News update from Datamonitor
pharmafile | May 1, 2007 | News story | Research and Development, Sales and Marketing |
Common pain medications do not prevent Alzheimer's disease
Over-the-counter pain medication naproxen and prescription pain reliever celecoxib do not prevent Alzheimer's disease, according to a study.
These findings appear to contradict earlier observational studies, which found sustained use of non-steroidal anti-inflammatory drugs (NSAIDs) may have a protective effect against Alzheimer's disease.
The trial involved more than 2,100 people over age 70 with no signs of dementia, but a family history of Alzheimer's disease. The participants were randomly assigned daily doses of naproxen, celecoxib, or placebo for up to four years, but most participants had received the treatments for less than two years.
The study found neither treatment was associated with a reduction in Alzheimer's disease or dementia. The findings appear to be inconsistent with other studies suggesting reduced risk of Alzheimer's disease among people who take NSAIDs over a long period of time.
"One possible explanation for this inconsistency is that our findings relate specifically to celecoxib and naproxen, but not to other commonly used NSAIDs, such as ibuprofen. Or the drugs may not prevent the progression of disease in people who have advanced Alzheimer's pathology without symptoms, the very people most likely to develop symptoms within a year or two," said John Breitner, with VA Puget Sound Health Care.
"While long-term follow-up of our study's participants is essential, for now we suggest celecoxib and naproxen not be taken to primarily prevent Alzheimer's disease," said Constantine Lyketsos.
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Cerus considers immunotherapy spin-off
Cerus Corporation has said it is considering making changes to its immunotherapy unit including partnering the business or creating a possible spin-off.
The company said it will consider several possible business structures, including partnering some or all of the programmes within its immunotherapy business with companies having established programmes in immunology or in cancer and infectious disease indications. Cerus said it may even spin out the business for an equity interest in a newly-formed immunotherapy company.
Cerus said the corporate realignment could provide more resources for its blood safety business.
In the field of immunotherapy, the company is employing an attenuated listeria vaccine platform to develop a series of therapies to treat cancer and chronic infectious diseases.
Cerus currently has three cancer immunotherapeutic product candidates, one of which entered phase I human clinical trials in 2006. The company has also developed a technology platform, called killed but metabolically active, or KBMA, for application to vaccines against infectious diseases, including hepatitis C and HIV, and certain oncology indications.
Related links
Cerus Corporation: LSA company report
Pfizer's CCR5 inhibitor for HIV treatment has won backing from an FDA advisory panel
Pfizer's maraviroc has received support from an FDA advisory panel. It will be the first drug of the new CCR5 inhibitor class on the market, offering a welcome alternative to patients with limited therapeutic options. However, its initial positioning in the salvage market means that its commercial potential will remain limited for now.
An FDA advisory panel voted unanimously to recommend approval for Pfizer's investigational HIV entry inhibitor maraviroc. Since maraviroc, expected to be marketed as Celsentri, may be the first CCR5 inhibitor on the market it will provide an alternative for patients who have failed all other therapies and have limited or no remaining treatment options.
CCR5 is a type of co-receptor required by most HIV viruses to attach to and infect human cells. However, particularly at advanced stages of the disease, the virus may switch to using another receptor called CXCR4. Since maraviroc only blocks CCR5, a so-called tropism assay is required to confirm which co-receptor the patient's virus uses.
Results from the pivotal MOTIVATE trials demonstrated that nearly twice as many treatment-experienced CCR5-tropic HIV-1 infected patients treated with maraviroc plus optimized background therapy (OBT) achieved undetectable viral loads at 24 weeks compared to those receiving placebo plus OBT. In addition, there were no significant increases in hepatotoxicity, malignancy or mortality in maraviroc's treatment arms, while there were slight increases in upper respiratory and herpes simplex virus infections as well as with ischaemic events, consistent with the rate observed in treatment experienced HIV/AIDs patients.
However, the committee has recommended further studies for the product, including testing in patients with liver disease as well as investigating potential interactions with erectile dysfunction treatments.
If successfully launched, maraviroc's use is most likely to be initially limited to treatment-experienced patients, a market that is currently dominated by Roche's Fuzeon. However, maraviroc's label could eventually be extended to newly-diagnosed patients.
Another new drug in late stage development, Merck & Co.'s integrase inhibitor raltegravir, is expected to be filed with the FDA within the next two months. With an anticipated launch towards the end of the year, it is also most likely to be used in treatment experienced patients.
Since both drugs offer a novel mechanism of action, Datamonitor expects considerable competition between the two. Nonetheless, their availability will extend treatment options for patients with more advanced HIV and those with AIDS, making them significant contributors to the growth in the HIV market.
Related links
Commercial Insight: HIV – Change of guard
Pipeline Insight: HIV – Extending treatment options
Ranbaxy gets final authorisation for generic Ambien
Ranbaxy Laboratories has received final approval from the FDA to manufacture and market zolpidem tartrate tablets in 5mg and 10mg strengths.
The FDA has determined the Ranbaxy formulation to be bioequivalent and therapeutically equivalent to the reference listed drug Ambien manufactured by Sanofi Aventis. Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia, characterized by difficulty with sleep intervention.
The product will be manufactured at the company's Ohm Laboratories facility, based in New Jersey. The drug has total annual market sales in the US of $2.12 billion according to IMS.
"This product will be launched immediately and presents yet another opportunity for Ranbaxy to expand its product portfolio by offering an affordable generic alternative for a molecule that has proven clinical value," said Jim Meehan, vice president of Sales and Marketing for Ranbaxy Pharmaceuticals.
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Pipeline Insight: Insomnia – Targeting the sleep maintenance market
Alkermes and Indevus start pulmonary disease study
Alkermes and Indevus Pharmaceuticals have started a phase IIa study of ALKS 27 in patients with chronic obstructive pulmonary disease.
ALKS 27 is an inhaled formulation of trospium chloride based on Alkermes' AIR pulmonary technology. The study will assess the safety, tolerability, pharmacokinetics and efficacy of single doses of ALKS 27.
As an inhaled formulation of trospium chloride, a muscarinic receptor antagonist that relaxes smooth muscle tissue, the companies believe ALKS 27 could potentially improve airflow and provide a new treatment option for patients with chronic obstructive pulmonary disease (COPD).
"By combining our proprietary AIR technology and Indevus' trospium chloride, a molecule with a known safety profile and proven efficacy in an approved indication, we hope to bring forward a more patient-friendly treatment option for people with COPD," stated Elliot Ehrich, chief medical officer of Alkermes.
The efficacy of ALKS 27 will be evaluated based on improvements in pulmonary function in patients with COPD. This phase IIa study follows completion of a phase I study which demonstrated that ALKS 27 was well tolerated over a wide dose range, with no dose-limiting effects observed. Alkermes and Indevus expect to report results from the study in the second half of 2007.
Related links
Alkermes Inc: LSA company report
Indevus Pharmaceuticals Inc: LSA company report
