Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 393)

[VaJo]

Antwort auf Beitrag Nr.: 36.255.019 von future_trader am 22.12.08 21:13:15

Zu den Milestones.

Im Moment verfügt SPPI über 90 Mio Dollar. Der Cashwert beträgt ca. 3 Dollar/Share.

Setzt man die möglichen 300 Mio Dollar Milestones für EOquin, die ca. 120 Mio Dollar für Fusilev in der Indikation CC und Zevalin als Erstlinientherapie bei Lymphdrüsenkrebs ins Verhältnis und läßt dabei die 7 weiteren Wirkstoffe in der Pipeline ausser Betracht und betrachtet man das Spectrum keine Schulden hat (sehr selten für ein Biotech), so müßte Spectrum irgendwo zwischen 10 und 20 Dollar stehen.

Da der Markt aber immer recht hat steht der Aktie bei 1,40 Dollar.

[VaJo]

Antwort auf Beitrag Nr.: 36.255.019 von future_trader am 22.12.08 21:13:15

Hallo future_trader

Die Ergebnisse zu EOquin in Phase III sind sehr bis jetzt sehr gut. EOquin oder besser Apaziquone wäre nach 20 Jahren die erste wirklich erfolgversprechende Behandlung bei Blasenkrebs. Allergan möchte sich im Bereich Urologie/Onkologie etablieren und setzt daher in das Joint Venture mit Spectrum große Hoffnungen. Die Milestone Zahlungen sind auch unüblich hoch bei Apaziquone.

Bei Fusilev (Levoleucovorin) kündigt sich für nächstes Jahr auch eine mögliche Zulassung für Dickdarmkrebs an. In der Indikation Knochenkrebs ist es seit 15 August am Markt und damit wurden bis Ende Oktober rund 2 Mio Dollar umgesetzt.

Überraschend war für uns alle der Deal mit Cell Therapeutics mit dem Medikament Zevalin. Damit hat nun wirklich niemand gerechnet. Spectrum möchte Zevalin als erst Linien Therapie bei Lymphdrüsenkrebs einsetzen. Ein Zulassungsantrag wurde gestellt. Die FDA hat ein Beschleunigtes Verfahren zugesagt.
Die letzte Studie hat einen Überlebensvorteil bei Zevalin gegenüber normaler Chemo von 67 Monaten gebracht. Eine unglaubliche Zeitspanne. Zudem soll die Verabreichung stark vereinfacht worden sein.

Über den Kursverlauf kann man nur spekulieren. Der ist mehr als enttäuschend.

[Macos]

Hoffe das es bei Spectrum auch mal so aussieht!! Hier wurde irgendwas zugelassen!! Bei EPIX http://www.nasdaq.com/aspx/nasdaqlastsale.aspx?symbol=ABK&sy…

[future_trader]

ich verfolge den kurs schon lange, aber der kursverlauf finde ich "strange"

wie wertet ihr das joint-venture?

was oder wer denkt ihr hält den Aktienkurs unten? Normalerweise hätte doch der Aktienkurs nach der Milestone-Zahlung durch die Decke gehen müssen?

Bin ein wenig ratlos, ob ich hier investieren soll. Helft mit ;-)

[VaJo]

