The Big Red Biotech Blog

Where The Deals Are… Cancer Remains Hot

This is a nice summary by the Pharmalot blog (via Deloitte) indicating where biopharma dealmaking occurred last year relative to disease areas.  Not surprisingly, cancer was in the number one slot with 161 deals and represented nearly 25% of the total. More than half the deals were signed during the discovery or pre-clinical phases.

Where The Deals Are… Cancer Remains Hot // Pharmalot.

Median deal sizes (at least those disclosed) were higher in areas other than cancer -- autoimmune and inflammatory -- followed by endocrine and metabolic -- were one and two. Not surprisingly, upfront payments rose in alignment with phase in the pipeline.  Phase I earned median payments $8.4 million, phase II $19.5 million and phase III $25 million. Registration stage compounds were more than double that at $59 million.

The five largest deals (out of 714 total) had an announced aggregate value of $8.2 billion with upfront payments totaling $738 million. So now you know where the money went, will it keep going there in coming years?

Posted by Bruce Lehr May 31st 2012.

Pharma R&D Follies

Here's a couple of links to blog posts outlining possible reasons that Big Pharma R&D is experiencing such a low return in bringing new products to market --- especially over the last 10 years.  One factor that is discussed is -- CULTURE (see Life Sci VC and In the Pipeline). 

The basic premise?  

Fundamentally, I think the bulk of the last decade’s productivity decline is attributable to a culture problem. The Big Pharma culture has been homogenized, purified, sterilized, whipped, stirred, filtered, etc and lost its ability to ferment the good stuff required to innovate. This isn’t covered in most reviews of the productivity challenge facing our industry, because its nearly impossible to quantify, but it’s well known and a huge issue.

These effects are variously attributed to a multitude of large cross functional committes, with all their associated bureacracy, making all the decisions very s-l-o-w-l-y......, risk aversion (i.e. ass covering) and unwillingness to kill bad projects before they've dragged on past their due date, and mega-mergers or internal reorgs that constantly stall projects while all the new players and pieces get assembled and reassembled. All of this plays havoc on continuity, quick decision making, empowerment of development teams, nimbleness, innovation, blah blah blah --basically all the positive characteristics organizations say they are striving for.

But the basic conclusion, for now, is that Big Pharma's culture is its own worst enemy when it comes to R&D productivity.  There seems to be a need to simplify and empower teams if you really want to see any results in an acceptable time frame.

The stakes are high too. If you doubt that, just look at this article from Fierce Biotech that details the R&D spending of the Top 10 Big Pharma -- which is topping $70 B per annum now.  Then look at the productivity of many of these same organizations as judged by new drug introductions in the last 10 years........not very pretty.

Posted by Bruce Lehr Apr 25th 2012.

 

Biotech Achieves a Milestone: Abbott's Humira Goes to No. 1

Humira, as noted in a post today in Xconomy, will rise to the number one revenue producing drug in the world in 2012 -- estimated at $9.3 B -- thus supplanting the old champ Lipitor that has reached its patent expiry. This is the first time that a biological drug is in the number one spot and perhaps marks a watershed when bio drugs take over from their small molecule bretheren.

According to Reuters data, Abbott's Humira is not only number one, but J&J's Remicade and Amgen's Enbrel are numbers two and three.  Thus, biological drugs, that are all anti-TNF, hold the top three slots.  And according to Reuters, 8 of the top 10 drugs are now biologicals.  That's an amazing emergence -- Humira is entering its 8th year on the market and was the third drug of its type in its class.  Hurrah!

From here on out, it looks like biologicals will now drive the growth of the world pharmaceutical market, and in addition to the leading Mab drugs we see now, we'll likely see many more non-Mab drugs emerge as the orphan disease classes begin to be better served.

Posted by Bruce Lehr Apr 16th 2012.

The Costly Myths about Pharmaceutical R&D

I love this back and forth debate about how much drugs cost to bring to market -- focusing ostensibly on the R&D costs.  Problem is -- apparently -- no one can agree on where R&D costs start and finish.  Nor can they agree on which drugs are coming to market.  Is it NMEs?  Is it variations on existing drugs? Both? Neither?

The Costly Myths about Pharmaceutical R&D - Health News Watchdog .

We also get to argue about whether discovery is included or not.  Whether the cost of capital should be considered or not.  Whether the government or public subsidizes the process, to what degree, and whether that should be deducted from the costs in the analysis.  We can't even agree whether we're including biotechs or not in our analyses.

That's how we end up with an estimate of the cost of developing a new drug falling somewhere between $56 M and $11.9 B.  We might be able to just barely slide a piece of paper through that crack.  More like dozens and dozens of reams.

Posted by Bruce Lehr Feb 17th 2012.

Which Pharma Spent The Most R&D On Each Drug?

Pharmalot just published (via Forbes) an analysis of Big Pharma R&D spending for period 1997-2011.  The data was provided by InnoThink Center For Research In Biomedical Innovation and Thomson Reuters Fundamentals via FactSet Research Systems.

Which Pharma Spent The Most R&D On Each Drug? // Pharmalot.

From this, one could calculate the dollars spent on R&D/new drug approved for each company concerned.  The link above provides a Table of the results for 12 Big Pharma (biotech).  Amgen, it turns out spent the least at $3.7 B per new drug (11) approved during this period.  AstraZeneca, it turns out spent the most at $11.8 B per new drug (5) approved during this period - OUCH!  This coupled with products reaching the patent cliff helps explain why the latter is experiencing really tough times now and cut over 30,000 jobs during the period.

Even $3.7 B per drug at Amgen seems like an astronomical amount of money.  It's no wonder the industry it trying to rethink its business and R&D model.  Clearly something better change when you are spending$3.7 B to $11.8 B PER DRUG.

One can't help but think to some degree this "ranking" over the period has a little to do with luck as well given some of the vaguaries in the approval process and perhaps timing of some projects relative to submission dates in this period.  I'm not certain you can state one company has any better development model than any other based on this data.  You can say Amgen made out slightly better than its peers for the period -- but who's to say that will hold up over the next period?  We're going to have to track some of these "new models" at companies like Novartis, GSK and Sanofi to see if they really see improvements.

Posted by Bruce Lehr Feb 10th 2012.

SEE some more commentary on this subject from In the Pipeline.

2011 Final FDA Drug Approval Statistics

The FDA approvals for full year 2011 can now be formally tallied.  The agency did approve more drugs this year than it has for any of the past seven.  Some points include 30 new drugs approved, including many novel applications that were approved in the US first.  Both J&J and GSK each achieved 3 new approvals.

Analysts attribute the higher approval numbers to such things as pharma's improved data packages being submitted with drug applications, specifically with more safety data.  Pharma companies also appear to be picking better candidates that represent more novel treatments as drug they preferential push toward approval.

The agency for its part says it is trying to streamline the approval process -- a process that heretofore has been under heavy criticism by pharma company's, industry analysts and investment groups. It remains to be seen if 2012 will be as rosy -- but we can start 2012 optimistically can't we?  See Fierce Biotech.

Posted by Bruce Lehr Jan 6th 2012.

Top 10 Biotech Deal Terminations in 2011

Fierce Biotech recounts the Top 10 biotech deals with big pharma partners that were axed in 2011.  They state that the right deal can make a company and when it sours it can break it too. Pharma partners look to pull the plug ASAP on souring deals to save as much money as possible. It's a "Terminate often, terminate early" philosophy at work many times.

Analysts (passing out advice & when don't they) say under that scenario, it is critical that the biotech gets back all licensing rights without paying reverse royalties -- so they can repartner the deal!  Many deals are repartnered in just this manner. With regard to blockbusters coming from these type of deals, analysis reveals that 8% had been partnered, re[partner4d and launched to successful outcomes.

