PHARMACY

Studies explore intra-nasal mode of combatting Alzheimer’s

BY Drew Buono

ST. PAUL, Minn. Studies have been taken place for decades to find ways to combat Alzheimer’s disease, but recently news has been spreading that the way to fight it is with intranasal treatments, according to published reports.

Several studies are using the nose-to-brain method of delivering drugs that was invented in the late 1980s and patented by William Frey II, director of an Alzheimer’s research center at Regions Hospital in St. Paul. Last month, researchers in Washington State reported using intranasal insulin to improve memory and attention for patients with early-stage Alzheimer’s.

Most nasal sprays are directed to the lower part of the nose so medication can quickly enter the bloodstream. Drugs to treat neurological conditions don’t work through this route, though, because of the protective blood-brain barrier.

While this blockade of cells and blood vessels protects the brain and spinal chord from harmful organisms, it also keeps out most drugs and has blocked otherwise promising therapies.

Avoiding this barrier is what makes intranasal delivery “a potentially powerful therapeutic tool,” according to the Washington research group. Its study was small, with 24 patients receiving daily insulin or a placebo, but the results, published in the journal Neurology, were persuasive.

Patients taking intranasal insulin were mentally sharper, and their blood sugar levels remained healthy.

The goal now is to see if pharmaceutical manufacturers will take this information and try to develop something for the market and the 5.1 million Americans who suffer from this disease.

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PHARMACY

Lilly and PsychoGenics partner on neuropsychiatric disorder treatments

BY Drew Buono

TARRYTOWN, N.Y. PsychoGenics and Eli Lilly have entered into a drug discovery agreement aimed at identifying drug candidates suitable for clinical developments.

Per the agreement, Lilly will supply precandidate compounds that PsychoGenics will evaluate using its proprietary drug discovery technologies for the treatment of neuropsychiatric disorders. Upon Lilly’s further development of clinical candidates, PsychoGenics would receive research and milestone payments, as well as royalties.

Emer Leahy, president and chief executive officer of PsychoGenics, said, “We are delighted to once again work with Lilly and play an integral and expanding role in a successful drug discovery collaboration. We are confident that by combining the complementary strengths and expertise of PsychoGenics and Lilly, we may identify a new generation of treatments for neuropsychiatric disorders.”

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PHARMACY

Roche asks for clearance to bring Mircera to market

BY Drew Buono

BASEL, Switzerland Roche is asking a U.S. judge for clearance to sell an anti-anemia drug by offering a royalty to Amgen and offering the drug at a price that is lower than what Amgen charges for its top anemia drug, according to published reports.

Roche won regulatory approval for Mircera as a treatment for anemia associated with kidney disease in November. But it hasn’t brought the drug to market because it lost a civil trial in October in which a federal jury found Mircera violated patents held by Amgen. Amgen sells drugs Aranesp and Epogen to treat anemia associated with kidney disease and cancer chemotherapy.

Although Roche lost the patent trial to Amgen, it is now seeking permission from Judge William Young to bring Mircera to the market by arguing that it would serve the public interest. Roche also has proposed selling Mircera at an initial “wholesale acquisition cost” that is about 5 percent less than the current “average selling price” of Amgen’s Aranesp. Also, it would pay Amgen a royalty 20 percent of net sales of Mircera while Amgen’s patents are still enforced, assuming the original ruling of infringement stands.

Roche said it would begin taking steps to market Mircera if the judge doesn’t rule on Amgen’s injunction request on Feb. 28, when oral arguments are scheduled in the case. Roche would be doing this even though they would be at risk to pay Amgen penalties if the infringement case isn’t overturned.

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