4Q Stock Wrap-Up: All's well that ends well

Two biotech tiers edge down in 4Q13, but all groups up for the year

Although two segments lost ground in 4Q13, all of biotech's market cap groups finished 2013 in the black.

Large caps valued at more than $5 billion led the way in the fourth quarter, tacking on 10%. The top tier gained 48% for the year, second only to the $1-$4.9 billion group, which closed up 51% in 2013 (see "Results by Market Cap, A11).

The two top tiers saw gainers overwhelmingly outnumber decliners 63 to 9 in 2013.

Endo Health Solutions Inc. was the best 4Q13 performer among the large caps. The majority of its 48% gain came during a week in early November in which the company announced strong earnings and a deal to acquire fellow specialty pharma Paladin Labs Inc. The deal is slated to close this half.

Runner-up Jazz Pharmaceuticals plc received a nice bump following 3Q13 earnings in November, and then jumped in December after announcing it would acquire rare disease company Gentium S.p.A. Jazz closed up 38% in 4Q13.

The largest decline in the $5 billion and larger segment came from Pharmacyclics Inc. The company fell 23% on profit taking following a stellar 74% gain in 3Q13 and FDA approval of Imbruvica ibrutinib in November.

FDA granted accelerated approval to Imbruvica to treat relapsed or refractory mantle cell lymphoma (MCL). The Bruton's tyrosine kinase (Btk) inhibitor also is under Priority Review to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL), with a Feb. 28 PDUFA date.

Puma Biotechnology Inc. and Paladin led the $1-$4.9 billion group. Puma popped in early December after reporting that a regimen containing the company's neratinib "graduated" from the adaptive Phase II I-SPY 2 trial. I-SPY 2 suggested a 78.1% Bayesian predictive probability of success in a Phase III trial in patients with HER2-positive/hormone receptor-negative breast cancer.

Neratinib is an inhibitor of EGFR1 (HER1; ErbB1), EGFR2 (HER2; ErbB2; neu) and EGFR4 (HER4; ErbB4) kinases.

Puma ended 4Q13 up 93%, while Paladin gained 91%.

The laggard in the segment, Amarin Corp. plc, fell 69% in the quarter following regulatory setbacks for its hypertriglyceridemia drug Vascepa icosapent ethyl. In October, an FDA panel voted against expanding Vascepa's label.

The ultrapure ethyl ester of eicosapentaenoic acid (ethyl-EPA) is approved in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels >500 mg/dL).

Later that month, the agency revoked an SPA for Amarin's Phase III ANCHOR trial, saying it no longer considers a change in serum triglyceride levels sufficient to "establish the effectiveness" of a compound for reducing cardiovascular risk in patients with triglyceride levels less than 500 mg/dL. Amarin is seeking to expand Vascepa's label based on the endpoint.

FDA then missed Vascepa's Dec. 20 PDUFA date, citing Amarin's request to reinstate the SPA for ANCHOR, which the agency said "remains under consideration."

Acceleron Pharma Inc. went public with a bumped-up IPO late in the third quarter, soared 33% in its first day of trading and went on to gain 78% in the fourth quarter. It was the best performance in the $500-$999 million group, which edged down 2% in 4Q13.

In the quarter, the company presented Phase IIa data for sotatercept in non-transfusion dependent beta-thalassemia and earned a $7 million milestone from partner Celgene Corp. after starting a

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