Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 136)

[Ville7]

Antwort auf Beitrag Nr.: 40.554.413 von Oberlaendler am 19.11.10 15:03:08

So wie ich das verstehe haben sie die Lieferprobleme bereits, weil Cangene es nicht schafft die vertraglichen Zusagen (Lieferung binnen 60 Tagen) einzuhalten. Es geht aktuell um ca. 5-6Mio USD, wenn man den Preis von 125USD bis 150USD je Vial ansetzt. Ziemlich diletantisch auch von Raj, für Fusilev nur einen (zweitklassigen) Lieferanten zu haben! Is halt wirklich ne Mickey Mouse Company. Kann man nur hoffen, dass das Gericht Spectrum wohlgesonnen ist. Mit Rechtsstrreitigkeiten haben sie ja nicht so ein glückliches Händchen - wie z.B. damals bei GPC, wo sie sich im Recht sahen, aber mit fliegenden Fahnen untergingen.

Den Kurs störts unterdes nicht, der schein wieder auf dem Weg über 5 USD. Scheint wohl langsam die Vorfreude auf das Ende der Patientenrekrutierung in PTCL zu sein und Aussicht auf die Ergebnisse.

Diese Meldung gab es auch noch die letzten Tage:

Spectrum Pharmaceuticals Announces Presentation of Four Key Belinostat Abstracts at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida on December 4-7, 2010

[Oberlaendler]

Spectrum sues Cangene for breach of contract
November 19, 2010 — 9:38am ET | By Liz Jones Hollis

Irvine, California-based Spectrum Pharmaceuticals is suing Cangene Biopharma in the U.S. District Court in Baltimore for allegedly breaching a 2008 contract to make Fusilev, an injectable cancer drug. Spectrum also accuses Cangene of failing to produce all of the drug it had ordered within the 60 days the contract requires, leaving Spectrum unable to fill orders for about 40,000 vials, according to the Baltimore Business Journal.

Spectrum added that it would be further damaged by Cangene's plans to temporarily close its Baltimore manufacturing plant for an undetermined period of time for maintenance and renovation, according to the lawsuit. It is seeking an unspecified amount of monetary damages and a court order forcing Cangene Biopharma to continue to manufacture Fusilev.

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After the suit was filed Nov. 10, lawyers for both sides agreed that Cangene would keep its plant open through the close of business on Dec. 3. A motions hearing is scheduled for Nov. 23, according to the court's website.

Read more: Spectrum sues Cangene for breach of contract - FierceBiotech http://www.fiercebiotech.com/story/spectrum-sues-cangene-bre…

Scheint dass auch Spectrum Lieferprobleme bekommt, wenn ich das richtig verstanden habe.

Grüße Oberländler

[future_trader]

Für Öffentlichkeit ist erstmal gesorgt. Hoffen wir, dass es so weiter geht.

http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseI…

Spectrum Pharmaceuticals Announces Presentation of Eleven (11) Key ZEVALIN Abstracts & Papers at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida on December 4-7, 2010

* Five of the Eleven Papers Have Been Selected, by the ASH Program Committee, for Oral Sessions
* Among Others, Presentations at Oral Sessions Include:
o Five-Year Update On Progression-Free Survival In "FIT" (First-Line Indolent) Trial involving 414 Patients; and,
o ZEVALIN as First Line Treatment of Follicular Lymphoma - First Results From An International Phase 2 Clinical Trial
* ZEVALIN Is Currently Approved by the FDA and Marketed For:
o Treatment of Patients with Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy
o Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma

IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced a total of 11 ZEVALIN related data presentations (five oral, six posters) at the 52nd Annual Meeting of the American Society of Hematology (ASH), being held at the Orange County Convention Center in Orlando, Florida, December 4-7, 2010.

For more information about the ASH annual meeting and for a complete list of abstracts, please refer to the conference Web site at www.hematology.org.

