Savient Pharmaceuticals: Hier gehts rund! - 500 Beiträge pro Seite
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Heute +50 Prozent! Am Dienstag entscheidet ein Expertenpanel, ob sie der FDA die Zulassung von KRYSTEXXA empfehlen. Die FDA richtet sich meist nach der Einstufung des Panels. Das Meeting ist daher entscheidende. FDA-Termin ist dann Anfang 2009.
Antwort auf Beitrag Nr.: 37.383.061 von blb am 12.06.09 17:39:09Anfang August muss es heißen, sorry...
Antwort auf Beitrag Nr.: 37.383.466 von blb am 12.06.09 18:31:05Jetzt wirds heiß! Aktie ausgesetzt, Entscheidung wohl so gegen Abend.
Antwort auf Beitrag Nr.: 37.403.150 von blb am 16.06.09 16:13:45Hat geklappt! Die Experten haben mit 14 zu 1 Stimmen für Krystexxa gestimmt. Aktie +40 Prozent! 
Antwort auf Beitrag Nr.: 37.413.658 von blb am 17.06.09 19:26:05FDA-Entscheid am 1.8.! Aktuell immer noch rund 20 Prozent short...
Trading Spotlight
In diesem Thread kann nun wieder diskutiert werden.
Viel Freude!
JMauersberger
Viel Freude!
JMauersberger
Antwort auf Beitrag Nr.: 40.161.466 von JMauersberger am 16.09.10 13:40:17FDA Approves Savient Pharmaceuticals, Inc. (SVNT)'s KRYSTEXXA(TM) (pegloticase) for the Treatment of Chronic Gout in Adult Patients Refractory to Conventional Therapy
15 Sep 2010
Savient Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy
EAST BRUNSWICK, NJ, USA | September 14, 2010 |
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
"KRYSTEXXA is the first-ever and only treatment approved by the FDA for adult patients who suffer with chronic gout that is refractory to conventional therapy," said Paul Hamelin R.Ph., President of Savient Pharmaceuticals. "The clinical data have demonstrated that many patients treated with KRYSTEXXA 8 mg administered every two weeks can experience within six months of treatment significant positive clinical improvement reversing the course of this severe, crippling and debilitating disease. A statistically significant proportion of patients in our pivotal clinical trials achieved a lowering of their serum uric acid level to a mean of 0.7 mg/dL and achieved a complete response for the resolution of tophi within the first six months of therapy. We believe that the approval of KRYSTEXXA is a significant step towards realizing our mission of transforming the lives of the patients in the U.S. suffering with chronic gout refractory to conventional therapy, as many of them finally have a treatment that gives them hope of reversing this severely debilitating disease."
Savient expects KRYSTEXXA to be available by prescription in the U.S. later this year and believes it is well advanced in its preparations for the U.S. launch of KRYSTEXXA. Specific timing for the launch of KRYSTEXXA will be determined within the context of the Company's commercialization plan and by the progress and status of the Company's efforts to pursue a strategic transaction for the sale of Savient. KRYSTEXXA was granted an Orphan Drug designation by the FDA in 2001 that the Company expects will provide the drug seven years of orphan drug market exclusivity. The composition, manufacture and methods of use and administration of KRYSTEXXA are also the subject of a broad portfolio of patents and patent applications that the Company expects will provide protection into 2026.
About the Pivotal Clinical Trial Results Supporting FDA Approval
The recommended dose and regimen of KRYSTEXXA for adult patients is 8 mg given as an intravenous infusion every two weeks. KRYSTEXXA should not be administered as an intravenous push or bolus.
The efficacy and safety of KRYSTEXXA was studied in patients with chronic gout refractory to conventional therapy in two replicate, multicenter, randomized, double-blind, placebo-controlled clinical studies of six months duration. Patients were randomized to receive KRYSTEXXA every 2 weeks or every 4 weeks or placebo in a 2:2:1 ratio. The primary endpoint in both trials was the proportion of patients who achieved plasma uric acid (PUA) less than 6 mg/dL for at least 80% of the time during month 3 and month 6. The data in both clinical studies demonstrated that a greater proportion of patients treated with KRYSTEXXA every 2 weeks achieved urate lowering to below 6 mg/dL than patients receiving placebo. During the first six months of treatment, 47% (P<0.001) and 38% (P<0.001) of patients in the KRYSTEXXA arms of the two clinical studies achieved the primary efficacy endpoint, compared with 0% of patients in the placebo arm.
The effect of treatment with KRYSTEXXA on tophi was a secondary efficacy endpoint of the clinical studies and was assessed using standardized digital photography, image analysis and a central reader blinded to treatment assignment. Tophi are deposits of monosodium urate crystals in people with longstanding high levels of uric acid in the blood and are commonly seen in conjunction with gout. Seventy one percent (71%) of patients had baseline tophi. A pooled analysis of data from both clinical studies at month 6 demonstrated that 45% (P<0.02) of patients with tophi treated with KRYSTEXXA every 2 weeks achieved a complete response, defined as 100% resolution of at least one target tophus, no new tophus appearing and no single tophus showing progression, compared to 8% of patients receiving placebo.
Important Safety Information About Treatment with KRYSTEXXA
The full prescribing information for KRYSTEXXA contains a boxed warning regarding anaphylaxis and infusion reactions. Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. KRYSTEXXA should only be administered in a healthcare setting and by healthcare providers prepared to manage anaphylaxis. Patients being treated with KRYSTEXXA should be pre-medicated with antihistamines and corticosteroids prior to infusion and should be closely monitored for an appropriate period of time after administration. Since the risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response, patients' serum uric acid levels should be monitored prior to infusions and discontinuation of treatment should be considered if such levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
KRYSTEXXA is contraindicated in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency due to the risk of hemolysis and methemoglobinemia. It is recommended that patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) be screened for G6PD deficiency before starting KRYSTEXXA.
As with most uric acid lowering therapeutics, an increase in gout flare is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued, however, gout flare prophylaxis (i.e., non-steroidal anti-inflammatory drugs [NSAID] or colchicine upon initiation of treatment) is recommended for at least the first 6 months of therapy unless medically contraindicated or not tolerated. In months 1 through 3, gout flares occurred in 74% of patients taking KRYSTEXXA every 2 weeks and in 51% of patients who received placebo. During the next three months of therapy (months 4 through 6), gout flares occurred in 41% of patients treated with KRYSTEXXA every 2 weeks and in 67% of patients who received placebo.
KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. As such, caution should be exercised when using KRYSTEXXA in patients who have congestive heart failure and such patients should be monitored closely following infusion.
As with all therapeutic proteins, there is a potential for immunogenicity with KRYSTEXXA. Due to this, patients receiving re-treatment may be at increased risk of infusion reactions and should be monitored carefully for such reactions. The impact of anti-PEG antibodies on patients' responses to other PEG-containing therapeutics is unknown.
The most commonly reported adverse reactions (occurring in at least 5% of KRYSTEXXA-treated patients) were gout flare, infusion reaction, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.
Savient will conduct a post-approval observational safety study in 500 patients treated for one year to further evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex-related adverse events, and to identify serious adverse events associated with KRYSTEXXA therapy.
Savient has worked with the FDA to create a Risk Evaluation and Mitigation Strategy (REMS) program to help physicians, healthcare providers and patients make treatment decisions for adults who suffer with chronic gout that is refractory to conventional therapy based on the KRYSTEXXA comprehensive and current benefit:risk information. The KRYSTEXXA REMS program consists of a communication plan for health care providers and a medication guide for patients.
About KRYSTEXXA
KRYSTEXXA(pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA and its uses from Duke University ("Duke") and Mountain View Pharmaceuticals, Inc. ("MVP"). Duke developed the recombinant uricase enzyme and MVP developed the PEGylation technology used in the manufacture of KRYSTEXXA. MVP and Duke have been granted U.S. and foreign patents disclosing and claiming the licensed technology and, in addition, Savient owns or co-owns U.S. and foreign patents and patent applications, which collectively form a broad portfolio of patents covering the composition, manufacture and methods of use and administration of KRYSTEXXA. Full prescribing information for KRYSTEXXA can be found at www.krystexxa.com.
