The Big Red Biotech Blog

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.