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With the Nasdaq Biotechnology Index up 65% since the start of the year, it's clear that the biotech sector performed extraordinarily well in 2013-but which stocks were the biggest winners? Several small-cap and mid-cap biotech companies posted returns of 200% or more through the middle of December this year, and, in this series, I review the 15 biggest movers of 2013. Let's continue this review with number 9 on the list, Organovo Holdings (NYSEMKT: ONVO).
When Organovo Holdings presented data on its 3-D liver tissue at the Experimental Biology conference in Boston in April, it signaled a turning point in the relationship between science and fiction.
Walking a long road to viability
The development of this new technology didn't occur overnight. It began in 2003 with a Clemson University professor, Thomas Boland, being awarded a patent for "Ink-jet Printing of Viable Cells." That patent, and a $15 million grant from the National Science Foundation, kick-started early research into the development of organ printing at the University of Missouri-Columbia in 2004 and 2005. That research, led by Professor Gabor Forgacs, led to a patent for "Self-assembling Cell-Aggregates and Methods of Making the Same," which proved the genesis of Organovo.
Organovo, led by former Amgen executive Keith Murphy, has been working to create human tissue to advance drug research and development ever since.
Wasting billions on failed drugs
The drug industry invested $800 billion on drug research and development over the past decade. That's enough money to buy brand new Teslas for every person in New York City, Washington, D.C., and Los Angeles, and still have a couple hundred thousand cars left over to hand out to friends and family.
Yet all that spending resulted in just 252 new FDA approvals during the period, raising the question why so few compounds ever make it to market?
Its a question big pharma is addressing by streamlining processes in the face of billions in lost revenue tied to patent expiration. Some $34 billion worth of brand name drugs are losing protection in 2014, including Teva Pharmaceuticals (NYSE: TEVA ) multibillion MS drug Copaxone.
That sales vacuum is sparking innovation across the development community, resulting in Teva and its peers adopting research outsourcing solutions provided by fast growing firms including Parexel (NASDAQ: PRXL ) , which has seen its revenue climb more than 50% since 2009.
It's also spawning an emphasis on polypharmacology, or how drug compounds interact across multiple targets rather than just how they react to one specific target.
Drug developer's ultimate goal is getting more bang from every research buck. That means innovating to shorten drug development time and shrink spending on drugs destined to fail.
Organovo believes bio-printing will help by providing organ tissue that can be used as part of polypharmacology analysis.
The company hopes its first product, 3-D liver tissue assays, will come to market at the end of 2014. Using these assays to Identify and eliminate drugs with liver toxicity before expensive and time consuming human trials may save developers billions.
From there, Organovo plans to create assays for other vital organs including the heart and kidney, giving researchers even more pre-human trial options for assessing polypharmacology.
Fool-worthy final thoughts
Bio-printing technology is maturing to a point where commercialization can be considered. And it's certainly not hard to imagine bio-printing could eventually become a standard in pre-clinical drug development in R&D departments at companies including Teva and Parexel.
However, we're still at least a year away from the launch of Organovo's first product and that means investors bidding shares up more than 250% this year will have a long wait before they're rewarded with revenue and profits. It also suggests Organovo is suited only for the most risk tolerant investors who are willing and able to withstand big swings in the company's share price, including a complete loss.
Growth stock to watch today