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Key FDA Events to Watch Out for in Jul 2017

Halfway into the year and the FDA has already crossed its total tally of 22 approvals in 2016. So far in 2017, the FDA has given its nod to 23 novel drugs including 2 in June. Key approvals so far in 2017 include Regeneron/Sanofi’s Kevzara (rheumatoid arthritis), Roche’s multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, Portoloa’s Bevyxxa (prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness) and BioMarin’s Brineura (treatment of a specific form of Batten disease) among others. Some of these drugs have blockbuster potential.

With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance and could act as major catalysts. Here is a look at a few important regulatory events scheduled for the month of July.

Puma’s Neratinib Set for FDA Approval?

Puma Biotechnology, Inc. PBYI looks set to gain FDA approval for its first drug, neratinib. Neratinib is under review for the extended adjuvant treatment of HER2+ early stage breast cancer based on a favorable risk-benefit profile. According to information provided by Puma, about 36k patients in the U.S. and 34k in the EU suffer from early stage HER2+ breast cancer. If approved, neratinib would be used in year 2 after adjuvant Herceptin, which generated adjuvant revenues of about $4.5-$5 billion in 2015 (year 1).

Currently, chances of gaining FDA approval look pretty good considering neratinib got support from the FDA’s Oncologic Drugs Advisory Committee. The panel voted 12 - 4 in favor of approving neratinib based on a favorable risk-benefit profile. While the FDA is not required to follow the advice of its advisory panels, it usually does so. A response from the agency is expected this month.

Puma’s shares are up 184.7% YTD, outperforming the Zacks-categorized Medical-Biomedical/Genetics industry which is up 6.5% so far in 2017.

Second Time Lucky for Ocular’s Dextenza?

Eye-disease focused Ocular Therapeutix, Inc. OCUL is awaiting a response from the FDA for Dextenza for the treatment of ocular pain following ophthalmic surgery this month. A decision is expected on Jul 19. Ocular had initially submitted a new drug application (NDA) for the treatment in Sep 2015 -- however, the FDA responded with a complete response letter (CRL) in Jul 2016 following which the company resubmitted the NDA. Ocular got an FDA Form 483 following a re-inspection of manufacturing operations that was completed in early May 2017.

Ocular’s shares are up 10.8% so far in 2017, performing better than the Zacks-categorized Medical-Drugs industry which is up 5.6% year-to-date (YTD). Dextenza’s approval would be a major boost for the stock. Once approval comes for the post-surgery ocular pain indication, Ocular intends to seek FDA approval for post-surgical ocular inflammation. Dextenza is being evaluated for the treatment of allergic conjunctivitis as well.

Another Indication for Eagle’s Ryanodex?

Eagle Pharmaceuticals, Inc. EGRX is currently seeking FDA approval for the use of Ryanodex for external heat stroke (EHS). There is significant unmet medical need for EHS with many patients facing long-term neurological damage as well as organ damage. The FDA granted priority review to Ryanodex -- currently, no approved drug is available for the treatment of EHS.

The FDA is expected to deliver a decision on Jul 23. Eagle Pharma is preparing for the potential launch with the company building a 50 person sales team to support the launch. The company is working on expanding the label of Ryanodex further.

Eagle Pharma’s YTD performance has been disappointing with shares declining 0.6% while the Zacks-categorized Medical Products industry has gained 20.9%.

CRL for Amgen/UCB Drug?

Amgen AMGN and partner UCB’s UCBJF experimental osteoporosis drug, Evenity, is under FDA review with a response expected on Jul 19. However, the companies’ plans for the treatment have stumbled with a new safety signal emerging in a late-stage study. Although Evenity met both the primary endpoints and the key secondary endpoint in the study, the companies said that an imbalance in positively adjudicated cardiovascular serious adverse events was observed. Based on the new safety event, Amgen said that it does not expect FDA approval in 2017. Given this development, the FDA will most likely issue a CRL on the PDUFA date.

Amgen’s shares are up 17.8% YTD, outperforming the Zacks-categorized Medical-Biomedical industry while UCB’s shares are up 13.6%.

FDA Advisory Panel Meetings for Pfizer, Novartis, Amgen, Intellipharmaceutics & Mylan Drugs

Apart from the above decisions, there are quite a few advisory panel meetings scheduled for this month.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) will be meeting on Jul 11 to discuss Pfizer’s regulatory application for Mylotarg -- the company is looking to get the product approved for use in combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo acute myeloid leukemia (AML).

Meanwhile, all eyes will be on the outcome of the Jul 12 meeting of the ODAC when Novartis’ NVS CAR-T treatment, tisagenlecleucel-T, will be reviewed for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).

Jul 13 will see the ODAC discussing regulatory applications for the biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab) submitted by Amgen and Mylan, respectively.   

Intellipharmaceutics’ IPCI Rexista abuse-deterrent oxycodone hydrochloride extended release tablets will be reviewed on Jul 26 in a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee. A final decision from the FDA is expected on Sep 25.

Intellipharmaceutics is a Zacks Rank #2 (Buy) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

And then later this month, on Jul 28, the Vaccines and Related Biological Products Committee (VRBPAC) will meet to discuss and make recommendations regarding the safety and efficacy of Dynavax’ hepatitis B vaccine.

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