Spectrum Pharmaceuticals - Chancen und Risiken? - Älteste Beiträge zuerst (Seite 397)

[VaJo]

CASI Pharmaceuticals sagt mir nichts.

[VaJo]

Die haben die Firma anscheinend übernommen.

http://investor.sppirx.com/secfiling.cfm?filingid=1193125-14…

[mobet]

Ääääh Vajo, wie genau beobachtest du deine Invests so?

http://investor.sppirx.com/releasedetail.cfm?releaseid=87147…

Spectrum Pharmaceuticals Out-Licenses Rights for Greater China to CASI Pharmaceuticals for Three of Its Drugs

Spectrum receives a 19.99% stake (pre-transaction) in CASI, a NASDAQ-listed, oncology-focused Company with
expertise and focus on markets in China and a $1.5 million promissory note

HENDERSON, Nev. & ROCKVILLE, Md.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, and CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a primary focus on China, announce the signing of license agreements whereby CASI has been granted exclusive rights to two of Spectrum Pharmaceuticals' commercial oncology drugs, Zevalin® (ibritumomab tiuxetan) Injection for intravenous use and Marqibo® (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion, and a Phase 3 drug candidate, Captisol-Enabled™ Melphalan (CE melphalan), for development and commercialization in China, including Taiwan, Hong Kong and Macau.

ZEVALIN is used in the treatment of non-Hodgkin's lymphoma (NHL) and MARQIBO is used in the treatment of acute lymphoblastic leukemia (ALL). CE melphalan has met the endpoints in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. Spectrum plans to file a New Drug Application with the U.S. Food and Drug Administration (FDA) for CE melphalan in the second half of 2014.

CASI will be responsible for the development and commercialization of the three drugs, including the submission of import drug registration applications to regulatory authorities and conducting any confirmatory clinical studies in greater China, if and as required.

"We are delighted to see our anticancer drugs to be developed and marketed in greater China through CASI, a NASDAQ-listed Company focused on China," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The management of CASI has a track record of successfully developing anticancer drugs in China. We are pleased to be a shareholder of CASI at this early stage of their development and look forward to CASI creating value for our shareholders as they grow. China's pharmaceutical market is growing at a rapid pace and is already approaching second place to only the United States in the world. The greater China drug market for anticancer drugs is projected to become the world's largest in the next decade and CASI has the opportunity to take a leading position to address these significant unmet medical needs. We are impressed with the management team at CASI and their expertise in China, and look forward to sharing in the success of our drugs in this important market."

Commenting on the transaction, Ken K. Ren, Ph.D., CASI's Chief Executive Officer, said, "We are very excited to have entered into this transaction with Spectrum, a Company with a successful track record of developing and commercializing drugs expeditiously in the U.S. The addition of these three drugs transforms our pipeline and significantly expands our market share potential in China. Our transaction is structured rather uniquely in that the shares and note represent the purchase price to Spectrum and is in lieu of royalties and milestones normally associated with traditional licenses, thereby aligning Spectrum's interest with our shareholders. We look forward to a productive relationship with Spectrum."

Dr. Ren added, "These drug products come with strong intellectual property protection and significant technology barriers. We are currently preparing the import drug registration applications in greater China, initially for ZEVALIN and MARQIBO, and since both drugs are approved for sale in the U.S., we anticipate that confirmatory clinical trials will be required for marketing approval in our territory. The submission of the import drug registration for CE melphalan will follow immediately after its approval by the U.S. FDA. The annual incidence in China for NHL, ALL and multiple myeloma is increasing each year with high mortality rates, it is our goal to have these innovative products available to patients in greater China as soon as possible to address these unmet medical needs, and as Spectrum expands these drugs into additional indications in the U.S., we too will apply for expanded labels in our territory."

In addition to its initial stake in CASI, Spectrum Pharmaceuticals will have certain rights to maintain its post-transaction ownership position. Spectrum Pharmaceuticals also will have the opportunity to designate a member to CASI's board of directors. Detailed information on the transaction can be found in CASI's Report on Form 8-K, which will be filed with the Securities and Exchange Commission." target="_blank" rel="nofollow ugc noopener">http://investor.sppirx.com/releasedetail.cfm?releaseid=87147…

Spectrum Pharmaceuticals Out-Licenses Rights for Greater China to CASI Pharmaceuticals for Three of Its Drugs

Spectrum receives a 19.99% stake (pre-transaction) in CASI, a NASDAQ-listed, oncology-focused Company with
expertise and focus on markets in China and a $1.5 million promissory note

HENDERSON, Nev. & ROCKVILLE, Md.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, and CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a primary focus on China, announce the signing of license agreements whereby CASI has been granted exclusive rights to two of Spectrum Pharmaceuticals' commercial oncology drugs, Zevalin® (ibritumomab tiuxetan) Injection for intravenous use and Marqibo® (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion, and a Phase 3 drug candidate, Captisol-Enabled™ Melphalan (CE melphalan), for development and commercialization in China, including Taiwan, Hong Kong and Macau.

ZEVALIN is used in the treatment of non-Hodgkin's lymphoma (NHL) and MARQIBO is used in the treatment of acute lymphoblastic leukemia (ALL). CE melphalan has met the endpoints in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. Spectrum plans to file a New Drug Application with the U.S. Food and Drug Administration (FDA) for CE melphalan in the second half of 2014.

CASI will be responsible for the development and commercialization of the three drugs, including the submission of import drug registration applications to regulatory authorities and conducting any confirmatory clinical studies in greater China, if and as required.

