Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 333)

[VaJo]

Noch ein paar Cent mehr und die meisten hier dürften im Plus sein. Was man wohl nicht von allen Aktien zur Zeit behaupten kann

Bei 1,34 schreib ich schwarz

[Ville7]

Antwort auf Beitrag Nr.: 36.659.920 von Magnetfeldfredy am 26.02.09 16:21:09

Kommt drauf an, was heute verkündet wird und wie die Märkte weiterlaufen.

Wichtig wäre auch, dass die Jahreszahlen bald verkündet werden und ein hoher Cashbestand von zum Jahresende 2008 von ca. 80Mio USD sichtbar wird. Aktuell verwenden die Analysten noch die 52Millionen, die endstand nach Q3 waren.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 36.655.171 von Ville7 am 26.02.09 07:16:14

Der Kurs zieht an, bald Ausbruch über 2 US Dollar?

[Ville7]

Antwort auf Beitrag Nr.: 36.653.226 von VaJo am 25.02.09 19:55:07

Die Hauptziele für 2009 sind.:
Die Umsätze bei FUSILEV und ZEVALIN zu steigern und einen Partner in Japan und Asien für Apaziquone (Eoquin) zu gewinnen

Na da hat man die Latte ja recht tief gehängt. Die Fusilev Umsätze im Vergleich zu 2008 sind ja schon gesteigert worden. Also erreicht.

Beim Partner wirds schwieriger, ich hoffe die kriegen das hin. Bitte möglichst ein front-loadad deal um Risiko rauszunehmen.

[Ville7]

Antwort auf Beitrag Nr.: 36.654.257 von future_trader am 25.02.09 21:49:01

Zu viele Variablen, ich finde keinen Match der Kriterien zwischen vergleichswerten und Studieneinschlußkriterien. Dadurch von mir keine Aussage möglich - sorry.

Historische Recurrence Rates etc. findet man hier:

http://blcwebcafe.org/content/view/146/157/lang,english/#bai…

Die Recrutierungskriterien der Phase II Studie findet man hier:

http://www.clinicaltrials.gov/ct2/show/NCT00141531?term=eoqu…

Man wird wohl oder übel die placebokontrollierten doppeltverblindeten Phase III Studienergebnisse abwarten müssen.

[future_trader]

Antwort auf Beitrag Nr.: 36.651.059 von Ville7 am 25.02.09 16:14:05

es wäre super, wenn du dazu etwas sagen könntest. Bzw. deine Einschätzung würde mich interessieren.

Danke.

Gruß future_trader

[VaJo]

Seit 2007 wurden alle Ziele die Spectrum genannt hat erfüllt.
Die Hauptziele für 2009 sind.:
Die Umsätze bei FUSILEV und ZEVALIN zu steigern und einen Partner in Japan und Asien für Apaziquone (Eoquin) zu gewinnen.

[VaJo]

Spectrum Pharmaceuticals Strengthens Management, Realigns Resources to Focus on Commercialization and Near-Term Opportunities

* Andrew Sandler, MD as Chief Medical Officer; More Than 10 Years of Oncology Clinical Development and Medical Affairs Experience; Development of ZEVALIN®, CAMPATH®, LEUKINE®, and NEXAVAR®
* Michael Adam, PhD as Sr. Vice President of Pharmaceutical Operations; More Than 23 Years of Pharmaceutical Development and Drug Manufacturing Experience
* Amar Singh MBA, as Chief Commercial Officer; More Than 25 Years Drug Marketing and Launch Experience; Launched XELODA®, KYTRIL®, ABRAXANE® and Others

* Wednesday February 25, 2009, 1:05 pm EST
* Spectrum Pharmaceuticals, Inc.

IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI - News) today announced the appointment of key executive management personnel as the company continues to transform into a commercial organization. Spectrum Pharmaceutical’s highest priority programs for this year are: FUSILEV™ (levoleucovorin for Injection); ZEVALIN® (ibritumomab tiuxetan); and Apaziquone.


“To maximize the value of our near-term opportunities with FUSILEV, ZEVALIN and Apaziquone, we have strengthened our management team with the additions of three key industry veterans, all of whom bring a wealth of knowledge and hands-on relevant experience to the Spectrum team,” said Rajesh C. Shrotriya, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “We look forward to leveraging both Dr. Sandler’s experience with ZEVALIN and his experience in a variety of hematologic/oncologic disease states with several types of technologic platforms, Dr. Adam’s knowledge of pharmaceutical development and regulatory activities, and Mr. Singh’s operational expertise as we focus on increasing sales of FUSILEV and ZEVALIN. Completing enrollment in the Phase 3 trials of Apaziquone and securing a partner in Japan and Asia remain of our key priorities and goals.”

Andrew Sandler, MD, comes to Spectrum Pharmaceuticals as the Company’s new Chief Medical Officer. Dr. Sandler is responsible for all medical affairs, regulatory, and clinical operations for the Company’s portfolio of drug candidates. Dr. Sandler has a broad-based experience in Phase I, I/II, II, III, IIIb, IV and all post-marketing studies and activities. He was also responsible for the global medical development and launch activities of CAMPATH® in first-line CLL, FLUDARA®, LEUKINE®, NEXAVAR® in HCC, and ZEVALIN®. Dr. Sandler was most recently the Vice President and head of Global Medical Affairs in the Oncology division of Bayer Healthcare Pharmaceuticals. At Bayer, he supervised all commercial input into clinical development plans, and provided strategic direction to all of Bayer’s marketed, pre-launch, and immediate post-launch products. From 2003-2006, Dr. Sandler was at Berlex Oncology, most recently as the Head of Global Medical Affairs, where he led and contributed to the development of lifecycle management plans, provision of continuous risk/benefit assessment, support in the Labeling and Protocol review process and, initiation, planning and approval of studies. From 1999-2003, Dr. Sandler was the Director of Clinical Development for Seattle Genetics, where he oversaw the strategic planning and clinical operations of the Phase 1 and Phase 2 studies, and participated in two IND submissions. Dr. Sandler received his BS in Neuroscience from the University of Rochester in New York, his MD from Mount Sinai School of Medicine in New York, his internship, residency, and chief residency at the Mount Sinai Hospital in New York, and his Fellowship in Medical Oncology from the University of California-San Francisco.

