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... Continue reading

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... Continue reading

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... Continue reading

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... Continue reading

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... Continue reading

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.... Continue reading

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... Continue reading

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... Continue reading

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 Continue reading

I couldn't help but notice that the Creature from the Black lagoon is screening at the Schlafly Bottleworks in Maplewood this evening. I used to watch OLD horro movies with my kids when they were small (e.g. 15 years ago) and we loved THE CREATURE. A combination frog and fish... Continue reading

I went to my first Cards game of the year versus the Reds on Tuesday (4/30) evening. It was a gorgeous night at 78 F at game time and clear skies with refreshing breeze. I had great seats in Row 2 of section 246 below the RedBirds club -- and... Continue reading

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... Continue reading

I recently caught the Da Vinci Machines Exhibit. It's being shown in the Bank of America building at 800 Market Street and has been extended through August 2013. The Exhibit is a celebration of Leonardo Da Vinci's genius and focuses explicitly on the many machines that he invented (conceived) in... Continue reading

I saw Webb Wilder was going to play Off Broadway last Friday (Apr 20th). I admit it. I didn't know Webb Wilder but he looked like someone I might like to hear so I took a chance and went to his show. The crowd was sparse -- about 50 people... Continue reading

Last Saturday (Apr 21st), the Four Hands Brewery (on 8th Street) sponsored its 2nd Annual Food Truck Festival. The weather was glorious, the crowd large and in a mood to celebrate and enjoy a Spring day with good food, friends, music and of course beer. Who could ask for more... Continue reading

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... Continue reading

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.... Continue reading

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... Continue reading

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... Continue reading

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... Continue reading

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... Continue reading

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... Continue reading

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... Continue reading

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. Continue reading