Eli Lilly launches Exenatide
Eli Lilly Philippines recently launched Exenatide, a new drug for type 2 diabetes and the first in a new class of compounds called incretin mimetics. Exenatide is synthetic exendin-4, a compound released in the mouth of the Gila monster-the largest lizard native to North America-when it eats, priming its body to receive, process, and store food. Diabetes specialists Augusto Litonjua and Araceli Panelo welcomed the new medicine to armamentarium the medical community now has against a disease that has become a worldwide epidemic. The two were guests at a press conference during which Eli Lilly announced Exenatide's launch following approval by the Bureau of Food and Drugs. Litonjua explained how exendin-4 works. Exendin-4 mimics the actions of incretins, naturally occurring hormones in the body released by the gut into the bloodstream in response to food. The most important of these hormones is glucagon-like peptide-1 (GLP-1), which plays a crucial role on maintaining glucose homeostasis. GLP-1 stimulates the body to produce insulin in response to rising levels of blood glucose, inhibits the release of glucose from the liver after meals, regulates nutrient absorption, promotes satiety, and reduces appetite-all important metabolic mechanisms that are disrupted when type 2 diabetes develops. Studies have also shown that it also improves beta-cell function, which is impaired as type 2 diabetes gets worse. Exendin-4 acts like GLP-1 but has a significantly longer half-life, allowing it to stay much longer in the bloodstream. Studies have shown that, like GLP-1, it enhances glucose-dependent insulin secretion and other glucose-lowering actions such as inhibiting glucagon release after meals, promoting satiety, and slowing down gastric emptying. In animal trials, treatment with exendin-4 resulted in preservation and formation of new beta cells, the insulin-producing cells in the pancreas. Exenatide is administered by injection. Clinical trials suggest that injecting Exenatide better suppresses blood glucose to achieve target levels and is also associated with weight loss, which is important since most diabetic patients are overweight. Exenatide was codeveloped by Eli Lilly and Amylin Pharmaceuticals. M G. Caballero
WASHINGTON The United States Food and Drug Administration (FDA) has decided to put more prominent warnings of potential hearing loss on erectile-dysfunction drugs sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra). The FDA said the goal was "to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing." Revatio, used to treat pulmonary hypertension, also will get the same labeling changes, the FDA said. The warnings followed what the administration called "a very small number" of patients reporting hearing loss and at times ringing in the ears and dizziness. "Because some level of hearing loss is usually associated with the ageing process, patients on these drugs may not think to talk to their doctor about it," said Dr. Janet Woodcock, deputy commissioner for scientific and medical programs. M AFP
SEOUL Data presented at the recent World Conference on Lung Cancer in Korea show that patients with nonsmall-cell lung cancer (NSCLC) treated with the oral anticancer drug gefitinib (Iressa) had equivalent survival to those treated with intravenous docetaxel. In addition, Iressa demonstrated a more favorable tolerability profile and superior quality of life for patients versus docetaxel. The Iressa Nonsmall-cell lung cancer Trial Evaluating Response and Survival against Taxotere (INTEREST) study recruited 1,466 patients and compared overall survival between Iress and docetaxel in the largest phase-III study ever reported comparing two active treatments for pretreated advanced NSCLC. "This large study validates the role of targeted therapy when compared to chemotherapy in previously treated advanced NSCLC patients," commented Dr. Edward Kim assistant professor of medicine at MD Anderson Cancer Center in Houston, Texas, one of the principal investigators for the INTEREST study. "The study showed that Iressa was as effective1 as docetaxel but with a more favorable tolerability profile, resulting in significantly more Iressa-treated patients experiencing clinically important improvements in quality of life compared with patients who received docetaxel. Clearly, improving efficacy while minimizing toxicity is the direction advanced cancer therapy is going," he added Iressa is currently approved for the treatment of advanced NSCLC in 36 countries. M
