A triumvirate is a three-person (or three-group) organization which is established for a specific administrative task(s). In Ancient Rome, the First Triumvirate was established between Julius Caesar, Pompey the Great, and Marcus Crassus.
Once Crassus dies, a civil war between Caesar and Pompey was fought, resulting in the death of Pompey and the establishment of Julius Caesar as the first Roman dictator (and, arguably, the official end of the Republic).
We were reminded of the First Triumvirate when thinking about the forces which drive Big Pharma in-licensing. What are the groups of characteristics which makes a particular therapeutic area or indication interesting to licensees? We came up with three of them:
Unmet Medical Need – This is a group of variables or issues which define the medical need that is present and which can be resolved by an available technology or asset.
Commercial Attributes – Epidemiology, pricing and reimbursement, current and future competition, safe and effective generics…all of the variables which are woven into the Revenue forecast.
Innovation & Technology – The characteristics of the asset or technology itself. It is a completely new mechanism of action? What animal data (if any) are available? What will it take to de-risk the asset to the point where it is licensable?
Looking at our Venn diagram, the overlaps amongst these groups of variables also lead to questions which are important, such as:
1. Can the unmet medical need be satisfied with an ROI that meets internal objectives relative to other opportunities?
2. How does this opportunity compare relative to others being assessed?
3. Are assets even available? If so, where? How can they be sourced and assessed?
One issue we see and hear over and over again is that companies looking to form some sort of partnership with a large pharmaceutical company simply fail to look at their asset or technology from the perspective of the potential partner.
Their stories are constructed to build the strongest revenue case possible, while simultaneously underestimating the investment required, underestimating risk, and by failing to consider other competitive opportunities which that potential partner may be examining.
Our triumvirate line of thinking also helps explain why some therapeutic areas with clear unmet medical needs fail to interest multinational companies, and is also why potential licensors struggle to find partners in the presence of significant unmet medical needs. Therapeutic areas such as HIV, diabetes, dyslipidemia, and others come to mind.
Our intention here is not to bash or criticize “Big Pharma.” If anything, our intention is to help potential licensors improve their understanding of what the “other side” may be considering when evaluating their opportunity.
For example, opportunities are always evaluated relative to others. So is the asset your trying to out-license better than others which are available for licensing AND better than what is already on the market? How do you know this? Do you consider that the products on the market will be genericized by the time your product is approved? If so, how will the sharply lower price influence treatment paradigms?
In future posts, we will explore these questions by focusing on specific therapeutic areas and indications, with HIV being the first one. Others may include some of the ophthalmic indications, metabolic diseases, and respiratory diseases.
We go to a lot of conferences. And, as a result, we see a lot of assets being marketed by pharma & biotech executives which will likely never find a partner.
Now we don’t have a really good sense of the fraction of unlicensed-able assets floating around our world, although it is likely to be quite high.
One way to think about this is to look at conference acceptance rates. If meeting acceptances are roughly 25%, can we assume that 25% of available assets have a remote chance of being licensed?
Ok, that’s a bit of a stretch…
You don’t care about the industry averages. You only care about your bimodal situation.
One service we provide is a License-ability Analysis. (The “LA” as we call it around here).
This is an admittedly awkward name for something which is not done as often as it should.
Basically, it is an attempt to handicap the probability of a given asset to be successfully out-licensed.
It also helps companies with multiple assets to prioritize their out-licensing activities and resources.
The analysis is essentially a modified gap analysis, with three components:
Asset Analysis – We first conduct a detailed review of the asset, reviewing and assessing the lead indication, data in hand, commercial opportunity, development plan, IP, competition, etc. We typically identify missing data which would enhance partnering discussions, like a reimbursement analysis.
Partner Perspective – The other side of the gap analysis involves exploring licensing from the partner perspective. So given a specific indication(s), we pre-identify and assess potential partners. We highlight which companies would be theoretically interested in the asset.
Then, for each company, we examine their licensing requirements. Many companies publish these freely, but a few phone calls with scouts adds a great deal of color and nuance to these requirements. We also look at partnering history and the current pipeline, identifying gaps in their business where the asset may fit.
Decision – Based on the comparison of the two portions of the analysis, we can arrive at three potential decisions for each asset:
YES – The asset is partnerable right now, and we have identified some priority companies to contact. Go for it, or let us do it for you.
