The Big Red Biotech Blog

Well, yeah! And your point.....

"No man but a blockhead ever wrote, except for money."            --- Samuel Johnson

Marketing vs. R&D Spend Debate in BIG Pharma

There has been an interesting (though not new) debate this week on In the Pipeline about whether Big Pharma actually spends more money on marketing its products than on developing them. Many of the detractors for this industry think much more is spent on the former -- as if Big Pharma were purely a bunch of hucksters. 

This morning In the Pipeline produces some data from 2010 that bascially indicates about 2x is spent on R&D as is spent on marketing.  This should end the debate.  Anyway, I'm not sure why critics would think that a company would take the time to develop its products but not to market/sell them?  Why should pharma be any different than other industries?  I guess if you believe pharma actually spent 10x on marketing compared to development, you might have some sort of point, but short of that I'm not sure what that point might be.............are critics really suggesting pharma is just selling snake oil?  Seems far-fetched doesn't it?

Posted by Bruce Lehr May 23rd 2013.

Mythbusters: Biotech Venture Capital

This from the LifeSci VC blog this morning.  A post on the myths that persist in the popular conscience about biotech venture capital. Since they are characterized as "myths", then it follows that data shows them not to be true.  Without further ado:

• Returns in Life Science venture investing lag other venture capital sectors.
• When biotech deals blow-up, they blow-up BIG.
• Biotech takes far longer from inception to "exit" than other sectors.
• The overall biotech venture capital funding environment is drying up.
• Early stage venture capital is even worse -- it's a "barren wasteland"
• Life Science VC's can't raise new funds.

Read the post for yourself for all the details. Suffice it to say that direct evidence or sources are cited where you can go to debunk the myths.

Posted by Bruce Lehr May 22nd 2013.

Pharma R&D Spending vs Other Industries

Here's an interesting post from the In the Pipeline blog that comments on the amount of R&D spending that is seen in Big Pharma versus what occurs in all sorts of other industries.  It turns out that Big Pharma spends more as a percentage of sales than any other industry besides semi-conductors.  That is eye opening to a degree -- eh? 

The post also provides a link to the Booz study that was the source of this information and lays out R&D spending for a host of industries.  It is a good reference piece to have I'm certain.

Posted by Bruce Lehr May 20th 2013.  

Innovation as Illustrated by Beer

It's not often that you get a blog post that talks to innovation and uses references to both Homer Simpson and beer to drive home its point.  Today's award goes to the Innovate on Purpose blog for -- well -- bringing us this innovation in writing.

The thrust of the article is that when aspects around the product become the focus - rather than innovations in the product itself -- you know you've reached the point of diminsihing returns.  This kind of hits home in the pharma industry in the past decades where maybe as much effort was put in evergreening through reformulation, new delievery systems and maybe indication extension as was put in developing novel meds in many instances.  Maybe that's why pharma return on R&D has been so dismal the past decade (if not longer).

Time to get back to real innovation with the actual PRODUCT -- for new meds, new mechanisms of action that effectively address unmet needs and perform BETTER than what we have already.  BTW - I think we're starting to move in that direction again.

Posted by Bruce Lehr May 17th 2013.

 

Global Biosimilar Market Report 2013

Visiongain published a new report on the global biosimilar market in 2013 and says the market size will reach $2.45 B, or approximately 20% higher than last year. Biosimilars now account for about 2% of the biologics market. 

PharmTech Talk » Global Biosimilars Market to Reach $2.445 Billion in 2013.

Monoclonal antibodies and insulin submarkets are expected to grow fastest for biosimilars over the next 10 years and should acont for 57% of the 2023 biosimilars market. Biosimilar erythropoietin and filagrastim are also expected to have increasing impact.

Said pharma industry analyst, James Evans, "Biologics are going to become so prevalent that every major company will be interested in having a stake in that expanding market."

Emerging markets, particularly China and India, have been leaders in biosimilars, accounting for the majority of global revenues in 2012.  By contrast, the US, EU and Japan combined only made up 20% of the market. Visiongain predicts the pace will pick up in the developed markets from 2013 to 2017 as many of the biggest blockbuster mAbs come off patent.

Posted by Bruce Lehr May 16th 2013.

