Over the last few weeks, Human Genome Sciences has moved out of Wall Street's dog house and become an overnight darling of the investor crowd. And the company did it the old fashioned way--with surprisingly promising data from a late-stage study of its lupus drug, Benlysta, and a sizeable government contract for their anthrax treatment.
A few months ago, HGS looked like it was tilting against windmills. Now it appears poised to make a crucial step, changing from a developer focused on late-stage drug trials to a more fully developed biopharma company with a small marketing force under its wings and some bright revenue prospects. And the next few months will tell the tale.
While failure in biotechnology is an orphan, success in this kind of feverish M&A market almost immediately triggers reports of pending takeover attempts. And partnered as it is with GlaxoSmithKline and Novartis, HGS shares have benefited from the market rumors that have flared up.
I took some time recently to ask Human Genome Sciences (HGSI) CEO Tom Watkins to review recent events, and get some insights into where the company is headed.
FierceBiotech: In an industry where nothing just happens overnight, where discovery is a long slow grind, you've been ringing a series of milestone bells on late-stage data and contracts. Was that a coincidence?
Watkins: I have to tell you the market and Wall Street was probably surprised, but we've been saying pretty consistently that these kinds of things were coming. But you never know for sure what clinical data will show you.
FierceBiotech: Looking ahead a year, what kind of company do you see?
Watkins: At the end of 2010 it's very possible this company will have two approved drugs that have enormous potential each: Benlysta (belimumab) and Zalbin (albinterferon-alfa 2b for chronic hepatitis C). The plans are to submit a BLA for Zalbin in the fourth quarter and plan for approval in the latter part of 2010. With successful positive data in a second Phase III trial for Benlysta unblinded in November, the timeline is for a BLA in the second quarter of next year. Were we to achieve an accelerated review, we could be launching that in the fourth quarter of next year.
We've already delivered 20,000 doses (of the antibody drug ABthrax, or raxibacumab) to the stockpile under the contract we have with HHS. In July, you saw a second order, or follow-on order, of 45,000 additional doses, and we'll begin shipping at the end of '09, 2010 and 2011. In a sense our first product sales have already come to the company. Of course, it's a different product with a single customer and no traditional promotion involved.
We have a marketing-planning group now. In 2010, as we move along this timeline for the build-out of the company organization, we do expect to have our own sales resources for Benlysta and Zalbin.
FierceBiotech: You've looked at projections on gaining a quarter of the lupus market, which is worth a billion dollars. You're planning to sell Benlysta to patients for $20,000 a year, Leerink Swann analyst Eric Varma said that Benlysta could garner upwards of $7 billion a year by 2015. What do you see as the upside here?
Watkins: It's easy to come up with all kinds of different numbers and some are very large just in the lupus field, where there has been no new product in 50 years. Clearly there's a huge unmet need, where patients are anxious for new options. Look at the numbers: 300,000 patients that have lupus in the U.S. We used a couple hundred thousand with moderate to severe lupus. If you take 50,000 patients in the U.S., clearly only a portion of the market, that's still a very sizeable drug in the U.S. alone. The potential is certainly immense; the patient need is high.