Michael Adam, PhD, has joined Spectrum Pharmaceuticals as Sr. Vice President of Pharmaceutical Operations. Dr. Adam has 23 years drug development experience. He was most recently the Senior Vice President, Drug Development Operations at Anadys Pharmaceuticals, Inc. He had primary responsibility for regulatory affairs, quality assurance, pharmaceutical development, manufacturing, and project management. Prior to Anadys, Dr. Adam was Vice President, Pharmaceutical Sciences in the Global Research & Development division of Pfizer, Inc. At Pfizer he led the La Jolla, California organization responsible for chemical, analytical and pharmaceutical development from compound identification through launch and product enhancement. Prior to Pfizer, Dr. Adam was Vice President, of Worldwide Regulatory Affairs, Quality Assurance and Compliance at Agouron Pharmaceuticals. Prior to Agouron, Dr. Adam was the Director of Worldwide Regulatory Affairs, CMC Group, at Bristol-Myers Squibb, where he managed Regulatory CMC projects in CNS and CV/MD therapeutic areas. Dr. Adam earned his Ph.D. in Organic Chemistry at the Massachusetts Institute of Technology in Cambridge, MA. Dr. Adam also holds an Entrepreneur-in-Residence at CONNECT helping pharmaceutical/biotech start-ups.

Amar Singh has joined Spectrum Pharmaceuticals as Chief Commercial Officer. Mr. Singh is responsible for aspects of sales and marketing, business development, and investor and public relations. Mr. Singh has more than 25 years of experience in the pharmaceutical industry with increasing responsibilities throughout his career. Mr. Singh was most recently the Chief Commercial Officer for Novacea, where he was responsible for commercialization and business development. Prior to Novacea, Mr. Singh served as Vice President of Marketing and Sales at Abraxis Oncology, a proprietary division of American Pharmaceutical Partners, Inc., where he was responsible for building the branded division that launched Abraxane. Mr. Singh served in multiple capacities at Roche Laboratories, a Division of Hoffmann La Roche, where he held positions in Market Research, Licensing and Business Development, New Product Planning, and Marketing. From 2000 to 2003, he was Executive Director for Oncology Marketing and subsequently for New Product planning for the Specialty Care business, where he led the launches of XELODA®, a novel oral chemotherapeutic agent for the treatment of metastatic breast cancer, and KYTRIL®, an anti-nausea agent used in combination with oncolytics. Mr. Singh holds a B.A. in Economics from the University of North Carolina Chapel Hill, and an MBA from New York University.

These appointments follow the retirement of Gino Lenaz, MD, our Chief Scientific Officer, and Dr. Ashok Gore, our Sr. Vice President of Pharmaceutical Operations and Regulatory Compliance. Both Dr. Lenaz and Dr. Gore continue to serve the Company in a consultant role.

[Ville7]

Endlich die Phase II Daten zu Eoquin:

(ob wirklich "gut" muss ich für mich noch prüfen)

http://www.ncbi.nlm.nih.gov/pubmed/19214526?ordinalpos=2&ito…

1: World J Urol. 2009 Feb 13. [Epub ahead of print]Click here to read Links
Two-year follow-up of the phase II marker lesion study of intravesical apaziquone for patients with non-muscle invasive bladder cancer.
Hendricksen K, van der Heijden AG, Cornel EB, Vergunst H, de Reijke TM, van Boven E, Smits GA, Puri R, Gruijs S, Witjes JA.

Department of Urology, Radboud University Nijmegen Medical Centre, Inter Mail 659, PO Box 9101, 6500 HB, Nijmegen, The Netherlands, [e-mail].

OBJECTIVES: To study the time-to-recurrence and duration of response in non-muscle invasive bladder cancer (NMIBC) patients, with a complete ablative response after intravesical apaziquone instillations.

METHODS: Transurethral resection of bladder tumour(s) (TURBT) was performed in patients with multiple pTa-T1 G1-2 urothelial cell carcinoma (UCC) of the bladder, with the exception of one marker lesion of 0.5-1.0 cm. Intravesical apaziquone was administered at weekly intervals for six consecutive weeks, without maintenance instillations. A histological confirmed response was obtained 2-4 weeks after the last instillation. Routine follow-up (FU) was carried out at 6, 9, 12, 18 and 24 months from the first apaziquone instillation.

RESULTS: At 3 months FU 31 of 46 patients (67.4%) had a complete response (CR) to ablative treatment. Side-effects on the long-term were only mild. Two CR patients dropped out during FU. On intention-to-treat (ITT) analysis 49.5% of the CR patients were recurrence-free at 24 months FU, with a median duration of response of 18 months. Of 15 no response (NR) patients, only two received additional prophylactic instillations after TURBT. On ITT-analysis 26.7% of the NR patients were recurrence-free (log rank test, P = 0.155). The overall recurrence-free survival was 39% (18 of 46 patients) at 24 months FU.

CONCLUSIONS: The CR of the marker lesion in 67% of patients was followed by a recurrence-free rate of 56.5% at 1-year FU, and 49.5% at 2-year FU. These long-term results are good in comparison with the results of other ablative studies.

[VaJo]

Spectrum müßte sie trotzdem zahlen. Die Gläubiger von CTIC wollen ja ihr Geld.