FreeStyle Navigator gets FDA nod
ABBOTT PARK, Illinois
The United States Food and Drug Administration (FDA) has approved the FreeStyle Navigator continuous glucose-monitoring system in the US for people with diabetes. Designed to continuously measure glucose levels through a sensor in the back of the upper arm or abdomen, Abbott's FreeStyle Navigator system provides minute-by-minute information about which way and how quickly blood-sugar levels are changing. This information can lead to proactive adjustments that can result in tighter glucose ranges. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood-glucose tests must be performed.
The FreeStyle Navigator system will be available in the second quarter of 2008 by prescription only. It received CE mark in June 2007 and has been available outside the United States since September 2007.
"Understanding glucose trends, with the goal of minimizing fluctuations, is an important part of improving the management of diabetes," said endocrinologist Richard Bergenstal, director of the International Diabetes Center. "We are always looking for new tools like these to enable people with diabetes to continuously monitor their glucose levels, putting them on the offense, not defense, so they can take action before a high or low glucose level occurs."
For people with diabetes, less time spent with hypoglycemia or hyperglycemia has been correlated with less risk for a number of serious short- and long-term diabetes-related complications. By measuring glucose levels continuously, the FreeStyle Navigator system is designed to provide more and better information than traditional fingerstick glucose measurements, and thereby lead to improved diabetes management.
Abbott's FreeStyle Navigator system offers a number of key advances for people with diabetes who require insulin and want to tightly manage their disease. The system monitors glucose levels by measuring and transmitting glucose information once per minute to the pager-sized receiver, which can be clipped to a belt or carried in a pocket or purse. It also provides audible or vibrating alarms before glucose levels become too high or too low, displays five directional trend arrows to help people understand if glucose is rising or falling, and stores historical data and glucose-trend information for up to 60 days. Additionally, the sensor and transmitter are designed to accommodate bathing, swimming, and a range of normal physical activities.
The accuracy, safety, and efficacy of the FreeStyle Navigator system have been demonstrated in two separate pivotal clinical trials, including a five-day, in-clinic study and a study of people with type 1 and type 2 diabetes at home.
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Novartis puts up vaccine institute
BASEL, Switzerland
Novartis recently opened a new research institute in Siena, Italy, with a nonprofit mission to exclusively focus on the development of vaccines for diseases of the developing world. The Novartis Vaccines Institute for Global Health (NVGH) is the first institute of its kind to be set up by a major vaccine manufacturer.
The NVGH seeks to address the unmet need for vaccines for diseases in the developing world by researching vaccines specifically tailored for developing countries and making them available first in those countries. The NVGH is a public-private partnership and will also collaborate with external organizations to build strength in resources.
The institute will be headed by Allan Saul, who has nearly 30 years of experience in translational research and development. Saul joined Novartis from the laboratory of Malaria and Vector Research at the National Institute of Allergy and Infectious Diseases in the United States. He has a strong background in vaccines research and his translational-vaccine-research experience has lead to numerous candidates taken into full development and testing.
"NVGH reinforces the Novartis commitment to R & D for neglected diseases and will potentially bring innovative vaccines to the patients who may need [them] most," said Dr. Daniel Vasella, chair and chief executive of Novartis. "Novartis will continue to draw on our expertise and the skills of our associates to contribute to sustainable corporate-citizenship initiatives."
Joerg Reinhardt, chief executive of Novartis Vaccines and Diagnostics said the opening of NVGH" will allow us to apply our knowledge and expertise of vaccines research to diseases that affect the developing world...[and] play a leading role in permanently reducing the burden of neglected diseases."
The world faces an urgent need to develop better drugs and vaccines for diseases that are largely confined to developing countries. Neglected diseases affect one-sixth of the world's population yet the drug and vaccine pipeline for these diseases is almost dry.
Currently, only about 10 percent of the world's medical research is devoted to conditions that account for 90 percent of the global disease burden.
All products discovered at NVGH will be introduced first in developing countries. While NVGH will focus on the R&D for vaccines for diseases of the developing world, the institute will license a third party to develop and distribute the vaccines at an affordable and accessible price to the target populations.
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Otsuka drive v. mental illness
Recognizing the need to seriously address the stigma attached to mental illnesses, Otsuka (Philippines) Pharmaceuticals Inc. launched an advocacy campaign dubbed as "Light One's Life: A Patient Quality Life Program." Dr. Benjamin Co, medical director of Otsuka, said the campaign seeks to raise public awareness about mental illnesses and empower not only patients but also their families.
