I am eyeing this one for starting position. Three strong buys, heavy volume, low float, some new patents, coming up from lows.
Check out the chart. Any feedback or comments are welcome.
Hi Stocky,
I'm going to guess the news that was released AH on 9/28/05 will help your cause. If you're not in, you might want to think about it now :)
News released 9/28/05 6:25pm::::
-------------------------------------------------
Spectrum Pharmaceuticals Receives FDA Approval for Fluconazole Tablets
9/28/2005
* This is the Third ANDA, Filed by Spectrum Approved by the FDA
* Nine ANDAs Currently Pending FDA Approval, One With Paragraph IV Certification
IRVINE, Calif., Sept 28, 2005 /PRNewswire-FirstCall via COMTEX/ --
Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that today that it has received approval from the Office of Generic Drugs of the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) for fluconazole tablets. Fluconazole is a widely used anti-fungal agent. The branded product, Diflucan(R), is marketed by Pfizer Pharmaceuticals.
"With three generic products now approved and several more pending FDA review, we have gained valuable experience in both developing generic drugs and achieving regulatory approval," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "As we receive marketing approval of our more specialized generics over the next several years, we believe that we will demonstrate the benefits of pursuing this opportunity as a way to enhance the financial resources of this company. At this time, our sales expectations from our generic portfolio is relatively modest, but we believe that our longer-term outlook remains positive."
The ANDA for fluconazole is the second oral product filed by NeoJB, LLC, a joint venture between Spectrum and J.B. Life Science Overseas Ltd, a subsidiary of J.B. Chemicals & Pharmaceuticals (JBCPL).
Spectrum Pharmaceuticals currently has nine ANDAs that are pending at the FDA, which among others include ophthalmic drugs, injectable anticancer drugs, and an ANDA with Paragraph IV certification for sumatriptan succinate injection.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. For more information, please visit our website at www.spectrumpharm.com.
Forward-looking statements
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, the Company's operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company's strategic alliance partners, that we will demonstrate the benefits of pursuing this generic opportunity as a way to enhance the financial resources of the Company, that the longer-term outlook of sales from our generic portfolio remains positive 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 price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, 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.
Contact: Laurie Little Sr. Director, Investor Relations (949) 743-9216
SOURCE Spectrum Pharmaceuticals, Inc.
Laurie Little, Sr. Director, Investor Relations of Spectrum Pharmaceuticals, Inc., +1-949-743-9216 http://www.prnewswire.com
Copyright (C) 2005 PR Newswire. All rights reserved.
UP ON NEWS TODAY !!!!!!!! :D
Spectrum Pharmaceuticals Announces the Presentation of New Preclinical Data on Apaziquone (E09) for the Treatment of Invasive Bladder Cancer
Thursday April 13, 11:25 am ET
* Apaziquone is the active drug substance of EOquin(TM), for which an IND has been filed with the FDA to begin a Phase 3 clinical trial for the treatment of superficial bladder cancer.
* Data from the current study suggests a potential application of E09 in an additional indication - invasive bladder cancer.
IRVINE, Calif., April 13 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) announced the presentation of new preclinical data on Apaziquone at the 97th Annual Meeting of the American Association for Cancer Research (AACR) in Washington, DC, earlier this month.
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A poster entitled "Analysis of NAD(P)H: quinine oxidoreductase-1 (NQO1), Cytochrome P450 Oxidoreductase (P450R) and glucose transporter 1 (Glut-1) protein expression suggests a possible role for E09 in the treatment of invasive bladder cancer" (Abstract # 546, authors Roger M. Phillips and colleagues from the Institute of Cancer Therapeutics, Bradford, UK and Spectrum Pharmaceuticals) showed the relationship between the expression of biomarkers Glut-1, NQO1 and P450R to tumor grade and stage.
The study found that invasive bladder cancer has significantly lower levels of NQO1 and higher levels of Glut-1, a marker for reduced oxygen tension (hypoxia). Many tumors grow under conditions of hypoxia. This makes them insensitive or resistant to treatment by X-rays. EO9 is activated in tumor cells both in normal oxygenation and in hypoxia. Data from the present study suggests that E09 can be used in combination with radiation as a hypoxic selective therapy for the treatment of invasive bladder cancer.
"We already have exciting data on EOquin(TM) for the treatment of superficial bladder cancer," commented Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum. "This study suggests that Apaziquone may also have anti-tumor activity in hypoxic tumors, such as invasive bladder cancer."
EOquin(TM) (Apaziquone, E09) is an anti-cancer agent formulated for administration directly into the urinary bladder. It is activated by certain enzymes present in higher amounts in cancer cells than in normal cells. Spectrum has proprietary worldwide rights to EOquin(TM) and plans to out-license it for markets outside the U.S., including Europe and Japan.
The American Cancer Society estimates there will be more than 61,420 new cases of and 13,060 deaths from bladder cancer in 2006 in the United States. There is an estimated 400,000 patient population currently in the U.S. and an even greater number estimated in Europe. Approximately 25% of all new patients have muscle-invasive bladder cancer at the time of diagnosis. Of the remaining 75% who initially present with superficial disease, 10%-15% will progress to invasive disease.
The initial treatment for superficial bladder cancer is usually surgical removal of the tumor(s), often followed by additional immunotherapy or chemotherapy drugs instilled directly in the bladder to prevent or delay recurrences. Treatment for invasive bladder cancer involves radical cystectomy (removal of the bladder) with or without radiation therapy and systemic chemotherapy. Radical cystectomy is a major surgery, associated with significant morbidity, and a mortality rate of 1-3%. Radiation therapy is an effective treatment for a number of tumors. Half of all cancer patients will receive radiation therapy during their course of treatment for cancer. While radiation therapy is one of the most widely used treatment modalities, many tumors are hypoxic, and most contain hypoxic areas, which are resistant to radiation therapy. There remains a need to improve the cure rate by radiation therapy, especially in hypoxic tumors.
