2010 FDA Approvals Could Lead to Launch of Eight Blockbuster Biotech Drugs

(MoneyWatch)  It's shaping up to be a big year for FDA decisions on biotech drugs. 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 Therapeutics (ACOR)'s multiple sclerosis walking drug Ampyra (dalfampridine) and Auxilium (AUXL)'s Xiaflex (collagenase clostridium 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 Genome Sciences (HGSI)'s lupus drug Benlysta (belimumab).

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; $500M
• 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. ?; $1.25B
• 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; $1B
• March or July?: Amgen (AMGN) bone drug Prolia. $95M; $4B
• 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. $209M; $265M
• Late Oct: Vivus (VVUS) obesity drug Qnexa. ?; $1B
• Late Oct: Arena (ARNA) obesity drug lorcaserin. ?; $850M
• TBD: Orexigen (OREX) obesity drug Contrave. ?; $1B
• TBD: MannKind (MNKD) diabetes drug Afrezza. $25M; $597M

*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.

Want More?

• Biotech Events to Watch in 2010: FDA Approvals, Expected Deals and Surprises!