Strategies v. malnutrition
VEVEY, Switzerland
The Nestlé Nutrition Institute has released a seven-tier strategy for reducing disease-related malnutrition in hospitalized and community patients. The strategy calls on health policymakers to:
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Add nutrition education to the core medical-school curriculum;
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Educate hospital physicians and allied health providers on the impact of undernutrition on morbidity and mortality;
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Position nutrition as a recognized medical specialty in its own right;
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Recognize that undernutrition is often a contributing factor to the disease process (not merely a consequence);
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Address nutrition as part of routine disease management;
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Develop clear, universal definitions for malnutrition and undernutrition; and
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Create clinical and regulatory partnerships to enable governments and
clinicians to work together to create modern, practical nutrition policies.
The proposals were developed at a multidisciplinary workshop in Peebles, Scotland, on March 25 to 28, where 45 leading nutrition experts from 15 countries met to discuss the global malnutrition epidemic.
Marinos Elia, professor of clinical nutrition and metabolism at the University of Southampton, United Kingdom, and cochair of the expert meeting said: "The clinical and economic evidence for treating malnutrition is now more compelling than ever. For example, in the UK alone, the cost of treating malnutrition and its associated morbidity, is more than £7 billion per year. This is greater than the cost of treating obese patients, an issue which is currently attracting a great deal of public and government attention. Estimates suggest that even in well-developed countries, malnutrition is an unnecessary health-care burden which could easily be reduced."
The core elements of the seven-tier strategy are echoed by a report from the European Nutrition for Health Alliance, an expert group that includes nine nongovernment organizations. This Europe-wide consensus report entitled From Malnutrition to Wellnutrition: Policy to Practice urges policymakers to recognize the benefits of treating malnutrition in hospitalized patients. It was recently submitted to the 27 European Union Ministers for Health, the European Commission, the European Parliament, the World Health Organization, and the Council of Europe.
Patricia Anthony, manager for Nestlé Nutrition Healthcare Nutrition Global Support Services and organizer of the meeting, said: "It is very rare that leading international clinical and political nutrition stakeholders ranging from practicing clinicians to health-care economists and policy regulators get together and share their own expert insights into this clinically pertinent and challenging issue of disease-related malnutrition. At our meeting, we provided an opportunity for them to do just this, and we are delighted that these highly beneficial discussions have enabled us to produce a seven-tier strategy that we believe will benefit all nutrition stakeholders and the millions of undernourished patients across the world."
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Sanofi, Oxford codevelop TroVax
PARIS
Sanofi-Aventis and Oxford BioMedica have entered into an exclusive global license agreement to develop and commercialize TroVax for the treatment and prevention of cancers. TroVax is Oxford BioMedica's lead cancer immunotherapy. This therapeutic vaccine has been evaluated in clinical trials involving more than 180 patients with various forms of cancer. A phase- III trial in renal cancer is ongoing.
Under the agreement, Sanofi-Aventis will make an initial payment to Oxford BioMedica of US$38 million and a further US$24.9 million as milestones during the course of the phase-III study, and will pay other milestone payments based on progress in the development and registration of the product. Assuming full development and registration success in all targeted indications, the total upfront payments, support of the ongoing study, and clinical and regulatory milestones could reach US$678.6 million.
The two companies will cofund the ongoing phase-III trial while Sanofi-Aventis will fund all future research, development, regulatory, and commercialization activities, including the immediate implementation of a development plan for TroVax in metastatic colorectal cancer. Sanofi-Aventis will be responsible for the commercialization of TroVax and will book the sales worldwide. Oxford BioMedica may exercise an option to participate in the promotion of TroVax in the United States and the European Union.
TroVax may be developed by Sanofi-Aventis as a treatment for any cancer type. Based on the broad distribution of the 5T4 tumor antigen, TroVax has potential applications in a wide range of other solid tumors, including lung, breast, and prostate cancer.
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Generic competition to heighten as several drugs come off patent
LONDON
With drugs worth nearly US$140 billion in sales coming off patent by 2016, including Pfizer's blockbusting drug cetirizine (Zyrtec) and GlaxoSmithKline's sumatriptan (Imigran), brand manufacturers can expect to face a decade of unrelenting generic competition, according to a new report from independent market analyst Datamonitor.