NO – The asset is not partnerable, even with incremental investment in additional data. The asset simply does not fulfill an unmet medical need, or reimbursement will be problematic, or the clinical trial or commercial spending requirements are too much for a large company to achieve ROI. We can try to out-license it for you, but it will be very very difficult.
MAYBE – Based on our analysis, you still have a shot. However, there are issues, such as overly-optimistic assumptions, unrealistically small and fast clinical development plans, or some other issue which can be resolved before entering into a full out-licensing process.
As we meet with companies at BIO Europe next week, this framework will come to mind as we meet with companies and learn more about their assets.
Having an independent consultant take the Partner Perspective is the critical piece of the analysis.
Because too often we see companies (and their investors) create stories around assets in which they try to convince a potential partner to make an investment in an asset which will never be of interest in the first place.
For example, if a multinational pharmaceutical company has made the strategic decision not to in-license antibiotics, it is near impossible to persuade that company to license an antibiotic, irrespective of the lofty revenue forecasts and rapid development path.
More often than not, this is exactly what we see in partnering decks. We see attempts at convincing any company who will listen that the opportunity is large, quick, and with low risk.
These things may be true, but if the prospective partner has made the decision not to be in that market, then it simply does not matter.
Putting this another way…out-licensing can learn a lesson from a basic marketing practice, namely, understand what your customer wants, and then develop your product to deliver on that want.
This is what this analysis can do for you.
See you in Munich next week!
Yesterday, North Carolina-based Pozen gave a detailed Investor Update, focused
on PA32540, a “Coordinated-Delivery Tablet Containing Enteric-Coated Aspirin and Immediate-RElease Omeprazole.”
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?
Pozen correctly noted that pricing is the key component to having a successful reformulation product.
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.
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:
…and you are met by a complete lack of response from your best leads.
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.
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.
Would You Like To Expand Your Business Into China? Or Perhaps You Seek An Investor or Development Partner? Through our local partners in China, we can help you navigate this rapidly growing, but complex market. Indeed, China is a large and growing opportunity for Western life science companies, as: Life Science in China is Booming –Read More»
Lacerta Bio is seeking parenteral products for in-licensing on behalf of a US-based client. Key criteria are: Products which can be developed via the 505(b)(2) regulatory process in the US No specific therapeutic area Injectable could be infusion, prefilled syringe, or related presentation Products already approved outside the US are especially welcome Delivery / formulationRead More»
Lacerta Bio is pleased to present two novel antibiotics with excellent properties on behalf of our client. The first is a peptide antibiotic which inhibits cell wall synthesis, making it suitable for the intravenous treatment of troublesome Gram Positive bacteria, such as MRSA, VRE, and many other resistant pathogens. The second is a liposlycodepsipeptide suitableRead More»
A r pointed out that some companies are abandoning their efforts in the biosimilars markets. Amgen, for instance, recently decided to until litigation issues are resolved, which could take years (if ever).
By the way, adalimumab is a $16.5 billion product.
An excellent review of the EU expereince, and some of the economic challenges faced by companies wishing to launch biosimilars in the US, . And much of what was written then remains true to form today.
But these markets are worth trillions of dollars over time. So why abandon them entirely?
Where to begin…
Patent Risk – Patents have always been THE key issue with generics. But with biosimilars, it’s a far more complex issue. An . What is patentable? Methods for growing cells? For harvesting them? API purification? Glycosylation patterns? Formulation? PK? Delivery systems? Other? All?
As an example, Amgen was able to receive a new patent on Enbrel (etanercept), extending protection until 2028. For a product which launched in 1998, that is an extraordinarily long lifetime for a branded product. Meanwhile, the developed by Sandoz in August, 2016.
According to MedTrack, there are 26 active programs for etanercept. Essentially, anyone developing an etanercept biosimilar today will likely have to enter into a complex litigation process, or abandon their development program altogether.
As an aside, this is precisely why analyst projections for the Biosimilars market should be interpreted with caution. Unlike the small molecule world, it is highly unlikely that any single patent expiration will trigger a flood of entrants into a particular market.
For instance, making the assumption that a generic entanercept will cut into Amgen Revenues in 2017 is clearly incorrect.