CHICAGO Pharmaceuticals giant Pfizer unveiled the results of lengthy tests on a new anti-AIDS drug that it said could help HIV patients stay healthy for longer. Maraviroc (Selzentry) is the first new class of oral HIV medicines to be introduced in more than 10 years, Pfizer said at an annual medical conference in Chicago. After a 48-week trial, nearly three times as many patients receiving the drug combined with traditional medication recorded undetectable levels of HIV, compared with those just getting the normal treatments. "The safety and durability of response seen with Selzentry ... in our study is reassuring. This drug is an important new weapon for clinicians who treat HIV," said Jacob Lalezari, director of Quest Clinical Research at the University of California. The US Food and Drug Administration in August approved the use of Selzentry, which is the first in a class of drugs called CCR5 antagonists. They prevent the virus from entering the body's T-cells, rather than fighting the virus once it already infected the cells. CCR5 is a protein on the surface of some types of immune cells. Among patients who have previously received HIV medications, approximately 50 percent to 60 percent have circulating CCR5-tropic HIV-1. "Selzentry is the first in a class of drugs known as CCR5 antagonists, which block the CCR5 coreceptor, the virus's predominant entry route into T-cells," Pfizer said. The drug "stops the R5 virus on the outside surface of the cells before it enters, rather than fighting the virus inside as do all other classes of oral HIV medicines." The drug, however, does not cure HIV infection or prevent it from being passed to another person, the company warned. The side effects are similar to those experienced with other anti-AIDS drugs, including nausea, fatigue, headaches, and diarrhea. The product label includes a boxed warning about liver toxicity (hepatoxicity) and a statement in the "warnings" section about the possibility of heart attacks. Maraviroc is approved for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood (viral load). Experts believe the eventual sales of the drug could generate US$500 million for Pfizer annually by 2011. The company is also seeking permission for worldwide sales. M AFP
CHICAGO A skin-patch vaccine can save the wearer from the rumblings of diarrhea when traveling to places where stomach bugs are endemic. A clinical trial by Maryland-based vaccine maker Iomai Corporation showed that of 59 people who used the patch-which is slapped on the skin to deliver the vaccine without a needle-only three found their guts growling with diarrhea. Comparing this to results from travelers who were given a placebo, the test showed that the patch cut outbreaks of diarrhea by three-quarters. "These are clinically significant results that suggest that the patch vaccine will address the most significant unmet need for travel medicine: prophylaxis for travelers' diarrhea," said Gregory Glenn, the company's chief scientific officer. "Those who received the Iomai vaccination were much less likely to get sick, and those who were sickened had far milder illness than those who received a placebo." The findings were presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). "The results presented at ICAAC are the most robust ever shown in the prevention of travelers' diarrhea," said Herbert DuPont, a doctor from the Center for Infectious Diseases at the University of Texas, who led the trial. "They suggest we may be near a turning point in the prevention of this common, often serious disease." The condition, sometimes known as "Delhi belly" for its association with sickly tourists in India, strikes some 20 million travelers a year. The bugs are common in Africa, Asia, and Latin America. The World Health Organization estimates that the bacteria kill 380,000 people each year in poor countries. Its most common cause is the "enterotoxigenic E. coli," the company said. The patch delivers a toxin caused by the bacteria safely through the skin to trigger an immune response. The phase-II trial headed by DuPont was carried out on 170 volunteers who wore the patches before traveling to Mexico and Guatemala. One further phase of clinical trials is required before the patch can be marketed. Iomai plans to start phase-III trials in 2008. Chief executive Stanley Erck valued the potential market for an effective diarrhea treatment at US$750 million a year. M AFP
WASHINGTON The United States Food and Drug Administration (FDA) has authorized the sale and use of Evista to prevent aggressive breast cancer in postmenopausal women. The drug, produced by Eli Lilly, is already approved for use to prevent osteoporosis among postmenopausal women. The approval "provides an important new option for women at heightened risk of breast cancer," said Steven Galson, director of the FDA Center for Drug Evaluation and Research. However, he cautioned that side effects are serious. Users of the drug must watch out for side effects such as blood clots in legs and lungs, which can cause deadly stroke. The drug is the second treatment authorized in the US to cut the risk of invasive breast cancers, ones that can metastasize into other tissues. Breast cancer is the leading cause of cancer deaths among women worldwide. The company warns women who are pregnant or could become pregnant not to use the drug, which in any case should not be used with hormones such as estrogen. M AFP
