) -- Thirteen biotech predictions for 2013:
1. The U.S. commercial launch of
weight-loss pill Belviq will be a major disappointment. Belviq will also fail to receive European approval.
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.
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.
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:
raises money at least twice. (I needed at least one prediction guaranteed to come true.)
will be the best-performing large-cap biotech in 2013.
13. Strong 2013 drug launches:
(BG-12), Onyx Pharma (Kyprolis).
Weak 2013 drug launches: Arena Pharma (Belviq), Amarin (Vascepa),
Here's a look back at how well my
strategy of returning cash to shareholders in form of share buybacks, Dutch tender offers and dividends is abandoned in favor of ramped up acquisitions i.e. Gilead Sciences buying Pharmasset. Large-cap biotech firms start acting like Big Pharma -- choosing to buy growth instead of seeking it from internal drug development.
Correct: Amgen remains the only biotech firm to offer a dividend. Amgen bought
; Gilead Sciences bought
( YMI); Biogen Idec acquired
; and Celgene acquired
2. After much wrangling, lawmakers pass important PDUFA V legislation but it's amended to prohibit FDA from issuing drug approval decisions on Friday evenings.
Correct. PDUFA V was passed and signed into law, although FDA still hasn't figured out how to avoid Friday drug-approval decisions.
3. Cancer immunothera-flop: Phase III cancer "vaccine" studies being run by
(Stimuvax in non-small cell lung cancer) and
(Allovectin in melanoma) both fail. The only positive clinical news in cancer immunotherapy in 2012 will come from
with its Mage-A3 therapy, in phase III for melanoma.
Partly correct. Stimuvax failed. Results from the respective Vical and Glaxo studies were pushed into 2013. I still believe the Vical drug fails while Glaxo will be positive.
4. By the end of the year, one or more of these companies will be gobbled up in an M&A deal:
, Celgene, Biomarin Pharmaceuticals,
, Onyx Pharma,
Incorrect. A big zero. None of my takeout picks were taken out. There's always this year.
5. Cell Therapeutics exits 2012 the same way it started -- with pixantrone still not approved anywhere. The only changes at the company will be to its share count and executive compensation -- both higher; and stock price -- lower.
Mostly correct. European regulators approved pixantrone, now known as Pixuvri, in May although Cell Therapeutics has yet to launch the non-Hodgkin's lymphoma drug. Cell Therapeutics' share count ended the year higher, its stock price much lower.
6. Roche doesn't buy
despite a half-dozen additional
articles penned by "Jeremy Richards" claiming otherwise.
Correct. Aeterna Zentaris is still single and "Jeremy Richards" disappeared.
7. Leucovorin shortages end, so too does
Correct. Leucovorin shortages have eased although not ended entirely but Spectrum shares ended the year down 24%.
cystic fibrosis drug Kalydeco will be approved. More importantly, studies testing Kalydeco combined with other Vertex's cystic fibrosis drugs will show strong benefit in a larger swath of patients. Vertex becomes a cystic fibrosis company. Hepatitis C? What's that?
Correct. Kalydeco was approved in January -- in my opinion, the most important drug approval in 2012. The Kalydeco-VX-809 combination study was successful, even though the Street is still debating the magnitude of the regimen's benefit to cystic fibrosis patients.
9. FDA rejects obesity drugs from Arena Pharmaceuticals and
for a second time.
Incorrect. My lamest prediction of 2012. I'll did better when I later warned of a disappointing launch for Vivus' Qsymia and I'll be right when Arena's Belviq launch flops in 2013.
10. Celgene will be the best-performing large-cap (market cap greater than $10 billion) biotech stock in 2012.
Incorrect: Celgene finished 2012 up a respectable 16%. Unfortunately, Gilead, Biogen and Amgen all posted stronger returns.
-- Reported by Adam Feuerstein in Boston.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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