It is inevitable that once the product patent of a pharmaceutical drug expires, generic companies will launch their own versions of the drug. These are usually at a discount price to the brand, which encourages switching from the branded product to the cheaper generic.
Switching from a branded product to a generic erodes the volume of branded drugs prescribed and so usually also erodes the brand's revenues, Datamonitor said. "However, the severity and speed of brand erosion can vary significantly, depending on factors such as country-specific prescription, and pricing and reimbursement regulations, product formulation, success of the targeted brand, and the implementation of life-cycle-management (LCM) strategies," said Alistair Sinclair, Datamonitor senior pharmaceutical analyst.
Datamonitor observed that between two and four generics usually enter the market during the first three months following a patent expiry, although there can be as high as 32 generic entrants, as in the case of Roche's injectable antibiotic ceftriaxone in Italy. Over time, additional generic manufacturers subsequently enter the market. "Datamonitor's research reveals that of the six major pharmaceutical markets (United States, France, Germany, Italy, Spain, and the United Kingdom), brands in Germany experience the greatest number of generic competitors, while those in the US and UK experience the least after two years of generic competition," Sinclair noted.
Brands with high revenues generally face a greater number of generic competitors than brands with low revenues. This is because generics companies can earn potentially greater revenues through targeting more successful brands. However, as more generics enter the market, the revenue potential for each individual generic company decreases accordingly. Nevertheless, the greater the brand value, the higher the number of generic competitors that can be accommodated.
Different levels of erosion
Datamonitor identified that in general, the value of a brand, whether a blockbuster or one with revenues of less than US$50 million per year, is not linked to the level of erosion it experiences after patent expiry. However, one characteristic that does affect sales erosion is the formulation of the brand. Manufacturers of standard oral tablets experience a greater level of brand erosion than those producing alternative formulations, Sinclair said. "Datamonitor believes this is indicative of the relative ease of producing oral tablets, capsules, and liquids, in addition to the higher prescription rate of such formulations. This in turn leads to greater revenue potential," he said. He noted that most of the leading generics companies have the capacity to produce standard oral formulations while few have the capability to produce injectable formulations.
Conversely, branded oral long-lasting drugs and other technologically advanced formulations, generally do not experience significant erosion from generics. This demonstrates the significant value of these formulations, as well as the brand-protecting ability of such LCM strategies. It is also a significant financial benefit to the manufacturer if it can switch patients to patent-protected formulations.
However, once the formulation patent covering branded, long-lasting formulations expires, or when generics companies develop their own noninfringing long-lasting formulations, which is happening more frequently, the original brand will inevitably face generic incursion and erosion. Said Sinclair: "While reformulation strategies may be effective at staving off generic competition in the short-term, ultimately manufacturers need to develop truly novel drugs in order to maintain franchise and portfolio revenues in the face of generic competition."
Pricing of generic products
Generic manufacturers usually price their products at a discount to the brand, which encourages switching from the branded product to the cheaper generic. However, as more generics enter the market, in order to remain competitive, generic manufacturers in the US, UK, and Germany lower their prices further, which results in the declining cost of generics over time. However, in France, Italy, and Spain, according to mandatory regulations, generics must enter the market at a significant discount to the existing brands. Subsequent generic entrants are therefore unlikely to willingly drop the price of their products, given the already tight profit margin, which results in the generic price remaining flat.
Conversely, branded prices following generic entry generally remain flat, if not increasing slightly due to normal price rises and inflation, Sinclair said. "However, manufacturers rarely raise their brand prices more than a few percent, as this may encourage further switching to cheaper generic substitutes."
M Datamonitor
Pocari Sweat to rehydrate
With temperatures peaking these past summer months, Otsuka (Philippines) Pharmaceutical Inc. introduced a new product that refreshes as much as it rehydrates-Pocari Sweat. This health beverage is intended to replace water and electrolytes in the body that are lost through perspiration. First introduced into the Japanese market in 1980, Pocari Sweat is the leading health drink in Japan today. It is enjoyed in 14 other countries including China, Korea, Malaysia, Thailand, and the United Arab Emirates. It was even the official drink of the 2006 Asian Games in Doha, Qatar.