The following are the key ZEVALIN-related abstracts being presented at the conference:

Date/Time


Abstract #


Presentation

Type/Location


Title


Lead Author

Saturday, December 4, 2010

5:30pm-7:30pm 1289 Poster Session: Clinical Care - Recurrent, Secondary Neoplasia and Late Complications after Transplantation: Poster I The Risk of Secondary Myelodysplastic Syndrome/Acute Leukemia Following High-Dose 90-Ibritumomab Tiuxetan Is Analogous to That Observed Following High-Dose Chemotherapy: a Matched-Pair Analysis in Non-Hodgkin Lymphoma Patients

Anna Guidetti, MD, Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.
5:30pm-7:30pm 1749 Poster Session: Lymphoma - Chemotherapy, Excluding Pre-Clinical Models: Poster I Bortezomib May Be Safely Combined with Y-90 Ibritumomab Tiuxetan in Patients with Relapsed/Refractory Follicular or Transformed Non-Hodgkin Lymphoma: A Phase I Trial of Combined Induction Therapy and Bortezomib Consolidation Rupali Roy, MD, Division of Hematology/Oncology and Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
5:30pm-7:30pm 1793 Poster Session: Lymphoma - Therapy with Biologic Agents, Excluding Pre-Clinical Models: Poster I Final Results of a Phase II Study of Sequential R-CHOP and Yttrium-90 Ibritumomab Tiuxetan (RIT) for Elderly High Risk Patients with Untreated Diffuse Large B-Cell Lymphoma (DLBCL) Paul A. Hamlin, Jr., MD, Hematologic Oncology — Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York City, New York.


Sunday, December 5, 2010


Abstract #


Presentation

Type/Location


Title


Lead Author
4:45pm Oral Session: Transplantation Regimen Toxicities and Engraftment: Preparative Regimens Comparative Analysis of Autologous Hematopoietic Cell Transplantation with Radioimmunotherapy (RIT) Based Conditioning Versus Total Body Irradiation (TBI) for High-Risk Diffuse Large Cell Lymphoma (DLCL): Toxicity and Efficacy Amrita Krishnan, MD, Hematology and Stem Cell Transplantation, City of Hope, Duarte, California.
5:00pm Oral Session: Clinical Care - Transplantation Regimen Toxicities and Engraftment: Preparative Regimens Y-90-Ibritumomab Tiuxetan, Fludarabine and TBI Based Non-Myeloablative Allogeneic Transplant Conditioning for High-Risk B-Cell Lymphoma Ajay K. Gopal, MD, University of Washington, Seattle, Washington.
6:00pm - 8:00pm 2866 Poster Session: Lymphoma - Therapy with Biologic Agents, Excluding Pre-Clinical Models: Poster II 90Y-Ibritumomab Tiuxetan Followed by Rituximab is a Safe Treatment Option for Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma Katarina Luptakova, MD, Hematology and Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.


Monday, December 6, 2010


Abstract #


Presentation

Type/Location


Title


Lead Author
3:45pm Oral Session: Lymphoma - Therapy with Biologic Agents, Excluding Pre-Clinical Models: Aggressive Lymphoma and Radioimmunotherapy 90-Yttrium Ibritumomab Tiuxetan as First Line Treatment for Follicular Lymphoma. First Results from an International Phase II Clinical Trial Antonio Pezzutto, Hematology Oncology, Charite Medical School, Berlin, Germany.
4:00pm Oral Session: Lymphoma - Therapy with Biologic Agents, Excluding Pre-Clinical Models: Aggressive Lymphoma and Radioimmunotherapy 90-Y-Ibritumomab Tiuxetan (ZEVALIN®) Consolidation of First Remission in Advanced-Stage Follicular Non-Hodgkin's Lymphoma: Updated Results After a Median Follow-up of 66.2 Months From the International, Randomized, Phase III First-Line Indolent Trial (FIT) in 414 Patients Anton Hagenbeek, MD, PhD, Academic Medical Center, Amsterdam/HOVON, Netherlands.
4:45pm Oral Session: Clinical Results - Autologous Transplantation: Lymphoma A Multi-Center Prospective Randomized Study Comparing Ibritumomab Tiuxetan (ZEVALIN) and High-Dose BEAM Chemotherapy (Z-BEAM) Vs. BEAM Alone as the Conditioning Regimen Prior to Autologous Stem-Cell Transplantation in Patients with Aggressive Lymphoma; Possible Advantage for Z-BEAM in Low-Risk Patients

