PHARMACY

Eli Lilly & Co. reports jump in revenue, net income for Q2

BY Alaric DeArment

INDIANAPOLIS Drug maker Eli Lilly & Co. saw total revenue grow by 3% and net income grow by 21% for second quarter 2009, the company announced in an earnings statement Wednesday.

Reported total revenue for the quarter was $5.29 billion, up from $5.15 billion in second quarter 2008. Net income increased from $959 million to $1.16 billion during the same period. Meanwhile, earnings per share increased from 88 cents to $1.06.

“Lilly continues to deliver solid financial results notwithstanding the challenging global economic environment,” Lilly chairman and CEO John Lechleiter said in a statement. “Our business remained strong in the second quarter, with volume-driven revenue growth, good operating leverage and double-digit [earnings-per-share] growth.”

During the quarter, the Food and Drug Administration approved the cardiovascular drug Effient (prasugrel) and gave Alimta (pemetrexed) an additional approval as a maintenance therapy for advanced non-small cell lung cancer.

Sales of the Lilly’s top-selling drugs, however, were mixed, with declines ranging from 2% for the osteoporosis drug Forteo (teriparatide) and 3% for the antipsychotic Zyprexa (olanzapine) to 20% for the chemotherapy drug Gemzar (gemcitabine hydrochloride), compared to second quarter 2008. At the same time, Alimta sales increased by 40%, while sales of the erectile dysfunction drug Cialis (tadalafil) remained flat.

Click here for the full financial results.

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Letter urges Waxman to push for provisions in H.R. 1427 for biosimilars regulatory pathway

BY Alaric DeArment

WASHINGTON In a letter Friday, a group of organizations urged a Congressman to push for provisions contained in a bill he introduced that would create a regulatory pathway for biosimilars if a House committee calls for a pathway as part of healthcare reform legislation.

The Generic Pharmaceutical Association, AARP, the Pharmaceutical Care Management Association, labor unions and other groups asked Rep. Henry Waxman, D-Calif., to try and insert provisions from his Promoting Innovation and Life Saving Medicines Act in health reform legislation, if the legislation includes a pathway for biosimilars.

Waxman’s bill, introduced on March 11, would grant biotech drugs five years of market exclusivity, much like the Hatch-Waxman Act he co-sponsored in 1984, which created an approval pathway for generic pharmaceutical drugs.

Nevertheless, the bill has garnered only 14 co-sponsors, compared to 137 for the Pathway for Biosimilars Act, a competing bill introduced days after Waxman’s by Rep. Anna Eshoo, D-Calif., which would allow 12 to 14 years of exclusivity. Earlier this month, the Senate Health, Education, Labor and Pensions Committee voted to amend the healthcare reform bill to allow 12 years of exclusivity for biotech drugs.

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Oramed announces mid-stage trial results for Type 1 diabetes treatment

BY Alaric DeArment

JERUSALEM A company that develops alternative drug delivery systems said it achieved positive results in a mid-stage clinical trial of an orally administered insulin for treating Type 1 diabetes.

Oramed Pharmaceuticals said the phase 2a trial of its insulin capsules, ORMD-0801, showed the capsules was well-tolerated and produced no serious harmful side effects.

“These results demonstrate that Oramed’s oral insulin capsule had a good safety profile and was effective on patients with Type 1 diabetes when taken prior to a meal,” Oramed chief scientific officer Miriam Kidron said in a statement.

The company said it is conducting a phase 2b trial in South Africa, evaluating the insulin’s effects on patients with Type 2 diabetes.

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