Hier zum Umfang der Studie

Trial Sites

U.S.A.
Arizona
Phoenix

Bladder Cancer Genitourinary Oncology, PC
Kay Johnson Ph: 602-493-6626
Donald L. Lamm Principal Investigator
Sun City
Sun Health Research Institute
Carolyn Liebsack Ph: 623-875-6514
Jeffery Stern, MD, MPH Principal Investigator
California
Laguna Woods
South Coast Urological Medical Group
Christy Leach, RN Ph: 949-499-2279
Jay Young, MD Principal Investigator
Colorado
Denver
Urology Center of Colorado
Sarah Koceja Ph: 303-421-5783
Lawrence Karsh, MD Principal Investigator
Connecticut
Middlebury
Connecticut Clinical Research Center, LLC
Brendaliz Konopka Ph: 203-757-2296
Robert Feldman, MD Principal Investigator
Florida
Longwood
Urology Consultants - Longwood
Stacey Kinsey Ph: 407-332-0777
Steven Brooks, MD Principal Investigator
Miami
University of Miami Sylvester Comprehensive Cancer Center - Miami
Dinorah Rodriguez Ph: 305-243-7207
Mark Soloway, MD Principal Investigator
New Port Richey
Urology Health Center
Gabrielle Handerson Ph: 727-835-3261
Juan Otheguy, MD Principal Investigator
Ocala
Florida Foundation for Healthcare Research
Joanne Grover Ph: 352-237-3949
Ira Klimberg, MD Principal Investigator
Sarasota
Florida Urology Specialists - Sarasota
Shannon Lynch Ph: 941-309-7000 Ext.7116
Thomas Williams, MD Principal Investigator
Tallahassee
Southeastern Research Group
Mary Anne Taylor Ph: 850-201-0411
J. Daniel Rackley, MD Principal Investigator
Tampa
Tampa Bay Urology
Linda Seibert Ph: 813-872-7881
Tod Fusia, MD Principal Investigator
Idaho
Meridian
Idaho Urologic Institute, PA
Katie Gries Ph: 208-639-4938
Stephen Miller, MD Principal Investigator
Illinois
Chicago
University of Chicago Cancer Research Center
Josephine Silvestre Ph: 773-702-3080
Gary Steinberg, MD Principal Investigator
Peoria
Specialty Care Research
Jackie Schultz Ph: 309-683-1125
Giovanni Colombo, MD Principal Investigator
Indiana
Ft. Wayne
Northeast Indiana Research, LLC
Mary Hageman, RN Ph: 260-434-1939
Christopher Steidle, MD Principal Investigator
Jeffersonville
Metropolitan Urology, PSC
Debbie Johnson Ph: 812-288-2611
James Bailen, MD Principal Investigator
Kansas
Overland Park
Kansas City Urology Care
John Beuscher Ph: 913-647-4173
Email: [e-mail]
Steven Nash, MD Principal Investigator
Maryland
Annapolis
Anne Arundel Urology, PA
Elizabeth D'Antonio Ph: 410-266-8049 Ext.143
Eric Schwartz, MD Principal Investigator
Greenbelt
Werner-Francis Urology Associates, LLC
Lisa Drezer, MD Ph: 301-441-8900 Ext.114
Myron I. Murdock Principal Investigator
Montana
Missoula
Five Valleys Urology
Jennifer Hays Ph: 406-329-2864
Karl Westenfelder, MD Principal Investigator
New Jersey
Lawrenceville
Lawrenceville Urology
Julie Prettyman Ph: 609-895-1991
Gary Karlin, MD Principal Investigator
Marlton
Delaware Valley Urology, LLC - Marlton
Diane Horner Ph: 856-985-4286
Charles Orth, Jr., MD Principal Investigator
Sewell
Delaware Valley Urology, LLC - Sewell Washington Township
Michelle Redman Ph: 856-218-3025
Robert Barsky, DO Principal Investigator
Voorhees
Center for Urologic Care at Centennial Medical Center