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing KRYSTEXXA(pegloticase) for the treatment of chronic gout in patients refractory to conventional therapy. Savient also manufactures and supplies Oxandrin® (oxandrolone tablets, USP) CIII in the U.S.
SOURCE Savient Pharmaceuticals, Inc.
Tja, am Ende gings erfolgreich aus. Wie gehts nun weiter mit der Aktie?
15 Sep 2010
Savient Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy
EAST BRUNSWICK, NJ, USA | September 14, 2010 |
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
"KRYSTEXXA is the first-ever and only treatment approved by the FDA for adult patients who suffer with chronic gout that is refractory to conventional therapy," said Paul Hamelin R.Ph., President of Savient Pharmaceuticals. "The clinical data have demonstrated that many patients treated with KRYSTEXXA 8 mg administered every two weeks can experience within six months of treatment significant positive clinical improvement reversing the course of this severe, crippling and debilitating disease. A statistically significant proportion of patients in our pivotal clinical trials achieved a lowering of their serum uric acid level to a mean of 0.7 mg/dL and achieved a complete response for the resolution of tophi within the first six months of therapy. We believe that the approval of KRYSTEXXA is a significant step towards realizing our mission of transforming the lives of the patients in the U.S. suffering with chronic gout refractory to conventional therapy, as many of them finally have a treatment that gives them hope of reversing this severely debilitating disease."
Savient expects KRYSTEXXA to be available by prescription in the U.S. later this year and believes it is well advanced in its preparations for the U.S. launch of KRYSTEXXA. Specific timing for the launch of KRYSTEXXA will be determined within the context of the Company's commercialization plan and by the progress and status of the Company's efforts to pursue a strategic transaction for the sale of Savient. KRYSTEXXA was granted an Orphan Drug designation by the FDA in 2001 that the Company expects will provide the drug seven years of orphan drug market exclusivity. The composition, manufacture and methods of use and administration of KRYSTEXXA are also the subject of a broad portfolio of patents and patent applications that the Company expects will provide protection into 2026.
About the Pivotal Clinical Trial Results Supporting FDA Approval
The recommended dose and regimen of KRYSTEXXA for adult patients is 8 mg given as an intravenous infusion every two weeks. KRYSTEXXA should not be administered as an intravenous push or bolus.
The efficacy and safety of KRYSTEXXA was studied in patients with chronic gout refractory to conventional therapy in two replicate, multicenter, randomized, double-blind, placebo-controlled clinical studies of six months duration. Patients were randomized to receive KRYSTEXXA every 2 weeks or every 4 weeks or placebo in a 2:2:1 ratio. The primary endpoint in both trials was the proportion of patients who achieved plasma uric acid (PUA) less than 6 mg/dL for at least 80% of the time during month 3 and month 6. The data in both clinical studies demonstrated that a greater proportion of patients treated with KRYSTEXXA every 2 weeks achieved urate lowering to below 6 mg/dL than patients receiving placebo. During the first six months of treatment, 47% (P<0.001) and 38% (P<0.001) of patients in the KRYSTEXXA arms of the two clinical studies achieved the primary efficacy endpoint, compared with 0% of patients in the placebo arm.
The effect of treatment with KRYSTEXXA on tophi was a secondary efficacy endpoint of the clinical studies and was assessed using standardized digital photography, image analysis and a central reader blinded to treatment assignment. Tophi are deposits of monosodium urate crystals in people with longstanding high levels of uric acid in the blood and are commonly seen in conjunction with gout. Seventy one percent (71%) of patients had baseline tophi. A pooled analysis of data from both clinical studies at month 6 demonstrated that 45% (P<0.02) of patients with tophi treated with KRYSTEXXA every 2 weeks achieved a complete response, defined as 100% resolution of at least one target tophus, no new tophus appearing and no single tophus showing progression, compared to 8% of patients receiving placebo.
