The Big Red Biotech Blog

Samuel Johnson paraphrased

"Your Big Red Biotech Blog is both good and original; but the part that is good is not original, and the part that is original is not good."

FINALLY! Bydureon Gets Through FDA

The FDA posted its approval of Bydureon to its website today. It's official.  Amylin (and Alkermes) will be able to market its once-weekly injectable GLP-1 diabetes medication.  It will now move into a closely watched competition with Novo's Victoza (also a GLP-1 drug). 

Since the last delay at the FDA in October 2010, Amylin has broken up with its co-marketing partner Eli Lilly and will be on its own in marketing the drug.  Lilly received $250 M to dissolve the partnership and will get $150 M with the FDA approval. It will also receive a 15% royalty on sales until a $1.2 billion note has been satisfied. Analysts say that Amylin sales of Bydureon could reach a peak value of $1.8 billion annually by 2018. See Xconomy, Seeking Alpha and Pharmalot.

If at first you don't succeed, try try again.

Posted by Bruce Lehr Jan 27th 2012.

RNAi Woes Continue to Force Cut Backs

Alnylam announced that it will need to trim back its staff by another 33% so that it can conserve cash and focus on its two lead candidates in the clinic.  The Company stated it will trim 56 persons' jobs -- saving about $20 M per year.  It will also focus on its phase I development programs with amyloidosis and hemophilia. 

The whole RNAi field has been thrown in disarray over the past couple years as the drugs have proven to be difficult to deliver into cells.  Roche, Merck and Novartis among big players have deeply curtailed or stopped their RNAi programs. No current RNAi drugs are on the market despite billions of dollars in development funding.

Undeterred (Ok maybe deterred), Alnylam will take its $260 M in the bank and push forward on its two candidates.  It says it will become less of a platform company and try to make the transition to a product company.  In the meantime, focus and austerity are the catch phrases until better clinical success and more investment is forthcoming. See Xconomy and Fierce Biotech.

Posted by Bruce Lehr Jan 23rd 2012.

Corporate VC Makes Biotech World Go Around

According to this post from Life Sci VC, corporate Venture Capital groups are now essential to the biotech ecosystem and provide the bulk of capital to fudn new companies -- at least from Atlas Funds point of view -- which appears to be a representative one indeed.

From Atlas data, corporate VC had only 5% involvement in their projects from 2000-2005, that rose to 33% from 2006-2008 and now stands at a whopping 67% from 2009-present. What's more?  The funds range in size from $100 M - $500 M and account for at least $2.5 B in VC money, according to author's estimates.

That's a lot of money.  Money that new companies in biotech are increasingly dependent upon. An Xconomy underscores this today with a piece on the dearth of cash available to biotechs from traditional VC sources.  Have a read. Clearly the availability of more money is needed to get these new biotech ventures off the ground to take advantage of innovative science.

 

Posted by Bruce Lehr Jan 23rd 2012

 

 

 

FDA Challenged to Make Rules of the Game Clear

Sanofi's CEO Chris Viehbacher, speaking in his role as leader of PhRMA, says the FDA needs to clearly state what drug makers have to meet when it comes to risk-benefit analysis with new drugs.  The uncertainty of FDA rulings is making it unattractive for Big Pharma to develop products for the primary care diseases, like obesity and diabetes, according to Viehbacher.  Both obesity and diabetes treatments have taken more than their share of lumps in recently agency rulings leading to a lot more work to get these treatments approved. See Fierce Biotech.

Clearly, I think it is fair for the industry to get transparent guidance on what it is going to take to get certain types of therapies approved.  Everyone working on a project should know what "success looks like".  I think we all expect that in our daily lives. Why not drug makers too?

I would think that the FDA and the US Goverment would want to provide this -- and I'm not saying they don't.  Diseases like obesity and diabetes have to cost US taxpayers and patients billions in treatment costs. These are diseases that have a major impact on the health of our citizen's and healthcare costs.  There should be ample motivation to get treatments out there that work (although eating better and exercise wouldn't hurt either). 

