News on trends and issues in the biopharm and pharmaceutical industry. Commentary on current events,clinical pipelines, facility expansions, competition, technology, legal and economic matters. M&A and licensing activity across the globe.
I am a Director of Research and Devopment for a leading supplier to biopharmaceutical producers. The views expressed are mine. I do not speak for any company or corporation.
Hey, I've got something for you Stat Junkies who like to review performance stats from various goverment agenices -- a new report from the Patents Doc Blog -- that outlines the 2012 US PTO performance in processing patent applications. Wow! Are you excited or what?
In a nutshell, the US PTO processed more patent applications in shorter times than their goals for 2012 called for and they improved across the board in all categories (see link above). Some highlights include:
Average first action pendency (21.9 months versus target of 22.6 months)
Average total pendency (32.4 months versus target of 34.7 months)
Patent applications filed electronically (97.1% versus target of 96.0%)
Number of applications filed increased from 537,171 in FY 2011 to 565,566 in FY 2012 (5.3% increase in both years)
Number of applications awaiting action dropped from 690,967 in FY 2011 to 633,812 in FY 2012 (4th consecutive year drop)
Total number of pending applications also decreased, dropping from 1,168,928 in FY 2011 to 1,157,147 in FY 2012.
For the next few years though, the sledding gets much tougher with respect to first action and total pendency. For first action pendency, the annual performance target drops from 22.6 months for FY 2012 to 18.0 months for FY 2013 and 15.8 months for FY 2014, and for total pendency, the annual performance target drops from 34.7 months in FY 2012 to 30.1 months in FY 2013 and 26.1 months in FY 2014.
Lilly CEO John Lechleiter, who is also the head of PhRMA this year, told China regulators that they need to speed up their review of drugs in the clinical pipeline if they want to be competitive with the rest of the world. He characterized current China review practices as "being 8 years behind the pace of major regulatory groups" (some might snarkily say the same about Lilly's pipeline).
The Chinese government is known to have a hankering for Western cash so it is likely they will take heed of this advice and look for ways to improve -- as it is in their best interest to speed new drug introductions and commerce in China. And -- oh by the way -- it could also raise health care level of care in China too. See Fierce Biotech.
Roche and Broad Institute are the latest groups to partner on "re-purposing" drugs. That is to say, Roche will give Broad insititute 300 or so drug candidates that have failed in clinical studies with their original "purpose". Presumably, these drugs have been found to effect a specific target and have shown safety in humans before -- so the hope is that if you can find a disease where these show a therapeutic effect then you are a lag up in getting the drug more quickly to market (with appropriate clinical trials, etc).
Some may view this as throwing stuff against the wall and seeing what sticks -- others think it is a rationale shortcut to try that has small relative cost and perhaps a big upside if you can find a good target. This is becoming a more popular approach to try with libraries of compounds sitting around in various companies, and apparently has academic centers like Stanford, Broad, or NIH who are willing to screen. Given that's the case, then we shoudl have data sooner rather than later as to whether this is really worth the effort or not........See In the Pipeline and Fierce Biotech.
In case you think Big Pharma is completely powerless against the patent cliff and the forces of generics, we have ths new study from Express Scripps with some counter data. It seems generics have made a whopping impact on drug prices in 2012 -- as prices for these drugs dropped by an amazing 21.9% since last September. Markedly different from the meager 2.9% decrease seen for the same drugs in 2011.
On the other hand, a "market basket" of widely used brand name drugs was able to command a 13.3% increase in price during that same time period -- in a time when inflation was only 2%. Clearly, with loss of revenue facing them from drugs that have gone "over the cliff", Big Pharma has been able to counter by some degree with substantial price increases on brand name drugs. Biologics in fact were able to up their prices by 22.6%. Still these types of branded "specialty meds" represent only about 21% of the total market with generics making up the rest. So Big Pharma has to work hard to squeeze profits out of the existing pie.
Generics are making their impact clearly. Anyone doubt that pay for delay may actually prevent this from being worse (from Big Pharma point of view)? And Express Scripts uses the generic price drop coupled with the big biologics increase to lobby for more emphasis on getting a biosimilar pathway in place so it can start profiting from big drops in the biologicals arena too when the first biosimilar drugs are approved. Not such a rosy profit picture for Big Pharma unless they have the ability to get new brand products on the market and extend the indications for the existing brand drugs -- before either generics or biosimilars start eating their lunch.