The Big Red Biotech Blog

New Drug Annual Report from PhRMA

Below appears the 2013 Report from PhRMA on the industries pipeline of new biologic drugs. This overview outlines drugs by therapeutic category, by clinical phase and by company. There are 907 biologics in development covering more than 100 diseases.

 Download Biologics2013 

The major category level includes: 338 drugs for cancers, 176 aimed at various infectious diseases, 71 at automimmune diseases, and 58 at cardiovascular disease. Other disease categories inclue diabetes, digestive disorders, genetics diseases, neurologic and respiratory diseases.

Posted by Bruce Lehr Mar 25th 2013.

IPO Files Amicus Brief in Support of Myriad Genetics

The Patent Doc blog outlines the arguments in the Intellectual Property Owners (IPO) Association's recent brief filed in support of Myriad Genetics.  The brief asks the Supreme Court to affirm that isolated human DNA are patent-eligible. 

The brief very pointedly calls out that we are not debating "human gene patenting" but whether an "specific sequence of isolated human DNA" is patent-eligible. Quite simply, IPO argues that it is as it passes the "hand of man" test established by the Court under Chakrabarty.  Clearly, it is argued, the isolated DNA sequence is a product of human ingenuity, "having a distinctive name, character and use."

The brief also points out that despite claims to the contrary by those in opposition, there is no evidence that this patent has had any effect in slowing down the science aroudn the subject matter, brac1 and brac2 sequences.  In fact, there are at least 10,652 references in the scientific literature to publications around these sequences. Moreover, the number of new publications is growing each year and have done so even after the patent issued.

You should read the whole discussion yourself which covers other aspects as well in rebuttal to Petitioners arguments.  At the end of the blog post, it is revealed that one of the amicus brief's authors is Kevin Noonan of the Patent Docs blog.  I must say the amicus brief is written a lot more coherently than the one submitted by Myriad's lawyers in the case.

Posted by Bruce Lehr Mar 22nd 2013.

Pre-Emptive Strike by Biotechs Over Biosimilars Substitution

Biotech innovators score this time by backng a new law in Virginia that dictates rules for allowing interchangeability of biosimlars for the original biologic drug.  The legislatins requires tha FDA must have specifically deemed the biosimilar to be interchangeable with the prescribed biologic for the indication in question. Physicians will also have the authority to specify "Do not substitute."  FDA, of course, has not even approved ONE biosimilar yet.

Biotechs Get First State Victory Over Biosimilars // Pharmalot.

"The legislation properly preserves the physician-patient relationship, protects patients, maintains incentives for innovation, and promotes a competitive market for biologic therapies.  Furthermore, it is a model for legislation necessary in all 50 states to address vital drug safety measures that accompany this cutting-edge technology," in BIO issued statement.

BIO certainly is reflecting the opinion of its members.  This pre-emptive law will make substitution harder.  No doubt it will help protect member revenues.  It may protect patients (but not their wallets).  It won't make any 3rd party payers happy.  And it is all too reminiscent of the battles that went on when generics were first introduced.  Nobody thinks twice about substitution with generics now.

Posted by Bruce Lehr Mar 22nd 2013.

Top Pharma R&D Spenders in 2012

The latest market report from GEN shows the top R&D spenders in the industry in 2012 as follows:

• Roche         $10.1 B (up $1.3 B with restructuring costs)
• Novartis      $9.3 B
• Merck         $8.2 B
• Pfizer         $7.9 B (down $1.2 B)  
• J&J            $7.7 B
• Sanofi         $6.4 B
• GSK            $5.95 B
• Lilly            $5.3 B
• AZ              $5.24 B
• AbbVie        $4.3 B

Total spend for the group wwas $70.37 B in 2012 versus a slightly higher $70.38 B in 2011.

Posted by Bruce Lehr Mar 18th 2013.

 

Eight of Top 20 Drugs in Sales are Biologics

This from The Cell Culture Dish (via GEN) shows the Top 8 biologic drugs in 2012.  They ranged from $4.0 B to $9.26 B, and all grew in sales in 2012. The stats appear below:

• Humira        $9.26 B    AbbVie
• Remicade    $8.22 B    Janssen & Merck
• Enbrel         $7.96 B    Amgen & Pfizer
• Rituxan       $7.29 B    Roche & Biogen Idec
• Lantus         $6.65 B    Sanofi
• Herceptin    $6.40 B    Roche
• Avastin        $6.26 B    Roche
• Neulasta      $4.09 B    Amgen

Roche and Amgen look like the leaders in the clubhouse. And of course, AbbVie's Humira took over title of top selling drug in the World.

Posted by Bruce Lehr Mar 18th 2013.