These are important areas of health where we do want to see continued improvement with treatments because of the high social and economic impact.  These would seem to be areas that are ripe for the FDA and drug makers to work together to come up with expectations on future therapies that are reasonable and safe.  The US governement also has a vested interest in helping to reach such a conclusion.

Posted by Bruce Lehr Jan 23rd 2012.

 

 

Sigma-Aldrich differentiates to HPAPIs for future

The market for production of small molecule APIs is becoming much more competitive - especially as these become more genericized and manufacturing moves to lower cost (for now) Asian suppliers.

Sigma-Aldrich looks to HPAPIs as generic sector heats up.

As a result, SAFC is moving its focus away from these more generic APIs and is focusing its efforts on the product of high potency APIs (HPAPIs).  SAFC has several new facilities that are geared toward this type of higher value more difficult manufacturing -- which separates its right away from some of the lower cost, less specialized manufacturers.  This capability allows SAFC to cater to drug developers working in cancer therapeutics with both HPAPIs and antibody drug conjugates.

Sigma-Aldrich CEO Rakesh Sachdev commented on this approach at the recent JP Morgan Healthcae Conference, "A greater percentage of [custom pharma] will become highly specialized offerings."  Sigma's focus will be "on very unique products" and this is driving our expansion in the high potency area to give ourselves a competitive advantage.

Posted by Bruce Lehr Jan 18th 2012.

 

Paragon Making the World Safer from Bioterrorism

The US Department of Defense awarded Paragon Bioservices a $15 M contract to develop a large scale mammalian cell culture process to produce vaccines to filoviruses. This virus class has long been considered by DoD to be a potential biological weapon and in this case is focusing on the Venezuelan equine encephalitis (VEE) virus and related viruses like Ebola and Marburg.

US DoD awards CMO Paragon Bioservices $15m vaccine deal.

The DoD expects the contract to be completed in 2020 and it is just another step in a long standing program by the agency to protect the US from potential filovirus events.

Posted by Bruce Lehr Jan 18th 2012.

Why is CEO of Onyx smiling?

There is news today that Bayer's new colorectal cancer drug, regorafenib (aka "son of Nexavar') will be submitted to the FDA for approval in 2012. Not only is this a potential blockbuster for Bayer, but this is likely to inspire some smiles at Onyx too. The biotech landed a $160 million payday and won a 20% royalty stake in the drug last fall after prevailing in a bitter dispute over the rights to regorafenib, which bears a close resemblance to the jointly-owned Nexavar. Onyx had accused Bayer researchers of secretly developing analogs of Nexavar before the two partners finally managed to reach an agreement on ownership.

Winning in court and then in the clinic is likely to inspire smiles -- especially for a $160 M plus payday -- and if the analysts are right about the drugs' billion dollar potential the 20% royalty will be worth A LOT.

As Onyx CEO Tony Coles put it, “we are in position to go from one product for two tumors (Nexavar) to potentially three products with strong data or [an FDA clearance] for seven different cancers by the end of this year,” Coles says. The other drug besides Nexavar and regorafenib is known as carfilzomib, which is being reviewed by the FDA as a new treatment for multiple myeloma.

“When you see that kind of momentum in the business in such a short period of time, it’s unrivaled,” Coles says. “We think the future is very bright.”

Say Cheese Tony.

See Fierce Biotech and Xconomy articles.

Posted by Bruce Lehr Jan 18th 2012.

 

China Wants to Boost Its Local Vaccine Industry

China has a goal of making itself the primary producer of vaccines that are used domestically.  To further that aim, the government is encouraging the development of production processes with proprietary IP rights. China is supporting the creation of new strains and technologies within this program.

China wants vaccine production innovation to boost local sector.

"It is clear from the plan that the Chinese government intends to create a favorable environment for the growth and development of China's domestic vaccine industry and to achieve self-reliance in the supply of vaccines", law firm Sidley Austin LLP released.

