiller would be favored by doctors who "had the opportunity to prescribe the same medication but with less potential to make it to the party scene." (Purdue spokesman Tim Bannon said that annual OxyContin sales used to total $1.5 billion, but have dropped "substantially" since drugmakers infringed the patent, slipping below $1 billion in 2005.)

The battle for OxyContin
Privately-held drugmaker Purdue holds patents on OxyContin. This drug has been the subject of patent battles with Teva Pharmaceuticals (up $0.24 to $34.17, Charts), the biggest generic drugmaker in the world, as well as Endo Pharmaceuticals - one of Durect's partners. Durect CEO Brown said these patent battles are related to generics and have nothing to do with his drug Remoxy.

In 2006, Purdue settled with Endo and Teva, which had been producing generic versions of oxycodone, the active ingredient in OxyContin. Teva and Endo agreed not to produce generics in exchange for Purdue's agreement not to pursue them for damages related to their production of generic OxyContin.

Purdue intends to keep defending its patent going forward.

"We have several valuable and valid patents with respect to OxyContin and we will enforce them," said Timothy Bannon, spokesman for Purdue.

Will this spell trouble for Durect?

Russell McAllister, analyst for Merriman Curhan Ford, doesn't think so. In a note published in September, he said the settlements "remove a significant overhang" from Durect, prompting the analyst in September to upgrade the company to a "buy" from "neutral." Also, McAllister and other analysts believe that Durect and its partners will be able to go forward producing Remoxy, despite Purdue's OxyContin patent.

"But to put it bluntly, Purdue's patents are not robust," said McAllister to CNNMoney.com.

Brown, the CEO of Durect, said Remoxy is legally protected and he isn't worried about legal threats to his product. "Our partners are moving forward and we feel comfortable with where we are," said Brown.

McAllister said Remoxy has billion-dollar blockbuster potential, though sales would be divided among the partners. Even still, the analyst expects Durect to garner $120 million in royalties in 2009, which is nearly five times the company's estimated revenue for 2006.

Glaxo fires shot over Merck's bow
Angela Larson, analyst for Susquehanna Financial Group, believes Durect a risky investment because the patent fight may not be over, though she gives the company a "positive" rating.

"The active ingredient for Remoxy may face patent infringement hurdles by Purdue, which has patents on the active ingredient in a different formulation," wrote Larson, in a published note from September, 2006.

Durect: Not a one trick pony
The next potential product in Durect's pipeline is Posidur, an injectable painkiller in late-stage testing. Unlike other painkillers that last a few hours, a single injection of Posidur is intended to last a few days.

The active ingredient is in a gel-like form, rather than a liquid. So Posidur breaks up and releases the active compound more gradually than a liquid, which dispenses quickly.

McAllister believes that Durect will launch Posidur in the second half of 2009. Durect will have to divide Posidur's European sales with its partner Nycomed. McAllister projected that Durect's portion of the sales for this drug will total $86 million in 2009, followed by $440 million in 2010, facing little or no competition.

"There are other companies that compete with [Durect] in terms of delivery technology," said McAllister. "But with Posidur specifically, there is very limited competition."

But testing of the drug has taken longer than investors expected, which put pressure on Durect's stock price in 2006 and attributed to its 13 percent decline, said Hickman of MDB.

House passes Medicare bill, but...
Durect is also developing a painkiller patch that delivers an FDA-approved local anesthetic without needles through a Durect patch. With the patch, the anesthetic's effect can last up to three days, instead of 12 hours with the other currently available patches, according to Durect.

Endo has partnered with Durect on its Transdur-bupivacaine, intended for shingles-related pain. Mid-stage testing began on January 3, according to Durect, and analysts believe that late-stage testing could begin this year.

The pain patch, if it's successful, would enter the market in 2009 and would compete against Johnson & Johnson's (up $0.05 to $67.76, Charts) duragesic patch, a $1.5 billion product, said Hickman of MDB. Hickman projects that Durect's annual royalties from the patch would reach $200 million.

2007 will be busy for Durect, and analysts project the stock price to more than double during the next 12 months, according to Thompson Financial.

In November, McAllister wrote that 2007 promises to be a "critical year" for Durect. The company's "numerous catalysts" include late-stage results for Remoxy and mid-stage results for Posidur in the first half of the year, with possible test results from Endo on the Transdur patch.

Hickman owns shares of Durect stock, but the other analysts quoted in this story do not. Susquehanna Financial Group might make a market in the company, but the other investment firms mentioned in this story have not conducted investment services with Durect in the last 12 months.

Quelle: http://money.cnn.com:80/2007/01/19/news/companies/durect/?po…

Schönen Tag noch
Erbse

[ducatiman]

Pain Therapeutics Q1 Profit Surges As Revenues Grow - Update [PTIE]

5/2/2007 12:23:54 PM Wednesday, Pain Therapeutics, Inc. (PTIE), a biopharmaceutical company, revealed first quarter financial results, reporting a surge in profit as revenues from collaboration grew. Following the announcement, the company's stock rose over 15% on the Nasdaq.

The South San Francisco, California based company's first quarter net income rose to $12.6 million or $0.28 per share from $0.9 or $0.02 per share in the prior year quarter. On average, six analysts polled by First Call/Thomson Financial expected the company to report a loss of $0.02 per share for the quarter.

Total revenues for the quarter improved to $22.05 million from $15.33 million in the comparable quarter a year ago. Five analysts had a consensus revenue estimate of $12.95 million for the quarter.

Revenue for the quarter included $6.6 million in program fee. The program revenue is part of the cash payment of $150 million made the company's collaborator, King Pharmaceuticals, which Pain Therapeutics intends to recognize in part as revenue every quarter through mid 2011. Collaboration revenues were $15.50 million, up from $8.78 million in the last year quarter. Collaboration revenues are part of an arrangement with King Pharmaceuticals that reimburses development expenses of Pain Therapeutics.

Total operating expenses for the quarter was $11.70 million, compared to $14.82 million in the prior year quarter. Research and development expenses decreased to $9.86 million from $12.85 million in the year ago quarter. General and administrative expenses were $1.84 million, compared to $1.97 million in the same quarter last year.

Operating income for the quarter rose to $10.36 million from $0.50 million in the comparable quarter a year ago.

As on March 31, 2007, cash, cash equivalents and marketable securities were $209.86 million, compared to $204.40 million as on December 31, 2006.

The company also initiated a $20 million stock repurchase program of its common stock end March, valid through March 2008.

Pain Therapeutics indicated cash requirements for operations to be approximately $10 million for 2007, apart from funding its $20 million common stock repurchase program.

Pain Therapeutics' abuse-resistant opiod painkiller, Remoxyl is currently in Phase III study and attained 80% enrollment for further trials. The company also is the process of enrolling patients with metastatic melanoma for a Phase I study in Israel.

PTIE is gaining $1.19 or 15.56% and currently trades at $8.84, on a volume of 1.39 million shares on the Nasdaq.

Na s wird doch langsam
Gruß Ducatiman