Important Safety Information About Treatment with KRYSTEXXA
The full prescribing information for KRYSTEXXA contains a boxed warning regarding anaphylaxis and infusion reactions. Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. KRYSTEXXA should only be administered in a healthcare setting and by healthcare providers prepared to manage anaphylaxis. Patients being treated with KRYSTEXXA should be pre-medicated with antihistamines and corticosteroids prior to infusion and should be closely monitored for an appropriate period of time after administration. Since the risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response, patients' serum uric acid levels should be monitored prior to infusions and discontinuation of treatment should be considered if such levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
KRYSTEXXA is contraindicated in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency due to the risk of hemolysis and methemoglobinemia. It is recommended that patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) be screened for G6PD deficiency before starting KRYSTEXXA.
As with most uric acid lowering therapeutics, an increase in gout flare is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued, however, gout flare prophylaxis (i.e., non-steroidal anti-inflammatory drugs [NSAID] or colchicine upon initiation of treatment) is recommended for at least the first 6 months of therapy unless medically contraindicated or not tolerated. In months 1 through 3, gout flares occurred in 74% of patients taking KRYSTEXXA every 2 weeks and in 51% of patients who received placebo. During the next three months of therapy (months 4 through 6), gout flares occurred in 41% of patients treated with KRYSTEXXA every 2 weeks and in 67% of patients who received placebo.
KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. As such, caution should be exercised when using KRYSTEXXA in patients who have congestive heart failure and such patients should be monitored closely following infusion.
As with all therapeutic proteins, there is a potential for immunogenicity with KRYSTEXXA. Due to this, patients receiving re-treatment may be at increased risk of infusion reactions and should be monitored carefully for such reactions. The impact of anti-PEG antibodies on patients' responses to other PEG-containing therapeutics is unknown.
The most commonly reported adverse reactions (occurring in at least 5% of KRYSTEXXA-treated patients) were gout flare, infusion reaction, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.
Savient will conduct a post-approval observational safety study in 500 patients treated for one year to further evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex-related adverse events, and to identify serious adverse events associated with KRYSTEXXA therapy.
Savient has worked with the FDA to create a Risk Evaluation and Mitigation Strategy (REMS) program to help physicians, healthcare providers and patients make treatment decisions for adults who suffer with chronic gout that is refractory to conventional therapy based on the KRYSTEXXA comprehensive and current benefit:risk information. The KRYSTEXXA REMS program consists of a communication plan for health care providers and a medication guide for patients.
About KRYSTEXXA
KRYSTEXXA(pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA and its uses from Duke University ("Duke") and Mountain View Pharmaceuticals, Inc. ("MVP"). Duke developed the recombinant uricase enzyme and MVP developed the PEGylation technology used in the manufacture of KRYSTEXXA. MVP and Duke have been granted U.S. and foreign patents disclosing and claiming the licensed technology and, in addition, Savient owns or co-owns U.S. and foreign patents and patent applications, which collectively form a broad portfolio of patents covering the composition, manufacture and methods of use and administration of KRYSTEXXA. Full prescribing information for KRYSTEXXA can be found at www.krystexxa.com.
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing KRYSTEXXA(pegloticase) for the treatment of chronic gout in patients refractory to conventional therapy. Savient also manufactures and supplies Oxandrin® (oxandrolone tablets, USP) CIII in the U.S.
SOURCE Savient Pharmaceuticals, Inc.
Tja, am Ende gings erfolgreich aus. Wie gehts nun weiter mit der Aktie?
Antwort auf Beitrag Nr.: 40.162.720 von Fruehrentner am 16.09.10 16:18:32Tja, was lange währt... Sollen nun übernommen werden habe ich gelesen, Management will das Unternehmen verkaufen. Sind aber schon recht teuer mittlerweile.
hoppla, was ist denn hier passiert??! 
Hallo selten eine krassere Marktreaktion gesehen.
Hier mal ein Kurzüberblick: Savient Pharma
- Marktkap. ca 850 Mio $
- ca 75-80 Mio Cash
- Pharmaunternehmen ohne jegliche Pipeline und R&D-Organisation
Einziges wertvolle Asset:
Krystexxa --> Medikament gegen behandlungsresistente Gicht
- FDA-Zulassung im September 2010
- Orphan-Drug Status, d.h. alleiniges Vertriebsrecht in dieser Indikation die nächsten sieben Jahre
- Zulassungsantrag in EU für Anfang Januar 2011 angekündigt/ Marktzulassung Anfang 2012 erwartet
- geschätzte Patientenzahl in USA : FDA ca. 90,000 Patienten /Savient geht von 170.000 Patienten aus
Medikament ist nur bei ca. jedem Zweiten wirksam, d.h. jeder Zweite fällt nach wenigen Dosierungen weg
- Infusion vierzehntägig nötig
- Medikamentenpreis per Dosis (Großhandelspreis) : 2.300 US $ --> das macht bei 26 Dosierungen 59.800 US $ per Jahr
kleines Rechenbeispiel:
1.000 Patienten = 59,8 Mio $
10.000 Patienten = 598 Mio $
20.000 Patienten =1.196 Mio $
usw.
Man sieht das Potential ist riesig. Es gibt allerdings sehr unterschiedliche Einschätzungen bezüglich Patientenzahl und Umsatzpotential.
Grüße Cristrader
Hier mal ein Kurzüberblick: Savient Pharma
- Marktkap. ca 850 Mio $
- ca 75-80 Mio Cash
- Pharmaunternehmen ohne jegliche Pipeline und R&D-Organisation
Einziges wertvolle Asset:
Krystexxa --> Medikament gegen behandlungsresistente Gicht
- FDA-Zulassung im September 2010
- Orphan-Drug Status, d.h. alleiniges Vertriebsrecht in dieser Indikation die nächsten sieben Jahre
- Zulassungsantrag in EU für Anfang Januar 2011 angekündigt/ Marktzulassung Anfang 2012 erwartet
- geschätzte Patientenzahl in USA : FDA ca. 90,000 Patienten /Savient geht von 170.000 Patienten aus
Medikament ist nur bei ca. jedem Zweiten wirksam, d.h. jeder Zweite fällt nach wenigen Dosierungen weg
- Infusion vierzehntägig nötig
- Medikamentenpreis per Dosis (Großhandelspreis) : 2.300 US $ --> das macht bei 26 Dosierungen 59.800 US $ per Jahr
kleines Rechenbeispiel:
1.000 Patienten = 59,8 Mio $
10.000 Patienten = 598 Mio $
20.000 Patienten =1.196 Mio $
usw.
Man sieht das Potential ist riesig. Es gibt allerdings sehr unterschiedliche Einschätzungen bezüglich Patientenzahl und Umsatzpotential.
Grüße Cristrader
Meinungen zu Savient Pharmaceuticals?
0.570 -0.120 (-17.38%)
52 week 0.48 - 7.82
Mkt cap 41.27M
http://www.google.com/finance?cid=67456
Savient Pharmaceuticals Receives Favorable Decision In Tang Capital Litigation
http://finance.yahoo.com/news/savient-pharmaceuticals-receiv…
0.570 -0.120 (-17.38%)
52 week 0.48 - 7.82
Mkt cap 41.27M
http://www.google.com/finance?cid=67456
Savient Pharmaceuticals Receives Favorable Decision In Tang Capital Litigation
http://finance.yahoo.com/news/savient-pharmaceuticals-receiv…
Bin seit Dienstag mit einer kleinen Posi dabei, GLTA
Kurs von 0.48 auf gegen die USD 3.00 und heute wieder noch knapp über USD 1.00.
BRIDGEWATER, N.J., Nov. 8, 2012 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today reported financial results for the three and nine months ended September 30, 2012, which reflects the Company's continuing commercialization of KRYSTEXXA (R) (pegloticase) in the U.S. Savient ended the quarter with approximately $116.2 million in cash and short-term investments.
