QCOR Questcor Pharmaceuticals, Inc.

[Carlito Brigante]

ottima news natalizia!!!
di conseguenza, fiammata con apertura a 5.45, max 5.83 e chiusura a 5.10

stiamo all'occhio alla riapertura. Buon Natale!!!

FDA Accepts for Review Questcor's Filing of Its Supplemental New Drug Application for H.P. Acthar(R) Gel for Treatment of Infantile Spasms



UNION CITY, Calif., Dec. 24, 2009 (GLOBE NEWSWIRE) -- Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) today announced the U.S. Food & Drug Administration (FDA) now considers that Questcor has provided a complete response to all prior action letters for its supplemental New Drug Application (sNDA) to market H.P. Acthar(R) Gel (repository corticotrophin injection) for the treatment of infantile spasms. The FDA has set the user fee goal date (PDUFA) of June 11, 2010 for this sNDA.

"The medical community and Questcor continue to believe that Acthar has an important role in the treatment of infantile spasms and we look forward to working with the FDA to answer any questions as they consider our application," said Don M. Bailey, President and CEO of Questcor. "We continue to expect the FDA will convene an Advisory Panel meeting to obtain independent expert advice on specific aspects of the sNDA," added Mr. Bailey.

Acthar is currently approved in the U.S. for the treatment of MS exacerbations, nephrotic syndrome and many other conditions. Acthar is not approved in the U.S. for the treatment of IS, a potentially life-threatening disorder that typically begins in the first year of life. However, pursuant to guidelines published by the American Academy of Neurology and the Child Neurology Society, many child neurologists use Acthar to treat infants afflicted with this condition. Previously, the FDA granted Orphan Designation to Acthar for the treatment of IS.

About Questcor

Questcor Pharmaceuticals, Inc. is a pharmaceutical company that markets H.P. Acthar(R) Gel (repository corticotropin injection). H.P. Acthar Gel ("Acthar") is an injectable drug that is approved for the treatment of certain disorders with an inflammatory component, including the treatment of exacerbations associated with multiple sclerosis ("MS") and to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that is due to lupus erythamatosus. In addition, Acthar is not indicated for, but is used in treating patients with infantile spasms ("IS"), a rare form of refractory childhood epilepsy, and opsoclonus myoclonus syndrome, a rare autoimmune-related childhood neurological disorder. The Company also markets Doral(R) (quazepam), which is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. For more information, please visit www.questcor.com.

 

[Carlito Brigante]

5.26 ultimo pre

 

[Carlito Brigante]

bella trimestrale, uscita a mercato chiuso. (ultimo after 5.26 vs 4.79 di chiusura).
la data-chiave resta l'11 giugno (approvazione farmaco).


Questcor Reports Solid Fourth Quarter Results

-Paid commercial Acthar prescriptions for MS up 223% over prior year quarter-
-Paid commercial IS prescriptions up 56% sequentially-
-Received initial set of nephrotic syndrome prescriptions-
-Fourth quarter 2009 net income per share $0.13 on $25.9 million in net sales-
-2.5 million common shares repurchased during fourth quarter-
-Conference call today at 5:00 PM ET-


UNION CITY, Calif., March 1 /PRNewswire-FirstCall/ -- Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) today reported financial results for the fourth quarter and year ended December 31, 2009. The Company's financial performance in the fourth quarter of 2009 was driven primarily by:

-- a 223% increase in the number of new paid Acthar commercial
prescriptions for the treatment of multiple sclerosis (MS) exacerbations
versus the fourth quarter of 2008,
-- a sequential 56% increase in new paid Acthar commercial prescriptions
for the treatment of infantile spasms (IS), and
-- lower sequential Medicaid usage.




In addition to the financial improvement in the quarter, the Company also received an encouraging initial set of Acthar prescriptions for the treatment of nephrotic syndrome (NS). Also, during the fourth quarter, the FDA accepted for review Questcor's supplemental New Drug Application (sNDA) filing which seeks approval for an indication for Acthar in the treatment of IS.