Catherine Kavalchick Ph: 856-751-5288
Louis Keeler, MD Principal Investigator
Westampton
Delaware Valley Urology, LLC - Westampton
Rene Haney Ph: 609-914-0021 Ext.125
Robert Goldlust, MD Principal Investigator
New Mexico
Albuquerque
Urology Group of New Mexico
Mary Lou Jones Ph: 505-872-4090 Ext.118
Frederick J. Snoy Principal Investigator
New York
Garden City
AccuMed Research Associates
Kerri Weingard Ph: 516-746-2190
Mitchell Efros, MD Principal Investigator
Urological Surgeons of Long Island
Vincent Gandolfo Ph: 516-742-3200
Robert Edelman, MD Principal Investigator
Kingston
Hudson Valley Urology, PC - Kingston Office
Jeanie Hefele Ph: 845-339-4900 Ext.110
Jose Sotolongo, MD Principal Investigator
New York
University Urology Associates
Betsy Ortiz Ph: 212-686-9015 Ext.9
Jed Kaminetsky, MD Principal Investigator
Oneida
Oneida Healthcare Center
Tracy Griffith Ph: 315-363-8862
Bashar Omarbasha, MD Principal Investigator
Poughkeepsie
Hudson Valley Urology, PC
Alexa Harrington Ph: 845-458-8730
Evan Goldfischer, MD Principal Investigator
Rochester
Urology Associates of Rochester - Clinton Crossing
Eileen Stone Ph: 585-232-2980
David Dever, MD Principal Investigator
Ohio
Cincinnati
Tri-State Urologic Services
Vicki Rice Ph: 513-366-3412
Bernard L Hertzman, MD Principal Investigator
Cleveland
University Urologists of Cleveland, Inc.
Claudia Lillibridge Ph: 216-844-8205
Edward Cherullo, MD Principal Investigator
Oregon
Springfield
Oregon Urology Institute
Janice Bebee Ph: 541-284-5508
Peter Bergreen, MD Principal Investigator
Pennsylvania
Bala Cynwyd
Urologic Consultants of South Eastern Pennsylvania
Cheryl Zinar Ph: 610-667-0458
Lawrence Belkoff, MD Principal Investigator
Lancaster
Urological Associates of Lancaster, Limited
Dorie Rodriguez Ph: 717-431-2285
Paul Seiber, MD Principal Investigator
Philadelphia
Fox Chase Cancer Center - Philadelphia
Christine Jerome Ph: 215-728-3853
Richard E. Greenberg Principal Investigator
Pittsburgh
Triangle Urological Group
Chantall Mitchell Ph: 412-281-1757
John Lyne, MD Principal Investigator
South Carolina
Myrtle Beach
Grand Strand Urology, LLP
Lori Gormanns Ph: 843-449-1010 Ext.251
Neal D. Shore Principal Investigator
Tennessee
Germantown
Conrad Pearson Clinic
Kathleen Meier Ph: 901-252-3402
Lynn Conrad, MD Principal Investigator
Texas
Corpus Christi
Corpus Christi Urology Group LLC
Christi Grunberg Ph: 361-884-6381
Robert Naismith, MD Principal Investigator
Dallas
Urology Clinics of North Texas - Dallas
Nicolette Ruiz Ph: 214-691-1902
James Cochran, MD Principal Investigator
San Antonio
Urology San Antonio, PA - Fredericksburg
Beatrice Escamilla Ph: 210-617-4116
Daniel R. Saltzstein Principal Investigator
Virginia
Norfolk
Urology of Virginia - Norfolk
Jennifer Kucenski Ph: 757-457-5166
Robert Given, MD Principal Investigator
Virginia Beach
Devine-Tidewater Urology - Virginia Beach
Laurie Jackson Ph: 757-457-5462
Kim Ramsey Ph: 757-457-5462
Washington
Mountlake Terrace
Integrity Medical Research, LLC
Cherrie Sia Ph: 425-275-0680
Karny Jacoby, MD Principal Investigator