Net sales for KRYSTEXXA were $4.5 million for the third quarter of 2012, a 13% increase over the second quarter of 2012. For the third quarter of 2012, the Company had a net loss of $39.7 million, or $0.56 per share, on total revenues of $4.9 million, compared with a net loss of $27.4 million, or $0.39 per share, on total revenues of $2.6 million for the same period in 2011. The net loss for the first nine months of 2012 was $90.3 million, or $1.28 per share, on total revenues of $13.1 million, compared with a net loss of $71.2 million, or $1.02 per share, on total revenues of $5.9 million for the same period in 2011. The net loss for the nine-month period ended September 30, 2012 includes a $21.8 million, or $0.31 per share, gain on the extinguishment of debt.
"During the third quarter we continued to drive awareness and adoption of KRYSTEXXA in the U.S., which resulted in our seventh consecutive quarter of sequential sales growth," said Louis Ferrari, President and Chief Executive Officer of Savient Pharmaceuticals. "We also made progress toward our goal of commercializing KRYSTEXXA outside of the U.S. with the positive opinion we received on October 19 from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). We remain confident in the long-term opportunity for KRYSTEXXA to address the significant unmet needs of patients suffering from refractory chronic gout. We are successfully executing our clinical development plan focused on expanding the clinical utility of KRYSTEXXA, and we believe that this coupled with our commercialization strategy will allow us to create long-term value for all of our stakeholders."
Operational Highlights:
-- Enhanced the executive team: Appointed John Hamill to the position of
Senior Vice President & Chief Financial Officer.
-- Achieved significant milestone in strategy to commercialize KRYSTEXXA
outside of the U.S.: Received a positive opinion from the CHMP that
recommended KRYSTEXXA for marketing authorization in the EU.
-- Positive financial results: KRYSTEXXA sales increased sequentially for
the seventh consecutive quarter and we began to realize the benefits of
the operational reorganization announced in July 2012.
-- Driving institutional acceptance: The release of the Veterans Affairs
(VA) monograph, and the KRYSTEXXA criteria for use allows Savient to work
more closely with VA Medical Centers and improves access for patients and
providers.
-- Continued to expand the universe of clinical data focused on KRYSTEXXA:
Eight KRYSTEXXA abstracts were accepted for presentation at the upcoming
American College of Rheumatology Annual Meeting. In addition, Savient
successfully submitted four manuscripts for publication at leading
medical journals and currently has seven additional manuscripts under
active development.
-- Executing clinical development strategy: Began actively recruiting for
the study of KRYSTEXXA in dialysis patients, which is expected to be
completed by mid-2013.
Financial Results of Operations for the Three Months Ended September 30, 2012
Net revenues increased $2.3 million, or 90%, to $4.9 million for the three-month period ended September 30, 2012, from $2.6 million for the three-month period ended September 30, 2011, as a result of the company's continued commercialization efforts and sales momentum of KRYSTEXXA.
Cost of goods sold decreased $0.4 million, or 8%, to $4.2 million for the three-month period ended September 30, 2012, from $4.6 million for the three-month period ended September 30, 2011. For the three-month periods ended September 30, 2012 and 2011, Savient recorded charges of $2.8 million and $3.4 million, respectively, against operations, related to in-process and finished goods KRYSTEXXA inventory that the company does not believe it will be able to sell through to commerce prior to expiration.
Research and development expenses increased $0.9 million, or 16%, to $6.8 million for the three-month period ended September 30, 2012, from $5.9 million for the three-month period ended September 30, 2011 in support of Savient's marketing authorization application, or MAA, filing for KRYSTEXXA in the EU.
Selling, general and administrative expenses decreased $1.9 million, or 8%, to $20.4 million for the three-month period ended September 30, 2012, from $22.3 million for the three-month period ended September 30, 2011. The decrease in expense resulted from the implementation of the company's corporate reorganization plan during the quarter, which was partially offset by an increase in severance expense.
Interest expense on the company's debt increased $3.3 million, or 93%, to $6.8 million for the three-month period ended September 30, 2012, from $3.5 million for the three-month period ended September 30, 2011. Interest expense for the three-month period ended September 30, 2012 reflects $2.7 million of cash interest expense and $4.1 million of non-cash interest expense. Interest expense for the three-month period ended September 30, 2011, reflects $2.9 million of cash interest expense and $0.6 million of non-cash interest expense.
Other expense, net, increased $6.4 million for the three-month period ended September 30, 2012 primarily related to the increase in the fair value of the company's warrant liability as a result of the mark-to-market valuation adjustment in the current quarter, primary driven by the higher underlying price of Savient's common stock during the quarter.
BRIDGEWATER, N.J., Nov. 8, 2012 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today reported financial results for the three and nine months ended September 30, 2012, which reflects the Company's continuing commercialization of KRYSTEXXA (R) (pegloticase) in the U.S. Savient ended the quarter with approximately $116.2 million in cash and short-term investments.
Net sales for KRYSTEXXA were $4.5 million for the third quarter of 2012, a 13% increase over the second quarter of 2012. For the third quarter of 2012, the Company had a net loss of $39.7 million, or $0.56 per share, on total revenues of $4.9 million, compared with a net loss of $27.4 million, or $0.39 per share, on total revenues of $2.6 million for the same period in 2011. The net loss for the first nine months of 2012 was $90.3 million, or $1.28 per share, on total revenues of $13.1 million, compared with a net loss of $71.2 million, or $1.02 per share, on total revenues of $5.9 million for the same period in 2011. The net loss for the nine-month period ended September 30, 2012 includes a $21.8 million, or $0.31 per share, gain on the extinguishment of debt.
"During the third quarter we continued to drive awareness and adoption of KRYSTEXXA in the U.S., which resulted in our seventh consecutive quarter of sequential sales growth," said Louis Ferrari, President and Chief Executive Officer of Savient Pharmaceuticals. "We also made progress toward our goal of commercializing KRYSTEXXA outside of the U.S. with the positive opinion we received on October 19 from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). We remain confident in the long-term opportunity for KRYSTEXXA to address the significant unmet needs of patients suffering from refractory chronic gout. We are successfully executing our clinical development plan focused on expanding the clinical utility of KRYSTEXXA, and we believe that this coupled with our commercialization strategy will allow us to create long-term value for all of our stakeholders."
Operational Highlights:
-- Enhanced the executive team: Appointed John Hamill to the position of
Senior Vice President & Chief Financial Officer.
-- Achieved significant milestone in strategy to commercialize KRYSTEXXA
outside of the U.S.: Received a positive opinion from the CHMP that
recommended KRYSTEXXA for marketing authorization in the EU.
-- Positive financial results: KRYSTEXXA sales increased sequentially for
the seventh consecutive quarter and we began to realize the benefits of
the operational reorganization announced in July 2012.
-- Driving institutional acceptance: The release of the Veterans Affairs
(VA) monograph, and the KRYSTEXXA criteria for use allows Savient to work
more closely with VA Medical Centers and improves access for patients and
providers.
-- Continued to expand the universe of clinical data focused on KRYSTEXXA:
Eight KRYSTEXXA abstracts were accepted for presentation at the upcoming
American College of Rheumatology Annual Meeting. In addition, Savient
successfully submitted four manuscripts for publication at leading
medical journals and currently has seven additional manuscripts under
active development.
-- Executing clinical development strategy: Began actively recruiting for
the study of KRYSTEXXA in dialysis patients, which is expected to be
completed by mid-2013.
Financial Results of Operations for the Three Months Ended September 30, 2012
Net revenues increased $2.3 million, or 90%, to $4.9 million for the three-month period ended September 30, 2012, from $2.6 million for the three-month period ended September 30, 2011, as a result of the company's continued commercialization efforts and sales momentum of KRYSTEXXA.
