Most people are aware that various agricultural crops have been engineered to increase the production benefits for farmers (the benefits of future products will be more consumer-facing). However, I'll bet substantially fewer people know that the U.S. Food and Drug Administration has guidelines for genetically engineered animals such as pigs, cows, chickens, and fish that could be used to produce pharmaceuticals, human organs for transplantation, or more. The broad statement that companies are engineering animals may sound frightening at first, but it's important to frame the discussion fairly. That's why I think it's key to think about the FDA guidelines and engineered animals in general in the proper context. Here are three specific examples that show how the animal kingdom is advancing human medicine and public health.
1. Human organs from pigs
In the not-too-distant future, bacon may be only the second-most valuable product produced from pigs. Synthetic Genomics and United Therapeutics (NASDAQ: UTHR ) recently announced a collaborative research and development agreement to produce humanized organs in pigs for human transplantation. It may sound like science fiction, but the approach could actually work (it also came with a $50 million equity investment, or about 7% of United Therapeutics' cash, to demonstrate the seriousness). Synthetic Genomics will use DNA synthesis and genome editing technologies on an unprecedented scale to create engineered pig cells, which will be used to create pig embryos that grow up containing organs that are compatible in humans.
The companies will initially focus their efforts to address the unmet medical need of treating lung diseases (by producing humanized lungs), which cause nearly 400,000 deaths every year in the United States. By comparison, only about 2,000 people are placed on the waiting list to receive a lung transplant each year. Could pigs really hold the key to saving tens or hundreds of thousands more people?
Investors have been captivated by the idea that medicine is advancing to a point that manufacturing human organs for transplantation could be possible -- and it's a major factor contributing to the market valuation of Organovo Holdings. The approach taken by Synthetic Genomics and United Therapeutics differs from that of Organovo (using pigs as a growing vessel, rather than trying to grow tissues with a "3-D bioprinter"), but the potential to revolutionize medicine is no less amazing. I'd actually expect United Therapeutics to beat Organovo in the race to create transplantable organs, although both could ultimately be successful.
2. Safer, more effective drugs from llamas
If you think swine are a crazy tool for advancing medicine, then you'll love the next animal target of the pharmaceutical industry. At the moment, AbbVie (NYSE: ABBV ) is the lucky company wielding the world's best-selling drug, Humira, which fetches over $10 billion per year (only the second drug ever to do so). Unfortunately for AbbVie, all good things must come to end, which will occur when Humira begins to lose patent protection in 2016.
AbbVie is leaning on several pipeline assets to soften the expected blow dealt by generic drugs, or biologics, but how can the company regain its lead in antibody biologics for inflammatory and autoimmune diseases after Humira is gone? The answer may lie in novel nanobodies designed from antibodies found in the immune system of llamas. Nanobodies are much smaller than current antibodies used for human therapeutics, which could result in deeper tissue penetration, less off-target effects, and cleaner safety and side-effect profiles.
To get its hands on nanobodies, AbbVie signed a deal worth up to $840 million with developmental biotech Ablynx. The deal centers on the nanobody ALX-0061, which is being evaluated as a treatment for rheumatoid arthritis in phase 2 trials. It may be too early to call it the next Humira, but the drug asset has shown great promise. We may owe a big "thank you" to our wooly friends for advancing treatment options for inflammatory diseases.
3. Combating antibiotic resistance with cloned animals
Dolly the Sheep might be the most famous farm animal today, but cloning domesticated animals may not be such a novelty in the near future. In fact, the FDA issued a final risk assessment on animal clones and their offspring way back in 2008. The agency concluded that meat and dairy products from cloned animals and their offspring were as safe to consume as conventionally produced food. So why clone livestock?
There are numerous advantages to cloning an animal. For instance, let's say a farmer has an amazing bull (male cow) that grows quickly, remains healthy, and produces the finest meat for miles around. Rather than cross-breed the nearly perfect specimen in an attempt to replicate its highly desirable features -- an expensive, lengthy, and unpredictable process -- the farmer may choose to simply make an exact copy through cloning.
How could cloning animals improve public health? As the FDA puts it:
Sick animals are expensive for farmers. Veterinary bills add up, and unhealthy animals don't produce as much meat or milk. A herd that is resistant to disease is extremely valuable because it doesn't lose any production time to illness, and doesn't cost the farmer extra money for veterinary treatment.
There's the added benefit of using fewer antibiotics, which are only being phased out of animal feed and livestock operations on a voluntary basis. There's a growing awareness that the overuse of antibiotics in farm animals contributes to antibiotic resistance for human health applications. In fact, the Centers for Disease Control and Prevention estimates that antibiotic resistance causes more than 2 million illnesses and 23,000 deaths in the United States each year. Something as simple as cloning livestock could offer a possible solution.
Genetically engineered animals for food or medical applications may sound scary, but with the proper context I think many fears can be alleviated. Simply considering the potential of specific applications helps provide a fact-based argument for the benefits and advantages, rather than relying on fear created by misunderstandings. Similarly, this could point to potential long-term investments in a future growth industry. How soon will it be before the world welcomes humanized pig lungs, llama-based nanobodies, and cloned dairy cows that require fewer antibiotics? Your guess is as good as mine, but the future of medicine and public health sure seems pretty wild thanks to the animal kingdom.
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