....

[VaJo]

Versucht man sich ein Bild vom Umfang der Studie bei EOquin zu machen wird man von der Masse der Informationen schier erschlagen.
Hier scheint Spectrum anderst als bei der nicht sehr erfolgreichen Ozarelixstudie alles besser machen zu wollen. Allein die Liste der Klinischen Zentren in den USA ist ellen lang.


http://www.cancer.gov/search/ResultsClinicalTrialsAdvanced.a…

In den Behandlungsempfehlungen taucht EOquin bereits auf.

Apaziquone
An indolequinone bioreductive prodrug and analog of mitomycin C with potential antineoplastic and radiosensitization activities. Apaziquone is converted to active metabolites in hypoxic cells by intracellular reductases, which are present in greater amounts in hypoxic tumor cells. The active metabolites alkylate DNA, resulting in apoptotic cell death. This agent displays activity towards both hypoxic solid tumors, which exhibits higher expression of cytochrome P450 reductase, and well-oxygenated malignant cells that overexpress the bioreductive enzyme NQO1 (NAD(P)H: quinone oxidoreductase). Apaziquone may selectively sensitize hypoxic tumor cells to radiocytotoxicity. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus)

US brand names: Eoquin
Neoquin
Code name: E09
Chemical structure name: 3-hydroxymethyl-5-aziridinyl-1-methyl-2-(1H-indole-4,7-dione) prop-beta-en-alpha-ol

[VaJo]

Nachdem wir alle gespannt auf Fusilev und Zevalin blicken, rückt die Fachwelt ihren Focus auf Blasenkrebs. Hier hantiert man immer noch mit 20 Jahre alten Medikamenten und Therapien. Die Ineffektiv sind und die Überlebenschancen nicht nachhaltig verbesseren.

2 neue wichtige Medikamenten stehen hier im Blickpunkt. Urocidin und EOquin. Interessant das in diesem Aktikel keine Firmen genannt werden.

Je weiter sich die Phase III bei EOquin dem Ende nähert desto unruhiger dürfte sich auch der Aktienkurs entwickeln. Mit geschätzten 1,5 Milliarden Dollar Umsatz haben wir hier einen wirklich echten Blockbuster im Portfolio.

Hier der Artikel:

Research and Markets: Bladder Cancer - New Drugs Needed to Challenge Ineffective 20-Year Old Drugs

Last update: 11:10 a.m. EST Dec. 19, 2008
DUBLIN, Ireland, Dec 19, 2008 (BUSINESS WIRE) -- has announced the addition of the "Stakeholder Opinions: Bladder Cancer - New Drugs Needed to Challenge Ineffective 20-year Old drugs" report to their offering.
The overall incidence of bladder cancer in the seven major markets is forecast to exceed 160,000 by the end of 2008. Treatment of bladder cancer employs mainly immunotherapy and chemotherapy. However, both these methods are ineffective in improving long-term survival. Thus, there is a lucrative commercial opportunity for drug developers to enter this market, especially in the metastatic setting.

Current diagnosis and treatment of bladder cancer, including treatment regimens by stage and geographical location Issues in diagnosis, treatment strategies and unmet needs Examination of pipeline activity and potential future opportunities for drug developers Stakeholder opinions based on qualitative interviews with five opinion leaders from the US and Europe

Discovery of more effective systemic therapies is crucial for the treatment of patients with advanced or metastatic disease as current therapies have little impact on survival.
BCG therapy, the current standard treatment for non-invasive bladder cancer has limited use in patients who experience multiple recurrences. Patients who become refractory or intolerant to further BCG treatment have few options. There is therefore a large patient potential for drugs that can replace BCG or treat BCG-refractory patients.

Bladder cancer therapy consists of cytotoxics and immunotherapy agents that have been genericized for many years. Late-stage pipeline drugs consist of targeted therapies and cytotoxics including Urocidin and EOquin. Some late stage drugs have demonstrated favourable efficacy in trials and look to fill some of the unmet needs in bladder cancer.

Understand the pathology and epidemiology of bladder cancer Understand the limitations of current bladder cancer treatment Obtain insight into the commercial opportunities available in the bladder cancer market

[walk_on]

Antwort auf Beitrag Nr.: 36.218.364 von VaJo am 16.12.08 22:02:41

Hallo VaJo,

möchte hier noch nachträglich meine Glückwünsche an deine Frau und dich einstellen.

