Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 103)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Spectrum Pharmaceuticals to Acquire Worldwide Rights to Market ZEVALIN(R)
Spectrum's Commercial Footprint Expands Beyond the U.S.;
Irrevocable License From Bayer Healthcare Leverages Spectrum's Existing Clinical, Regulatory and Marketing Investments;
Spectrum Will Continue To Advance ZEVALIN's Clinical Development Program And Will Now Be Better Positioned To Grow ZEVALIN Sales Globally In The Long-Term.
HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS:SPPI) announced that it has entered into an agreement to acquire licensing rights to market ZEVALIN (ibritumomab tiuxetan) injection for intravenous use outside of the United States of America from Bayer Healthcare. ZEVALIN is currently approved in more than 40 countries outside the U.S. for the treatment of follicular B-cell non-Hodgkin's lymphoma, including countries in Europe, Latin America and Asia. Under the agreement, Spectrum will have all rights related to marketing, sales, and patents, and access to existing inventory of ZEVALIN from Bayer. Spectrum will utilize a combination of company resources and partnerships to support the product outside the U.S.
"We are excited to expand our commercial footprint globally with an approved, state-of-the-art drug that we know very well," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Our experience in the U.S. marketplace and the impressive and broadening clinical outcome data from ZEVALIN, as presented at major international scientific conferences over the past two years, has increased our confidence in the long-term potential of ZEVALIN. With the licensing of ex-U.S., worldwide rights to ZEVALIN, we will be able to further leverage our existing clinical, regulatory and marketing investments. Working closely with European investigators who have spearheaded exciting new data with ZEVALIN in recent years, Spectrum will continue to advance its clinical development program and will now be better positioned to grow ZEVALIN sales globally in the long-term. Our access to the worldwide market will help patients with follicular lymphoma who can benefit from ZEVALIN."
"The global market for ZEVALIN is several times larger than the US, with more than 350,000 cases of non-Hodgkin's lymphoma diagnosed every year. Since acquiring the U.S. rights to ZEVALIN in 2008, we have successfully reversed the declining sales trajectory and nearly tripled 2008 sales. We hope to achieve similar milestones outside the U.S. with our focused sales and marketing efforts. This licensing transaction demonstrates our commitment to being focused on our strategy of bringing novel cancer treatments to patients while at the same time delivering value to our shareholders," concluded Dr. Shrotriya.
The closing of the agreement is subject to customary closing conditions. The Merchant Banking Group of Burrill & Company acted as advisor to Spectrum Pharmaceuticals in this transaction.
http://www.sppirx.com/
LG Tommi
Spectrum's Commercial Footprint Expands Beyond the U.S.;
Irrevocable License From Bayer Healthcare Leverages Spectrum's Existing Clinical, Regulatory and Marketing Investments;
Spectrum Will Continue To Advance ZEVALIN's Clinical Development Program And Will Now Be Better Positioned To Grow ZEVALIN Sales Globally In The Long-Term.
HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS:SPPI) announced that it has entered into an agreement to acquire licensing rights to market ZEVALIN (ibritumomab tiuxetan) injection for intravenous use outside of the United States of America from Bayer Healthcare. ZEVALIN is currently approved in more than 40 countries outside the U.S. for the treatment of follicular B-cell non-Hodgkin's lymphoma, including countries in Europe, Latin America and Asia. Under the agreement, Spectrum will have all rights related to marketing, sales, and patents, and access to existing inventory of ZEVALIN from Bayer. Spectrum will utilize a combination of company resources and partnerships to support the product outside the U.S.
"We are excited to expand our commercial footprint globally with an approved, state-of-the-art drug that we know very well," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Our experience in the U.S. marketplace and the impressive and broadening clinical outcome data from ZEVALIN, as presented at major international scientific conferences over the past two years, has increased our confidence in the long-term potential of ZEVALIN. With the licensing of ex-U.S., worldwide rights to ZEVALIN, we will be able to further leverage our existing clinical, regulatory and marketing investments. Working closely with European investigators who have spearheaded exciting new data with ZEVALIN in recent years, Spectrum will continue to advance its clinical development program and will now be better positioned to grow ZEVALIN sales globally in the long-term. Our access to the worldwide market will help patients with follicular lymphoma who can benefit from ZEVALIN."
"The global market for ZEVALIN is several times larger than the US, with more than 350,000 cases of non-Hodgkin's lymphoma diagnosed every year. Since acquiring the U.S. rights to ZEVALIN in 2008, we have successfully reversed the declining sales trajectory and nearly tripled 2008 sales. We hope to achieve similar milestones outside the U.S. with our focused sales and marketing efforts. This licensing transaction demonstrates our commitment to being focused on our strategy of bringing novel cancer treatments to patients while at the same time delivering value to our shareholders," concluded Dr. Shrotriya.
