Five FDA Approvals and Reviews at Risk Under a Government Shutdown
It looks like Congress and the president still cannot figure out how to play well with each other, and now we have another impending government shutdown. The reality is that some government offices will shut entirely and others would run on skeleton crews. You might not get government economic reports until things return to normal. One other big risk is the U.S. Food & Drug Administration. It turns out that several pharmaceutical and biotech drug candidates have pending FDA reviews in the month of October.
In the first three weeks of October various FDA reviews are due for Pfizer Inc. (NYSE: PFE) and Ligand Pharmaceuticals Inc. (NASDAQ: LGND), followed by Antares Pharma Inc. (NASDAQ: ATRS), Amarin Corp. PLC (NASDAQ: AMRN), one for pSivida Corp. (NASDAQ: PSDV) and Alimera Sciences Inc. (NASDAQ: ALIM), and a final one for AMAG Pharmaceuticals Inc. (NASDAQ: AMAG).
The reality is that until the FDA or the companies make announcements, investors will be in the dark over how these FDA approvals are progressing. If the government shutdown lasts for more than three weeks, then other Prescription Drug User Fee Act (PDUFA) dates likely will be at risk also.
Pfizer Inc. (NYSE: PFE) and Ligand Pharmaceuticals Inc. (NASDAQ: LGND) have a PDUFA date of October 3, 2013, for the new drug application of bazedoxifene conjugated estrogens. The review is for symptoms associated with menopause and for the prevention of osteoporosis, both of which have big upside in sales if ultimately approved. BZA/CE has been studied in a Phase III clinical development program made up of approximately 7,500 postmenopausal women. Ligand’s share price of $42.10 generates a market cap of $860 million, and its 52-week trading range for its stock is $14.75 to $50.85.
Antares Pharma Inc. (NASDAQ: ATRS) has an assigned a PDUFA date of October 14, 2013, for its Otrexup new drug approval. This is its self-administration of methotrexate to boost the treatment of rheumatoid arthritis. Antares has a small market value of $520 million, and its $4.08 share price compares to a 52-week range of $3.35 to $4.67.
Amarin Corp. PLC (NASDAQ: AMRN) has an October 16, 2013, review date for Vascepa’s supplemental new drug application. The FDA panel is set to review Vascepa in combination with approved statins to help reduce triglycerides in the blood. Some 6,000 patients have been involved in the trial. Amarin’s $6.45 share price generates a market cap of $1.1 billion, and shares have a tough year as the 52-week range is $5.12 to $12.96 after raising $121 million in a summer stock sale. Vascepa is the company’s only product and is approved as an adjunct to diet for reducing triglyceride levels. Amarin hopes that Vascepa will be approved for the treatment of adults with high triglyceride levels as an expansion of its target audience.
pSivida Corp. (NASDAQ: PSDV) has a review of ILUVIEN for the treatment of chronic diabetic macular edema (DME). The FDA accepted a resubmission of this from Alimera Sciences Inc. (NASDAQ: ALIM) of the new drug application for ILUVIEN for DME, with a PDUFA date of October 17, 2013. Alimera has been granted marketing authorization for ILUVIEN for DME in six EU countries, and it already has began the commercial launch in Europe. Please note on this that a press relations person wanted to clarify as follows: “Alimera has licensed the delivery device from pSivida, and Alimera is the company that developed and submitted the new drug application for ILUVIEN to the FDA. pSivida has not been involved in working with the FDA on the review of ILUVIEN.” pSivida has a share price of only $4.10, and a 52-week range of $1.17 to $4.28, with a market cap of only $95 million. Alimera trades at $3.72, with a $117 million market cap, and its 52-week range is $1.26 to $5.69. Please note a clarification from the
AMAG Pharmaceuticals Inc. (NASDAQ: AMAG) has a review date of October 21, 2013, for its Feraheme supplemental new drug application. This would be a decision to expand its indication beyond treatment of iron deficiency anemia in adult patients with chronic kidney disease to adult patients with iron deficiency anemia who have not been responsive to oral iron. AMAG shares were recently knocked down by more than 10% after the FDA disclosed a notification of deficiencies in the application. This was not a final decision and the meeting date of October 21 appears to be left intact. AMAG trades at $21.30, against a 52-week range of $13.85 to $27.00, and its market cap is $462 million.
FierceBiotech.com warned last week that “it seems clear that a government shutdown would delay PDUFA dates for any companies looking to get a near-term approval.” As with any PDUFA date, these often change or get pushed out even without worries of a government shutdown. Some of these dates may hold and some may not.