The use of GlaxoSmithKline's (GSK) diabetes treatment rosiglitazone does not increase the risk of cardiovascular (CV) death in patients, a metaanalysis by Drs. Rodrigo Lago, Premranjan Singh and Richard Nesto showed. The study results published in The Lancet show that use of rosiglitazone and pioglitazone, another thiazolidinedione (TZD), did not increase the risk of CV death in more than 20,000 patients with prediabetes or type 2 diabetes in randomized trials with a mean follow-up of about 2.5 years. In addition, there was no statistically significant difference between rosiglitazone and pioglitazone in the incidence of CV death or the reported increased event rate of congestive heart failure (CHD), a known side effect of TZDs. The findings of the recent analysis are consistent with the results of several long-term outcomes trials with TZDs, all of which suggest no increased risk (or a nonsignificant reduction in risk) of CV death across a broad range of patients with type 2 diabetes and prediabetes. In addition, the analysis suggests that CHF due to TZD-related fluid retention may be different from CHF due to other causes such as left-ventricular systolic or diastolic dysfunction. However, further study is needed to validate this hypothesis. Information about CHF has been included in the prescribing information for rosiglitazone and pioglitazone. The safety and efficacy of rosiglitazone is supported by data from 116 clinical trials involving more than 52,000 patients, as well as epidemiological studies of databases involving over a million patients. Only rosiglitazone has been shown to control blood sugar for up to five years, as well as 32-percent more effective than metformin and 63-percent more effective than a sulfonylurea in maintaining blood-sugar control over the long term. Clinical studies show that effective treatment of diabetes requires intensive, long-term, day-to-day control of blood-sugar levels to reduce the risk of serious complications and ultimately save lives. Rosiglitazone is the one of the most widely studied oral medication for type 2 diabetes, and is a sound option for patients in need of a combination of diabetes medicines to control blood-sugar levels. M
Barcelona New data from the large international First BEAT trial unveiled at the European Cancer Conference in September showed that a high number of patients treated with bevacizumab (Avastin) plus standard chemotherapy for colorectal cancer underwent complete surgical removal of their metastatic lesions. Complete removal of metastatic lesions was achieved in almost 80 percent of patients previously considered inoperable. This outcome with bevacizumab is higher than has been previously seen in trials with other biologics/chemotherapy combinations. The First BEAT trial included 1,965 patients with advanced colorectal cancer with primarily inoperable metastatic disease. Patients received bevacizumab in combination with the commonly used fluoropyrimidine-based chemotherapy regimens as first-line treatment and were assessed for their suitability for potentially curative surgery during the course of the treatment. "The complete resection of metastatic lesions is the only option for cure in patients with metastatic colorectal cancer. Therefore, these results represent a major step forward for the patient." said Dr. Mondher Mahjoubi, global head, Roche Medical Affairs Oncology. "The high rates of successful, curative surgery achieved with bevacizumab plus standard chemotherapy are impressive, especially because First BEAT is a trial looking at a general, real-life patient population." The study demonstrated that 215 (11.5 percent) of all patients included in the data analysis (1,914) became eligible for and underwent surgery with curative intent during the course of treatment. Successful, complete removal of the metastatic lesions (R0 resection) was achieved in 170 patients, a success rate of 79 percent. The best outcomes as expected were achieved in the subgroup of patients with metastatic disease confined to the liver only (n = 704). In this subgroup, 102 (14.5 percent) patients underwent surgical removal of their liver metastases in curative intent with successful complete (R0) resection achieved in 81 patients. No increase in wound-healing complications or bleeding incidents was observed compared with historical controls underlining the favorable safety profile of bevacizumab in this setting. Bevacizumab is the first treatment that inhibits angiogenesis-the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Bevacizumab targets a naturally occurring protein called VEGF (vascular endothelial growth factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for tumor growth and metastasis. M