ich zeige meinen Kids als Motivation immer folgenden Lebenslauf

Shrotriya, Rajesh
Brief Biography

Dr. Shrotriya, 64, has been Chairman of the Board, Chief Executive Officer and President since August 2002 and a director of Spectrum since June 2001. From September 2000 to August 2002, Dr. Shrotriya served as President and Chief Operating Officer of Spectrum. Dr. Shrotriya also serves as a member of the Board of Directors of Antares Pharma, Inc., an AMEX listed drug delivery systems company. Prior to joining Spectrum, Dr. Shrotriya held the position of Executive Vice President and Chief Scientific Officer from November 1996 until August 2000, and as Senior Vice President and Special Assistant to the President from November 1996 until May 1997, for SuperGen, Inc., a publicly-held pharmaceutical company focused on drugs for life-threatening diseases, particularly cancer. From August 1994 to October 1996, Dr. Shrotriya held the positions of Vice President, Medical Affairs and Vice President, Chief Medical Officer of MGI Pharma, Inc., an oncology-focused biopharmaceutical company. Dr. Shrotriya spent 18 years at Bristol-Myers Squibb Company in a variety of positions, most recently as Executive Director, Worldwide CNS Clinical Research. Previously, Dr. Shrotriya held various positions at Hoechst Pharmaceuticals, most recently as Medical Advisor. Dr. Shrotriya was an attending physician and held a courtesy appointment at St. Joseph Hospital in Stamford, Connecticut. In addition, he received a certificate for Advanced Biomedical Research Management from Harvard University. Dr. Shrotriya received his M.D. degree from Grant Medical College, Bombay, India, in 1974; his D.T.C.D. (Post Graduate Diploma in Chest Diseases) degree from Delhi University, V.P. Chest Institute, Delhi, India, in 1971; M.B.B.S. (Bachelor of Medicine and Bachelor of Surgery - equivalent to an M.D. degree in the U.S.) from the Armed Forces Medical College, Poona, India, in 1967; and a B.S. with Chemistry degree from Agra University, Aligarh, India, in 1962.

[VaJo]

Kann diese Notsituation in der Leucovorin Versorgung zu einer schnelleren Zulassung von SPPI's Levoleucovorin (Fusilev) führen. Der Termin bei der FDA war ja Ende April? (Ich weis es im Moment nicht genau).

Nächste Frage, ist auch Levoleucovorin betroffen?

Dieses Jahr wird mit hoher Wahrscheinlichkeit nicht mehr viel passieren. Nächstes Jahr wirds dann wieder spannend.

[VaJo]

Der Engpass bei Leucovorin bei den beiden größten Generika Herstellern hält weiter an.

Aktuell ein Bericht auf Forbes.

Die Lage ist wirklich dramatisch. Im Bericht wird die Verlässlichkeit von Generika Herstellern angezweifelt.

Cancer
Cancer Doctors Fear Chemo Drug Shortage
Matthew Herper, 12.16.08, 02:45 PM EST
The inability of two drug makers to produce a generic cancer medicine endangers both patients and research.

Doctors and patient advocates say a shortage of a key drug for colorectal cancer could deprive thousands of patients of appropriate treatment and stall the testing of new experimental drugs.

Leucovorin, a modified B vitamin, has been a key ingredient in chemotherapy regimens for 30 years, ever since studies found it tripled the number of patients whose tumors shrank when given another drug, called 5-flurouracil. A drug cocktail of 5FU and leucovorin is now a backbone of colon cancer chemotherapy. Newer drugs like Erbitux and Avastin have never been tested without it.

But leucovorin, which is generic, is made by only two companies: Teva Pharmaceuticals (nasdaq: TEVA - news - people ) of Jerusalem and Bedford Laboratories, a Bedford, Ohio, subsidiary of the German drug giant Boehringer Ingelheim. In November, the Food and Drug Administration said that both companies were unable to make an adequate supply, but hard information about the shortage has been difficult to obtain, beyond what is posted on the FDA Web site.

More than 140,000 Americans are diagnosed with colorectal cancer annually, but it is not clear how many are affected by the shortage, as the degree of rationing varies. M.D. Anderson Cancer Center says it anticipated the shortage and just received a bulk shipment, but at the University of California, San Francisco, "the average patient" is not getting leucovorin, says UCSF oncologist Alan Venook, and a committee meets weekly to decide how to use the existing supply.

