PHARMACY

Baxter, Momenta partner on biosimilar development

BY Rob Eder

NEW YORK — Baxter and Momenta have agreed to partner to develop and market biosimilar  drugs to treat cancer, autoimmune disorders and other chronic conditions.

Baxter — which makes biosurgery products and drugs for a number of specialty areas, including hemophilia, kidney disease, immune disorders, and vaccines — Baxter will leverage its expertise in clinical development and biologic manufacturing, sterile injectables and global commercialization, while Momenta will bring expertise in high-resolution analytics, characterization, and product and process development.

"As biologics have become an increasingly important part of patient care, the collaboration with Momenta allows us to tap both companies’ expertise to expand access to these important therapies," said Ludwig Hantson, president of Baxter’s bioscience business. "The collaboration complements [our] early-stage pipeline and allows the company to expand its leadership in biologics at a time when the global regulatory pathway for approval is becoming more clear."

Baxter will pay Momenta $33 million upfront under the agreement for its collaboration on up to six follow-on biologic compounds.

The companies expect the deal to close in the first quarter.

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Research: Viagra being studied for heart benefits

BY Michael Johnsen

QUERENBURG, Germany — According to research to be published in the journal Circulation released Friday, sildenafil, the active ingredient in Viagra, can help alleviate heart problems.

The research was conducted in collaboration with the Mayo Clinic in Rochester, Minn.

Researchers studied dogs with diastolic heart failure, a condition in which the heart chamber does not sufficiently fill with blood. The scientists showed that sildenafil makes stiffened cardiac walls more elastic again. The drug activates an enzyme that causes the giant protein titin in the myocardial cells to relax. "We have developed a therapy in an animal model that, for the first time, also raises hopes for the successful treatment of patients" stated Wolfgang Linke of the RUB Institute of Physiology.

Sildenafil inhibits a specific enzyme (phosphodiesterase 5 A), which causes the increased formation of a messenger substance (cGMP). The messenger substance activates the enzyme protein kinase G, which attaches phosphate groups to certain proteins. This phosphorylation causes blood vessels to relax, which was why the "potency pill" Viagra originally came onto the market. The Bochum and Rochester researchers found that the cardiac muscle protein titin is also phosphorylated through the same mechanism. "The titin molecules are similar to rubber bands" Linke explained. "They contribute decisively to the stiffness of the cardiac walls." The activity of the protein kinase G causes titin to relax. This makes the cardiac walls more elastic. The effect occurs within minutes of administering the drug.

"Of all the patients aged over 60 who are in hospital because of a weak heart, half suffer from diastolic heart failure," Linke added. "Although we know that the decreased distensibility of the cardiac walls is the cause, the disease cannot be treated properly with today’s medicines." In the "Relax" study of the Heart Failure Network, the efficacy of sildenafil in people is already being tested. "If, for the first time, the drug is found to have a positive effect on heart failure, we would already have a molecular mechanism on hand to explain the effect," Linke said.


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FDA panel to review Qnexa in February 2012

BY Allison Cerra

MOUNTAIN VIEW, Calif. — The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee is set to review an investigational treatment for obesity.

Biopharmaceutical company Vivus said the panel will review its new drug application for Qnexa on Feb. 22, 2012.

Meanwhile, the FDA will complete its review of the NDA for Qnexa on April 17, 2012. The regulatory agency accepted the NDA in November after Vivus’ resubmission of the NDA in October.


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J.GLADSON says:
May-21-2012 05:15 am

This is indeed a great news. This committee has taken valuable steps in reviewing the treatment for obesity. Inorder to overcome this , a new drug is introduced. Basically obesity is a condition which occurs when excess body fat is accumulated in the body. Regards, James Gladson

a.steveni says:
Apr-30-2012 07:45 am

I think that nowadays lot of people are facing the problem of obesity and hence such type of FDA panels will really be helpful for them. Regards, Arnold Steveni

jack1000 says:
Apr-04-2012 10:47 pm

I would love to see this work for obesity. I hope to see more research done on this and get approved. There is so many people dealing with this and need help.

D.Ringold says:
Feb-17-2012 02:01 am

I has been that Qnexa and the other drugs would provide effective weight-loss without the dangerous side effects such as Fen-phen, Meridia and Alli. But FDA recently warned consumers about Alli's link to severe liver damage. I mean that sounds pretty dangerous. So stay away.

Ned Phan says:
Feb-16-2012 04:19 am

The drug should completely and thoroughly be reviewed and checked before it is introduced in the market..Many people will be waiting for this drug to be launched in the market as so many are facing the problem of obesity.

a.steveni says:
Feb-14-2012 06:02 am

I guess that something great and beneficial is going to happen here in this panel.I would like to recommend this to my friends and also to peolpe who are facing the problem of obesity.

drjone says:
Dec-24-2011 01:35 am

It is really anyones guess as to what will happen here. If this is not prescribed to any woman who could become pregnant, I don't see the problem.

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