Patients suffering from a host of difficult to treat orphan disorders have found marked relief from using HP Acthar Gel. Some disorders Acthar helps include seizure complex in babies and young children, referred to as West's syndrome or infantile spasm; Still's disease and ulcerative colitis; Bell's palsy; multiple sclerosis; adrenocortical insufficiency and non-endocrine disorders that are responsive to glucocorticoids.
For the past four years, however, the drug has only been available through a limited access program administered by the National Organization for Rare Disorders (NORD), a federation of more that 135 non-profit health organizations serving people with rare disorders.
U.S. physicians who were interested in obtaining Acthar Gel for their patients with life-threatening or severely debilitating conditions who did not respond to any other treatment were given first access to the drug. Others with "non-life-threatening" cases had to enroll in a computerized random selection process administered by NORD.
An estimated 1,600 patients, primarily suffering from West's syndrome and multiple sclerosis who experience episodes of "flare," have been allowed access to HP Acthar Gel each year for the past four years under the limited access program. More than 5,000 additional patients whose physicians requested the drug were denied.
The origins of this drug shortage crisis date back to 1996 when Aventis Pharmaceuticals stopped making Acthar for a few months because of manufacturing difficulties.
But now, Questcor Pharmaceuticals, Inc. (AMEX: QSC) has signed an agreement with Aventis to acquire the worldwide rights to HP Acthar Gel. Questcor has also reached a manufacturing agreement with Aventis and will gradually move production to an independent manufacturing facility.
Bextra - Drug History
Bextra was created in the late 1990s by the G.D Searle & Co. division of Pfizer Pharmaceuticals for the handling of arthritis, inflammation, and painful menstrual cramping without the risk of severe stomach irritation. Clinical tests of arthritis patients over six months showed the relative safety of Bextra, and it was approved by the FDA on November 16, 2001. Bextra became one of the best selling drugs on the market, with sales in the tens of billions of dollars. Doctors were happy with the low percentage of stomach irritation, and patients were pleased with the boost in quality of life th ..
As a result, HP Acthar Gel is now back in full production and is returning to normal levels of distribution. Questcor began shipments of HP Acthar Gel to wholesalers the last week of September 2001, giving patients in need access to the product.
"We are delighted that Questcor is making this critically important product more widely available after this long period of restricted distribution," said Abbey S. Meyers, president of NORD. "We have been working closely with the company over the last several months to ensure that anyone with a need for Acthar Gel is now able to readily receive the product through more traditional channels. Too many people have suffered as a result of limited access to Acthar Gel."
Questcor Pharmaceuticals, Inc. is a fully integrated specialty pharmaceutical company that serves the needs of acute and critical care hospitals with its proprietary products. Visit http://www.questcor.com for more information on the company and its products.
If you are a patient with a disorder that can be treated with Acthar, ask your doctor to contact Questcor Pharmaceuticals at (510) 400-0700. For more information about Acthar, including distribution information, please visit http://www.Acthar.com.
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ARA ContentLife-Saving Pediatric Drug Becomes Readily Available to Those in Need
