The Big Red Biotech Blog

List of Last Year's New Drug Approvals

Here's the list of drugs approved last year by FDA courtesy of the Patent Docs blog.  It is always good to have a list someplace easy where you can find it.

Posted by Bruce Lehr Jan 23rd 2013

Random Coffee Cake Recipe

I found this in Parade magazine and made it for my kids and me when they were visiting over Christmas break. It was delicious and we decided it was definitely "a keeper".

Cranberry Upside-Down Cake

• 1 1/2 cups fresh cranberries (I used canned whole because I had them)
• 2 Tbsp chopped walnuts
• 1 tsp grated orange rind
• 1/2 cup butter, softened and divided
• 1/2 cup packed brown sugar
• 2 Tbsp freshly squeezed orange juice (I used a blood orange that I had)
• 1/4 tsp cinnamon
• 1 1/2 cups all-purpose flour
• 1/2 tsp salt
• 1 tsp baking powder
• 1 cup granulated sugar
• 1 tsp vanilla extract (used some from Madagasscar that was on hand)
• 1 egg
• 1/2 cup fat-free buttermilk (I used regular 2% milk)

For the glaze

• 1 cup confectioner's sugar
• 1 tsp melted butter
• 2 Tbsp freshly squeezed orange juice

How do we make this classic? 

1. Preheat oven to 350 F. Coat a 9-inch square or a 9- or 10-inch round baking pan with cooking spray and dust with flour
2. Combine cranberries, walnuts and orange rind in a  small bowl.  In a saucepan, melt 2 Tbsp butter over medium.  Stir in brown sugar, orange juice and cinnamon. Cook for 3 minutes, stirring constantly. Pour into your pan. Sprinkle cranberry mixture on top.
3. Whisk flour, salt and baking powder in a medium bowl.
4. In a large mixing bowl, with an electric mixer (I did by hand and it worked fine) set on medium, beat granulated sugar and remaining butter until creamy.  Add vanilla, egg, buttermilk to the flour mixture. Spoon over the cranberries.
5. Bake 40 minutes or until a toothpick inserted in center of the cake comes out clean.  Cool in pan for 5 minutes.  Invert onto a (plate) on rack to finish cooling. Beat glaze ingredients. Drizzle over cake and serve.

It was very rich and sweet.  But very good. Cranberries help temper sweetness of other ingredients. Serves 4-5.

Posted by Bruce Lehr Jan 19th 2013.

States Are Crafting Biosimilar Laws

This is an intersting post from Pharmalot.  As we know, FDA has not approved any biosimilars yet and have not determined whether a biosimilar could be interchanged or substituted for the original biological.

Never Mind FDA, States Are Crafting Biosimilar Laws // Pharmalot.

Don't let that be a deterrent.  Six States so far -- including Illinois, Pennsylvania and Virginia -- are already crafting bills that would allow substitution or interchangeability (if FDA says OK).  Can't be left waiting in the gate can we?  This is what makes America great!

Posted by Bruce Lehr Jan 18th 2013.

WIPO Report says China Takes Lead in New Patent Apps

The Patent Doc blog summarized a new report from the World Intellectual Property Organization (WIPO) that shows world patent filings grew by 7.8% in 2011, and China reached the top as judged by number of patent applications filed.  Yes.  China's State Intellectual Property Office (SIPO) became the world's largest by new applications with 526,412, followed by USPTO with 503,582 and JPO (Japan) with 342,610. 

In the past 100 years, only 3 patent offices have ever led in the number of new applications -- those being US, Japan and Germany's Deutsches Patent and Marktnamt (DPMA).  In 2011, 2.14 M applications were filed worldwide and this is the first time the 2 million mark has been breached.

Finally, with respect to country of origin, residents of Japan filed the largest number of applications worldwide (472,417), followed by Chinese residents and then US residents. Digital communications apps grew fastast at 8.1%, and biotech apps grew by 3%, while pharma actually dropped by 1.6%.  So much for pharma R&D productivity! Japan also had the highest number of granted patents with 238,323 and was followed closely by the US with 224,505. Look for the Chinese to catch up here too in the near future.

Posted by Bruce Lehr Jan 17th 2013.

Breakthrough Therapy Designation

In the fifth renewal of PDUFA, section 902 authorized a 'Breakthrough Therapy Designation' to speed regulatory review and (potential) approval of drugs that offer "substantial improvement over existing therapies on 1 or more clinically significant endpoints such as substantial treatment effects observed early in clinical development". 

When a application is submitted, the agency has 60 days to grant 'breakthrough' status or not. If 'breakthrough status' is designated, then the applicant can collaborate closely with the FDA on trial design for the intended patient populations reflecting the most up to date thinking on design.  A quick approval provides potential huge benefits to not only target patient populations but to the company sponsor itself - it could have a tremendous impact on economic state of smaller companies. This could give shot to investors as well with a more predictable pathway and shorter timelines to commercialization.

Thus the door is opened to the FDA for another accelerated approval pathway. The agency is encouraging applications. Said Janet Woodcock, "...We're excited about it.  In fact, although the law is only a few months old, we're already putting it to use. Recently, we identified the first therapy (Vertex's Kalydeco for some CF patients) to this special designation. And it likely won't be long before we have more..."  See Xconomy.

Posted by Bruce Lehr Jan 15th 2013.

Solstice Delivers the RNAi

Solstice Biologics says that is has solved the problem of delivering RNAi into a cell with its new 'limitless' RNAi technology.  The technology employs a covalently bound molecule to form an RNAi pro-drug -- called Ribonucleic Neutrals (RNN).  The pro-drug crosses the membrane and is converted by an intracellular enzyme into an active RNAi drug. 

Company founder, Steven Dowdy, says "The only reason that these Big Pharmas got out of the RNAi business was because of delivery.  Therefore by solving the delivery problem it will likely bring most of them back inside to take a second look."

Previously, Novartis, Roche and others have withdrawn from clinical programs in the RNAi area. Seemingly Solstice believes, 'if you build it they will come'. We'll see. See In-Pharmatechnologist.

Posted by Bruce Lehr Jan 15th 2013.

Analysts Pick their Top Phase III Drugs in 2013

The analysts have lined up their projections for most likely drugs to hit it big, e.g. achieve blockbuster status, in 2013.  Without further adieu, their picks:

• BiogenIdec, BG-12, multiple sclerosis
• J&J, canagliflozin (SGLT2 drug), diabetes
• Novo Nordisk, Tresiba (long-acting insulin), diabetes
• Novo Nordisk, liraglutide, obesity
• Gilead & AbbVie, hepatitis C
• Roche, T-DM1, breast cancer
• Roche, bitopertin, schizophrenia
• GSK, darapladib, heart disease
• GSK, MAGE-A3, cancer vaccine

There you have it. Place your bets for 2013.  You won't have that long to wait to see how it shakes out. See Fierce Biotech.

Posted by Bruce Lehr Jan 15th 2013.

India's Government Targets Cancer Drugs

India's government has been rattling sabres for some time with regard to high priced drugs and compulsory licenses.  Now they will go after three more cancer drugs and their makers to force licenses.  The drugs are Roche's Herceptin (breast cancer), BMS' Ixabepilone chemotherapeutic agent, and Dasatinib for leukemia. 

Last year, the government forced Bayer to give a compulsory license for its Nexaver (kidney and liver disease).  The drug's price dropped by a whopping 95% in country after the generic maker Natco Pharma took a license.

This is all about the price Western companies charge in India for cancer meds.  Herceptin is priced at $1400 per month, Ixabepilone is similarly priced and Dasatinib is priced at $300 per month.  These are out of the reach of India's common man.

One enthusiastic oncologist was quoted , "It's a very good move and will not just benefit Indians but possibly also bring down cancer drug prices in countries where the pharma market is not controlled by the US and western European countries."

Said another patient advocate from the group Knowledge Ecology International, "Companies like Roche have cut prices of Herceptin in the past but the price cust has been a joke."

So there continues to be a strong backlash against western style pricing in emerging markets like India. This will no doubt result in companies having to re-evalute their competitive strategies in these markets -- and certainly will affect the profits they can expect.  The so-called pharmerging markets are fighting back more frequently now and may not be the panacea once supposed for Big Pharma struggling to gain new profits to make up for those that have gone over the "patent cliff".  India, for sure, is not cooperating so far. See Pharmalot.

Posted by Bruce Lehr Jan 15th 2013.

Samsung Sinks Another $2B into CMO

I guess making TVs is not exciting enough. 

Samsung announced at this week's JP Morgan Conference that it would be spending another $2 B to add to its CMO facility in the Songdo Free Economic Zone in Seoul, Korea.  The multi-national giant has already built a 30,000 sq ft facility with 6 x 5000 L reactors by the end of Dec 2012.  It plans to add a further 150,000L of mammalian cell culture manufacturing capacity and 40,000L of microbial fermentation.  This would make it among the top 4 or 5 CMOs in capacity in the world.  It would be similar in capacity to Celltrion also located in the Korean enterprise zone. See Fine.

TH Kim, Samsung BioLogics CEO, says the company can exploit its construction and manufacturing expertise in this business. They have also hired experts and professionals from other CMOs in the industry to staff their new facility.  Samsung believes that it will be able to manufacture biologics (and biosimilars) at lowered costs over the competition and therefore deliver value to clients and patients.

There is no doubt that they have the financial muscle to make an impact -- assuming they can get the right staff in place to run the business.

Posted by Bruce Lehr Jan 9th 2013.

More Big Pharma Woes Decried

Big Pharma performance continues to receive muted reviews from various analysts and industry commentators.  Pharma Reform starts with an analysis of drug approvals in 2012 by FDA.  It is TRUE that 35 drugs were approved last year.  It is also TRUE that this represents the fruit of only 31 sponsoring companies and only 13 of these 35 could be classified (somewhat generously) as Big Pharma. Of 12 priority approvals, only 4 came from Big Pharma. How about discovery?  Of the 35 new approvals, only 7 (20%) came from Big Pharma. So while the total number of approvals in 2012 is slightly up from previous years -- is Big Pharma actually doing any better? 

PharmaTech Talk chimes in with a piece describing how Big Pharma's "firepower" -- i.e. ability to compete and conduct M&As -- has been reduced.  Partly this is caused by Big Pharma's lack of growth. In 2011, the overall drug market saw growth that exceeded Big Pharma's by $20 B.  In 2012, this is expected to have widened to $50 B and predictions are that it will reach $100 B by 2015.  This is largely due to the much discussed patent cliff and lack of replacment product revenues in Big Pharma pipelines. So of course, Big Pharma should bail itself out with M&As right?  Wrong according to Ernst & Young. Big Pharma's firepower according to their calculations has decreased by 23% between 2006 and 2012. Specialty pharma and biotechs have become much more hardy competition and have increased their firepower. So now, Big Pharma might get bumped from M&A deals they heretofor would have taken if they wished. Uh-oh.

That means more bolt-on deals, more divesititures, and more offshore deals in emerging markets. Big Pharma will need to pursue actions that boost and conserve firepower if it wishes to pursue transactions that require it to bail themselves out of revenue holes.

Posted by Bruce Lehr Jan 9th 2013.

Maybe It's Just Me

When looking at all the fines that Big Pharma is absorbing -- primarily for violations of selling and marketing regulations around the world -- did you ever find yourself saying "ho-hum" business as usual.  Especially when the fines involved are much less than $1 B!  I do.

Just this week Pharmalot reported fines for Lilly ($29 M), Sanofi ($109 M) and Amgen ($762 M).  The Amgen is big enough for me to take more notice but the others -- "ho-hum".  That's kind of sad.

These pale next to some of the multi-billion dollar settlements we've seen in the past two years as well.

Posted by Bruce Lehr Dec 20th 2012.

Can a Young Biotech Go Long?

YES! That's the answer given by Katrine Bosley, former CEO of Avila Therapeutics, in a piece in today's Xconomy.

I liked her whole perspective in the piece.  She argues that if a company's management focuses on creating value -- then they will have the chance to grow into a fully integrated pharmaceutical company (FIPCO) or they may also be offered opportunities for other types of deals including being acquired.  The key is to focus on the value creation first -- so you will have something tangible to consider in making a 'go long" or M&A decision. 

If you do create value, you could have the chance to become an Ironwood, Aveo, Regeneron, or Onyx Pharmaceuticals. Or you coudl get a good purchase offer from a big pharma partner that is a good fit like those realized by Plexxikon, Adnexus, Avila, Intellikine, or Calistoga. 

Either way you can be successful in bringing new medicines to market and pleasing your investors.

Posted by Bruce Lehr Dec 20th

 

ADCs Prominent in Celgene-Sutro Deal

Sutro Biopharma and Celgene struck a deal that could be worth as much as $500 M plus royalties to Sutro if milestones are met.  Celgene will gain access to Sutro technology that enables it to make biologicals by  a cell free protein synthesis approach.  Sutro will make drugs from Celgenes pipeline including both bi-specific Abs and ADCs to two undisclosed targets. Sutro will get a "substantial [undisclosed]" cash upfront and Celgene will make an equity investment and provide R&D funding. 

The Sutro ADC technology is considered to be next generation compared to that of leaders Seattle Genetics and ImmunoGen.  Mainly, the Sutro technology can incorporate non-natural amino acids in specific sites to allow it to make single species ADCs by conjugation of linker and payload at the site. Sutro can also identify the optimal sites in antibodies to make these site specific insertions. This leads to more controlled molecules and shorter timelines in development.

Sutro has been on a bit of a roll with other development deals with the likes of Pfizer.  They also have from venture investments from Lilly and Amgen venture groups among others. I like to see ADCs becoming more successful in the market and look forward to more exploitation of this technology. See Xconomy and Fierce Biotech.

Posted by Bruce Lehr Dec 18th 2012.

Report Card on Late Stage Drug Development in Big Pharma

Deloitte and Thomson Reuters generated data on the late stage drug programs of the top 12 Big Pharma companies. The good news - more drugs were approved in 2011-12 (41) versus 2010-11 (32).  The bad news - forecasted revenues 2011-12 cohort ($211 B) versus 2010-11 ($309 B) -- an almost 32% drop. The latter translated into a 7.2% R&D return. The average cost of development was pegged at $1.1 B (see previous post where that figure was reported as $1.9 B). The D-TR Report further notes that 22 late stage drugs died in 2011-12 as compared to 19 the prior year.  This wiped away $73 B and $77 B of potential value respectively in those two years.

Deloitte's head analyst, Julian Remnant, noted that half of the top 12 companies experienced a decline in net value realized from product commercialization last year. This is exacerbated as goverments and third party payers exert downward pressure on prices -- or make it more difficult to get reimbursement without clear product benefits over existing competition. They suggest companies battle this challenge through better clinical trial design aimed at targeted patient populations to establish the clear comparative benefit.

In other words, companies need to show payers why they should buy the new drug by demonstrating enhanced clinical benefit to patients and or superior cost effectiveness in use.  As Mona Lisa Vito might say, "Oh my God.  What a f**king nightmare!"  See Fierce Biotech.

Posted by Bruce Lehr Dec 5th 2012.

 

 

 

 

 

Economists Agree - Drug Development Costs a Sh*tl**d!

Fierce Biotech reports this morning that the Office of Health Economics (UK think tank) says that the average cost of developing an approved drug has risen from $199 M in 1970 to more than $1.9 B today.  They cited four factors for this:

• Soaring out of pocket R&D costs
• A success rate that has been halved from 1:5 to 1:10
• A vast increase spent in clinical trials up from 6 years to 13.5 years
• Significant increase in cost of capital due to increasing regulatory complexity

Not everyone agrees with this of course, but if taken at face value the results are sobering.  The Financial Times after looking the report over said that the increase to 13.5 years alone was enough to scare off venture capitalists for good. 

Posted by Bruce Lehr Dec 2nd 2012.

Supreme Court to Review Myriad Case on "Gene Patent Eligibility"

Are human genes patentable?  That is the BIG question.

The US Supreme Court granted certiorari to petitioners to hear arguments in answer to this question, ostensibly by examing issues in the Myriad case.  There are many many (one could say myriad) petitioners from the ACLU, PubPat, and amici including academics, patients, doctors, and other advocacy groups opposed to gene patenting.

Myriad (the company) filed in opposition to the plaintiff's certiorari petition -- supporting patenting -- but obviously didn't prevent the case being heard.

US Supreme Court To Review Gene Patent Ruling // Pharmalot.

Myriad did however get its arguments on the record as to why the Supremes should not prevent genes being patented, and why the petitioners arguments are factually incorrect. For a really good discussion of the Myriad opposition filing see The Patent Docs blog. 

In addition to its many scientific, technical and legal arguments, Myriad also pointed out that "despite 30 years of isolated DNA patents, this case is the first and still only appellate decision to address the patent-eligibility of such compositions."  Always got to be a first time.  But, they further correctly state that many biotechnology companies have relied on precedent of standing DNA patents as important intellectual property protection that their investors rely upon to induce their financial participation in these companies.

Myriad argues the Court should not switch the rules of the game now, and that if a policy switch is to occur, it should emanate from the legislative policy-making process not by legal fiat. The Patent Doc blog author further advises that anyone with "skin in this game who sits on the sidelines should be ashamed."

Posted by Bruce Lehr Dec 3rd 2012.

BIG RED REACHES NEW MILESTONE

 

BIG RED HITS 200,000 Page Views on November 29, 2012 at 10:45 am CST.  Yay! Yay! Double Yay!

 

Posted by Bruce Lehr Nov 29 2012.

 

 

New US PTO Performance Stats Report Out

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.

Mush PTO. Mush.

Posted by Bruce Lehr Nov 29th 2012.

Lechleiter Tells China 'Go Chop-Chop' with Drug Reviews

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.

Posted by Bruce Lehr Nov 29th 2012.

Can't Make Drug on Purpose? Why not Re-purpose?

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.

Posted by Bruce Lehr Nov 29th 2012

Price 'Em High Boys. We Need the Profits

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.

Brand-Name Drug Prices Rose How High? Look Up… // Pharmalot.

On the other hand, a "market basket" of widely used brnad 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 there 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 profting 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.

Posted by Bruce Lehr Nov 28th 2012.

Sigma-Aldrich is re-aligning its business segments

St. Louis life science company Sigma-Aldrich announced today that it is restructuring into three market-focused business units: Applied Markets, Research Markets and SAFC Commercial Markets.

Sigma-Aldrich is re-aligning its business segments and SAFC will be reamed the SAFC Commercial Markets Business Unit.

Gilles Cottier will continue to lead the SAFC business. This business will be renamed the SAFC Commercial Markets Business Unit and will continue to serve customers in the life science and electronic markets.

Company officials intend to provide more information about the structure, sales and growth prospects of each of the three business units early in 2013, according to a statement.

Posted by Bruce Lehr Nov 20th 2012.