Although Otsuka Philippines already has a firm foothold in the country's pharmaceutical industry for the past 10 years, "it does not under any circumstance intend to stop there," said Hirofumi Inoue, president. "Otsuka Philippines wants to reach a broader range: consumers." This is why the company introduced Pocari Sweat.
Pocari comes from the Japanese word "pokkari," meaning "clouds floating in the sky," which could very well describe the feeling one gets from drinking the beverage, said Pol Dimerin, sales and marketing director. He added: "Pocari Sweat is unlike other commercially available beverages because it has no preservatives and artificial coloring."
Pocari Sweat is an electrolyte- and carbohydrate-containing beverage (ECB), said Dr. Benjamin Co, medical director. Unlike energy drinks that contain caffeine, ECBs are designed to rehydrate and to replenish lost electrolytes and sugar. He also stressed athletes are not the only ones that lose a lot of carbohydrates and electrolytes. "There are what we call physiologic losses in our everyday lives," he said, "every time we move, especially now it's really hot out there."
Co added that the body feels thirsty when it has already incurred a water deficit of about two percent of its body weight. "You don't need to wait until you're thirsty because by that time, you end up having to hydrate yourself with more," he said.
An isotonic beverage that contains six- to eight-percent carbohydrates (such as Pocari Sweat) can help prevent dehydration.
Aside from containing electrolytes such as sodium, potassium, and magnesium, Pocari Sweat has calcium, which the leading isotonic beverage does not have. It is also less acidic than the leading isotonic beverage. Studies have shown that to prevent enamel loss, one must use an ECB that is less acidic and contains calcium, explained Co.
Pocari Sweat is now available in leading supermarkets and drug stores.
M Carisa Paraz, MD
Rapid test for meningitis gets OK
The United States Food and Drug Administration (FDA) recently cleared for marketing a test that uses molecular biology to quickly detect the presence of viral meningitis. The Xpert EV test, when used in combination with other laboratory tests, will help physicians distinguish between viral meningitis and the less common but more severe version of meningitis caused by bacteria.
Meningitis is an infection of the cerebrospinal fluid surrounding a person's spinal cord and brain, causing inflammation of the tissues in these areas. The illness is diagnosed by testing the fluid obtained from a patient during a spinal tap. Typically, diagnostic tests for meningitis can take up to a week to get results. But results from the Xpert EV test are available in two and one-half hours.
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"Because this test is significantly faster than existing methods for diagnosing meningitis, it could minimize delays in treating patients. Swift recognition of the cause and appropriate treatment is critical to patient recovery," said Dr. Daniel Schultz, director of the Center for Devices and Radiological Health. "Since bacterial meningitis can be deadly within as little as two days, patients who have viral meningitis are frequently treated with antibiotics as a safeguard against the more dangerous bacterial meningitis. This test should help physicians manage patients appropriately and prevent unnecessary treatment with antibiotics."
Knowing whether the meningitis is viral or bacterial is imperative to early effective treatment. But distinguishing between the two types of infection is difficult because of similar symptoms. Patients with viral meningitis usually recover within two weeks without any medical intervention. Bacterial meningitis, however, can lead to brain damage, hearing loss, and even death if not treated properly.
The Xpert EV test is the first fully automated medical-diagnostic test that isolates and amplifies viral genetic material present in a patient's cerebrospinal fluid by a process called reverse-transcription-polymerase chain reaction. The test identifies infection resulting from enteroviruses, which are responsible for approximately 90 percent of all viral-meningitis cases.
The Xpert EV test is performed by adding the sample directly to a disposable, single-use cartridge. The cartridge is loaded into the GeneXpert DX instrument which then conducts all the necessary laboratory procedures in a one-step, easy-to-use format that helps minimize errors.
The accuracy of the Xpert EV test was confirmed in a study involving six institutions. A total of 255 patient samples tested demonstrated that 96 percent of patients who tested positive had viral meningitis, and 97 percent of patients who tested negative did not have viral meningitis.
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AstraZeneca buys MedImmune
LONDON
AstraZeneca, the third-biggest European drug maker behind GlaxoSmithKline and Sanofi-Aventis, said it has agreed to buy US biotechnology company MedImmune for US$15.6 billion. The deal is expected to be completed in June.
