|Gilead offers Egypt new hepatitis C drug at 99 percent discount; Novartis Announces FDA Approval of Xolair®|
|By Mary Davila|
|Friday, 21 March 2014 19:42|
Gilead Sciences, (NASDAQ:GILD) facing mounting criticism over the high price of its new hepatitis C pill Sovaldi, has offered to supply the medicine to Egypt at a 99 percent discount to the U.S. price.
While the drug will still cost $900 for a 12-week course of treatment, that is a fraction of the $84,000 charged for a course of treatment in the United States. The high price tag in America prompted questions from U.S. lawmakers on Friday, after U.S. health insurers said they were seeking help from state health officials to foot the bill.
Gilead said it was "pleased to have finalized an agreement" for the introduction of Sovaldi in Egypt, which has the highest prevalence rate of hepatitis C in the world. "We believe Sovaldi could have a major impact on public health in Egypt by significantly increasing the number of people who can be cured of hepatitis C," Gregg Alton, head of corporate and medical affairs at Gilead, said in an emailed statement.
Egyptian health minister Adel El-Adawi said Cairo had struck a deal with U.S.-based Gilead for the government to buy Sovaldi for $300 for a one-month box, according to a recent report on the state news agency MENA. That would imply a cost of $900 if Sovaldi is used as part of a 12-week drug regimen, although the cost would be higher if it was used for 24 weeks, which is also an option based on different drug combinations.
El-Adawi said Gilead's offer would apply to Sovaldi supplies used in government clinics, adding that access programmes would start in the second half of 2014, following completion of registration procedures in Egypt. Sovaldi is in the vanguard of a wave of pills which could cure the liver-destroying disease in millions of people worldwide, or even eradicate it entirely. But that will only happen if the new therapies are affordable enough to allow widespread use.
Nowhere is the problem more acute than in Egypt, which has the world's highest prevalence of the virus, following the use of poorly sterilized needles in campaigns dating back to the 1970s to stamp out the parasitic disease schistosomiasis. Like HIV, hepatitis C (HCV) can be spread through blood, often via contaminated needles.
The World Health Organization estimates that more than 150 million people worldwide are chronically infected, most of them in developing countries, putting them at risk of cirrhosis and liver cancer.
Novartis (NYSE:NVS) announced the US FDA approved Xolair® (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for patients 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy. Xolair is not used to treat other forms of urticaria (hives) and is not for use in children less than 12 years of age. Xolair is jointly developed by Genentech and Novartis Pharma AG and is co-promoted by Novartis Pharmaceuticals Corporation with Genentech in the United States.
CIU is characterized by hives that spontaneously occur without an identifiable cause and reoccur for six weeks or more. CIU symptoms include red, swollen, itchy and sometimes painful hives on the skin that can be burdensome and last for many months and even years. Nearly 50% of these patients remain symptomatic despite treatment with approved doses of H1-antihistamines, the only previously FDA-approved therapy for CIU. In the US, it is estimated that approximately 1.5 million people suffer from CIU. Women are twice as likely as men to experience CIU and most people develop symptoms between the ages of 20 and 40 years.
“For CIU patients, it can take months or even years to get the right diagnosis and some relief,” said André Wyss, President, Novartis Pharmaceuticals Corporation, and President, Novartis Corporation. “Novartis is proud to have collaborated with clinicians to bring forward a new treatment option for those who suffer from this serious skin condition. This is part of our quest to deliver innovative medicines that address unmet need.”
“CIU can be a frustrating condition for patients,” said Mike Tringale, senior vice president at the Asthma and Allergy Foundation of America (AAFA). “This new use for Xolair gives hope to appropriate patients who can go for months or even years without getting satisfactory itch and hive reduction.”
Xolair is the first medicine approved by the FDA for CIU since H1-antihistamines.
Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that the Centers for Medicare & Medicaid Services (CMS) has released an updated version of ICD-10 MS-DRGs (version 31R) and maintained assignment to Diagnosis Related Groups (MS-DRGs) 216-221 for the category of devices that includes Impella® pumps.
BioCorRx, Inc. (OTCQB: BICX), a leader in addiction treatment and rehabilitation programs, announces three new additions to its advisory board.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN), a global leader in providing therapies for rare genetic diseases, today announced the appointment of Dennis J. Slamon, M.D., Ph.D., director of Clinical/Translational Research and director of the Revlon/UCLA Women's Cancer Research Program at UCLA's Jonsson Comprehensive Cancer Center, to the company's board of directors.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based diagnostics, announced today that it will report its results for the fourth quarter and year-end 2013 after the market close on Wednesday, March 26, 2014.
Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, today announced that it will report its results for the fourth quarter and year-end 2013 on Monday, March 31, 2014.
Cellular Dynamics International, Inc. (Nasdaq:ICEL) today announced scientific presentations at the Society of Toxicology's 53nd Annual Meeting (SOT), March 23 to 27 in Phoenix.
Endocyte, Inc. (Nasdaq:ECYT) today announced results from the Phase 2b TARGET trial, which showed that the study met the primary endpoint for the combination of vintafolide (EC145/MK-8109) and docetaxel in folate receptor (FR)-positive recurrent non-small cell lung cancer (NSCLC) patients.
FutureWorld (OTCQB: FWDG), a U.S. Diversified Holding Company formed to capitalize on the burgeoning markets of the Industrial Hemp, Legal Medical Marijuana and related Pharmaceuticals & Nutraceuticals globally, announces today that HempTech, a FutureWorld subsidiary, has selected Mr. Cameron Cox as VP of Business Development to head the land and property acquisition division for HempTech Corp.
Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today reported its financial results for the year ended December 31, 2013.
Lion Biotechnologies, Inc. (OTCQB:LBIO), a biotechnology company focused on the development and commercialization of novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TILs), today announced that Chief Executive Officer Manish Singh, Ph.D., will be presenting at the BioCentury Future Leaders in the Biotech Industry Conference at the Millennium Broadway Hotel in New York City.
The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) announced that trading of Versartis, Inc. (Nasdaq:VSAR), a biopharmaceutical company developing long-acting therapeutic proteins for the treatment of endocrine disorders, commenced on The NASDAQ Stock Market® on March 21, 2014.
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that Emil D. Kakkis, M.D., Ph.D., the company's Chief Executive Officer, will be presenting at the BioCentury Future Leaders in the Biotech Industry Conference on March 28, 2014 at 2:00pm ET at the Millennium Broadway Hotel & Conference Center in New York.
uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced that its management will present a corporate overview at the 21st Annual Future Leaders in the Biotech Industry Conference March 28, 2014, to be held at the Millennium Broadway Hotel, New York City, NY, USA.