When you’re trying to save the world, you’ve got to think big. So it’s hard to condemn West Haven, Conn.-based biopharmaceutical concern NanoViricides for its outsized ambition. But as to their claim to be the latest in a line of century-winning revolutionary advances in the treatment of infectious diseases? To be the last on a short list that includes smallpox vaccine (18th century), antisepsis (19th), penicillin (20th), and now… NanoViricides in the 21st? Hold up, now.
What do these revolutionaries do? In their own words, they “specialize in creating nanomaterials for antiviral therapy” that “both envelop and dismantle harmful virus particles.” Which viruses? Apparently, all of them. At various times, the company has claimed to be developing drugs that will “dismantle” the likes of swine flu, bird flu, you-and-me flu, HIV, hepatitis, herpes, rabies, Dengue fever and Ebola. “Before NanoViricides, we only had drugs like Tamiflu and AIDS cocktails, which merely suppressed but didn’t destroy the virus,” the company’s president, Dr. Anil Diwan, said last year.
They’re not just out to save humanity. In a recent interview with the cheerleading “research” organization Red Chip Review, the company’s CEO, Dr. Eugene Seymour, was asked about NNVC’s technology. “We don’t care if you’re a man, a mouse, a whale or a salamander,” he said. “As long as you have a virus in your circulation, we destroy it.” So a multi-billion dollar valuation is in the cards? “Oh, easily,” he replied.
It’s here that we begin to part ways with this company’s self-diagnosis. Although it’s somehow managed to jawbone its way to a $200 million market capitalization, we doubt NanoViricides is ever going to be much more than it is today: a company rife with conflicts of interest, bogus résumés, nonexistent scientific ratification of its “technologies” and a remarkable tendency for exaggerating not just the promise of its drugs, but almost every other thing they talk about, too.
NANOVIRICIDES WAS INCORPORATED IN FLORIDA May 2005 by a guy named John S. Flynn, the husband of Beverly Hills Housewife Dana Wilkey. The paperwork named Dr. Seymour as CEO and Dr. Diwan as secretary. NanoViricides’ sole asset at its founding was a licensing agreement with one TheraCour Pharma in West Haven, which was owned by Dr. Diwan.
NanoViricides’ life as a Florida company was short-lived, though, because not a month went by before it was merged with a Nevada shell company. Dr. Diwan was now president of the company, with Dr. Seymour as CEO, one Leo Ehrlich as CFO, Mr. Flynn as secretary and medical research luminary Dr. Paul Marks—who led Memorial Sloan Kettering Cancer Center for 19 years—on board as a director (and later as chairman of its scientific advisory board).
The agreement between NNVC and TheraCour was signed by Dr. Diwan on behalf of TheraCour and Mr. Ehrlich on behalf of NNVC. This, despite the fact that both men were shareholders of TheraCour, and because they both owned more of TheraCour than they did of NNVC, stood to reap disproportionate gains from any dollars diverted to TheraCour from NNVC. One can only wonder just how hard Mr. Ehrlich negotiated on behalf of NNVC in that original deal. Or one could ask the company itself. Alas, when Up & Down the Street submitted a list of questions to the company in mid-March, the initial response was an email from a defamation lawyer seeking to confirm our identity. Once confirmed, we received nary a response from NNVC, nor its lawyer.
Just a short time after NanoViricides became publicly traded, a website went up and the press releases started to fly. My favorite early product name: SuperCide, a “novel microbicide that will be used in condoms and vaginal lubricants to minimize the spread of [STDs].” There was also Hivi-Cide-I, which promised to “neutralize and disable” HIV. In 2005, they were predicting the ability to cure HIV by 2009.
And why wouldn’t they have been so optimistic? Because it was around this time that a new employee—one Krishna Menon—joined the firm as chief regulatory officer. Dr. Menon’s original bio said he was the co-inventor of two blockbuster drugs at Eli Lilly, Gemzar and Alimta, that he held seven U.S. patents and that he received his Ph.D. from Harvard. “People work a lifetime in this industry without getting a single drug approved,” Mr. Ehrlich told a reporter at the time. “Dr. Menon not only got a single drug, he got two blockbuster drugs.”
But that reporter did a little reporting, and the resulting article in INDIA New England published in 2008 revealed an almost comical level of exaggeration in Dr. Menon’s résumé. Eli Lilly disputed the whole “co-inventor” thing. In fact, the owner of the patent of one of the drugs said he’d never even heard of Dr. Menon. The good doctor, it seems, had simply been a lab technician during animal testing of the drug.
A more recent bio claims he received his Ph.D. from Kerala University. One of the questions we submitted to the company was whether Dr. Menon was, in fact, in possession of two Ph.Ds. We received no reply. A more recent bio claims, “He has been responsible for seven FDA approved drugs, three of which are blockbusters.”
Résumé padding seems endemic at NNVC. The CEO, Dr. Seymour, has claimed to have received an M.D. from Columbia Medical School, while other résumés have him receiving “training” at Columbia.
You may recall the bird flu scare of the fall of 2005. NanoViricides was quick to announce that August that the government of Vietnam’s National Institute of Hygiene and Epidemiology had “extended an invitation to the company to help in the battle against bird flu.” That’s an odd way to describe buying clinical testing services from the NIHE labs. That September, NNVC announced FluCide-1, citing “progress in developing” the drug. The press release did clarify things with Vietnam, saying that NIHE had merely “extended an invitation to the company to discuss” fighting bird flu.
Clearly not the types to miss the chance to talk about something, the company announced its intention to go to Vietnam to do that talking, after which they intended to “redevelop” FluCide-I into AvianFlucide-I. In March 2006, they reported that the results from a mouse study of FluCide made the drug “worthy of filing an Investigational New Drug Application” with the F.D.A. Alas, it’s been eight years and not only has no I.N.D. been filed, there’s no longer any word of AvianFluicide on the company’s web site.
