Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 126)
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ISIN: US84763A1088 · WKN: 164623 · Symbol: SPPI
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Ich schätze die Chancen für eine Fusilev Zulassung dieses mal richtig gut ein. Aber wer weiß schon wie die FDA tickt. Die FDA forderte übrigens nicht besser zu sein, sondern lediglich Gleichwertigkeit. Das müsste aus bestehendem Datenmaterial beweisbar sein.
Fakt ist, Fusilev ist gerade eine ziemlich gute Cash-Cow in der Shortage.
Zitat von VaJo: Re: Friday - CRL? Who cares... 27-Apr-11 05:13 am
Ich bin mir da nicht mehr sicher. Wir hatten vor 2 Jahren da schon mal darüber diskutiert und du hattest Recht. Levoleucovorin hat keinen echten Vorteil gegenüber Leucovorin. Jedenfalls habe ich mir die Finger wund gesucht und keinen Vorteil gefunden. Was soll Spectrum da jetzt innerhalb von 6 Monaten zusammengetragen haben?
Biologisch gesehen ist es bis auf die Dosierung völlig wurscht was man gibt.
Wenn die FDA zustimmt dann doch nur um die Versorgung mit (Levo)Leucovorin in den USA irgendwie in den Griff zu bekommen?
Warum haben die dann nicht schon beim letzten mal Ja gesagt?
Ich schätze die Chancen für eine Fusilev Zulassung dieses mal richtig gut ein. Aber wer weiß schon wie die FDA tickt. Die FDA forderte übrigens nicht besser zu sein, sondern lediglich Gleichwertigkeit. Das müsste aus bestehendem Datenmaterial beweisbar sein.
Fakt ist, Fusilev ist gerade eine ziemlich gute Cash-Cow in der Shortage.
Antwort auf Beitrag Nr.: 41.418.566 von Ville7 am 27.04.11 18:49:02Wie hoch schätzt Du denn die Chancen für die Zulassung für Fusilev ein?
Zitat von Ville7: Das ist ja das geile, SPPI macht derzeit das vollständige Leucovorin-USA Geschäft mit ihrem hochpreisigem Medikament. Sollte das alles ein ganzes Quartal andauern und Pfizer genug liefern können, so wird Spectrum möglicherweise in Q1 über 50Mio USD Fusilev Umsätze melden. Einziger Wehrmutstropfen: SPPI's Marge wird aufgrund des Imports und der Shortage ihres einzigen Lieferanten nicht so hoch sein.
Nicht ganz getroffen. Aber immerhin tendenziell sehr richtig gelegen.
WOW!
Spectrum Pharmaceuticals Announces Record Revenue and Record Profit in First Quarter 2011
* First Quarter 2011 Product Revenues in Excess of $40 Million as Compared to Approximately $7 Million in the First Quarter of 2010
* Anticipate Reporting a Record Quarterly Profit in the First Quarter 2011
o Second Consecutive Profitable Quarter
* FUSILEV® sNDA For Use In Advanced Metastatic Colorectal Cancer is Currently Under Review by the FDA
o PDUFA Action Date – This Week – April 29, 2011
* ZEVALIN® Prior Approval Supplement for the Removal of the Bioscan Requirement Currently Under Review by the FDA
o PDUFA Action Date – November 20, 2011
* Belinostat and Apaziquone Clinical Programs on Track for New Drug Application Filings in 2012
* Conference Call to be Held on Wednesday, May 4, 2011
Spectrum Pharmaceuticals Announces Record Revenue and Record Profit in First Quarter 2011
* First Quarter 2011 Product Revenues in Excess of $40 Million as Compared to Approximately $7 Million in the First Quarter of 2010
* Anticipate Reporting a Record Quarterly Profit in the First Quarter 2011
o Second Consecutive Profitable Quarter
* FUSILEV® sNDA For Use In Advanced Metastatic Colorectal Cancer is Currently Under Review by the FDA
o PDUFA Action Date – This Week – April 29, 2011
* ZEVALIN® Prior Approval Supplement for the Removal of the Bioscan Requirement Currently Under Review by the FDA
o PDUFA Action Date – November 20, 2011
* Belinostat and Apaziquone Clinical Programs on Track for New Drug Application Filings in 2012
* Conference Call to be Held on Wednesday, May 4, 2011
Trading Spotlight
Antwort auf Beitrag Nr.: 41.415.472 von Ville7 am 27.04.11 10:56:09Jeder hat eine andere Meinung!
