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Labopharm ....Nur geschenkt ist noch billiger - 500 Beiträge pro Seite


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Labopharm ist einer meiner heißesten Favoriten für die kommenden Wochen u.a wegen der bevorstehenden FDA-Zulassung in August .

Was Labopharm zubieten hat :

- Tramadol (Schmerzmittel) ist bereits in Europa + Canada zugelassen (siehe link "Übersicht Tramadol" ganz unten)
- Tramadol US-FDA entscheidung in August 2008
- Trazadone (Depression) Phase III in Februar 2008 erfolgreich beendet
- Trazadone NDA-filing + Partner fürs 2H geplant
- Tramadol-Acetaminophen (Akute Schmerzen) Phase III Daten im 4Q 2008
- Cash ist reichlich vorhanden

Das alles wird noch nicht mal für ganze 40 million US$ bewertet !!!
Wenn alles gut geht dürfte Labopharm wieder zu den Kursen von 2006 zurückfinden (8-10 US$) .

Hab vorhin nochmal 2000st (1,13€) ins Depot gelegt .


Labopharm (DDSS) ..(DDS.TO)

Marktkap: 98 million US$.....( 62,9 million € )
Cash: 64,4 million US$ ...... ( 41,3 million € )
Kurs: 1,75 $


Labopharm sees FDA OK for tramadol drug in 4 months
http://www.reuters.com/article/companyNews/idUSN083951202008…


2/8/2008
Labopharm Reports Positive Results for Phase III Study on Once-daily Trazodone
http://www.labopharm.com/Default.aspx?id=83&reqId=1106026


3/10/2008
Labopharm Initiates Phase III Clinical Trial for Twice-Daily Formulation of Tramadol-Acetaminophen
http://www.labopharm.com/Default.aspx?id=83&reqId=1116693


Investor Presentation Q2 2008
http://www.labopharm.com/docs/Investor%20Presentation%20Q2%2…


Übersicht Tramadol
http://www.labopharm.com/default.aspx?id=25
Auszug aus dem Quartalsbericht (Mai 2008 )

"While we continue to make strong progress in the global commercialization of our once-daily tramadol product, we are preparing the New Drug Application for our second product, trazodone Contramid® once-a-day, for submission prior to year-end, and have initiated the Phase III clinical study for our third product, a twice-daily formulation of tramadol and acetaminophen," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "In our global commercialization program for once-daily tramadol, our product has been launched in 10 countries, including Poland earlier this year, and is steadily gaining market(1) share in Europe(2) and Canada. In February, the latest month for which data is available, our product was the best selling once-daily tramadol product in four of the five largest European markets."

Mr. Howard-Tripp added, "We are encouraged by the positive Phase III results for trazodone Contramid® once-a-day. One of the greatest challenges in treating depression is that up to 50% of patients discontinue their medication within six months of initiating treatment and, therefore would benefit from an alternative treatment option. Patients need rapid improvement of their depressive symptoms and may experience insomnia and agitation. Our study demonstrated that trazodone Contramid® once-a-day was statistically superior to placebo by the end of the first week of treatment and was associated with an improvement in overall sleep quality. Accordingly, we are optimistic about the prospects for our formulation in the market for antidepressants."

Recent Developments

Once-Daily Tramadol Global Commercialization Program

Product Continues to Gain Market Share - Labopharm's product continues to steadily gain market share in those countries in which it has been launched. In February 2008, overall share of the European(2) tramadol market(1) had grown significantly from December 2007 and penetration of the once-daily segment of the European(2) tramadol market(1) exceeded 41%. Growth in the broader tramadol market(1) was particularly strong in France and Spain, where market share in February 2008 reached 6.8% and 17.4%, respectively. In Canada, the product's share of the tramadol product market increased to 15% in March 2008.

Product Launched in Poland - Labopharm's product was launched in Poland by its marketing partner for that country.

Appealed FDA's Decision to Next Supervisory Level After Additional Analysis Supported Efficacy - Labopharm continued the Formal Dispute Resolution process, appealing the U.S. Food and Drug Administration's (FDA) decision on its once-daily tramadol formulation to the next supervisory level. Labopharm's continuation of the appeal process followed the completion of additional statistical analysis of existing data per the Agency's suggestion as a means to potentially satisfy its requirements for regulatory approval. The Company believes that the additional analysis confirms the conclusions of efficacy of its once-daily tramadol formulation as demonstrated in previous analyses that were included in its New Drug Application (NDA) and additional submissions thereafter.

Trazodone Contramid® Once-a-Day for Treatment of Depression

Reported Positive Results for Phase III Trial - Labopharm reported positive results for its Phase III clinical trial for once-daily trazodone (study 04ACL3-001). In addition to achieving statistical significance for the primary endpoint (p value of 0.0183) for efficacy in the treatment of depression, the study shows an improvement of the overall quality of sleep. Moreover, the study demonstrated that once-daily trazodone was statistically superior to placebo by the end of the first week of treatment. The Company plans to file a New Drug Application (NDA) for its once-daily formulation with the FDA later this year.

Twice-Daily Tramadol-Acetaminophen Combination Product

Initiated Phase III Clinical Trial - Labopharm began enrolling patients in its North American Phase III clinical trial for its twice-daily, tramadol-acetaminophen combination product (study 06CCL3-001). The Company expects data to be available later this year.
es wird billiger. unter 1,40 bietet sich der Einstieg mit 10c stop an.
Der Zeitpunkt zum Kauf ist ebenfalls ungeeignet. Warten sie noch einige Tage ab
@seblas

Möglich ist alles aber ich selber glaube nicht das Labopharm unter 1,40 geht ,hab schon die ganze Zeit die Aktie im auge aber jeder kleine rücksetzer wurde zum Kauf genutzt .
Ausserdem gabs nach langer Zeit wieder mal Insider aktivitäten deshalb halte ich es eher für unwahrscheinlich das Labopharm billiger wird obwohl ich mich darüber freuen würde.
Eventuelle vorzeichen für eine Zulassung in August :

Short interest ist fast auf den niedrigsten Stand seit Nasdaq-listing
http://www.nasdaq.com/aspxcontent/shortinterests.aspx?symbol…

Institutional Holdings / Morgan Stanley die eigentlich einen guten riecher für Biotechs haben stockt weiter auf.Auch Natcan Investment hat wieder zugelegt auf 5,74million aktien (stand April08) .
http://www.nasdaq.com/asp/holdings.asp?FormType=Institutiona…
Mit der Zulassung von Tramadol in den USA wäre die Zukunkft von Labopharm so gut wie gesichert.
Und da ist noch Trazadone das auch schon bald den Markt erreicht .


Tramadol Potential

The number of prescriptions written for tramadol products in the United States – the single largest market for tramadol – has more than doubled in the last decade, surpassing 21 million in 2006. The vast majority of these were for multiple dose products that must be taken anywhere from four- to six-times per day. Dollar sales related to these prescriptions was in excess of US$635 million.


The potential market for a once-daily tramadol treatment, however, is considerably larger. Compliance with multiple-times daily dosing regimens can be challenging for patients, potentially limiting the efficacy of a drug. A once-daily formulation of tramadol offers significant value and satisfaction to both patients and physicians through the potential to improve compliance.


Overall, the market for tramadol is expected to experience continued strong growth, driven primarily by three factors:

As an opioid with additional unique mechanisms of action, tramadol is an excellent option in the treatment of moderate to moderately severe pain, providing effective pain relief without many of the potential side effects seen with stronger opioids;
Tramadol is often prescribed for pain related to conditions that become more prevalent with age, such as osteoarthritis. The aging of the world’s population will precipitate a higher demand for therapeutics such as tramadol that address these age-related conditions;
Third, in recent years, the U.S. pain market has become underserved as physicians and patients have eschewed certain classes of analgesics due to safety concerns.
Antwort auf Beitrag Nr.: 34.261.656 von BrauchGeld am 07.06.08 21:58:24LABOPHARM INC COM NPV (DDS.TO) 1.39CAD sehr stark ... boden
Achtung, jetzt geht die Post ab !
Die Zulassung ist bald da.
Das Warten hat sich gelohnt!!!!!
Labopharm Receives Response from FDA Regarding its Once-Daily Tramadol Product
Monday June 30, 7:18 am ET


- Company Expects to Submit Complete Response by End of Week -
LAVAL, QC, June 30 /CNW/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that the Company has received a response from the U.S. Food and Drug Administration (FDA) regarding its most recent appeal of the decision in the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process.
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Procedurally, Dr. Douglas Throckmorton, M.D., the FDA's Deputy Director, Center for Drug Evaluation and Research, agreed with Dr. Jenkins, M.D., Director for the Office of New Drugs, Center for Drug Evaluation and Research and denied the appeal. However, he suggested a regulatory path forward. Dr. Throckmorton has suggested that the Company submit the analysis put forward by Dr. Jenkins in his letter of earlier this year. In the response, the FDA has concluded that a positive finding using this analysis could provide the needed assurance to support the efficacy of Labopharm's once-daily tramadol. Following resolution of any issues with labeling, such a finding would lead to the approval of the product.

The Company expects to submit the complete response before the end of the week and the FDA has agreed to conduct its review of the response in a timely basis.

"We are encouraged by the Agency's request to formally submit the data analysis that Dr. Jenkins suggested we undertake and believe that this is a positive step towards regulatory approval in the U.S.," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "The request follows a meeting with the FDA, as well as constructive discussions over the past two months. We continue to believe that the comprehensive data generated by our global clinical trial program demonstrates the efficacy and safety of our once-daily tramadol formulation and that we have met the statutory standards for approval of our formulation."

Labopharm has completed the statistical analysis of data suggested by Dr. Jenkins and believes that the findings confirm the conclusions of efficacy of its once-daily tramadol formulation.

About Labopharm's Once-Daily Tramadol Product

Labopharm's once-daily tramadol product is based on the Company's proprietary Contramid(R) technology, which provides a dual matrix delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range providing a full 24 hours of pain relief. The Company believes that maintaining drug concentrations within the therapeutic range has the advantage of fewer and less severe side effects while maintaining efficacy. Under its global commercialization program, Labopharm's once-daily tramadol product has been launched in 11 countries, including the five largest markets in Europe and Canada and is approved in 19 other countries. Including those countries in which its product has been launched, Labopharm has licensing and distributions in place for more than 50 markets globally.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.

For further information

At Labopharm: Mark D'Souza, Senior Vice-President and Chief Financial Officer, Tel: (450) 686-0207
At The Equicom Group: Jason Hogan, Media and Investor Relations, Tel: (416) 815-0700, jhogan@equicomgroup.com
French: Joe Racanelli, Tel: (514) 844-7997, jracanelli@equicomgroup.com



--------------------------------------------------------------------------------
Source: Labopharm Inc.
Labopharm Submits Complete Response to FDA as a Result of Outcome of Appeal Process for Once-Daily Tramadol
Wednesday July 2, 4:08 pm ET


LAVAL, QC, July 2 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that it has submitted a complete response to the Food and Drug Administration (FDA) per the suggestion of Dr. Douglas Throckmorton, M.D., the FDA's Deputy Director, Center for Drug Evaluation and Research (CDER), as the next step in the regulatory path towards potential U.S. approval of the Company's once-daily formulation of tramadol. The complete response centers on the additional analysis of existing data using the methodology put forward by Dr. John K. Jenkins, M.D., Director for the Office of New Drugs, CDER, in his letter earlier this year.
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Upon acceptance for review of the response, the FDA will assign an action date under the Prescription Drug User Fee Act (PDUFA).

About Labopharm's Once-Daily Tramadol Product

Labopharm's once-daily tramadol product is based on the Company's proprietary Contramid® technology, which provides a dual matrix delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range providing a full 24 hours of pain relief. The Company believes that maintaining drug concentrations within the therapeutic range has the advantage of fewer and less severe side effects while maintaining efficacy. Under its global commercialization program, Labopharm's once-daily tramadol product has been launched in 12 countries, including the five largest markets in Europe and Canada and is approved in 19 other countries. Including those countries in which its product has been launched, Labopharm has licensing and distribution agreements in place for more than 50 markets globally.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Labopharm Inc.
Labopharm Reaquires UK Sales And Marketing Rights to Its Once-Daily Tramadol Product
Monday July 7, 7:00 am ET
- Company to Engage Contract Sales Organization And Seek New Marketing Partner to Promote Product in UK -


LAVAL, QC, July 7 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that it has reacquired the sales and marketing rights to its once-daily tramadol product (Tradorec XL®) for the United Kingdom from Recordati Ireland Ltd. (Recordati). To promote its product in the UK, the Company will engage a contract sales organization and pursue a new licensing and distribution agreement with an appropriate marketing partner.
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"Our once-daily tramadol product is achieving strong market penetration, particularly in Spain, Italy and Canada, and we believe that this success can be replicated in the UK with the appropriate sales and marketing effort behind Tradorec XL®," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "The market for tramadol products in the UK continues to exhibit strong growth and we are confident in both our product and its prospects in this market."

Under its agreement with Recordati to reacquire the UK rights to its once-daily tramadol product, Labopharm will continue to use the brand name Tradorec XL® in marketing its product. Labopharm will also receive a (euro)700,000 milestone from Recordati upon termination of Recordati's rights.

Labopharm is in discussions to finalize an agreement with a contract sales organization to promote Tradorec XL® in the UK. The Company is also in discussions to establish a licensing and distribution agreement with a new marketing partner.

The UK is the second largest European market for tramadol products (on a standard units basis) and one of the fastest growing of the five largest European markets for tramadol products (on a standard units basis). The UK tramadol market has experienced compound annual growth of 18% over the last five 12-month periods ended March 30.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Labopharm Inc.
Antwort auf Beitrag Nr.: 34.451.561 von Bombenleger am 07.07.08 15:43:31Hallo Zusammen

Da meine Englischkenntnisse ziehmlich mies sind .....

Kann mir das bitte jemand in zwei drei Sätze auf Deutsch übersetzen?

Danke Greez
Sacha
Antwort auf Beitrag Nr.: 34.454.567 von sacha1978 am 07.07.08 20:29:23ich bin auch kein Englischgenie...
Aber mit diesem Link von Babelfish geht es auch.

http://de.babelfish.yahoo.com/
Antwort auf Beitrag Nr.: 34.454.567 von sacha1978 am 07.07.08 20:29:23Zum Beispiel so...
LAVAL, QC, 7. Juli /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - Nachrichten; Nasdaq: DDSS - Nachrichten) heute verkündet, dass sie die Verkäufe und die Marketing-Rechte zu seinem sobald-täglich tramadol Produkt (Tradorec XL®) für das Vereinigte Königreich aus Recordati Irland Ltd. (Recordati) reacquired. Um sein Produkt in Großbritannien zu fördern, engagiert sich die Firma eine Vertragsverkaufsorganisation und übt eine neue Genehmigen und Verteilungsvereinbarung mit einem passenden Marketing-Partner aus. REKLAMEANZEIGE " Unser, sobald-täglich tramadol Produkt starke Marktpräsenz, besonders in Spanien, Italien und Kanada erzielt und wir glauben Sie, dass dieser Erfolg in Großbritannien mit den passenden Verkäufen und der Marketing-Bemühung hinter Tradorec XL® wiederholt werden kann, " gesagt worden James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. " Der Markt für tramadol Produkte in Großbritannien fährt fort, starkes Wachstum aufzuweisen und wir sind in unserem Produkt und in seinen Aussichten in diesem market." überzeugt; Unter seiner Vereinbarung mit Recordati reacquire die BRITISCHEN Rechte zu seinem, sobald-täglich tramadol Produkt, Labopharm fortfährt, den Markennamen Tradorec XL® zu verwenden, wenn es sein Produkt vermarktet. Labopharm empfängt auch Meilenstein 700.000 a-(Euro) von Recordati nach Endpunkt von Recordati' s-Rechte. Labopharm ist in den Diskussionen, zum einer Vereinbarung mit einer Vertragsverkaufsorganisation zu beenden, Tradorec XL® in Großbritannien zu fördern. Die Firma ist auch in den Diskussionen, zum einer Genehmigen und Verteilungsvereinbarung mit einem neuen Marketing-Partner herzustellen. Großbritannien ist der zweitgrösste europäische Markt für tramadol Produkte (auf einer Standardeinheitbasis) und eins von den schnell wachsendsten der fünf größten europäischen Märkte für tramadol Produkte (auf einer Standardeinheitbasis). Der BRITISCHE tramadol Markt hat zusammengesetztes jährliches Wachstum von 18% über die letzten fünf 12-beendeten Monats-Zeiträume 30. März erfahren. Über Labopharm Inc. Labopharm ist ein auftauchender Führer, wenn er die Leistung der vorhandenen kleinen Moleküldrogen unter Verwendung seines eigenen optimiert, kontrolliert-freigeben Technologien. Das Company' s-Bleiprodukt, ein einzigartiges, sobald-täglich Formulierung von tramadol, Handels- in Schlüsselmärkte global gestartet wird. Die Firma hat auch eine robuste Rohrleitung der Folgenprodukte in der präklinischen und klinischen Entwicklung. Labopharm' s-Anblick ist, einem integrierten, internationalen, Spezialgebiets-pharmazeutischen Unternehmen mit der Fähigkeit zu stehen, zum seiner eigenen Produkte innerlich zu entwickeln und in den Handel zu bringen. Zu mehr Information besuchen Sie bitte www.labopharm.com. Dieses Pressekommuniqué enthält vorausschauende Aussagen, die das Company' reflektieren; s-gegenwärtige Erwartungen betreffend zukünftige Ereignisse. Die vorausschauenden Aussagen beziehen Risiken und Ungewissheiten mit ein. Die tatsächlichen Ereignisse konnten von denen materiell sich unterscheiden hierin projektiert und von einigen Faktoren, einschließlich die Ungewissheiten abhängen, die in zahlreichen Ländern auf dem regelnden Prozess für die Zustimmung des Company' bezogen wurden; s-Produkte und die erfolgreiche Kommerzialisierung der Produkte weltweit, wenn sie anerkannt sind. Investoren sollten das Company' konsultieren; s-laufende vierteljährliche Archivierungen und jährliche Berichte für zusätzliche Information über Risiken und Ungewissheiten in Bezug auf diese vorausschauenden Aussagen. Der Leser wird, gewarnt nicht auf diese vorausschauenden Aussagen zu bauen. Die Firma dementiert jede mögliche Verpflichtung, diese vorausschauenden Aussagen zu aktualisieren.http://img.wallstreet-online.de/smilies/rolleyes.gif
@ swissdm

Ich danke dir für deine hilfe!!und deinen tip!!
Bin sehr erleichtert!!

@ all

Wie seht Ihr die Enrwicklung von Labopharm??

Eure Ansichten und Meinungen sind gefragt!!

Dauert ja nicht mehr lange bis zum FDA Entscheid!!

greez
Slash
Antwort auf Beitrag Nr.: 34.464.147 von sacha1978 am 08.07.08 19:43:44Kaum zu glauben das der Kurs von Labopharm immer noch im keller ist trotz den guten Nachrichten .
Die Zulassung ist nur noch eine frage von wenigen Wochen und sehe den aktuellen Kurs als Geschenk an .
Also wenn es diesmal nicht klappt obwohl Labopharm sehr eng mit der FDA zusammengearbeitet hat dann geht es nicht mit rechten Dingen zu.

Falls die Zulassung kommt :

Dann gibts 10 million US$ von Purdue Pharma (Partner für USA)

Biovail die dasselbe Produkt haben wobei das von Labopharm effektiver ist macht nach knapp 3 jahren Zulassung rund 100 million US$ Umsatz jährlich .

Short interest ist auf Rekordtief
http://www.nasdaq.com/aspxcontent/shortinterests.aspx?symbol=DDSS&symbol=SYMBA&symbol=PP&symbol=DNDN&symbol=PRAN&symbol=ALSE&symbol=EPCT&selected=DDSS
-----------

Ich denke mit der Einstellung von Dr. Brulle geht Labopharm den richtigen Weg .

4/28/2008
Labopharm Appoints Dr. Claire Brullé as Senior Vice-President and Chief Medical Officer
LAVAL, QC, Apr 28, 2008 (Canada NewsWire via COMTEX News Network) -- - Dr. Sylvie Bouchard to Retire from Company -

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that Claire Brullé, M.D. has been appointed Senior Vice-President and Chief Medical Officer of the Company. Incumbent Chief Medical Officer Dr. Sylvie Bouchard has retired from Labopharm Inc. to focus on her career practicing medicine.

"Dr. Brullé brings to Labopharm a proven track record in medical affairs and clinical development and an impressive portfolio of competencies ranging from global clinical development to medical support for commercial operations," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "With extensive experience interacting with regulatory agencies in both North America and Europe and specific expertise in the area of pain therapeutics, Dr. Brullé is a strong addition to our team as we pursue our objective of commercializing multiple large market opportunity drugs."

Dr. Brullé has more than 25 years experience in the medical profession, including more than 15 years experience in the pharmaceutical industry with Pfizer Inc. During her tenure at Pfizer, Dr. Brullé held a series of increasingly senior medical roles, including lead positions for the Pain and Arthritis Franchise. Dr. Brullé received her Medical Degree from the Université de Paris and has completed International and Leadership Development Programs from INSEAD Institute and Harvard Business School, respectively.

Mr. Howard-Tripp continued, "Dr. Bouchard's expertise and diligence has been invaluable to Labopharm's success to date. On behalf of the Company and the Board of Directors, I would like to thank her for her very significant contribution to Labopharm and wish her well as a full-time practicing physician."

Dr. Bouchard will continue to be available to Labopharm to transition the role to Dr. Brullé and will act as a consultant to the Company going forward.
Antwort auf Beitrag Nr.: 34.494.778 von BrauchGeld am 12.07.08 13:56:30Ich schließe mich Deiner Meinung an. Es wäre unverständlich wenn es keine Zulassung gibt.
Antwort auf Beitrag Nr.: 34.494.778 von BrauchGeld am 12.07.08 13:56:30......wo handels du diese??

Bei der Xetra?oder bei den Amis?

Ich möchte mir auch ein paar stücke ins Depot legen!:D

Danke für dein Tip!!

Greez
Approval for Labopharm's Tramadol seen by January
Thu Jul 17, 2008 3:28pm EDT Email | Print | Share| Reprints | Single Page| Recommend (0) [-] Text [+]
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Learn to Trade with a FREE Guide.TORONTO (Reuters) - Labopharm Inc (DDS.TO: Quote, Profile, Research, Stock Buzz) inched closer to U.S. approval of the once-daily version of its Tramadol pain treatment on Thursday, after the Food and Drug Administration accepted the analysis provided by the Canadian drug company.

Labopharm's shares were up 6 Canadian cents, or 4 percent, at C$1.57 late Thursday afternoon after climbing as high as C$1.83 earlier in the session.

Labopharm said acceptance of the data should lead to an FDA decision on the approval of once-daily Tramadol for use in the United States by January 2, 2009.

Late last month, the FDA suggested the company submit a previously requested analysis of the drug and said that a positive finding using this analysis could support the efficacy of the product, which could lead to regulatory approval.

The company received notification from the FDA in May 2007 that its Tramadol treatment would not be approved until certain conditions were met.

The drawn-out approval process has been costly for Labopharm and its development partner, Purdue Pharma LLP. The company expected FDA approval in September 2006, and had prepared for a U.S. launch in both 2006 and mid-2007.

By not receiving FDA approval during this quarter, it stands to lose a $10 million milestone payment agreed to with Purdue, Versant Partners analyst Doug Loe said in a note.

Loe sees Labopharm filing a new drug application in the third quarter of this year, with regulatory approval in the first quarter of 2009.

Labopharm's once-daily version of Tramadol has been launched in 11 countries, including Canada, and is approved in 19 others.

(Reporting by Scott Anderson; editing by Rob Wilson)
Labopharm to host conference call Friday, August 8, 2008 at 8:30 A.M. (ET)
Friday July 25, 11:54 am ET


- Management to discuss second quarter financial results -
LAVAL, QC, July 25 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that it will host a conference call on Friday, August 8 at 8:30 a.m. (ET) to discuss its second quarter 2008 financial results. Labopharm will report its second quarter 2008 financial results via news release at approximately 7:00 a.m. the same day.

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To access the conference call by telephone, dial 416-646-3095 or 1-800-814-4859. Please connect approximately 15 minutes prior to the beginning of the call to ensure participation. The conference call will be archived for replay until Friday, August 15, 2008 at midnight. To access the archived conference call, dial 416-640-1917 or 1-877-289-8525 and enter the reservation number 21278611 followed by the number sign.

A live audio webcast of the conference call will be available at www.labopharm.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to join the webcast. The webcast will be archived at the above web site for 30 days.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Labopharm Inc.
Labopharm will report its second quarter 2008 financial results via news release at approximately 7:00 a.m. the same day.:eek:
Labopharm's Once-Daily Tramadol Product Launched in South Korea, Australia, Romania and Austria
Thursday July 31, 7:00 am ET


- Product Now Being Sold in 14 Countries Worldwide -
LAVAL, QC, July 31 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that its once-daily formulation of tramadol has been launched in the following countries:

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South Korea - Labopharm's marketing partner for South Korea, WhanIn Pharmaceutical Co. Ltd., launched the product in July under the brand name TramaConti CR®.

Australia - Labopharm's marketing partner for Australia, iNova Pharmaceuticals (Australia) Pty Limited launched the product in July under the brand name Durotram XR®.

Romania - Labopharm's marketing partner for Romania, CSC Pharmaceuticals, launched the product in July under the brand name Noax® Uno.

Austria - Labopharm's marketing partner for Austria, CSC Pharmaceuticals, launched the product in June under the brand name Noax® Uno.

"With these launches, our once-daily tramadol product is now being sold in 14 countries that, combined, account for almost 55% of the world's market for tramadol products," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "South Korea and Australia, in particular, represent significant opportunities as the 6th and 12th largest markets for tramadol products in the world, respectively. We look forward to leveraging the experience we have gained through our previous European and Canadian launches and working with our marketing partners to maximize our product's potential in these markets."

Labopharm's product is available in 100mg, 200mg and 300mg dosage strengths in Australia, Austria and Romania and in 100mg and 200mg dosage strengths in South Korea. The 300 mg dosage strength is approved for sale in South Korea and may be marketed at a later date.

About Labopharm's Once-Daily Tramadol Product

Labopharm's once-daily tramadol product is based on the Company's proprietary Contramid® technology, which provides a dual matrix delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range providing a full 24 hours of pain relief. The Company believes that maintaining drug concentrations within the therapeutic range has the advantage of fewer and less severe side effects while maintaining efficacy. Under its global commercialization program, Labopharm's once-daily tramadol product has been launched in 14 countries, including the five largest markets in Europe and Canada and is approved in 16 other countries. Including those countries in which its product has been launched, Labopharm has licensing and distribution agreements in place for more than 50 markets globally.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.




--------------------------------------------------------------------------------
Source: Labopharm Inc.
Es wäre meiner Meinung nach sehr verwunderlich wenn die Zulassung in den USA nicht erfolgen würde.;)
UPDATE 1-Labopharm loss narrows despite revenue drop
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TORONTO, Aug 8 (Reuters) - Labopharm Inc (DDS.TO: Quote, Profile, Research, Stock Buzz) reported a smaller second-quarter loss on Friday despite a slip in revenue as it neared preparation of a new drug application for its anti-depression treatment.

The small Canadian biotechnology company said it lost C$10.1 million ($9.4 million), or 18 Canadian cents a share, for the quarter ended June 30, compared with a loss of C$11 million, or 19 cents a share, for the same period last year.

Revenue for the quarter was C$4.9 million, down from C$5.9 million for last year's quarter, hurt by a decrease in licensing revenue from Purdue Pharma related to its once-daily tramadol pain-relief formula.

Licensing revenue, which includes a portion of payments received from its licensing and distribution partners for Labopharm's version of tramadol, was C$1.1 million, down from C$1.7 million for the same quarter last year.

Research and development expenses were C$6.3 million, up from C$5.7 million.

Expenses typically mount for biotech companies as they advance further into trials before receiving regulatory approval.

The company said it was in the final stages of preparing a new drug application for an antidepressant that it hopes to submit to the U.S. Food and Drug Administration some time in the third quarter.

It is still waiting for a decision from the FDA on its once-daily version of the tramadol formula. The agency said last month it planned to make a decision by Jan. 2, 2009. ($1=$1.06 Canadian) (Reporting by Scott Anderson; Editing by Peter Galloway)
Labopharm to present at Canaccord Adams 28th Annual Global Growth Conference
Monday August 11, 7:00 am ET


LAVAL, QC, Aug. 11 /CNW/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that James R. Howard-Tripp, Chief Executive Officer of the Company, will present at the Canaccord Adams 28th Annual Global Growth Conference at the InterContinental Hotel in Boston, on Wednesday, August 13, 2008 at 9:00 a.m. ET.
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Interested parties may access the live webcast for this presentation by visiting the "Events" section of the homepage of the Company's website at www.labopharm.com. Please connect at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to join the webcast. An audio archive of the presentation will be available for 30 days.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.

For further information

At Labopharm: Mark D'Souza, Senior Vice-President and Chief Financial Officer, Tel: (450) 686-0207
At The Equicom Group, Jason Hogan, Media and Investor Relations, Tel: (416) 815-0700, jhogan@equicomgroup.com
French: Joe Racanelli, Tel: (514) 844-7997, jracanelli@equicomgroup.com



--------------------------------------------------------------------------------
Source: Labopharm Inc.
Antwort auf Beitrag Nr.: 34.700.321 von Bombenleger am 11.08.08 15:18:21weshalb fällt der Kurs immer tiefer, obwohl die Zulassung in den USA bald erfolgen wird.
Hat jemand einen Tipp?http://img.wallstreet-online.de/smilies/rolleyes.gif
Antwort auf Beitrag Nr.: 34.703.344 von swissdm am 11.08.08 20:40:14@ swissdm

Das liegt wohl daran das einige enttäuschte Anleger die von einer Zulassung ausgingen verkauft haben .

