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Questcor Pharmaceuticals Evaluating Acthar(R) Gel As a Potential New Treatment for Kidney Disorder

Posted on: Tuesday, 28 October 2008, 06:00 CDT

Nephrotic Syndrome Already An Approved Indication for Acthar Key Nephrology Experts Have Shown Interest in Acthar as a Potential New Therapy; Patient Enrollment for First Study Expected to Begin in First Quarter of 2009

UNION CITY, Calif., Oct. 28, 2008 (GLOBE NEWSWIRE) -- Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) today announced that it has identified Nephrotic Syndrome as a potential new therapeutic area for its principal product H.P. Acthar(r) Gel. Nephrotic Syndrome is characterized by excessive spilling of protein from the kidneys into the urine, known as proteinuria. Acthar is specifically indicated to induce a diuresis or a remission of proteinuria in the Nephrotic Syndrome without uremia of the idiopathic type or that due to lupus erythamatosus. If not adequately treated, patients suffering from Nephrotic Syndrome can often progress to end-stage renal disease. Current treatment options are effective in some patients, but frequently are only partially effective and can carry significant side-effects. Leading nephrologists indicate there is a significant need for additional therapies, particularly in patients who do not respond to current treatment approaches. Questcor has been in discussions with leading nephrologists and currently expects an exploratory proof-of-concept study with a major U.S. medical center to begin in the first quarter of 2009. While Nephrotic Syndrome is an approved indication for Acthar, at this time there is no modern published data regarding its use in this condition.

"We have been intrigued by what we have been hearing from top nephrology experts about Acthar's possible therapeutic application in this condition," said Don Bailey, President and Chief Executive Officer of Questcor. "We recently formed a nephrology advisory board which includes some of the world's top experts on kidney disease. Based on certain recent evidence they have shared with us pointing to a possible therapeutic role for Acthar, they strongly recommended that Acthar be studied in this condition."

Nephrotic Syndrome results from damage to the kidneys' glomeruli, tiny blood vessels that filter wastes and excess water from the blood and send them to the bladder as urine. The condition can be caused by a number of underlying diseases and disorders, including membranous nephropathy, diabetic nephropathy, focal segmental glomerular sclerosis and others. The condition can range from mild to severe, with more severe patients generally having a poorer prognosis. Nephrotic Syndrome often results in dramatically elevated cholesterol levels, hypertension and other serious health consequences. If allowed to progress, Nephrotic Syndrome can lead to end-stage renal disease, which requires life-long dialysis or a kidney transplant.

"We are encouraged by our extensive discussions with nephrology experts," said Steve Cartt, Executive Vice President, Corporate Development. "This clearly is an area warranting clinical exploration with Acthar. The leading nephrologists advising us have indicated that it will be very important to conduct new, modern studies of Acthar in Nephrotic Syndrome in order to fully assess the drug's value in treating this condition. Should such studies produce positive results, our very preliminary analysis indicates the potential market for Acthar in the treatment of Nephrotic Syndrome to be in the same general revenue range as the markets for Infantile Spasms or Multiple Sclerosis," Mr. Cartt added. "Since Acthar has primarily been a neurology-focused therapeutic, used in the treatment of patients with Infantile Spasms and Multiple Sclerosis, the idea that there could potentially be application of Acthar in this additional organ system -- the kidneys -- has caused us to begin looking at the drug in a completely different light. If results from the upcoming studies in Nephrotic Syndrome are positive, it could indicate that Acthar may have broader therapeutic application than we previously realized."

Conference Call

The Company will host a conference call and webcast on Thursday, October 30, 2008 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the Company's third quarter and current corporate developments. The dial-in number for the conference call is 800-257-6607 for domestic participants and 303-262-2130 for international participants.

A taped replay of the conference call will also be available beginning approximately one hour after the call's conclusion and will be available for seven days. This replay can be accessed by dialing 800-405-2236 for domestic callers and 303-590-3000 for international callers, both using passcode 11120825#. To access the live webcast of the call, go to Questcor Pharmaceuticals' website at www.questcor.com. An archived webcast will also be available at www.questcor.com.

About Questcor

Questcor Pharmaceuticals, Inc. is a pharmaceutical company that markets two commercial products, H.P. Acthar(r) Gel ("Acthar") and Doral(r). Acthar (repository corticotropin injection) 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 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. Doral is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The Company is also developing QSC-001, a unique orally disintegrating tablet formulation of hydrocodone bitartrate and acetaminophen for the treatment of moderate to moderately severe pain. For more information, please visit www.questcor.com.

Note: Except for the historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties and are subject to certain factors, which may cause Questcor's results to differ from those reported herein.

Factors that may cause such differences include, but are not limited to:

--Questcor's ability to continue to successfully implement its Acthar-centric business strategy; --the introduction of competitive products, --regulatory changes including possible outcomes relating to a July 2008 Congressional hearing regarding orphan drug pricing; --Questcor's ability to accurately forecast the demand for its products; --the gross margin achieved from the sale of its products; --Questcor's ability to estimate the quantity of Acthar used by government entities and Medicaid-eligible patients; --that the actual amount of rebates and discounts related to the use of Acthar by government entities and Medicaid-eligible patients may differ materially from Questcor's estimates; --the expenses and other cash needs for upcoming periods; --the inventories carried by Questcor's distributors, specialty pharmacies and hospitals, --volatility in Questcor's monthly and quarterly Acthar shipments and end-user demand; --Questcor's ability to obtain finished goods from its sole source contract manufacturers on a timely basis if at all; --Questcor's ability to attract and retain key management personnel; --Questcor's ability to utilize its net operating loss carry forwards to reduce income taxes on taxable income; --research and development risks, including risks associated with Questcor's sNDA for IS, its preliminary work in the area of nephrotic syndrome and QSC-001; --uncertainties regarding Questcor's intellectual property; --the uncertainty of receiving required regulatory approvals in a timely way, or at all; --uncertainties in the credit and capital markets and the impact a further deterioration of these markets could have on Questcor's investment portfolio; --as well as the risks discussed in Questcor's annual report on Form 10-K for the year ended December 31, 2007 and other documents filed with the Securities and Exchange Commission. The risk factors and other information contained in these documents should be considered in evaluating Questcor's prospects and future financial performance.

Questcor undertakes no obligation to publicly release the result of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

This news release was distributed by GlobeNewswire, www.globenewswire.com

CONTACT: Questcor Pharmaceuticals, Inc. Don Bailey 510-400-0776 dbailey@Questcor.com EVC Group, Inc. Investors Doug Sherk 415-896-6820 Dahlia Bailey 415-896-5862 Media Steve DiMattia 646-201-5445

Source: PrimeNewswire

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