Antwort auf Beitrag Nr.: 41.413.604 von Magnetfeldfredy am 26.04.11 20:30:41Nach meiner Meinung vollkommener Quatsch.
Antwort auf Beitrag Nr.: 41.407.459 von Magnetfeldfredy am 24.04.11 19:09:36Hört sich gut an:
Teva Positioned to Acquire Spectrum Pharmaceuticals after April 29 Approval
publication date: Apr 26, 2011
|
author/source: Justin M. Hall
Previous |
Teva Positioned to Acquire Spectrum Pharma after April 29 Approval
Justin M. Hall
Rx Investors
4/26/11
PART I. THE APPROVAL
This Friday, April 29, 2011 Spectrum Pharmaceuticals (SPPI) will announce whether the FDA will approve its supplemental new drug application (sNDA) for Fusilev (levo-leucovorin) which is indicated for metastatic colorectal cancer (mCRC).
As argued back on February 16, 2011, I think the FDA is likely to approve the treatment.
Last Thursday, April 21, SPPI announced that the FDA has approved the company’s sNDA for a ready-to-use version of Fusilev (RTU) under the existing osteosarcoma indication that the drug is already approved.
With a serious short supply of generic leucovorin, it looks like US regulators decided to go ahead and approve the RTU version several months in advance in order to offer additional supplies to a very needy market. Presuming supplies of Fusilev RTU exist; patients will now have access to treatment. From my view the early RTU approval is a big deal and suggests that Friday (April 29) is highly likely to be a good day for SPPI.
PART II. THE SHORTAGE
In April 2010, Teva Pharmaceuticals (TEVA) voluntarily stopped making generic leucovorin and other injectable cancer drugs due to manufacturing issues at the company’s plant in Irvine California. As result, the second leucovorin shortage within the past three years was ignited. According to the FDA, the current shortage began in June 2010.
Fast forward one year later – the leucovorin shortage continues to be a major problem. Patients are not receiving adequate treatment. Last month, the FDA characterized the current leucovorin shortage as “severe” and indicated it will likely continue for some time.
For more details on the Fusilev and the shortage, please be sure to review my February 16 article at Seeking Alpha.
Leucovorin for Colorectal Cancer
In an April 1, 2011 report, Kate Murphy of Fight Colorectal Cancer.org noted, “[m]ost of the medicines with shortages are necessary for emergency care, sedation, or chemotherapy — including leucovorin which is a backbone of most colorectal cancer treatment regimens.”
Reasons for Drug Shortages
Quality of Raw Materials
Nearly half of shortages were related to quality issues including impurities, microbials contamination, and chemical instability. Eighty percent of raw materials for medications manufactured in the United States come from outside of the US.
Manufacturer Financial Decisions
Nearly 1 in 5 of injectable drug shortages was due to a manufacturer stopping making the drug. Pressures from (1) patent expirations, (2) cost of FDA compliance and healthcare reform impact profits and (3) financial decisions.
Enforcement of FDA Standards and Regulations
Meeting manufacturing inspections requirements and the high costs of FDA’s Unapproved Drug Initiative, launched in 2006, have led some manufacturers to cease production rather than invest to meet requirements and regulatory user fees inherent in the drug approval process.
Leaner Inventories
In recent years, “just-in-time” inventory management has led to lower quantities of raw materials and finished products.
Gray Market Price Gouging
During shortages distributors may buy up all available supplies and sell them at greatly inflated markups. Premier members reported as much as a 335 percent markup for a drug in shortage.
Stockpiling by Users
Shortages can be worsened when hospitals and doctors try to protect themselves by ordering larger amounts of drugs than they really need.
Changes in Clinical Practice and Emergency Situations
Shortages of one drug can lead to shortages of a replacement medicine.