Der Kurs wurde mit sehr niedrigen Umsätzen nach unten gedrückt
http://finance.yahoo.com/q/hp?s=DDSS

Was noch positiv zu erwähnen ist , sind die steigenden Umsätze die sich im Vergleich zum Vorquartal fast verdoppelt haben.
Mit den Markteinführungen in Australien,Südkorea,Österreich und Rumänien wird der Umsatz bestimmt weiter ansteigen und weitere Länder werden noch folgen .

South Korea - Labopharm's marketing partner for South Korea, WhanIn Pharmaceutical Co. Ltd., launched the product in July under the brand name TramaConti CR®.

Australia - Labopharm's marketing partner for Australia, iNova Pharmaceuticals (Australia) Pty Limited launched the product in July under the brand name Durotram XR®.

Romania - Labopharm's marketing partner for Romania, CSC Pharmaceuticals, launched the product in July under the brand name Noax® Uno.

Austria - Labopharm's marketing partner for Austria, CSC Pharmaceuticals, launched the product in June under the brand name Noax® Uno.


Ausblick 3Q 2008 - 2Q 2009

Trazodone Zulassungsantrag in USA für´s 3Q 2008 geplant
Vermarktungspartner für Trazadone (Depression)
Vermarktungspartner für Tramadol-Acetaminophen (Akute Schmerzen)
Einmaltäglich Tramadol US-Zulassung in 2 Jan 2009
Tramadol-Acetaminophen Phase III Daten im 1Q 2009


Hab mein Labopharm-Anteil auf 6000st. erhöht (~0,90€)
Marktkap: 46 million €
Cash : 37,4 million €
Kurs : 0,83 €

Noch im 3Q wird Labopharm den Zulassungsantrag für das Hauptprodukt Trazadone gegen Depression bei der FDA einreichen
.
In kürze soll dann der Vermarktungspartner für Trazadone folgen .

Tja warum die Aktie so spottbillig ist kann ich auch nicht erklären ich hoffe das ändert sich bald .

Short interest bewegt sich weiter auf sehr niedrigem Niveau
http://www.nasdaq.com/aspxcontent/shortinterests.aspx?symbol…
Labopharm beantragt US-Zulassung für Trazodone ..

Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression
Monday September 22, 7:00 am ET

- Novel Formulation Has Potential to Address Unmet Need in Global
Anti-Depressant Market -

LAVAL, QC, Sept. 22 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that it has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act to the U.S. Food and Drug Administration (FDA) for DDS-04A, a once-daily serotonin antagonist reuptake inhibitor (SARI) that provides an effective alternative in the treatment of major depression.

"According to published market data and a survey of more than 300 primary care physicians and psychiatrists, the slow onset of action, coupled with increased anxiety, sleep disturbance and unwanted side effects, such as weight gain and sexual dysfunction, are cited as the primary reasons why patients discontinue existing treatments early," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "The profile of our formulation addresses these concerns and we believe that may allow us to capture a significant share of the global anti-depressant market."

Major depression is one of the most prevalent central nervous disorders, affecting more than 120 million people worldwide. In 2007, $19 billion worth of anti-depressants were prescribed globally, with more than $12 billion in the U.S. According to the World Health Organization 40% of patients treated with current medications may discontinue treatment within the first 12 weeks due to limitations with existing products and their unwanted side effects.

Labopharm's NDA for its novel antidepressant formulation containing trazodone is based on data from five pivotal pharmacokinetic studies and the positive results from its North American Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients. In the Phase III study, the primary endpoint achieved statistical significance providing an improvement from baseline to the end of the study as measured by the Hamilton Rating Scale for Depression (HAMD-17). Patients experienced rapid onset of action as demonstrated by a clinically significant improvement in HAMD scores within the first two weeks of treatment. In addition, the study demonstrated an improvement in the overall quality of sleep and a favourable adverse event profile, including transient mild to moderate somnolence, no difference from placebo in anxiety, agitation, sexual dysfunction and weight change.

Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act typically applies to reformulations of drugs that are already approved and being marketed, allowing the Company to refer to existing efficacy and safety data on trazodone. The Agency advised the Company that one positive Phase III study is required for the formulation to be approved.

In addition to the U.S., Labopharm plans to pursue regulatory approval for DDS-04A in Canada and other markets worldwide for which it holds the rights under a cross-licensing agreement with Gruppo Angelini. Under the terms of the agreement, Labopharm has the rights to commercialize its formulation in the U.S., (the largest market for trazodone) and Canada in addition to most other countries outside Europe. Gruppo Angelini, has the rights to commercialize in Europe and some Asian markets.
Antwort auf Beitrag Nr.: 35.229.955 von BrauchGeld am 23.09.08 09:45:57ich glaube, jetzt ist der Augenblick gekommen, um einzusteigen.

(Hatte schon den guten Einstieg bei SQNM verpasst...)
Antwort auf Beitrag Nr.: 35.258.697 von swissdm am 24.09.08 19:58:20@swissdm

Ob es der richtige Zeitpunkt für den Einstieg ist bei dieser Marktlage ist schwer zu sagen ,fakt aber ist das Labopharm äußerst günstig bewertet ist .


Geschäftsführung kauft nach langer Zeit wieder Aktien
http://canadianinsider.com/coReport/allTransactions.php?tick…


Viel Glück

Ausblick 2009

Vermarktungspartner für Trazodone 4Q 2008 /1Q 2009
Tramadol US-Zulassung geplant für 2.Jan 2009
Tramadol-Acetaminophen Phase III Daten im 1Q 2009
Trazodone US-Zulassung im 3Q 2009
Antwort auf Beitrag Nr.: 35.259.411 von BrauchGeld am 24.09.08 20:35:20Danke

Ich bin überzeugt, dass dieser Titel extrem unterbewertet ist.
Tiefer kann er fast nicht mehr fallen. :-)
Ist ja extrem wie dieser Titel gesunken ist!!!

Müssten da nicht endlich mal News kommen? (dez08)

Greez
Antwort auf Beitrag Nr.: 36.126.474 von sacha1978 am 01.12.08 20:19:41Labopharm notiert bereits unter Cash ,da kann mann nur noch den Kopf schütteln .

Kommt die Zulassung am 2.Januar ist eine Kursexplosion unvermeidlich damit wäre auch Labopharm gerettet .

Gute nachrichten gibts auch von Trazodone so laufen bereits erste Gespräche mit möglichen Vermarktungspartner .

Durchhalten ist angesagt !

Labopharm (DDSS)

Market Cap .. 27 million US$
Cash .. 36,3 million US$
Price : 0,45

Labopharm's NDA for Novel Trazodone Formulation accepted for review by FDA
Monday November 24, 7:00 am ET

Outlook 2009

Partnering agreement Trazadone (Depression )
Partnering agreement Tramadol-Acetaminophen (Acute Pain)
Tramadol-Acetaminophen Phase III results in 2Q 2009
Once a Day Tramadol US approval 2 Jan 2009
Once a Day Trazodone (Depression) US approval 22 July 2009

Recent Developments


Once-Daily Tramadol Global Commercialization Program

Product Continues to Exhibit Steady Growth in Market Share and In-Market Sales Globally - Labopharm's once-daily tramadol product continues to exhibit steady growth in market(3) share and in-market sales in Europe(4) and Canada. Labopharm's product continued to hold the number one position in Europe(4) in August in the once-daily segment of the market(3) with more than a 44% share. In Canada, the Company's product moved into the number two position of the overall tramadol product market with a 28% share. In-market sales of Labopharm's product in Europe(4) for the three-month period ended August 31, 2008 (the latest month for which data is available) increased to 7.1 million standard units, bringing total in-market sales for the year-to-date to 18.3 million standard units. In Canada, the number of prescriptions written for Labopharm's product has grown on a month-over-month basis by an average of 23% from July to September 2008.

Product Launched in South Korea, Australia, Austria and Romania - During the third quarter, Labopharm's product was launched in South Korea under the brand name TramaConti CR®, in Australia under the brand name Durotram XR®, in Austria and Romania under the brand name Noax® Uno. The launches bring the total number of countries in which the product is being sold to 14, representing almost 55% of the global market for tramadol products.

Received Regulatory Approval in Israel - During the third quarter, Labopharm's product received regulatory approval from the Israeli regulatory authority for marketing and sales in that country. The Company expects its product to by launched in Israel before the end of 2008.

DDS-04A Containing Trazodone for Treatment of Depression

Submitted NDA to U.S. FDA - Labopharm submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act to the U.S. Food and Drug Administration (FDA) for DDS-04A, a once-daily serotonin antagonist reuptake inhibitor (SARI) that provides an effective option in the treatment of major depression. In addition to the U.S., the Company plans to pursue regulatory approval for DDS-04A in Canada and other markets worldwide for which it holds the rights, including most countries outside Europe. Labopharm has initiated discussions with several potential partners in view of establishing a marketing partnership for the United States in 2009.

Twice-Daily Tramadol-Acetaminophen Combination Product

Phase III Clinical Trial Continues - Enrolment for the North American Phase III clinical trial (study 06CCL3-001) continues, as do discussions with potential marketing partners for distribution of the product. The Company expects to report the results of the study in the second quarter of 2009.

Misuse and Abuse Deterrent Platform

Preparing to Initiate Clinical Studies for a Widely Misused Pain Drug - Labopharm is preparing to enter the clinic in the first half of 2009 with the first of potentially several misuse and abuse deterrent formulations of widely prescribed pain drugs.
Antwort auf Beitrag Nr.: 36.128.767 von BrauchGeld am 02.12.08 09:45:56Hallo BrauchGeld

Danke für die Info!
Habe diese zwar schon gekannt tut jedoch immer wieder gut dies zu lesen!!

Du kannst mir sicher sagen warum der Kurs immernoch so in die Knie geht?!

Werden da die Kurse gedrückt??

Ich bin mir am überlegen ob ich nicht noch ein paar ins Depot hole bei diesen Traumpreisen:laugh:

Handelst du diese in Frankfurt?

Ich habe Sie in Toronto gehandelt.Irrtümlicherweise!!!
..... wollte diese eigentlich an der Nasdaq:rolleyes:

Greez
Ich handle in FRANKFURT , hat mehr Umsatz.

Ich bin mir sicher, dass die Zulassung für USA erfolgen muss.
Schliesslich ist das Medikament schon " welteweit" im Verkauf.
Zudem braucht die USA mehr Marktwirtschaft.



Viel Glück


Geduld bringt Rosen ( und Dollars )
Antwort auf Beitrag Nr.: 36.128.767 von BrauchGeld am 02.12.08 09:45:56Ich glaube, es geht los.
s werden grössere Volumen gehandelt.
In canada ist auch ein grosses Volumen zu sehen.

Sind das Insiderkäufe??
Danke an brauchgeld und swissdm für ihre arbeit !

DDSS ist tausendmal besser wie ANSV und DVAX zusammen das werden wir spätestens am 2 Januar merken und das wird auch ohne gepushe passieren.

Sieht super aus
http://chart.finance.yahoo.com/c/3m/d/ddsshttp://chart.finance.yahoo.com/c/3m/d/ddss
Antwort auf Beitrag Nr.: 36.228.585 von mademoremoney am 18.12.08 10:47:56Vorbörslich wieder rauf momentan bei 1,18$ (0,68€) in CA

http://www.stockhouse.com/tools/?page=%2FFinancialTools%2Fsn…
Gehts über 1 US$ dann geht die Post ab
In 2 wochen gibts die Zulassung yabbbadabbadoooo

Zulassung für Tramadol (2 Jan 2009) wird die Aktie bis auf 2-3$ hieven und wenn Trazodone am 18 Juli zugelassen wird sehen wir locker kurse zwischen 4-6 $ .
Labopharm kennt nur eine richtung und zwar up kein wunder komplette pipeline wird gerade mal mit 26 million dollar bewertet .

Hier ist noch sehr viel spielraum nach oben .
Antwort auf Beitrag Nr.: 36.241.341 von mademoremoney am 19.12.08 18:44:02DDSS schließt über wichtige Marke(200MA) von 1,42 CA$ damit dürfte auch die nächste Woche positiv verlaufen.

Nur noch wenige Tage bis zur Zulassung .

Antwort auf Beitrag Nr.: 36.244.141 von mademoremoney am 20.12.08 13:36:10DDSS ist ein Investment nach meinem Geschmack

Wo fange ich an ,okay also

1) Tramadol Zulassung am 2.Jan 09 in USA bedeutet Labopharm könnte schwarze Zahlen schreiben

2) Deal für Trazodone wird zusätzliches Geld in die Kasse spülen(ich rechne mit 30-50 million US$)

3) Und schon am 18.Juli steht die Zulassung für Trazodone an spätestens dann hat es Labopharm endgültig geschafft was sich auch im Kurs wiederspiegeln wird

4) Aber es geht noch weiter Tramadol-Acetaminophen PIII resultat wird für das 2Q 09 erwartet die dürften mit hoher wahrscheinlichkeit positiv ausfallen .

5) Deal für Tramadol-Acetaminophen dürfte abermals Geld in die Kasse bringen auch wenn die es nicht mehr nötig hätten .

6) NDA für Tramadol-Acetaminophen wird beantragt damit naht das dritte Produkt der Zulassung.

7) Das beste ist ,alles was ich aufgezählt habe dürfte bis zum 3Q 2009 über die Bühne laufen .


Kontostand = 36,7 Million US$
MKap = 66 Million US$

Auch wenn DDSS eine Perle ist trotzdem besteht RISIKO z.b. das die FDA nicht mitspielt das ist halt Biotech .


Auf gehts knacken wir heute die 1€ Marke .

Long and Strong on DDSS
Antwort auf Beitrag Nr.: 36.252.302 von StaatsKnecht am 22.12.08 15:41:531,50$ wohooooooo und immer noch saubillig
Hab vorhin ein paar von meinen Labopharm aktien verkauft und in Cipher Pharma reingesteckt .

Produkte von Cipher :

1. Cip-Fenofibrate in Kanada und USA zugelassen seit knapp 15 monaten auf dem Markt erhältlich

2. Cip-Tramadol die Zulassung in USA ist schon seit ein paar Tagen fällig kann also jeden Tag kommen .War auch der grund für meinen einstieg .

3. Cip Isotretinoin hat schon 2 approvable letter bekommen muss noch eine Phase III Studie dürchführen dann sollte auch hier die Zulassung erfolgen .

Alles in allem kriegt man die Aktie so gut wie Geschenkt .

Cipher Pharma (DND.TO)

Marketcap: 11 million C$
Cash: 10,3 million C$
Price: 0,46 C$

Präsentation Sep 2008
http://cipherpharma.com/downloads/DND_September_2008.pdf

Pipeline
http://cipherpharma.com/web/main.cfm?docID=11

Insider
http://canadianinsider.com/coReport/allTransactions.php?tick…


Q3 2008 results

Summary
---------------

- Entered into a definitive development, distribution and supply
agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy") for
CIP-ISOTRETINOIN in the United States.
- Recorded licensing revenue of $672,000.
- Achieved net income of $0.2 million for the quarter.
- Solid balance sheet with cash of $10.3 million and no debt at
quarter end; during Q3 2008, cash increased by $0.4 million.
- Subsequent to quarter end, strengthened management team with the
appointment of John MacInnis as Vice President, Portfolio Development
and Licensing.