The closing of the agreement is subject to customary closing conditions. The Merchant Banking Group of Burrill & Company acted as advisor to Spectrum Pharmaceuticals in this transaction.
http://www.sppirx.com/
LG Tommi
Jetzt ist auch die ASHP Site (von ihrem Fehler befreit und) aktualisiert und Fusilev als einzig verfügbares Produkt gelistet.
* Teva bringt Ende Januar/Anfang Februar neue Importe.
* Bedford wird sehr lange Zeit nicht liefern können.
* APP wird die nächste Charge erst wieder Ende März liefern können.
Q1 wird wahrscheinlich wieder ein Rekordquartal im Umsatz werden.
In Q1/Q2 noch gute Daten von Apaziquone und/oder Belinostat und das Ding kommt wieder ans Fliegen.
* Teva bringt Ende Januar/Anfang Februar neue Importe.
* Bedford wird sehr lange Zeit nicht liefern können.
* APP wird die nächste Charge erst wieder Ende März liefern können.
Q1 wird wahrscheinlich wieder ein Rekordquartal im Umsatz werden.
In Q1/Q2 noch gute Daten von Apaziquone und/oder Belinostat und das Ding kommt wieder ans Fliegen.
Antwort auf Beitrag Nr.: 42.636.547 von Ville7 am 24.01.12 06:18:35Die Fusilev Shortage, die auf der ASHP Homepage
http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=4…
veröffentlicht ist, ist wohl nicht vorhanden.
Laut Info der IR und von ASHP.
Sehr schön, weiter full Speed. Chance der Shorts ist gesunken.
http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=4…
veröffentlicht ist, ist wohl nicht vorhanden.
Laut Info der IR und von ASHP.
Sehr schön, weiter full Speed. Chance der Shorts ist gesunken.
Der Chart scheint ein rolling top auszubilden mit Ziel um die $10. Damit hätten die vielen neuen Shorts dann recht. Hoffen wir als Alternativszenario auf ein paar gute News um einen Squeeze in die andere Richtung zu starten.
Trading Spotlight
Fusilev jetzt wohl auch von der Shortage beroffen. Entweder müssen sie jetzt schlagartig eine noch viel höhere Nachfrage befriedigen oder ihr Lieferant hat auch Probleme. Ersteres wäre ja trotz der schlechten Nachricht noch sehr positiv, zweiteres verheerend. Spätestens bei den Q1 Zahlen wissen wir mehr. Möglicherweise auch schon bei den Jahreszahlen über die Q1 Prognose- sofern es eine gibt.
Mit Zevalin wird Krebs nur noch zu einer chronischen Krankheit.
“This study highlights a major advance for DLBCL and other patients with relapsed/refractory aggressive lymphomas since the PARMA study (1995) established ASCT as standard of care in this setting,” said Rajesh C. Shrotriya,
*BINGO* - würd ich sagen
ZEVALIN Plus High Dose Chemotherapy (Z-BEAM) Highly Effective in Aggressive Lymphoma; Randomized Study Published in “CANCER”, the Journal of the American Cancer Society
Two Year Overall Survival Rate Was 91% for Z-BEAM vs. 62% for BEAM Alone (p= 0.05);
Publication in "Cancer" Shows Increasing Recognition and Importance of ZEVALIN in Improving Outcomes in the Treatment of Refractory High-Risk Lymphomas;
ZEVALIN Has the Potential to Become Standard-of-Care in Pre-Treatment of ASCT Patients With Aggressive Lymphomas;
ZEVALIN® is Currently Approved by the FDA and Marketed by Spectrum Pharmaceuticals in the United States for:
Treatment of Patients with Previously Untreated Follicular Non-Hodgkin’s Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy
Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
Two Year Overall Survival Rate Was 91% for Z-BEAM vs. 62% for BEAM Alone (p= 0.05);
Publication in "Cancer" Shows Increasing Recognition and Importance of ZEVALIN in Improving Outcomes in the Treatment of Refractory High-Risk Lymphomas;
ZEVALIN Has the Potential to Become Standard-of-Care in Pre-Treatment of ASCT Patients With Aggressive Lymphomas;
ZEVALIN® is Currently Approved by the FDA and Marketed by Spectrum Pharmaceuticals in the United States for:
Treatment of Patients with Previously Untreated Follicular Non-Hodgkin’s Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy
Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
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