Source
Kate Murphy, Fight Colorectal Cancer.org
Contaminated Supplies
As I understand it, TEVA’s leucovorin supply was contaminated by a form of bacteria that is potentially harmful to patients receiving the treatment.
It appears that the FDA and not the company discovered the bacteria during a routine inspection of the company’s plant. It should be noted that the FDA has stepped up plant inspections in recent years. For patients, that’s a good thing.
Foreign Suppliers
According to the American Society of Health-System Pharmacists [ASHP], 80% of the raw materials used to make drugs in the US are purchased from foreign suppliers.
Source: OncLive
TEVA Cuts Jobs in 2011
Due to contamination and other manufacturing issues, TEVA is scaling back their workforce at the Irvine plant.
On January 20, 2011, In-Pharma Technologist reported:
“Teva has confirmed it will cut 200 jobs this year after a voluntary hold was placed on all manufacturing at its Irvine, California, US facility.
Denise Bradley, a Teva spokesperson, told in-PharmaTechnologist that manufacturing and distribution was put on pause at the site in April 2010 and remains at a standstill . . . .
The decision to suspend production and lay off employees at the Irvine plant was prompted by quality control after the company received an FDA warning letter for violating current good manufacturing practice (cGMP) regulations.”
With TEVA eliminating jobs, it now seems likely that the leucovorin shortage could continue through year-end 2011.
A Severe Shortage
Just last month, Captain Valerie Jensen, RPh, Associate Director of the FDA’s Drug Shortage Program told OncLive:
“Many of the shortages of chemotherapy drugs that occurred in 2010 are being resolved by the manufacturers; however, the leucovorin [and cytarabine] shortages continue to be severe.
Leucovorin has been in shortage due to one firm having manufacturing issues and the remaining firm has not been able to meet demand.
For leucovorin . . . and the others, FDA continues to offer assistance to all of the manufacturers and is exploring all possible options to help with supplies.”
By characterizing the leucovorin shortage as severe, it appears the FDA expects leucovorin to remain in short supply for the foreseeable future.
The Bottom Line
As result of the shortage, demand for SPPI’s Fusilev, a pure form of leucovorin, has increased dramatically. On March 16, the company reported Q4 2010 Fusilev sales at a whopping $23 million and crushed analyst expectations.
Looking ahead to Q1 2011, SPPI is likely to beat analyst estimates again. According to recent sales data I obtained through a premium service provided by Bloomberg, it appears Fusilev sales might have surged in January 2011. The increase was likely due to stockpiling. As SPPI’s supplies were already limited due to the Cangene plant closing in early December 2010, I was not surprised to see that Fusilev sales had settled a bit in February and March 2011.
While the leucovorin shortage drags on, SPPI will continue to benefit. I estimate Fusilev sales to come in at or near $40 million for 2011. Total revenue for the year should be somewhere near the $100 million mark.
So, what does this mean? When SPPI’s Q1 2011 results are released next month (May 2011), they’ll likely beat analyst estimates again.
PART III. THE OPPORTUNITY
Now, let’s get to the main point of this article.
I now believe that TEVA may be planning to acquire SPPI after Fusilev is approved. Again, that decision will be announced on or before this Friday, April 29, 2011.
Here’s why TEVA buys SPPI:
#1 Due to disappointing earnings and a recent setback, shares of TEVA have taken a beating this year (reference chart below). The company needs to act soon. I believe that TEVA may already have a plan in place and could take meaningful action in the near future.
#2 During the ongoing leucovorin shortage, one thing has become clear – TEVA controls most of the leucovorin that is supplied in the US. That said, the revenue derived from sales of generic leucovorin is less than impressive. Right now, SPPI’s Fusilev costs about 10X more than TEVA’s leucovorin. This begs the question – why on Earth would TEVA continue making the generic version? Acquiring SPPI and securing control of Fusilev would be a smart move and enable TEVA to boost its product sales immediately. This is exactly the kind of move that I believe many TEVA shareholders would welcome.
