NYC Winter in Central Park
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NYC Winter in Central Park
Photo by Latimeria, March 6, 2009, by Zulima Palacio — Recently, the World Health Organization (WHO) announced that the emergence of parasites, along the Thai-Cambodia border, that are resistant to the medicine artemisinin could seriously undermine global malaria control.

The recent shift from drugs that were failing to the highly effective artemisinin-based combination therapies allowed great progress in fighting malaria, one of the world’s major killers.

More than one million people die of malaria each year, mostly in Africa.

The disease poses a risk to half of the world’s population, according to the World Health Organization

Now, along the Thai-Cambodian border, researchers have discovered a malaria parasite that is resistant to the most effective anti-malaria medicine.

Colonel Gray Heppner

Colonel Gray Heppner is a key researcher on malaria and Deputy Commander at the Walter Reed Research Institute in Maryland.

He says if drug resistance spreads, the number of yearly deaths could double.

“And it’s not just the death toll, it is the number of people who are chronically ill because we can’t cure them,” Heppner said. “So if you can imagine all the people that are chronically ill with malaria today. And some estimates are that there are a half a billion people that have a recognized episode of malaria every year. And if you think about doubling this, well it puts an incredible burden in a society.”

The recent news in a report by U.S. Army researcher Mark Fukuda, published in the New England Journal of Medicine, shows that some malaria parasites are resistant to artemisinin.

“The artemisinins are the most rapidly effective medicine that has ever been invented for malaria,” he said.

Artemisia plant

“Artemisia” is a plant. Its derivatives are known as artemisinins. The Chinese have used the plant for centuries against fever.

But a few decades ago, when malaria parasites became immune to chloroquine and other medications, artemisinin became the world’s great hope.

In the last decade, malaria control programs have also included insecticide-treated bed nets – to shield against mosquitos that carry the parasites. The nets and artemisinins have helped lower infection rates in many countries, mostly in Africa.

For the moment, there is no replacement for artemisinin-based drugs.

The Walter Reed Institute has been working to develop a vaccine against malaria as well as new medicines.

Colonel Peter Weina, who specializes in tropical diseases, and specifically malaria, led the U.S. Army’s effort to develop a drug against the most severe form of malaria. “Intravenous Artesunate” has not yet received final approval, but is now being use in certain cases.

“We have our formulation available on compassionate use here in the U.S. and recently in Canada. We have donated several hundred vials to clinical trials that are being done in Africa with some of our partner groups,” Dr. Weina said.

But this drug is also derived from artemisinin.

“There was an assumption and there was a hope and there was a prayer that resistance to artemisinin would never happen,” he said.

Child being treated for malaria

Research to find new medications against malaria continue.

“Out of every 5,000 compounds that show promise,” Dr. Weina said. “Only one of them statistically will make it to being a drug that is useful.”

The World Health Organization and the Bill and Melinda Gates Foundation have launched a multi-million dollar campaign to control the spread of the artemisinin resistant parasite.

But as Dr. Weina says, malaria is a disease of poverty. It thrives in areas lacking hygiene and resources. And it will be with us for years.

Definition of Artemisinin — Artemisinin: An antimalarial agent extracted from the dry leaves of the Chinese herb Artemsisia annua (qinghaosu or sweet wormwood). This plant is grown each year starting from seed and only yields artemesinin under specific agricultural and climatological conditions. Wormwood is cultivated only in China, Vietnam and pilot projects in Tanzania and India. It takes eight months to mature.

Artemisinin acts rapidly and potently against the malarial parasite, including some drug-resistant strains. Without significant side effects, it quickly reduces fever and lowers the blood levels of the parasite. This help to keep small outbreaks of malaria from becoming epidemics and to quell ongoing epidemics. In a malaria epidemic in the early 1990’s in Vietnam, artemisinin reduced the death rate by 97%.

To decrease the risk of resistance, artemisinin is taken as part of a “cocktail.” The cocktail of artemisinin and lumefantrine (Benflumetol) is marketed as Coartem and Riamet. Artemisinin was first isolated in 1965 by Chinese military researchers. Pronounced ar-te-mis’-in-in with the accent on the mis.

What is Artemisinin?, December 2008, by Jordan Lite — Coartem, a malaria drug whose potency is derived from a Chinese herb, may soon be approved for sale in the United States.