"The third quarter was highlighted by the out-licensing agreement for CIP-ISOTRETINOIN with Ranbaxy, which we believe is an excellent partner for the product," said Larry Andrews, President and CEO of Cipher. "With their financial support, we are moving forward with the pivotal Phase III safety study, with enrolment expected to begin in early Q1 2009. The third quarter also saw continued growth in Lipofen(R) prescriptions under Kowa, resulting in steadily increasing royalty revenue, which contributed to positive net income during the quarter. With more than $10 million in cash, no debt and limited spending required for our current products, we are in a solid financial position from which to build our pipeline and expand distribution of our current products in selected markets."

Product Update
--------------


In July 2007, Cipher entered into a licensing and distribution agreement with ProEthic Pharmaceuticals under which ProEthic was granted the exclusive right to market, sell and distribute Lipofen(R) (Fenofibrate) in the United States. In Q3 2008, ProEthic was acquired by Kowa Company, Ltd. and changed its name to Kowa Pharmaceuticals America, Inc. ("Kowa"). During Q3 2008, weekly prescriptions continued to show steady growth, and Cipher expects this trend to continue as Kowa increases penetration of the primary care physicians in its targeted regions and expands its sales force.

In Q2 2007, Cipher received a second approvable letter from the FDA pertaining to its CIP-ISOTRETINOIN NDA. In the letter, the FDA indicated that Cipher's application is approvable subject to the resolution of two remaining issues. In addition to one question related to chemistry, manufacturing and controls, which the Company responded to, the FDA requested that Cipher provide additional clinical safety data. The Company appealed the position taken by the FDA in its approvable letter using the formal dispute resolution process. After subsequent discussions, the representative from the FDA agreed with the Division of Dermatology and Dental Product's original view that a Phase III safety study was needed to further demonstrate the safety of CIP-ISOTRETINOIN. During Q3 2008, Cipher and its advisors met with the Division regarding the appropriate design of a safety trial. The Company expects to finalize the study protocol shortly under a Special Protocol Assessment ("SPA") and plans to begin trial enrolment in early Q1 2009. Subsequent to quarter end, another important milestone was reached with notice that the United States Patent and Trademark Office issued a patent for CIP-ISOTRETINOIN.

During the third quarter, the Company entered into a definitive development, distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy"), a wholly owned subsidiary of Ranbaxy Laboratories Limited, under which Cipher has granted Ranbaxy the exclusive right to market, sell and distribute CIP-ISOTRETINOIN in the United States. Under the terms of the agreement with Ranbaxy, Cipher received an initial upfront milestone payment of US$1 million. The agreement includes additional pre- and post-commercialization milestone payments of up to US$23 million, contingent upon the achievement of certain milestone targets. Once the product is successfully commercialized, Cipher will also receive a royalty in the mid-teens on net sales. In addition, Ranbaxy will reimburse Cipher for all costs associated with any remaining clinical studies required to obtain FDA approval, up to a predetermined cap. Any additional development costs associated with initial FDA approval will be shared equally. After product-related expenses are deducted, approximately 50% of all milestone and royalty payments received by Cipher under the agreement will be paid to Galephar.

In May 2007, Cipher received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's extended-release formulation of tramadol. In December 2007, Cipher announced that it had appealed the position taken by the FDA using the FDA's formal dispute resolution process. In the written response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research supported the original approvable action. During Q2 2008, Cipher submitted a revised NDA to the FDA, which the Company concluded was the most expeditious path to final regulatory approval. Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER. The revised NDA was accepted for review in Q2 2008, and the Company originally expected the review to be completed by mid-October 2008. Subsequent to quarter end, Cipher was informed that additional time will be required for the FDA to complete its review of the NDA as the FDA has indicated that it plans to inspect the facilities of the Company's manufacturer and packager in Puerto Rico. No other outstanding issues have been identified. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. Out-licensing discussions with potential commercial partners are ongoing
Mit Zulassung für Cipher´s Tramadol sehen wir locker 2 C$ und mehr .
Der CEO allein hält knapp 10 millionen Aktien von den 24 million Aktien im Umlauf.
Antwort auf Beitrag Nr.: 36.256.972 von StaatsKnecht am 23.12.08 10:11:52Die ersten 20% sind schon da boooyaaahhhh...Aktie bleibt super extrem billig :D

DDSS erwartet die Zulassung für Tramadol am Freitag spätestens Montag sollte die Entscheidung da sein ..

zu Cipher Pharma :

Cipher wartet auch auf die Zulassung die schon überfällig ist,hier ist aber mit einem signifikanten Kurssprung zurechnen da sich nur wenige Aktien in Umlauf befinden .

CEO(Larry Andrews) hält ca. 9,7 million Aktien
Corriente Master Fund(Zweitgrösster Investor) ist mit ca. 5 million Aktien dabei und kaufen ständig welche dazu .

http://www.newswire.ca/en/releases/archive/February2008/22/c…

http://canadianinsider.com/coReport/allTransactions.php?tick…

Corriente Master Fund, L.P. announces acquisition of common shares of Cipher Pharmaceuticals Inc.



May 07/08 May 07/08 Corriente Master Fund, LP Direct Ownership Common Shares 10 -
Acquisition in the public market 300 $1.610

May 06/08 May 06/08 Corriente Master Fund, LP Direct Ownership Common Shares 10 -
Acquisition in the public market 3,800 $1.480

May 05/08 May 02/08 Corriente Master Fund, LP Direct Ownership Common Shares 10 -
Acquisition in the public market 200 $1.325

May 01/08 May 01/08 Corriente Master Fund, LP Direct Ownership Common Shares 10 -Acquisition in the public market 16,400 $1.158

May 01/08 Apr 09/08 Corriente Master Fund, LP Direct Ownership Common Shares 10 -
Acquisition in the public market 39,000 $1.008

Apr 30/08 Apr 30/08 Corriente Master Fund, LP Direct Ownership Common Shares 10 -
Acquisition in the public market 900 $1.200

Apr 30/08 Apr 29/08 Corriente Master Fund, LP Direct Ownership Common Shares 10 -
Acquisition in the public market 1,000 $1.200

Apr 29/08 Apr 28/08 Corriente Master Fund, LP Direct Ownership Common Shares 10 -
Acquisition in the public market 11,400 $1.200

Apr 25/08 Apr 25/08 Corriente Master Fund, LP Direct Ownership Common Shares 10 -
Acquisition in the public market 10,000 $1.150

Apr 22/08 Apr 17/08 Corriente Master Fund, LP
Direct Ownership Common Shares 10 - Acquisition in the public market 44,400 $1.175
Wieder action bei Labopharm
http://finance.yahoo.com/q?s=ddss

Cipher´s bid/ask zieht auch langsam an bisher aber noch kein Handel.
zu Cipher :

Positive aussichten...

Marktkap: 11 million CDN$ = 6,3 million € << Gehts noch billiger???
Cash: 10,3 million CDN$ = 5,9 million € << Ich glaub kaum...

1.Cipher ist finanziell sehr gut abgesichert und die Profitabelität klopft bereits an der Tür .

2.Lipofen (seit knapp 1 Jahr auf dem Markt) Umsatztrend zeigt nach oben ,US-Partner Proethic wurde von Kowa Pharma übernommen die noch aggressiver Lipofen vermarkten wollen .

3.Mit Ranbaxy Pharma hat Cipher für Isotretinoin ein idealen Partner gefunden.Isotretinoin könnte eventuell noch in 2009 zugelassen werden .

3.Das beste zuletzt : Tramadol zulassung muss bald kommen << FDA:mad: die lassen sich zeit

Der aktuelle Stand bzgl Tramadol:
(Cipher was informed that additional time will be required for the FDA to complete its review of the NDA as the FDA has indicated that it plans to inspect the facilities of the Company's manufacturer and packager in Puerto Rico. No other outstanding issues have been identified)

Januar 2006 gabs damals die US-Zulassung für Fenofibrate und genau so in etwa wird Cipher abgehen wenn Tramadol zugelassen wird .
Labopharm Announces FDA Approval of Once-Daily RYZOLT(TM) (Tramadol HCL Extended Release Tablets) for Management of Moderate to Moderately Severe Chronic Pain
Wednesday December 31, 2008, 7:00 am EST
Yahoo! Buzz Print Related:Labopharm Inc.
Product to be Launched in the U.S. in the Second Quarter of 2009

Related Quotes
Symbol Price Change
DDSS 1.3499 0.0000


{"s" : "ddss","k" : "c10,l10,p20,t10","o" : "","j" : ""} LAVAL, QC, Dec. 31 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that RYZOLT(TM) (tramadol HCl extended release tablets), Labopharm's once-daily formulation of the analgesic tramadol, has been approved by the U.S. Food and Drug Administration (FDA). RYZOLT is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

"The approval of our first product in the United States is a major milestone for our Company and we look forward to our product's launch in the world's largest market for pain medications," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We believe that RYZOLT offers physicians and patients an excellent option for the treatment of pain with the benefit of once-daily dosing. We look forward to the launch of our product by our marketing partner for the U.S., Purdue Pharma."

RYZOLT is a centrally acting analgesic composed of a dual-matrix delivery system with both immediate-release and extended-release characteristics. Labopharm's marketing partner for its product in the United States, Purdue Pharma L.P., anticipates launching RYZOLT tablets in 100 mg, 200 mg and 300 mg dosage strengths in the second quarter of 2009.

The approval of RYZOLT is the first U.S. FDA approval that Labopharm has obtained for a medication using its patented Contramid® controlled-release technology for oral administration of solid dosage medications. Labopharm believes that its Contramid technology can be applied to a wide range of complex, small, highly water soluble molecules to control their release over a 24-hour period with a desired pharmacokinetic profile.

Pain is a potentially debilitating condition that affects an estimated 75 million Americans - more than diabetes, heart disease and cancer combined. The United States is the world's largest market for tramadol products with sales for the 12-month period ended September 2008 of more than US$650 million resulting from more than 25 million prescriptions, which have grown at a compounded annual rate of 11% over the last five corresponding periods. Labopharm believes, however, that RYZOLT will compete not only with other tramadol products, but also with other medications indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

"In a society where people with pain are increasingly demanding simplified dosing regimens, this once-daily formulation of tramadol should be embraced by physicians and patients alike," said Nicholas J. Messina III, MD, with Vista Medical Research Inc., Mesa, AZ, who was a principal investigator in the U.S. clinical studies on RYZOLT.

Labopharm will host a conference call on Tuesday, January 6, 2009 to discuss this announcement. Additional details for the conference call will be provided via separate news release shortly.


About the Global Commercialization Program for Labopharm's Once-Daily
Tramadol Product

Labopharm's once-daily tramadol product is being commercialized globally and to date has been launched in 14 countries, including Canada and the five largest individual markets in Europe. In addition, it has received regulatory approval or is under regulatory review in 29 countries and the Company has established marketing partnerships for its product in 38 countries. Labopharm is continuing to pursue regulatory approval and marketing partnerships for its once-daily tramadol product for other markets around the world in support of its global commercialization program.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally and its second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit http://www.labopharm.com/.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.
Das ist eine sehr gute Nachricht ...Um Labopharm brauche ich mir keine sorgen mehr zu machen ..

Auch meine Cipher bewegt sich :D
http://finance.yahoo.com/q?s=dnd.to&x=0&y=0
Der Kursverlauf ist ähnlich enttäuschend wie bei Labopharm vor der Zulassung .Also nochmal ich halte Ciper für sehr aussichtsreich selbst wenn die Zulassung nicht erfolgen sollte (wovon ich nicht ausgehe) ist die Aktie, die bereits ein Produkt auf dem US-Markt haben sehr günstig .
Warum sollte die FDA nicht Tramadol zulassen ? Cipher ist denselben Weg gegangen wie Labopharm bzgl. FDA .


Cipher Pharma
Marktkap: 11 million CDN$ = 6,3 million €
Cash: 10,3 million CDN$ = 5,9 million €


In May 2007, Cipher received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's extended-release formulation of tramadol. In December 2007, Cipher announced that it had appealed the position taken by the FDA using the FDA's formal dispute resolution process. In the written response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research supported the original approvable action. During Q2 2008, Cipher submitted a revised NDA to the FDA, which the Company concluded was the most expeditious path to final regulatory approval. Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER. The revised NDA was accepted for review in Q2 2008, and the Company originally expected the review to be completed by mid-October 2008. Subsequent to quarter end, Cipher was informed that additional time will be required for the FDA to complete its review of the NDA as the FDA has indicated that it plans to inspect the facilities of the Company's manufacturer and packager in Puerto Rico. No other outstanding issues have been identified.
Was erwartet uns noch bei der nach wie vor sehr günstigen Aktie(DDSS) :

1. Vermarktungspartner für Trazodone << steht unmittelbar bevor (rechne mit upfront zahlungen in höhe von min. 20 -50 mioUS$)

2. Zweimaltäglich Tramadol-Acetaminophen Kombi Phase III Daten werden im 2Q veröffentlicht << mit hoher wahrscheinlichkeit positiv

3. Markteinführung von Tramadol in USA durch Purdue << 2Q

4. 18.Juli fällt die Entscheidung über die zulassung von Trazodone

Also ist einiges was da im 1.Halbjahr 2009 auf uns zukommt :lick:

Labopharm (DDSS) ..(DDS.TO)

Marktkap: 106 million US$.....( 76,1 million € )
Cash: 36,3 million US$ ...... ( 26 million € )

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

Und zu Cipher ist zusagen das der Kurs meiner meinung nach absichtlich unten gehalten wird wie man am Mittwoch schön sehen konnte .
Damit werden anscheinend ängstliche Anleger um ihre Aktien gebracht mit dieser Taktik scheint Corriente Master Fund erfolg zuhaben .
Corriente hat am Mittwoch wieder mal 121.000 aktien ins Depot gelegt ,dazu ist noch zusagen das die meisten Käufe über 1,50 C$
statt gefunden haben .
Es ist schon sehr selten das ein Fond in solchen kleinen Biotechs investieren das macht mich sehr zuversichtlich .
Ich halte schon 10000stück (kk ~0,40€)und würde auch sofort mehr kaufen aber mein zweites Depot ist nocht nicht fertig.:lick:

Kauf von Corriente ist hier zusehen ....
http://canadianinsider.com/coReport/allTransactions.php?tick…

Cipher Pharma (DND.TO)

Marktkap: 11 million CDN$ (6,3 million €)
Cash: 10,3 million CDN$ (5,9 million € )
Kurs : 0,46 C$


Die Aktie kennt nicht jeder so zusagen ein Geheimtip .

Cipher´s Pipeline :

Lipofen << Umsatz steigt (s.Bild2)



Isotretinoin << Best in Class potential ,Zulassung wahrscheinlich noch in 2009


Tramadol << Zulassung kommt vielleicht nächste Woche ?



Die FDA bekommt übernächste Woche einen neuen Chef der wird hoffentlich den Saftladen mal gründlich säubern .
Antwort auf Beitrag Nr.: 36.297.781 von StaatsKnecht am 03.01.09 16:42:58Vorteile:

1. Cashbestand wurde zum Vorquartal um 400tsd C$ auf 10,3 mio C$ gesteigert << sehr wichtig in einer Krise
2. Cipher hat keine Schulden
3. Cipher hat so gut wie keine Ausgaben da sich Lipofen bereits auf dem Markt befindet,Tramadol nur noch auf die Zulassung wartet und Isotretinoin von Ranbaxy Pharma finanziert wird .

Nachteile:

Ich sehe und finde keine,außer das die Aktie kaum gehandelt wird weder in Kanada noch in Deutschland .Die einzigen die sich bisher die Aktien zuhause stapeln ist die Geschäftsführung und Corriente Fund .Die Aktie kennt wirklich kaum jemand und hier liegt das riesige Potential .Was zum Teufel kann man hier falsch machen ,normalerweise bin ich vorsichtig was Biotechs angeht aber für mich ist Cipher schon eine totsichere Investition .



Q3 2008 Summary
---------------

- Entered into a definitive development, distribution and supply
agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy") for
CIP-ISOTRETINOIN in the United States.
- Recorded licensing revenue of $672,000.
- Achieved net income of $0.2 million for the quarter.
- Solid balance sheet with cash of $10.3 million and no debt at
quarter end; during Q3 2008, cash increased by $0.4 million.
- Subsequent to quarter end, strengthened management team with the
appointment of John MacInnis as Vice President, Portfolio Development
and Licensing.
Hallo zusammen.

Cipher sieht in der Tat nach einem guten Investment aus, daher überlege ich die Tage da noch ein bisschen Geld reinzuschießen...

Da ich noch nicht so lange im Aktienmarkt bin, folgende Frage an die Experten: Würdet ihr Cipher eher in den USA (NASDAQ) oder am Börsenplatz Frankfurt kaufen?
Meine Überlegung ist folgende: In den Staaten steht der Kurs z.Zt. bei 0,44 USD bei zuletzt +10% Veränderung, in Frankfurt bei 0,17 EUR bei zuletzt -36% Veränderung. An beiden Börsen scheint Cipher wenig gehandelt zu werden, so dass die allgemeine Regel, eine Aktie am aktivsten Börsenplatz zu handeln für mich in diesem Fall nicht so zwingend erscheint. Von den Kursen her ist Frankfurt deutlich attraktiver (was mich in dieser Größenordnung sowie angesichts der unterschiedlichen Kurstendenzen) schon etwas überrascht :rolleyes: Außerdem könnte man in Frankfurt einiges an US-Ordergebühren sparen (comdirect...).

Besten Dank für eure Antworten!
Hallo zusammen

....Sollte kein Vorwurf sein lediglich eine Bitte ....Für Cipher gibt es bereits ein Tread könntet Ihr bitte dort beiträge über diese posten...

http://www.wallstreet-online.de/diskussion/1127432-1-10/cipher-pharma-am-abgrund

vielen dank

Greez
Antwort auf Beitrag Nr.: 36.301.221 von Jan-Henning am 04.01.09 18:36:20Hallo Jan

Du hast deine Frage eigentlich schon selbt beantwortet da weder in CA noch in D kaum gehandelt wird ist es eigentlich egal wo außer in USA da auf keinenfall .

Die 0,17 € in F ist nur fake zu diesen Kurs kriegst du die Aktie niemals ich hab auch meine zum Ask-kurs bekommen und das erst nach einigen Tagen .Die 5000st zu 0,33€ vorletzte Woche stammen von mir war nicht einfach die zu bekommen .
Du kannst ja versuchen die zum Bid-kurs zubekommen wäre ein schnäppchen aber ich bin mir sicher Du wirst vergeblich warten .

TSX .. Ask:0,48 Bid:0,43
F ...Ask: 0,32€ Bid:0,22
Antwort auf Beitrag Nr.: 36.301.383 von sacha1978 am 04.01.09 19:09:25http://www.wallstreet-online.de/diskussion/1127432-1-10/cipher-pharma-am-abgrund << ein toller Titel :D:D kein Wunder das die Anleger verschreckt werden außerdem steht da nichts gescheites drin .sorry
Antwort auf Beitrag Nr.: 36.301.454 von StaatsKnecht am 04.01.09 19:26:03.......war ja nur eine bitte..... :look:

Dies ist ja ein Tread über Labopharm.......

greez
Antwort auf Beitrag Nr.: 36.301.477 von sacha1978 am 04.01.09 19:30:19Dann schlage ich Dir vor einen neuen mit einem besseren Titel zu eröffnen .
Was hälst Du davon ?
Antwort auf Beitrag Nr.: 36.301.495 von StaatsKnecht am 04.01.09 19:34:58Ich Interessiere mich ja nicht für Cipher........jedoch für Labopharm
Partyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyy bei Cipherrrrrrrrrrrrrrrrrrrrrrr:D:D:D:D:D:D:D schaut euch mal den Ask an :laugh:
http://finance.yahoo.com/q?s=dnd.to
Antwort auf Beitrag Nr.: 36.308.861 von StaatsKnecht am 05.01.09 20:03:58Ich habe die Aktie von Cipher auch schon länger.
Nach der Zulassung wird hier die Post abgehen.
Die Firma ist eine der kleinen Pharmafirmen die perfekt finanziert da steht.
Hier läßt sich auch viel spekulieren was die zukunft dieser firma angeht.:look:
Antwort auf Beitrag Nr.: 36.301.570 von sacha1978 am 04.01.09 19:50:46Labopharm wird in 2 Jahren sowiso bei etwa 9 US $ sein.

( ist nach meiner Einschätzung interessanter )
Antwort auf Beitrag Nr.: 36.309.499 von swissdm am 05.01.09 21:09:46Interessanter ????

Du vergisst das Labo schon fast 10X höher bewertet ist als Cipher .

Hab zwar ein teil verkauft bin aber immer noch in Labopharm investiert.
Hallo zusammen..

Hier den link zum heutigen Gespräch mit Labopharms CEO auf BNN

http://watch.bnn.ca/market-morning/january-2009/market-morning-january-6-2009/#clip126901

Greez
Antwort auf Beitrag Nr.: 36.319.006 von sacha1978 am 06.01.09 20:53:20kann das jemand auf deutsch zusammenfassen ?
Danke
Ist bei Labopharm die Luft schon wieder draussen??

Oder weiss jemand warum diese von Tag zu Tag nachlässt??

FDA Entscheid positiv...
Aussichten Positiv....
Umsaätze in CA auch gut.....

??

Greez
Ausblick Labopharm

1. Vermarktungspartner für Trazodone << steht unmittelbar bevor (rechne mit upfront zahlungen in höhe von min. 20 -50 mioUS$)

2. Zweimaltäglich Tramadol-Acetaminophen Kombi Phase III Daten werden im 2Q veröffentlicht << mit hoher wahrscheinlichkeit positiv

3. Markteinführung von Tramadol in USA durch Purdue << 2Q

4. 18.Juli fällt die Entscheidung über die zulassung von Trazodone

3 Analysten (RBC,Versant,CIBC) sagen Buy bis Strong Buy mit Kursziel zwischen 3 C$ - 5 C$ ...Mein Persönliches Kursziel liegt bei 12 C$ bis ende 2010 .
http://online.wsj.com/quotes/main.html?mod=search_ticker&sym…

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

Ausblick Cipher Pharma

US-Zulassung Tramadol 1Q
Start Phase III für Isotretinoin 1Q
Vermarktungspartner für Tramadol 1Q-2Q

Mein Kursziel für Cipher 3 C$-5C$ für 2009 (falls Zulassung für Iso noch 2009 stattfindet dann mindestens 5 C$)

Los gehts ............
Antwort auf Beitrag Nr.: 36.362.857 von StaatsKnecht am 13.01.09 13:20:14Das versucht einer seit tagen 6000st. für 0,60$ zu kaufen doch leider ohne erfolg anscheinend hat er jetzt auf 0,61$ erhöht .
Sein Kauf würde schneller durchgehen wenn er auf 3$ erhöht da ist mein erstes limit :laugh: .

http://www.stockhouse.com/tools/?page=%2FFinancialTools%2Fsn…
Es ist gar nicht lange her da konnte man Labopharm für anfang 30cent haben und es waren wirklich sehr wenige die sich für diese Aktie interessiert haben.
Und jetzt ist DDSS ein Fels in der Brandung.

Upcoming Milestones ....Das wird ein schönes Jahr :)

1. Vermarktungspartner für Trazodone << steht unmittelbar bevor (rechne mit upfront zahlungen in höhe von min. 20 -50 mioUS$)

2. Zweimaltäglich Tramadol-Acetaminophen Kombi Phase III Daten werden im 2Q veröffentlicht << mit hoher wahrscheinlichkeit positiv

3. Markteinführung von Tramadol in USA durch Purdue << 2Q

4. 18.Juli fällt die Entscheidung über die zulassung von Trazodone
Labopharm hält sich stabil über 1,30$ ,nächste Woche gibts Zahlen .
Die Aktie ist nach wie vor unterbewertet und für dieses Jahr stehen jede menge News an .

Marktkap: 76 Million US$
Cash : 35 Million US$
Kurs: 1,35 $

Auch Charttechnisch sieht es gut aus ...
1) Einmaltäglich Tramadol ist jetzt Weltweit (US ab 2Q) erhältlich
2) Trazodone mit mehreren Hundert million US$ potential wird hoffentlich am 18 Juli 09 Zugelassen
3) Zweimaltäglich Tramadol-Ace Kombi Phase III Daten werden auch im 2Q veröffentlicht

Wenn alles gut geht sind Kurse über 5$ bis zum Jahresende drin .:lick:

Antwort auf Beitrag Nr.: 36.586.980 von BrauchGeld am 16.02.09 13:59:40.....jaaa mit 5$ wäre ich auch schon zufrieden....:lick:
...zumindest vorerst!!!:D

Bin mal auf die Zahlen gespannt!!!
Greez
Warum sich ein Investment in Labopharm lohnen könnte ..

1.Markteinführung von Ryzolt in USA könnte dafür sorgen das Labopharm profitabel oder mindestens die kosten für die Forschung decken wird .

2.Trazodone zulassung in USA am 18.Juli 09 ,gibt FDA grünes licht dann wird jeder glücklich sein der diese Aktie besitzt .

3.Einen Vermarktungspartner für Trazodone müsste auch bald abgeschlossen sein ,das wird einige million US$ upfronts in die Kasse spülen .

Ich halte Labopharm für ein Top Pick 2009 ...


Labopharm Reports Results for Year End and Fourth Quarter Fiscal 2008
Thursday February 26, 7:00 am ET

- Quarter Highlighted by Regulatory Approval of Once-Daily Tramadol in
the U.S and FDA Acceptance of NDA for Novel Treatment for Depression -

LAVAL, QC, Feb. 26 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today reported its results for the fourth quarter and year ended December 31, 2008. All figures are in Canadian dollars unless otherwise stated.

"With our first product about to be rolled out in the world's largest pharmaceutical market, our second under consideration for regulatory approval by the FDA and our third undergoing a Phase III study, 2009 will be an eventful year with a series of value-driving milestones." said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc.

Labopharm's key milestone events in 2009 include:
- Launch of its once-daily tramadol product in the U.S. during the
second quarter;
- The PDUFA date for its novel trazodone formulation on July 18; and
- Results of the Phase III clinical trial for its twice-daily
tramadol-acetaminophen formulation during the first half of the
year.

Financial Summary

Revenue from product sales of Labopharm's once-daily tramadol for the fourth quarter of fiscal 2008 increased to $3.3 million from $1.6 million for the fourth quarter of fiscal 2007. Adjusted gross margin for the fourth quarter of fiscal 2008 increased to 51.8% from 43.5% for the fourth quarter of fiscal 2007, primarily due to higher average selling prices. Research and development expenses, net of research and development tax credits, for the fourth quarter of fiscal 2008 were $5.2 million compared with $6.3 million for the fourth quarter of fiscal 2007. Selling, general and administrative expenses for the fourth quarter of fiscal 2008, were $10.6 million compared with $4.5 million for the fourth quarter of fiscal 2007 and included an accrual of $4.8 million for the Company's share of litigation costs related to patent enforcement following approval of its once-daily tramadol product in the U.S. Net loss for the fourth quarter of fiscal 2008 was $14.7 million, or $0.26 per share, compared with $10.0 million, or $0.18 per share, for the fourth quarter of fiscal 2007.

Key Developments for the Fourth Quarter

Once-Daily Tramadol Product Approved in the U.S. - Labopharm's once-daily tramadol product received regulatory approval from the U.S. Food and Drug Administration (FDA) on December 30, 2008. The Company expects its product, which will be marketed under the brand name RYZOLT®, to be launched by its marketing partner, Purdue Pharma L.P., in the second quarter of 2009.

NDA For Novel Trazodone Formulation Accepted For Review and Filed by FDA/Company in Ongoing Discussions for U.S. Marketing Partnership - Labopharm's New Drug Application (NDA) for its novel trazodone formulation was accepted for review and filed by the U.S. Food and Drug Administration (FDA) with an action date under the Prescription Drug User Fee Act (PDUFA) of July 18, 2009. The Company is in ongoing discussions with potential marketing partners towards establishing a licensing and distribution agreement for the United States.

Enrolment Completed for Phase III Clinical Trial for Twice-Daily Tramadol-Acetaminophen Formulation - Labopharm completed enrolment for its North American Phase III clinical trial for its twice-daily formulation of tramadol-acetaminophen (study 06CCL3-001). The Company expects to report the results of the study in the coming weeks. The Company is in discussion with potential marketing partners towards establishing licensing and distribution agreements for the U.S. and other key markets globally.

Other Recent Developments

Once-Daily Tramadol

Market Share in Canada Increases to 36% - Market share for Labopharm's product in Canada continued to grow, reaching 36% for the month of January 2009.

In-Market Sales in Europe Exhibit Strong Year-Over-Year Growth - In-market sales of Labopharm's product in major European markets(1) for 2008 grew 72% to more than 27 million standard units compared to 2007. Labopharm's product was the best selling once-daily tramadol product in these markets(1) in 2008 with 44% share of the market(2), up from a 30% share in 2007.

Product Launched in Israel - Labopharm's once-daily tramadol product was launched in Israel by its marketing partner for that country, Dexcel Pharma Technologies Ltd.

Established Marketing Partnerships for Three Additional Countries - Labopharm signed licensing and distribution agreements for three additional countries: Brazil, Denmark and Switzerland.

Abuse Deterrent Platform

Preparing to Initiate Clinical Studies for a Widely Misused Combination Pain Drug - Labopharm is preparing to enter the clinic in the first half of 2009 with an abuse deterrent formulation of a widely prescribed pain drug. The Company has completed pre-clinical, proof-of-principle studies of its platform using once-daily tramadol as a safe representative of the controlled-release opioid class of drugs. The positive results of the pharmacokinetic study demonstrated controlled-release characteristics and bioequivalence to once-daily tramadol and the in vitro studies demonstrated misuse and abuse deterrent characteristics.

----------------------------------
(1) Includes France, Germany, the United Kingdom, Spain and Italy.
(2) Labopharm's target market in Europe consists of the market for
immediate-release, twice-daily, once-daily and drop formulations of
tramadol.