Put on ur list ;)
Spectrum Has A Rosy Glow
When Spectrum Pharmaceuticals (SPPI ) (SPPI) announced on Sept. 25 that results from the Phase 3 trials of its Satraplatin were "positive," its shares bolted from 3.49 to 5 in a day--and are now at 5.34. Satraplatin is platinum-based chemotherapy taken orally for hormone-resistant prostate cancer. After the stock's jump, some warn there may be limited room to run. Not so, says Ren Benjamin of Rodman & Renshaw, who rates it "outperform," with a 12-month target of 13. Based on early results and the timeline for accelerated approval, he says, Satraplatin may be launched in the U.S. in the third quarter of 2007. Assuming world sales of $500 million a year, Benjamin figures Spectrum's royalties from partners GPC Biotech and Pharmion (PHRM ) will total $50 million by 2012. But he says the price doesn't yet reflect Spectrum's other products, such as Ozarelix for enlarged prostates. On Oct. 2, Spectrum announced that Phase 2 trials for Ozarelix were "significantly positive." The trials, held in Europe with partner Æ terna Zentaris, had "an excellent safety profile" in treating benign prostatic hypertrophy, says CEO Rajesh Shrotriya. Megan Murphy of Lazard Capital Markets, who rates Spectrum a "buy," has a 12-month price target of 1
Chart update: 50sma crossed above the 200's ;)
SPPI has awaken from its sleep ;)
Hi Terliso
I didn't know we have a SPPI thread in the free area so let me copy my posting from the premium area. It is time that we spread the word about this great opportunity :)
SPPI printed another Gap on the daily chart on Friday and made another 52 week high under almost 5 times normal volume.
(http://www.3stocksonfire.org/trading/index.php?action=dlattach;attach=32419;image)
This time the run was initiated by the start of phase IIb trial for Ozarelix in Patients with Benign Prostate Hypertrophy: http://biz.yahoo.com/prnews/070125/lath013.html?.v=90
28 million men are suffering from this disease and Ozarelix has shown very promising results till now. This drug alone could justify SPPI's market cap of 154 million USD (especially as they have more than 50 million USD in Cash!)
But as you can see if you read this thread from the start SPPI has so much more to offer the investor who takes a little time investigate their Pipeline.
The next trigger is the filing of the NDA for Satraplatin. GPC expects to file the NDA at the end of January and Pharmion expects to file the MAA in Europe before end of June. Unless the stock runs from here I would expect it to post yet another gap when the announcement is made (and that should be within short time!)
Goldman Sachs recently upgraded GPC: http://www.bloomberg.com/apps/news?pid=20601100&sid=aNthsfjrl8o4&refer=germany
QuoteGPC Biotech AG, a biotechnology company, jumped 7.8 percent to 21.82 euros, the biggest gain in the HDAX. Goldman, Sachs & Co. analysts including Stephen McGarry in London raised their price estimate for the stock and added it to their ``conviction buy list,'' on the outlook for revenue from the prostate cancer drug Satraplatin.
I don't have access to the research but what I am hearing is that they also increased the revenue forecast for Satraplatin. For the valuation of SPPI we do however not need to use any increased revenue figures for Satraplatin. The generally accepted yearly revenue is 500 million USD giving SPPI annual royalty income of 50 million USD. As SPPI's cost associated with Satraplatin is zero this revenue will go directly to the bottom line.
So 50 million USD in cash, annual royalty income 50 million USD and a very exiting pipeline with several near term price triggers. If the market thinks this stock deserves a market cap of 154 million USD then I think the market is wrong and it seems to me that the market has started to realize the mistake ;)
The biggest mistake seems to have been made by the short community. 1.66 million shares are short as of January 9 that is 6.7% of the float and it will take the shorts 13 days to cover their position.
(http://www.3stocksonfire.org/trading/index.php?action=dlattach;attach=32420;image)
As we are trading at 52 week high it is safe to assume that all shorts are in the red. The volume on Friday was as said were 5 times higher than the average and I can see a nice short squeeze unfold from here.
That should not be the main reason to buy SPPI. There are so many other fundamental and technical reasons for this pick but it could make the appreciation in price go so much faster >:D
Quote from: Michael on January 29, 2007, 07:32:04 AM
Hi Terliso
I didn't know we have a SPPI thread in the free area so let me copy my posting from the premium area. It is time that we spread the word about this great opportunity :)
Yes, Michael we got it right here and thanks for your post. ;)
I bought some SPPI today when it was slightly in red.
SPPI is Up again, slowly but surely! ;)
SPPI broke out of a symmetrical triangle in mid-jan. I put the target at 6.75 for this triangle. Was strugglng a little on Friday with the 6.50 level, but I think there is a pretty good chance of that target getting made in the short term. Longer term, Terliso's targets in the $8 range seem entirely doable.
Quote from: ScottishTrader on February 04, 2007, 09:17:27 AM
SPPI broke out of a symmetrical triangle in mid-jan. I put the target at 6.75 for this triangle. Was strugglng a little on Friday with the 6.50 level, but I think there is a pretty good chance of that target getting made in the short term. Longer term, Terliso's targets in the $8 range seem entirely doable.
Biotech is notorious difficult to put a target on. I am not sure where Terliso got his from but as I know Terliso it is probably a technical target.
There are three analysts following the stock and they have targets between $10 and $13 which from a fundamental point of view makes more sense. If both Levofonic Acid and Satraplatin will be launched this year (LFA is just waiting for CMC response and a NDA for Satraplatin should be filled within a short time) I would expect that SPPI generates free cash flow of around 50 million USD per year from 2009. A conservative P/CF would be 20 (especial having in mind that they would at that time have several more drugs in late stages).