The Outcomes Era

Here's another post on the importance of "outcomes" research in gaining acceptance for a new drug.  It quotes results from a new Camelot Management Consultants study -- where 60% of US and European companies agree outcomes research to show the effectiveness of a new drug is important in gaining acceptance --- yet disturbingly 30% say they don't plan to change the way the go about launching their products.

The Outcomes Era .

Camelot says new launches will have to have the following features:

• Aim at expanding the market not just take share
• Re-define therapy guidelines
• Develop smarter pre-launch activities, with more investment in early phases
• Have stakeholders awaiting product and its differentiating features at launch
• Win recognition for creating multi-shareholder value (i.e. patients, prescribers, payers)
• Adapt to changes in the environment during and after the launch

Posted by Bruce Lehr May 16th 2013.

 

Latest Myriad Case Commentary

I like to keep info flowing on the Myriad ("gene patent") case as it percolates through the Supreme's toward a final decision.  This from Patent Docs blog yesterday summarizes some findings in a recent Nature Biotechnology paper as to the impact on existing patents -- and this effect is expected to be less impactful than it might have been 30 years ago.

Frankly, one wonders why this case is even going to court now.  Many of the diagnostic techniques being challenged are effectively obsolete (or soon will be) due to the fruits of the genome project and sequencing.  But there is some level of trepidation that a sweeping ruling with regard to "products of nature" by the Court could actually damage other fields of biotechnology.  That might cause harm to economic incentives for commercializing genetic technology, which in turn could lead to inhibited disclosure of knowledge to the detriment of progress in the industry.

And more to the point, any ruling in Myriad at this juncture is unlikely to alter the current access to diagnostic testing that the case was purportedly about.

Posted by Bruce Lehr May 16th 2013.

 

Related articles

The Myriad Case and "Gene" Patents: Much Ado about Nothing?

Pharma Need for Adapting to Change

When I was a youngster, my father used to ask us kids in the family a question: Why did the dinosaurs go extinct?  It was an interesting question to us as we all loved dinosaurs and knew a lot about them.  Not long after the question was posed, possible answers started flying around -- an asteroid collision, more volcanic activity, disease, ice age (climate change), movement of tectonic plates, etc.  My father's response no matter the proffered answer was No, no, no, no and no. 

The RIGHT answer was -- Dinosaurs became extinct because they couldn't adapt to changing conditions.

PharmTech Talk » Adapting to Change.

I thought of that when I saw this post this morning.  It deals with the need of pharma and biotech companies to be able to adapt to the changing healthcare climate in order to survive.  The post points out that increasingly, it is not enough to get a drug approved by regulators. To thrive, you need to get the drug accepted by payers. 

As such, companies need to be attuned to Changing Conditions. What is the competitive standard of care out there at any moment in time?  If it changes, can you adapt your clinical trials in progress to examine relevant endpoints to the new standard?  Can you add a drug to a study in oncology, for example, if a new therapy is demonstrated using two or more drugs?

Bascially, you need to think about how to differentiate yourself from competitors.  Can you show enhanced safety, fewer side effects, greater efficacy, lower toxicity, or identify a patient niche where your drug outpeforms?  You need to be able to adapt on the run. 

If you can, you will be set up to thrive under the new conditions.  If not, you (or your therapy) may be the one who next goes extinct.

Posted by Bruce Lehr May 14th 2013.

US Drug Market Contracts for First Time - EVER!

As Fierce Biotech reports via IMS data, te US drug market shrunk by 1% in 2012.  This is the first time that has ever happened. This is due, of course, to the much talked about patent cliff arriving in a big way -- mpacting market share and revenues of some of the world's top selling small molecules. The US market is now down to $325.8 B. 

Patent cliff drugs took a $29.8 B dollar hit. Yes, with a Big B.  Branded producers in general saw revenues decline by $11.8 B.  Generics producers of course saw he upside of things as their sales increased by $8 B. A drug market Yin and Yang as it were. Generics now account for 84% of all drugs prescriptions dispensed in the US.

The bright side for branded manufacturers are for their new drugs (< 24 months old). These actually grew by $0.5 B to a total of $10.8 B.  These all fell into the specialty category with drugs like - Incivek (hep C), Eylea (macular degeneration), Xgeva (bone drug), Gilenya (MS), and Yervoy (melanoma).  At least the FDA is on an upward trend with approvals, so there may be hope for a continued flow of more new drugs to bolster brand name revenues. 

However, the next wave over the patent cliff is also still coming.  Here's a report from the end of last year in Fierce Biotech that outlines the next 15 top sellers to go off patent this year.

Posted by Bruce Lehr May 9th 2013.

 

 

 

R&D Spending may not be ALL Bad

Fierce Biotech yesterday reported that R&D spending was up as many significant biotechs -- like Gilead, Amgen, Celgene, Shire, Regeneron, Onyx and Biomarin.  In other words, many of the darlings of biotech investors -- companies who have experienced significant share price appreciation of late. Overall, the top 10 biotechs spent $11.8 B on R&D in 2012 -- nearly a 15% increase over the prior year.

So while it may be very trendy in Big Pharma to be trimming the internal R&D budget in favor of seeking outside collaborators or properties to fill the pipeline, focused, smart R&D spending in biotech seems to be working.  That suggests R&D spending is not inherently BAD as you could be led to believe if you spent all your time listening to Big Pharma CEOs and their R&D Heads. Rather, R&D appears to require focus with spending on the right projects at the right time -- while minimizing waste -- not eliminating the budget.

This suggests that the top 10 biotechs will continue to thrive and may well find themselves to be the well sought after beauties at the ball. That means possible acquisitions, partnerships or licensing deals on the horizon -- and expect the Big Pharma guys to be the callers.

Posted by Bruce Lehr May 9th 2013.

Myriad BRCA Test Cost is In-Line

This post from Patent Docs blog is self-explanatory.  Suffice it to say that any hoo-haw over the exhorbitant price of a BRCA diagnostic test at $3000 is -- shall we say overblown.  Assertions of this sort couldn't be more wrong-headed.  If you want to blame somebody on this front, it is likely more apt to blame a particular insurer for NOT covering the test cost. 

Posed by Bruce Lehr May 3rd 2013

 

Pharma vs Society - Let's Get Ready to Stuuuummmbbble!

Both In the Pipeline and PharmaGossip today recounted comments by Bernard Munos in Forbes on the state of pharmaceutical industry.  To wit, drugs cost too much to create and the R&D return is lousy and unsustainable.  Plus all the new drugs, e.g. cancer meds cost too damned much. 

Maybe it will eventually occur to the industry that this model will not continue to work.  Governments with struggling economies, in particular, just don't have the stomach for it.  Thus, it is unlikely that policy will allow this to continue and that pharma management teams that continue to stumble around pursuing this model will soon meet their comeuppance.

All will likely struggle with low sales, possible imposition of severe price controls on their products, and struggles to get thrid parties to pay for their drugs -- especially without clear cost benefits.  and the likely result is that more of the weaker parties will be absorbed by the strong(er) and the industry will continue to consolidate.  Adapt or perish still holds.

Posted by Bruce Lehr Apr 29th 2013

Biotech Needs to Focus on Demonstrating Product Value

According to a recent Ernst & Young study, future success in launching and selling new drugs will increasing depend upon the Company's ability to "show value" for its product -- i.e. comparative effectiveness.  This recognizes the increasing reality that to be successful -- you don't only need regulatory approval (FDA, EMEA, etc) but also it is critical that you get 3rd party payer approval in a timely manner to support launch.  Otherwise, you can look forward to lagging sales -- which can lead to a dramatic collapse in stock price and threaten a "one-hit" wonder Company's very existence.  See Dendreon's Provenge as a poster child for this effect -- though there are others like HGS' Benlysta.

PharmTech Talk » Biotech Needs to Focus on Demonstrating Product Value.

Curiously, the E&Y study found that small and mid-size biotech's in particular seemed blind to this possibility.  While 94% agreed that it is “important” or “very important” for biotech companies to have a strategic focus on matters of evidence. most companies indicated that they are unlikely to undertake specific evidence-focused initiatives. Of the respondents who rated evidence measures as “important” or “very important,” 11% have added payer/reimbursement expertise to their management teams, 13% have brought such expertise to their clinical development teams and only 4% have included people with such expertise in their boards of directors. 

E&Y advised biotech companies to debunk any myths that are holding them back, stressing that the shift to evidence is happening faster than anticipated, and it will affect companies regardless of their size, maturity or disease focus

You know what they say about failure to learn from history and impending doom to repeat it? 

Posted by Bruce Lehr Apr 26th 2013.

M&A Activity - Usual Suspects

Fierce Biotech reports on latest Moody analyst's take on M&A activity for 2013 in the pharma industry. The news was similar to predictions that I've seen for the past couple of years -- that being a few cash flush Big Pharma players will be looking for bolt on acquisitions from the biotech flock to bolster their pipelines -- to help fill in lost sales due to patent expirations within the existing product portfolio.

Potential big acquirers on the latest list included: Pfizer, Novartis, Roche and AstraZeneca. Their purposrted prey might include these analysts favorites: Theravance, Onyx Pharmaceuticals and Cubist Pharmaceuticals. There is no particular word out there that this is actually happening as we speak but these companies have profiles the analysts love to love as acquisition targets due to their relatively smaller size, existing commercial products and current pipelines.

In the past (May 2011), rumors have circulated that AZ was interested in buying Cubist for its antibiotics versus MRSA.  So some of the candidate deals on the table are not new notions -- at least for analysts.

Posted by Bruce Lehr Apr 23rd 2013.

Supremes Hear Oral Arguments in Myriad v. AMP? Or do they?

I've written about this before, but wouldn't it be nice if the arguments presented before the Supreme court in a potentially pivotal patent eligibility definition case like Myriad, actually contained discussions of science to illustrate the Law? 

We're trying to discern whether isolated DNA should be patent eligible or not.  OK.  Then why do we have to resort to analogies like if the DNA were a tree, sap from a tree, chocolate chip cookie, baseball bat, or a liver or kidney? Huh?  Why can't we discuss isolating and replicating a DNA sequence from say .... DNA?

I know we are science challenged as a Nation at least across the population as a whole -- but you'd think we'd have the ability to discuss the science and that Supreme Court justices could have access to ANY experts that they wished to explain basics to nuances of what was being presented.  I'm not arguing that arcane jargon should be the basis of oral arguments but can we do a bit better than comparisons to baseball bats and chocolate chip cookies?  See Patent Doc blog.

Posted by Bruce Lehr Apr 19th 2013.

VC Deals - especially Life Science - Have BAD 1st Quarter

New reports from PricewaterhouseCooper (MoneyTree Report) and National Venture Capital Association (Reuters data) show that VC investment in Qtr 1 2013 dropped 12% by dollars and 15% by number of deals as compared to Qtr 4 2012.  In a Qtr over Qtr comparison with Q1 2012, the amount of dollars invested this Qtr was down 6%. 

VC funding was therefore $5.9 B for 863 deals in Qtr1 vs $6.7 B for 1013 deals in Qtr4.  Life Science specific investment fared even worse - with $875 M for 96 deals versus $1.3 B for 138 deals in Qtr 4.  That represented a 33% drop in dollars and 30% drop in deals. Even worse, first-time deals dropped 52% and garnered only $98 M dollars for 20 companies, the worst performance since Qtr 3 1996 and Qtr 2 1995 respectively. See Fierce Biotech.

If there is a silver lining (and maybe there is), some speculation exists as to whether more companies are preparing for IPOs, as 175 IPO filings have been submitted to the SEC for review. This is discussed extensively in Xconomy. 

Posted by Bruce Lehr Apr 19th 2013.

Liquid versus Powder Media Choice in Production

I like to recognize when a colleague's work gets good coverage in scientific or trade journals. My kudos go out to Joanna Hudson this time for her article "Choosing Liquid or Powedered Media" in April's issue of BioProcess International, page 18. 

As pointed out in the article, the old automiatic choice to use powdered media at scale is less obvious now.  Liquid in many cases becomes a much better option as the scale of manufacture at commercialization has come down due to improvements in cell productivity in culture, and because there have been many imporvements made to the disposable systems that can support commercial manufacturing now. 

In fact, companies are actively choosing to design new plants to run on disposables to cut capital costs associated with installing so much stainless steel, and to increase their ability to run multi-product flexible facilities -- which increases their ability to be responsive to market conditions.  

Under many circumstances, liquid media can and should commercial production instead of the powdered alternative in order to reap some of the benefits alluded to above.

Posted by Bruce Lehr Apr 18th 2013.

Obama Budget May Cause Big Pharma to Take Its Own Pain Meds

PharmaTech Talk reports what's in the new FY 2014 budget proposal that's in favor of Big Pharma?  Not much apparently.  First off, it appears FDA will be losing more money for drug oversight.  Any added resources they will get will have to come from pharma user fees, i.e. they will pay as they go.

Pharma will also be asked to pay for more of the Medicare drug benefits, especially to help the government close the Medicare Part D "donut hole".  The proposal is for pharma to increase discounts from 50% to 75% in this category -- which should cost them about $11 B over 10 years.

What else is in the grab bag?  Well, under Medicare Part B pharma will be asked to to accept a reimbursement rate of ASP plus 3% instead of the current 6%.  This will cost them another $9 B over 10 years.

Obama also proposes to extend Medicaid drug rebates to Medicare dual eligibles.  This should cost pharma $3 B more next year and a tidy $142 B over 10 years.  Couple this to a ban on pay-for-delay and ring the cash register to the tune of another $740 M next year and $11 B over 10 years. This is suppposed to increase generic drug use.

Further, there is a proposal to cut the exclusivity period for biosimilars from 12 years to 7 years.  That's expected to be worth $3 B in savings.

Add it all up.  Looks like potentially $176 B over 10 years.  Put that in your patent cliff and smoke it! Then take 2 aspirin and call me in the morning.

Posted by Bruce Lehr Apr 17th 2013.

Surprise! Surprise! Big Biotech's Outdo Big Pharma on Several Measures

As reported in Fierce Biotech, Burrill & Co did an analysis comparing biotechs to pharma over the past 3 years.  Biotechs emerged as the winner on several key measures.  Companies in the Big Pharma camp included J&J, Pfizer, Novartis, Merck, Roche, Sanofi, Novo Nordisk, GSK, Bayer, Lilly, AZ, and BMS.  Under the biotech tent, we had Amgen, Biogen, Gilead, Celgene, Alexion, Regeneron. Shire, BioMarin, Elan and Onyx. 

Key findings as reported by Fierce for the past 3 years, included:

• Value of biotech group up 57% to 17.4% by pharma
• Net income for biotech's were up 23.8% compared to 1.1% for pharma (OUCH!)
• Revenue was up 40.6% in biotech versus 17% for big pharma.  Actual revenue was $48.6 B total vs $526.8 total. So pharma is still more than 10x larger in aggregate
• R&D spending went up 38.8% for biotech ($10.3 B) as compared to 11.7% for pharma ($76.3 B). Here pharma is only 7x in size.  Is that a good thing given their returns on R&D of late?

Biotech's are clearly offering better results for their investors at the moment but are they just smaller and at an earlier stage of hitting the "pharma wall".  Don't know. We'll find out.

Posted by Bruce Lehr Apr 17th 2013

Top 10 Companies for New Drug Approvals Over Past 10 Years

Fierce Biotech via Mathew Herper's column in Forbes, reports that J&J had the most drug approvals in the 10 year period ending in 2012. This is one measure of R&D pipeline success (personally I'd like to see the amount of revenue generated from these drugs as the lead measure). Regardless, here's the score:

• Johnson & Johnson 13 approvals
• Pfizer + Wyeth  13
• Merck + Schering Plough 12
• Roche + Genentech 12
• GlaxoSmithkline 11
• Sanofi + Genzyme 11
• Novartis 10
• Bristol-Myers Squibb 9
• Amgen 5
• Bayer 5

I'm representing the ranking slightly differently than either the Forbes or Fierce Biotech article as I've combined the production of companies that have themselves combined through M&A activity.  This makes a large difference for companies like Pfizer, Sanofi and Roche.

Posted by Bruce Lehr Apr 16th 2013.

 

PBS Newshour Covers Myriad v. AMP Oral Arguments with The Supremes

Here's video of from the PBS Newshour discussing the oral arguments presented before the Supreme court yesterday in the Myriad v. AMP "gene patent" case.  The link to the newshour comes courtesy of the Patent Doc blog -- authored by Kevin Noonan -- who also appeared in the Newshour segment. 

Posted by Bruce Lehr Apr 16th 2013.