The press releases continue like this for nearly a decade, but the company has yet to get a single drug out of the lab. There have been no human clinical trials, and not a single I.N.D. filing with the F.D.A.
As quickly as products such as AvianFlucide have disappeared from NNVC’s roster, replacements have been added, including those targeting rabies, viral eye diseases, HIV, Hepatitis B & C and Herpes Types I and II. There’s also a “bio-defense” program they call “Accurate-Drug-in-Field,” which is a “unique” technology (aren’t they all?) that governments will be able to use to “quickly” create a nanoviricide “in the field…to stop an epidemic from spreading.” Al Qaeda thinks it can scare us with biowarfare? Pshaw! Not if we’ve got NanoViricides’ technology in our pocket out there “in the field.”
Their current front-runner is FluCide. And how far along is that? Well, they like to say that they’ve had a “pre-I.N.D.” meeting with the F.D.A. about it. Yes, they’ve had a meeting with the F.D.A. about an I.N.D. At some point, though, one would expect that I.N.D. to actually be filed, and time is a-wasting. NNVC claims that FluCide demonstrates “significantly superior activity” to Tamiflu, the best-selling flu treatment in the world. And by superior, they mean a 100x to 1,000x greater viral load reduction than Tamiflu. You should read the peer-reviewed research on it. And by that, I mean that you can’t. Because there isn’t any.
Let’s just suspend a legitimate skepticism, though, and assume that they’re actually serious about developing drugs. For all its claims about breakthrough technology, NanoViricides is woefully short on the kinds of progress—and proof—that one usually sees out of development stage. Another company, Bind Therapeutics, is promoting a similar concept called Accurins. But unlike NNVC, Bind has a drug in Phase 2 trials, as well as collaborations with large pharmaceutical players. Bind has a ton of patents and published papers. A search of Pubmed shows no published papers describing any of the pre-clinical work supposedly done by NNVC in the near-decade of its existence.
ONE THING NNVC CAN STAKE A SERIOUS CLAIM TO is the ability to raise money from credulous investors. The statement of shareholders’ equity in the company’s latest 10Q filing is the size of a Russian novel. Which, as they say in the trades, can also be a red flag.
They raised $4.3 million in October 2009, at which point they said they had enough capital to get through year-end 2010. They filed a shelf registration in March 2010, though, and then raised $5 million more before year-end. But then…in April 2011, they raised another $5 million. In October 2011, the company said it had sufficient funds to advance its drug pipeline “further into the [F.D.A.] approval process”—a curious characterization, considering that none of their drugs have ever entered the F.D.A. approval process, and then, surprise!—three weeks later they announced another $5 million raise. And another $5 million in June 2012. In February 2013, another $6 million—enough, the company said, to fund the initial human clinical trials for FluCide.
In August 2012, the company announced “success” in “developing” an orally ingested anti-influenza drug candidate. Said NNVC: “We believe this may be the very first targeted nanomedicine that is available via the oral route. Oral availability of FluCide would open up a much larger market than the injectable version.” The injectable version of what? FluCide? It shouldn’t be that hard to open a much larger market for a drug for which there is no market as yet. Not only that, one can only assume that NNVC has never heard of FluMist. It’s been around for years, and 13 million doses of it were administered in the U.S. this past flu season alone. That market is already, shall we say, “opened up.”
In September 2013, they raised $10.33 million, the largest contributor to such being wealthy ophthalmologist (and NNVC member of the board of directors as of May 2013!) Dr. Milton Boniuk. Not included in the announcement was the fact that NNVC had been paying Dr. Boniuk’s sister, Vivian, a 73-year-old ophthalmologist in Great Neck, N.Y., to do preclinical work in animal studies for a conjunctivitis drug. In other words, NNVC hired the sister of one of its board members to do clinical work that she clearly does not specialize in. She has not published a single paper about any of these animal studies.
In January of this year, they raised another $20 million, which, they said, will get them through Phase I and II of human clinical studies for their injectable FluCide drug. (The oral version, it seems, will have to wait, despite the “much larger market.” Priorities, people!) And on it goes. All told, this company burned through $46.3 million in cash by year-end 2013 with not a lot to show for it. NNVC recently claimed they had enough cash to get them through Dec. 31, 2015. Let’s see if they make it that far.
DID I MENTION THAT IN THE FIRST SEVEN YEARS OF its existence, the company failed to hold a properly-noticed meeting of shareholders for the purpose of electing directors?
Or that in mid-March, they put out a press release denying a rumor on website Seeking Alpha that an unknown acquirer had valued the company between $2.25 billion to $4.5 billion? The numbers were patently absurd, and the same afternoon, I was compelled to issue my own press release denying the persistent rumors that Scarlett Johansson and I have been secretly dating.
have any idea if any of Nanoviricide’s drug candidates do hold any legitimate promise. Of course, no one else does either, as they’ve published no papers on them, and they’re hasn’t been a single FDA trial of anything they make. Or will never make. It all brings to mind a certain song lyric: “The only thing we knew for sure about Henry Porter was that his name wasn’t Henry Porter.”
“Our drug development costs have been substantially lower than industry standards so far because of our rapid drug development platform technology,” says NNVC. By my understanding, drug development costs are best measured once a drug has hit a milestone such as F.D.A. approval or, barring that, entry into F.D.A. trials. None of NanoViricides’ drug candidates have hit either. Considered in that light, my own development efforts for a flu vaccine are as far along as theirs, and I haven’t spent a dime. All I need now is a Real Housewife of Beverly Hills, and I’ll be ready to save us all.