#3 Back in 2010, many investors were puzzled when - out of nowhere - SPPI just decided to replace two of their top-level executives. One of the two replacements was Mr. James Shields, who prior to joining SPPI had worked for TEVA. His expertise involves marketing and selling injectable cancer drugs.
Shields began working at SPPI sometime in May 2010 just one month after TEVA voluntarily stopped production of leucovorin and other injectables in Irvine. After the leucovorin shortage was declared by the FDA, SPPI announced that Shields had joined the company in late June 2010. Interestingly, SPPI hired Shields to improve product sales. Funny thing - the company’s product sales were already growing each quarter at that time. Hmmm.
Is this just coincidence? Possibly. A more probable explanation is that TEVA put a smart plan in place back in April 2010, and the company is executing that plan right now.
By acquiring SPPI, TEVA gets four cancer drugs - Zevalin, Fusilev, Belinostat, and Eoquin. Both Zevalin and Fusilev are approved in the US and generating an attractive revenue stream for SPPI. Looking ahead, both of these drugs also have excellent growth potential.
For 2011, I conservatively estimate SPPI’s total revenue will come in at or near $100 million – Zevalin sales at $50 million+, Fusilev sales at $40 million+, and $10 million from the company’s collaboration with Allergan (AGN) and other foreign drug makers.
In addition, TEVA would also receive the rights to make a bio-similar version of Rituxan (rituximab). Even if TEVA already has the rights to make generic Rituxan, acquiring SPPI is a win-win. Here, TEVA will either (1) obtain rights that they didn’t already have OR (2) eliminate one of their potential competitors. Note: Rituxan is currently made and sold by partners Biogen Idec (BIIB) and Roche (RHHBY.PK).
To me, this seems like a no-brainer. With a favorable decision this Friday, April 29, I think TEVA is likely to make a move to take out SPPI.
What might TEVA be willing to pay for SPPI? In this space, the standard metric used to calculate an acquisition is 10X revenue. As previously indicated, I think SPPI is likely to bring in revenue of $100 million in 2011. So, TEVA’s offer would likely be in the area of $1 billion or $20 per share of SPPI’s common stock.
With the Fusilev approval, a fair value for SPPI is $15 OR with a market cap of $750 million - three-quarters of the potential acquisition price (10X 2011 revenue).
TARGET
For the reasons detailed above, I think shares of SPPI are likely to hit $15 and could climb as high as $20 after the Fusilev approval.
Teva Positioned to Acquire Spectrum Pharmaceuticals after April 29 Approval
publication date: Apr 26, 2011
|
author/source: Justin M. Hall
Previous |
Teva Positioned to Acquire Spectrum Pharma after April 29 Approval
Justin M. Hall
Rx Investors
4/26/11
PART I. THE APPROVAL
This Friday, April 29, 2011 Spectrum Pharmaceuticals (SPPI) will announce whether the FDA will approve its supplemental new drug application (sNDA) for Fusilev (levo-leucovorin) which is indicated for metastatic colorectal cancer (mCRC).
As argued back on February 16, 2011, I think the FDA is likely to approve the treatment.
Last Thursday, April 21, SPPI announced that the FDA has approved the company’s sNDA for a ready-to-use version of Fusilev (RTU) under the existing osteosarcoma indication that the drug is already approved.
With a serious short supply of generic leucovorin, it looks like US regulators decided to go ahead and approve the RTU version several months in advance in order to offer additional supplies to a very needy market. Presuming supplies of Fusilev RTU exist; patients will now have access to treatment. From my view the early RTU approval is a big deal and suggests that Friday (April 29) is highly likely to be a good day for SPPI.
PART II. THE SHORTAGE
In April 2010, Teva Pharmaceuticals (TEVA) voluntarily stopped making generic leucovorin and other injectable cancer drugs due to manufacturing issues at the company’s plant in Irvine California. As result, the second leucovorin shortage within the past three years was ignited. According to the FDA, the current shortage began in June 2010.
Fast forward one year later – the leucovorin shortage continues to be a major problem. Patients are not receiving adequate treatment. Last month, the FDA characterized the current leucovorin shortage as “severe” and indicated it will likely continue for some time.
For more details on the Fusilev and the shortage, please be sure to review my February 16 article at Seeking Alpha.