Commercial & Reimbursement Risk – While it took years for physicians to feel comfortable with generics, it will be interesting to see if physicians will jump on the opportunity to prescribe biosimilars, or if they will push back and insist on DAW prescribing. Given the cost of these medications, even with a sightly lower price, there will be arguments in many hospitals over this issue.
How might this differ in different therapeutic areas? Given what we know about discounting and reimbursement practices, will the cost savings truly be that significant?
Competitive Risk – A quick perusal of MedTrack shows there are 35 active development programs for bevacizumab ($6.8 billion in 2016 sales), and another 32 for trastuzumab ($6.9 billion in 2016 sales). Obviously, many of these companies will not succeed. Some will likely give up as other competitors finish development and commercialize their own products.
For example, bevacizumab has two programs Pending Approval (Amgen, R-Pharm), and another 7 in Phase III. It is not unreasonable to think we could have 3-5 versions of bevacizumab on the market very soon, across multiple geographies, sold by different companies (assuming the patent landscape allows such diversity).
What happens to the other 20+ programs?
We can’t say, but there may be some unhappy investors in the future.
Infrastructure Risk – Biopharmaceutical contract manufacturers have been riding the wave of biosimilars product development. Reports suggest that , largely due to biosimilars projects. But as the market evolves, capacity constraints may be observed in some parts of the world. As products are approved, capacity investment will likely be made.
For example, Celltrion is increasing their capacity >2x to accomodate the manufacturing of Inflectra, a biosimilar version of infliximab approved in the US in 2016. We note that the manufacturing investment was triggered by the approval, suggesting management waited until they were 100% certain that they had a commercial product on their hands.
Regulatory Risk – To be fair, the US FDA has made progress. In the US, we have Zarxio (Sandoz/Novartis) and Inflectra (Janssen Biotech/J&J), the latter achieving $239 million in Global Sales in 2016. Erelzi (Sandoz) was approved by the FDA in August, 2016.
So the US FDA is clearly moving in the right direction, after many years of uncertainty.
Development Risk – Biosimilars tend to be indicated for rather serious conditions, and often with small patient populations. How challenging will it be to recruit enough patients for a clinical trial, especially when an established active comparator is available?
To put it another way…suppose you or a loved one had breast cancer, and trastuzumab is the drug of choice. Would you want to be shuttled into a clinical trial aiming to demonstrate the efficacy of the biosimilar version? Probably not.
As Wessman correctly states there will be relatively few companies who will have the value chain (especially infrastructure), the long-term vision, and cojones to succeed in this complex, evolving marketplace.
In Europe, large, established companies (Sandoz, Teva, etc.) are the major players in the biosimilars market, and a similar competitive dynamic is anticipated in the US.
Performing clinical trials and getting products approved is one thing. Getting through the lawsuits will be another matter. These are record-setting, multi-billion dollar products we are talking about
These molecules are complex. Their complexity lends itself to multiple patent opportunities, and hence multiple defensive stakes in the patent fence protecting these revenues. Will enough companies get around these fences to capture market share?
But it may be very difficult for companies, especially in the US, to achieve any market share for molecules with complex, multilayered patent protection.
Indeed, the most successful companies in the biosimilars space may be the ones with the infrastructure, products, AND the legal/commercial expertise necessary to compete in selected markets where litigation is less of an issue.
Join Lacerta Bio at the 2017 RESI Conference in San Diego, June 19. If you are looking to meet Early Stage investors in a highly focused, dynamic, but manageable partnering event, then RESI is for you.
Since you will be there anyway, why not pop into the Westin for the day before the “other” conference?
Use promo code LACERTA100 and receive $100 off the registration!
We just returned from a brief trip to England, where we met with a client, plus a few friends and colleagues. Over several meetings and meals, three issues consistently came up during conversation: Terrorism, Brexit and Trump. Terrorism – The United Kingdom is no stranger to terrorism, as this lengthy list of terrorist attacks in London illustrates. The
Last week, the US Centers for Disease Control published a rather alarming report on drug overdose deaths in the US. Here are a few items which we found surprising and/or interesting: On The Rise – Age-adjusted drug overdose deaths have steadily increased since the late 1990s. But now we’re seeing “hockey stick”
BIO starts in June, right? Wrong. Perhaps BIO starts in late April, when partnering opens? Sorry. Wrong again. BIO started the moment you decided to include this important conference into your in- or out-licensing plan. For those of you us out-licensing assets, there is at least a 30-60 day