DEADLY BITE The Food and Drug Administration may soon approve a drug derived from the herb artemisinin to treat malaria.
Public Health Image Library/James Gathany

The Food and Drug Administration (FDA) is poised to decide by Friday whether to green-light the use of the malaria drug Coartem as part of an expedited review reserved for life-saving treatments that the agency believes are more effective than existing therapies. An FDA advisory panel earlier this month overwhelmingly determined the drug to be safe and effective; the agency is not bound by recommendations but typically follows them.
Coartem, derived from the Chinese herb artemisinin, wipes out malaria in more than 96 percent of patients in regions where malaria has become resistant to older drugs, according to drug-maker Novartis. Traditional meds such as chloroquine work in only 50 percent of patients where the parasite is drug-resistant. There were an estimated 247 million malaria cases in 2006, and nearly 881,000 patients died, according to the World Health Organization.

Only around 1,500 people in the United States — mostly travelers returning from abroad or service members stationed in malaria hot spots — are diagnosed with the infection annually. But disease specialists said travelers might carry Coartem in case they contracted malaria — and bypass preventive meds such as Lariam, which can have psychological effects.

A Novartis spokesman said the company would release pricing information if Coartem receives FDA approval. We asked journalist Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest in Washington, D.C., who has covered the development of Coartem and written for on multi-drug resistant tuberculosis in Siberia, to tell us a bit more about it. Below is an edited transcript of our chat.

What is coartem?

It is a combination drug of two ingredients, neither of which has been approved in the U.S. One is artemether, a chemical derivative of artemisinin, an extract from the sweet wormwood bush that was used in Chinese medicine as a fever cure for 500 or 600 years. Artemether stays in the body for three days. The other is lumefantrine, a broad-spectrum antibiotic that stays in the body for about seven days. Coartem is the most effective treatment for Plasmodium falciparum malaria, the more lethal form.

Artemether is a very potent, but fast-clearing drug, which is why you take both it and lumefantrine. Malaria has a whole life cycle in the body; there can be slow-emerging parasites that can come out of the liver after three days, which is why it’s good to have the lumefantrine around a little longer. If anything should reemerge after three days, the lumefantrine will combat it.

Tell us a little bit about Coartem’s history.

Coartem was approved by the Swiss in the late 1990s and put on the World Health Organization (WHO) essential drug list in 2002, so it’s not a new drug by any stretch of the imagination.

It’s a combination pill. In a third-world setting where Coartem is primarily used, this is very convenient because it increases compliance.

It is the preferred treatment for falciparum malaria because many strains are resistant to choloroquine. As the strain developed resistance, there was a horrible need for new drugs, and this drug met it.

What would FDA approval do for Americans with malaria?

This is a drug of no consequence in the U.S. Artemether is available in intravenous form. If you were a hospital where a soldier were returning who had cerebral malaria, which is life-threatening, you could make a call to the Centers for Disease Control and tap its supply chain.

[The Tropical Disease Priority Review Voucher law, which took effect this fall, allows drug companies that develop treatments for neglected diseases like malaria an expedited review by the FDA. That means that in the future, Novartis can bring another, more lucrative drug candidate before the agency for quicker approval — or sell that right for hundreds of millions of dollars, Goozner says. “Yes, well, this is a gift from heaven,” Silvio Gabriel, who manages Novartis’ malaria initiatives, told today’s New York Times.

WASHINGTON, March 4 /PRNewswire/ — Denis A. Cortese, M.D., president and CEO of the Mayo Clinic, offered a new vision for personalized healthcare in America at a time when Congress and the administration are discussing changes in the healthcare system.

The Mayo Clinic is committed to implementing personalized medicine for its patients. By targeting specific treatments to individual patients based on an analysis of differences in their molecular makeup, personalized medicine increases the effectiveness and safety of many existing therapies and spurs the creation of new treatments.

Dr. Cortese was introduced by Paul Stoffels, M.D., company group chairman, global pharmaceutical research and development, Johnson & Johnson. Dr. Stoffels said that Johnson & Johnson is committed to a personalized approach to medicine, using its broad expertise in healthcare research and development to develop targeted therapies for major diseases.

The keynote address at the Personalized Medicine Coalition’s annual luncheon took place against the backdrop of the Obama Administration’s health reform summit, which the president announced last week in his address to Congress. Johnson & Johnson sponsored the luncheon, which was held at the National Press Club.

