Lacerta Bio

Oral Insulin Capsule Entering Phase II

Posted on May 23, 2013 | Leave a comment

Paul Langerhans would be proud…

Oramed announced last week that their oral insulin capsule is ready for Phase II trials in the US:

Oramed’s ORMD-0801 is an orally ingestible insulin capsule indicated for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite. Moreover, orally administered insulin has the potential benefit of enhanced patient compliance at this crucial stage as well as the advantage of mimicking insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.

Attempts at developing an oral insulin product go back to the 1990s. Several companies have tried, and failed, to develop such a product. Plus, API cost concerns resulted in a few companies dropping their programs.

We hope Oramed succeeds. Diabetes is an are where innovation is desperately needed. And even a “reformulated” insulin product would be a major shift in how we think about treating diabetes.

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Posted in Drug Development

Tagged Diabetes mellitus

Let Us Now Praise Pharma

Posted on May 22, 2013 | Leave a comment

Photo of sharecropper Floyd Burroughs by Walker Evans. (Photo credit: Wikipedia)

In 1941, Let Us Now Praise Famous Men was published. This unusual book is an account of Southern sharecroppers in the Deep South in 1936. It is a difficult read, but as title suggests, the authors suggest that these poor folks should be praised for trying, for living, and for doing the best they can with the cards life dealt to them.

We were reminded of this book as we reviewed a series of late-stage, high profile clinical trial failures which occurred this year:

Aastrom’s decision to halt a Phase III study of a cellular therapy for critical limb ischemia
Merrimack’s Phase II failure with MM-121 in NSCLC
Lilly’s Phase III failure with enzastaurin in BCL

Too often we see the press using terms like “flunk” to describe these failures. This often goes hand in hand with some criticism leveled at a CEO or other Senior Managers, as if they are somehow at fault for a failed clinical trial.

This schadenfreude is pointless. If anything, we should be standing up and applauding these companies (and their shareholders & investors) for taking risks and trying to develop innovative new therapies.

The press seems to forget (or perhaps not understand) the effort that it takes from dozens of scientists, clinicians, and investors to even get to that point.

Even something that is not considered innovative, like a reformulation, can require multiple PK studies just to perfect a formulation…a formulation which can reduce side effects, improve compliance, and improve outcomes.

Shouldn’t we be applauding that effort, even if it results in failure…a failure which is extraordinarily difficult to predict in the first place?

Now it’s true that pharma, like any other industry, has its share of incompetent senior executives who muddle their way through their careers without creating much value (except perhaps for themselves). Mistakes are made, and some trial designs may seem nonsensical in hindsight.

But that pales in comparison to the efforts made by internal champions, many of whom stake their professional reputations on the outcome of a trial or two.

It may not be their money, but the risk and failure are nevertheless strongly felt.

Think about it. “Responsible for flunking a clinical trial” is not something you’ll see on a LinkedIn profile.

Let’s stop the sensationalism for the sake of headlines.

Instead, let’s give some credit and praise where it’s due.

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BIO2013: The Afterglow Edition

Posted on April 30, 2013 | Leave a comment

As we were making our way back home from Chicago (on delayed flights, of course), several things struck us about BIO2013. We’ve talked about BIO in the past. But how was the ’13 edition different? The same?

We spend all of our time in the Business Forum conducting One-on-One meetings. So it is difficult for us to discuss sweeping conference overviews. Regardless, here are a few observations based on our limited participation.

Assets: Assets? You want assets? No problem. There are an innumerable number of assets available in all therapeutic areas and all stages of development.

Psst… Want to buy a Phase III asset that’s completely derisked and has a clear path to market? (Photo credit: Bryn_S)

Good Assets: Now these are a bit harder to come by, especially those that are near-to-market. After all, if they are good and near-to-market, then they’re likely partnered already. And if not…watch out (just ask Allergan about the risks associated with acquiring late-stage, un-partnered assets).

In fact, one of the more common questions we heard from prospective clients was “Is my asset licensable?” This is a complex question, and we’re formulating some thoughts around how to answer this question.

Earlier is Better: We’re definitely seeing more companies interested in earlier stage assets compared to previous years. This is no surprise, and others with more data have made similar comments. Plus, now that competition from VCs is decreasing, it’s likely that big pharma/big biotech can drive better deals for themselves.

International Mix: Over 40% of our meetings were with folks from North American companies, down slightly from 2012. We met many more representatives from Asia (29%) compared to 2012, with Europe (27%) down slightly compared to 2012. Now much of this is driven by the projects we are working on currently. So we wouldn’t recommend drawing much of a conclusion from this limited sample.

Social Life: We were quite puzzled at 5 pm on Monday when the entire convention center closed and everyone was “encouraged” to leave quickly. What happened to the 5 pm refreshments? It sounds trite, but we consider these social events a very important part of our overall networking goal at BIO.

Exhibition Floor Traffic: Foot traffic felt a bit light this year. We don’t know what the final attendance was, and it could be that the cavernous McCormick center had room for all. Still, walking around was not a problem, except for the times when we hustled between the Business Forum and meetings in the Exhibition. (We can now claim to have walked from China to Argentina in 5 minutes). It’s good to have meetings with companies who are in the Exhibition and no in the Business Forum, but some Segways may prove useful next year.

One suggestion we have which may not be physically possible is to have the Business Forum in the middle of the Exhibition, with exits on all sides. This and clear signage can make our travels between the Exhibition and the Business Forum more efficient.

TweetUp: HT to CoryTromblee for organizing the TweetUp.

The Bag: The bag was nothing compared to that fetching man purse we received

We missed you, man.

last year.

BIO Stats: BIO posted their official stats here.

BIO2014: We’re pleased to see that BIO 2014 will be in San Diego in June. We can all but guarantee that the weather will be far better than Chicago in April!