Net sales totaled $25.9 million for the quarter ended December 31, 2009 compared to $13.9 million for the quarter ended September 30, 2009, and $27.0 million for the fourth quarter of 2008. Net income for the fourth quarter of 2009 was $8.4 million, or $0.13 per diluted common share compared to $1.2 million, or $0.02 per diluted common share for the third quarter of 2009, and $16.2 million, or $0.24 per diluted common share for the fourth quarter of 2008. An additional $1.2 million in sales reserves was recorded during the fourth quarter of 2009 for retroactive Tricare rebates. Significantly higher sales reserves adjustments reduced net sales and operating income for the third quarter of 2009 by $4.6 million. Tax benefits resulting from the reversal of a valuation allowance positively affected net income in the fourth quarter of 2008 by $4.4 million.

Net sales totaled $88.3 million for the year ended December 31, 2009, compared with $95.2 million for 2008. Net income for 2009 was $26.6 million, or $0.40 per diluted common share compared with net income applicable to common shareholders of $35.3 million, or $0.49 per diluted common share for 2008. The 2008 earnings were impacted by a one-time net tax benefit of $5.2 million and a deemed dividend of $5.3 million.

"We are making excellent progress on all of Questcor's top priorities," said Don M. Bailey, President and CEO. "Our fourth quarter financial performance improved significantly on a sequential basis. Questcor's sales in the MS market showed marked growth and there are preliminary indications that Acthar may also begin to be adopted in the NS market, which is much larger than either the IS or MS markets. In addition, IS prescriptions and payer mix both improved during the fourth quarter from a very weak third quarter. To date, we are seeing little or no impact on Acthar sales in the IS market from the September 2009 introduction of Sabril (vigabatrin)."

IS, MS, and NS Sales

During the fourth quarter of 2009, Questcor shipped 1,626 vials of Acthar compared to third quarter 2009 shipments of 1,354 vials and fourth quarter 2008 shipments of 1,510 vials. Because Acthar prescriptions are filled at specialty pharmacies, the Company does not receive complete information regarding either the number of prescriptions or the number of vials by therapeutic area for all of the patients being treated with Acthar. However, Questcor is able to monitor historic trends in payer mix for new Acthar prescriptions based on data it receives from its reimbursement support center. Questcor estimates that approximately 90% of new Acthar prescriptions are processed by this support center, but that very few refill prescriptions are processed at this center. The following tables show the number of prescriptions shipped by payer category for each of three therapeutic areas for those new prescriptions processed by the Questcor support center:



Multiple Sclerosis New Prescriptions
------------------------------------
Paid/Commercial Medicaid Tricare/VA
--------------- -------- ----------
Q108 24 5 0
Q208 35 1 0
Q308 50 5 1
Q408 66 3 2
Total 2008 175 14 3


Q109 78 5 3
Q209 125 11 6
Q309 141 14 5
Q409 213 10 5
Total 2009 557 40 19


Infantile Spasms New Prescriptions
----------------------------------
Paid/Commercial Medicaid Tricare/VA
--------------- -------- ----------
Q108 98 38 2
Q208 114 47 3
Q308 113 67 3
Q408 103 56 3
Total 2008 428 208 11


Q109 104 70 5
Q209 93 63 5
Q309 61 55 3
Q409 95 40 5
Total 2009 353 228 18


Nephrotic Syndrome New Prescriptions
------------------------------------
Paid/Commercial Medicaid Tricare/VA
--------------- -------- ----------
Q109 1 0 0
Q209 3 0 1
Q309 2 0 0
Q409 14 2 1
Total 2009 20 2 2

Note: Historical trend information is not necessarily indicative of
future results. The total number of vials associated with an individual
prescription varies by the condition being treated and by patient.



"As the above tables illustrate, our efforts in MS continue to show that the use of Acthar is expanding," commented Steve Cartt, Executive Vice President. "Our initiatives to educate MS specialists about the treatment benefits of Acthar have resulted in a tripling in MS prescriptions year over year."

