SPPI

[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

[la-onda]

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:

[Putangina Mo]

SPPI breakaway gap....

[Putangina Mo]

Worth the wait my friends.

[setravis]

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.

[setravis]

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

[setravis]

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.

[=idFix=]

yes- they're expecting FDA's accord for Zev' on sept.7th

[=idFix=]

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

[=idFix=]

[la-onda]

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.

[=idFix=]