April has been a good month for AMRI ($AMRI). More than two weeks after signing an exclusive option with Bessor Pharma to license AMRI's tubulin inhibitor program, it has scored a new deal with Australian drug developer Biota Holdings Limited. Under the agreement, AMRI will further develop and manufacture laninamivir, an influenza antiviral, as it pursues an NDA with the FDA.
Not your typical preventative flu shot, laninamivir is rather a second-generation, long-acting neuraminidase inhibitor. It could be used as a preventative against the flu, or as a treatment. And unlike first or current-generation neuraminidase inhibitors, laninamivir has the potential to be administered only once for the flu.
"The agreement with Biota demonstrates AMRI's global reputation as a preferred partner for delivering best-in-class drug discovery, development and manufacturing services," as AMRI Chairman, President and CEO Thomas E. D'Ambra described in a statement. "We look forward to working with Biota to accelerate the advanced development of laninamivir."
As both a contract research organization and a contract manufacturing organization, AMRI certainly has a lot to offer its clients. And its work with Biota may not end with getting laninamivir ready for FDA approval in the U.S. If all goes well during the development and clinical stages leading to final FDA approval, Biota may retain AMRI to become the commercial manufacturer for the drug, according to a press release. Given that it is already approved for sale in Japan under the name Inavir, laninamivir certainly has momentum going for it as it tries to make a positive showing stateside.
- read the press release
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