Under Construction - Pharmaceutical Executive

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Under Construction


Pharmaceutical Executive


Niacin/simvastatin combination: KS 01-019 pursues the same strategy as Ad-vicor, combining Niaspan with a statin—in this case, simvastatin (the active ingredient of Merck's Zocor). "Many doctors, when they step up to combination therapy, would like to stay with their statin of choice," says Adams. Patients are currently being recruited for a pair of Phase III trials, and Kos is aiming for a 2007 launch, shortly after the expiration of Merck's simvastatin patent. Further back in the pipeline are products for cardiovascular disease, diabetes, and the area where Mike Jaharis first made his mark: respiratory disease.

Inhaled insulin: In late August, Kos announced the results of a phase IIa study of its inhaled insulin formulation that compared the product head to head with insulin glargine (marketed by Sanofi-Aventis under the brand name Lantus), the most prescribed insulin in the United States. After a month of treatment, insulin-na patients receiving Kos' crystallized recombinant human insulin showed a mean reduction in mean blood glucose of 28 percent, compared with 23 percent with insulin glargine.

Kos' product is not the only inhalable insulin in development. Pfizer and Sanofi-Aventis have submitted Exubera for European approval, and Lilly recently moved an inhaled insulin into Phase III. Kos hopes to differentiate its product with an excipient-free formulation and an easy-to-use, hand-held inhaler.

In addition, with its strong interest in metabolic syndrome, the company has been collecting data on the product's effects on blood lipids. In the recent trial, Kos' insulin produced a 10 percent reduction of LDL cholesterol at day 28, compared with an increase of 1.4 percent with insulin glargine. "When we presented the data to our advisors, they said that to their knowledge this was the first time the data have shown that controlling glucose levels positively impacts LDL and triglyceride reduction," says Adams.

Environmentally friendly Azmacort: Kos acquired Aventis' asthma drug Azmacort (triamcinolone) for about $200 million this spring. (Azmacort, a declining product for Aventis, produced $88 million in revenue in 2003 with minimal sales force support.) The inhaled steroid is already on the market for Kos with a CFC propellant. Rosskamp explains that Aventis received an approvable letter for Azmacort with an environmentally friendly HFA propellant, and Kos is completing the work required for approval.

KS 01-017, currently in formulation, is a dual regulator of glucose and lipids. The market for such a product is enormous as nearly 50 million Americans have been diagnosed with metabolic syndrome.

Looking forward, says Adams, "We've got to maintain momentum, add products to development, maintain our aggressive stance on product acquisition, and look for opportunities for corporate M&A activity, which is part of logical pharmaceutical development. But I want to do that while maintaining the special nature of Kos and the culture."

To Daniel Bell, this is just part of the plan. "We didn't start Kos with the idea of only being a $200 million company," he says. "We started Kos with the idea of growing it as quickly as possible to be at least a billion-dollar company. That was our goal from the get-go."


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Source: Pharmaceutical Executive,
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