It’s shaping up to be a big year for FDA decisions on biotech
products. And if all of those products get approved, the industry could
be looking at upwards of $20 billion in new peak annual sales.
Already the agency has approved Acorda
(ACOR)’s multiple sclerosis walking drug Ampyra
(dalfampridine) and Auxilium
histolyticum) for Dupuytren’s contracture.
Neither of those drugs is expected to reach blockbuster status (i.e.
more than $1 billion in annual sales), but several others coming up for
FDA approval decisions this year are — among them Amgen
(AMGN)’s osteoporosis drug Prolia
(denosumab) and Human
(HGSI)’s lupus drug Benlysta
Here’s a sneak peak at some of the biotech drugs scheduled to face
the FDA this year and how analysts expect them to perform (2010 sales
estimates are followed by peak sales estimates):
- Approved: Acorda (ACOR) Ampyra, MS walking. $70M; $280-500M
- Approved: Auxilium (AUXL) Xiaflex for Dupuytren’s. $24M; $400M
- Feb 12: Cadence (CADX) pain drug acetavance. $25M;
- Feb 13: Gilead (GILD) CF drug Cayston
(aztreonam). ?; $300M
- Feb 28: Shire (SHPGY) velaglucerase,
Gaucher’s. $75M; $300M
- March 5: Amylin (AMLN), Exenatide LAR, diabetes. ?;
- April 23: Cell Thera (CTIC) pixantrone,
lymphoma. ?; $50M-$1B*
- May 1: Dendreon (DNDN) Provenge,
prostate ca. $90M; $1.5B
- May 4: Intermune (ITMN) IPF drug pirfenidone. $36M;
- March or July?: Amgen (AMGN) bone drug Prolia.
- Late July: NicOx (COX.PA) arthritis drug
naproxcinod. ?; $1.5B
- Sept 25: Human Genome (HGSI) Benlysta,
lupus. $300M; $4B
- Late Oct: Shire Fabry drug Replagal.
- Late Oct: Vivus (VVUS) obesity drug Qnexa.
- Late Oct: Orexigen (OREX) obesity drug Contrave. ?; $1B
- TBD: Arena (ARNA) obesity drug lorcaserin. ?; $850M
- TBD: MannKind (MNKD) diabetes drug Afrezza. $25M;
*Note: Estimates for pixantrone sales are all over the map.
Granted not all of these drugs will receive approval…but if they did,
that could mean almost $1 billion in new sales this year and upwards of
$20 billion in annual sales at peak. And this list is by no means
comprehensive — you’ll notice some holes where I couldn’t find the info.
Nor does it count big pharma approvals or label expansions.