Avichai Shimoni, MD, Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel-Hashomer, Israel.
6pm-8pm 3947 Poster Session: Lymphoma - Therapy with Biologic Agents, Excluding Pre-Clinical Models: Poster III Phase II study of 2-Weekly CHOP+Rituximab Followed by Yttrium-90 Ibritumomab Tiuxetan (ZEVALIN) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): Final Analysis Reem Karmali, MD, Hematology/Oncology, Rush University Medical Center, Chicago, Illinois.
6pm-8pm 3946 Poster Session: Lymphoma - Therapy with Biologic Agents, Excluding Pre-Clinical Models: Poster III Update on a Prospective Study Evaluating the Safety and Efficacy of Combination Therapy with Fludarabine, Mitoxantrone, and Rituximab Followed by Yttrium-90 Ibritumomab Tiuxetan and Maintenance Rituximab as Front Line Therapy for Patients with Indolent Lymphomas Reem Karmali, MD, Hematology/Oncology, Rush University Medical Center, Chicago, Illinois.


About ZEVALIN® and the ZEVALIN Therapeutic Regimen

ZEVALIN (ibritumomab tiuxetan, injection for intravenous use) is indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.

ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of three components: rituximab, Indium-111 (In-111) radiolabeled ZEVALIN for imaging, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. The ZEVALIN therapeutic regimen is a form of cancer therapy called radioimmunotherapy. Radioimmunotherapy (RIT) is an innovative form of cancer treatment with a mechanism of action that is different from traditional chemotherapy. RIT builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.

Important ZEVALIN® Safety Information

Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.

Please see full Prescribing Information, including Boxed WARNINGS, for ZEVALIN and rituximab. Full prescribing information can be found at www.ZEVALIN.com.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company's strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company's website at www.sppirx.com.

Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

[VaJo]

Nov. 12, 2010, 7:00 a.m. EST
Spectrum Pharmaceuticals Ranked One of the Fastest Growing Companies in North America on Deloitte's 2010 Technology Fast 500(TM)


http://www.marketwatch.com/story/spectrum-pharmaceuticals-ra…

[Ville7]

Leucovorin Shortage dürfte noch eine Weile für gute Umsätze sorgen. Einer der beiden Hersteller hat angekündigt, dass er erst wieder frühestens April 2011 liefern können wird. Das sollte nicht nur für weiterhin gute Umsätze sorgen, sondern auch den Druck auf die FDA erhöhen, Fusilev für CC zuzulassen.

[Oberlaendler]

Spectrum Pharmaceuticals Announces Third Quarter 2010 Financial and Operating Results

Strong Financial Results Include 174% Increase in 3Q10 Total Product Revenue Vs. 3Q09
64% Increase in 3Q10 ZEVALIN® Revenue Vs. 3Q09
47% Sequential Increase In Total Product Revenue Over 2Q10
Three and Nine-Month 2010 Consolidated Revenues Approximately $16.7 Million and $40.2 Million, Respectively
Three and Nine-Month 2010 Product Revenues Approximately $13.7 Million and $30.1 Million, Respectively
Approximately $92 Million in Cash, Cash Equivalents and Investments as of September 30, 2010
Submitted FUSILEV Data in Colorectal Cancer in October 2010
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today reported financial results for the three and nine-months ended September 30, 2010.

“We are pleased with our accomplishments in the third quarter and year-to-date,” said Rajesh C. Shrotriya, M.D., Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “We achieved record total product revenue and quarterly sales of ZEVALIN. We also submitted a response to the “Complete Response” letter for FUSILEV® for advanced metastatic colorectal cancer treatment. Lastly, we further strengthened our management team. We appointed Brett Scott, a proven healthcare executive, as our Acting Chief Financial Officer, to build and expand upon the existing financial and accounting infrastructure to support product revenue growth from our FDA approved anticancer drugs.”

