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SPPI

Started by stocky, July 21, 2005, 02:08:05 AM

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stocky

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.

ssubirias3

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.

REALDEALS21

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.


Terliso

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

Terliso

Chart update: 50sma crossed above the 200's ;)

Terliso

SPPI has awaken from its sleep ;)

Michael

#6
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.



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.



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
Michael Bang Koenig
www.3stocksonfire.org


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Terliso

#7
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. ;)


nullzero

I bought some SPPI today when it was slightly in red.

Terliso

SPPI is Up again, slowly but surely! ;)

ScottishTrader

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.

Michael

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  :)
Michael Bang Koenig
www.3stocksonfire.org


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Terliso

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


Terliso

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.

brandyjoco

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....
Brandyjoco