Amylin and Alkermes clearly had to work hard to create Bydureon, but the results are a mixed bag that diminishes the advantage of a once-weekly injection schedule.
In the interest of brevity, I'll touch briefly on other potential problems: Amylin must market Bydureon without a partner, since Eli Lilly (LLY) abandoned ship in late 2011 after a decade-long collaboration. Bydureon causes twice as many efficacy-sapping anti-drug antibodies as Byetta. Then there's the mysteriously absent "Section 15" in the Bydureon label. (Even conspiracy theorists have yet to notice that the drug's label seems to be missing a section; my guess is the FDA nixed something at the last minute.)
We could also just take a step back and consider the simplest view: Amylin submitted the Bydureon New Drug Application (NDA) under section 505(b)(2), a regulatory pathway intended to streamline FDA approval for reformulations of marketed drugs. (This explains why Bydureon's long-term safety database is very limited.) By using this route to land Bydureon's approval, Amylin tacitly acknowledges that the drug is a slightly but not drastically different version of Byetta. As such, why should we expect something vastly different from the drug's sales trajectory? It is almost always better to have more, rather than fewer, treatment options, but does that make Bydureon a blockbuster?
I doubt it.One last word: Amylin bulls believe the company is a hot takeover target. I think not. Given the considerable investment necessary to sell Bydureon, an increasingly competitive landscape for diabetes drugs, and the uncertainty of success, I don't see what makes Bydureon such a compelling asset. It's impossible to say with certainty that Amylin won't be taken out, but at these prices there are probably better bets to make. Disclosure: Sadeghi has no position in Amylin or any other stocks mentioned in this column.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV