Attention Biotech Investors: February PDUFA Catalysts Come Calling

Although the action was light on the FDA approval front, biotech stocks took the spotlight in January, thanks to a few multi-billion-dollar deals announced in the space.

Celgene Corporation CELG announced a deal to buy Juno Therapeutics Inc JUNO.

Ahead of that deal, Celgene also inked a buyout deal with privately-held Impact Biomedicines for an upfront payment of $1.1 billion.

Sanofi SA (ADR) SNY agreed to acquire rare blood disease drug company Bioverativ Inc BIVV in a $11.6 billion all-cash deal.

The iShares NASDAQ Biotechnology Index (ETF) IBB and the SPDR S&P Biotech (ETF) XBI gained 11.16 percent and 8.52 percent, respectively, for the month-to-date period. The gains came on top of the 21 percent and 43 percent advances for the ETFs in 2017.

Let's look ahead atwhat is in store for February from the perspective of FDA decisions.

AMAG Seeks Label Extension For Iron Deficiency Anemia Treatment

• Company: AMAG Pharmaceuticals, Inc. AMAG
• Type of Application: Supplemental New Drug Application, or sNDA
• Candidate: Feraheme
• Indication: Treating all adults with iron deficiency anemia
• Date: Feb. 2, 2018

AMAG Pharma accepted the sNDA for Feraheme to treat all adults with iron deficiency anemia, who have an intolerance or unsatisfactory response to oral iron, on Aug. 31, 2017.

Feraheme or ferumoxytol, is indicated to treat iron deficiency anemia in adults with chronic kidney disease.

Gilead Knocks The FDA Altar For its HIV Cocktail

• Company: Gilead Sciences, Inc. GILD
• Type of Application: New Drug Application, or NDA
• Candidate: Bictegravir and emtricitabine/tenofovir alafenamide
• Indication: HIV-1 treatment
• Date: Feb. 12, 2018

Following Gilead's filing of the NDA for the drug combo with a priority review voucher on June 12, 2017, the FDA set an action date of Feb. 12, 2018. The NDA submission was based on four Phase 3 studies that evaluated the fixed-dose combination among treatment-naïve patients and among virologically suppressed patients.

Meanwhile, GlaxoSmithKline plc (ADR) GSK may be prepping to initiate a lawsuit against Gilead over bictegravir, alleging that the HIV drug infringed its portfolio, Barron's reported quoting RBC Capital Market analyst Brian Abrahams.

See Also: Pharma M&A Picks Up Momentum

Valeant In-Licensed Bowel Treatment Candidate Up For Approval

• Company: Valeant Pharmaceuticals Intl Inc VRX
• Type of Application: NDA
• Candidate: Plenvu
• Indication: Bowel cleansing, with additional focus on ascending colon
• Date: Feb. 13, 2018

Valeant in-licensed the U.S. and Canadian rights for Plenvu, or NER 1006 from Holland-based Norgine BV in 2016.

Plenvu is a low-volume polyethylene glycol-based bowel preparation meant for complete bowel cleaning, with an additional focus on ascending colon.

The FDA accepted Norgine's NDA for Plenvu on June 28, 2017. The company is aiming for a launch date somewhere in the first quarter of 2018

AMAG/Antares Pharma Looking to Deliver With Makena For Cutaneous Use

• Company: AMAG Pharma/ Antares Pharma Inc ATRS
• Type of Application: sNDA
• Candidate: Makena auto-injector
• Indication: Reducing the risk of preterm birth in pregnant women with a single baby having a history of singleton spontaneous preterm birth
• Date: Feb. 14, 2018

AMAG submitted the sNDA for its drug-device combination product Makena, chemically hydroxyprogesterone caproate injection, auto-injector for subcutaneous use on April 17, 2017. The company is jointly developing this subcutaneous formulation with Antares.

The application was accepted for review in June 2017, with the PDUFA data set for Feb. 14, 2018.

Makena intramuscular injection has already been approved for the indication in the past.

Although AMAG indicated last April that it anticipated the FDA decision to come through in the fourth quarter of 2017 following a six-month FDA review period, it later said the FDA was shooting for a standard 10-month review instead of the previously communicated six-month review.

Apricus' Second Attempt

• Company: Apricus Biosciences Inc APRI
• Type of Application: NDA
• Candidate: Vitaros
• Indication: topical cream for treating erectile dysfunction
• Date: Feb. 17, 2018

Apricus announced on Aug. 31, 2017, the FDA accepted its resubmitted NDA for Vitaros, considering it a complete class 2 response to the company's 2008 action letter.

Will It Be Pain Or Gain For KemPharma?

• Company: KemPharm Inc KMPH
• Type of Application: NDA
• Candidate: KP201/APAP
• Indication: short-term management of acute pain
• Date: Feb. 23, 2018

KemPharma announced FDA acceptance of the NDA for KP201/APAP on Feb. 10, 2016, granting it priority review status. The PDUFA action date was initially set for June 9, 2016.

However, on June 13, 2016, the FDA issued a Complete Response Letter, or CRL. Subsequently, on Sep. 12, 2017, the company said it has completed the Formal Dispute Resolution Request process by submitting an amended NDA. The FDA set a new PDUFA action date of Feb. 23, 2018 for this abuse-deterrent product candidate meant for short-term management of acute pain.

Will Second Time Be a Charm For Sorrento's Pain Patch

• Company: Sorrento Therapeutics Inc SRNE
• Type of Application: NDA
• Candidate: ZTlido, or lidocaine patch 1.8 percent
• Indication: Treating pain associated with post-herpetic neuralgia, a severe neuropathic pain condition
• Date: Feb. 28, 2018

The FDA accepted Sorrento's resubmission of the NDA for its lead product candidate ZTlido on Sep. 12, 2017, acknowledging it as a complete class 2 response to the prior action letter. Giving it a standard six-month review period, typical for a class 2 response, the PDUFA action date was set as Feb. 28, 2018.

The company said it planned for a commercial launch in the U.S. in 2018, contingent on the FDA approving the patch.

Vertex Seeks FDA Nod For Expanded Label Of Cystic Fibrosis Drug

• Company: Vertex Pharmaceuticals Incorporated VRTX
• Type of Application: NDA
• Candidate: Tezacaftor (VX-661)/ivacaftor
• Indication: treating cystic fibrosis
• Date: Feb. 28, 2017

Vertex announced on Aug. 24, 2017, FDA acceptance of its applications for tezacaftor/ivacaftor combo for treating cystic fibrosis in people aged 12 years and older, who either have two copies of F508del mutation or one F50del mutation and one residual function mutations that is responsive to the combo.

With the FDA according priority review status, the PDUFA action date falls on Feb. 28, 2018.

Adcom Meeting Schedule

Pacira Pharmaceuticals Inc PCRX's sNDA for exparel is set to be evaluated by the Anesthetic and Analgesic Drug Products Advisory Committee on Feb. 14, 2018. The PDUFA action date for the sNDA is April 6, 2018.

The filing is based on positive Phase 3 data on exparel in femoral nerve block for total knee arthroplasty and a Phase 3 study of exparel in brachial plexus block for shoulder surgeries.