This is another example where the East is rapidly investing to make itself more market competitive.  It is also another example of where government policy is used in a strong way to drive economic development and technological advancement in a programmed direction.  The US policies need to support similar initiatives in the US biotechnology industry.

Posted by Bruce Lehr Jan 16th 2012.

Is 2012 a Biotech Buyout Year in Making?

Statements from the recently concluded JP Morgan conference indicate that many big pharma BD groups are actively seeking to purchase biotechs in 2012 as a means of extending their pipelines.  An industry analyst observed that there are 18 biotechs trading at only twice the value of their cash reserves.

Companies that have been named by industry observers as potential acquisition candidates include GenMab, Active Biotech, and Achillion.  Big Pharma players who have indicated they are in buying mode include BMS' CEO Lamberto Andreotti with its continuing "string of pearls" strategy, Roche's CEO Schwan indicates a $3 B budget for aquisitions, Sanofi's Viehbacher has $2.6 B set aside, and Novartis' Jimenez says they could spend $2 B - $3 B. Biogen's CEO Scangos also indicates their willingness to go out and buy early stage assets to compliment the later stages of their pipeline. See Fierce Biotech.

Early indications are that there should be good activity in the M&A arena in 2012.

Posted by Bruce Lehr Jan 13th 2012.

Pharmalot Follows Pharma Investments

I liked this article from Pharmalot today that tracked Big Pharma's investment in R&D and Manufacturing facilities in the periods 2003-2006 and 2007-2010 respectively and collated the top 10 countries of the world where this occurred for each period.  The results are interesting (at least to me). 

Follow The Money: Where Pharma Is Investing // Pharmalot.

Top 10 Countries 2003-2006

1. USA  - $38.7 B
2. Ireland - $37.1 B
3. Singapore - $27.6 B
4. China - $19.7 B
5. Germany - $14.8 B

Rounding out the top 10 for this period were Spain, France, Puerto Rico, India and Sweden. Let's look at how the picture has changed over the next period.

Top 10 Countries 2007-2010

1. USA - $73.3 B
2. China - $29.8 B
3. Singapore - $17.7 B
4. India - $16.8 B
5. Ireland - $16.0 B

Rounding out the top 10 for this period are Italy, Germany, Switzerland, Canada and Brazil. You can see that the Asia-Pacific region is being enriched in the top 10.  European countries are dropping on the list, and 4 fell out of the 2007-2010 top 10 though 2 new Euro countries snuck in. 

The USA still is the lead country for investment though.  Someone please take note.  We have a leadership position and it would be a good time to implement policies that helped to cement that lead.  European financial issues and controls may be eroding their position as we write -- and Puerto Rico's new tax policy may hasten their further demise as well.

It appears indisputable to me that activity will continue to flow to the East if that's where the new investment in R&D and manufacturing is gaining momentum.

Posted by Bruce Lehr Jan 12th 2012.

 

 

"Wee Willie" Viehbacher on Pharma Investing?

My mind sometimes works in strange and mysterious ways.  I was reading Fierce Biotech this morning and saw that Chris Viehbacher indicated that Sanofi will spend up to $2.6 B on acquisitions next year -- at least that is the budget for a more limited "string of pearls" strategy. 

But I had to smile when he was quoted in the article as saying, "The trick in M&A is to go find something not everybody is looking at."

I will now dub this, in homage to Wee Willie Keeler, the "Buy 'em where they ain't" strategy.

 

Posted by Bruce Lehr Jan 12th 2012.

Sanofi Chases Cheaper String of Pearls

BMS has touted its so called "string of pearls" business development model for building its pharma business over the past few years -- successes include the Medarex (Yervoy approval) and Adnexus Therapeutics.  And, the BMS stock price has responded favorably - enough so to embolden the just announced deal for Inhibitex at $2.5 B.

Competitors -- who may not have been sold when the strategy was first being touted -- seem to be more inspired.  Teva recently hired BMS' chief dealmaker as its CEO to direct its future strategy for growth.  Merck has also indicated it may be working on its own pearls by declaring it is in the market for big and small companies to augment its assets.