Biotechnology is causing enduring changes to the planet through breakthroughs in the life sciences, medicine, agriculture, and food products-as Novartis, the world's third-largest pharmaceutical outfit, has it, "biotechnology has become a key technology for any national economy with an eye on the future as well as a global industry that spans national borders." Call them rare birds, but talents imbued with the science and passion for biotechnology are hard to come by. Novartis wants these talents-"cultivation of talent with a global vision is essential for biotechnological innovation." In scouting for rare talents, the pharmaceutical giant, which earned US$37 billion in sales in 2006 while allotting US$5.4 billion for research and development, has put up an annual biotechnology camp "to bring the sector and opportunities closer to young talents worldwide." Biotechnology experts from the industry and academia, including prominent government officials and top postgraduate students, are gathered to learn about and explore opportunities in the field. Called BioCamp, the four-day biotechnology seminar is conducted for postgraduate students with high management and leadership potential. Last year's BioCamp was held in Singapore and got positive response from participants from all over the world. This year's BioCamp was held in Tokyo October 6 to 8, with two delegates from the Philippines: microbiologist Michael Bahrami-Hessari, an instructor in biological science at the University of Sto. Tomas's College of Science; and molecular biologist Carla Bianca Victorio, a junior faculty member of UP Diliman's National Institute of Molecular Biology and Biotechnology. More than a reality check, BioCamp provides an opportunity check for fledgling experts in biotechnology: "Participants acquire in-depth knowledge of the newest developments in the industry. They also learn to develop sharp expertise and management skills that are essential for success in the biotechnology business." A typical BioCamp day is divided into lectures, panel discussions, group activities and team building for the participating 40 postgraduate students. Their selection was based on their academic excellence and professional focus. Delegates tackle both science and business in BioCamp, as they competed among themselves to generate the best business plans for the future global market. M Dong de los Reyes
Citing the new emerging dispensation in global health care, St. Luke's Medical Center (SLMC) is aiming to suit up Filipino ophthalmologists for an international patient base through independent continuing-medical-education opportunities. "Patients now have the means to research health-care providers all over the world to arrive at a decision (on) which doctor to see, which hospital to patronize, and what country to go," said Dr. Noel Chua, director of the SLMC International Eye Institute. "It is no longer individual doctors nor hospitals but international conglomerates or even nations that offer health-care services under the umbrella of medical tourism." Two important factors leading to this scenario, he noted, are the global trend towards an ageing population with proportionately higher disposable income and faster Internet connectivity. "We envision the institute to take the lead in ensuring that the Filipino eye doctors are globally competitive by practicing international standards of care supported by world-class technology," Chua said during SLMC's first international eye symposium held recently. The symposium was held on the occasion of the eye institute's 20th anniversary. Local and foreign speakers discussed common and emerging eye problems. The event also marked the launch of a professional chair on glaucoma research at the St. Luke's College of Medicine for noted ophthalmologist and former institute head Mario Aquino Sr. Founder and first president of the Philippine Glaucoma Society and chair of three other ophthalmology departments in major local hospitals, he is credited with, among others, helping the institute actively recruit well-trained specialists. SLMC president and chief executive officer Jose Ledesma said he takes prides in the hospital's capability to hold educational sessions without having to solicit support from industry suppliers like drug companies. He said: "We're proud that our speakers will be able to speak their minds without having to worry about who sponsors them, because at SLMC, we try to set the standards of being independent-minded in terms of professional management of our patients." Referring to SLMC's soon-to-rise second site at The Fort, which will also host another eye institute, Ledesma assured the assembled specialists that the quality of the facilities in the Quezon City eye institute will continue to be "top-notch." He also announced the appointment of Chua as the new eye institute director at the second site of the SLMC. M Grace Roxas |
