Merck's Erbitux Recommended for Approval in Europe
DARMSTADT, Germany
German pharmaceuticals specialist Merck KGaA said its new cancer drug cetuximab (Erbitux) has been recommended for approval by the Committee for Proprietary Medicinal Products, a scientific advisory board of the European Agency for the Evaluation of Medicinal Products.
The recommendation would be forwarded to the European Commission, paving the way for anticipated European approval of Erbitux by the middle of this year, Merck said.
Erbitux will be used to treat cancer of the colon or rectum.
In the medium term, Merck expects to generate annual sales of US$300 to 600 million from the drug. Merck KGaA bought the marketing rights for Erbitux outside the United States from ImClone Systems for US$60 million.
Bristol-Myers owns the US rights for the drug.
In February, the US Food and Drug Administration (FDA) approved Erbitux for treatment of patients with advanced metastatic colorectal cancer.
Erbitux is the first monoclonal antibody approved to treat this type of cancer and is indicated as a combination treatment to be given intravenously with irinotecan, another drug approved to fight colorectal cancer, or alone if patients cannot tolerate irinotecan.
Erbitux got the green light under FDA's accelerated approval program, which allows the agency to approve products for cancer and other serious or life-threatening diseases based on early evidence of a product's efficacy. Although treatment with Erbitux has not been shown to extend patients' lives, it was shown to shrink tumors in some patients and delay tumor growth, especially when used as a combination treatment.
Erbitux is a genetically engineered version of a mouse antibody that contains both human and mouse components. Antibodies are substances produced by the immune system to fight foreign substances. This new monoclonal antibody, which can be produced in large quantities in the laboratory, is believed to work by targeting a natural protein called epidermal growth factor receptor (EGFR) on the surface of cancer cells, interfering with their growth.
For patients with tumors that express EGFR and who no longer responded to treatment with irinotecan alone or in combination with other chemotherapy drugs, the combination treatment of Erbitux and irinotecan shrank tumors in 22.9 percent of patients and delayed tumor growth by approximately 4.1 months. For patients who received Erbitux alone, the tumor response rate was 10.8 percent and tumor growth was delayed by 1.5 months.
AFP
Physiomed Elektromedizin Unveils Electrotherapy Products
Electricity can either stimulate or relieve pain. The ancient Egyptians applied this knowledge for various physical complaints. Thousands of years later, electricity is still being used widely in medicine, particularly in rehabilitation and sport.
Last March 24, Physiomed Elektromedizin of Germany, an ISO 9001-certified company that specializes in technology for therapy, came to the Philippines.
For 30 years, it has been developing and manufacturing high-quality equipment for classical and innovative physical therapy in rehabilitation and sport.
Physiomed representative Michael Schleibing presented and discussed the various therapeutic uses of units in electrotherapy, ultrasound therapy, microwave therapy, shortwave therapy, and laser therapy. These Physiomed products are used to treat pain, injury, spasms, and paralysis, among others.
Also of special interest are Hivamat 200, a machine that applies deep oscillation on targeted tissues, and vocaSTIM, which uses electrostimulation for speech problems and nerve and muscle problems in the larynx.
Schleibing added that unlike other electrotherapy units, which act only on muscles and nerves, Hivamat 200 have beneficial effects on connective tissue.
Physiomed's products presentation was arranged by Axis Unlimited Corp.
M. Ciriacruz
USFDA Okays Apokyn for Parkinson's Disease
The United States Food and Drug Administration (FDA) has approved apomorphine (Apokyn) as an injectable drug for treating Parkinson's patients during episodes of "hypomobility," so-called "off periods" in which the patient becomes immobile or unable to perform activities of daily living.
Apokyn was given priority review because injectable apomorphine is the first therapy approved to treat these episodes acutely (during the episode). Apokyn was also designated as an orphan product.
An estimated 1.5 million Americans have Parkinson's disease, which brings tremors, rigidity, postural instability, slowness, and difficulty moving.
Within three to five years of treatment with standard Parkinson's drugs, many patients experience episodes of hypomobility (inability to rise from a chair, to speak, or to walk). The episodes can occur toward the end of a dosing interval with standard background medications (so-called "end-of-dose wearing off") or at unpredictable times (spontaneous "on/off"). Approximately 10 percent of Parkinson's patients who are unresponsive to standard medications may benefit from Apokyn.
Apokyn was designated an orphan drug in l991 to treat Parkinson's patients who progress to stage four and experience the severe on/off motor fluctuations unresponsive to other therapies.
Orphan drugs are drugs that treat a rare disease or condition that affects fewer than 200,000 patients in the US. After receiving FDA approval, orphan drugs are eligible for seven years of exclusive marketing.
The effectiveness of Apokyn in the acute symptomatic treatment of both types of recurring episodes of hypomobility or "off" episodes associated with advanced Parkinson's disease was established in three randomized, controlled trials.
On average, patients participating in these trials had had Parkinson's disease for 11.3 years and were being treated with L-dopa and at least one other agent, usually an oral dopamine agonist.
Apokyn must be taken with an antiemetic drug because, when taken alone, it causes severe nausea and vomiting. It must not be taken with one class of very effective antinausea drugs, the 5HT3 antagonists (ondansetron and similar drugs), because the combination of Apokyn and these drugs can lead to very low blood pressure and loss of consciousness.
Apokyn is intended for subcutaneous injection only. Other oral drugs, taken chronically, are also used to help decrease the amount of time Parkinson's patients spend in the "off" state.
Apokyn is a new molecular entity-a medication containing an active substance that has never before been approved for marketing in any form in the US. It is manufactured by Canada's Draxis Pharma for North Carolina-based Bertek Pharmaceuticals.
FDA
Glaxo Hikes Stake in US Pharma Firm
LONDON
British pharmaceuticals giant GlaxoSmithKline said it was increasing its stake in US pharmaceutical company Theravance to 19 percent.
Theravance was to receive US$129 million-"a significant part of which" relates to Glaxo's purchase of shares to increase its stake in the firm from six to 19 percent, Glaxo said. The deal sees the firms building on their existing collaboration in research on respiratory diseases. The two have also undertaken a strategic alliance to develop and market new medicines to treat a variety of infections. Glaxo would receive an exclusive option to license potential new medicines from current and future programs.
Through the tie-up, "the two companies can create medicines that make a difference and improve patient outcomes," said Theravance chief executive Rick Winningham.
AFP
St. Luke's Gets DOT Accreditation
St. Luke's Medical Center (SLMC) recently became the first tertiary hospital to be accredited by the Department of Tourism (DOT) for its Health Tourism Program, which positions the Philippines as a premier health holiday destination in Southeast Asia.
Health tourism capitalizes on an emerging trend in leisure travel where people eagerly adopt a "healthy way of life" and associate holidays with health. They embark on a few days of travel to pamper themselves, seek medical treatment, or simply improve and maintain their health.
One component of the Health Tourism Program is Medical Tourism, which involves traveling to get health-care services or seek treatment. Hospitals and medical facilities accredited by the DOT must provide one-stop, quality health-care facilities and services for in and out patients.
SLMC was also accredited by the Joint Commission International, the worldwide leader in improving the quality of health care by creating environments that focus on quality, safety, and continuous improvement. The hospital aims be one of the top five medical institutions in Asia by 2010.
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