Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 406)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Danke Dir. Das ist etwas seltsam, dass Kanada und Mexico nirgends mehr auftaucht. Auch das Levoleucovorin die selbe Substanz wie Leucovorin ist 
Für mich verwirrend.
Für mich verwirrend.
Antwort auf Beitrag Nr.: 35.901.215 von VaJo am 10.11.08 12:55:02Geschäftsbericht Seite 34, klick einfach auf den Link in meinem Posting und gehe auf Seite 34.
Antwort auf Beitrag Nr.: 35.901.023 von Ville7 am 10.11.08 12:34:21Ville wo hast du den Satz:" We have only licensed the rights to develop, market and sell LEVOleucovorin in North America" gefunden?
Letter From the CEO
From the Spectrum Pharmaceuticals, Inc. 2007 Annual Report
May 8th, 2008
Dear Stockholders
On March 7th, 2008 Spectrum reached an important milestone – the New Drug Application (NDA) for its first proprietary anticancer drug was approved by the FDA. This was the result of tireless efforts on the part of our employees and their deep understanding of the requirements of the FDA. There are hundreds of small biotech companies that never achieve an FDA approval, even after spending hundreds of millions of dollars and years of work. We are truly excited about the team we have built and the potential of our portfolio.
The FDA approved our NDA for Levoleucovorin for Injection, which we plan to launch in June 2008. LEVOleucovorin is a folate analog indicated for rescue after high-dose methotrexate therapy in osteosarcoma. LEVOleucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. To expand the potential of LEVOleucovorin, we plan to file two additional regulatory submissions with the FDA. First, we plan to file an NDA amendment for an oral tablet formulation. The Oncology Drug Advisory Committee has already voted affirmatively that the oral formulation is safe and effective when used in the rescue of high dose methotrexate. Second, we plan to file a supplemental NDA for its use in colorectal cancer with 5-fluorouracil containing regimens.
LEVOleucovorin has been on the market in Europe and Japan for more than ten years, where it is marketed by Takeda, Wyeth and Sanofi-Aventis among others. This product sells approximately $200 million outside the U.S. We see this as a large test market and are optimistic about its prospects in North America. Our Company is currently building an internal commercial infrastructure to support LEVOleucovorin. We are committed to becoming a commercial-stage company with revenues and profits from the sale of our own drugs. With a pipeline of promising products, we believe this is the right strategy.
Profits from the sale of LEVOleucovorin will be used to help fund the clinical development of our pipeline. Our most advanced programs include:
EOquin®, which is currently enrolling patients into two registrational Phase 3 clinical studies for the treatment of non-invasive bladder cancer in the United States and Canada;
Ozarelix, which is being studied in patients with benign prostate hypertrophy; and
SPI-1620, which is in a Phase 1 clinical trial as an adjunct to chemotherapy for solid tumors.
We added $20 million of cash to our balance sheet on April 30th, 2008, without diluting our existing shareholders. Not a single share of stock was issued. We sold our share of the profits from sumatriptan injection to Par Pharmaceutical Companies. Sumatriptan injection has provided us with more than $25 million in non-dilutive funding since 2006, when we saw an opportunity outside of our core business in the field of oncology and urology. This $20 million cash infusion represents approximately 60% of our estimated 2008 net use of cash for operations. Not only does this cash infusion obviate the need to raise cash anytime soon, it adds to our ability to successfully launch LEVOleucovorin and carry out our business plan without having to worry about the financial markets at this time.
Our core expertise is in acquiring, developing and commercializing a diversified portfolio of drug candidates, with a focus mainly in the fields of oncology and urology. We are proud to have a team of experienced, committed and passionate people who have a track record of success. This, in my experience, is rarely seen at a Company of our size. These are the four pillars of our strategy:
1. Advancing our diversified portfolio;
2. Establishing a commercial organization;
3. Building a “Culture of Success” that allows our people to thrive; and
4. Leveraging the expertise of partners around the world to assist us in the execution of our strategy.
We are committed to success at Spectrum Pharmaceuticals. Today, May 1, 2008, we have approximately $65 million in cash, one approved drug, nine drugs in development, and more than 70 employees working every day to bring new treatments to those who currently don’t have many
options available. We are truly excited about our future.
On behalf of the Board of Directors and employees, I would like to thank you, our shareholders, for your continued support.
Sincerely,
Rajesh C. Shrotriya, M.D.
Chairman, CEO and President
Spectrum Pharmaceuticals, Inc.
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From the Spectrum Pharmaceuticals, Inc. 2007 Annual Report
May 8th, 2008
Dear Stockholders
On March 7th, 2008 Spectrum reached an important milestone – the New Drug Application (NDA) for its first proprietary anticancer drug was approved by the FDA. This was the result of tireless efforts on the part of our employees and their deep understanding of the requirements of the FDA. There are hundreds of small biotech companies that never achieve an FDA approval, even after spending hundreds of millions of dollars and years of work. We are truly excited about the team we have built and the potential of our portfolio.
