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.

 

Consider the following situation:

English: "Wilshire Room," company in...

Where is everybody over there?

…and you are met by a complete lack of response from your best leads.

Sound familiar?

After all, you have a desirable asset, and the initial meetings were enthusiastic, with promises of follow-up calls, exchange of confidentiality agreements, etc., etc.

Why are you being met with silence? With a lack of responsiveness?

Where was the enthusiasm that you felt during that 30 minute meeting in the grey numbered cubicle?

In our experience, there are three general reasons why your desirable asset is met with enthusiasm, then silence. In this post, we discuss these three reasons, but there may be others! Please feel free to offer alternatives.

Wrong Audience – This is one reason why so many company executives argue against the use of networking conferences. Namely, that the person you met is simply the wrong person for that meeting.

Now what do we mean by wrong person? It could be that the person on the other side of the table:

Moved On – We recently ran into a situation where our key contact on the other side of the table suddenly became unavailable for an extended period of time due to a death in his immediate family. In another case, a key contact went on an extended maternity leave without notifying us. When situations like this happen, it can be weeks to months before a company responds, especially if the person who has moved on has not communicated the situation internally.

Wrong Asset – It’s entirely possible that the asset presented was simply not a fit, but the meeting was held for any number of reasons, such as:

So what can you do to reduce the amount of BD&L radio silence? Here are a few tips:

1. Pay very close attention to the exact person(s) you are meeting. Where possible, try to schedule a meeting directly with an individual, not a company.

2. Be choosy when deciding which companies you want to meet. Blanket conference coverage will likely result in a lower percentage of quality leads.

3. Keep your presentation very short, and leave a lot of time to ask questions about their internal process. For example, will the person you are speaking with lead the process internally? If not, who is that internal champion? What are the key criteria or questions that can be addressed immediately?

4. In select cases, if the meeting goes very well, you can schedule a follow-up meeting right on the spot. Suggest picking a date 2 weeks after the conference for a follow up. After all, isn’t that what smartphones are for?

5. Send a LinkedIn invitation soon after that initial meeting.

6. Mail a hand-written thank you note, along with a hard (bound) copy of the slides. Trust us. You will likely be the only person mailing a paper copy! For a greater impact, use overnight delivery.

These are but a few techniques we have used to overcome the “radio silence” problem sometimes seen in business development.

What techniques have you used in the past? What has worked for you?

 

At Lacerta Bio, we’re in the middle of several international out-licensing projects. This process is enabling us to re-connect with many companies around the world. In addition, we’re making new contacts in other companies, especially in Central/South America, Korea, China, and Japan.

The benefits for you are:

If you have a late-stage asset and are looking for help out-licensing your asset, let us know…we can help.

So said Shams Ruston from Labopharm at last week’s Interphex conference in New York.

We happen to agree.

In fact, there are two ways to look at this.

From the branded side, drug delivery can help extend the patent life of existing assets…a far less risky and less costly approach than trying to in-license the next blockbuster. A reformulation approach buys the innovator time to reap the fruits of earlier investments, or make the necessary ones in the near term to sustain growth. The underlying challenge may be an organizational one, as companies fixated on acquiring safe, effecting Phase II+ assets for a pittance continue to struggle to execute in-licensing deals. Broadening the in-licensing mandate (or the in-licensing mindset) would help companies tremendously.

From the other side, generic companies are competing on price, service, and distribution, and not the actual asset. Drug delivery & reformulation approaches enable generic companies to develop a branded product line. However, we recognize that reformulations require a clinical benefit in order to garner acceptable reimbursement levels.

As we’ve talked about before, drug delivery is far from dead. If anything, the current patent cliff can result in innovative ideas for companies willing to look for them.

 

As FiercePharma correctly points out, GSK’s Q II report reflects the overall industry trends quite accurately:

The rest of Glaxo’s report, like the rest of Big Pharma’s Q2 results so far, reflect current industry trends; sales in U.S. and Europe are on the wane, thanks in part to pricing pressures from cash-strapped governments. Cost-cutting helped deliver bottom-line improvements, and that drive will continue. The company has already identified another £300 million worth of cuts to annual spending, bringing the restructuring savings to £2.5 billion a year. Plus, GSK is eyeing more cost reductions, some of which mimic Novartis’ efficiency efforts, namely supply-chain and procurement efficiencies, and cash-conversion improvements.

The full GSK report (PDF) is here (link). Reports from Reuters, WSJ, and Fierce are also out there.

Luke Timmerman at Xconomy wrote a provocative piece today entitled The Missing Ingredient in Today’s Biotech: Guts. His thesis is that the industry is so paralyzed by fear and insecurity that it lacks the collective fortitude to take risks, even if they seem delusional. To quote:

If the industry–VCs, scientists, entrepreneurs, everybody—can’t get the mojo back, then we could be sitting around with a lot of scientific insights in the lab that nobody really knows how to turn into products for human health. Everybody will be fixated on the 100 reasons why something won’t work, and failing to see the one reason why it might.

It’s interesting to think about this. Who lacks the guts? Is it the academic scientist who doesn’t want to pursue a potential dead end in the lab, but instead wants to pursue more low-risk projects to get publications and tenure? Is it the VCs, feeling the pressure from the LPs, who want to take fewer scientific and clinical risks? Are the entrepreneurs (especially the ones merely thinking about taking the leap into entrepreneurship) feeling insecure about being paycheck-less for awhile? Is it management, fearing to take risks for fear of losing their jobs or next round of financing?

Is it all of the above?

The answer might lie in Seth Godin’s post today on waiting for fear to subside:

By the time the fear subsides, it will be too late. By the time you’re not afraid of what you were planning to start/say/do, someone else will have already done it, it will already be said or it will be irrelevant. The reason you’re afraid is that there’s leverage here, something might happen. Which is exactly the signal you’re looking for.

 

 

 

We previously posted our comments on BIO 2011. However, one aspect of the conference that really stood out was the use of social media. Attendees were encouraged to provide links to our LinkedIn, FaceBook, Twitter, and other accounts for the myBio web site. The velocity of tweets from the convention was astounding (and continues). And, of course, an informal tweetup was held at a local pub on Monday night.

There is already a lot of banter on the web on how pharma/biotech companies should/should not use social media tools. But what about employees and professionals affiliated with the industry?

BIO demonstrated that private, personal, and professional lives will continue to blur. As we share more personal information on Facebook/Google Plus, professional information will begin to creep into our personal profiles. Conversely, we already see LinkedIn (the “professional” site) encourage users to include personal information, hobbies, interests, etc.

As more of us become more comfortable exposing ourselves online, more of us will be more readily found and accessible. We concede that this is not always a good thing, and some things should definitely be off limits. But, those who are increasingly active and easy to find will likely have access to opportunities that “off line” folks will never see through traditional channels.

This doesn’t mark the end of traditional networking. Far from it. An increasingly noisy blogosphere/twitterverse will make traditional networking functions like BIO increasingly important, especially to build long-term relationships.

In other words, business networking will become more social, and social media will involve business/professional contact points even more. As BIO 2011 demonstrated, a balance of digital and face-to-face approaches will have to be managed (and encouraged) over time.

 

 

The Lacerta Bio team attended the annual BIO Convention in Washington, DC last week. BIO has become one of the key conventions for pharma/biotech business development, and is a “must attend” event for many of us in business development.

Our observations are somewhat limited, as we spent the bulk of our time in one-on-one partnering meetings. For broader coverage of the event, we recommend the official BIO press release, report by LES, and one by Popper and Co.

Generally speaking, the conference was well-attended and well-organized. The cavernous Convention Center never felt crowded, especially since the Exhibition and the Partnering areas were so far apart. Attendance “felt” reduced compared to previous meetings in Chicago and Atlanta, but this may have been due to the size of the convention center itself. But even in the partnering sessions, we noticed more companies were sending one delegate instead of two or three. This is not necessarily a bad thing, as there were plenty of decision makers at meetings. The speed of the follow up which is taking place this week is a testament to the enthusiasm of the folks we met with.

