Ranbaxy First to Offer Tablet and Suspension Forms
Ranbaxy (Haryana, India) received full market approval from the US Food and Drug Admnistration on Oct. 2 for its anti-infective
agent clarithromycin oral suspension, USP (125 mg/5 mL and 250 mg/5 mL). The approval makes the company the first to win generic
approval for the oral suspension form and the tablet form.
FDA's Office of Generic Drugs determined that Ranbaxy's formulation was bioequivalent and offers the same therapeutic effect
as that of the reference listed drug, "Biaxin" granules of Abbott Laboratories. Total annual market sales for clarithromycin
were $99.7 million, with suspension sales totaling $25.3 million.
New Center in North Carolina
North Carolina State University opened an 86,000-ft2 biotechnology training and education center on Sept. 18 to teach manufacturing sciences in a real-time environment. Commercial-grade
equipment is being used for the first time in a pilot-scale training facility to train students in microbial fermentation
and cell-structure biotechnologies for the development of protein-based therapeutic drugs and commercial products. The facility,
called the Biomanufacturing Training and Education Center, employs ABB's "Industrial IT System 800xA Extended Automation"
technology, instrumentation, analyzers, and variable speed drives to achieve continuous validation and control of the bioreactors
for real-time release under strictly maintained and regulated conditions.
Bristol-Myers Squibb To Buy Adnexus Therapeutics for $430 Million
Reflecting a strategic interest to strengthen its position in biologics, Bristol-Myers Squibb (BMS) agreed to acquire the
biopharmaceutical company Adnexus Therapeutics (Waltham, MA) for $430 million on Sept. 24. "Bringing Adnexus into the Bristol-Myers
Squibb family builds upon a successful and productive collaboration between the two companies in oncology and is an important
step in accelerating the strategic transformation of our pharmaceutical business to a biopharma business model," said Jim
Cornelius, chief executive officer at BMS, in a company release.
"Biologics are one cornerstone of our growth strategy. This investment in biologics discovery complements our continued investment
in a growing biologics pipeline and portfolio, and will benefit from our expanding biologics manufacturing capabilities, both
at our existing site in Syracuse, New York, and our future large-scale bulk biologics facility in Devens, Massachusetts."
Adnexus is a developer of a proprietary class of biologics called "Adnectins," which are derived from fibronectin, an extracellular
protein that is naturally abundant in human serum. Fibronectin binds to other proteins using protein structures called targeting
domains. An Adnectin consists of a backbone of the natural amino-acid sequence of a certain domain of human fibronectin and
one to three targeting loops redirected to enable an Adnectin to specifically recognize a therapeutic target of interest,
according to the company. The Adnectins are generated using the company's "Profusion" proprietary protein-engineering system.
According to Adnexus, although Adnectins and antibodies have targeting domains with three-dimensional shapes that resemble
each other, the amino-acid sequences of each protein class are distinctly different.