Leucovorin for Colorectal Cancer
In an April 1, 2011 report, Kate Murphy of Fight Colorectal Cancer.org noted, “[m]ost of the medicines with shortages are necessary for emergency care, sedation, or chemotherapy — including leucovorin which is a backbone of most colorectal cancer treatment regimens.”
Reasons for Drug Shortages
Quality of Raw Materials
Nearly half of shortages were related to quality issues including impurities, microbials contamination, and chemical instability. Eighty percent of raw materials for medications manufactured in the United States come from outside of the US.
Manufacturer Financial Decisions
Nearly 1 in 5 of injectable drug shortages was due to a manufacturer stopping making the drug. Pressures from (1) patent expirations, (2) cost of FDA compliance and healthcare reform impact profits and (3) financial decisions.
Enforcement of FDA Standards and Regulations
Meeting manufacturing inspections requirements and the high costs of FDA’s Unapproved Drug Initiative, launched in 2006, have led some manufacturers to cease production rather than invest to meet requirements and regulatory user fees inherent in the drug approval process.
Leaner Inventories
In recent years, “just-in-time” inventory management has led to lower quantities of raw materials and finished products.
Gray Market Price Gouging
During shortages distributors may buy up all available supplies and sell them at greatly inflated markups. Premier members reported as much as a 335 percent markup for a drug in shortage.
Stockpiling by Users
Shortages can be worsened when hospitals and doctors try to protect themselves by ordering larger amounts of drugs than they really need.
Changes in Clinical Practice and Emergency Situations
Shortages of one drug can lead to shortages of a replacement medicine.
Source
Kate Murphy, Fight Colorectal Cancer.org
Contaminated Supplies
As I understand it, TEVA’s leucovorin supply was contaminated by a form of bacteria that is potentially harmful to patients receiving the treatment.
It appears that the FDA and not the company discovered the bacteria during a routine inspection of the company’s plant. It should be noted that the FDA has stepped up plant inspections in recent years. For patients, that’s a good thing.
Foreign Suppliers
According to the American Society of Health-System Pharmacists [ASHP], 80% of the raw materials used to make drugs in the US are purchased from foreign suppliers.
Source: OncLive
TEVA Cuts Jobs in 2011
Due to contamination and other manufacturing issues, TEVA is scaling back their workforce at the Irvine plant.
On January 20, 2011, In-Pharma Technologist reported:
“Teva has confirmed it will cut 200 jobs this year after a voluntary hold was placed on all manufacturing at its Irvine, California, US facility.
Denise Bradley, a Teva spokesperson, told in-PharmaTechnologist that manufacturing and distribution was put on pause at the site in April 2010 and remains at a standstill . . . .
The decision to suspend production and lay off employees at the Irvine plant was prompted by quality control after the company received an FDA warning letter for violating current good manufacturing practice (cGMP) regulations.”
With TEVA eliminating jobs, it now seems likely that the leucovorin shortage could continue through year-end 2011.
A Severe Shortage
Just last month, Captain Valerie Jensen, RPh, Associate Director of the FDA’s Drug Shortage Program told OncLive:
“Many of the shortages of chemotherapy drugs that occurred in 2010 are being resolved by the manufacturers; however, the leucovorin [and cytarabine] shortages continue to be severe.
Leucovorin has been in shortage due to one firm having manufacturing issues and the remaining firm has not been able to meet demand.
For leucovorin . . . and the others, FDA continues to offer assistance to all of the manufacturers and is exploring all possible options to help with supplies.”
By characterizing the leucovorin shortage as severe, it appears the FDA expects leucovorin to remain in short supply for the foreseeable future.
The Bottom Line
As result of the shortage, demand for SPPI’s Fusilev, a pure form of leucovorin, has increased dramatically. On March 16, the company reported Q4 2010 Fusilev sales at a whopping $23 million and crushed analyst expectations.
Looking ahead to Q1 2011, SPPI is likely to beat analyst estimates again. According to recent sales data I obtained through a premium service provided by Bloomberg, it appears Fusilev sales might have surged in January 2011. The increase was likely due to stockpiling. As SPPI’s supplies were already limited due to the Cangene plant closing in early December 2010, I was not surprised to see that Fusilev sales had settled a bit in February and March 2011.
