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.
FDA advisory committee shoots down Vivus’ Qnexa
MOUNTAIN VIEW, Calif. The possibility of a new drug for treating obesity suffered a setback Thursday as a Food and Drug Administration advisory committee voted against recommending its approval.
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10 to 6 against recommending approval for Vivus’ drug Qnexa (phentermine and topiramate), citing safety concerns such as the possibility of psychiatric problems and birth defects.
“We appreciate the advisory committee’s recognition of obesity as a significant health crisis and the challenges associated with the treatment of this disease,” Vivus CEO Leland Wilson said. “We are disappointed with the advisory committee’s vote.”
The company said it would attempt to address the committee’s concerns. An advisory committee vote is a recommendation, and while the FDA will take it into account when deciding whether to approve a drug, it is not bound to follow it.
Post-it launches Shopping Genius widget
LONDON 3M has developed a bargain-shopping widget with the help of its Post-it brand.
Inspired by usage of the classic Post-it note as a shopping list, 3M has developed an evolution of the shopping list for the digital age called Post-it Shopping Genius. How it works: Post-it Shopping Genius sits on your computer desktop, keeping an eye on the price changes for you, locating the cheapest price, and letting you know when it changes. The customizable application enables you to choose from thousands of electricals, durables and other consumer goods, and track up to five at a time.
The application — which can be directly downloaded from http://bit.ly/Post-itGenius and is available on iGoogle, Mac OS X desktop and Windows 7 / Vista desktops — displays up-to-date prices on many thousands of products, which are searchable within the tool.
In related news, 3M announced that it is offering a monthly monetary prize of 1,000 GBP ($1,542) or the value of a user’s shopping list if less as an incentive to those who refer the Shopping Genius application to a friend.