"This is a very serious and scary situation for patients," says Kate Murphy, director of research communication for the Colorectal Cancer Coalition, a patient advocacy group. Murphy has personally survived three bouts of colon cancer over a 25-year period, the most recent last year.

"There are no answers at the FDA, and there are no answers at the manufacturers as to what is causing the shortage or how soon it might be resolved." Murphy says. "With no leucovorin in the pipeline, patients are just faced with no good alternatives."

Multiple requests for comment by Forbes to Teva were unanswered, and Boehringer had no immediate comment. The FDA is "aware that leucovorin injection is in shortage due to manufacturing delays," says Karen Riley, an FDA spokeswoman. "Bedford and Teva are both releasing product currently, and we are continuing to monitor this situation," she says.

But the Web site of the American Society of Health-System Pharmacists says that leucovorin powder for injection from both Teva and Bedford is on back order, that the companies "cannot estimate a release date," and that "the manufacturers will not provide a reason for the shortage."

On an Internet chat room support group called the Colon Club, one patient wrote of not receiving any leucovorin at a scheduled infusion of the cancer drug Eloxatin, made by Sanofi-Aventis. "Neither the distributor nor the manufacturer had any in stock." Another patient reported being switched from Eloxatin to Xeloda, a pill made by Roche that does not require intravenous leucovorin. Camptosar, a competing drug from Pfizer, is also administered with leucovorin.

Sanofi-Aventis is "aware of the situation," says spokeswoman Noelle Boyd. "We are currently looking into the implications both from a research and a commercial perspective."

The Eastern Cooperative Oncology Group (ECOG), an independent group of academic cancer doctors that has played a key role in testing new cancer medicines, started hearing from hospitals that they were almost out of leucovorin.

"We've been fielding phone calls from institutions that are running out," says Albert Benson, head of clinical investigation at the Robert H. Lurie Cancer Center and chairman of an ECOG committee that oversees colon-cancer drug studies. "There may be institutions that have a good supply, but it is getting harder and harder to find. This is going to affect a lot of people, and we need to have some answers."

ECOG and other similar clinical trial groups are holding an emergency conference call Tuesday to try to figure out how to handle ongoing clinical trials if more leucovorin does not emerge. These groups are running 100 studies of cancer drug regimens that might improve on current cancer drug regimens. Genentech says the shortage is not yet affecting research on its drug Avastin.

"This is starting to be an issue nationally," says Leonard Saltz, a leading colon cancer doctor and researcher at Memorial Sloan-Kettering Cancer Center in New York. He warns that there is short supply for "a number of drugs," including vinblastine for lymphoma, and dexraxozane, used to protect the heart from another chemotherapy, doxorubicin.

In a blog post on the Web site of HemOnc Today, a trade publication for cancer doctors, oncologist Noelle LoConte of the University of Wisconsin writes that there are ongoing shortages of other drugs, including cyclosporine and doxorubicin.

"There is no clear endpoint in the shortage," she writes, "and clearly some patients need it without question." She adds that as rumors of the shortage spread, some doctors have stockpiled the drug. "One of my partners was at a site yesterday which had two years of leucovorin stored! The drug will likely expire before they can use it all!"

UCSF oncologist Venook says he is not sure leucovorin is necessary. It was added when 5FU was a new drug, and its not clear whether there will be a real impact from removing it. Still, the shortage is leading to general fears about access to generic cancer drugs.

"I've never heard of anything like it," says Michael Katz, a cancer survivor who is chair of a committee of patients that advises ECOG. He worries that the leucovorin shortage is a "red flag" that the cheap generic drugs cancer doctors use in addition to the pricey drugs like Avastin, made by Genentech and Roche, and Erbitux, from Eli Lilly and Bristol-Myers Squibb.

"This could be something that could occur much more frequently with generic drugs, because the margins of generic drugs are so thin. And many of the drugs that are the most important drugs in the cancer armamentarium are the drugs that have gone off patent," says Katz. He wonders why there is no system to catch such shortages and prevent them from harming patients or halting clinical trials.

Katz asks, "How many drugs are out there that are just being produced by the grace of God?"