While the leucovorin shortage drags on, SPPI will continue to benefit. I estimate Fusilev sales to come in at or near $40 million for 2011. Total revenue for the year should be somewhere near the $100 million mark.
So, what does this mean? When SPPI’s Q1 2011 results are released next month (May 2011), they’ll likely beat analyst estimates again.
PART III. THE OPPORTUNITY
Now, let’s get to the main point of this article.
I now believe that TEVA may be planning to acquire SPPI after Fusilev is approved. Again, that decision will be announced on or before this Friday, April 29, 2011.
Here’s why TEVA buys SPPI:
#1 Due to disappointing earnings and a recent setback, shares of TEVA have taken a beating this year (reference chart below). The company needs to act soon. I believe that TEVA may already have a plan in place and could take meaningful action in the near future.
#2 During the ongoing leucovorin shortage, one thing has become clear – TEVA controls most of the leucovorin that is supplied in the US. That said, the revenue derived from sales of generic leucovorin is less than impressive. Right now, SPPI’s Fusilev costs about 10X more than TEVA’s leucovorin. This begs the question – why on Earth would TEVA continue making the generic version? Acquiring SPPI and securing control of Fusilev would be a smart move and enable TEVA to boost its product sales immediately. This is exactly the kind of move that I believe many TEVA shareholders would welcome.
#3 Back in 2010, many investors were puzzled when - out of nowhere - SPPI just decided to replace two of their top-level executives. One of the two replacements was Mr. James Shields, who prior to joining SPPI had worked for TEVA. His expertise involves marketing and selling injectable cancer drugs.
Shields began working at SPPI sometime in May 2010 just one month after TEVA voluntarily stopped production of leucovorin and other injectables in Irvine. After the leucovorin shortage was declared by the FDA, SPPI announced that Shields had joined the company in late June 2010. Interestingly, SPPI hired Shields to improve product sales. Funny thing - the company’s product sales were already growing each quarter at that time. Hmmm.
Is this just coincidence? Possibly. A more probable explanation is that TEVA put a smart plan in place back in April 2010, and the company is executing that plan right now.
By acquiring SPPI, TEVA gets four cancer drugs - Zevalin, Fusilev, Belinostat, and Eoquin. Both Zevalin and Fusilev are approved in the US and generating an attractive revenue stream for SPPI. Looking ahead, both of these drugs also have excellent growth potential.
For 2011, I conservatively estimate SPPI’s total revenue will come in at or near $100 million – Zevalin sales at $50 million+, Fusilev sales at $40 million+, and $10 million from the company’s collaboration with Allergan (AGN) and other foreign drug makers.
In addition, TEVA would also receive the rights to make a bio-similar version of Rituxan (rituximab). Even if TEVA already has the rights to make generic Rituxan, acquiring SPPI is a win-win. Here, TEVA will either (1) obtain rights that they didn’t already have OR (2) eliminate one of their potential competitors. Note: Rituxan is currently made and sold by partners Biogen Idec (BIIB) and Roche (RHHBY.PK).
To me, this seems like a no-brainer. With a favorable decision this Friday, April 29, I think TEVA is likely to make a move to take out SPPI.
What might TEVA be willing to pay for SPPI? In this space, the standard metric used to calculate an acquisition is 10X revenue. As previously indicated, I think SPPI is likely to bring in revenue of $100 million in 2011. So, TEVA’s offer would likely be in the area of $1 billion or $20 per share of SPPI’s common stock.
With the Fusilev approval, a fair value for SPPI is $15 OR with a market cap of $750 million - three-quarters of the potential acquisition price (10X 2011 revenue).
TARGET
For the reasons detailed above, I think shares of SPPI are likely to hit $15 and could climb as high as $20 after the Fusilev approval.