"We are delighted to see our anticancer drugs to be developed and marketed in greater China through CASI, a NASDAQ-listed Company focused on China," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The management of CASI has a track record of successfully developing anticancer drugs in China. We are pleased to be a shareholder of CASI at this early stage of their development and look forward to CASI creating value for our shareholders as they grow. China's pharmaceutical market is growing at a rapid pace and is already approaching second place to only the United States in the world. The greater China drug market for anticancer drugs is projected to become the world's largest in the next decade and CASI has the opportunity to take a leading position to address these significant unmet medical needs. We are impressed with the management team at CASI and their expertise in China, and look forward to sharing in the success of our drugs in this important market."

Commenting on the transaction, Ken K. Ren, Ph.D., CASI's Chief Executive Officer, said, "We are very excited to have entered into this transaction with Spectrum, a Company with a successful track record of developing and commercializing drugs expeditiously in the U.S. The addition of these three drugs transforms our pipeline and significantly expands our market share potential in China. Our transaction is structured rather uniquely in that the shares and note represent the purchase price to Spectrum and is in lieu of royalties and milestones normally associated with traditional licenses, thereby aligning Spectrum's interest with our shareholders. We look forward to a productive relationship with Spectrum."

Dr. Ren added, "These drug products come with strong intellectual property protection and significant technology barriers. We are currently preparing the import drug registration applications in greater China, initially for ZEVALIN and MARQIBO, and since both drugs are approved for sale in the U.S., we anticipate that confirmatory clinical trials will be required for marketing approval in our territory. The submission of the import drug registration for CE melphalan will follow immediately after its approval by the U.S. FDA. The annual incidence in China for NHL, ALL and multiple myeloma is increasing each year with high mortality rates, it is our goal to have these innovative products available to patients in greater China as soon as possible to address these unmet medical needs, and as Spectrum expands these drugs into additional indications in the U.S., we too will apply for expanded labels in our territory."

In addition to its initial stake in CASI, Spectrum Pharmaceuticals will have certain rights to maintain its post-transaction ownership position. Spectrum Pharmaceuticals also will have the opportunity to designate a member to CASI's board of directors. Detailed information on the transaction can be found in CASI's Report on Form 8-K, which will be filed with the Securities and Exchange Commission.

[VaJo]

Antwort auf Beitrag Nr.: 47.890.643 von mobet am 27.09.14 13:46:05

Zitat von mobet: Ääääh Vajo, wie genau beobachtest du deine Invests so?

SPPI nur noch sporadisch weil ich nur noch einen kleinen Bestand von 3k habe. Ich schaue hier nur rein wenn eine AdHoc reinflattert.
Ansonsten bin ich nicht so auf dem laufenden.

[Ville7]

Bezüglich Fusilev gehe ich davon aus, dass Sandoz und zwei andere Generikahersteller generisches Fusilev ab März 2015 verkaufen. Im März 2015 läuft der Orphan Schutz für Osteosarcoma aus (der ganz kleinen Indikation). Orphan Schutz für die Colorectal Cancer Indikation besteht noch bis April 2018.

Spectrum versucht auf zwei Fronten seine Fusilev Umsätze zu schützen:
1. durch die Patentschutzklage. Mit einem Urteil ist aber nicht bis März zu rechnen
2. durch eine Petition an die FDA, dass Sandoz und Co keine ANDA Genehmigung für Flaschen (Vials) > 50mg bekommen, da diese nicht für die kleinere Indikation benötigt werden.

[VaJo]

Spectrum Pharmaceuticals Reports Strong Product Sales for the Third Quarter 2014; Sales of $47.9 Million up 15.6% Over Last Year

• Total product sales for the three months ended September 30, 2014 increased 15.6% to $47.9 million from $41.4 million in the same period last year.

• Non-GAAP diluted EPS was $0.08, and GAAP EPS was ($0.18).

• Spectrum’s fifth oncology drug, Beleodaq ® (belinostat) for Injection was approved by the FDA and launched this quarter using our existing sales forces.

• Spectrum is advancing its global Phase 3 development program for its novel GCSF, SPI-2012; Spectrum met with the EMA in October and is scheduled to meet with the FDA in December.

• NDA submission for our sixth anti-cancer drug Captisol-enabled TM (propylene glycol-free) melphalan expected by the end of the year.

[123fly]

Ineressant auch, dass die Geschäftsleitung offen sagt, dass eigentlich alle Medis, die bis jetzt Vermarktet werden, eigentlich nur dazu dienen, um den (potentiellen) Blockbuser SP 2012 zu finanzieren.

[123fly]

Antwort auf Beitrag Nr.: 48.147.389 von Ville7 am 28.10.14 07:10:39

Hallo Ville7,

Wie viel Prozent des Fusilev-Umsatzes macht eigentlich "Osteosarcoma" aus?

[Ville7]

Antwort auf Beitrag Nr.: 48.315.265 von 123fly am 13.11.14 22:16:20

Hi, das weiß man natürlich nicht genau, da SPPI das nicht kommuniziert. Nach der Größe der Indikation zu Urteilen sind das aber sehr wahrscheinlich weniger als 5% des Umsatzes.

[VaJo]

Spectrum Pharmaceuticals said Friday that it has submitted its experimental blood-cancer treatment to the U.S. Food and Drug Administration for approval.

Spectrum SPPI, +1.01% which got the license rights to the treatment from Ligand Pharmaceuticals Inc. in 2013, has submitted a new drug application to the FDA and expects the review to take about 10 months.

Multiple myeloma is a type of blood cancer usually treated with a harsh regimen of chemotherapy and a stem-cell transplant. A new wave of drugs in recent years has helped extend the life expectancy of patients, though there is still no cure.

Spectrum’s treatment, CE-Melphalan, uses an intravenous formula that allows for slower infusion rates and longer administration times, resulting in a high-intensity treatment with a reduced risk of toxicity.