Some companies see 2008 as make-or-break time

WASHINGTON

The new year will be a year of last resorts for some companies, as they hope to receive approval for some of their drugs, according to the Washington Post.

MiddleBrook Pharmaceuticals is expecting the Food and Drug Administration to approve its once-daily antibiotic amoxicillin. The company has invested a good deal of money on the drug, which has seen failed late-stage testing and therefore has left the company low on cash.

Vanda Pharmaceuticals is expecting approval from the FDA in August for its schizophrenia drug, iloperidone, which it acquired from Novartis in 2004 for $500,000. The drug is part of Vanda’s concept to take abandoned drugs from other companies and either start testing them again or find new uses for them. Vanda is also expecting final testing results this year on an insomia drug that it bought from Bristol-Myers Squibb.

United Therapeutics plans to seek approval for an inhaled version of a drug to treat pulmonary hypertension and it will also release final testing results for a pill version of a pulmonary hypertension treatment.

Human Genome Sciences plans on selling its first product, a drug called ABThrax, which would be used to treat anthrax exposure. The company is also developing drugs for lupus and hepatitis. By the end of this year, Human Genome Sciences plans to release results of the first of two pivotal tests for the hepatitis drug, which it is partnering with Novartis to develop. If certain milestones are hit, the company could receive $507 million from Novartis.