Financial Results

Three-Month Period Ended December 31, 2008

Revenue for the fourth quarter of fiscal 2008 increased to $4.4 million from $2.6 million for the fourth quarter of fiscal 2007. Revenue from product sales increased to $3.3 million from $1.6 million for the fourth quarter of fiscal 2007. The increase in revenue from product sales was the result of higher sales volumes and higher average selling prices in the fourth quarter of fiscal 2008.

Adjusted gross margin (as a percentage of revenue from product sales) for the fourth quarter of fiscal 2008 increased to 51.8% from 43.5% for the fourth quarter of fiscal 2007. Adjusted gross margin for the fourth quarter of fiscal 2008 excludes the reversal of $150,000 of previously recorded write downs while adjusted gross margin for the fourth quarter of fiscal 2007 excludes the reversal of $390,000 of expenses previously recorded in 2007, primarily related to the U.S. pre-launch inventory. The increase in adjusted gross margin was due primarily to a higher average selling price.

Licensing revenue for the fourth quarter of fiscal 2008 was $1.2 million and represented a portion of licensing payments received from the Company's licensing and distribution partners for once-daily tramadol. Licensing revenue for the fourth quarter of fiscal 2007 was $1.1 million.

Research and development expenses, before research and development tax credits, for the fourth quarter of fiscal 2008 were $4.2 million compared with $7.9 million for the fourth quarter of fiscal 2007. The decrease was primarily the result of lower costs related to clinical trial activity in the fourth quarter of fiscal 2008. Research and development tax credits for the fourth quarter of fiscal 2008 were negative $1.0 million, the result of the Company's change in tax planning strategy. Research and development tax credits for the fourth quarter of fiscal 2007 were $1.6 million.

Selling, general and administrative expenses for the fourth quarter of fiscal 2008 were $10.6 million compared with $4.5 million for the fourth quarter of fiscal 2007. The increase is primarily the result of the accrual of $4.8 million for the Company's share of litigation costs incurred by Purdue Pharma to enforce certain of Purdue's U.S. patents related to Labopharm's once-daily tramadol product, which received U.S. regulatory approval on December 30, 2008. Payment of Labopharm's share of litigation costs will be made through deductions from quarterly royalty payments made by Purdue to Labopharm on sales of Labopharm's once-daily tramadol product, up to 50% of the amount of the royalty payment. Any outstanding amount due Purdue at December 31, 2010 or thereafter, if any, for such litigation costs will be due immediately. The increase in selling, general and administrative expenses was also the result of higher sales and marketing costs.

During the fourth quarter, the Company made an additional adjustment to the estimated fair value of its asset backed commercial paper (ABCP) investment and took an additional impairment charge of $0.2 million. The total impairment charge taken to date on the ABCP is $2.8 million. The initial ABCP investment was $5.6 million.

Net loss for the fourth quarter of fiscal 2008 was $14.7 million, or $0.26 per share, compared with $10.0 million, or $0.18 per share, for the fourth quarter of fiscal 2007.

Cash, cash equivalents and marketable securities at December 31, 2008 were $44.9 million, compared with $44.1 million at September 30, 2008. The cash, cash equivalents and marketable securities position at December 31, 2008 does not include the Company's ABCP investment with an estimated fair value of $3.2 million that was reclassified as a long-term investment in the third quarter of 2007. During the quarter, the Company drew down an additional US$5 million (Cdn$5.8 million) of its existing US$25 million term loan facility with Hercules Technology Growth Capital, Inc., bringing the total principal outstanding under the facility to US$20 million.

Twelve-Month Period Ended December 31, 2008

For fiscal 2008, revenue increased to $22.0 million from $19.0 million for fiscal 2007. Revenue from product sales increased to $13.2 million from $11.9 million for fiscal 2007. The significant growth in in-market sales for fiscal 2008 compared to fiscal 2007 is not reflected in product sales due to a large portion of 2007 shipments being composed of initial launch quantities and some marketing partners having entered 2008 with high inventory levels that delayed follow on orders, resulting in lower sales volumes. These were partially offset by higher average selling prices as a result of a more favourable product mix.

Adjusted gross margin (as a percentage of revenue from product sales) for fiscal 2008 increased to 56.9% from 50.4% for fiscal 2007. Adjusted gross margin for fiscal 2008 excludes a write off of inventory of $255,000 and a 2007 royalty provision reversal of $105,000, while adjusted gross margin for fiscal 2007 excludes a $1.4 million provision for once-daily tramadol pre-launch inventory and related deposits to manufacturers, net of adjustments of $341,000 with respect to the reversal of previously recorded accounts payable. The increase in adjusted gross margin was due primarily to lower packaging costs and higher average selling prices per tablet.

Licensing revenue for fiscal 2008 was $8.9 million and represented a portion of licensing payments received from the Company's licensing and distribution partners for once-daily tramadol. Licensing revenue for fiscal 2007 was $5.8 million. The increase was primarily due to the recognition of the balance of the licensing payments previously received from Recordati as a result of the Company reacquiring the sales and marketing rights to its once-daily tramadol product in the United Kingdom.

Net loss for fiscal 2008 was $40.5 million, or $0.71 per share, compared with $36.6 million, or $0.64 per share, for fiscal 2007. The increase in net loss was primarily the result of higher selling, general and administrative expenses related to the litigation costs due Purdue Pharma, as well as higher headcount and related compensation expenses and higher sales and marketing expenses.
Heute sind ja die Zahlen gekommen.....

http://www.labopharm.com/Default.aspx?id=83&reqId=1260302


http://www.reuters.com/article/marketsNews/idCAN2653763520090226?rpc=44

Greez
:confused::confused::confused:

kann mir mal jemand den traurigen Kurseverlauf von Labopharm erklären??

Die sacken ja immer mehr ab!!

Nicht mehr lange und wir sind wieder da wo wir angefangen haben......Preise wie vor der Zulassung!!!:mad:

Greez
:mad::mad::mad::mad:

fällt.....und fällt.......und fällt....und fällt

:mad::mad:
Was ist den da bloss los!!!!??
Antwort auf Beitrag Nr.: 36.682.915 von sacha1978 am 02.03.09 17:25:12Alles was ich hierzu sagen kann ist RIESEN GELEGENHEIT MEHR ZU KAUFEN .

Ich werde die Anteile zurückkaufen die ich mit Gewinn verkauft habe .
Antwort auf Beitrag Nr.: 36.683.889 von BrauchGeld am 02.03.09 19:13:03Immer kurz vor irgendwelchen News wird gekauft das ist mir bei Labopharm schon häufiger aufgefallen.

Enrolment Completed for Phase III Clinical Trial for Twice-Daily Tramadol-Acetaminophen Formulation - Labopharm completed enrolment for its North American Phase III clinical trial for its twice-daily formulation of tramadol-acetaminophen (study 06CCL3-001). The Company expects to report the results of the study in the coming weeks. <<< VERMUTLICH HAT ES DAMIT ZU TUN

Labopharm ,Allergy und Alchemia für alle drei ist das Jahr 2009 das entscheidende und alle drei befinden sich in mein Depot :) .

http://canadianinsider.com/coReport/allTransactions.php?tick…

Mar 09/09 Mar 03/09 Porte, Frédéric Indirect Ownership Common Shares 10 - Acquisition in the public market 500 $1.050
Mar 09/09 Mar 03/09 Porte, Frédéric Indirect Ownership Common Shares [Amended Filing] 10 - Acquisition in the public market 39,500 $1.050
Antwort auf Beitrag Nr.: 36.740.879 von BrauchGeld am 10.03.09 20:42:48....inclusive Stem cells (SSS.V)

:D:laugh::D:laugh:

Hoffen wir das beste!!!!

Greez
Hier stehen jede menge News in den nächsten Wochen an ...

Marktkap: 58,5 Million US$ << viel zu billig
Cash : 35 Million US$
Kurs: 1,03 US$


Upcoming Milestones ...

1. Vermarktungspartner für Trazodone << steht unmittelbar bevor (rechne mit upfront zahlungen in höhe von min. 20 -50 mioUS$)

2. Zweimaltäglich Tramadol-Acetaminophen Kombi Phase III Daten werden im 2Q veröffentlicht << mit hoher wahrscheinlichkeit positiv

3. Markteinführung von Tramadol in USA durch Purdue im 2Q

4. 18 Juli fällt die Entscheidung über die zulassung von Trazodone


Antwort auf Beitrag Nr.: 36.767.150 von BrauchGeld am 14.03.09 13:50:23Irgendwas kommt da auf uns zu und es scheint positiv zu sein .....
Antwort auf Beitrag Nr.: 36.776.331 von BrauchGeld am 16.03.09 17:26:26Ja sehe ich auch so!!!!!

Freuen wir uns auf das was kommt und lassen uns Überaschen...
:lick::lick::lick::lick:
:laugh:
Antwort auf Beitrag Nr.: 36.776.816 von sacha1978 am 16.03.09 18:15:36Labopharm ist eigentlich die Topaktie für´s 1H 2009 ...Go Labo
Antwort auf Beitrag Nr.: 36.781.658 von BrauchGeld am 17.03.09 11:41:28Labopharm rennt davon und trotzdem immer noch saubillig :lick:
Antwort auf Beitrag Nr.: 36.791.935 von BrauchGeld am 18.03.09 13:48:11Hab das mal von Yahoo kopiert zum thema " Cowen Präsentation "

Positives hab ich rot markiert ...

CEO quotes

Fully expects Traz approval Jul18
Partnership deep into negociation prior to approval date

Perdue ready to roll out Tram in EARLY Q2 (april!)

mentioned the market will be very very pleased with the pgm Perdue has come up with

2daily tram - phaseIII completed - awaiting data any day now - if all ok(as planned) SUBMITS new NDA to FDA before year end

and also mentioned in negociation with other drug co. who want to use their technology

lastly
abuse-deterrent one - very confident and along the way

Slow rise to previous level IMO - med-long term Year end on this one can see a very nice pps

previous highs reached , who knows - ALL positive
glta
Labopharm reports results for Phase III study on twice-daily tramadol-acetaminophen formulation
Thursday April 2, 2009, 7:15 am EDT
Buzz up! Print Related:Labopharm Inc.
LAVAL, QC, April 2 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced the results of its recently completed North American Phase III clinical trial for its twice-daily formulation of tramadol and acetaminophen (study 06CCL3-001).

Related Quotes
Symbol Price Change
DDSS 1.29 0.00


{"s" : "ddss","k" : "c10,l10,p20,t10","o" : "","j" : ""} Study 06CCL3-001 was a multi-centre, randomized, double-blind, parallel-arm study that compared the efficacy and safety of Labopharm's twice-daily tramadol-acetaminophen formulation to placebo in the treatment of moderate to severe acute low back pain. A total of 277 patients were included in the study. Thirteen percent (13%) of patients in the active treatment group discontinued early (12% due to adverse events) and 5% of patients in the placebo group discontinued early (2% due to adverse events).

Results of the efficacy measures in the study demonstrated a statistically significant difference from placebo in some cases but not in others. An analysis of covariance demonstrated a statistically significant difference from placebo on the Sum of Pain Intensity Differences (SPID) over 50 hours using LOCF (last observation carried-forward) as the imputation method, however, the results were not statistically significant using LOCF/BOCF (baseline observation carried-forward), the primary endpoint. A non-parametric analysis, however, demonstrated statistical significance using both LOCF and LOCF/BOCF as imputation methods. The difference from placebo on the Total Pain Relief (TOTPAR) score was also statistically significant using both LOCF and LOCF/BOCF imputation methods and the patients' global impression of the effectiveness of the study medication was statistically different from placebo. Statistical significance reflects a p-value of less than 0.05 in each of the analyses.

Regulatory authorities throughout the world have different requirements for the analysis and demonstration of efficacy in clinical trials. Labopharm believes that it is likely that the results of this trial are insufficient to support the acceptance of a New Drug Application (NDA) by the Food and Drug Administration (FDA) in the United States. The Company intends to discuss the matter with the FDA's Division of Anesthesia, Analgesia & Rheumatology Products (DAARP) to determine the path forward. The results of this study are however statistically significant under analyses that the Company believes may be accepted for the evaluation of analgesics in Europe, Canada and other jurisdictions. Accordingly, the Company intends to meet with the regulatory authorities for these jurisdictions at the earliest available opportunity in pursuit of regulatory approval. Should the authorities be in agreement, the Company expects that it would submit a regulatory application in those jurisdictions.

The Company will provide additional information following discussions with the various regulatory authorities.

The results of the study have no bearing on the upcoming launch of the Company's once-daily tramadol product in the United States.

About Tramadol-Acetaminophen Combination Products

Tramadol-acetaminophen products leverage the unique but complementary modes of action of each of the active ingredients to provide the analgesic strength of a mild opioid (tramadol) and the rapid pain relief of acetaminophen. Tramadol-acetaminophen combination products were first launched in 2001 in the United States and in 2003 in other major markets and are indicated for the short-term (five days or less) management of acute pain in the U.S. and the symptomatic treatment of moderate to severe pain in the rest of the world.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally and its second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the price of the Company's shares, the uncertainties related to the regulatory process for drug approval and the commercialization of the Company's products, if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.

EmailIM Bookmarkdel.icio.usDigg Buzz up!
Antwort auf Beitrag Nr.: 36.907.584 von sacha1978 am 02.04.09 16:57:24Was gibts da zu heulen ?

Ok die Daten sind nicht so wie ich es mir gewünscht hätte aber so ist das halt mit Biotechs .

Trotzdem Labopharm bleibt weiterhin sehr attraktiv wir haben Tramadol das bald geld in die Kasse spülen wird und dann noch das Hauptprodukt Trazadone wenn hier die Zulassung kommt sind wir schnell bei 3$-5$ .

Alles im bereich von 1$ sind gute Kaufkurse
:D:D:D

Herrlich diese Entwicklung bei Labopharm....
Da kommt freude auf!!!!!!!!

.......auch wenn ich das Volumen anschaue!!

Einfach Super!!!!:laugh::D:laugh::D

Greez
oups Sorry hab ich vergessen.....


http://finance.yahoo.com/q?s=DDS.TO
Mal schauen wie die Abarbeitung der FDA-Bedenken dauern - aus meiner Sicht hochgradig unprofessional, sich so zu verhalten!
:cry::cry:

Scheiss Spiel!!!!!!!!!!!!

:cry::cry::cry:

http://www.reuters.com/article/marketsNews/idCAN206677920090720?rpc=44

.....
Antwort auf Beitrag Nr.: 37.607.078 von Gulliver am 20.07.09 15:55:50aus meiner Sicht hochgradig unprofessional, sich so zu verhalten!


...dies ist jedoch kein aussergewöhnlicher Fall, dass die FDA Beanstandungen hinsichtlich der Produktion einer Aktivsubstanz anzumelden hat. Selbst bei Pharmariesen kommt es immer wieder mal vor, dass die FDA-Gewaltigen ein Haar in der "Produktionssuppe" finden. Und bei kleineren Firmen wie z.B. Angelini (der Produzent der Aktivsubstanz) ist dieses Risiko natürlich noch etwas grösser. Denen dann die Professionalität vollständig abzusprechen halte ich dann doch für etwas überzogen, zumal die FDA-Auditoren wie gesagt auch den Verantwortlichen der allergrössten Pharma-Firmen (z.B. auch bei meinem Arbeitgeber) mitunter Schweissperlen auf die Stirn treiben.

