Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates

The weakness that surfaced in biotech in October in the wake of disappointing earnings from some companies in the sector extended into November. Notwithstanding the short-term weakness, biotech stocks are well in the green for the year-to-date period, as fears concerning a clamp down on price gouging eased over the year and amid hopes for reduced FDA regulations.

The iShares NASDAQ Biotechnology Index (ETF) IBB is down 1.39 percent in the month-to-date period. This compares to the S&P 500's 1.51 percent gain and the Nasdaq Composite's 2.25 percent advance.

FDA approvals slated for November mostly yielded positive outcomes. NME, or new molecular entities, approvals were brisk in November, with five NMEs gaining approval, taking the tally for the year to 40. In comparison, there were only 22 approvals for all of 2016. So what's coming up in Decmeber?

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Look Ahead

1. Mylan's Breast Cancer Biosimilar On FDA Altar After Extended Wait

• Company: Mylan N.V. MYL and India's Biocon
• Type of Application: BLA (Biologics License Application) Drug/Treatment
• Candidate: trastuzumab (Herceptin) biosimilar
• Indication: Adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer
• Date: Dec. 3

Mylan and Biocon had submitted the BLA to the FDA in November 2016, and with the standard review period being ten months, a PDUFA action date of Dec. 3 was set. The FDA's Oncologic Drugs Advisory Committee, which reviewed the drug in July voted 16-0, recommending approval of it. However, in late August, the FDA extended the review period by three months, citing the additional time needed to review some of the clarificatory information submitted as part of the application review process.

2. Will FDA Go With Committee Verdict for Novo Nordisk's Diabetes Drug?

• Company: Novo Nordisk A/S (ADR) NVO
• Type of Application: NDA (New Drug Application) Drug/Treatment
• Candidate: Semaglutide (once-a-week dosing)
• Indication: Glycemic control in adults with type 2 diabetes
• Date: Dec. 5

Novo Nordisk submitted the NDA for Semaglutide in December 2016. FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which met on Oct. 18, 2017, voted 16-0, in favor of approving the drug, with one committee member abstaining from the voting.

3. Aclaris Awaits Clarity On Skin Condition Treatment Candidate

• Company: Aclaris Therapeutics Inc ACRS
• Type of Application: NDA Drug/Treatment
• Candidate: A-101, 40% topical solution
• Indication: treating seborrheic keratosis, a common skin condition
• Date: Dec. 24

The FDA accepted Aclaris's NDA for A-101 in May, with the PDUFA action date set for Dec. 24, 2017.

4. Can Agile's Twirla Scale The FDA Barrier On Second Attempt?

• Company: Agile Therapeutics Inc AGRX
• Type of Application: NDA Drug/Treatment
• Candidate: Twirla (AG200-15)
• Indication: low-dose hormonal contraceptive patch
• Date: Dec. 26

Agile Therapeutics made a NDA resubmission in June after it was served with a Complete Response Letter, or CRL, in Februrary 2013, seeking a new clinical trial and provide additional information on the manufacturing process.

5. Valeant Pharma Eyeing Approval for Ocular Redness Drug

• Company: Valeant Pharma's VRX Bausch + Lomb unit
• Type of Application: NDA Drug/Treatment
• Candidate: brimonidine tartrate ophthalmic solution, 0.025% (Luminesse)
• Indication: treating ocular redness
• Date: Dec. 27

The company announced that the FDA has accepted the NDA for Luminesse, a topical vasoconstrictor formulation to be used over-the-counter as an eye drop to relieve redness of the eye due to minor eye irritations. The company claims, if approved, the drug will provide patients with significant benefits relative to other currently available treatment options.

6. Aeterna Zentaris On Second Try

• Company: Aeterna Zentaris Inc. (USA) AEZS
• Type of Application: NDA Drug/Treatment
• Candidate: Macimorelin Acetate (Macrilen)
• Indication: Evaluation of growth hormone deficiency in adults, or AGHD
• Date: Dec. 30

Aeterna Zentaris's NDA resubmission was accepted as a complete response letter in July, with the PDUFA action date set for Dec. 30, 2017. The company said in July, confident of the drug clearing the FDA hurdle, it has begun preparations to commercially launch it in the first quarter of 2018.

The company had a received a CRL for the therapy in November 2014, as the drug watchdog sought additional clinical trials and also suggested insufficiency of data for determining whether patients were accurately diagnosed with AGHD.

7. Pfizer Has Multiple PDUFA Catalysts

Pfizer Inc. PFE's sNDAs Xeljanz, 5mg twice daily, and an extended release 11mg dosings, are up before the FDA, seeking expansion in the usage to treat adult patients with active psoriatic arthritis. In August, FDA's Arthritis Advisory Committee voted 10 to 1 to recommend approval of the treatment. The PDUFA action date is set for December.

Pfizer and Avillion LLP announced FDA acceptance of their sNDA for Bosulif to expand its approved use to include patients with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myeloid leukemia.