BOSTON ( TheStreet) -- Thirteen biotech predictions for 2013:
1. The U.S. commercial launch of Arena Pharmaceuticals (ARNA) and Eisai's weight-loss pill Belviq will be a major disappointment. Belviq will also fail to receive European approval.
2. Sarepta Therapeutics (SRPT) will have another big year, with an accelerated approval filing mid year for the Duchenne muscular dystrophy drug eteplirsen in the U.S. and a significant and lucrative ex-U.S. partnership for the company's exon-skipping drug technology platform.
3. Orphan drug pricing comes under scrutiny and increasing criticism.4. The Nasdaq Biotechnology Index will close 2013 flat or down single digits. 5. Amarin (AMRN) delays the commercial launch of its triglyceride-lowering fish-oil pill Vascepa to the second quarter due to manufacturing and supply issues. Vascepa sales fail to meet lowered expectations. 6. Gilead Sciences (GILD) hits a snag that delays the filing, approval or launch of its all-oral hepatitis C drug regimen. Investors also wake up to the realization that the commercial market for Hep C drugs is far smaller than expected. Gilead shares close in the red for the year. This is my Black Swan prediction for 2013. 7. FDA takes steps to liberalize overly restrictive conflict-of-interest rules that are preventing "A list" medical and scientific experts from participating in advisory committee meetings. 8. U.S. courts decide that off-label drug marketing is a form of constitutionally protected free speech and therefore legal. 9. "Expert networks" Gerson Lehrman Group and Guidepoint Global see a significant drop off in investor and doctor participation. Revenues plummet and the two companies either merge or one goes out of business. 10. By the end of the year, one or more of these companies will be gobbled up an M&A deal: BioMarin Pharmaceuticals (BMRN), Onyx Pharmaceuticals (ONXX), Medivation (MDVN), Achillion Pharmaceuticals (ACHN) and Incyte (INCY). 11. Cell Therapeutics (CTIC) raises money at least twice. (I needed at least one prediction guaranteed to come true.) 12. Celgene (CELG) will be the best-performing large-cap biotech in 2013. 13. Strong 2013 drug launches: NPS Pharma (NPSP) (Gattex), Medivation (MDVN) (Xtandi), Aegerion Pharma (AEGR) (Juxtapid), Roche (RHHBY) (T-DM1), Biogen Idec (BIIB) (BG-12), Onyx Pharma (Kyprolis). Weak 2013 drug launches: Arena Pharma (Belviq), Amarin (Vascepa), Ariad Pharma (ARIA) (Iclusig), Alexza Pharma (ALXA) (Adasuve), Navidea Biopharma (NAVB) (Lymphoseek), AVEO Pharma (AVEO) (tivozanib.) Here's a look back at how well my 2012 predictions fared:
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $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
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV