3 Things In Biotech You Should Learn Today: July 9, 2017

Summary

• Inotek combo trial flops in glaucoma.
• Elite Pharmaceuticals suffers a setback, too.
• Pfizer's ODAC meeting for an AML drug poses some ominous challenges.

Welcome to another edition of "3 Things in Biotech You Should Learn Today," a daily series dedicated to helping you sift through the avalanche of pharma news to help solidify your due diligence and find companies you may not be considering.

Let's jump in!

Inotek combo trial flops in glaucoma

The small-cap Inotek (ITEK) has been developing a fixed-dose combination of its own investigational compound, trabodenoson, and the approved prostaglandin F2alpha analog latanoprost for the treatment of glaucoma. Since a recent phase 3 trial of trabodenoson alone failed to yield benefit over placebo, a lot has been riding on the continuing development of the combination.

Unfortunately, it was not meant to be. ITEK announced data from the fixed-dose combination study that showed that the combination failed to significantly improve intraocular pressure compared with latanoprost alone.

The combination was well tolerated, but the lack of efficacy does not spell good things for the further development of trabodenoson.

Looking forward: Like I said, this combo study meant a lot to ITEK, as this is rapidly approaching the end of the line for them. With no other compounds in the pipeline, if they decide to suspend development of their lead compound here, it's difficult to imagine where they'll be able to head next. They maintain about a year's worth of capital at this time, but can they move forward? Shareholders don't seem to think so, as the valuation of the company hovers in microcap limbo.

Elite Pharmaceuticals suffers a setback, too

Elite Pharmaceuticals (OTCQB:ELTP) is a specialist in the development of generic pharmaceuticals, so their main trials are going to be relating to small-scale bioequivalence studies, which comprise a foundational core of their submissions to the FDA.

One of their late-stage agents is an equivalent version of an abuse-deterrent combination of naltrexone and oxycodone, branded SequestOx.

ELTP announced top-line data from a bioequivalence study compared with Roxicodone, specifically to compared the time where the drug is at maximal blood concentration (Tmax) following a high-fat meal.

Unfortunately, SequestOx had a significantly longer Tmax than the comparator, which is bad news considering that this study was required by the FDA as part of their complete response letter to the company from last July. ELTP have decided to pause the clinical development for SequestOx until they get some clarification on how to proceed from the FDA.

Looking forward: The difference of the Tmax values don't seem THAT different, 4.6 vs. 3.4 hours for SequestOx and the comparator, respectively. However, it's important to recall that the FDA takes the "equivalence" part very seriously when considering generic pharmaceuticals. And the consequences could be significant here, as patients would potentially be exposed to the opiate longer, with unknown effects as far as adverse events and abuse potential. It's tough to tell exactly where ELTP will take SequestOx next, given these results.

Pfizer's ODAC meeting for an AML drug poses some ominous challenges

Pfizer (PFE) has been developing an antibody-drug conjugate called gemtuzumab ozogamicin (branded Mylotarg) for treatment of patients with acute myeloid leukemia (AML), a serious unmet need. Back in January, PFE announced that their new drug application with the FDA had been accepted.

Now, they face an upcoming oncology drug advisory committee meeting, which will determine if their agent is sufficiently effective and safe to receive the nod in terms of clinical science. This is one extremely important component of the FDA approval process, which pharma companies take very seriously.

The FDA has provided PFE with the briefing document for this meeting, which outlines the potential questions and concerns that PFE will need to address to the ODAC.

Several challenges were raised in this particular brief, with potential concerns relating to pivotal trials showing sufficient efficacy and lack of overall survival benefit from gemtuzumab ozogamicin. Perhaps more alarming was the safety question: gemtuzumab ozogamicin appears to increase the risk of veno-occlusive disease, a condition whereby an agent damages tissue in the liver, leading to life-threatening complications.

Looking forward: It's not possible to predict with accuracy whether PFE will be able to sufficiently address the concerns of the ODAC here, though we have seen other companies come through with a thumbs up despite significant questions. No doubt, PFE is working overtime to get their ducks in a row for this meeting, and the results will be well worth watching. AML remains a substantial unmet need for patients.

Conclusions

So today we have some dark clouds floating overhead, with some trial failures, clinical pauses, and looming challenges for the drugs we've talked about. Hopefully, later we can keep on the optimistic stuff.

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Analyst’s Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.