Demand for clinical and/or commercial assets appeared strong, with many companies seeking assets in areas such as CNS and pain. Niche areas such as parenteral hospital products appeared to be of interest. Our impression is that if a product is ~1 year or less from the market, then it will garner interest, irrespective of therapeutic area. In other words, companies seem to be more willing to shift their strategy and organization in order to embrace a near-term revenue opportunity, even a small one.

BIO usually attracts a strong ex-US contingent, and this year was no different. Over 70% of our meetings were with companies based outside the US. If you exclude Canada and Mexico, 64% of our meetings were with companies from Europe, Asia, and South America. We’re curious if the major European conferences attract such a large US contingency.

BIO continued to encourage the use of social media such as Twitter both prior and during the convention. The tweetup on Monday evening was well attended, and we were pleased to meet @3NT, @FierceBiotech, @IAmBiotech, @InVivoBlogChris, @ldtimmerman, and others. We believe BIO should continue to push for increased use of social media across our industry as a way to foster dialogue and communication amongst all of our industry stakeholders. Events like the 5K race on Monday were also a good way to stimulate social/informal discussion amongst attendees.

The Exhibition felt rather quiet at times (flash mob excepted). We think this was in part due to the East/West orientation of the hall. Exhibitors along the North wall away from the entrances may have suffered traffic-wise…at least it felt this way as we traversed the floor.

BIO 2012 returns to Boston next year. You can keep up with the action on Twitter by following @BostonBIO2012. See you in Boston!

The June, 2011 issue of Nature Drug Discovery has a interesting short article based on a survey conducted by our good friends at PharmaVentures. The authors surveyed 180 business development executives on their perceptions surrounding deal making.

One of the survey’s findings is that biotech BD executives believe that pharma licensees have greater power in driving deal terms due to their purchasing power. Conversely, pharma licensors believe that the biotechs have the power to drive terms because they are selling a scare asset(s). Another observation was that biotechs generally believed that upfront payments have dropped, while pharma executives believes that upfront payments have risen.

However, data from the PharmaVentures database suggest that these perceptions are not supported by the facts. According to PharmaVentures, the mean upfront deal value from 2006 is very close to the value in 2010.

The authors conclude (correctly, in our opinion) that these data reflect the real tensions existing in today’s market between desperate pharma companies looking to fill pipelines and desperate biotechs looking to monetize assets. While the former may cause bidding wars for highly sought after assets, the latter may cause downward pricing pressure from biotechs looking to remain financially alive (and hence willing to strike deals at lower values).

A singular observation made by the authors was:

We conclude that deal-making is strongly affected by issues other than the recent, persisting pressures in the financial environment – in particular, it is affected by the long standing failure of the research and development model of licensee pharmaceutical companies to produce sufficient late-stage assets, even through deal-making. [Emphasis added]

In other words, the authors note that pharma licensees have been unable to develop assets, irrespective of their source (internal discovery or external discovery). Thus, deal-making, even for “derisked” assets, does not actually increase the probability of successfully completing product development.

But why? Is it because big company bureaucracy interferes with product development? Is is that drug development is simply a remarkably difficult undertaking? Do we not understand pathophysiology well enough? Are the regulatory agencies becoming barriers to innovation?

The truth probably lies somewhere in between all of these factors, and likely others.

Now these results can be influenced by any number of factors, such as respondent experience, NCE versus non-NCE deals, therapeutic area, geographic scope of deals, asset maturity, etc. However, the results clearly point to issues that many of us in business development have noticed over the past few years, namely, that deal-making is more difficult, but not necessarily more rewarding, for either set of parties involved.

Today we learn that Rigel has raised $130 million in financing, in part, to develop candidates in rheumatoid arthritis and other areas. But, as reported by Xconomy, the real gem may be R343 for the treatment of asthma.

Essentially, the Big Pharma partner, as part of its cost-cutting and portfolio review, took a Rigel drug for allergy-induced asthma through early-stage clinical trials, prepared it for Phase 2, then decided to bail out on allergy and respiratory drugs entirely. So Pfizer, after investing its money in critical early stage tests, gave a much more valuable drug, called R343, back to Rigel.

The moral of the story is that a “divorce” from Big Pharma is not necessarily a bad thing, especially when the partner has made value-creating investments in the asset. Whether Rigel decides to invest in R343 or not, Rigel has a much more valuable, de-risked asset in their portfolio. Other prospective partners have undoubtedly started calling Rigel already.

Flowtown has a terrific (and large!) graphic entitled “The New Marketing Trifecta.” The trifecta refers to the three ways companies should (or could) be marketing their products and services. These are eMail, Mobile Devices, and Social Media.

This trifecta is clearly an approach that pharma/biotech companies will have to use in order to reach physicians with their messages. Indeed, the increasing number of “no-rep” physicians has been well documented elsewhere. So a lower-cost, digital approach makes sense (although whether pharma can be successful is an open question). What we notice from the Flowtown graphic is:

We believe that the use of this trifecta will extend beyond the company-physician relationship. In our field (business development), we already see a number of small innovator companies who are using social media to “promote” their technologies and projects. Their aim, in part, is to establish themselves in the eyes of potential licensing partners and even future acquirers and investors. In fact, we typically advise our clients to develop a social media strategy for the company and their products or services as early as possible. This gets their names into the digital information flow, and can result in inquiries from all over the world at lower cost.

Hat Tip to Karl Schmieder and our friends at Bridge6, who discuss this graphic in their most recent newsletter.

 

 


Current Projects

China: Opportunities to Access Partnerships and Capital  
Posted on Feb 14, 2015

Article

Would You Like To Expand Your Business Into China? Or Perhaps You Seek An Investor or Development Partner? China is a large and growing opportunity for Western life science companies, as: Life Science in China is Booming – China’s life science industry has been growing at more than 20%+ per year, and is expect to

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Licensing Opportunity: Parenteral Diclofenac  
Posted on Mar 06, 2015

Article

Lacerta Bio is pleased to represent the opportunity to in-license an innovative, approved parenteral formulation of diclofenac for acute / postoperative pain. While parenteral diclofenac products are available in a number of markets, our client’s formulation is clinically proven to have superior safety and efficacy characteristics. Key product benefits over the currently marketed product include:

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Licensing Opportunity: Superior Topical Diclofenac Product  
Posted on Mar 06, 2015

Article

Lacerta Bio is pleased to represent the opportunity to in-license an innovative, approved topical formulation of diclofenac for pain. While topical diclofenac products are available in a number of markets, our client’s formulation is clinically proven to have superior safety and efficacy characteristics. This topical diclofenac has a number of advantages over available topical diclofenac

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Our Latest Article

Adaptive Licensing: An Idea Ready For Prime Time? 
Posted on May 28, 2015

Article

 

We  just finished reading a terrific academic piece by Jack Scannell and colleagues at the University of Oxford. Entitled Financial Returns on R&D: Looking Back at History, Looking Forward to Adaptive Licensing, the authors discuss adaptive licensing in the context of historical returns on R&D in our industry. (Email us if you would like a PDF copy.) 

So what is Adaptive Licensing?

The authors provide an excellent explanation (with our emphasis), 

Adaptive Licensing structures clinical development around a graded, but prospectively planned, introduction of a new drug as evidence on its risk-benefit profile accumulates by a variety of means….For example, commercial sales in a high-need subset of patients can be permitted on the basis of the results of Phase II trials, while further evidence is collected that eventually allows a broader label and wider use in a larger patient population.

It is important to note that Adaptive Licensing is NOT Accelerated Approval. In Adaptive Licensing, the data is collected and reviewed in a gradual, planned manner. It differs from a “sudden” approval based on outstanding Phase II results, or from impressive interim results in a large, Phase III trial. 

The theoretical benefits are clear:

  • Drugs are introduced into the marketplace faster, generating Revenues sooner and improving IRR
  • Drug development costs are reduced

Importantly, an adaptive approach means that drug development is iterative, and adjustable based on incoming data. This ability to adjust based on results is far more consistent with good experimental design compared to the traditional “all or none” approaches we have today. 

The key is to choose therapeutic areas and indications where “the same underlying pathophysiology must be present in patients across the spectrum of disease severity.”  

In fact, oncology drug development is pseudo-adaptive already because new approvals are typically for later-stage disease until physicians gain experience and introduce these new drugs into earlier stages of disease.

EMA Leading The Way

The European Medicines Agency is already leading the way with Adaptive Licensing. In 2013, the EMA initiated a pilot program by accepting 34 applications from drug sponsors. Their experiences are documented in this report (PDF). 

Based on the EMA experience and the discussion in Scannell, et al., it looks like Adaptive Licensing will be initially introduced in oncology drug development first, with anti-bacterials following closely behind.

With the EMA leading the way, sponsors could be faced with the problem of a de-harmonized development program between the EMA and the FDA. Could some companies decide to follow the EMA lead with Adaptive Licensing and simultaneously follow the more traditional two Phase III trials/all-or-none FDA scenario? Perhaps this can be done in sequence, i.e., pursue EU approval first, provided that data can roll into an FDA-approved Phase II or Phase III trial? 

Based on our reading of this paper, we agree with the authors that projects following the Adaptive Licensing route will have minimal impact on IRR unless the EMA and FDA are harmonized for that development program. 

The Fingolimod Case

The authors discuss the case of fingolimod as a potential example of an adaptive licensing approach. Fingolimod underwent five Phase II and III trials and extension studies which spanned seven years and 3,900 patients. 

An Adaptive Licensing approach suggests an approval could have been possible with four Phase II and III trials spanning 5 years and 2,800 patients. So the initial approval would have been for moderate to severe multiple sclerosis, with a label broadening to any severity after another 30 months of data collection. 

However, the authors also note several problems with this approach.

First, the indication of “moderate to severe multiples sclerosis” is vague. Second, fingolimod has some side effects which could possibly not be detected in a smaller set of trials. Lastly, would a sponsor risk not being able to demonstrate efficacy in a broader population with only efficacy in the moderate to severe population? 

Clearly regulators need more examples and data before providing guidelines to sponsors. 

BD Implications

We would be interested to hear from prospective licensees and licensors about Adaptive Licensing. IF Adaptive Licensing means products reach the market sooner at a lower cost, then that would make them very attractive, albeit with a smaller market potential at launch. Conversely, will prospective partners simply wait for the broader approval? Or have an option in place? And, what are the pricing implications of having a staged, adaptive approval approach? 

Based on our read, we don’t think Adaptive Licensing will be something that will take off quickly. It’s a nice buzzword, and undoubtably a conference or two will emerge based on this topic. But as the EMA is demonstrating, this is an amazingly complex process that will take case studies and time (and money) to sort out. Importantly, harmonization with the FDA is a long-term requirement if Adaptive Licensing is to make sense for drug development on a global scale.


Latest Posts

What Pharma Want: Comments On Article 
Posted on May 11, 2015

  Earlier this month, our friends at Biotech and Money published a transcript from a panel discussion at their London 2015 congress.  The discussion was quite interesting, and we encourage readers to check it out.  The topic for this discussion was whether or not M&A is being brought earlier and earlier into the R&D lifecycle.

Preparing for #BIO2015 in Philadelphia…Already? 
Posted on Apr 27, 2015

  We’ve started preparing for the BIO convention in Philadelphia in June. Preparing? Already?  Yes.  Why start now? We’ll give you three reasons: New Partnering Interface – BIO has unveiled a brand new interface for the One-on-One Partnering system. Everything is new, and the old profiles will NOT automatically populate the new system. You will have

Independent Consultants Wanted 
Posted on Apr 27, 2015

  Are you an independent consultant? Are you looking for a new platform or channel to help grow and expand your practice? Why not join us! Lacerta Bio is looking for independent consultants to both work on projects and to form new biotech companies. Projects – We regularly need expert help in a few key

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