With a P/CF of 20 the market cap would be 1 Billion USD and the stock price 39.8.
So here you are the target is somewhere between 6.75 and 39.8 only time will show who is right but I certainly wouldn't sell at these levels :)
Quote from: Michael on February 04, 2007, 02:22:19 PM
Biotech is notorious difficult to put a target on. I am not sure where Terliso got his from but as I know Terliso it is probably a technical target.
It is a technical breakout from a 2 year Falling Wedge pattern. ;)
** Breakout on heavy volume somewhere at $4.71 **
7.50 minus 3.36 = $4.14
4.14 plus 4.71 = $8.85
Spectrum Pharmaceuticals Announces Successful Completion of Patient Accrual in Its EOquin(R) Pilot Study, Prior to Initiating Phase 3 Studies in the U.S.
Tuesday February 6, 8:00 am ET
* EOquin(R) Was Found to Be Well Tolerated, Have No Adverse Effect on Wound Healing and Was Not Absorbed Systemically, When Given as an Intravesical Instillation Immediately Following Transurethral Resection (TUR) of Noninvasive Bladder Cancer
* Company Plans to Initiate Phase 3 Studies Before Mid-Year
IRVINE, Calif., Feb. 6 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals (Nasdaq: SPPI - News) announced today that the Company has completed patient accrual in the U.S. pilot safety study of EOquin® in patients with noninvasive bladder cancer. In this study, EOquin® was found to be well tolerated when administered to patients immediately following surgery for noninvasive bladder cancer in clinical results to date.
The pilot study was a multicenter, single-arm, open-label study. Twenty patients received 4 mg of EOquin® in 40 mL of diluent. EOquin® was instilled via an indwelling catheter that was then clamped for one hour. After an hour the bladder was drained and the catheter was removed. Patients were assessed for adverse events during the one-hour retention and at follow-up visits on postoperative days eight and 15. Wound healing was assessed by cystoscopy performed at postoperative day 85. In six patients, systemic absorption, if any, was assessed by measuring the blood levels of EOquin® and its metabolites. Results confirmed previous clinical results where EOquin® administration was well tolerated. In addition, there was no adverse effect on wound healing and when administered immediately after surgery, EOquin® was not absorbed into the bloodstream.
"We are pleased with the results of this study, that was requested by the FDA, which demonstrate that EOquin is well tolerated and does not affect surgical wound healing and is not systemically absorbed even when given immediately after surgery; we therefore will not expect side effects outside of the bladder. We look forward to finalizing the Phase 3 protocol, which has been submitted to the FDA for a Special Protocol Assessment. We expect to initiate the Phase 3 studies before mid year," stated Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum Pharmaceuticals. "Bladder cancer is a difficult and expensive disease to treat, and we believe that EOquin® has the potential to make a difference in the lives of bladder cancer patients."
Spectrum anticipates full data from the completed pilot study to be presented at a scientific conference in the coming months.
About EOquin®
EOquin® (apaziquone for intravesical instillation) is a drug currently being developed for the treatment of noninvasive bladder cancer, cancer that has not invaded the muscle of the bladder wall. EOquin®, an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. In studies performed to date, EOquin® was not absorbed in any significant amount from the bladder wall into the bloodstream and would carry a lesser risk of harming the rest of the body.
Spectrum Pharmaceuticals completed multi-center, Phase 2 clinical trials in Europe. The results of the trial were favorable, showing that EOquin® was safe and efficacious. These data were presented to the FDA in early 2006.
About Bladder Cancer
The American Cancer Society estimates that there were more than 61,420 new cases of and 13,060 deaths from bladder cancer in 2006 in the United States. The estimated patient population with bladder cancer is over 400,000 in the United States and even greater in Europe. Noninvasive bladder cancer accounts for 75 to 80 percent of all cases of bladder cancer at first diagnosis. According to Botteman et al., (PharmacoEconomics 2003), bladder cancer is the fifth most expensive cancer to treat. The initial treatment of this cancer is surgical removal of the tumor. Because of the high frequency of early recurrences of the tumor, many current practice guidelines recommend immediate instillation of a chemotherapeutic agent after surgery for which there is currently no approved drug in the U.S. During the past 20 years or so, no new drugs have been introduced in the market for treatment of bladder cancer.
Is the short term target for the breakout of the symetrical triangle $7.75 (vs $6.75)?
$6.25 top of triangle
-4.25 bottom of triangle
--------
$2.00 difference
+5.75 breakout
-------
$7.75 target ?
Thanks....
Quote from: brandyjoco on February 06, 2007, 05:10:45 PM
Is the short term target for the breakout of the symetrical triangle $7.75 (vs $6.75)?
$6.25 top of triangle
-4.25 bottom of triangle
--------
$2.00 difference
+5.75 breakout
-------
$7.75 target ?
Thanks....
You were right brandy, scottish was wrong on his target @ $6.75.
but if you look at longer term the target is near at $9.00 or above $10.00 from descending wedge pattern.
My target was off the first reaction low after it reached the initial high. Having looked at triangle breakouts a bit it seems more prudent to do this than to take it from the very base of the pattern. i did get the math a little wrong, however, and actually I put it at 6.90.
I should also mention that when targets get made, it doesn't mean it can't go higher. The main thing about a symmetrical triangle brekaout like this is that we have a consolidation phase followed by an advance phase. The advance phase can go a lot higher than the initial consolidation may suggest. Fortunately SPPI is showing us exactly what this should look like, and I think we shall see $7+ prety soon.
http://stockcharts.com/school/doku.php?id=chart_school:chart_analysis:chart_patterns:symmetrical_triangle
Thanks Terliso and Scottish Trader. Those charts and instructions help me alot. Sounds like SPPI is a real winner! I am very interested in it and hope to get a good entry point.