Now Sanofi CEO, Chris Viehbacher says he is looking at his own "string of pearls" strategy in apparent homage to BMS but will look to do so with a "mere" $2.6 B in available cash for 2012. Viehbacher though is looking both inside and outside biotech assets and doesn't want to go after any big oysters preferring perhaps assets with lesser luster but more affordability.  See Fierce Biotech.

Just another designer knock-off I guess.

Posted by Bruce Lehr Jan 11th 2012.  

Does Big Pharma Have More Dollars Than Sense?

On the heels of BMS acquisition of a Phase 1 hepatitis C therapy through its $2.5 B acquisition of Inhibitex, some industry naysayers question whether the risk is worth it at such an early stage and such a high price (Gilead's $11 B buy of Pharmasset can also be thrown into the discussion). It looks like the competitive bidding embodied by "auction fever" may be taking over as some company's scramble to fill in their revenue holes.

Pharma Pays A Premium For Its Shopping Spree // Pharmalot.

Analysts note that Pharma in general pays a 44% premium in their takeover efforts with biopharma -- as compared to 26 percent in other industries. That may seem eye popping to some but is nothing compared to the 89% premium that Gilead's purchase represents and BMS upped the bar to a 163% premium for Inhibitex. 

Investors and analysts can now hold their breath for several years to see if these deals pay off or not -- there will always be plenty of ammunition available for second guessing if it doesn't work out.

Posted by Bruce Lehr Jan 11th 2012.

 

Do FDA Approvals Even Guarantee Success?

Much has been made about the welcomed increase in the number of FDA approved new drugs in 2011 -- up to 30 this year.  Time for a hip-hip-hurrah no doubt. See Fierce Biotech.

I'm not so sure though if you worked for Dendreon (Provenge) or Human Genome Sciences (Benlysta).  Both companies -- when the afterglow of approval waned -- experienced slower than forecasted sales.  The result was that Dendreon's stock price plummeted more than 60% overnight when its Q3 earnings were released. The Company was forced to layoff more than 500 (mostly manufacturing) employees shortly thereafter. See Pharmalot and Seeking Alpha.

Much the same story has occured with HGS.  It's sales have lagged -- only $25 million in Q4.  It's stock price has suffered.  It is now going to layoff more than 150 of its staff.  So much for the first lupus drug in 50 years showing a quick sales takeoff. See Fierce Biotech.

Analysts and investors still remain cautiously optimistic that both treatments will catch on -- but the jury is out -- and it shows that the FDA is NOT the only obstacle to filling the coffers with geld when it comes to new drug approvals. You still have to pass muster with the subscribers and reimbursement community too.

Posted by Bruce Lehr Jan 10th 2012.

Hepatitis C Deals Take Center Stage

Market analysts have projected that sales of products that are newly on the market or in late phase clinicals to treat hepatitis C could have worldwide sales in excess of $20 B by 2020. That's a big number! See Pharmalot.

So it is easy to see why more deals are happening in this area with a few more possibilities looming.  In just the past few weeks and months, Gilead bought Pharmasset for its PSI-7977 therapy for $11 B.  BMS followed suit to buy Inhibitex for its phase I hepatitis C drug for an impressive $2.5 B - a startling sum for a phase I compound that is still years from the market. Both acquiring companies are trying to introduce an oral hepatitis C treatment that does NOT rely on interferon (and its well described side-effects). See Fierce Biotech and PharmaGossip.

Now Merck is rumored to be a leading suitor to buy perhaps, Achillion for its hepatitis C treatments.  This would add to Merck's newly approved Victrellis and its mid-stage drug MK-5172 still in development. Merck also had previously announced a collaboration with Roche.

Said Merck's Roger Pomeranz at a recent JP Morgan Healthcare Conference, "Our goal is to be a leader in hepatitis C, and we will do what it takes to get there."  Merck is ready to do small or larger deals to rapidly build its position.  See Fierce Biotech.