Top 10 Terminate Deals for 2011:

• GSK and Targacept (neuronal nicotine receptors)
• Shire and Renovo (Justiva for scarring)
•  Merck and Addex Pharmaceuticals (ADX63365 for schizophrenia)
• Janssen Pharmaceuticals (J&J) and Diamyd Medical (GAD65 for type I diabetes)
• Cephalon and ImmuPharma (lupus)
• Novartis and Peptimmune (PI-2301 for MS)
• Novartis and Paratek Pharmaceuticals (PTK 0796 wide spectrum antibiotic)
• Merck and Portola Pharmaceuticals (Betrixaban anticoagulant)
• Eli Lilly and Amylin (Byetta for type 2 diabetes)
• Solvay and Depomed (DM-1796 for pain)

Time to repartner up.

Posted by Bruce Lehr Dec 19th 2011.

 

 

ADCs are Hot and Offer CROs/CMOs Opportunities

As covered in the BioProcessBlog, BPTC's first bioPULSE survey found that the market was bullish on the prospects of antibody drug conjugates (ADCs) to become a major therapeutic area going forward.

Increasing interest in ADCs.

Key findings in the web-based survey included:

• 83% of respondents expect to see a signifcant increase in the number of ADCs entering the pipeline in the next 5 years
• 24% indicated that they were not currently working on ADCs but expected to be doing so soon
• 24% indicated that they were already working on ADCs
• 95% of respondents said ADCs would be as big as mAbs or very important but not quite as big as mAbs (only 5% felt it was a niche application)

Conjugation technology and linker chemistry was seen to be the biggest challenge. Survey participants cited this as an opportunity for CROs/CMOs who could provide help with conjugation and linkers and provide manufacturing.  See Big Red Biotech posts here and here.

Posted by Bruce Lehr Dec 16th 2011.

Drugmakers Go From Abundance To Scarcity

A new report from Oliver Wyman puts numbers to the dismal trend seen in Big Pharma R&D from 2005-2010 as compared to "boom" years of 1996-2004.  The down period was named the "drought" years and some of the more disturbing statistics appear below:

Drugmakers Go From Abundance To Scarcity // Pharmalot.

• R&D spending doubled to an average of $125 billion during the drought period, from $65 billion in better times. And the ROI dropped like a stone to an average of $75 million in sales during a product's fifth year for every $1 billion spent on R&D, down dramatically from $275 million in better days.


• The development drought also led to a declining economic value of approved drugs, to an average $430 million from $515 million. 


• Drug approval itself plunged about 40% in the dry years, amounting to 22 FDA approvals per year on average, versus 36 in the better years.


• Drugs produced an average of $9.4 billion in fifth-year sales in the dry period, half of the $18.3 billion during the more productive years. Fewer blockbusters and fewer new drugs overall contributed.


• In all, 17 of the 20 companies faced productivity declines, though Novo Nordisk, Bristol-Myers Squibb and Johnson & Johnson did better than most.  Dips in high levels of productivity hit everyone though.

What to do about it?

The paper's authors recommend raising standards for product innovation and working more closely with payers as they face pressures to hold down costs. They also want companies to treat new compounds as rare (don't take development success for granted), with focused investments that don't rely as much on speed to market, .i.e. actually create better products and understand more about their mechanism of action in treating disease.

Another recommendation: Play to win. This means using strategies like closely assessing the competition (to create novel products), seeking alternative financing and joint R&D efforts with other parties (including rival drug makers), and making everyone focus more on business development. (See Fierce Biotech).

Posted by Bruce Lehr Dec 4th 2011.

 

Rise of Asian biopharm creates investment targets for Quintiles

Quintiles says it plans to invest more in Asia as the biopharm industry continues to develop rapidly over there.  

Rise of Asian biopharm creates investment targets for Quintiles.

Anand Tharmaratnam, head of Asia markets at Quintiles, said that global biopharm companies accounted for 90 percent of Quintiles clients in Asia only 3 years ago, whereas the ratio of global to local clients is now closer to 50:50 today. That's a dramatic shift in only 3 years.

Tharmaratnam attributes the rapid growth to government support and return of highly qualified staff (with an entrepreneurial bent) from the US.  Korea, Singapore and Taiwan in particular were singled out as biopharm hotbeds.  The rapid growth in India and China has also stimulated global pharma companies to locate more and more operations there to open up these potentially lucrative markets. 

Anyone think the US needs a policy to further promote US Biotech growth and industry health to maintain our current leadership position?  Or can we just watch Asia grow at our expense?

Posted by Bruce Lehr Dec 1st 2011.

Those Returns On R&D Are Falling Fast

Here's one post (of many) reporting on the results of a new Deloitte study on the R&D productivity of the world's 12 largest BIG pharma companies.  As would be expected if you have been paying attention to talk of patent cliffs and dry pipelines, the results are not too pretty. 

Those Returns On R&D Are Falling Fast // Pharmalot.

Let me hit you with the Reader's Digest version of Deloitte's findings from last year:

• The average cost of bringing a drug to market rose by 25% to more than $1 B up from $830 M (note these figures are hotly disputed by others as "grossly inflated" and several posts on this site discuss the controversy)
• The number of late stage drugs in development dropped from 23 to 18 (22% decrease) per company on average
• Ten of twelve firms saw R&D ROI decline resulting in a group drop from 11.8% return to only 8.4%
• Two-thirds of the top 12 did realize "more value" from product commercialization than they lost in late stage failures (Thank God for minor blessings)
• Non-R&D costs declined across the top 12 to free up cash to go back into R&D

This analysis should be viewed as a snapshot and may or may not reflect a trend. Deloitee stated that more improvments need to be made, and suggested that "more collaboration" occur between companies to "pool" disease knowledge. In particular, sharing knowledge on failed molecules and approaches could be very helpful to industry learning. Drugmakers may also share "non-competitive" areas of R&D to reduce costs for all.  See more in PharmaGossip and Fierce Biotech.

Finally, In the Pipeline had an interesting post the same day talking about "what if" the principles espoused in Moneyball could be applied to the Big Pharma pipelines?  It's an interesting thought and one I'd like to see undertaken (at least do the math and assess predictive value as theoretical exercise).  Anyone got Bill James' phone number?

Posted by Bruce Lehr Nov 29th 2011

 

 

EMA Stats Point To Improved Pipelines

According to PharmTech Talk approvals in EMA in 2011 look much rosier than the picture seen at the end of 2010 -- and this may give us hope that this will continue in 2012 and beyond. Let's look at the numbers.

PharmTech Talk » EMA Stats Point To Improved Pipelines.

2010 Jan - Dec

• positive opinions 51
• finalized marketing authorization applications 54
• finalized new drug applications 21
• finalized new orphan drug applications 6

2011 Jan - Sep

• positive opinions 74
• finalized marketing authorization applications 79
• finalized new drug applications 32
• finalized new orphan drug applications 11

There seems to be a pretty substantial increase in authorizations even when comparing a partial year 2011 to a full [dismal] year in 2010 - which coudl be interpreted as a sign of hope for the industry in 2012.

Posted by Bruce Lehr Nov 11th 2011.

 

 

 

 

 

 

 

FDA Approves 35 Drugs in 2011 YTD

The FDA released a statement touting that it has approved 35 drugs YTD which is only 2 less than its best year in the past 10 years (37 in 2009).  What's more?  The approval times are faster than elsewhere - 24 of the 35 newly approved drugs occurred in the US before any other country in the world and also before the European Union.

The FDA Approved How Many New Drugs? // Pharmalot.

According to the agency, of the 35 approvals, two are “breakthroughs” in personalized medicine that were approved with a diagnostic test; seven provide major advances in cancer treatment; 10 are for orphan diseases; 16 were approved under priority review; two-thirds were completed in a single review cycle; three were approved under accelerated approval, and 34 were approved on or before the agreed-upon review time targets, including three cancer drugs approved in less than six months (you can read the complete report here).

Beat your drum loudly while you can.

 

 

 

 

Posted by Bruce Lehr Nov 3rd 2011.

New Leader - Sanofi overtakes Pfizer

Sanofi will overtake Pfizer as the world's biggest drug company, largely on the strength of its acquisiton of Genzyme and Pfizer's loss of sales through patent expirations.  Can anyone say Lipitor....

Sanofi overtakes Pfizer as world’s biggest drug company .

We soon will have a new sales leader in the clubhouse $51.6 B to $49.8 B. And believe it or not, Novartis is expected to slip into second at $49.9 B.

Posted by Bruce Lehr Nov 1st 2011.

 

Tora Tora Tora -- Big Pharma Fights for Share in Japan

Many Big Pharma companies -- like Pfizer, Eli Lilly, Merck and Novartis -- have identified boosting share and sales in Japan as a key strategy to mitigate the effects of lost revenue from drugs with expiring patent protection. And they are upping their sales and marketing activities to battle it out in the world's 2nd largest pharma market.

Signs of this increased emphasis include doubling the size of sales forces and increasing promotional spending as an industry by more than 26% since 2006 -- to reach $27.6 billion. Japan is attractive as a very developed market with a rapidly aging population -- 23% are > 65 years old -- or more than any developed country.

 
Japan's increased attractiveness is underscored by an increasing numbers of new product launches -- Merck with 7 in past 2 years and Novartis with 11 since 2009.  The latter had sales of $3.3 billion in 2010 and wants to exceed $4 billion in a couple of years -- as well as move from No. 6 in market share to the top 3 in share.  Similarly Lilly is trying to double its 2010 sales of $1.64 billion by 2015.

"China, you have to grow th market.  With Japan, it's big already, you just have to get your share," says Ludwig Kanzler, partner at McKinsey & Co.

 

 

 

Posted by Bruce Lehr Sep 30th 2011.

India May Cap Foreign Investment In Pharma

India has been worried about protecting its domestic pharma industry from MNC takeover for several years now -- especially as foreign buying companies have grown their market share to more than 15% in the last couple of years.

India May Cap Foreign Investment In Pharma // Pharmalot.

A high-level government think tank called the Planning Commission now has recommeded that India cap foreign investment in drug manufacturers to less than 49% rather than allow up to 100% investment as is theoretically possible now. Ostensibly this is to protect India's poor populace from being priced out of the market when the evil foreigners take over. This does not bode too well for foreign investment in India. Other members of the government argue that such protectionism is retrograde policy making -- and a few more forward looking Indian companies, like Biocon, say bring on the competition. 

Its chairman, Kiran Mazumdar-Shaw says, "Companies will do what makes business sense for them. This is a high-growth sector and you will devalue it if you start putting restrictions."

It's worth noting that India makes more than 20% of the world's generics now and its industry is expected to grow from $19 B in 2009 to $50 B by 2020.

 

 

 

Posted by Bruce Lehr Sep 27th 2011.

 

Bernstein 'Bears' Say Lilly Needs to Buy or Be Bought

Here's a pessimistic piece that appeared in Phamagossip last week quoting an analyst from Bernstein Research as saying that Eli Lilly's revenue will be taking such a hit from upcoming patent expirations that the Company will have no choice but to acquire someone or be acquired. No shades of grey there, eh?  

http://pharmagossip.blogspot.com/2011/09/patent-cliff-losses-mean-eli-lilly-must.html.

The analysis said Lilly's $21.7 B in sales in 2010 could plummet to as low as $9.7 B in 2020 if a doomsday scenario develops -- i.e. drugs go off patent and their pipeline fails.  Yeah, and if I go swimming tonight with my hands and feet tied, I could drown. Using similar, analytical skills, Bernstein also called out AZ and Pfizer as two others who are about to take the plunge. Interestingly, the analyis predicted Pfizer's revenue plummet would be even worse if it activated Ian Read's divestiture plan to focus on its "core pharma business."  That's cheery.

On the bright side, Bernstein picked Novartis to soar to the top of the Big Pharma heap by 2020 as it is predicted to hit $70.8 B in revenues that year.

 

 

 

 

Posted by Bruce Lehr Sep 26th 2011.

 

 

 

Top 10 Vaccines of All Time

I've seen it stated many times that vaccines are more responsible for saving lives than any other field of medicine -- which of course makes it all the more vital that PEOPLE actually go get their vaccinations rather than worry about a plethora of rare side effects or pseudo-science claims stemming from BAD science and histrionics.

I saw this post on the "10 MOST Important Vaccines in Human History" and thought people might to remind themselves about how much disease and death vaccines prevent on an annual basis.  Vaccines have effectively eliminated diseases like Small Pox and Polio - once feared killers.

Posted by Bruce Lehr Sep 18th 2011.  

Is Reproducibility on New Drug Targets 50% or 20%?

This post from In the Pipeline talks about how venture capitalists with long careers investing in drug development have estimated in the past that only 50% of new drug target findings can be reproduced in an independent lab setting.  Now we have more data on that from Bayer Pharmaceuticals.

In the Bayer study that looked at its own in-house validation program aimed at showing which new targets in the literature could be confirmed -- and therefore developed into a potentially profitable drug -- uncovered that only 1/4 to 1/5 of all putative targets were reproducible in their labs. That's right, in looking at 67 projects (47 in cancer), the analysis showed only a 20% to 25% confirmation rate.

The conclusion is obvious.  You can't take the literature at face value.  You need to do the work to confirm which targets in the literature will actually be reproducible and it appears that rate will be well under 50%.  Keep that in mind when investing in new targets!

 

Posted by Bruce Lehr Sep 2nd 2011.

Merck Serono Opens Its R&D Site in China

Merck Serono (MS) opened the doors on its new $225 m R&D center in Beijing, China this week.  The center will focus on drugs for cancer, neurodegenerative disorders, autoimmune and inflammatory diseases.  MS says these programs will be tailored to specific target populations using biomarkers and companion diagnostics to identify likely responders. (See previous blog post on Roche for more on this trend).

The new R&D center complements other Merck Serono hubs in the US, Germany and Switzerland.  MS management also notes that it is keeping a very close watch on the developing domestic China drug market.  China is expected to become the number 2 pharma market (behind the US) within the next 6 years.  So this R&D move also gets Merck Serono closer to a patient population that it hopes to serve more in the very near future. See Fierce Biotech.

 

 

Posted by Bruce Lehr Sep 2nd 2011.

 

India Biotech Grows 25%

Ernst & Young published its 25th annual report - Beyond borders: Global biotechnology report - 2011.  in it, E&Y cited India's biotech as hitting $4 B in 2010 compared to about $3 B in 2009.  Vaccines, diagnostics and devices and personalized medicine were seen as the innovative growth areas. But, while the overall industry grew, most of that growth came from large firms while small firms fell back and continued to struggle to get investor funding.

"The domestic biotech firms wil need to adapt creatively to this environment by doing more with the funding that is available [ed. Pull on those bootstraps!] and by working from the earliest stages of development to demonstrate the potential value of their products to investors, payers and regulators, " said Ajit Mahadevan E&Y partner.  See Fierce Biotech.

Sounds like some small guys will fail or be snapped up by the larger guys for a pittance as the industry goes through a shakeout of the weaker players.

Posted by Bruce Lehr Aug 30th 2011.

Contract Manufacturing Will Explode for Pharma

In a new report, Visiongain says contract manufacturing in the pharma industry will hit $64 billion by 2016 and more than double in the next 10 years. The manufacturing of final dosage forms is expected to grow fastest (CAGR 8.7%) - though making APIs still constitutes more than 71% of the total market.

US companies currently enjoy a 42% masrket share of contract manufacturing business, but this is expected to change as India and China are increasingly, successfully competing in this segment. The Asia and Pacific region is expected to grow by 9.6% annually over the next 5 years compared to an overall market rate of 6.7%. 

While these emerging regions are expected to grow more rapidly in the next 5-10 years, analysts also expect that costs of labor and raw materials will rise over time dampening the rate of future growth.  Markets can be expected to level out to a greater degree as the industry establishes its global footprint. See Pharmalot.

Posted by Bruce Lehr Aug 23rd 2011.

 

Top 50 Pharma Companies by Sales

Seeking Alpha recently published the top 50 pharmaceutical companies ranked by their 2010 sales.  Number one is of course still Pfizer at $58.4 billion.  The number two position changed hands last year though with Novartis ($42.0 B) passing Sanofi ($40.3 B). Merck moved up from number 7 to number 4 with $39.8 B and Roche rounds out the top 5 with $39.1 B. 

The top 10 companies account for $352.5 B in sales and 59.4% of total industry revenues.  The top 20 companies account for $483.8 B in sales and 81.5% of total industry revenues -- kind of an 80/40 rule for top 50 pharma. All 50 companies in the top 50 had sales topping $2 B.  This may yet leave some room for more industry consolidation.

I was interested to see that Teva moved up to number 12 with $16.1 B in sales. Thereby lending some credence to my theory that there will soon become less of a distinction between innovator and generic producers as companies begin competing in both worlds as it were. You can access the entire report below.

Download Top-Pharama-Companies-2011-RPT

Posted by Bruce Lehr Aug 15th 2011.

Will biosimilars really have an impact on capacity?

Here's an interesting point of view from The Bioprocess Blog where they weigh in on the question of whether or not biosimilars will have any impact on the worldwide need for biological manufacturing capacity.  Short version: they conclude they will not have a significant impact.

Will biosimilars really have an impact on capacity?.

I don't really agree with their reasoning. I think when yo ufocus on the current pipeline and use it as a surrogate for what will happen you aren't properly viewing success rates.  In the current pipeline you end up with lots of failures from the novel drug candidates.  But with biosimilars, you should see much higher success rates in development as the targets are proven. 

Secondly, the authors focus on the impact of biosimilars that have hit Europe to date -- mainly molecules like EPO and hgh.  I think this neglects all the mAbs that we should be seeing soon and I think those will have a higher impact on manufacturing needs. 

Thirdly, the discussion seems to be centered on what is happening (or not) in Europe and the US.  The post was ostensibly about "worldwide biological manufacturing" capacity.  If so, there should be much more attention paid to what will happen as biosimilars start coming on line in China, India, Korea, etc.  I don't think the EU model will be a very good surrogate for what will happen in those local markets when local producers start bringing their drugs to market. 

So I respectfully disagree with the authors conclusions. I think the new players in the new economies will have a much bigger impact and represent a much larger opportunity.

Posted by Bruce Lehr July 26th 2011.

 

FDA's Woodcock says Drug Approvals at 20-year high

The FDA's Janet Woodcock, Director CDER, testified before Congress that the number of new chemical and molecular entity approvals had reached a 20-year high to date in 2011. Twenty drugs have been approved in 2011 so far as compared to 21 drug for all of 2010.

Woodcock further pointed out that the low number of approvals was more a function of attrition in the pharma pipelines than due to regulatory rulings by the FDA.  A recently issued report states that drugs moving to phase III dropped by 55% in 2010, with comparable decreases of 50% and 47% for phase II and phase I respectively.  Thus, the number of drugs reaching a submission for approval is down and therefore the number of approvals would be expected to follow.  See Fierce Biotech.

 

 

Posted by Bruce Lehr July 8th 2011.