Quote from: brandyjoco on February 06, 2007, 07:55:55 PM
Thanks Terliso and Scottish Trader. Those charts and instructions help me alot. Sounds like SPPI is a real winner! I am very interested in it and hope to get a good entry point.
You are welcome Brandy!... on SPPI Symmetrical Triangle breakout, if we put a parallel trendline we got a target below $8... Scottish target @ $6.90 was still very conservative target for a Symmetrical Triangle upside breakout. ;)
yeah, I know ;)
Spectrum Pharmaceuticals to Present at the 9th Annual BIO CEO & Investor Conference
Wednesday February 7, 9:00 am ET
IRVINE, Calif., Feb. 7 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals (Nasdaq: SPPI - News) announced today that Rajesh Shrotriya, M.D., Chairman, President and CEO of Spectrum, will present an overview of the Company on Tuesday, February 13, 2007 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time), at the BIO CEO & Investor Conference, being held at the Waldorf Astoria in New York City. Spectrum's presentation will be held in the Conrad Suite.
A live webcast of Spectrum's presentation will be available under the investor relations section of its corporate website, http://www.spectrumpharm.com. Replays of the presentation will be available for 30 days following the event. Please connect to Spectrum's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
Thanks so much! I picked up 3000 shares this morning at $6.59.
awsome news:
Spectrum Pharmaceuticals Announces Completion of NDA Filing for Satraplatin for Hormone Refractory Prostate Cancer
Friday February 16, 2:00 am ET
* Spectrum to Receive $4 Million Milestone Payment Upon Acceptance by FDA
IRVINE, Calif., Feb. 16 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) today announced the completion of the submission of the New Drug Application (NDA) to the US Food & Drug Administration (FDA) for satraplatin, the Company's lead drug candidate for the treatment of hormone refractory prostate cancer (HRPC) for those patients who have failed prior chemotherapy. This clinical submission, the third and final portion of the rolling NDA, is based on data from the SPARC (Satraplatin and Prednisone Against Refractory Cancer) Phase 3 registrational trial. The trial enrolled 950 patients, and the study data results for progression-free survival (PFS) were highly statistically significant (p<0.00001). Satraplatin was granted fast-track status, which allowed the FDA to accept a rolling NDA. Major components of the NDA, including, chemistry, manufacturing and controls and nonclinincal (safety) information have previously been accepted for review by the FDA. The FDA has up to 60 days to formally accept the completed application. Upon acceptance, the FDA will determine if the application will be granted priority review, which has already been requested and would allow for a six-month review of the NDA.
The FDA's acceptance of the NDA will trigger a $4 million milestone payment to Spectrum. Spectrum is also entitled to receive milestone payments upon the achievement of additional regulatory milestones in the U.S., Europe, Japan and other countries. Further payments are due on achieving certain sales targets. In addition to milestones, Spectrum is entitled to receive royalties on worldwide sales of satraplatin. The company also has co- promotion rights in the U.S., if its partner markets satraplatin itself in the U.S.
"The completion of the filing of the satraplatin NDA is an important landmark for Spectrum as we are now one step closer to bringing forth a new treatment option for patients with prostate cancer. The completion of this rolling NDA also validates our business model of identifying promising drug candidates and opportunistically advancing those candidates through clinical development," said Rajesh C. Shrotriya, M.D., Spectrum's President and Chief Executive Officer. "Beginning with the acceptance of this filing, Spectrum will be entitled to receive a series of milestone payments that will serve as a source of non-dilutive funding, a key part of our strategy for the advancement of our broad and deep pipeline of drugs. We plan to follow this strategy as we continue to develop our portfolio of 10 drug candidates, two of which are expected to be in phase 3 clinical trials this year: Ozarelix for benign prostate hypertrophy and EOquin® for noninvasive bladder cancer."
EMA20 as support, but it should be a wonderful SPPI trading day
Wonder if it will gap up from the news. Will keep it on my watch list.
Spectrum Pharmaceuticals Announces Completion of NDA Filing for Satraplatin for Hormone Refractory Prostate Cancer
Friday February 16, 2:00 am ET
* Spectrum to Receive $4 Million Milestone Payment Upon Acceptance by FDA
IRVINE, Calif., Feb. 16 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) today announced the completion of the submission of the New Drug Application (NDA) to the US Food & Drug Administration (FDA) for satraplatin, the Company's lead drug candidate for the treatment of hormone refractory prostate cancer (HRPC) for those patients who have failed prior chemotherapy. This clinical submission, the third and final portion of the rolling NDA, is based on data from the SPARC (Satraplatin and Prednisone Against Refractory Cancer) Phase 3 registrational trial. The trial enrolled 950 patients, and the study data results for progression-free survival (PFS) were highly statistically significant (p<0.00001). Satraplatin was granted fast-track status, which allowed the FDA to accept a rolling NDA. Major components of the NDA, including, chemistry, manufacturing and controls and nonclinincal (safety) information have previously been accepted for review by the FDA. The FDA has up to 60 days to formally accept the completed application. Upon acceptance, the FDA will determine if the application will be granted priority review, which has already been requested and would allow for a six-month review of the NDA.
The FDA's acceptance of the NDA will trigger a $4 million milestone payment to Spectrum. Spectrum is also entitled to receive milestone payments upon the achievement of additional regulatory milestones in the U.S., Europe, Japan and other countries. Further payments are due on achieving certain sales targets. In addition to milestones, Spectrum is entitled to receive royalties on worldwide sales of satraplatin. The company also has co- promotion rights in the U.S., if its partner markets satraplatin itself in the U.S.
