As recently as a decade ago, the biggest hurdle for biotech companies wasn't competition from their peers or even the sale price of their drugs. It was simply getting their drug approved by the Food and Drug Administration. In the past, simply getting a drug approved by the FDA meant that it had a pretty good chance of succeeding from a financial perspective.
However, times have certainly changed, and that's certainly not the case now. The decade-long multimillion-dollar process that it takes to get a drug approved is really only half the battle now with better funding, new breakthrough designations to help move drugs along in the review process, and more staff available to review prospective drugs. The other half of the battle is marketing and pricing a drug properly so as to drive sales and coerce physicians to prescribe it.
The fact of the matter is that not all biotech companies choose to partner up with a more experienced marketing partner. Occasionally this works out, but for smaller biotechnology companies, that isn't always the case. Over the past couple of years, I've watched numerous biotechs try to "go it alone" only to fall flat on their face.
Perhaps none caught my attention more -- or faced more ridicule -- than KV Pharmaceutical, whose pre-term birth injection, Makena, was approved by the FDA and priced at $1,500 per treatment when a previous combination of drugs had been priced around $20 per injection. The company's lack of empathy (and common sense) drew critics ranging from angry mothers to Congress, which eventually caused the company to drastically slash the price of Makena. About a year later, KV Pharmaceuticals was bankrupt.
This is but one case, and there are many more. Over the next three days, I plan to highlight three additional biotech companies that would do well to find a marketing partner for their lead drug. Today, we'll look at a company trying to get fat off profits, but it's also seen its share price slim dramatically: VIVUS (NASDAQ:VVUS)
An opportunity wasted?
Not to take anything away from what VIVUS has accomplished by bringing Qsymia, its chronic weight management drug, to market, but sales in its first few quarters have been absolutely dreadful. Part of the blame rests with insurers, which were slow to cover Qsymia, because we know all too well that consumers usually won't pay for drugs out of pocket. However, the remainder of blame I place on VIVUS for not seeking a marketing partner for its fat-busting drug.
What's truly saddening (and maddening) about Qsymia's sales potential is that it has an honest chance at being the top dog among anti-obesity drug makers. Arena Pharmaceuticals' (NASDAQ:ARNA) Belviq, which was approved just a few weeks prior to Qsymia, offers a marginally better safety profile based on the clinical trial results, but Qsymia delivered the higher percentage of patients that lost 5% of more of their weight. Yet, even with Belviq stuck on the sidelines for months waiting for scheduling from the Drug Enforcement Agency, Qsymia failed to prosper. Worse yet for VIVUS, the DEA finished labeling Belviq as a schedule IV drug, and it could find its way onto pharmacy shelves in less than two weeks!
Arena, unlike VIVUS, has made the smart move of partnering up with Eisai Pharmaceuticals in most of North and South America and Ildong Pharmaceuticals in South Korea. Sure, Arena will be giving up some of its potential revenue, but it also gives Arena an experienced marketing staff and the ability to let Eisai handle the marketing and authorization costs in certain regions of the world.
What's more, competition in the sector could be ready to heat up with Orexigen Therapeutics (NASDAQ:OREX), which concluded patient screening for its Light Study of 9,000 patients in December and is expected to report on the safety of its anti-obesity drug, Contrave, sometime in the second half of the year. If all goes well with these safety trials -- Contrave was rejected by the FDA once before over concerns that it posed an unacceptable cardiovascular risk -- we could see a new drug approval resubmission very soon!
In other words, VIVUS needs to get off its laurels and either beef up its marketing or make the humbler and smarter move of finding a marketing partner before it's too late.
Bristol teamed up with AstraZeneca (NYSE:AZN) to purchase Amylin Pharmaceuticals and its portfolio of diabetes drugs in 2012 for $7 billion. With obesity rates in the U.S. rising rapidly, the deal made a lot of sense for both parties -- if not for the fact that it's in a rapidly growing disease, because both companies' pipelines are aging. In addition, the two have teamed up on revolutionary new SGLT-2 inhibitor Forxiga, which is approved in Europe.
For Bristol, forging a marketing deal with VIVUS would make a lot of sense because it would continue to vertically integrate and tie-in its growing diabetes pipeline with VIVUS' weight-loss drugs. These two classes of drugs (diabetes and weight loss) work to the same end of controlling glycemic balance and inducing weight loss to help us live longer and healthier lives. For VIVUS, it would get a marketing partner with incredible experience and someone to help bear the burden of increased marketing expenses.
Stay tuned as tomorrow I'll reveal my second of three biotech companies that would be wise to seek out a marketing partner.
Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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