Author Archives: Carlos

Let Us Now Praise Pharma

 

 

Photo of sharecropper Floyd Burroughs by Walke...

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.

 

BIO2013: The Afterglow Edition

 

 

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 watch?

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.

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!

ExcipientFest 2013

 

 

Now that we’re back from BIO2013, we have to leave again! ExcipientFest

We’ll be at ExcipientFest 2013 in Baltimore for a few days. We’ll be meeting with several Exhibitors, then meeting with a new client.

So if you’ll be in Baltimore early next week, please let us know!

A blockbuster on $1 a day pricing?

 

 

Yesterday, North Carolina-based Pozen gave a detailed Investor Update, focused

English: Dollar General variety shop at 800 Br...

Tomorrow’s Pharmacy?

on PA32540, a “Coordinated-Delivery Tablet Containing Enteric-Coated Aspirin and Immediate-RElease Omeprazole.”

Information on the company’s pipeline is available here, while the investor presentation (lengthy PDF) is here.

At Lacerta Bio, we follow the drug delivery/reformulation space quite closely. We happen to have a lot of experience in this space. Plus, we believe that there can be a lot of therapeutic value gained from these approaches, especially if this therapeutic value can be achieved using an efficient development plan and reasonable drug pricing.

So with PA32540, it appears that Pozen has really latched onto this second point (reasonable drug pricing). But first, a little background…

There is no question that aspirin is a valuable agent to prevent cardiovascular and cerebrovascular events. However, as Pozen points out, nearly 70% of patients who should be on aspirin therapy are actually taking it. So even though aspirin is very cheap, the side effects make long-term aspirin therapy prohibitive for many patients.

In fact, Pozen’s clinical data support this. They demonstrated that nearly 12% of their subjects on enteric coated aspirin experiences gastric and/or duodenal ulcers. Further, over 11% of subjects discontinued enteric-coated aspirin due to any adverse event.

Now that’s not to say aht PA32540 is perfectly safe either. For example, Pozen’s own data demonstrate a 17.5% incidence of gastritis, versus 16% for enteric coated aspirin.

Nevertheless, the safety data, coupled with the well-established efficacy data supporting aspirin in this population, make PA32540 a compelling product.

But what about cost?

As one would suspect, Payers responded with little enthusiasm when initially presented with the PA32540 profile.

What changed their minds?

$1

Pozen correctly noted that pricing is the key component to having a successful reformulation product.

Pozen Payer Market Research Findings

Pozen Payer Market Research Findings

Specifically, at $1 a day, this makes PA32540 cost neutral to the Payers. Even better, the product will likely be on Tier 2 on the formularies, instead of Tier III.

Brilliant.

In fact, since Tier II copays are around $30 a month anyway, a contracting approach will likely not be required.

Now stop and think about this for a second. Let’s suppose you currently sell a branded product in a category where there are generic alternatives (statins, for example). With a generic available, the brand would have to have compelling clinical evidence of superiority to have Tier II pricing, and even that will be a challenge.

The way many companies handle this is through bundling a basket of products, offering different prices on the products in a basket in order to make that branded Tier III product more compelling for the Payers.

So while a Pfizer or an AstraZeneca can do this, a small company without a substantial portfolio of products cannot.

This is critically important from a business development perspective (and hence another reason why we’re so interested). Time and time again we see plans and business models which do not have substantive payer research supporting the model. There is a real danger that products can be approved, yet fail miserably in the marketplace, partly due to unreasonable pricing and revenue expectations.

The “Affordable Medicine” concept Pozen is supporting can really resonate with a number of Payers. Importantly, if a developer can execute on a plan while maintaining an Affordable Medicine mindset, and not the Wall Street/Investor-driven blockbuster mindset, then we may see more approved products on the market, with broader usage for each product.

Further, by moving aspirin from OTC to Rx, we will now have a much better tracking system for aspirin prescribing, usage, adverse events, etc. Again, this is another way the entire system benefits from their approach.

We can’t say whether or not Pozen (or their commercial partner) will hit their Revenue targets. We dont’ even know if Pozen will successfully out-license this asset to strong commercial partners. However, given some of the plans we’ve seen recently, we have to commend Pozen for their pricing and commercial strategy.