Ich hoffe dann doch, dass die beanstandeten Mängel innerhalb kurzer Zeit beseitigt werden und dann die Zulassung von Trazodone für den US-amerikanischen Markt ausgesprochen wird.
Jaaawooohl!!!
:D:D

Scheint endlich so das sich das warten doch noch Lohnen wird!!
Endlich positive Nachrichten!!

http://finance.yahoo.com/q?s=DDS.TO

http://finance.yahoo.com/news/Labopharm-announces-that-its-cnw-1658186595.html?x=0&.v=2

http://www.reuters.com/article/marketsNews/idCABNG39922020091007?rpc=44

Greez
Antwort auf Beitrag Nr.: 38.135.594 von sacha1978 am 07.10.09 21:43:443 Dollar werden im Sommer schon drin liegen.



GLTA
So langsam kann man hier wieder einsteigen!

Der 11. Februar rückt näher!

Vertriebspartnerschaft in GB abgeschlossen.


'The FDA has assigned Labopharm a new Prescription Drug User Fee Act (PDUFA) action date of February 11, 2010,'
Labopharm wurde nun, rechtzeitig vor den viel versprechenden Neuigkeiten zu Trazodone, in das Biotechnologie-Depot aufgenommen. Weiterführende Info gibts hier:

http://www.wallstreet-online.de/diskussion/1136906-neustebei…
Anbei ein aktueller Artikel zu bevorstehenden FDA-Approval-Terminen. Wie bereits im Thread erwähnt soll am 11.2. für DDSS die Stunde der Wahrheit schlagen.

Quelle: http://www.todaysfinancialnews.com/investment-strategies/fda-decision-dates-10579.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+todaysfinancialnews+%28Today%27s+Financial+News%29

********************************************************************
Upcoming FDA decision dates… and the companies that may benefit

We’ve compiled a list of January and February FDA decision dates – and the companies that could see massive movement in their share price as those dates approach.

by Laura Cadden, TodaysFinancialNews.com

Baltimore (TFN): Favorable FDA decisions can mean resounding gains for pharma investors…

Vanda Pharmaceuticals (NASDAQL:VNDA) experienced an 800% increase in share price when it when the FDA granted approval for Fanapt, a drug to treat schizophrenia, back in May.

On Dec. 1, Santarus Inc. (NASDAQ: SNTS) announced its heartburn medication, Zegerid, was approved by the FCA. The Stock went up over 40% in 24 hours.

More modest (but still significant) was the 20% increase Dyax Corp. (NASDAQ: DYAX) saw on Dec. 2 when it was announced that the company’s treatment for the genetic disorder hereditary angiodema, Kalbitor, had received FDA clearance.

So what company could be next for these kinds of gains?

Below is a list of January and February FDA decision dates – and the publicly traded companies that could see massive price movement in their share prices as those dates approach:

FDA decision due: Jan. 16, 2010
MannKind Corporation (NASDAQ:MNKD)
Regarding: Preliminary approval an inhaled insulation device called Afresa.
Share price as of 12/30/2009: $25.40

FDA decision due: Jan. 18, 2010
Roche Holding Ltd. (OTC:RHHBY)
Regarding: Approval for the use of Taceva for the treatment of lung cancer in patients already responding to chemotherapy.
Share price as of 12/30/2009: $42.18

FDA decision due: Jan. 22, 2010
Acorda Therapeutics (NASDAQ:ACOR)
Regarding: New drug application review for Fampridine-SR to be used to improve conduction in nerve fibers when the insulating layer (myelin) has been damaged.
Share price as of 12/30/2009: $25.39

FDA decision due: Jan. 30, 2010
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Regarding: The results of a meeting with the FDA to discuss the viability of continuing to seek approval for Fusilev for the treatment of colon cancer will be announced.
Share price as of 12/30/2009: $4.42

FDA decision due: Feb. 9, 2009
XenoPort, Inc. (NASDAQ:XNPT)
Regarding: FDA review results of gabapentin encarbil for the treatment of moderate-to-severe primary Restless Legs Syndrome.
Share price as of 12/30/2009: $18.48

FDA decision due: Feb. 11, 2009
Labopharm Inc. (NASDAQ: DDSS)
Regarding: Approval of Trazodone Contramid for depression.
Share price as of 12/30/2009: $2.03


FDA decision due: Feb. 12, 2009
Cadance Pharmaceuticals (NASDAQ: CADX)
Regarding: Approval of acetavance (intravenous acetamenophin) for the treatment of fever and pain.
Share price as of 12/30/2009: $9.73

FDA decision due: Feb. 13, 2009
Gilead Sciences (NASDAQ:GILD)
Regarding: Approval of Cayston for the treatment of cystic fibrosis.
Share price as of 12/30/2009: $43.93

********************************************************************
Antwort auf Beitrag Nr.: 38.686.561 von yxcv1234 am 07.01.10 18:56:08:eek:UND noch ein Artikel, brandaktuell::eek:

Source: Beacon Equity
Market Watch for Labopharm Inc. Issued by Beacon Equity

DALLAS, Jan. 7, 2010 (GLOBE NEWSWIRE) -- BeaconEquity.com announces an investment report featuring pharmaceutical company Labopharm Inc. (Nasdaq: DDSS). The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

The full report is available at: http://www.beaconequity.com/i/DDSS

Get our alerts BEFORE the rest of the market. Follow us on Twitter: http://twitter.com/BeaconEquity

Labopharm Inc. (DDSS) is a worldwide specialty pharmaceutical company engaged in the application of its advanced controlled-release technologies to existing marketed drugs. Its lead technology, Contramid(R), is designed to improve performance of presently available drugs through a time-release function. The Company's lead drug, Tramadol, is marketed as a moderate to severe pain reliever. Other drugs presently in FDA trials include DDS-04A (SARI) containing Trazodone Hydrochloride, DDS-06C containing Tramadol-Acetaminophen, DDS-06A containing Acetaminophen, DDS-06B containing Tramadol, DDS-07L and DDS-07U, DDS-04F (Propofol) and DDS-06E: SN-38 for the treatment of colon cancer.

In the report, the analyst notes:

"The Company's novel pain relief technologies are an innovative approach to anti-inflammation, which is estimated to address an approximate 400 million number of incidents of acute inflammation conditions each year. The market for anti-inflammation products is anticipated to grow beyond the current $10 billion market, worldwide.

"The Company's DDS-06E is under development for the treatment of colon cancer. According to the Cancer Market Outlook report published by Business Insights, the market for cancer therapeutic drugs is expected to reach $40.9 billion by 2012. If approved by the U.S. Food and Drug Administration (FDA), the market for the Company's drug candidates has a potential to reach more than $1 billion at market saturation."

To read the entire report visit: http://www.beaconequity.com/i/DDSS

See what investors are saying about DDSS at penny stock forum.

BeaconEquity.com is one of the industry's largest small-cap report providers striving to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on Beacon Research, please visit http://www.BeaconEquity.com

Beacon Equity Disclosure

DO NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND ON THIS REPORT. We are not registered as a securities broker-dealer or an investment adviser either with the U.S. Securities and Exchange Commission (the "SEC") or with any state securities regulatory authority. We are neither licensed nor qualified to provide investment advice. Beacon Equity nor its affiliates have a beneficial interest in the mentioned company; nor have they received compensation of any kind for any of the companies listed in this communication. The information contained in our report is not an offer to buy or sell securities. We distribute opinions, comments and information free of charge exclusively to individuals who wish to receive them.

CONTACT: Beacon Equity Research
Jeff Bishop
(469)-252-3505
press@beaconequity.com
Wann geht der Run los????;)

"The Company's novel pain relief technologies are an innovative approach to anti-inflammation, which is estimated to address an approximate 400 million number of incidents of acute inflammation conditions each year. The market for anti-inflammation products is anticipated to grow beyond the current $10 billion market, worldwide.

"The Company's DDS-06E is under development for the treatment of colon cancer. According to the Cancer Market Outlook report published by Business Insights, the market for cancer therapeutic drugs is expected to reach $40.9 billion by 2012. If approved by the U.S. Food and Drug Administration (FDA), the market for the Company's drug candidates has a potential to reach more than $1 billion at market saturation."

Antwort auf Beitrag Nr.: 38.689.260 von Biotechspezialx am 07.01.10 23:10:57Ja ich bin auch gespannt, wann den der Kurs anspringt. Normalerweise steigen die Kurse schon Tage vor Bekanntgabe des Ergebnisses. Entweder durch Insiderkäufe oder durch Leute die nichts verpassen wollen. Das hat man bei Vermillion und anderen Werten gesehen, wie schnell der Kurs durch die Decke gehen kann, wenn das FDA Approval kommt. Kurs kann natürlich dann auch ganz schnell in die andere Richtung gehen, falls die FDA "rejected".

Aber mal schauen, ob´s hier wie bei anderen Werten in der Vergangenheit ähnlich läuft, und der Kurs schon vor Bekanntgabe anzieht. ;)
Antwort auf Beitrag Nr.: 38.689.800 von yxcv1234 am 08.01.10 08:04:37Die Probleme die bei Herstellung, in der Qualität Trazodon /was die FDA bemängelt hat Juli 2009 /um Trazodon zu produzieren /sind behoben.

Wie am 7. Oktober DDSS FDA sagte, dass alle Fragen im Zusammenhang mit der Anlage zufriedenstellend gelöst worden sind.


Erstes Kussziel nach Zulassung am 11. Februar 7-9 $ nach Bekanntgabe weiterer Ankündigung von Partnerschaften.... werden wohl die 10$ Marke überschreiten.
Bei nicht Zulassung werden wir uns bei 1,50 –1,30 $ wieder finden .

Chance für Zulassung sehe ich persönlich bei 75%
:lick:
Antwort auf Beitrag Nr.: 38.691.479 von Biotechspezialx am 08.01.10 11:17:44"Die Probleme die bei Herstellung, in der Qualität Trazodon /was die FDA bemängelt hat Juli 2009 /um Trazodon zu produzieren /sind behoben."



Kannst Du bitte noch ein paar mehr Infos hierzu geben ? Bin leider erst seit wenigen Tagen dabei und bin durch den bevorstehenden FDA Termin aufmerksam geworden. Vielleicht auch für andere Leser interessant...
Antwort auf Beitrag Nr.: 38.692.086 von yxcv1234 am 08.01.10 12:15:58Das Problem was unten angesprochen wurde ist behoben!!

WICHTIG ! WIRKSAMMKEIT UND SICHERHEIT WURDEN NICHT BEANSTANDET!!!


TORONTO, 20. Juli (Reuters) - Labopharm Inc, sagte am Montag der US Food and Drug Administration hat die Zustimmung verweigert der Labopharms einmal täglich Depressionen Behandlung Trazodon unter Berufung auf Mängel bei einer Produktionsanlage.

Die FDA sagte die kleine Montreal ansässige Unternehmen in einem Brief, dass die Behandlung nicht würde, bis alle seine Besorgnis über Defizite zugelassen werden konnten befriedigt werden.

Das Unternehmen hat nicht angegeben, was die Mängel waren, sagte aber keine Wirksamkeit oder Sicherheit Fragen über die Behandlung erhoben wurden.
Der Wirkstoff in der Behandlung enthalten ist, durch einen Vertrag Arzneimittelhersteller namens Angelini hergestellt.

"Wir wollen eng mit der FDA und Angelini mit diesen Fragen so schnell wie möglich zu beheben, 'James Howard-Tripp, President und Chief Executive bei Labopharm, sagte in einem Release.

"Wir sind weiterhin für die Kommerzialisierung unserer neuartigen Antidepressiva vorzubereiten und die Absicht, in den US-Markt so schnell wie möglich, nachdem wir die Genehmigung erhalten zu starten."

Das Unternehmen war nicht zur weiteren Kommentar.

Anfang dieses Jahres, so das Unternehmen hofft, das Produkt in den Vereinigten Staaten bis Ende 2009 oder Anfang 2010 starten.

Antidepressiva einen Umsatz von 12 Milliarden Dollar in den Vereinigten Staaten im Jahr 2007.
Antwort auf Beitrag Nr.: 38.686.693 von yxcv1234 am 07.01.10 19:08:41...ich möchte nur ungern auf die Euphoriebremse treten, aber verschiedene "Analystenhäuser" jubeln gegen bare Münze auch über die kleinste Hinterhoffirma - meines Erachten gehört Beacon Equity in diese Liga.

Trotzdem bin ich sehr zuversichtlich was die Zulassungsentscheidung betrifft. Da die Klinik (Wirkung/Nutzen/Risiko) im Complete Response Letter der FDA nicht thematisiert wurde und die Beanstandungen beim Hersteller der Aktivsubstanz (Grupo Angelini) angeblich gelöst sind ( --> http://www.labopharm.com/Default.aspx?id=83&reqId=1339542 "Labopharm announces that its trazodone API supplier has resolved outstanding manufacturing issues with the FDA")
sollte einer Zulassung spätestens zum 11.2.2010 michts mehr im Wege stehen. Allerdings wäre ich sehr vorsichtig, mit den prognostizierten Kurssprüngen Ich denke nämlich, dass ein positiver Zulassungsentscheid erwartet wird und somit sich die Reaktion auf die Entscheidung nicht so spektakulär im Kurs auswirken sollte wie verschieden Teilnehmer sich erhoffen (Biotechspezialx: "Erstes Kussziel nach Zulassung am 11. Februar 7-9 $."). Es sei daran erinnert, dass bei vergangenen Zulassungsentscheidungen (AlTH, SPPI) der Kurs trotz Zulassung geschwächelt hat. Erst eine veröffentlichte Kooperation mit einem etablierten Unternehmen zur Vermarktung von Trazodone könnte die Phantasie gehörig anheizen.

Link zum Musterdepot mit weiteren Informationen zu Labopharm:
http://www.wallstreet-online.de/diskussion/1136906-neustebei…
Antwort auf Beitrag Nr.: 38.699.113 von Cyberhexe am 09.01.10 07:34:43Um den angedeuteten Ausbruch (Bollinger-Band) Anfang Januar zu manifestieren und damit die Ausbruchsrichtung zu bestätigen sollte sich der Schlusskurs in den nächsten Tagen oberhalb der $ 2,40 festsetzen.