"The completion of the filing of the satraplatin NDA is an important landmark for Spectrum as we are now one step closer to bringing forth a new treatment option for patients with prostate cancer. The completion of this rolling NDA also validates our business model of identifying promising drug candidates and opportunistically advancing those candidates through clinical development," said Rajesh C. Shrotriya, M.D., Spectrum's President and Chief Executive Officer. "Beginning with the acceptance of this filing, Spectrum will be entitled to receive a series of milestone payments that will serve as a source of non-dilutive funding, a key part of our strategy for the advancement of our broad and deep pipeline of drugs. We plan to follow this strategy as we continue to develop our portfolio of 10 drug candidates, two of which are expected to be in phase 3 clinical trials this year: Ozarelix for benign prostate hypertrophy and EOquin® for noninvasive bladder cancer."
also check latest presentation:
http://www.spectrumpharm.com/presentations/corporate/index.html
awesome news, up we go >:D
Quote from: la-onda on February 16, 2007, 04:42:06 AM
awesome news, up we go >:D
Indeed great news and yet another 52-week high. It finally seems like the chart has got some direction after the break away gap in September. I could see this trend continue to $12, which is the target I have for SPPI >:D
Hit $7.00 ;)
Expanded Access Program Launched for Satraplatin
Wednesday February 21, 8:00 am ET
IRVINE, Calif., Feb. 21 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) today announced that the Satraplatin Expanded Rapid Access protocol (SPERA) has been launched by the company's partner, GPC Biotech. Expanded Access Programs (EAPs) are intended to give patients access to investigational drugs to treat serious or life-threatening diseases or conditions for which there are limited treatment options available. Under the SPERA program, satraplatin will be provided to patients free of charge.
"Prostate cancer patients who have failed first line therapy have very limited treatment options available to them," said Rajesh C. Shrotriya, Spectrum's Chairman, President, and Chief Executive Officer. "The SPERA program provides these patients with an additional treatment option."
U.S. physicians interested in receiving more information about SPERA can contact 1-800-349-8086 or www.speratrial.com.
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and Europe. Approximately 234,000 men in the U.S. are expected to be diagnosed with the disease in 2006 and more than 27,000 men are expected to die from the disease. In the European Union, over 200,000 new cases are expected to be diagnosed, and more than 60,000 patients are expected to die each year. Since the incidence of prostate cancer increases with age, the aging of the overall population is expected to further increase the number of prostate cancer patients. Most patients diagnosed with prostate cancer initially receive surgery or radiation therapy, and some of these patients are cured. For many others, though, the disease recurs. Recurrent disease is treated with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumor cells become resistant to the hormones -- or hormone-refractory -- and the tumor again progresses. Increasingly, chemotherapy is being used as an effective first-line treatment for HRPC. However, it is not a cure. Consequently, there is a growing need for effective therapeutic options, such as second-line chemotherapy treatments, for patients once they have progressed.
GPC Cancer Therapy to Get Sped Up Review
Monday April 16, 2:12 pm ET
GPC Biotech to Get Faster FDA Review for Prostate Cancer Drug; Triggers Payment to Spectrum
NEW YORK (AP) -- German drug maker GPC Biotech AG and specialty drug developer Spectrum Pharmaceuticals Inc. said Monday that the Food and Drug Administration will give its cancer therapy candidate a quicker than usual review.
Shares of GPC rose $1.87, or 6.5 percent, to $30.66 in afternoon trading on the Nasdaq Stock Market. Shares have traded between $13.15 and $33.04 in the past 52 weeks.
The companies said the FDA accepted an application to use the chemotherapy satraplatin in combination with the steroid prednisone to treat hormone-refractory prostate cancer patients who have failed prior chemotherapies.
The acceptance triggers a $4 million milestone payment to Spectrum. In 2002, the company licensed satraplatin's global rights to GPC Biotech. In turn, Spectrum will have to pay $500,000 in Spectrum shares and $500,000 cash to Johnson Matthey PLC, which holds original rights to the drug.
Also, the FDA granted the drug a priority review, meaning it will review the application in six months rather than the standard 10, placing an expected decision in August.
GPC has a co-development and licensing agreement with Pharmion GmbH, a unit of Pharmion Corp., which has exclusive rights for the drug in Europe. Pharmion expects to file an application for the drug with European regulators in the second quarter.
Spectrum shares rose 4 cents to $7.39, and Pharmion shares fell 25 cents to $30.15. Both stocks trade on the Nasdaq.
SPPI hit my target @ $7.72 ;) Too bad, I also sold this one went the market went crazy last month.
Are you still holding your shares La-onda?
unfortunately not Terliso :'( :'(
also sold in March
what about SLP?
http://www.3stocksonfire.org/trading/index.php?topic=8579.msg95561#new
cheers
Oliver
Hi Michael & Terliso, just fyi:
Spectrum Discusses FDA Approval of Levoleucovorin for Injection
Spectrum Pharmaceuticals, Inc. (SPPI) conducted a conference call after the bell on Monday to discuss the FDA's approval of Levoleucovorin for Injection. It is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. The Company currently expects its commercial launch by June 2008.
The Chairman and CEO of Spectrum, Dr. Rajesh Shrotriya, stated in the conference call, "We
believe this approval can be the springboard for the next phase of our company's growth. Levoleucovorin can be the foundation for commercial success. This approval puts us in a different league, and this launch will be a transforming event for the company."
Levoleucovorin has been available for more than ten years in Europe and Japan. The Company
plans to file for a supplemental New Drug Application with the FDA for use of leucovorin in colorectal cancer in 5-fluorouracil containing regimens and an NDA amendment for an oral tablet formulation by mid-year 2008.
Dr. Shrotriya added, "We are expecting approval without the requirement of conducting any more clinical trials. It will be more of a matter of preparing the data for submission. Once the other indications for this drug have been approved, you are talking about a U.S. market of $100 million for levoleucovorin."
