Counting on Crofelemer

Sanjeev Neelakantan | 19-December-2012

There’s a new beacon of hope and relief for millions of HIV/AIDS patients and children suffering from debilitating diarrhea. A US-based pharmaceuticals major, Napo Pharmaceuticals, is all set to revolutionise the healthcare sector with a pioneering drug, called Crofelemer, that can effectively address the issue of chronic diarrhea among such people. The drug, which has completed Phase 3 of clinical trials, is under the review of the US Food & Drug Administration. In an interview with Future Medicine, Napo Pharmaceuticals Founder and Chief Executive Officer Lisa Conte talks about the immense healing potential of this drug that can redefine healthcare

By Sanjeev Neelakantan

What made you take up entrepreneurship and enter the drug manufacturing business?

It dates back more than 20 years. I was working as a venture capitalist analysing biotech companies at the time and decided to climb Mount Kilimanjaro while vacationing in Tanzania. I noticed that one of the other climbers, who was suffering from altitude sickness, was ingesting some sort of plant-based concoction he had bought from a trailside pharmacy, which actually seemed to help him. There was something about the simplicity of it (medicines safe and effective because they’ve been used traditionally for hundreds/thousands of years) and just how natural it all felt that inspired me. Both of my parents were pharmacists, so perhaps at some level, that played a role in my decision to shift career paths, but this was my real “eureka” moment.

It must have been a rollercoaster ride from Shaman to Napo Pharmaceuticals. What brought about the transformation and how different are these two business models?

Shaman was a natural outgrowth of the experience I had on Mount Kilimanjaro. Even the name reflects that. We started the company in an effort to discover new drugs derived from plants that, in some cases, had yielded medicines that had been used for thousands of years. The rain forests of all continents, in particular the Amazon, were a natural source, and Shaman was specifically created to seek out this knowledge and adapt it to modern technology. Shaman was a risk-based R&D company. To accomplish what we wanted to do, we needed significant equity financing. When equity was not available due to capital market unrest, we brought in some debt, which was devastating to the company balance sheet. It turned out to be a very steep learning curve for us.

Napo was created to continue all that Shaman had done and provide global access to the products we developed. Napo continued Shaman’s innovation and added a business model that focussed worldwide on every country, every population, and every channel of distribution regardless of socio-economic relevance. Most importantly, we discovered a product, Crofelemer, which has an enormous potential to address a worldwide health issue. Initially, if approved by the US Food and Drug Administration (FDA), we will address the issue of diarrhea in people living with HIV/AIDS, which is a real problem and growing with expanded use of anti-retroviral therapy in a prophylactic setting. The global potential of Crofelemer is further to address the worldwide issue of the millions of children who die each year in resource-constrained environments from dehydration associated with acute diarrhea. Our research to date shows there are no serious side effects and our product is incredibly effective in addressing this worldwide scourge of mankind. The market potential is enormous.

What’s the status of the clinical trials of Crofelemer? Is it just an anti-diarrhea drug or can it help in fighting other serious ailments?

Crofelemer has completed Phase 3 of Clinical Trials and is awaiting approval by the US FDA. It addresses all forms of watery diarrhea. Initially, it has been submitted to address chronic diarrhea created by anti-retroviral treatment of HIV/AIDS patients, which is a very significant market. Eventually, we hope and expect it will be approved to treat the global problem of watery diarrhea caused by cholera and other infectious agents, which results in the deaths of millions of people, including close to two million children each year, and causes measurable morbidity in hundreds of millions more. In all our trials, there have been no significant side effects seen by this very natural product. One other indication we’ve published data on is Irritable Bowel Syndrome, IBS, for which the endpoint is patient relief of pain. This is a global issue as well, affecting the lives of up to 20 per cent of adults.

Tell us something about your drug portfolio, procurement of medicinal plants and herbs, and research and development initiatives.

Our discovery process starts with ethnobotanist and Western-trained physicians working with ‘shamans’ or healers in the field focussing on symptoms of diseases we’re interested in. Our second product in the clinical pipeline is for diabetes.

What are your focus areas in the emerging markets, especially India and China? Are you planning any mergers or acquisitions?

Crofelemer is a product for which there is a worldwide need and application. There isn’t any population anywhere in the world that doesn’t have the problems addressed by Crofelemer. India and China, with their large populations, are specific targets where we feel the product can make a huge difference. Once approved, we are committed to making sure crofelemer will be available to all who need it.

What are the challenges, especially on the patents and intellectual rights front, confronting the pharma industry?

India’s compliance with the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights in 2005 was an important step towards allowing us to bring a proprietary treatment like Crofelemer to the emerging markets.

What are your corporate social responsibility initiatives?

The Healing Forest Conservancy is a non-profit organisation through which we give back to the communities with which we collaborate, providing benefit sharing from our future profitability. We also sustainably harvest our raw plant material in the rain forest utilising fair trade work practices. And, we’ve established a B corporate subsidiary focussing on our social commitment to reach out to communities worldwide, where young children are dying needlessly, and provide accelerated development access to Crofelemer for pediatric purposes.