Cost of goods sold decreased $0.4 million, or 8%, to $4.2 million for the three-month period ended September 30, 2012, from $4.6 million for the three-month period ended September 30, 2011. For the three-month periods ended September 30, 2012 and 2011, Savient recorded charges of $2.8 million and $3.4 million, respectively, against operations, related to in-process and finished goods KRYSTEXXA inventory that the company does not believe it will be able to sell through to commerce prior to expiration.
Research and development expenses increased $0.9 million, or 16%, to $6.8 million for the three-month period ended September 30, 2012, from $5.9 million for the three-month period ended September 30, 2011 in support of Savient's marketing authorization application, or MAA, filing for KRYSTEXXA in the EU.
Selling, general and administrative expenses decreased $1.9 million, or 8%, to $20.4 million for the three-month period ended September 30, 2012, from $22.3 million for the three-month period ended September 30, 2011. The decrease in expense resulted from the implementation of the company's corporate reorganization plan during the quarter, which was partially offset by an increase in severance expense.
Interest expense on the company's debt increased $3.3 million, or 93%, to $6.8 million for the three-month period ended September 30, 2012, from $3.5 million for the three-month period ended September 30, 2011. Interest expense for the three-month period ended September 30, 2012 reflects $2.7 million of cash interest expense and $4.1 million of non-cash interest expense. Interest expense for the three-month period ended September 30, 2011, reflects $2.9 million of cash interest expense and $0.6 million of non-cash interest expense.
Other expense, net, increased $6.4 million for the three-month period ended September 30, 2012 primarily related to the increase in the fair value of the company's warrant liability as a result of the mark-to-market valuation adjustment in the current quarter, primary driven by the higher underlying price of Savient's common stock during the quarter.
Savient Pharmaceuticals files for Chapter 11 bankruptcy
(Reuters) - U.S. biotech firm Savient Pharmaceuticals Inc filed for Chapter 11 bankruptcy protection in a Delaware court on Monday and said it has agreed to sell most of its assets to Sloan Holdings CV for about $55 million.
The agreement with Sloan, a unit of US WorldMeds LLC, would serve as a "stalking horse" bid in a court-supervised auction of Savient's assets, the company said in a statement.
A stalking horse bid serves as the minimum offer for the business, which could still be topped by others.
The drugmaker, which has been under pressure from its largest creditor to liquidate, said it would keep its gout drug Krystexxa commercially available in the United States.
Krystexxa, which treats chronic gout in adults who do not respond to conventional therapy, has had disappointing sales since its launch in September 2010.
Savient listed total assets of about $74 million and liabilities of $260 million as of June 30, court documents filed on Monday showed.
Shares of the company, which have fallen 47 percent this year, closed at 57 cents on Monday on the Nasdaq.
http://finance.yahoo.com/news/savient-pharmaceuticals-files-…
(Reuters) - U.S. biotech firm Savient Pharmaceuticals Inc filed for Chapter 11 bankruptcy protection in a Delaware court on Monday and said it has agreed to sell most of its assets to Sloan Holdings CV for about $55 million.
The agreement with Sloan, a unit of US WorldMeds LLC, would serve as a "stalking horse" bid in a court-supervised auction of Savient's assets, the company said in a statement.
A stalking horse bid serves as the minimum offer for the business, which could still be topped by others.
The drugmaker, which has been under pressure from its largest creditor to liquidate, said it would keep its gout drug Krystexxa commercially available in the United States.
Krystexxa, which treats chronic gout in adults who do not respond to conventional therapy, has had disappointing sales since its launch in September 2010.
Savient listed total assets of about $74 million and liabilities of $260 million as of June 30, court documents filed on Monday showed.
Shares of the company, which have fallen 47 percent this year, closed at 57 cents on Monday on the Nasdaq.
http://finance.yahoo.com/news/savient-pharmaceuticals-files-…
Crealta ist eine Gesellschaft, die im August 2013 gegründet wurde und der substantiell alles von Savient im Rahmen des Insolvenzverfahrens zu billigpreisen verkauft wurde.
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