"In addition, spontaneous IS prescriptions during the fourth quarter rebounded to 140 new paid prescriptions from a low level of 119 in the third quarter," noted Mr. Cartt. "If we are able to receive approval from the FDA to market Acthar for the treatment of IS, we may be able to expand our sales in this therapeutic area."

"The modest set of prescriptions for NS in the fourth quarter was an unexpected development at this stage in our efforts to generate sales in this market," added Mr. Cartt. "NS is a devastating kidney disorder which leads to end-stage renal disease (ESRD). NS is an on-label indication for Acthar and we are working to generate more clinical data to further support the effectiveness of Acthar in the treatment of this disease."

Sales Reserves—Medicaid, Tricare and VA Adjustments

As required by federal regulations, the Company provides rebates to state Medicaid programs for Acthar dispensed to Medicaid patients. The Medicaid rebate portion of sales reserves for the fourth quarter of 2009 was $8.4 million or 22% of 2009 fourth quarter gross sales. While total new commercially paid Acthar prescriptions for the treatment of IS processed through the Company's reimbursement support center increased to 95 in the fourth quarter from 61 in the third quarter, the number of Medicaid-reimbursed IS prescriptions dropped 27% sequentially.

The Department of Defense (DOD) operates a prescription drug program through its Tricare Management Administration (Tricare). As a result of uncertainties in an on-going dispute between the pharmaceutical industry and the DOD over Tricare rebate regulations, Questcor recorded a sales reserve related to a portion of Tricare-claimed rebates during the third quarter of 2009. Due to recent developments in that dispute, Questcor recorded an additional $1.2 million in sales reserves during the fourth quarter of 2009 for the remaining potential Tricare-claimed rebates. Effective January 1, 2010, Questcor established new prices for Acthar purchased by Tricare and Veterans Administration (VA) medical centers. Additionally, Questcor has removed uncertainty regarding Tricare rebate liabilities going forward. The new agreement with Tricare does not diminish Questcor's rights in regards to the fully reserved 2008-2009 liability. Any sales in 2010 to Tricare or the VA will represent an increase from the negligible net sales to these customers in 2009.

Regulatory Activity

Acthar is currently approved in the U.S. for the treatment of MS exacerbations, nephrotic syndrome and many other conditions. Acthar is not approved in the U.S. for the treatment of IS, a potentially life-threatening disorder that typically begins in the first year of life. However, pursuant to guidelines published by the American Academy of Neurology and the Child Neurology Society, many child neurologists use Acthar to treat infants afflicted with IS.

On December 23, 2009 the FDA accepted for review Questcor's supplemental New Drug Application (sNDA) seeking approval to market Acthar for the treatment of infantile spasms. The FDA has notified Questcor that an Advisory Committee Meeting of independent experts will be held to discuss the approval and use of Acthar in infantile spasms. The FDA has also notified Questcor that it has set a PDUFA goal date of June 11, 2010, but there is no assurance that this date will not be delayed. Approval of the IS indication would allow Questcor to promote the use of Acthar in treating IS to child neurologists.

Previously, the FDA granted Orphan Designation to Acthar for the treatment of IS. As a result of this Orphan Designation, if Questcor is successful in obtaining FDA approval for the IS indication, Questcor believes that it will also qualify for a seven-year exclusivity period during which the FDA is prohibited from approving any other adrenocorticotropic hormone (ACTH) formulation for IS unless the other formulation is demonstrated to be clinically superior to Acthar.

Cash, Accounts Receivable and Share Repurchase Program

At February 26, 2010, Questcor's cash, cash equivalents and short-term investments totaled approximately $81 million, and accounts receivable totaled approximately $9 million.

During the fourth quarter, the Company repurchased 2.5 million shares of its common stock at a total cost of $9.9 million. In the last two years, Questcor has spent $67.0 million for the repurchase of 14.5 million common and preferred shares.

As of December 31, 2009, Questcor had 61.7 million common shares outstanding, with 5.1 million shares remaining under its common share repurchase program.

 

[Carlito Brigante]

open 5.25
last 5.395

 

[Carlito Brigante]

5.64

 

[Carlito Brigante]

6.04
anche oggi corre!