Dr. Cortese discussed how Mayo Clinic’s implementation of personalized medicine works in practice and what it means for Mayo’s patients. He emphasized the importance of interoperable computerized patient records and communication among different providers in determining the optimal treatments for individual patients.

“Health information technology plays a huge role in synthesizing large amounts of data, creating knowledge that will drive evidence-based decision making,” Dr. Cortese said.

These insights should guide spending for two sums in the economic stimulus package: $19.2 billion for health information technology, and $1.2 billion to compare the effectiveness of different treatments for diseases.

Dr. Stoffels described Johnson & Johnson’s commitment to incorporating pharmacogenomics and biomarkers during the drug development process, which allows scientists and researchers to improve outcomes of successful drug candidates while better meeting patient needs. He emphasized that collaboration among industry, academia, providers, and payers has the power to fuel even faster development and implementation of personalized medicine solutions.

“At Johnson & Johnson, patients drive everything we do. Our goal is to use the latest science and technology and a patient-focused mindset to move away from a one size fits all approach to more targeted and personalized therapies,” Dr. Stoffels said. “This vision is aligned with Johnson & Johnson’s mission to care for the world, one patient at a time. With broad based expertise in healthcare R&D, we are uniquely positioned to lead the development and application of personalized solutions for major disease states.”

About the Personalized Medicine Coalition

The Personalized Medicine Coalition (PMC), representing a broad spectrum of academic, industrial, patient, provider, and payer communities, seeks to advance the understanding and adoption of personalized medicine concepts and products for the benefit of patients. For more information on the Personalized Medicine Coalition, please visit

About the Mayo Clinic

Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. Doctors from every medical specialty work together to care for patients, joined by common systems and a philosophy that “the needs of the patient come first.” More than 3,300 physicians, scientists and researchers and 41,000 allied health staff work at Mayo Clinic, which has sites in Rochester, Minn., Jacksonville, Fla., and Scottsdale/Phoenix, Ariz. Collectively, the three locations treat more than half a million patients each year.

About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, the world’s most broadly-based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Pain, Cardiovascular, Metabolic, and Infectious Diseases, to address unmet medical needs worldwide. More information can be found at

Chicago Tribune, March 6, 2009, by Bruce Japsen — The Food and Drug Administration will take longer to review an experimental diabetes drug developed by a Deerfield drug maker.

Takeda Pharmaceuticals said the FDA will apply new safety guidelines to its algoliptin drug.

It is unclear when FDA might consider algolipton for possible approval but the agency said there is not “sufficient” information currently to approve it.


Takeda Receives New Information on Alogliptin (SYR-322) NDA

OSAKA, Japan, March 6, 2009 – Takeda Pharmaceutical Company Limited today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, was informed as part of regular discussions about the alogliptin New Drug Application (NDA) with the United States Food and Drug Administration (FDA), that although the alogliptin NDA was filed prior to issuance of FDA’s December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.

Additionally, the FDA does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional CV studies with alogliptin. Alogliptin’s Prescription Drug User Fee Act (PDUFA) date – June 26, 2009 – remains unchanged.

In December, 2008 the FDA issued “Guidance for Industry: Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes”.

In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original PDUFA date — October 27, 2008 — due to internal resource constraints. The FDA did not raise any issues with the data in the alogliptin NDA at that time. In December 2007, Takeda submitted its NDA for alogliptin to the FDA.

Alogliptin, which was discovered by Takeda’s wholly owned U.S. subsidiary, Takeda San Diego, Inc. is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes.

About DPP-4 Inhibitors

DPP-4 inhibitors inhibit the enzyme dipeptidyl peptidase IV (DPP-4), which metabolizes the insulin-increasing hormones glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). By maintaining the blood levels of GLP-1 and GIP, DPP-4 inhibitors are a newer type of oral anti-diabetic with a novel mechanism of action for lowering blood sugar levels.

GLP-1 and GIP are secreted by the digestive tract following food intake, and stimulate the beta cells in the pancreas—thereby stimulating increased insulin secretion—and it has the potential to improve pancreatic beta-cell function. Furthermore, it is known that because GLP-1 suppresses glucagon secretion from the pancreas, the production of sugar in liver cells is also suppressed.