October 3, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Arbor Pharmaceuticals LLC is allegedly exploring a potential sale that could bring in more than $1 billion, according to people who are close to the situation. The Georgia-based specialty biopharmaceutical company primarily creates drugs for the cardiovascular and pediatric markets.
J.P. Morgan is rumored to be working on the potential sale, and people who are involved in the situation have asked not to be named, as ongoing discussions are private.
Arbor Pharmaceuticals has a staff of more than 300 people, and a dozen partners throughout the world. Through its partners, the company licenses, manufactures and develops late-stage pipeline products. One drug that recently received a second NDA acceptance from the U.S. Food and Drug Administration was Nymalize, also known as nimodipine.
Moving Forward with Nymalize
Arbor received acceptance for its second New Drug Application from the FDA for Nymalize back in March. The FDA initially approved it in May of last year.
“I am pleased with the progress of both our branded and generic development pipeline,” said Laurence Downey, VP of Medical and Scientific Affairs. “We believe this most recent NDA filing meets an unmet medical need and has the potential to improve pharmacotherapy for certain patients.”
Arbor has seven other branded projects in development that consist of both 505(b)(1) and 505(b)(2) type filings. One of the projects is in phase 3 clinical development, while three are in phase 2 studies.
Arbor announced the first NDA approval back in May 2013. Nymalize is an oral solution that is the first of its kind dedicated to the improvement of neurological outcome in adult patients with subarachnoid hemorrhage.
“I am pleased that Arbor’s first NDA approval has the potential to save lives by reducing the opportunity for hospital administration errors,” said Ed Schutter, President & CEO of Arbor. “To further ensure that we minimize the potential for administration error, each Nymalize unit dose cup will be packaged with an oral syringe. Nymalize adds to our growing portfolio of approved prescription products that can improve the lives of our patients.”
The most common adverse reactions that have been noted by people who took Nymalize were hypertension, headache and nausea.
“Approval of our first NDA is an important milestone in the evolution of Arbor Pharmaceuticals,” said Downey. “This is the first of what we hope will be multiple NDA approvals over the next several years. I would like to thank and congratulate our team that worked on the Nymalize NDA.”