MedImmune is based in Maryland and specializes in vaccines. Cost savings from the acquisition were expected to be toward US$500 million per year by 2009.
AstraZeneca chief executive David Brennan said that the purchase "creates a leading fully integrated biologics and vaccines business." He added that the transaction enhances AstraZeneca's research and development base "through which we will deliver a stronger product pipeline."
Last year, AstraZeneca won full control of Cambridge Antibody Technology (CAT), which makes drugs using antibodies, in a deal that valued the Britain-based group at US$1.4 billion.
David Mott, president of MedImmune, said that his company was "very pleased" to become part of AstraZeneca. "We believe that this transaction is in the best interest of all parties, including shareholders, employees, and ultimately patients. The potential to harness the combined skills and capabilities of MedImmune, AstraZeneca, and CAT and take our combined world-class biologics capabilities to the next level, is very exciting and a challenge to which I am personally committed."
AstraZeneca reported that it had made a "good" start to the group's financial year. Pretax profits increased 11 percent to US$2.27 billion in the three months to March 31 compared with US$2.04 billion in the same period last year.
M AFP
Sanofi posts US$2.88B profit
PARIS
Sanofi-Aventis reported better-than-expected first quarter results, boosted by sales of its Ambien sleeping pill and a recovery in sales of its antiplatelet agent Plavix in the United States. Its adjusted net profit came to US$2.88 billion, a drop of 2.6 percent from a year earlier. When extraordinary items are taken out of the equation the adjusted net profit increased by 11.8 percent to US$2.59 billion, above market expectations.
Sales in the first quarter were US$9.76 billion, up 6.9 percent on a year-on-year basis.
The company has faced stiff competition from generic drugs. Its sales of Plavix, an antiplatelet agent used to reduce the risks of strokes and heart attacks, collapsed after a generic version was put on the market, before recovering when the generic was banned by US authorities.
The group is also looking to put its antiobesity drug Acomplia on the United States market at the end of the year, executive vice president Hanspeter Spek said.
The group also reiterated its interest in making acquisitions in Japan.
M AFP
Roche trims Tamiflu production
BASEL, Switzerland
Roche said it would trim production of the front-line bird-flu drug oseltamivir (Tamiflu) unless demand picked up, but warned that the world was still not ready for a pandemic. Manufacturing capacity for the antiviral treatment has reached 400 million treatment courses a year and is outstripping demand, said William Burns, chief executive for pharmaceuticals division.
Roche has received orders for 215 million treatments from governments and private companies, and just 40 million still have to be fulfilled, he added. "Today we can satisfy significant additional orders from governments and corporations, and unless the demand picks up Roche will be tailoring its production schedule accordingly," Burns said. "The question is how much do we need to activate."
The drug is now the company's fourth best seller.
Roche faced pressure just over a year ago to rack up and spread out its output of the drug, amid fears that it would be in short supply in an emergency, especially during a threatened flu pandemic. Production grew from 55 million treatment courses in 2004 to 190 million last year.
Roche has licensed production by Chinese, Indian, and South African companies. The production network includes eight Roche sites and 19 external manufacturing partners in nine countries.
However, the group delivered less Tamiflu during the first quarter of 2007, a sign that demand was tailing off, according to Eugene Tierney, head of Roche's virology department.
The group said it could halt production now and still satisfy current demand. It will maintain a buffer stock at all times and remain in close contact with manufacturing partners "to respond speedily to a surge in demand," Burns said, adding it would take four months to bring production back up to full capacity.
Governments and the World Health Organization have also been building up stockpiles of the drug to guard against a threatened global flu pandemic.
"The pandemic risk is still around, it's still imminent and the preparations should not ease," Burns cautioned. "I realize that for many in the media the story seems to have become somewhat cold but certainly if you talk to any of the world experts, one clear message is 'we have to still get ready,'" he added.
Orders for Roche's drug so far have come from 80 countries. It faces competition from GlaxoSmithKline's zanamivir (Relenza). Both are used for flu prevention and treatment purposes.
Oseltamivir has been favored by the WHO in pandemic preparations for technical reasons. Some scientific studies have shown cases of resistance to the drug.
M AFP
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