The Game is On.

Posted by Bruce Lehr Jan 10th 2012.

Sigma-Aldrich to Acquire BioReliance

Sigma-Aldrich will add BioReliance to its portfolio of products and services aimed at supporting the development of biological drugs.  The deal adds BioReliance's $110 M in revenues in the biopharm space and projected double digit growth for 2012 to Sigma's coffers for a cash price of $350 M.

Sigma-Aldrich to offer start to finish bio-testing thanks to BioReliance takeover.

The SAFC group within Sigma-Aldrich focuses on the supply of raw materials to make pharmaceuticals and biopharmaceuticals, does some process development, and offers contract manufacturing and testing services.  BioReliance's capabilities in biologics testing, specializes toxicology and in animal health testing will add to SAFC's portfolio.  In particular, SAFC will now be able to support testing of both raw materials and final product.

In the production of biological drugs, the combined companies can work together as well in areas like cell line development, banking and testing to support biologics processes -- as well as provide more extensive testing and characterization of final product produced in SAFC plants.  Plus with the burgeoning biosimilars area, the combined group will be able to collaborate in areas like glycoanalysis to support product comparability or "biosimilarity".

It's an exciting combination that may promote more of a "one-stop-shop" menu of services to existing clients. Said Sigma-Aldrich President and CEO, Rakesh Sachdev, "As the market continues its focus on biological drug development, our leadership in this area should enable us to build even better, more customer-specific solutions."

Download Press Release_BioReliance_010912[1]

 

Posted by Bruce Lehr Jan 10th 2012.

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.

Revenue Challenged Big Pharma Reveal Hopes to Cope

Both Merck and Eli Lilly were in the news today as two companies extremely revenue challenged due to expiring drug patents on top sellers with replacments not ready for prime time to pick up the slack.

Merck CEO, Ken Frazier, maintained that he was pushing his licensing group to pick up the pace to help fill in pipeline gaps -- and indicated he thought this was the future of the industry. He said Merck would be looking for early stage deals and in particular was interested plumbing the hepatitis C arena for new opportunities.  Merck is banking on its big bankroll in helping it see its was through this pipeline dip. See Fierce Biotech.

Lilly CEO, John Lechleiter, was more reduced to grasping at his pipeline to save him.  Lilly announced today that it expected to see a $3 B revenue drop from loss of patent protection on Zyprexa as the generics moved in.  Lechleiter continues to eschew big mergers and is banking on the 12 late-stage drugs Lilly has in its pipeline.  This did not prevent a price hit to its stock today however.  One big pipeline test that looms is for Lilly's Alzheimer's drug, solanezumab -- that's trial results should be shared in Q3.  There is a lot riding on this and one wonders what might happen to Lechleiter's plan (or even Lechleiter) should some of these key dozen projects go down. See Fierce Biotech.

One must remember though that Hope is not a Strategy.

Posted by Bruce Lehr Jan 5th 2012.

 

Dendreon Under-promises and Over-delivers in Q4

Temperence sometimes has its rewards. Dendreon suffered through a poor sales year in 2011 of its own making that hammered the company's stock.  But in Q4, Dendreon achieved Provenge sales ($82 M) that were considerably higher than its guidance. As such, their stock price is being rewarded today -- despite a considerable shortfall of $228 M in revenue for 2011 versus its beginning of year forecast of $350-$400 M.

But by giving the market an expectation of $66 M or so in Q4 Provenge revenue but achieving $82 M instead, its price ramped up $1.98 per share to $9.58 or more than 26 percent.  Better to be under-promisers and over-deliverers than the converse when it comes to speaking with the Market -- as the Market has once again affirmed. 

Of course, that doesn't help the 500 workers laid off in September, but it may remind Dendreon CEO Mitch Gold of a valuable lesson.  See Xconomy.

 

Posted by Bruce Lehr Jan 5th 2012.

BMJ Plays Clincal Data "Hide and Go Seek"

Several sources today reported on British Medical Journal articles that show that not all human trial clinical data is being reported.  Apparently, this is shocking to many clinicians and the public -- but also reflects charges critics have made for years (without the needed proof).

The BMJ is one of a number of journals to take developers to task on their data reporting practices. But despite the new mandates, there's no evidence that the pharma industry is drawing any closer to achieving true transparency. The BMJ concludes that some developers are purposefully keeping some data under lock and key, or publishing it on obscure sites. They want an end to what they call a "culture of haphazard publication and incomplete data disclosure."

These articles confirm the fact that a large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately. The absence of the data about harm in trials can harm patients, and incomplete data about benefit can lead to wasted costs to health systems. Moreover, researchers or others who deliberately conceal trial results breach their ethical duty to trial participants.

In BMJ, one paper examined unpublished evidence of existing meta-analyses of nine drugs approved by the FDA in 2001 and 2002, but found identical estimates of drug efficacy in only three of 41 cases, or 7 percent.  In the remaining cases, estimates of drug efficacy were evenly split between more (19/41) and less (19/41). Missing data did not always reduce estimates of drug benefits, as this study shows that “publication bias” can cut both ways. Each increment of data can change the overall picture, but in most cases with no certainty that the picture is complete.

Prior registration of all trials became a condition for later publication in 2005.  Yet, a survey of NIH funded research in the United States between 2005 and 2008 shows that only 46 percent of studies were published in a peer reviewed biomedical journal indexed by Medline within 30 months of trial completion. And three years later, one third still remained unpublished.  The law calls for publication of all Government sponsored trial data in 12 months.  Apparently, that doesn't mean much in terms of behavior.

Meanwhile, another paper found that at least 3,000 records of randomized controlled trials entered into Medline between 2006 and 2011 were NOT indexed, which means that many trials will be missed when entering the commonly used research term - randomized clinical trial - into the database. As the authors noted, important evidence in searches - design and methods, baseline characteristics, long term follow-up, and secondary data analyses - can be missed

It's like playing Hide N Seek -- searching all over through documents in regulatory bodies and drug companies to piece data together that should have been freely available. Even when data on individual participants are made available, they only form part of the picture, and Ahmed and colleagues describe the problems of fitting in such data when the whole picture is not known.

Past failures to ensure proper regulation and registration of clinical trials, and a current culture of haphazard publication and incomplete data disclosure, make the proper analysis of the harms and benefits of common treatments almost impossible for systematic reviewers. Patients will have to live with the consequences of these failures for many years to come.

The main challenge is to ensure better systems for the future. This may require the global organisation of a suitable shared database for all raw data from human trials— perhaps the next job for the World Health Organization. Concealment of data should be regarded as a serious ethical breach, and clinical researchers who fail to disclose data should be subject to disciplinary action by professional organisations. This should serve as a wake-up call to both the NIH and the FDA to restrict grants to researchers who receive government funds, but violate the rules. This may achieve quicker results than legislation in individual countries, although this is also desirable. 

See PharmaGossip, Pharmalot and Fierce Biotech reports.

Posted by Bruce Lehr Jan 4th 2012

 

Alnylam Claims 1st with RNAi in Clinic

Today Alnylam reported a preliminary assessment of a small Phase I study (20 patients) showing statistically significant  results in sharply reducing the levels of bad cholesterol in patients suffering from severe hypercholesterolemia. Alnylam also touted the use of second-generation lipid nanoparticles to effectively deliver an RNAi treatment (called ALN-PCS) in this study.

"...we believe is the first ever demonstration of efficacy for an RNAi therapeutic toward a clinically validated endpoint, namely LDL-C, a defined risk factor for coronary artery disease and acute myocardial infarction....," said Akshay Vaishnaw, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Alnylam.

The new drug was well-tolerated at a variety of doses, and no one has dropped out of the study because of side effects, although a mild rash was observed in patients on the treatment, the company said. The study is still ongoing.

Albeit with a very small patient population and in aa early phase I trial, this is the first positive news from the clinic for an RNAi treatment in some time -- and comes on the heels of several Big Pharma players giving up on RNAi last year.  Kudos for now.  See Fierce Biotech and Xconomy.

 

Posted by Bruce Lehr Jan 4th 2012

 

Jury Still Out on FDA Approval Rate

The jury is still out on whether the FDA increased drug approval rate in 2011 represents the start of a more positive trend or is just a one year hiccup. By November the FDA had 35 approvals to claim--with 24 coming ahead of OKs in other countries. The agency publicly noted that 2011's approval rate will go down as one of the best years in the past decade after years of anemic approval rates. 

True, but will it be sustained?

Most industry execs aren't ready to cheer just yet. The industry is still struggling with a poor productivity rate over the past decade, and is undergoing an unfinished revolution on the development front.  Next year, we could see a drop in approvals.  And if that happens, the FDA will be under even more pressure to work more closely with developers to better turn the odds in their favor.  See Fierce Biotech.

Posted by Bruce Lehr Dec 26th 2011.

More on Relative Value of Patents for Bio Drugs in a Biosimilar World

More from the Patent Doc blog on why biologic drug producers in the future will stay away from patents and rely more on trade secrets to protect their interests. The Biologics Price Competition and Innovation Act of 2009 (particularly the litigation provisions) contains incentives for biologic drug innovators not to rely on patents to protect these drugs and the return on investment.  A recent analysis also showed that patent protection provides (on average) about one additional year (~327 days) of exclusivity past the end of the 12-year exclusivity provided by the BPCIA. So statutory protection is about equivalent with patent protection and the former can be accomplished through much less information disclosure on one's biological drug.

The blog post below talks about using trade secret approach more in late stages of development for process related steps like cell line optmization -- that generally doesn't benefit from patent protection.  This would make it harder on a follower to try to copy a bio-drug.

...the expected de-emphasis on patent protection for later-stage development (including regulatory approval) can be expected to change the relative importance of patents in the two stages.  Such de-emphasis will also change where the valuation in biologic drugs may lie, because there will be a relatively greater advantage in optimizing cell lines and other process parameters (which even today rarely benefit from patenting) than in patents on the biologic drugs per se. 

So less emphasis on composition of matter and more emphasis on the process. The author further concludes that "the future will be different than the past regarding biologic drug development and efforts to obtain the benefits of biologic drug development at a reduced price."

Posted by Bruce Lehr Dec 26th 2011.

ImmunoGen and Lilly Cut ADC Deal

From Fierce Biotech, ImmunoGen and Eli Lilly announced a deal for the latter to gain an exclusive license to a defined number of treatments utilizing the formers antibody drug conjugate technology.  ImmunoGen will receive $20 M in upfront payments, can earn up to $200 M in milestones and also can earn royalties when the drugs reach commercialization.

Lilly plans to exploit the ADC technology with its pipeline of oncology drugs to "develop agents with clear clinical benefit in specific patients populations."

Posted by Bruce Lehr Dec 20th 2011.

Bio-drug Innovators Eschew Patents in Future to Block Biosimilars?

Here's interesting post from the Patent Doc Blog that argues that there are incentives for producers of innovator drugs to NOT file patents to block information access to biosimilars producers in the future.

The writer argues that instead of filing patents innovator drug producers could file the bare minimum information with the FDA to get their drug approved.  Because biologic drugs are so complex, this degree of stealth would prevent knowledge flow to biosimilar producers who wanted to copy their drug. Thus, the innovator would not disclose the cell used to produce the drug, or any optimization of that cell line.

The bloggist argues that this would produce obstacles for the biosimilar follower and would also avoid litigation under the biosimilars statute. The innovator could thus avoid protracted biosimilar patent infringement lawsuits. 

It is an interesting post.  But if non-filing is this easy, why doesn't someone do it now? It would save time and money.  It may protect from a biosimilar follower but does it protect from a fellow innovator?

Posted by Bruce Lehr Dec 20th 2011.