 

Good Gene Patent Discussion

I'm a regular reader of the Patent Docs blog written by patent attorneys Kevin Noonan and Donald Zuhn. In a series of blogs this week, there was a good discussion of an article from the recent issue of Genome Medicine.  The thrust of the article was that patents were being allowed for genetic sequences that were so common in the whole genome, that the patent's broad claims could cover huge percentages of total genes (84%-100%).  This was deemed to have a potentially chilling effect on future research being blocked by potential patent infringement by the paper's authors.

You can read the series of posts discussing this topic here, here, here and here. 

Key comments that came out of the discussion from Patent Docs authors were that non-lawyers are frequently misinterpreting patent claims, i.e. misunderstanding what is actually claimed.  Also, commentators frequently give more credence than is due to a patent application versus an actual patent.  The latter being enforceable while the former is not. On the other hand, Patent Doc authors conceed that some claims are written to broadly in the attempt to extend clients' rights as far a permissible.  Unfortunately, many are so broad as to really run afoul of prior art and would never be allowed.  So author's agree that better claim construction would also help the situation.

Posted by Bruce Lehr Apr 12th 2013

Biosimilar State Legislation Score Card

The Pharmalot blog is doing a good job keeping us up to date on the legislative efforts of various States to put forth regulations on the interchangeability of biosimilars --- assuming any ever get approved by FDA in our lifetime. 

Maryland is the latest State to reject a law that would make substitution of a biosimilar harder, or allow a physician to prescribe and specifically prevent substitution. AZ, MI and WA states have also voted down such legislation. 

States that have accepted limits on biosimilar substitution include ND, VA and UT.  But Virginia and Utah have sunset provisions in their laws that would require them to pass updated legislation when FDA sets their final guidelines. 

Arkansas has a bill in committee. And nine other States have legislation that is expected to be considered by their lawmakers.  These include CA, CO, FL, IL, IN, MA, OR, PA and TX. 

Backers of these types of limitation bills include the Alliance for Safe Biologic Medicines, Amgen and Genentech who would like to protect their innovator franchises.  Opponents include generic manufacturer trade groups like the GPA -- who obviously would like to make and sell biosimilars as easily as possible.

I still tend to believe the economic incentives for health payers and governments favors allowing substitution and would expect this to eventually occur when we actually get some drugs on the market.  I think legislators ought to consider other types of tax incentives and credits for innovators to keep them doing their good work toward creating new products for the rest of us.

Posted by Bruce Lehr Apr 11th 2013.

Just Back from Final Four

I just returned from an exciting trip to Atlanta to see the Final Four.  Unfortunately, my Orangemen didn't win but all 3 games were very competitive, the people were nice, and I had a wonderful time.  I even fit in a Braves-Cubs game on the off-day Sunday before seeing Sting and Dave Matthews.  Really good stuff.  Congratulations to Louisville.

Regardless, good season for the Cuse and Let's Go Orange!

Posted by Bruce Lehr Apr 10th 2013.

Biotech Top 10 Revenue Stragglers

Fierce Biotech today published the top 10 new drugs with sales that lag the analysts' bullish pre-launch estimates. This ranking was based on drugs launched in the past 5 years that had been projected to earn blockbuster status.  Unfortunately, thus far they have not and have not likely prospects for doing so:

• Pfizer's Relistor - Projected $865 M and Actual $37 M
• Intermune's Esbrist - Projected $917 M and Actual $132 M
• Vertex's Incivek - Projected $4.05 B peak and new peak $669 M
• Amarin's Vascepa - Projected peak $2 B and new $505 M
• GSK's Benlysta - Projected peak $2.8 B and new $696 M
• Takeda's Nesina - Projected $2.53 B peak and new $788 M
• AZ's Brilinta - Projected $2.52 B and new $865 M
• Amylin's Bydureon - Projected $1.66 B and new $615 M
• Vivus's Qysmia - Projected $1.13 B and new $437 M
• Genentech's Actemra - Projected $2.25 B and Actual $896 M

This proves that analysts are too bullish, and tend to overestimate the mark (a lot like marketing research).  It may also be reflective of a changing healthcare environment that wants to see actual value for its expenditures.  If you can't be what's already on the market cost effectively, then we don't want to buy it.

Posted by Bruce Lehr Apr 10th 2013.