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Johnson & Johnson division releases low-dose version of HIV drug for children

BY Alaric DeArment

BRIDGEWATER, N.J. A division of Johnson & Johnson has announced the availability of a lower-dose formulation of an HIV drug for children aged 6 and older.

Tibotec Therapeutics, part of Centocor Ortho Biotech Products, said it released a 75 mg formulation of Prezista (darunavir) for children with HIV. The Food and Drug Administration had approved Prezista for use in children 6 and older administered with Prezista/r (ritonavir) and other antiretroviral agents on Dec. 18.

According to the Centers for Disease Control and Prevention, there were 2,587 children younger than 13 living with HIV and 1,116 living with AIDS in the United States at the end of 2006, in addition to about 56,500 between 13 and 24 with HIV.

“The HIV epidemic continues to affect thousands of children in the U.S., and these patients have fewer treatment options than adults,” Chicago Children’s Memorial Hospital director of pediatric, adolescent and maternal HIV infection Ram Yogev said in a statement.

According to the Centers for Disease Control and Prevention, there were 2,587 children younger than 13 living with HIV and 1,116 living with AIDS in the United States at the end of 2006, in addition to about 56,500 between 13 and 24 with HIV.

“The HIV epidemic continues to affect thousands of children in the U.S., and these patients have fewer treatment options than adults,” Chicago Children’s Memorial Hospital director of pediatric, adolescent and maternal HIV infection Ram Yogev said in a statement.

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NACDS applauds Senate version of economic stimulus package

BY Rob Eder

WASHINGTON, D.C. The Senate passed its version of the economic stimulus bill late Monday afternoon — just in time for President Barack Obama’s first primetime TV address since taking office — to the tune of $838 billion.

As the Senate’s interpretation of the American Recovery and Reinvestment Act moves to Congressional Conference and the final components of the package are hammered out, it appears that retail pharmacy has made some significant progress on some of the key privacy provisions contained in the HIT stimulus piece of the legislation.

Perhaps most notably, the Senate version makes key changes to the “marketing” provisions part of the bill, “to ensure that new privacy requirements will not interfere with the ability of  pharmacies to communicate with and treat patients to help improve health outcomes,” NACDS noted in a statement. 

In the House version of the bill, pharmacies would have been required to capture an authorization for each communication it makes to one of its patients for any reason, including refill reminders.

“Pharmacies are committed to protecting sensitive patient information. We applaud the Senate for taking action to ensure that pharmacists can communicate with patients about medication treatment options and alternatives,” said NACDS President and CEO Steve  Anderson.  

According to NACDS, the Senate bill also marks improvement on the “breach notification” requirements part of the bill; the House version left the definition of what constituted an actual “breach,” in which a patient’s information is inappropriately disclosed, too open-ended, including even the most inadvertent and harmless disclosures.

NACDS also applauded Senate leaders for boosting federal funding for state Medicaid programs. “It is vital that states have adequate funding to ensure that low-income patients have access to medications and pharmacy services,” said Anderson.  “As the face of neighborhood healthcare, pharmacies can help patients to stay healthy and prevent more costly forms of care such as emergency room visits.  We are very pleased that Congress is taking action to provide much-needed support for state Medicaid programs.”

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Drug makers aim to hasten drug approval process

BY Alaric DeArment

BOSTON —The Food and Drug Administration’s review time for new drugs has declined in recent years, yet the development of new drugs still takes eight years.

A study by the Tufts University Center for the Study of Drug Development released early last month, titled “Outlook 2009,” indicated that despite a review process that declined by 1.1 years between 2005 and 2007, the complexity of new diseases for which drug makers develop medicines has increased clinical development times and thus offset the accelerated review.

“Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress,” CSDD director Kenneth Kaitin said. “Many factors are leading to longer clinical times, including a focus on complex diseases and more complicated development design protocols.”

According to the Pharmaceutical Research and Manufacturers of America, the average drug on the market is the end result of 15 years of research and development from the earliest stages of drug discovery to FDA approval. The last phase of development before a drug receives FDA approval, phase 3 clinical trials, typically includes thousands of patients at several research centers.

Kaitin said that drug companies have sought to speed development by improving project management, expanding use of partnerships and licensing arrangements, and increasing surrogate endpoints and adaptive clinical trials.

But other trends also could slow down the approval process. In particular, a shortage of experienced personnel, especially among upper-level management staff, and vacancies in advisory committees resulting from conflicts of interest and public disclosure rules could hamper the FDA’s ability to fulfill its mandate.

Still, as cost and time for research and development increase, drug companies will likely continue to partner, outsource and in-source to improve productivity, according to the report. They are likely to continue globalization of preclinical and clinical development to overcome local capacity constraints and increase the speed at which drugs make it to market, as India-based generic drug maker Ranbaxy Labs has done with phase 3 trials for the malaria treatment arterolane maleate and piper-aquine phosphate, announced in November and set to take place in Asia and Africa. Companies also may increase their use of services from contract research organizations, which the report predicted would grow by 15% a year.

But as the development time for new drugs appears likely to increase, so will the number of biotech drugs called monoclonal antibodies. The FDA has approved 22 mAbs for the U.S. market, and more than 200 are in the pipeline worldwide. These include Dutch biotech firm Crucell’s experimental flu vaccine CR6261 and bapineuzumab, an Alzheimer’s disease treatment by Elan Corp. and Wyeth in phase 3 trials set to end later this year.

This string of new antibodies could create a lot of opportunities for large drug companies looking to acquire biotech firms. In November, Indianapolis-based Eli Lilly & Co. acquired ImClone, developer of Erbitux (cetuximab).

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