3 Things In Biotech, March 7: Aimmune Scores, Bristol-Myers Compresses, Dermira Bombs

Summary

• Aimmune shows up big in preventing peanut allergic reactions.
• Bristol-Myers lands their more favorable dosing schedule for nivolumab.
• Dermira bombs on phase 3 acne data.

Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication.

Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

Aimmune shows up big in preventing peanut allergic reactions

Company: Aimmune (AIMT)

Therapy: AR101

Disease: Peanut allergy

News: AIMT presented full results of their phase 3 PALISADE trial, which examined the ability of AR101 to prevent allergic reactions in patients with peanut allergy who were exposed to varying doses of peanut protein. These findings were formally presented at the 2018 American Academy of Allergy, Asthma, and Immunology-World Allergy Organization Joint Congress. At the exit challenge, AR101 led to a massive increase over placebo in patients who were able to tolerate each dose of peanut protein.

Looking forward: I covered the top-line data announcement for this back in February, but it's still important to see that the full data were reported and can be scrutinized, and with some more detail. For example, AIMT also divulged the usage of adrenaline in the exit challenge. Only 9% of patients in the AR101 arm needed adrenaline, compared with 44% in the placebo arm. AR101 was also associated with a relatively small rate of treatment discontinuation due to gastrointestinal adverse events (6.7%). But overall, these findings highlight some serious promise for AR101 in patients with peanut allergies, and I won't be surprised if Aimmune pursues approval later this year on the basis of these data.

Overall, a great reminder of very good news for Aimmune that portend big, important things for the company in 2018.

Bristol-Myers lands their more favorable dosing schedule for nivolumab

Company: Bristol Myers-Squibb (BMY)

Therapy: Nivolumab

Disease: Various forms of cancer

News: BMY announced that the FDA has granted approval to their supplemental application for nivolumab, expanding its use to include dosing at twice the strength (480 mg vs 240 mg) half as frequently. So now patients have access to a once-every-four-week schedule, making it the most convenient of the immune checkpoint inhibitors at this time.

Looking forward: If you follow my new monthly column "PDUFA Watch List," then this news won't come as a shock to you, as the date for the application's action date was well publicized. As it stands, this potentially gives BMY a significant edge over competitors, since doctors will have to make treatment decisions for their patients who may live far away from an infusion center. Considering nivolumab is equal to other immune checkpoint inhibitors in terms of efficacy (where it's approved), this could actually make a very big difference for the drug.

I think this is underrated great news for BMY, which may give them a serious edge over competitors in a crowded, rather undifferentiated space.

Dermira bombs on phase 3 acne data

Company: Dermira Inc (DERM)

Therapy: Olumacostat glasaretil

Disease: Moderate-to-severe acne vulgaris

News: DERM announced top-line findings from their two pivotal phase 3 trials assessing the anti-acne activity of olumacostat glasaretil. Unfortunately, although there was a numeric reduction in the number of non-inflammatory and inflammatory lesions compared with placebo, this fell well short of significance. Luis Peña, the chief development officer for DERM, indicated that the program will likely be discontinued.

Looking forward: Definitely bad news for DERM. Although this wasn't the only program (or even the most important one, arguably), having a failure in phase 3 is a very expensive way to find out the drug does not work as intended. And now DERM will need to rely more heavily on the hopeful approval of their topical drug for hyperhidrosis.

Overall, it's bad news, but it's definitely not the end of the line for DERM.

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Comments

[Germain Garand]

oh, and also they ended up being complementary with PCSK9i being brought in for worst cases where LDL levels could not be controlled by statins alone

[Germain Garand]

I think that's the same problematic as whether PCSK9 Mab inhibitors are statins killers.. Sure they work nicely, but they are so expensive for a limited benefit that it's very hard to get it covered by insurance. So in the end, good old cheap statins win and sales of PCSK9 inhibitors have been a disappointment.

[Keith Glanz]

Thank you Zach (sorry I spelled your name incorrectly above; brain quick, fingers slow). I appreciate you taking the time to delve into this tricky realm.

[Zach Hartman]

Hi Keith, thank you for reading and for your questions. My answers will be more generalized than coming from a place of expertise on Aimmune, in particular, an area where you clearly dwarf me.

Re: Price not appreciating on good news, take heart that Aimmune is not unique here, and secondary offerings are very common after big news for a company. They will look to shore up their cash position as best they can, and what better time than during the post-results glee?

1) Re: realistic timing - I would anticipate a filing for approval in 2H 2018 at the earliest, with approval then coming a year later or so. This would be the optimistic timeline, in my opinion, and assumes that the FDA accepts the app and that there are no delays in a decision. Of course, priority review could also speed things up, possibly to a 1H 2019 decision at the earliest.