The FDA approved our NDA for Levoleucovorin for Injection, which we plan to launch in June 2008. LEVOleucovorin is a folate analog indicated for rescue after high-dose methotrexate therapy in osteosarcoma. LEVOleucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. To expand the potential of LEVOleucovorin, we plan to file two additional regulatory submissions with the FDA. First, we plan to file an NDA amendment for an oral tablet formulation. The Oncology Drug Advisory Committee has already voted affirmatively that the oral formulation is safe and effective when used in the rescue of high dose methotrexate. Second, we plan to file a supplemental NDA for its use in colorectal cancer with 5-fluorouracil containing regimens.
LEVOleucovorin has been on the market in Europe and Japan for more than ten years, where it is marketed by Takeda, Wyeth and Sanofi-Aventis among others. This product sells approximately $200 million outside the U.S. We see this as a large test market and are optimistic about its prospects in North America. Our Company is currently building an internal commercial infrastructure to support LEVOleucovorin. We are committed to becoming a commercial-stage company with revenues and profits from the sale of our own drugs. With a pipeline of promising products, we believe this is the right strategy.
Profits from the sale of LEVOleucovorin will be used to help fund the clinical development of our pipeline. Our most advanced programs include:
EOquin®, which is currently enrolling patients into two registrational Phase 3 clinical studies for the treatment of non-invasive bladder cancer in the United States and Canada;
Ozarelix, which is being studied in patients with benign prostate hypertrophy; and
SPI-1620, which is in a Phase 1 clinical trial as an adjunct to chemotherapy for solid tumors.
We added $20 million of cash to our balance sheet on April 30th, 2008, without diluting our existing shareholders. Not a single share of stock was issued. We sold our share of the profits from sumatriptan injection to Par Pharmaceutical Companies. Sumatriptan injection has provided us with more than $25 million in non-dilutive funding since 2006, when we saw an opportunity outside of our core business in the field of oncology and urology. This $20 million cash infusion represents approximately 60% of our estimated 2008 net use of cash for operations. Not only does this cash infusion obviate the need to raise cash anytime soon, it adds to our ability to successfully launch LEVOleucovorin and carry out our business plan without having to worry about the financial markets at this time.
Our core expertise is in acquiring, developing and commercializing a diversified portfolio of drug candidates, with a focus mainly in the fields of oncology and urology. We are proud to have a team of experienced, committed and passionate people who have a track record of success. This, in my experience, is rarely seen at a Company of our size. These are the four pillars of our strategy:
1. Advancing our diversified portfolio;
2. Establishing a commercial organization;
3. Building a “Culture of Success” that allows our people to thrive; and
4. Leveraging the expertise of partners around the world to assist us in the execution of our strategy.
We are committed to success at Spectrum Pharmaceuticals. Today, May 1, 2008, we have approximately $65 million in cash, one approved drug, nine drugs in development, and more than 70 employees working every day to bring new treatments to those who currently don’t have many
options available. We are truly excited about our future.
On behalf of the Board of Directors and employees, I would like to thank you, our shareholders, for your continued support.
Sincerely,
Rajesh C. Shrotriya, M.D.
Chairman, CEO and President
Spectrum Pharmaceuticals, Inc.
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Antwort auf Beitrag Nr.: 35.901.023 von Ville7 am 10.11.08 12:34:21Ich habe hier noch was:
Spectrum Pharmaceuticals maintains the rights to market LFA in the U.S., Canada and Mexico. It is estimated that the current annual market of LFA outside North America is nearly $200 million...
Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin
IRVINE, Calif., July 02, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., today...
In Kanada haben Sie ja auch ein Vertriebsbüro eröffnet.
Spectrum Pharmaceuticals maintains the rights to market LFA in the U.S., Canada and Mexico. It is estimated that the current annual market of LFA outside North America is nearly $200 million...
Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin
IRVINE, Calif., July 02, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., today...
In Kanada haben Sie ja auch ein Vertriebsbüro eröffnet.
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Antwort auf Beitrag Nr.: 35.900.909 von VaJo am 10.11.08 12:22:47Geschäftsbericht Seite 34:
http://library.corporate-ir.net/library/83/832/83249/items/2…
The marketing and sale of our drug product LEVOleucovorin, may be adversely affected by the marketing and sales efforts of third parties who sell LEVOleucovorin outside North America.
We have only licensed the rights to develop, market and sell LEVOleucovorin in North America. Other companies, such as Wyeth and Sanofi-aventis, Inc., market and sell the same product in other parts of the world. If, as a result of their actions, negative publicity is associated with the product, our own efforts to successfully market and sell LEVOleucovorin, may be adversely impacted.
http://library.corporate-ir.net/library/83/832/83249/items/2…
The marketing and sale of our drug product LEVOleucovorin, may be adversely affected by the marketing and sales efforts of third parties who sell LEVOleucovorin outside North America.
We have only licensed the rights to develop, market and sell LEVOleucovorin in North America. Other companies, such as Wyeth and Sanofi-aventis, Inc., market and sell the same product in other parts of the world. If, as a result of their actions, negative publicity is associated with the product, our own efforts to successfully market and sell LEVOleucovorin, may be adversely impacted.
"LEVOleucovorin provides physicians and patients with an important treatment alternative to leucovorin," said Richard A. Bender, M.D., F.A.C.P., Chief Medical Officer of Spectrum Pharmaceuticals. "With this drug, patients undergoing cytotoxic chemotherapy are spared the administration of the pharmacologically inactive dextro-isomer. Preclinical studies have shown that the dextro-isomer may compete with the active levo-isomer for transport into cells."
The Company plans to file for a supplemental New Drug Application with the FDA for use in colorectal cancer in 5-fluorouracil containing regimens and an NDA amendment for an oral tablet formulation by mid-year 2008.
Levoleucovorin for Injection is currently listed as a replacement for calcium leucovorin in the NCCN Clinical Practice Guidelines in Oncology. The NCCN Drugs and Biologics Compendium is an important reference that has been recognized by United HealthCare as a formal guidance for approval of coverage policy. Visit www.nccn.org for more information.
________
Bezüglich der Rechte und woher der Wirkstoff kommt schau ich nochmal genauer nach.
The Company plans to file for a supplemental New Drug Application with the FDA for use in colorectal cancer in 5-fluorouracil containing regimens and an NDA amendment for an oral tablet formulation by mid-year 2008.
Levoleucovorin for Injection is currently listed as a replacement for calcium leucovorin in the NCCN Clinical Practice Guidelines in Oncology. The NCCN Drugs and Biologics Compendium is an important reference that has been recognized by United HealthCare as a formal guidance for approval of coverage policy. Visit www.nccn.org for more information.
________
Bezüglich der Rechte und woher der Wirkstoff kommt schau ich nochmal genauer nach.
Antwort auf Beitrag Nr.: 35.900.447 von VaJo am 10.11.08 11:48:49Nichts spricht dagegen, das Fusilev in Zukunft auch in Europa, Japan und dem Rest der Welt durch Spektrum vertrieben wird.
Das einzige was dagegen spricht ist und ich bin mir diesbezüglich zu fast 100% sicher, ist, dass Spectrum nur die USA Rechte hat. Fusilev wird unter anderem Markennamen weltweit schon seit Jahren vertrieben - von den hier genannten Firmen. In USA wurde es nur bisher nicht zugelassen, da die FDA eine Politik verfolgte unwirksame Leucovorins zu eliminieren. Fusilev fällt lt. Spectrum aber nicht in diese Kategorie.
Das einzige was dagegen spricht ist und ich bin mir diesbezüglich zu fast 100% sicher, ist, dass Spectrum nur die USA Rechte hat. Fusilev wird unter anderem Markennamen weltweit schon seit Jahren vertrieben - von den hier genannten Firmen. In USA wurde es nur bisher nicht zugelassen, da die FDA eine Politik verfolgte unwirksame Leucovorins zu eliminieren. Fusilev fällt lt. Spectrum aber nicht in diese Kategorie.
Antwort auf Beitrag Nr.: 35.900.670 von VaJo am 10.11.08 12:04:35Da hast du Recht!! Sehr Spannend die Sache! Die Pipeline ist auf jeden Fall interessant!
Antwort auf Beitrag Nr.: 35.900.545 von Macos am 10.11.08 11:56:45Warten wir doch erstmal ab, ob die 2 Indikation zugelassen wird. 100 Mio+ ist die Schätzung. Ende 2009 könnte es soweit sein.
Bei Knochenkrebs ist es nur ein Zubrot, da die Erkrankung (zum Glück) nur so selten ist. Ville hat mal bemerkt, das es ein Minusgeschäft ist, aber Rajesh das als Sprungbrett sieht. Das sehe ich auch so.
Lassen wir uns überraschen, schließlich war Fusilev eins von 2 Medikamenten gegen Krebs die 2008 durch die FDA zugelassen wurden. Nicht alles wird einfach nur so zugelassen. Ein riesen Erfolg der leider keine Beachtung gefunden hat.
Bei Knochenkrebs ist es nur ein Zubrot, da die Erkrankung (zum Glück) nur so selten ist. Ville hat mal bemerkt, das es ein Minusgeschäft ist, aber Rajesh das als Sprungbrett sieht. Das sehe ich auch so.
Lassen wir uns überraschen, schließlich war Fusilev eins von 2 Medikamenten gegen Krebs die 2008 durch die FDA zugelassen wurden. Nicht alles wird einfach nur so zugelassen. Ein riesen Erfolg der leider keine Beachtung gefunden hat.
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