What is Napo’s involvement in meeting the critical medical needs of the African population, who are trapped in the vicious circle of death and poverty?

We have no borders! All who can benefit from Crofelemer should have access to it and we are committed to doing everything within our power to make sure that happens. Once in a rare while, there is an opportunity for a company to develop a product like Crofelemer. It has been a long road for us. We are both near the end of this road and the beginning of a whole new world that will open to us and those who can benefit from our product. Again, we are committed to making that happen.

Like Shaman, does Napo take part in continuing medical education programmes?

Once we start generating income from the distribution of our product, we will be looking at medical education programmes. The very nature of our product is a worldwide education in itself.

According to you, how well are the US companies positioned to tackle the gradual shift of economic axis from the West to the East?

Napo surely recognises the significant development of emerging economies that until recently have often been considered part of the “developing world”. We are committed to focussing our business in that area as well as the traditionally higher margined West. We feel we are surely one of the first companies to bring social change to the pharma industry with the ultimate goal of sustainably optimising profitability through local partnerships while addressing global populations and their health needs.

One of the main reasons I got into this business in the first place was to help people with business practices that align financial incentives with the provision of novel medicines to all. It goes to the heart and soul of what Napo is all about. To see millions of lives negatively impacted by a disease that should be easily be treated is every bit as frustrating as it is heartbreaking because it doesn’t have to be that way.

We know we have a “first in class” medicine with Crofelemer and are anxious to have it produced and distributed for the masses, so more lives do not have to be needlessly lost or impacted with suffering. This product has the potential to change the world for the better in so many different ways. People should know that help is on the way.

A socially committed entrepreneur

Lisa Conte has dedicated much of her professional life to finding ways to build high risk/high reward businesses. Her travels have taken her all over the world, from Tanzania to the Peruvian Amazon, from London to Haiti and back. For well over 20 years, she has been a pioneer in a unique segment of the biotech and pharmaceutical industries, never giving up in the face of adversity.

One of Lisa’s primary interests has always been to bring about social change in the pharmaceutical industry by focussing on access to new and novel medicines for populations that must typically wait for generics to be made available to them.

Early in her career, Lisa conducted risk and strategy audits for start-up companies at Strategic Decisions Group (1985-1987) and served as Vice-President at Technology Funding, Inc., a venture capital firm (1987-1989). In 1989, while on vacation, climbing Mount Kilimanjaro, she observed another climber treating a bad case of altitude sickness with a plant-based remedy purchased at a local pharmacy. Inspired by what she saw, Lisa began researching ways in which plants could be used to combat illness. What she discovered was a market that offered tremendous potential, one that she hoped to tap into by founding Shaman Pharmaceuticals, Inc., a natural product pharmaceuticals company.
At Shaman, Lisa focussed her efforts on developing remedies derived from medicinal plants that could be used to treat various ailments, from diabetes to diarrhea.

In November 2001, Lisa founded San Francisco-based Napo Pharmaceuticals, which brings medicinal products to the global marketplace by working together with the indigenous populations in communities throughout the world. The company’s lead drug, Crofelemer, is intended for the treatment of diarrhea, which proves fatal for as many as two million children each year in emerging and developing countries, and is among the side effects of anti-retroviral therapy in people living with HIV/AIDS. Crofelemer is sustainably harvested from the Croton lechleri tree found in rain forest areas. Following successful Phase 3 clinical trials, the FDA is currently reviewing the efficacy of Crofelemer.
Lisa earned a Bachelor’s degree in Biochemistry from Dartmouth College and a Master’s degree in Physiology and Pharmacology from University of California at San Diego. She later enrolled in the Tuck School at Dartmouth, where she graduated with an MBA. She is the recipient of several entrepreneurship awards, including the 1994 E&Y Entrepreneur of the Year Award, and was a nominee for the 2009 BIO Humanitarian Award. She has also sat on several industry and academic boards.

‘Breach of trust’ hurts the healer
The development of Crofelemer as a drug is the result of more than two decades of efforts on the part of Napo and dozens of other contractors and licensees who have worked to bring this drug to market. US-based Salix Pharmaceuticals became a formal party to that collaboration in December 2008, yet has not performed any of its obligations as promised, says a statement issued by Napo.
Without informing Napo, Salix has filed a new drug application with the US Food and Drug Administration (FDA) for approval of Crofelemer as a botanical drug. Since 2011, Salix has refused to share any information with Napo about its filing with the FDA or their claimed characterisation of the product as a botanical drug, despite contractual obligations and Napo’s ownership of this drug. Given this and other alleged breaches of the contract between Napo and Salix, Napo filed a suit in May 2011 to terminate the contract, which is proceeding in the New York State Supreme Court. During this period, Salix, a $3-billion company, has been selling a product, rifaximin, that many analysts believe overlaps with a market indication for Crofelemer.
On Salix’s new application, Napo CEO Lisa Conte said, “We are dismayed that Salix would take action that may negate and undermine almost two decades of work on Crofelemer as a new chemical entity by proceeding with a regulatory filing as a botanical in light of the strong objections, regulatory precedents, and scientific integrity presented by Napo and Shaman.”

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