Unigene Laboratories ($UGNE) can hold on to its patent for Fortical, after the Supreme Court denied Apotex's attempt to produce a generic form of the nasal spray.
Fortical is a once-a-day nasal inhalant that uses Unigene's patented calcitonin-salmon formulation to reduce the risk of bone loss and increase vertebral bone mineral density in women with osteoporosis, according to the company. In its lawsuit, Apotex claimed that the spray was overtly similar to Novartis' ($NVS) Miacalcin in an attempt to nullify Unigene's patent. Had the court ruled in favor of Apotex, the drugmaker could have put a generic form of the spray on the market before the patent's expiration.
But the Supreme Court agreed with an August ruling by the federal court of appeals, supporting Unigene's claim that while Fortical and Miacalcin are similar, the two drugs reached the same result through different formulations.
The news might help Unigene recover from its recent fallout with GlaxoSmithKline ($GSK). In December, the pharma giant backed out of a deal with the company to develop an oral formulation designed to treat osteoporosis--much like Fortical--abandoning a partnership that could have brought in $140 million over time. Instead, GSK backed out after Phase II, leaving Unigene with just $8 million to pay for the trials.
And while the recent ruling lets Unigene keep the exclusive rights to Fortical, the nasal spray is no longer the company's cash cow, according to its 2011 financial statement. Unigene reported a continual decline in Fortical revenue in 2011, and the company is instead banking on a new oral peptide drug delivery platform called Peptelligence and its late-stage pipeline. The company says the ruling won't impact its growth objectives.
- read Unigene's release on the ruling
- check out the company's 2011 financial summary
Editor's Note: This story has been updated in the last paragraph to correctly refer to Peptelligence as a drug delivery platform, with an added statement from Unigene on its growth objectives.
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