Speaking during the project's launch in February, Dr. Paul Lee, a medical consultant at the University of the Philippines-Philippine General Hospital, said the stigma people attached to mental illnesses, particularly schizophrenia and bipolar disorder, causes those suffering from these disorders to feel shame, discriminated, and isolated. Discrimination can cause the patient to have low self-esteem, aggravate their stress, and lead to greater disability, he said.
He deplored that public attitude toward the mentally ill is worse today than in the 1950s. "The perception of people with psychosis as being dangerous is stronger today than in the past," Lee said, noting that the stigma even goes beyond the patient and extends to the medications, treatment, and even psychiatry as a field of medicine and to psychiatrists. Because of these, patients forego or delay going to a psychiatrist for consultation, thereby causing delay in diagnosis and treatment. "A lot of times, they go to the hospital or mental-health clinic when their conditions have worsened," said Lee.
He added that the stigma is made worse by misconceptions perpetrated in media, among them, that nobody recovers from schizophrenia, that it's an untreatable disease, that patients are usually violent and are likely to inflict others with their madness. But he stressed patients with schizophrenia can be treated and recover because there are now effective medicines. He clarified that these patients are not always violent. "They become violent because they are not treated well and because of complications," he explained.
The "Light One's Life" hotline can be reached at +63-2-8114723 and 1-800-18888-4723.
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Marketing Agreement
Novartis Healthcare
Phils. Inc. recently renewed its appointment of New Marketlink
Pharmaceutical Corporation as its marketing arm in the Philippines for
Novartis Vaccines' antirabies vaccine Rabipur (purified chick-embryo-cell
rabies vaccine). Peter Goldschmidt, president and chief executive of
Novartis Healthcare Phils. Inc. and Amado Tadena, chair and chief executive
of New Marketlink, shake hands after signing the agreement. Also in photo are (from
left) Oscar Aragon, president of New Marketlink; Gemma Llamado, group
manager of Novartis Healthcare Phils.; and Raul Anonas, chief finance
officer of New Marketlink. Novartis Vaccines is one of the world's leading
vaccines companies, focused on creating innovative products to prevent
influenza, meningitis, and other diseases. In 2004, it opened the Novartis
Institute for Tropical Diseases in Singapore's new Biopolis research
facilities. The Institute is focused on advanced biomedical research for
neglected diseases, initially dengue fever and drug-resistant tuberculosis.
Merck posts US$24B sales in 2007
WHITEHOUSE STATION, New Jersey
Merck & Co. Inc. posted worldwide sales of US$24.2 billion in 2007, seven-percent higher than in 2006. Net income was US$3.3 billion million, lower than the 2006 net income of US$4.4 billion. The company reported a net loss in the fourth quarter of $1.6 billion, reflecting an aggregate reduction in net earnings of US$3.4 billion resulting from charges that included settlement cases in the United States involving Vioxx.
"Our performance in 2007 shows that the customer-focused, more efficient business model we began implementing more than two years ago is working," said Richard Clark, chairman and chief executive. "We have a strong portfolio of products, a robust pipeline of potential new therapies and a leadership team focused daily on improving operational performance. This positions us to build on our record of delivering essential breakthrough medicines and vaccines like Januvia, Isentress, and Gardasil to the global marketplace."
Worldwide sales of montelukast (Singulair) reached US$4.3 billion, a 19-percent increase compared with the prior year's. Singulair continues to be the leading prescribed product in the US respiratory market.
Combined global sales of ezetimibe (Zetia) and ezetimibe/simvastatin (Vytorin) reached US$5.2 billion, 34-percent higher than in 2006. Meanwhile, losartan (Hyzaar) and losartan/hydrochlorothiazide (Hyzaar) generated sales of US$3.4 billion, an increase of six percent.
New antidiabetes drug sitagliptin (Januvia) sold US$668 million in 2007 while the combination sitagliptin and metformin (Janumet) reported $86 million in global sales.
Vaccines sales, on the other hand, more than doubled to US$4.3 billion, boosted by cervical-cancer vaccine Gardasil, which accounted for US$1.5 billion. Gardasil been approved in 93 countries. Rotateq, a vaccine against rotavirus gastroenteritis, achieved worldwide sales of US$525 million.
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