For decades the biotech industry has been hounded by activists over animal testing. Most notably, a campaign against Huntington Life Sciences in the late 1990s through 2000s included arson, harassment, threats and alleged fire bombings. Less severe, but still troubling for biotech, animal rights activists join with anti-GMOers most years to protest at the Biotechnology Innovation Organization (BIO) convention.
But as biotech has branched into cultured meat and alternatives to animal testing, the companies and scientists involved have been praised by animal rights groups.
Chip technologies unite animal activists and biotechs
Biotechs developing chip technologies are at the forefront of the praise from animal rights groups. In 2014, People for the Ethical Treatment of Animals (PETA) named Boston-based Emulate Inc. its Company of the Year for its work on organs-on-chips. According to Emulate’s website, it “can predict human response with greater precision and control than today’s cell culture or animal-based testing methods.”
“We love animals, and humans,” said James Coon, CEO, in the announcement on Emulate’s website.
Such mutual support is a sign of hope that both sides will put aside differences when working for mutually beneficial aims, despite their contentious history.
Last year PETA praised Swiss biotech Oncotheis Sarl for its in vitro cell cultures that can be used as replacements for experiments on animals, such as inhalation experiments involving rats stuffed into tubes. The Geneva, Switzerland-based company’s Oncocilair is an in vitro human lung cancer model.
“Not only does this innovative tool have the potential to save countless animals’ lives, it could also potentially save countless humans,” a PETA article stated.
PETA also has praised Tampa, Fla.-based Syndaver Labs for its Synthetic Canine. The anatomically accurate skinless dog model has a heartbeat, working circulatory system, the ability to bleed, and it uses the company’s Syntissue that mimics living tissue. This allows veterinary students to avoid medically unnecessary “terminal” surgeries on live animals.
In other news, in 2015 PETA gave a grant to student researchers at Iowa State University who are working on placentas-on-a-chip technology. The same year, the PETA International Science Consortium Ltd. and Ashland, Mass.-based Mattek Corp. teamed up to offer free 3-D reconstructed human tissue equivalents from Mattek to decrease the use of animal testing.
Bay Area bio accelerator banking on cultured meat
San Francisco is a hotbed for both biotech and eco-friendly politics, so it’s not surprising that it’s emerging as a hub for earth- and animal-friendly biotech. The accelerator Indiebio is at the center of the movement with its portfolio of companies working on alternatives to using animals for food. In 2015, Mercy for Animals praised Indiebio for its contest offering $250,000 in seed funding to startups looking to create cultured animal products.
Perfect Day Foods, a biotech named after the Lou Reed song, received seed funding from Indiebio and is part of a cellular agriculture non-profit research institute that focuses on developing animal products without animals. Google Inc. will be offering vegan shrimp from another Indiebio portfolio company, New Wave Foods, as soon as it’s commercially viable. Other Indiebio companies include Memphis Meats, which is creating cultured meat, and Clara Foods, which is creating ex vivo egg whites.
Back in 2008, PETA offered a $1 million reward to the first team of scientists to develop a method for commercially viable quantities of lab-grown chicken meat.
As more biotechs use technology to break into the expanding market of cellular agriculture, we can expect animal activists to continue to offer their praise and support.
What the future holds
None of these examples are to say that the rift between biotech and animal rights activists is over. Groups like PETA continue to put biopharmas on their lists of companies that are worst for animals. For the time being, PETA is still criticizing biotech more often than not. Supporters even bought up shares in Amgen Inc. to influence the company’s policies.
There are signs that the criticism is fading, including a decrease in protesters at BIO meetings. At the 2001 BIO meeting in San Diego, eight people were arrested. At the 2004 BIO meeting in San Francisco, police came prepared in riot gear in anticipation of protests. Anyone who’s been to BIO recalls the often massive groups outside protesting animal testing and GMOs.
But two years ago at BIO in San Diego, only a few protesters could be found. Far from anti-biotech activists, they were senior citizens decked out in red, white and blue to protest keynote speaker Hillary Clinton’s response to Benghazi.
Every year, more than 56 billion animals are killed for food worldwide, making veganism one of the biggest-pushed agendas of groups like PETA. As more people around the world adopt the meat-heavy Standard American Diet, those numbers will only increase. Rather than an ethical alternative, lab-grown meats may become imperative to feed the world’s growing population.
If biotech can produce commercially viable cultured meat, there will be no marketing fiasco like what’s surrounded GMOs. Instead, animal rights activists and radical ecologists will lead the charge of encouraging consumers to choose biotech products over farm-raised animal meat. As biotech works on eliminating animal testing, it will receive similar support its former adversaries.
Biotech must understand that animal rights activists aren’t anti-science or against the industry in general. In fact, this vocal minority can be used for positive publicity whenever biotechs engage in earth- and animal-friendly policies.
Those protesting biotech should understand that most who work biotech don’t like animal testing, for its moral implications and its inaccuracy in predicting human response. Biotechs are stuck between investors who insist on low operating costs on the one hand, and the FDA’s rigorous requirements for pre-human trials on the other.
These recent collaborations between animal activists and biotechs give hope that in the future the two sides will work together on projects that can save human lives, animal lives and the planet.
The day before news broke of the lawsuit against Valeant Pharmaceuticals International Inc. – lodged by former shareholders of Sprout Pharmaceuticals Inc. over Valeant’s non-promotion of Addyi (flibanserin) for female sexual dysfunction – officials of Palatin Technologies Inc. groused to me about that very topic. “It’s just there, doing nothing,” he said of Addyi, a non-hormone agonist at the 5-HT1A receptor and an antagonist at the 5-HT2A receptor.
Palatin hoped that Valeant’s $1 billion buyout last year of Sprout in order to get its hands on then just-approved Addyi would mean a big push for greater awareness of the drug as well as its long-neglected condition, specifically known as hypoactive sexual desire disorder (HSDD).This would pave the way for Palatin’s therapy, bremelanotide, or BMT, a melanocortin 4 receptor agonist and synthetic peptide analogue of naturally occurring alpha-melanocyte-stimulating hormone.
The would-be scenario held promise for Palatin. Although Addyi has the advantage over subcutaneously administered BMT in that it’s orally taken as a tablet, it must – unlike BMT – be used chronically. What’s more, Addyi interacts with alcohol (hence a black-box warning on the label), and causes dizziness as a side effect.
Palatin (and former Sprout shareholders) expected Valeant to promote Addyi in ob-gyn office visits, urging doctors to talk with their patients about sexual dissatisfaction and make them aware that a treatment is available. Then BMT, which just completed favorable phase III trials, could step in when approved and tout an even better one. Valeant dropped the ball. To be sure, the company has had plenty else to keep busy on, given the controversies over its drug pricing and business practices, and investigations by U.S. regulators and Congress.
But even before all that, the buyout of Sprout at such a premium stunned me.
Any drug will have a problem selling if it must be used chronically in order to address a situation (sexual activity) that, for many people, doesn’t manifest regularly. Healthy people don’t want to put chemicals in their bodies every day, unless doing so is necessary to remedy pains or problems that also recur on a daily basis. Nor do they don’t want to be dizzy as a result of ingesting those chemicals, if they get no practical benefit in the near term. And, not to put too fine a point on it, a lot of people don’t want to take a drug that purports to ensure their sexual satisfaction by boosting libido and blocks them from enjoying alcohol at the same time.
Wrongly dubbed “the female Viagra,” Addyi differs greatly in its mechanism of action from the sildenafil product marked by Pfizer Inc. for men. The label differs as well: There’s no black-box warning on Viagra’s label with regard to alcohol use. (Since Viagra’s approval, the male-dominated industry has won approval for more erectile-dysfunction therapies, but – until Addyi – nothing to address libido in women: a separate issue. Or maybe not.)
Even if Valeant had stuck to its Addyi knitting after the Sprout purchase, instead of firing everybody and doing practically nothing, the company would have faced a big hurdle in getting the drug widely accepted, especially with BMT in the wings. Spana, of Palatin, called Addyi “a product that can be used by women and should be used by women” for whom it’s appropriate. At least, you can almost hear him saying, for now.
The scenario reminded me of what Nitromed Inc.’s Bidil for heart failure in African Americans faced after the FDA granted approval in June 2005. Bidil is made up of two generic ingredients, isosorbide dinitrate and hydralazine, available separately at a much cheaper price than the combined pill. It seemed obvious to me that doctors would prescribe the two components separately as a way of keeping the out-of-pocket cost lower for patients – that “convenience” wouldn’t carry the day.
In May 2006, shares of Nitromed took a 30 percent hit when investors got a gander at the low sales numbers. Liana Moussatos, analyst with Pacific Growth Equities (now at Wedbush), told me that “Bidil sales would have been fantastic, had the separate components not been available.” Nitromed later sold the rights to Bidil to Arbor Pharmaceuticals LLC.
With Bidil, Nitromed targeted a different, more serious indication and a different populace than those to be served by Valeant with Addyi, but they may be overlooking in a similar way how the real world will work – in terms of doctors prescribing two pills vs. one, or an HSDD therapy self-administered subcutaneously as needed instead of taken by mouth daily.
Palatin plans to file the NDA in the second half of next year and could get a decision by the second half of 2018, chief financial officer and chief operating officer Stephen Wills told me. With only 22 employees, the company will need to sign a marketing collaborator that has a presence in women’s health. Roth Capital Partners views Pfizer or Allergan plc as likely bidders. Wills said, “I think the most important thing is, we’re going to have a focused partner that’s going to do what needs to be done in the marketplace.” In BMT, Palatin has something that deserves the effort.