“We are continuing to see benefits from the sales force optimization program put in place by our Chief Commercial Officer, Jim Shields, to maximize our return on investment,” continued Shrotriya. “Before year end, we expect to file the data supporting removal of the bioscan requirement for ZEVALIN. We expect additional FDA filings in 2011 and 2012 for belinostat and apaziquone, respectively.” We believe that the steps we have taken will help us achieve our mission of bringing more effective treatments to cancer patients as quickly as possible.

Third Quarter Results Ended September 30, 2010 (All #s are approximates)

During the three-month period ended September 30, 2010, net cash, cash equivalents and investments used was approximately $2.5 million.

Consolidated revenue of $16.7 million was comprised of product sales of $13.7 million ($7.7 million from ZEVALIN, $6.0 million from FUSILEV) and $3.1 million from licensing fees. This compares to $7.1 million in consolidated revenue in the third quarter of 2009, which was comprised of $5.0 million from product sales ($4.7 million from ZEVALIN, $0.3 million from FUSILEV) and $2.1 million from licensing fees. The Company recorded a net loss of $4.6 million, or ($0.09) per basic and diluted share, compared to net income of $474 thousand, or $0.01 per basic and ($0.07) per diluted share, in the third quarter of 2009. Total research and development expenses were $7.5 million, as compared to $5.5 million in the same period of 2009, primarily due to a non-cash charge of $1.7 million related to acquisition of intellectual property in the third quarter of 2010. Selling, general and administrative expenses were $11.4 million compared to $7.0 million in the same period in 2009 an increase primarily due to commercial activities.

Nine-Month Results Ended September 30, 2010 (All #s are approximates)

During the nine-month period ended September 30, 2010, net cash used in operations was approximately $32.8 million, including the one-time upfront payment of $30 million for belinostat.

Consolidated revenue of $40.2 million was comprised of product sales of $30.1 million ($21.1 million from ZEVALIN, $9.0 million from FUSILEV) and $10.1 million from licensing fees. This compares to $29.4 million in consolidated revenue in the same nine-month period of 2009, which was comprised of $23.0 million from product sales ($10.6 million from ZEVALIN, $12.4 million from FUSILEV) and $6.4 million from licensing fees. The Company recorded a net lossof $53.3 million, or ($1.08) per basic and diluted share, compared to a net loss of $29.2 million, or ($0.80) per basic and diluted share, in the same nine-month period of 2009. Research and development expenses were $50.3 million, as compared to $17.5 million in the same period of 2009, an increase primarily related to the $30 million one-time, upfront license fee for belinostat. Selling, general and administrative expenses were $36.1 million compared to $22.5 million in the same period in 2009, an increase primarily due to commercial activities.

Cash, cash equivalents, and investments in marketable securities, including long-term bank certificates of deposits, totaled $92 million as of September 30, 2010.

There are approximately 50 million shares of common stock issued and outstanding.

Company Accomplishments, Goals and Upcoming Milestones

ZEVALIN

Continue to grow the brand;
Submit to the FDA data supporting removal of the bioscan requirement; and,
Continue to evaluate and design clinical trial strategies to expand ZEVALIN’s approved indications to treat additional patient populations.
FUSILEV

Submitted response on October 29, 2010, to FDA’s complete response letter for its use in colorectal cancer; and,
Currently expect FDA to render a decision in 2011.
Apaziquone

Top-line data from the registrational Phase 3 bladder cancer trials is expected in 2012.
Belinostat

Peripheral T-Cell Lymphoma - Anticipate NDA filing in 2011.
Carcinoma of Unknown Primary – TopoTarget on track to complete enrollment by year-end 2010 in the ongoing Phase 2 CUP trial.
Conference Call

Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

Fusilev ist ja schön, aber Zevalin ist noch nicht der große Umsatzbringer. Wie schätzt ihr die Zahlen und die weitere Entwicklung ein?