2) While those reports you attempted to read are important and enlightening, they should be viewed with caution. There you can take my words as an insider on biomedical research. Cell-based and mouse-based research should only be taken with a major grain of salt, and I wouldn't trust this finding as relevant to humans until I see a convincing correlation in a clinical study. I suppose the natural hypothesis that you'd want to look out for would be "ANB020 will increase the risk of metastatic gastric and colorectal cancer." But I highly doubt this will be the case, ultimately, for dry and boring reasons relating to my relatively few years in the lab before I became a writer.

3) Hmm, I doubt it. Promoting a risk of metastasis would only be relevant in patients who already have gastric cancer or CRC, which is much much much more common in adults than in children. So if I was really worried about a risk of metastasis, I would START in children and not adults, given the prevalence of these tumors.

4) That is a rather broad question that I can't personally attest to. It is compounded by the fact that different biologics will have different adverse events, some much worse than others. The only common adverse event that I'm aware of among most biologics is an infusion reaction.

5) It's possible, and it speaks to why I personally wouldn't be gravely worried about "competition" when you're talking about two totally different approaches. It is clear that for a subset of patients, Aimmune's desensitization approach does not work. The same will be seen with the anti-IL-33 approach. So I expect a lot of crossover, and indeed this could end up meaning collaboration at some point, should it be necessary.

And for sure this places Aimmune in the realm of takeover target, but assuming anything in that line has always led me down the road of "wrong, wrong, wrong," whether it be with respect to timing, pricing, or otherwise. So I don't like to speculate much about buyouts, other than to say that big pharma is always interested in low-risk bets.

[Keith Glanz]

Hi Zack,

Thank you for your always informative daily column. I consider it a must read, as do so many biotech traders.

The recent price action of Aimmune has been disappointing for those of us who understand the very bullish case for this company that will most likely be able to deliver a very efficacious treatment for a currently unmet medical need. I recently wrote a SA article so stating after the stock plummeted following the excellent PALISADES data (https://seekingalpha.c... ).

There have been various theories put forth as to why the stock is meeting headwinds at a time when investors should feel more confident in AIMT's prospects for success. There is little question that the timing of the secondary announcement so soon after the PALISADES data caught traders off-guard. And many -including me- think word of the secondary leaked a full trading day before the actual announcement, giving many broker dealers a chance to sell in advance of the news.

Some feel that the fall in the stock is simple profit taking on good news. Others insist that DBVT will have a serious competitor with their Viaskin patch.

But the PALISADES data is so compelling that the DBVT issue really does not hold water. Most rational minds understand that Aimmune will have a best in class treatment and will be able to garner significant market share, perhaps as high as 80% relative to the patch.

The above issues have been mulled and talked about ad nauseam. But I believe a seldom addressed issue is really now responsible for holding AIMT in check: the potential threat to Aimmune's desensitization approach by Anaptys Bio's monoclonal antibody ANB020 and it's future application in peanut allergies (2a trial data to be released at any time).

There is so little discussion here and so much opacity surrounding whether this is a threat or not, that it has the investment community on edge. I was hoping you could shed some light on this subject. If I had been at the recent Aimmune question and answer session at the 2018 American Academy of Allergy, Asthma, and Immunology-World Allergy Organization Joint Congress, this is the one question I would have asked the very engaging CEO Steve Dilly. I am disappointed no one brought it up.

Questions left unanswered include:

1) What is the realistic timing of an approval of ANB020 for peanut allergy? I have read that peak sales would not be achieved until 2027. What does that imply? Even if ANB020 is efficacious, how far behind Aimmune are they?

2) I have read arcane research papers -very dry and difficult to understand if you are not a scientist- that claim that some research suggests that an IL-33 antibody could raise the risk of metastesis in gastric and colorectal cancers.

3) Is the above a reason why Anaptys is targeting adults and not children, two seperate populations?

4) What is the safety differential in desensitization vs. injectable biologics?

5) Will ANB020 be a stand alone product, or would it be used in conjunction with Aimmune's AR101 very much like Sanofi/Regeneron is hoping to do with Dupixent/AR101?

There are many unanswered questions. I could go on. But answering some of them would go a long way to clarifying a difficult to understand issue.

I believe the new data that was revealed regarding PALISADES at the Orlando conference was so incredible that Aimmune will not only lead in this field for years to come, but clearly the company is a ripe target for takeover. One new piece of data that no one is yet talking about is the new slide that Mr. Dilly revealed that shows that the same 85% desensitization rate that applies to the 4-17 year olds also holds for 18 -55 year olds, essentially doubling their potential patient population!

Zack, if you can illuminate some of the darkness surrounding the issues I have brought up it would be greatly appreciated.

Best wishes to you,
Keith

[MarineCorps]

Keith great post. We salute you.