Antwort auf Beitrag Nr.: 41.407.399 von Oberlaendler am 24.04.11 18:11:44Spectrum Pharmaceuticals: Pending Approvals Could Send This Stock Flying 2 comments | by: VFC's Stock House April 24, 2011 | about: SPPI Font Size: PrintEmail Recommend 0 Share this page
Share0 Already an attractive pick because of growing revenue and upcoming catalysts, Spectrum Pharmaceuticals (SPPI) announced last week that the FDA has granted approval of a "ready-to-use" formulation of Fusilev, which is already approved by the FDA in its lyophilized form to treat Osteosarcoma.
The new "ready-to-use" formulation "requires no reconstitution, and is of a higher strength than the currently available lyophilized formulation," according to Spectrum CEO Dr. Rajesh C. Shrotriya in comments published in a press release issued on Thursday, and tt the very least will offer Doctors and medical professionals another option for utilizing Fusilev.
The share price and volume of SPPI reacted positively to the news on Thursday, as the stock closed higher by over two percent on more than double the average volume.
The real short term catalyst for Fusilev, however, is the upcoming 29 April decision day for the FDA regarding Spectrums application to have Fusilev approved for the treatment of colorectal cancer.
Fusilev for the colorectal indication has been denied once before by the FDA, but after supplying the regulatory agency with additional data, Spectrum hopes to see a reversal from the FDA's previous decision.
Keep an eye on shares of Spectrum into the new week. Friday is decision day for the FDA's Fusilev decision, but it's not out of the realm of possibility to see news at any point during the week.
Thursday's modest price and volume spike may have been related to the positive approval news for the "ready-to-use" formulation of Fusilev, but it may have also been related to investors getting a head start for the colorectal indication news that is pending this week.
With growing revenues and the upcoming catalysts still expected, SPPI could still be trading in buy territory. If the company receives approval for the colorectal indication, and if the FDA approves the removal of the bioscan criteria that currently accompanies treatment with Spectrum's non-Hodgkins Lymphoma treatment Zevalin, then it's expected that this stock will see some significant price appreciation over the short to mid term.
SPPI could become a high flyer for 2011.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Share0 Already an attractive pick because of growing revenue and upcoming catalysts, Spectrum Pharmaceuticals (SPPI) announced last week that the FDA has granted approval of a "ready-to-use" formulation of Fusilev, which is already approved by the FDA in its lyophilized form to treat Osteosarcoma.
The new "ready-to-use" formulation "requires no reconstitution, and is of a higher strength than the currently available lyophilized formulation," according to Spectrum CEO Dr. Rajesh C. Shrotriya in comments published in a press release issued on Thursday, and tt the very least will offer Doctors and medical professionals another option for utilizing Fusilev.
The share price and volume of SPPI reacted positively to the news on Thursday, as the stock closed higher by over two percent on more than double the average volume.
The real short term catalyst for Fusilev, however, is the upcoming 29 April decision day for the FDA regarding Spectrums application to have Fusilev approved for the treatment of colorectal cancer.
Fusilev for the colorectal indication has been denied once before by the FDA, but after supplying the regulatory agency with additional data, Spectrum hopes to see a reversal from the FDA's previous decision.
Keep an eye on shares of Spectrum into the new week. Friday is decision day for the FDA's Fusilev decision, but it's not out of the realm of possibility to see news at any point during the week.
Thursday's modest price and volume spike may have been related to the positive approval news for the "ready-to-use" formulation of Fusilev, but it may have also been related to investors getting a head start for the colorectal indication news that is pending this week.
With growing revenues and the upcoming catalysts still expected, SPPI could still be trading in buy territory. If the company receives approval for the colorectal indication, and if the FDA approves the removal of the bioscan criteria that currently accompanies treatment with Spectrum's non-Hodgkins Lymphoma treatment Zevalin, then it's expected that this stock will see some significant price appreciation over the short to mid term.
SPPI could become a high flyer for 2011.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Shrotriya said. "Whether we keep building our business or somebody comes and buys it remains to be seen. So far there are no offers."
Wird hier Spectrum ins Schaufenster gestellt?
Nachdenkliche Ostergrüße
Oberländler
Wird hier Spectrum ins Schaufenster gestellt?
Nachdenkliche Ostergrüße
Oberländler
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