"Although a final determination has not been made, we want to price this product as a branded drug that is premium to currently available generic drugs. Our sales and ramp-up will occur slowly until we get approval for all indications."
Vice President of Marketing & Sales for Spectrum, George Uly added, "We have recently been in
discussions with two potential partners for this drug. One has a market cap of over $20 billion, and the other is a private company with a sales force in place. When we get the colorectal indication approval, our target market will increase significantly. It would probably make more sense for a strategic partnership at that time, but we will make that decision when appropriate and in the best interest of Spectrum. In the meantime, we have been busy building the infrastructure for launch."
EOquin(R) is the Company's synthetic Bio-reductive prodrug that is being investigated in the treatment of non-invasive bladder cancer, and began two Phase 3 studies in 2007. Spectrum also has three drugs in the Phase 2 stage of development: Ozarelix, for the treatment of prostate cancer and benign prostatic hypertrophy, Ortataxel, for the treatment of taxane-refractory tumors, and Satraplatin, a Phase 2 oral, anti-cancer drug, being investigated for non-small cell lung cancer (NSCLC). The Company has three drugs in the Phase 1 stage of development: SPI-1620, an adjunct to chemotherapy, Elsamitrucin, which will target advanced solid tumors and Lucanthone, a chemotherapy sensitizer in the treatment of recurrent, malignant brain tumors. Other drugs in development include RenaZorb(TM), used in the treatment of hyperphosphotemia in end stage renal disease (ESRD), and SPI-205 for chemotherapy induced neuropathy.
In addition, the Company has the right to market authorized versions of sumatriptan injection, the generic version of GlaxoSmithKline's Imitrex(R) Injection for migraine, which Spectrum will in the second half of 2008.
Dr. Shrotriya concluded, "It is important to remember that this company has only existed for five years. We currently have ten proprietary drugs. By the end of the year, our company
should have two revenue producing drugs."
any opinion from your side?
Chart:
SPPI breakaway gap....
Worth the wait my friends.
FDA fast tracks Spectrum, Allergan cancer drug...
Spectrum Pharma and Allergan say FDA gives fast track status to EOquin for bladder cancer
On Tuesday July 21, 2009, 11:48 am EDT
NEW YORK (AP) -- Spectrum Pharmaceuticals Inc. and Allergan Inc. said Tuesday the Food and Drug Administration will grant a faster review to their drug candidate EOquin, which is intended to treat non-muscle invasive bladder cancer.
The drug candidate received fast track status from the FDA. The fast track designation is intended to speed up the development and review of drugs that treat serious illnesses, including those for which no treatment exists, or that could be a significant improvement over drugs currently on the market.
The companies are enrolling patients in a late-stage clinical trial of the drug. Spectrum says it expects to finish enrollment by the end of the year, and to report the results two years later.
EOquin, or apaziquone, is intended to treat bladder cancer that has not that has not yet spread deep into the muscle layer. Spectrum and Allergan estimated that the non-muscle invasive type accounts for 70 percent of new bladder cancer diagnoses, and said it affects more than a million patients in the U.S. and Europe.
Spectrum shares rose 54 cents, or 9.2 percent, to $6.41 in midday trading. Allergan shares declined 53 cents to $49.38.
In October, Allergan paid Spectrum $41.5 million to get the rights to market EOquin as a bladder cancer treatment in the U.S., Europe and Canada. If the drug advances through development and regulatory approval and reaches sales milestones, Allergan will pay Spectrum up to $304 million more. Spectrum is also eligible to receive royalties on sales of the drug outside the U.S.
The companies plan to co-promote EOquin in the U.S., with Allergan covering most of the development costs. Spectrum owns the rights to EOquin in Asia.
Spectrum and Allergan are located in Irvine, Calif.
Good news and future FDA news...
FDA accepts Zevalin application Fusilev in the pipeline for October.
Also reference this here...
http://www.3stocksonfire.org/trading/index.php?topic=7100.msg119331#msg119331
52wk Range: 0.55 - 8.15
Volume: 4,043,994
Avg Vol (3m): 1,338,570
Technicals
Last Price Quote is:
19.10%above 13-day MA
30.37%above 50-day MA
RS Rating: 97
Fundamentals
Key Data:
Market Cap (M): $183.13
P/E Ratio: N/A
PEG Ratio: N/A
Next Earnings: 08/11/2009
Last Analyst Rating: Buy
Monday, July 20, 2009, 12:30pm PDT
FDA accepts Spectrum's Zevalin applicationLos Angeles Business from bizjournals
The U.S. Food and Drug Administration has accepted Spectrum Pharmaceuticals Inc.'s application for expanded use of the company's drug Zevalin, and will make a ruling on September 7.
Currently Zevalin is approved for use with patients with relapses of non-Hodgkin's Lymphoma. Spectrum has applied to have Zevalin be used as an initial treatment for non-Hodgkin's Lymphoma.
Earlier this month, the FDA requested more information about a subset of data related to the application.
Irvine-based Spectrum (NASDAQ: SPPI) acquires, develops and commercializes drug products, with a focus on oncology.
yes- they're expecting FDA's accord for Zev' on sept.7th
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FDA approval for Zevalin due Sept. 7th
http://seekingalpha.com/article/157299-spectrum-pharmaceuticals-the-labor-day-catalyst?source=email
the symetrical triangle has been broken Up
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fyi:
SPPI Fundamentals:
1. Strong Cash Position to Continue to Execute on Business Plan with $106M in Cash, Equivalents, and Financing Receivable as of June 30, 2009
2. $8.1M in 2Q09 Revenue
3. 2Q09 ZEVALIN® Net Sales vs. 1Q09 ZEVALIN Net Sales Up 25%
4. Institutional Holdings - 37.7%
5. Short Interest As Of 7/31 - 12% of total float
6. 41.9M Shares Outstanding
7. FDA Approved sBLA for ZEVALIN in First Line non-Hodgkin's Lymphoma 9/4/09. Spectrum said the Zevalin approval would expand the treatable population to about 43,000 patients annually."We believe the approval of ZEVALIN as an effective treatment option following a first-line regimen represents a notable advance in the treatment of non-Hodgkin's Lymphoma, and significantly expands the addressable population for ZEVALIN," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "We are confident that the strategic and tactical initiatives we have implemented will overcome the clinical, logistical, and reimbursement challenges that have previously hindered physician and patient access to ZEVALIN."
8. FDA Decision on sNDA for FUSILEV™ in Metastatic Colorectal Cancer Expected by October 8th
9. * Strong Cash Position to Continue to Execute on Business Plan with $106M in Cash, Equivalents, and Financing Receivable as of June 30, 2009
10. On 8/6/09 SPPI announced they aquired full rights to RenaZorb, or SPI-014, which is a non-aluminum, non-polymer, non-calcium, lanthanum-based nanotechnology with highly potent and selective phosphate binding properties, for the potential treatment via oral administration, of hyperphosphatemia, (high phosphate levels in the blood), in patients with chronic kidney disease (CKD). Hyperphosphatemia in Stage 5 CKD, also known as end-stage renal disease (ESRD), can lead to significant bone disease (including pain and fractures), secondary hyperthyroidism in renal sufficiency, cardiovascular disease, and is independently associated with increased mortality. Currently marketed therapies for treating hyperphosphatemia include polymer-based and lanthanum-based phosphate binders, aluminum-based phosphate binders, and calcium-based phosphate binders. According to the United States Renal Data System (USRDS), over the last 20 years, the number of patients with ESRD in the US has grown 4-fold. By 2010 there will be an estimated 661,330 patients with ESRD.
11. Biomedreports over the next 6 to 12 months, a price target for SPPI between $23.80 and $26.67 with a market cap from $1.0 to $1.12 billion. WIth the pending Fusilev decision due 10/8/09, there is no reason to cash in just yet. Biomedreports also reports that with the increased sales of Zevalin, SPPI becomes a likely buyout target. For full update here's the link (THIS IS A MUST READ!):
Spectrum Pharma's Drug Granted FDA approval (Updated)
Spectrum Pharmaceuticals (Nasdaq:SPPI), has received approval from the U.S. Food and Drug Administration (FDA) for an expanded label 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. This new and expanded indication supplements the 2002 FDA approval of ZEVALIN as treatment for patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.
Shares, which were halted ahead of the news, jumped 10% to $9.67 but ended up closing the day down at $8.33 -$0.43 (-4.91%) . Spectrum's stock has surged since March, and is up sharply from the 52-week low of 55 cents in October. Still, it is far off the all-time high of more than $600 in 2000. That price is adjusted based on a 1-for-25 reverse split in 2002.
The decision expands the treatable population to approximately 43,000 patients annually and should add susbtantially to the company's market cap. Some analysts say the current valuation in shares fails to realize the potential of ZEVALIN and completely discounts the value of the company's pipeline.
The FDA's decision on Zevalin was being closely watched by analysts, with some saying the drug's sales could rebound if it won approval. Sales have been falling since its launch in 2005, when it reached about $20 million a year. Last month, the company reported $3.3 million in sales of Zevalin for its second quarter.
The FDA's decision came a few days ahead of schedule, expanding the label for first-line therapy in treatment of non-Hodgkin's lymphoma, or NHL. The expansion allows for a treatable population of about 43,000 patients annually.
"We believe the approval of Zevalin as an effective treatment option following a first-line regimen represents a notable advance in the treatment of non-Hodgkin's lymphoma, and significantly expands the addressable population for Zevalin," said Chief Executive Rajesh Shrotriya.
Approval of the new indication was based on a Phase III study that evaluated the safety and efficacy of Zevalin in 414 patients who received a partial or complete response after receiving a first-line chemotherapy regimen.
Spectrum owns all rights to Zevalin, after acquiring the 50% it didn't already own in March.
"We believe the approval of ZEVALIN as an effective treatment option following a first-line regimen represents a notable advance in the treatment of non-Hodgkin's Lymphoma, and significantly expands the addressable population for ZEVALIN," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "We are confident that the strategic and tactical initiatives we have implemented will overcome the clinical, logistical, and reimbursement challenges that have previously hindered physician and patient access to ZEVALIN."
The company will be presenting an overview of their business strategy at the 11th Annual Rodman & Renshaw Global Investment Conference being held at the New York Palace Hotel in New York City next week. In addition, the company is expecting a second FDA decision (for Fusilev) in early October.
http://biomedreports.com/articles/most-popular/8243-spectrum-pharmaceuticals-recieves-fda-approval.html
SEEKING ALPHA:
Bayer's Bold New Bet Fails to Rain on Spectrum Pharma
Despite recent progress and the availability of novel therapies, radiation is still an effective tool in the war against cancer – as it has been for more than a century. The original and still predominant mode of administration is via external methods wherein a radiation source is directed at the intended target or region. Unfortunately, this "outside in" approach has the drawback of causing collateral damage to healthy organs and tissues that lie on either the path between the source and the target or beyond the intended target on the "exit" pathway.
In the 1990s, the U.S. Food and Drug Administration [FDA] cleared for marketing the first intravenously delivered, particle emitting radionuclides for the treatment of pain arising from the spread of cancer to bone. Termed Systemic Targeted Radionuclide Therapy (STaRT), this new approach offered the promise of selectively irradiating disease sites while sparing normal tissue. Metastron® [strontium-89 chloride injection] was introduced in 1993 and Quadramet® [samarium-153 EDTMP] was later introduced in 1997.
In 2003, the FDA cleared for marketing two different radioactive labeled monoclonal antibodies for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma [NHL]. Both of these STaRT products utilize monoclonal antibodies that target an antigen expressed by certain normal and malignant B-cell lymphocytes. However, Zevalin® [ibritumomab tiuxetan] employs yttrium-90 as its therapeutic payload, while Bexxar® [tositumomab] uses iodine-131.
Despite great promise and STaRT's established safety and efficacy, a July 14, 2007, article in the New York Times stated that only 10% of patients who are suitable candidates for the drugs ever receive treatment. Spectrum Pharmaceuticals, Inc. (SPPI) reported that U.S. sales of Zevalin were $11.4 million in 2008; while a similar non-radioactive product Rituxan® [rituximab] is a top-selling cancer drug by Genentech and Biogen Idec, Inc. (BIIB), with reported U.S. sales of $ 2.6 billion in 2008.
The lack of commercial success for existing STaRT products may be due to a mixture of clinical and commercial factors, including the following:
* Clinical considerations
o Half-life, or the amount of time required for a given amount of radionuclide to lose 50% of its strength or activity
+ In general, a half-life of 10 days or less is considered optimal, as longer half-lives may create waste management issues and clinically, are more likely to show toxicity problems.
o Particle range
+ Higher particle ranges may result in greater damage to surrounding normal tissue, leading to side effects such as myelosuppression.
o Specificity
+ Some radionuclides, such as strontium-89, have general disease-targeting properties, while others are conjugated to antibodies or other carriers to reach the intended target.
* Commercial considerations
o Production
+ Radioisotopes utilized for STaRT are produced commercially in nuclear reactors, cyclotrons or linear accelerators, and radionuclide generators, the selection of which can impact the cost-effectiveness of manufacturing.
o Shipment
+ Radionuclides that have very short half-lives or that require extensive shielding as a result of high-energy gamma ray emissions [eg, iodine-131] create logistical issues for shipment and handling and may even require a local production unit close to the treatment center.
o Administration
+ Marketers often assume that oncologists' decisions about therapy are driven purely by the scientific data. While medical oncologists are the key prescribing audience for marketed STaRT therapies, most aren't licensed to administer radiopharmaceuticals – resulting in patient referrals to radiation oncologists and/or nuclear medicine physicians. Therefore, these physicians may not be economically incentivized to prescribe products that they are not paid to administer.
o Reimbursement
+ Reimbursement by the Centers for Medicare and Medicaid Services [CMS] and private insurance carriers is critical to the commercial success of any product. In a letter by GlaxoSmithKline plc (GSK) to CMS regarding changes to the Hospital Outpatient Prospective Payment System [HOPPS], the company indicated that the proposed 2008 payment rate for Bexxar "results in a reimbursement rate that is approximately 50% below hospitals' actual acquisition cost for the therapy."
While some commercial considerations, namely administration and reimbursement, still need to be addressed, "next-generation" STaRT product candidates appear to address many historical clinical considerations and could ultimately fulfill the promise of this therapeutic class.
For example, Algeta ASA (OSE: ALGETA) is developing Alpharadin, the first in a new class of STaRT therapies based on the alpha-emitting radionuclide radium-223. Phase 2 studies in patients with hormone-refractory prostate cancer [HRPC] have already demonstrated that Alpharadin can prolong patient survival, improve quality of life and offer a benign safety profile. A Phase 3 trial is underway to confirm Alpharadin's efficacy and safety as a targeted treatment for bone metastases in patients with HRPC.
Radium-223 appears to offer the perfect mix of clinical characteristics (see table 1 for a comparison of STaRT products). It has an 11.4 day half life, which is significantly shorter than the 50.6 day half-life for strontium-89, but not too short to create logistical issues with shipment. Further, radium-223 has an extremely short particle range of 0.04 millimeters, which is equal to approximately 2-10 cell diameters. This likely explains Alpharadin's benign toxicity profile.
Table 1: comparison of STaRT products
Year Introduced Product Indication Radioisotope Half-life Max Particle Range in Tissue
1993
Metastron®
Treatment of bone pain arising from cancer
Strontium-89
50.6 days
8.00mm
1997
Quadramet®
Samarium-153
1.9 days
3.00mm
2003
Bexxar®
Treatment of non-Hodgkin's lymphoma
Iodine-131
8.0 days
2.00mm
2003
Zevalin®
Yttrium-90
2.7 days
12.00mm
Phase 3 trial underway
Alpharadin
Treatment of bone metastases in hormone-refractory prostate cancer
Radium-223
11.4 days
0.04mm
Lending credibility to the future of next-generation STaRT products, Algeta today announced an $800 million global agreement with Bayer AG (BAYRY.PK) for the development and commercialization of Alpharadin. In view of the fact that Bayer currently markets Zevalin outside of the U.S., this news could be interpreted as either good or bad news for investors betting on an acquisition of Spectrum Pharmaceuticals.
The bullish case is that Bayer is making a fresh $800 million investment in the field of STaRT, which could lend support to a consolidation of Zevalin marketing rights by Bayer. However, the bear case is that Algeta has already demonstrated in vivo the potential of linking alpha-emitting radionuclides to existing monoclonal antibodies, including rituximab, which could ultimately pose quite a competitive threat to earlier-generation STaRT products like Zevalin. In view of recent 52-week highs for Spectrum Pharmaceticals, however, it appears for now that investors are opting for the bullish thesis.
# # #
Disclaimer: This article contains the author's own opinions, and none of the information contained therein constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is suitable for any specific person. To the extent any of the information contained in the article may be deemed to be investment advice, such information is impersonal and not tailored to the investment needs of any specific person.
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