Quote Of The… Year? $1B Drug Cost Is ‘A Myth’

Andrew Witty, CEO of GSK has let the Cat out of the Bag.  He says oft-cited $1B figure is inflated as it includes costs of all failed drugs. 

Quote Of The… Year? $1B Drug Cost Is ‘A Myth’ // Pharmalot.

He reasons if Big Pharma (and others) didn't fail so often and weren't so inefficient, then costs would drop.  And that coul dbe passed on to the consumer. That's the first time I've seen that kind of statement out of a leading Big Pharma Exec's mouth.  He should know better than I.

It might appear Witty is trying to appeal to EU government cost cutters by holding out strong hope that drug costs can be contained, in part, through more efficient development leading to lower prices to consumers and payers.  Not likely to win many friends in rest of Big Pharma or at Tufts.

See also In the Pipeline.

Posted by Bruce Lehr Mar 18th 2013.

Happy St. Patrick's Day

A Happy St. Patrick's Day to you from Saint Frank O'Harris. Patron St. of the Black N' Gold.

Posted by Bruce Lehr March 17th 2013

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Happy St. Patrick's Day

Myriad Flubs "Its Day in Court" with the Supremes

They did if you concur with the opinion of Kevin Noonan, author of the Patent Docs Blog.  According to him, their response in AMP v. Myriad Genetics will not stir the Supremes passions. 

He opines that Myriad should have made a point of "Emphasizing the negative consequences on progress and innovation of a decision in the ACLU's favor would have provided the Court with greater motivation to pause before taking a broad, sweeping and unnecessary position on where the balance should be struck on patenting isolated human DNA.  Myriad's brief gives the Court no basis for doing so."

And their lukewarm brief is likely to go down in defeat. The consequences may not be so good for those pursuing (or holding) gene patents.

Posted by Bruce Lehe Mar 12th 2013.

 

 

Should FDA Panel Review A Bird Flu Vaccine Again?

In short, of course it should.  Science should be guided by data.  If you have new compelling data to examine, you should do it. Decisions can change if there is new data to support the change.  That should be self-evident to scientists and policy makers to my mind.

Should FDA Panel Review A Bird Flu Vaccine Again? // Pharmalot.

In this case, you are talking about purported new data that shows an elevated rate of narcolepsy being associated with persons who received the bird flu vaccine that contains a new adjuvant, AS03.  Supporters and detractors of review both rightly point out that the vaccine was approved as it battles a flu that to date has shown a 59% mortality rate in the 566 confirmed cases. The number of infected is small but the mortality is EXTREMELY high.  So I don't think we should focus too much on the original decision to approve -- it seems merited and was not capricious.

However, there is also new data developing that suggests an association with narcolepsy that is 14 times higher than what would be expected.  Couple that with the fact that narcoplepsy is considered to be an autoimmune disease manifestation, and there is also some suggestion that there might be elevated rates of rheumatoid arthritis (also autoimmune) in this vaccinated population.  It would seem prudent to check it out whether the adjuvant might be affecting this.

This seems to me to potentially be yet another very unfortunate fallout of the falisfied study linking autism to vacccination.  In that case, healthy children were placed at risk by parents choosing against vaccination against very common childhood diseases because of falsified data linking the vaccinations to autism. Scandalous really and extraordinarily damaging from a public health perspective, not to mention some unvaccinated individuals and other exposed naive populations. 

But let's don't overcompensate the other way and not look at new data coming in with regard to narcolepsy.  One fraud doesn't necessarily mean another is being perpetrated.  In this case, let's not go to sleep at the wheel without looking at the facts, and acting then on the merits of the case.

Posted by Bruce Lehr Mar 11th 2013.

AbbVie Sues EMA Over Trial Data

If you had any doubt that Abbott, now Abbvie, was quite serious about legally protecting its trade secrets.  Think again.  AbbVie is suing the EMA to prevent possible sharing of its trial data in support of Humira.  Competitors, specifically UCB and InterMune, are seeking the data through a Freedom of Information filing.

Transparency? AbbVie Sues EMA Over Trial Data // Pharmalot.

The previous blog post similarly discusses Abbvie's Citizen Petition to the FDA over the same issue.  In that letter, AbbVie highlights that it believes that an FDA revelation of its Humira data would represent a breach under the Takings Clause of the Fifth Amendment.  If AbbVie is suing EMA above, it most certainly would pursue similar action if the FDA were to move toward sharing of its trade secrets with potential biosimilar filers. 

This is shaping up to be quite an interesting set of legal challenges.  I don't know if there is a good negotiated legal solution to be had here or not.  Presumably it would be very expensive as AbbVie is trying to protect its $9 B per year franchise in Humira.  That's a healthy compensatory amount at minimum for FTO permision.  See Fierce Biotech for more.

Posted by Bruce Lehr Mar 11th 2013.

WLF Backs Abbott's Citizen Petition to FDA on Biosimilars

Here's an update from the Patent Doc blog.  It details the Washington Legal Foundation (WLF) comments on Abbott's Citizen Petition to FDA regarding its policy on approval of biosimilars. Regular readers of this blog will have seen previously that Abbott asked the FDA to not share any of its BLA filing information on Humira or any other manufacturers filing on their drugs that were submitted to the agency prior to March 23, 2010 when looking to approve a biosimilar.  The March date being when BPCIA was enacted into law.

Abbott's argument is that to share the information with a competitor would constitute the government taking its valuable trade secrets, which Abbott had every right to expect would be held confidential when filed, without just compensation to Abbott.  This would constitute an infringment by the goverment of Abbott's rights under the Takings Clause in the Fifth Amendment.

In short, WLF agrees with Abbott. WLF says while the government has the right to enact biosimilar legislation in part to help reduce the costs of biological drugs which in turn might decrease the profits of innovators ...it doesn't have the right to do so by taking private property (e.g. taking information from a BLA filed before the biosimilar law existed).   On balance, WLF argues that such appropriation of private proprty is more harmful than any benefits one might see in having biosimilars on te market from such an action. Some companies should not bear a disproportionate burden of costs to benefit the public which should be borne by the public as a whole.

So far other groups have weighed in against Abbott as well. These include the Generic Pharmaceutical Association (GPhA), Therapeutic Proteins International LLC (biosimilar's manufacturer), and Zuckerman Spaeder LLP (litigation firm). 

We haven't heard the last of this.  I expect to see this in the Supreme Court someday.

Posted by Bruce Lehr Mar 8th 2013.

Sometimes "Greed....Is Not Good."

The latest on the egregious troubles from the New England Compoundng Center are posted today in Pharmalot.  It seems employees are now giving interviews to the effect that "we got greedy" and that resulted in blowing up their scale of work beyond their capabilities, becoming overwhelmed, and producing shoddy-product on a National scale. Spread the wealth, right?

New England Compounding Center ‘Got Greedy’ // Pharmalot.

This will all be laid out on 60 Minutes this weekend.  And Gordon Gecko's bromide is decidely disproven in this instance.

Posted by Bruce Lehr Mar 8th 2013.

India and China Start Ups?

Here's a post from In the Pipeline discssing latest information on status of VC investment in biopharm R&D with start ups in India and China.  Conclusion?  VC activity is still fairly low by comparison to US standards.  The study author's estimate was that approximately $1.7 B had been invested in 116 firms over the past 12-13 years.  By comparison, the US industry would expect about that much investment activity per quarter. 

No where to go but up -- and that does appear to be the direction in which things are moving -- albeit slower perhaps than one might imagine.

Posted by Bruce Lehr Mar 8th 2013. 

EMA proposes virus testing for food sector-derived trypsin used in drugmaking

The EMA says that food industry controls on porcine-trypsin do NOT guarantee that it is virus-free. The agency is therefore proposing new procedures for drug and vaccine makers who use it as part of their process.

EMA proposes virus testing for food sector-derived trypsin used in drugmaking.

This arises most recently from the rotavirus vaccine contamination event by porcine circoviruses that was ultimately traced to porcine trypsin used in its manufacture. Based on events like this, the EMA made new recommendations:

• Use only trypsin from glands from pigs that have appropriate official health certificates
• Test for specific viruses using both porcine and primate cell lines
• It advises use of two complementary virus reduction steps in processing -- e.g. low pH and irradiation

Under the guidelines proposed the drug or vaccine producer would have the responsibility to ensure proper testing (via its vendor if desired) and safety processing steps had been undertaken.

The EMA also noted that potential alternatives to trypsin could be used from recombinant sources or could be plant-derived (like TrypZean) saying ---- "the use of bacterial or plant derived recombinant trypsin minimizes in principle the risk for animal virus contamination and the application of such alternatives is therefore encouraged."

Posted by Bruce Lehr Mar 6th 2013.

SAFC is Adding Powdered Medium Plant in Scotland

SAFC will expand manufacturing capacity for dry powdered media in its Irvine, Scotland facility to serve local European customers.  The new plant will give SAFC redundant powder manufacuring capability in both Europe and the US.

SAFC is adding large-scale production of bulk dry power media and reagents at its manufacturing plant in Irvine, Scotland.

The new facility will have the same processes, same procedures, same validation packages and use the same raw materials as the US plant in Kansas, which itself expanded in the past year. European customers have expressed a strong interest in qualifying the new plant. The plant is slated to open in the first quarter of 2014.

Posted by Bruce Lehr Mar 6th 2013.

I Liked This Post on Leadership

I read this post in Xconomy today and liked it.  I think that it rings true and they we all can relate to its message that sometimes less is more and that you know when you need to back off or ask for help.

Enjoy.

Posted by Bruce Lehr Mar 6th 2013.

 

 

SMILE! BE HAPPY!

Posted by Bruce Lehr Mar 6th 2013

EC Funds up to 200 New Rare Disease Drugs

Fierce Biotech reports this afternoon that the European commission has pledged $187M in new research funds aimed at helping develop up to 200 new drugs for rare diseases by the year 2020.  Rare diseases have become a popular target these days for drug makers so the uptake of the R&D in these projects should be good. Part of the popularity with developers is that these drugs can take a more streamlined path in clinical trials and with regulatory approval.  Another popular feature is that these drugs often command among the highest prices per patient in the biotech world.   

It's ironic that the previous post talks about Express Scripts latest analysis of drug prices. The so-called Specialty category experienced an 18%+ growth rate last year and that is expected to continue. Drugs to combat rare diseases typcially fall squarely in this category as well.  So these drugs while provided needed therapies for the afflicted will tend to further exacerbate the financial and issues that 3rd party payers and governments are grappling with. 

It's further ironic to me that many of the groups that advocate for the development of more rare disease drugs -- which have been historically neglected -- tend to also be the first groups that raise objections to ultra-high prices these drugs often command. Therein lies the rub.

Posted by Bruce Lehr Mar 5th 2013.

2012 Rx Spending Report

Every year Express Scripts publishes and analysis spending on prescripotion drugs in the US. 

Rx Spending: What Goes Down, May Go Back Up // Pharmalot.

Here are some of the factoids for 2012:

• Spending by private health insurers dropped 1.5%
• Spending on brand name medications rose 12.5%
• Generic drug prices fell a whopping 24%
• Spending on specialty meidcations rose a whopping 18.4%
• Overall this resulted in a 2.7% increase in spending on drugs

The 2.7% figure doesn't sound so bad and in fact is consistent with the previous year - but what is more worrying to 3rd party payers is that specialty drugs that account for only 2% of the populaion accounted for 24.5% of the total spending.  This is the highest percentage on record -- and more specialty medicines are on their way. 

Here's some more facts just for the specialty meds catagory:

• Spending on RA drugs rose 23%
• Spending on cancer meds increased 25.9%
• Spending on Hep C drugs went up 33.7% -- highest for an therapeutic area
• Spending on Hep C drugs (according to Express Scripts) is expected to increase another 32.3% this year and an incredible 56.3% in 2014)
• Diabetes is the category where te most money is spent and it went up 11% in 2012

What's really troublesome to payers is that more and more specialty medicines are expected to be introduced in the next several years.  Last year, 39 new drugs were approved by FDA including 22 specialty drugs, many of which cost more than $10,000 per month to utilize. Since, Big Pharma in concentrating its efforts on producing more of these drugs, the payers are worried how they will pay and control costs. 

Personally, I think this will be another economic and political driver to figure out how to make biosimilars a bigger part of the mix in te US to offer price competition in some of this specialty categories -- like RA for example. But in the real short term, we can expect more new drugs in specialty categories and more spending.  An alternative would be to adopt models to restrict access to newer drugs pending trial of older cheaper ones first -- but i don't think that will (or should) happen across the board. I do think a biosimilar model that works in the US needs to be developed. See Fierce Biotech too.  

 

Posted by Bruce Lehr Mar 5th 2012.

 

FDA Begins Crackdown On ‘Risky’ Compounders

The FDA says it has begun a new crackdown on compounding pharmacies that is targeting about 30 so-called ‘high risk’ operations in nearly a dozen states.  Late last week, it disclosed that inspections reports were issued for four compounders for a variety of serious manufacturing violations.

FDA Begins Crackdown On ‘Risky’ Compounders // Pharmalot.

The agency used a “risk-based model that relied on adverse event reports, historical inspection data, reports of quality problems and public information, to identify a number of pharmacies that may pose higher risks and that are known to have engaged in sterile compounding. These include many with which the FDA has had issues in the past.”

The agency has been criticized for moving too slow in the past and has at least one house committee looking over its shoulder.  In response to this mounting pressure, the FDA has begun coordinating its efforts with state boards of pharmacy in identifying compounders and making its findings available to all states on its website, since many of the riskier compounders ship across state lines.

As The Thing might say, "It's clobbering time."  Of course, FDA might have to ask permission to do so and be relegated to refering cases to state boards for actual action.  Not ideal.

 

 

 

Posted by Bruce Lehr Mar 4th 2013.

Build Blockbusters One Block at a Time

Fierce Biotech reports that Novartis CEO, Joe Jimenez, says that the company will switch away from expecting single indication drugs to result in blockbuster status (i.e. > $1 B in annual sales).  Instead, Novartis will introduce drugs, gain approval as quickly as possible, and then extend the drug's indications -- perhaps in niche markets -- to cobble together its $1 B in annaul sales across all the indications.

In other words, they will continue to do what they have been doing in cancer fields for a long time. Just build em one block at a time.

Posted by Bruce Lehr Mar 4th 2013.

Luke Takes Umbrage to LaSalle Biotech Hub Rankings

Here's a good article from Xconomy's BioBeat today.  In it, Luke Timmerman calls to task a recent report from Jones Lang LaSalle purportedly ranking the top biotech hubs in America and the World.  Luke argues persuasively they got it wrong and calls for someone to provide a "real analysis" and produce a better set of rankings.

I think most of his points have merit.  Read the blog post yourself and decide. I do think a careful consideration of most, if not all, of his 15 points would provide a more holistic ranking and one that would be more robust in its conclusions.

Posted by Bruce Lehr Mar 4th 2013.

India Rejects Bayer Appeal On Compulsory License

India's Intellectual Property Appellate board rejected Bayer's appeal fighting a compulsory license to its drug Nexavar.  The license was granted last year to the generic manufacturer Natco when authorities determined that Nexavar cost to much for Indian consumers -- patents or no stinkin' patents.

India Rejects Bayer Appeal On Compulsory License // Pharmalot.

Needless to say, Bayer was not impressed.   “The order of the Intellectual Property Appellate Board weakens the international patent system and endangers pharmaceutical research,” the Bayer (BAY) spokesman writes.

Consumer advocates on the other hand were dancing in the streets.  “The decision confirms that the Indian patent office is able to use all the means legally at its disposal to check the abuse of patents and open up access to affordable versions of patented medicines,” says Leena Menghaney, the access to medicines campaign manager in India for Medicins Sans Frontierers, also known as Doctors Without Borders. “Most importantly, the decision means that the way has been paved for compulsory licenses to be issued on other drugs now patented in India and priced out of affordable reach.”

This can't be good news for multi-national pharma companies in India if the decision stands -- not unless they want to drop prices by 90%.  Ouch!  Certainly, there appear to be disincentives developing for Western companies to introduce new drugs to India if their patents are not to be respected. 

Posted by Bruce Lehr Mar 4th 2013.

Life Sci VC Reviews 2013 Deals

Here's some interesting commentary and facts about some of the early biotech structured deals in 2013 between Pharma and the small pre-clin stage biotechs.  The post is from Bruce Booth of Life Sci VC.

The upshot is that the deals look good so far.   All appear to be high science plays (two orphans), share risk and capability between partners, are capital efficient, were driven by interest in the program and have low asset bases, and could all return outsized downstream returns (albeit low probability for full pay-outs). 

The upfront return (IRR) on only one deal is particularly attractive. Questions now arise as to whether there will be more movement toward pre-clin type deals.  If so, will this shorten or lengthen the time to liquidity for drug discovery companies once the big pharma bureacracy takes over?

Posted by Bruce Lehr Mar 1st 2013.

India May Drop Compulsory Licenses Based On Price

Does it really matter?  It appears that India will no longer issue compulsory licenses to generic or biosimilar manufacturers to make a patented drug based solely on whether that patented drug's price is perceived to be too high.  Good news for the multi-nationals right?  They seem to think so.

India May Drop Compulsory Licenses Based On Price // Pharmalot.

Instead India has set up a new Committee to set pricing for patented drugs by comparing to prices negotiated between manufacturers and governments in US, Canada, France, Australia and New Zealand.  The thought seems to be this comparison will lead to higher prices than what consumer advocates in India would like to see but less than what pharma companies would charge on their own, but woud still be acceptable to these same companies.

But....the Committee would take per capita gross national income (GNI) and purchasing power parity in these countries into account.  The ratio of GNI in comparison country/GNI in Indiawould be calculated and used to adjust the price of the medicine for India from that of the comparison country.  This adjusted price would also serve potentially as the starting point for future reductions.

Ok. No compulsory licensing. Yes to a Pricing Committee.  What if they price products lower that what pharma is expecting?  Are we back where we were?

Posted by Bruce Lehr Mar 1st 2013.