1. The U.S. commercial launch of Arena Pharma 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.
So wrong.3. Orphan drug pricing comes under scrutiny and increasing criticism. Scrutiny? Definitely. Criticism? Yes, but perhaps not as much as I expected. 4. The Nasdaq Biotechnology Index will close 2013 flat or down single digits. Oy. 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. My bear call on Amarin kicked ass in 2013. 6. Gilead Sciences 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. Wrong, but then, it was my Black Swan prediction. 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. Wrong, even though complaints about the quality of FDA advisory panels are increasing. 8. U.S. courts decide that off-label drug marketing is a form of constitutionally protected free speech and therefore legal. Wrong. Too early. 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. Partially correct. Expert network firms remain in business but participation on both sides of the table is down. 10. By the end of the year, one or more of these companies will be gobbled up in an M&A deal: BioMarin Pharmaceuticals, Onyx Pharmaceuticals, Medivation (MDVN), Achillion Pharmaceuticals (ACHN) and Incyte (INCY). I got Onyx Pharma right! Given my historically horrible track record with M&A predictions, this is a breakthrough. 11. Cell Therapeutics raises money at least twice. (I needed at least one prediction guaranteed to come true.) Bingo. 12. Celgene (CELG) will be the best-performing large-cap biotech in 2013.
CELG data by YCharts Yes! 13. Strong 2013 drug launches: NPS Pharma (Gattex), Medivation (Xtandi), Aegerion Pharma (AEGR) (Juxtapid), Roche (ROG) (T-DM1), Biogen Idec (BIIB) (BG-12), Onyx Pharma (Kyprolis). Booyah! 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.) Taking a bow. -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
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