Big Pharma Scramble for China Foothold

Fierce Biotech this morning reports on the top 10 Big Pharma companies investing in China.  Clearly, these companies are jockeying for position to be able to exploit commercial opportunities in the BIG Chinese market.  In many cases, these is seen as essential to future company growth and survival given some of the issues with patent cliffs, and stagnant growth in many of the traditional Western markets.

Pharma investments are aimed at gaining market access and in particular gaining face time with health budget decision makers.  Investment in China is certainly seen by the government to be a "good thing" and goes a long way toward establishing credibility. Hooking up with local drug companies and developers is a good way to enter the market.  Alliances with local players may ultimately be a necessity for the Western companies to crack this market -- and many have established early relationships accordingly.

This is interesting to me in that many of these same companies right now are trying to eliminate China-produced raw materials from their supply chains. Yet, if their goal is to crack the Chinese market and to partner with local developers and manufacturers to do so, then how can they eliminate Chinese suppliers in the long-term?  They can't.  You will want to source locally for manufacturing support -- maybe not some specialty items but bulk of raws will likely come from local sources.  The economic drivers and incentives are just too great in my view -- and local goverment will expect it.

So time is now to start qualifying the best local suppliers, and to educate and incentivize them to continually improve their quality systems in anticipation of them being integral to a long-term supply chain.  It only makes sense.

Posted by Bruce Lehr Nov 19th 2012

Gang of 31 AG's Takes Pay-to-Delay to Supremes

Thirty-one State AG's have filed an amicus brief with the US Supreme Court in favor of ending pay-for-delay delas between pharma innovators and generic producers.  The AG's are backing the US Federal Trade Commission position that says these deals cost States and consumers dearly in increased healthcare costs. The FTC estimates the increased cost at approximately $3.5 B per year. The AMA has also come aroudn to support the FTC position.

31 States Urge Supremes To End Pay-To-Delay // Pharmalot.

Drug manufacturers say the deals are legal and that they actually get generic drugs to market faster than might be possible otherwise. In fact the GMA (generics trade group), says the deals have never stopped a drug getting to market beyond a product's patent expiration date -- and in many cases months or years sooner.

Opponents counter that the deals prevent patent challenges and thereby weaken the patent system by allowing marginal patents to stand.  This in turn allows holders of those patents to maintain a monopoly position witha drug longer than they might otherwise -- and this is anticompetitive.

So far, lower courts have sided both ways.  The 3rd, 6th and DC Circuits have generally ruled to make pay-for-delay harder, and the 2nd, 11th and Federal Circuits have made rulings more likely to allow pay-for-delay. Normally, the USD prefers to have law that is a bit more consistent across the land, so the Supreme court is being asked to review the issue. But will they hear the case and break the ties?  Hard to say.

Posted by Bruce Lehr Nov 15th 2012.

 

Top Selling Biological Drugs in 2011

The Cell Culture Dish reprinted data from Nature Biotechnology that lists the top 10 selling biological drugs in 2011.  It also indicates that 7 of the top 10 drugs are produced in CHO cells, 2 in E. coli, and 1 in mouse myeloma.  So despite reports that more clinical development progams may be working with systems other than CHO -- particularly a resurgence in prokaryotic systems -- the dominant sellers are still in CHO and will remain so in the foreseeable future.

The TOP 10 follows:

1. Humira, $7.93 B, CHO, Abbott
2. Enbrel, $7.36 B, CHO, Amgen
3. Rituxan, $6.77 B, CHO, Biogen Idec
4. Remicade, $6.75 B, myeloma, J&J     
5. Avastin, $5.98 B, CHO, Roche
6. Herceptin, $5.92 B, CHO Roche
7. Neulasta, $3.95 B, E. coli, Amgen  
8. Lucentis, $3.76 B, E. coli, Roche
9. Avonex, $2.68 B, CHO, Biogen Idec
10. Rebif, $2.35 B, CHO, Merck

That's all folks!

Posted by Bruce Lehr Nov 14th 2012.