Reporters Notebook

Supplier News

Metabolex has entered an agreement to discover and develop Type 2 diabetes drugs with a subsidiary of Johnson & Johnson, Metabolex said.

Under the agreement, Ortho-McNeil-Janssen Pharmaceuticals will receive an exclusive worldwide license to develop, manufacture and commercialize several Metabolex compounds currently in preclinical development.

Metabolex will receive an upfront payment and be eligible for potential milestones of up to $330 million, as well as royalties.

A new cholesterol drug made by Eli Lilly and Kowa Pharmaceuticals America has become available, the two drug makers said.

Livalo (pitavastatin), which received Food and Drug Administration approval in August 2009, is available in doses of 1 mg, 2 mg and 4 mg for the treatment of primary hyperlipidemia and mixed dyslipidemia. Clinical trials have shown Livalo to reduce “bad” LDL cholesterol by 39% at the 2 mg dose, and by 45% at the 4 mg dose, the companies said.

The drug may be an attractive option for patients taking multiple medications due to its relatively low risk of certain drug interactions, according to the companies.

Drug maker Ferring Pharmaceuticals has launched a new treatment for women with cyclic heavy menstrual bleeding, Ferring said.

The company bills Lysteda (tranexamic acid) tablets as the only nonhormonal and nonsurgical therapy for women with cyclic HMB. As many as 22 million women in the United States experience HMB.

The FDA has approved a generic cholesterol medication made by Mylan, the company said. The FDA approved Mylan’s simvastatin tablets in the 5 mg, 10 mg, 20 mg, 40 mg and 80 mg strengths. The drug is a generic version of Merck’s Zocor.

Various versions of simvastatin had sales of $361 million during the 12-month period ended in March, according to IMS Health.

The FDA has approved Novartis’ Tasigna (nilotinib) as an early treatment for newly diagnosed Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia, also called Ph+ CP-CML, a rare form of blood cancer, the agency said.

The disease is a slowly progressing cancer of the blood and bone marrow resulting from a genetic abnormality. The agency originally approved Tasigna in 2007 for Ph+ CP-CML in adults whose disease had progressed or who could not tolerate other therapies, such as Gleevec (imatinib), also made by Novartis.

The FDA approved Amneal Pharmaceuticals’ lorazepam oral concentrate—a generic version of Roxane Labs’ Lorazepam Intensol—in the 2-mg-per-mL strength, to treat anxiety disorder, Amneal said. The drug is a schedule IV controlled substance.

Amneal said it received approval to manufacture the drug in December 2009 and began shipping it in March. The drug is sold as a clear, flavorless liquid that can be mixed with other liquids or semisolid food.

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