 

[RW1392]

6.04
anche oggi corre!

Complimenti.

Muretto rosso a $ 6.07
Intraday e giornaliero in formazione

 

[Carlito Brigante]

Complimenti.

Muretto rosso a $ 6.07
Intraday e giornaliero in formazione

che onore, grazie!

come avrai visto sono dentro da un bel po' (e ho già perso un gain), speriamo nell'approvazione del farmaco per toglierci soddisfazioni ancora maggiori

 

[Carlito Brigante]

last 6.30

 

[Carlito Brigante]

6.2 -0.16%
è il momento di correggere

 

[Carlito Brigante]

ieri chiusura a 6.39, open 6.19 max 6.49 min 6.13
alla fine non ha corretto...
volumi in calo, forse si va stabilizzando ma la correzione penso sia dietro l'angolo.
oggi c'è un discreto pre a 6.40, vediamo come apre...

 

[RW1392]

ieri max 6.49
oggi c'è un discreto pre a 6.40, vediamo come apre...

Ieri sono arrivati in prossimita' della dinamica verde in area $ 6.50.
A $ 6.60 secchi, un importante livello psicologico.
Sopra, con decisione, possono accellerare verso $ 7.35/7.50 (BLU) / 7.75
con pull evidenti da marcare su fino a 8.55

Per difenderti al meglio, vedi che succede in area $ 6.50 (sopra la verde) 6.60 sotto l'area psicologicamente rilevante ( max inizi 2008)
$ 5.70 rimane un'area rilevante,per eventualmente riprendere posizione.

Ciao

Ps . Anche COIN in pre sta a 1.07 ,gli serve un top superiore a 1.09

 

[Carlito Brigante]

Ieri sono arrivati in prossimita' della dinamica verde in area $ 6.50.
A $ 6.60 secchi, un importante livello psicologico.
Sopra, con decisione, possono accellerare verso $ 7.35/7.50 (BLU) / 7.75
con pull evidenti da marcare su fino a 8.55

Per difenderti al meglio, vedi che succede in area $ 6.50 (sopra la verde) 6.60 sotto l'area psicologicamente rilevante ( max inizi 2008)
$ 5.70 rimane un'area rilevante,per eventualmente riprendere posizione.

Ciao

Ps . Anche COIN in pre sta a 1.07 ,gli serve un top superiore a 1.09

Grazie mille maestro!

Vediamo cosa combinano nel resto della giornata, non sembrano prendere una strada in modo deciso, forse tocca aspettare lunedì per qualche segnale più significativo...

 

[Carlito Brigante]

chiusura venerdì: 6.50
apertura oggi a 6.48, poi sempre in loss...fino ad ora, si è girata e ha ora una fiammata a 6.55
vediamo che succede...

 

[Carlito Brigante]

6.628

momento topico!

 

[RW1392]

6.628

momento topico!

Batte $ 6.73 ... ora incontri una statica a $ 6.80
Volumi in continua diminuzione.

40 candele per venti sedute ultima in formazione

 

[RW1392]

Batte $ 6.73 ... ora incontri una statica a $ 6.80

Ci siamo !
Hanno voglia di passare
Ora $ 6.60 (psicologico) e' a tuo vantaggio

Allargando gli orizzonti,nonostante sia abbastanza tirata, mi sento di poter dire che e' diretta in area $ 7.53

 

[RW1392]

Ci siamo !
Hanno voglia di passare
Ora $ 6.60 (psicologico) e' a tuo vantaggio

Batte $ 6.85 .... 6.87..... 6.88

 

[Carlito Brigante]

Ci siamo !
Hanno voglia di passare
Ora $ 6.60 (psicologico) e' a tuo vantaggio

Allargando gli orizzonti,nonostante sia abbastanza tirata, mi sento di poter dire che e' diretta in area $ 7.53

mamma mia, non me l'aspettavo!
adesso bisogna gestire bene la posizione, già ho mancato il gain una volta

 

[RW1392]

Vendi sulla forza quando soddisfatto.
Alza il tuo profit ( mentale) e decidi a mente fredda dove non tornare.