Grüße Oberländler

[Ville7]

Zahlen sollten heute nacht kommen oder morgen mittag. Der Q3 CC ist auf morgen angekündigt. Mal sehen, ob die Zevalinumsätze gesteigert werden konnten und ob die Leucovorin Shortage wesentlichen Einfluss auf die Fusilev Umsätze hatte. Desweiteren interessiert natürlich auch, wie es bei Belinostat weitergeht. Ein Filing in 2011 auf Basis einer kleinen unverblindeten Phase II Studie in PCTL halte ich ja für ziemlich fragwürdig. Ich denke hier ist wohl noch eine Phase III Studie nötig (-> teuer). CUP Phase II Daten noch in 2010, das wird wohl auch noch nicht klappen, aber schau'n mer mal. Vielleicht hört man ja auch endlich mal was zu Renazorb (das ex-USA auslizensiert werden und in die Klinik kommen sollte), zu SPI-1620 (dessen Phase I eigentlich schon seit Anfang 2009 abgeschlossen sein sollte, aber immer noch rekrutiert) oder zum Bio-Scan Removal Vorhaben bei Zevalin ... We will see..

[Ville7]

Antwort auf Beitrag Nr.: 40.029.413 von VaJo am 23.08.10 14:21:30

Die Leucovorin Shortage geht immer noch weiter - zwar nicht in der extremen Form wie Anfang 2009, aber sie besteht weiterhin. Das ein oder andere Milliönchen dürfte damit in Q3 zusätzlich gemeldet werden.

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.…

Angst vor den Q3 Zahlen braucht man somit nicht zu haben. Und 2011 kommt dann das Jahr, das die Fantasie bei Apaziquone und Belinostat wecken könnte. Damit rechne ich aber erst gegen Jahresende 2011.

[VaJo]

Handling the Leucovorin Shortage
AHSP and ASCO clarify implications for practitioners
Article | Mon, 08/09/2010 - 06:16
On July 20, the US Food and Drug Administration (FDA) announced shortages of leucovorin for injection. One manufacturer, Bedford, has not supplied a reason for the shortage or a date when supplies will be available. The other manufacturer, Teva, has cited manufacturing delays and provided an estimated release date in the fourth quarter of 2010.

Levoleucovorin, a related project, is still available. However, the American Society of Health-System Pharmacists (AHSP) cautions that the two agents are not interchangeable, noting the potential dosing errors. The dose for levoleucovorin is 50% of the usual dose of leucovorin. In addition, levoleucovorin is not FDA-approved for oncology indications and may carry a higher price tag.

For some malignancies, substitution of capecitabine for the combination of 5-fluorouracil (5-FU)/leucovorin is supported based on high-quality randomized clinical trials, according to an American Society of Clinical Oncology (ASCO) press release. However, the release noted that such data are not available for all 5-FU/leucovorin-containing regimens. Also of consideration, the side effect profile of capecitabine differs from that of 5-FU/leucovorin (eg, more hand-foot syndrome) as does gastrointestinal absorption.

* Capecitabine has been found to be noninferior to intravenous (IV) FU/leucovorin as single agents for both metastatic colorectal cancer and adjuvant therapy for stage III colon cancer.
* The combination of capecitabine and oxaliplatin was found to be noninferior to IV 5-FU/leucovorin and oxaliplatin (FOLFOX).
* Capecitabine and irinotecan (CAPIRI) was less efficacious and more toxic compared with IV 5-FU/leucovorin and irinotecan (FOLFIRI) at the doses of CAPIRI used in the BICC-C Study.
* No efficacy data are available from two trials testing capecitabine with oxaliplatin in the adjuvant therapy setting for colon cancer to date.

[VaJo]

So wie es aussieht besteht der Leucovorin Shortage in den USA immer noch. Weder Bedford noch Teva können liefern. Spectrum kann Levoleucovorin liefern und die FDA weist auf die geänderte Dosierung bei Fusilev hin.

Warum in aller Welt erhält Fusilev dann keine Zulassung wenn SPPI schon wieder seit gut 2 Monaten aushelfen muss um die Landesweite Versorgung sicher zu stellen

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.…