Gruss aus dem verschneiten wilden Süden.
Schnauggi
Antwort auf Beitrag Nr.: 38.709.035 von schnauggi am 11.01.10 15:54:07Leider heute kein Trend nach oben zu erkennen, obwohl die Umsätze in USA schonmal erfreulich über dem Durchschnitt der letzten Monate liegen.
Heute wird zwar nicht in USA gehandelt, hab mir aber trotzdem mal den Chartverlauf angesehen. Für mich sieht es so aus als, als das in Kürze ein Ausbruch erfolgen muß, entweder nach ober oder unter.
Bis zum FDA Approval-Termin sind es noch knapp 3 Wochen, so daß ich hoffe, daß hier langsam mal ein regerer Handel reinkommt.

http://www.marketwatch.com/investing/stock/DDSS/charts?count…
Antwort auf Beitrag Nr.: 38.759.780 von yxcv1234 am 18.01.10 20:10:23Sieht so aus, als ob jetzt Bewegung rein kommt. Steigender Kurs und steigende Umsätze. Nur noch 23 Tage bis zur Enscheidung der FDA! :laugh:
Antwort auf Beitrag Nr.: 38.699.113 von Cyberhexe am 09.01.10 07:34:43... Allerdings wäre ich sehr vorsichtig, mit den prognostizierten Kurssprüngen Ich denke nämlich, dass ein positiver Zulassungsentscheid erwartet wird und somit sich die Reaktion auf die Entscheidung nicht so spektakulär im Kurs auswirken sollte wie verschieden Teilnehmer sich erhoffen (Biotechspezialx: "Erstes Kussziel nach Zulassung am 11. Februar 7-9 $."). Es sei daran erinnert, dass bei vergangenen Zulassungsentscheidungen (AlTH, SPPI) der Kurs trotz Zulassung geschwächelt hat...

muss ich dir leider widersprechen...das problem, welches ALLOS
den erwarteten kurssprung nach zulassung "versaut" hat,
war das doch sehr,sehr kleine indikationsfeld bzw. die extrem
hohen kosten der therapie pro patient...dies wurde zeitnah zur zulassung in allen medien diskutiert (ich war vor bzw. während der zulassung selbst in ALTH investiert) und hat die augenblicklich erzielbaren
revenues bei ALTH doch ziemlich auf den boden zurückgeholt...

die euphorie bzw. phantasie bei trazodone- approval sollte
sich vorsichtig ausgedrückt, erheblich mehr entwickeln...
ohne den naheliegenden vanda-vergleich ins spiel zu bringen;)
aber wir bewegen uns in ähnlichen märkten mit identischem
potential und erzielbaren peak-sales...
darauf cash-aufbauend dann eine forcierte weiterentwicklung
der vorhandenen pipeline bei labopharm lässt erhebliches potential im
zweistelligen dollarbereich erwarten...

hoffen wir, dass die SEDA-tranche zum jahreswechsel
die letzte in der geschichte von labopharm war
Antwort auf Beitrag Nr.: 38.769.857 von Gustl24 am 20.01.10 08:15:54trotzdem gratulation zur entwicklung deines biotech-depots, liebe hexe...
600% plus sind nicht zu verachten.:)
Nachbörslich ist sie noch auf 2,47 $ gestiegen, bin mal gespannt ob die Reise heute weiter nach oben geht...

http://www.marketwatch.com/investing/stock/ddss

die amis werden jetzt auch auf die kommende spur
gesetzt:

RTTNews) - With only weeks left for the FDA to decide on Labopharm Inc.'s ( DDSS | Quote | Chart | News | PowerRating) (DDS.TO) investigational drug DDS-04A, a novel once-daily formulation of antidepressant Trazodone, investors and traders are placing their bets. The decision date is on February 11. This is DDS-04A's second go-around with the FDA.

On July 20, 2009, Labopharm received a complete response letter from the FDA for the new drug application submission of DDS-04A. The FDA in its complete response letter indicated the deficiencies related to the API (active pharmaceutical ingredient) supplier's manufacturing facility. Angelini is the manufacturer of the API for Labopharm's novel Trazodone formulation. However, no efficacy or safety issues were raised.

Angelini submitted an action plan addressing the deficiencies to the FDA on July 24, 2009. The following month, Labopharm submitted its response to the FDA's complete response letter regarding the novel formulation of Trazodone. The regulatory agency, which accepted Labopharm's response, assigned a new action date of February 11, 2010.

Major depression is one of the most prevalent central nervous disorders, affecting more than 120 million people worldwide. The annual sales of antidepressants in the U.S. alone total in excess of $12 billion.
The antidepressants that are currently used are plagued by certain limitations like delayed onset of therapeutic response, insomnia or sleep disturbance, sexual dysfunction and anxiety to name a few. According to the World Health Organization, 40% of patients treated with current antidepressants discontinue treatment within the first 12 weeks due to limitations with existing products and their unwanted side effects.

Trazodone is a SARI (serotonin antagonist reuptake inhibitor) with proven efficacy as an antidepressant. Labopharm's novel formulation of Trazodone is a controlled release formulation designed to optimize the efficacy of Trazodone, and address the major challenges in treating depression.

The novel Trazodone formulation contains Contramid, which is Labopharm's clinically validated proprietary technology that controls the release of active substances from oral medications to optimize drug delivery.

The October 2009 issue of the international journal of neuropsychiatric medicine, CNS Spectrums, has published the potential benefit of Labopharm's novel Trazodone formulation.
According to the author of the article, Stephen Stahl, "Controlled-release Trazodone should theoretically allow adequate dose escalation to administer high doses for antidepressant action while avoiding sedation of the immediate release formulation. As an antidepressant, the new Trazodone formulation should be as effective as SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin norepinephrine reuptake inhibitors), yet as a serotonin antagonist reuptake inhibitor, have a low incidence of anxiety, insomnia and sexual dysfunction."

Labopharm filed its New Drug Application for DDS-04A in September 2008 under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. This section typically applies to reformulations of drugs that are already approved and being marketed, allowing the company to refer to existing efficacy and safety data on Trazodone.

Labopharm's NDA was based on data from five pivotal pharmacokinetic studies and the positive results from its North American phase III placebo controlled clinical trial, which enrolled over 400 patients.

DDS-04A is the rapid-onset formulation of Trazodone that was approved by the FDA in 1982 for the treatment of depression in adults. Trazodone was sold under the brand name Desyrel by Bristol-Myers Squibb Co. (BMY). Following the expiry of the drug's patent, generic version of Trazodone became available and the brand-name version is no longer being manufactured.

According to Labopharm, in the phase III study dubbed 04ACL3-001, the primary endpoint achieved statistical significance providing an improvement from baseline to the end of the study as measured by the Hamilton Rating Scale for Depression (HAMD-17).

Patients treated with DDS-04A experienced rapid onset of action as demonstrated by a clinically significant improvement in HAMD scores within the first two weeks of treatment. In addition, the study demonstrated an improvement in the overall quality of sleep and a favorable adverse event profile, including transient mild to moderate somnolence, no difference from placebo in anxiety, agitation, sexual dysfunction and weight change.

Meanwhile, preparations for the commercialization of the drug in the U.S. are underway and if approved, the company intends to launch the drug in the first half of 2010. The company is also in discussions for partnership.

Labopharm has also sought approval of the novel formulation of Trazodone in Canada and its new drug submission is under regulatory review with Health Canada. The Canadian regulatory agency is expected to decide on the drug on August 4, 2010.

Ryzolt, a once-daily formulation of the analgesic Tramadol is the company's first U.S. FDA-approved drug. Ryzolt, approved by the FDA in December 2008 for the management of moderate to moderately severe chronic pain in adults, was launched in the U.S. last May by Labopharm's U.S. marketing partner, Purdue Pharma Products L.P.

Under its licensing and distribution agreement with Purdue Pharma for Ryzolt in the United States, Labopharm is entitled to royalty payments of 20% of Purdue's net sales of the product.

Labopharm's once-daily tramadol product is already marketed in Europe, Canada, South Korea, Australia, and a number of countries. The company markets its product primarily through licensing and distribution arrangements with local pharmaceutical companies.

The company has completed phase III trials evaluating an investigational drug, which is a twice-daily formulation that combines the analgesics Tramadol and Acetaminophen. According to the company, the results of the trial are insufficient to support the acceptance of a New Drug Application by the FDA in the United States. However, the company believes that the trial results may be accepted for the evaluation of analgesics in Europe, Canada and other jurisdictions.

Last month, Labopharm initiated the regulatory approval process for its twice-daily tramadol-acetaminophen formulation in Europe under the DCP (Decentralized Procedure). The DCP provides an efficient mechanism that allows a company to simultaneously pursue regulatory approval for a medicinal product in multiple jurisdictions in Europe. The DCP is expected to take approximately one year to complete after which the national Marketing Authorizations will be provided.

In order to better support the full commercial potential of its products, pipeline and technologies, the company embarked on streamlining its operations last November, eliminating 35 positions. According to Labopharm, the reduction in workforce is expected to result in annual cost savings of about $3 million.

For the third-quarter ended September 30, 2009, the company's net loss widened to C$6.9 million or C$0.12 per share from C$6.02 million or C$0.11 per share in the year-ago quarter.

The company generates revenue from product sales, research and development collaborations, and licensing arrangements.

Quarterly revenue declined to C$6.62 million from C$9.44 million in the comparable year-ago quarter. While product sales of the company's once-daily Tramadol product rose an impressive 34% to C$5.19 million in the recent third-quarter, compared to the year-ago third-quarter, licensing revenue plunged 79% to C$1.19 million.

The company made its trading debut on the Nasdaq only on April 28 2006, with its IPO priced at $8 per share. However, the company's shares have been trading on the Toronto Stock Exchange since 1996.

In the last twelve months, the stock has been trading in the range of $0.76-$2.95 on the Nasdaq and in the range of C$0.43- C$3.40 on the Toronto Stock Exchange.

The upcoming FDA decision on DDS-04A is a significant catalyst for Labopharm's stock. Will the drug pass muster with the FDA this time? Stay tuned...

For comments and feedback: contact editorial@rttnews.com
Antwort auf Beitrag Nr.: 38.774.560 von Gustl24 am 20.01.10 16:24:49Ja, jetzt sind es nur noch 22 Tage.
Heute leider ein recht lauer Handelstag.
Hallo,

bin durch MannKind auf diese Aktie aufmerksam geworden, für wie wahrscheinlich seht Ihr die Zulassung?
...nun ganz so einfach ist Börse wohl dann doch nicht. Die Zulassung von Trazodone ist zwar wahrscheinlich und dennoch gibt es da einige Unbekannte. Einerseits scheint der Absatz von Tramadol in den US nach wie vor hinter den Erwartungen zurück zu bleiben und ausserdem sind diesbezüglich einige Patententscheidungen für Labopharm ungünstig ausgegangen.

Die geäusserten Kurserwartungen nach Zulassung erscheinen mir deswegen zu optimistisch. Sollten Sie dennoch eintreffen, dann würde ich diese Gewinne natürlich mit Freuden realisieren.

Anbei eine aktuelle Unternehmenspräsentation:

http://www.labopharm.com/docs/San%20Francisco%20Jan%202010%2…
Antwort auf Beitrag Nr.: 38.769.857 von Gustl24 am 20.01.10 08:15:54muss ich dir leider widersprechen...das problem, welches ALLOS
den erwarteten kurssprung nach zulassung "versaut" hat,
war das doch sehr,sehr kleine indikationsfeld bzw. die extrem
hohen kosten der therapie pro patient..


...das stimmt so nicht. Die geringe Prävalenz/Inzidenz bei PTCL war bereits vorher bekannt und die extrem hohen Kosten für Pralatrexate sind doch aus betriebswirtschaftlicher Sicht (also von Allos) doch nur positiv, zumal sich derzeit in den US solche Preise am Markt noch durchsetzen lassen. In Europa allerdings, da würde ich dir recht geben, wäre eine derartige Preispolitik kotraproduktiv.
Antwort auf Beitrag Nr.: 38.780.109 von Cyberhexe am 21.01.10 11:07:45...ausserdem sind diesbezüglich einige Patententscheidungen für Labopharm ungünstig ausgegangen...

kannst du mir quellen hierzu geben - gern auch per BM

vielen dank!
Antwort auf Beitrag Nr.: 38.780.256 von Cyberhexe am 21.01.10 11:23:58... Die geringe Prävalenz/Inzidenz bei PTCL war bereits vorher bekannt und die extrem hohen Kosten für Pralatrexate sind doch aus betriebswirtschaftlicher Sicht (also von Allos) doch nur positiv, zumal sich derzeit in den US solche Preise am Markt noch durchsetzen lassen...

da gebe ich dir schon recht...;)
nur als dies "medial in usa ausgeschlachtet wurde" ging
es sehr,sehr bald mit dem kurs, selbst am tag
der zulassung, in usa abwärts, da dies die
überschäumende erwartung des "kleinanlegers" doch merklich
gedämpft hat...

genau gegensätzlich sehe ich die "erwartungshaltung"
bei trazodone...:

...Major depression is one of the most prevalent central nervous disorders, affecting more than 120 million people worldwide. The annual sales of antidepressants in the U.S. alone total in excess of $12 billion...

mögliche peak sales für trazodone werden konservativ mit
500-600 mio.$ veranschlagt...

für einen massiven kurssprung sollten diese vorraussetzungen
an den us-börsen sehr wohl ausreichen...wie sich die firma
dann in den monaten und jahren nach der zulassung mit der
vermarktung bzw. kooperationen im markt tatsächlich positioniert
wird man dann sicherlich sehen müssen...dies liegt nicht
in unserer hand;)
Antwort auf Beitrag Nr.: 38.780.507 von Gustl24 am 21.01.10 11:50:49mögliche peak sales für trazodone werden konservativ mit
500-600 mio.$ veranschlagt...



Ich gehe jedoch davon aus, dass Labopharm Trazodone nicht selbst produzieren und vermarkten wird, sondern, ähnlich wie Tramadol, an einen Partner auslizenzieren wird und somit im besten Fall ähnliche Bedingungen wie mit Partner Purdue bei Tramadol (Slide 10 von 23) erzielen kann (20 bis 25% vom Umsatz).

Wie gesagt, die Bäume werden auch bei Labopharm nicht in den Himmel wachsen!


--> 10/23
http://www.labopharm.com/docs/San%20Francisco%20Jan%202010%2…
Antwort auf Beitrag Nr.: 38.780.603 von Cyberhexe am 21.01.10 12:00:43wie hoch würdest du, ich finde deine positive jedoch abwartende
haltung wirklich gut - lassen wir uns einfach überraschen -;)
bei auslizenzierung weltweit, sicherlich mit
verschiedenen partnern, die sonstigen revenues insb.
upfronts NEBEN den royalties einschätzen?
Antwort auf Beitrag Nr.: 38.780.507 von Gustl24 am 21.01.10 11:50:49ihr habt schon recht, die vielen Shorties bei Allos darf man aber auch nicht vergessen die den Kurs gedrückt haben.

Aber lasst uns doch hier lieber über labopharm diskutieren.
Hallo zusammen,

mal ne kurse Frage, mich würde Eure Einschätzung bzw. die Kursfantasie bei erreichen des Approvals von Trazodone interessieren.
Denke Depressionen sind heutzutage schon eine Volkskrankheit.
Antwort auf Beitrag Nr.: 38.793.207 von crivit am 22.01.10 17:17:50.....allerdings erfordert nicht jede Depression ein Antidepressiva,.....!!;)
Antwort auf Beitrag Nr.: 38.793.207 von crivit am 22.01.10 17:17:50hier gute zusammenfassung bzw. analyse:

http://www.newbiomedicine.com/Revere/UploadFiles/file/DDSS Trazodone Contramid FDA Approval.pdf
Antwort auf Beitrag Nr.: 38.797.125 von Gustl24 am 23.01.10 11:40:23supi, danke dir!:kiss: