More on Biotech Generics and the Democratic Congress

I noted yesterday the article on TheHill.com reporting the new Dem Congress intentions to legislate a pathway for biotech generics. I was skeptical of how they would approach the difficult trade offs involved, and the article didn't give many details. Seems there is still work to be done:

Hatch, Republican of Utah , said yesterday that the issue is too important to try to pass before the Senate recess, expected at the end of next week .

``There's no question we can't do much in this Congress," he said. ``I look forward to working with [Waxman], if we can do a balanced approach -- because nothing else is going to pass."

One of the problems is going to be deciding whether or not to put biotech generics through clinical trials of their own. If they're not required to undergo trials, I'm curious to see how they deal with the reality that slightly different drugs will have different effects. Some good, some bad. Who is liable when they're bad, considering there were no trials? This article suggests the burden may be put on the prescribing doctors:

The FDA says it needs similar authorization before it gives copies of biotech drugs speedy reviews. Deputy Commissioner Janet Woodcock says the process would have to be different from the way traditional generic drugs are reviewed. That's because science hasn't advanced far enough for the agency to establish that the biotech copies are identical to the originals - only to say they are similar.

That's why the FDA calls imitations of biotech drugs "follow-ons," not generics. Likewise, the agency wouldn't allow pharmacists to freely substitute follow-on biotech drugs for originals, as they can do with traditional medicines. A doctor would have to specifically request the follow-on, unless the generic drug makers prove through studies that the original and its imitation are the same.

No doubt a lack of pharmacist discretion will mean less generics being used. If you couple that with how direct to consumer marketing campaigns increase prescription rates, it seems biotech companies would be able to defend their market share from generics much better than traditional pharma's can. I would be disappointed but not surprised to see marketing regulations in the bill.

More From India

Protesting Patent Law:

Hundreds of Indian activists protested in New Delhi on Monday against a challenge to the country's patent law by Swiss pharmaceutical giant Novartis, saying the move could leave millions without access to affordable medicine.

"Hundreds" doesn't seem like much in India.

Tougher Standards for Biotech

Fierce Biotech:

With the number of patents on gene-related discoveries soaring, IP experts say that the process of gaining a patent has become much more complex. Isolating and sequencing a protein won't cut it anymore, say attorneys. You now have to demonstrate a "credible utility" outlining what it can do. Biotech patent applications are considered a prime reason why the total number of patent filings in the U.S. hit 409,500 last year. And many of these patents are out to protect new therapies rather than genetic links to disease.

Pulmonary Arterial Hypertension

Maybe good news for PAH:

Pharmaceutical and biotechnology companies have evinced interest in the PAH markets despite the small patient population. The robust late stage drug pipeline has resulted in in-licensing deals and M&A activity.

Due to a lack of awareness about the disease, the rate of diagnosis and treatment is low, resulting in higher mortality rate among patients diagnosed at a late-stage of the disease.

"The average survival time of patients upon diagnosis is between 3-4 years chiefly due to the low diagnosis rates," says Barath Shankar. "Several patients are unaware of the existence of the disease until progression to a chronic stage.

"Several leading pharmaceutical and biotechnology companies have shown interest in this market. The development of improved therapies, combined with increased awareness is likely to enable the growth of this market

Novartis Patent Case in India

It's the standard treatment of IP arguments and trade offs:

The treatment of thousands of AIDS patients will be in jeopardy if Swiss drug maker Novartis succeeds in changing India's patent law, Medecins Sans Frontieres (MSF) has warned.

Here's a summary time line of Patent Law in India.

Another article puts it this way:

Profit over life

In 2000, antiretroviral (ARV) treatment cost was estimated at $10,000 per patient annually. But the availability of generic drugs produced mainly in India, allowed costs to plummet to about $70 per patient per year, Mwangi adds.

They do briefly mention:

Novartis argues that the principle of intellectual property protection must be safeguarded if innovation is to flourish.

Speeding up Tech Transfer

Sounds cool:

PALM DESERT, Calif., Jan. 30 /PRNewswire-USNewswire/ -- Searching for
the "missing link" to research just got easier. The iBridge(SM) Network, a
program of the Kauffman Innovation Network, Inc., and its accompanying Web
site, debuted today at DEMO 07, the premier launch venue for new products,
technologies and companies. University researchers, industry
representatives, and entrepreneurs can use the iBridge Web site to search
for innovations that, until now, have been lost and untapped behind
university walls.

Here's the iBridge web site: http://www.iBridgeNetwork.org.

America's Costliest Drugs

A breakdown:

In 2004, American adults spent $32 billion on cardiovascular drugs, putting them at the top of the five costliest classes of drugs prescribed by doctors for people age 18 and over, according to the latest News and Numbers from the Agency for Healthcare Research and Quality. The five costliest classes of drugs combined accounted for two thirds – $119 billion – of the $181 billion total expenditures spent on outpatient prescription medications by adults in the United States in 2004. Hormones were the second-costliest drug class ($25 billion), followed by central nervous system drugs ($24 billion), which can be used to treat pain and control seizures; cholesterol-lowering medications ($22 billion); and anti-depressants and other psychotherapeutic drugs ($18 billion).

Someone (Other Than You) May Own Your Genes? Say Who?

My first reaction to this NYTimes article was one of surprise. To be honest I don't regularly take the Times. After a glance in fact I hesitated for one second thinking, "wait.. what are they saying?" So thrown I felt compelled to go look up some things before I got animated. Then of course I came down with a nasty case of the Mundees, as is the style of the time.

So, more on this tomorrow. But, I am somewhat surprised that a paper supposedly of the NYTimes caliber would put in the business section something this factually wrong and, quite frankly, silly.

Background basics, per a simple google search:

Trying to patent a human gene is like trying to patent a tree. You can patent a table that you build from a tree, but you cannot patent the tree itself.
William Haseltine - President, Human Genome Sciences

Much of the controversy surrounding patenting genes stems from a misunderstanding of the limitations of patent law. Numerous media sources often refer to "gene patents." This term is imprecise and can lead to the belief that it is possible to file for a blanket patent covering all the possible uses of a gene, or even a patent on the sequence itself. Further misunderstandings arise from the failure to differentiate between a patent that is pending and a patent that has been granted.

Patent Docs offers a further technical orientation for the lay reader:

This begins with the title of the piece, "Framing: Someone (other than you) may own you genes." Readers of this space will recognize the falsity of this statement: no one (other than you) owns your genes. Patent offices around the world, including in the U.S., require that a gene be "isolated and purified" by a scientist before patent rights will attach. Moreover, this is but the threshold for patenting in the U.S.: in addition, the nucleic acid sequence of the gene must be new (meaning that it wasn't disclosed previously by anyone), and the function of the gene product must be known (or it lacks utility). ... Finally, the title implies that someday a patent holder will knock on your door and ask for royalties because they "own" the gene for alcohol dehydrogenase, and since there is a bottle of wine in your garbage can we know your liver is busy using this gene to make the enzyme that detoxifies the alcohol in the wine. Hogwash, to quote our current Vice-President.

The subtitle is in some ways worse: "Is it time to consider an alternative to patenting life forms." This is part of a new "vitalism" expressed by some writers (such as Lori Andrews of Kent College of Law) when it comes to DNA patenting. DNA "is a chemical, albeit a complex one" according to the Federal Circuit, and as such is no different than substances such as vitamins and proteins that are non-controversial subjects of patent protection. But there is something about DNA, perhaps because its status as the "genetic material" is so compelling, that renders irrational otherwise sober discussion. Western science rejected the concept of vitalism, that biological molecules or processes are not subject to chemical and physical laws of other matter, late in the 19th century when Pasteur and Wohler and others showed that there was no basis for the concept. Rapid progress in biology and biochemistry followed. Yet the framing of the issues in the new vitalism seems to revive these simply incorrect views for political rather than scientific reasons...

Vitalism, geez. More tomorrow..

Dems to Deal with Biotech Generics?

The Hill.com:

Senior Democratic lawmakers are close to introducing legislation to create a pathway for the approval of generic biological drugs in the hopes that the cheaper medicines will create billions of dollars in budget savings, which could be used to offset some of the cost of expanding federal health programs.

Here's some background on this.

So what steps will generic drug makers need to take in order to market biologic therapies, which fall in a different category? Biotech companies argue that protein-based medicines are more complicated than chemical entities: They are larger, not as well characterized, and are manufactured by cultured cells under closely guarded proprietary processes.

Insulin and human growth hormone may be simple, easily characterized proteins, but most biotech therapeutics are considerably more complex. For instance, it's well known that a vial of a protein-based therapy such as Epogen actually contains a heterogeneous mixture of recombinant proteins, with different sugar groups or glycoforms, for instance – making it all the more difficult to duplicate.

According to this logic, espoused by biotech firms and the Biotechnology Industry Organization (BIO), generic manufacturers would have to test their products in clinical trials anyway, which would probably erode the price differential between a branded drug and a generic one.

What are they proposing? Fund the FDA more? Allow biologics to be approved without trials? The article doesn't really say. From the Hill.com article:

The Biotechnology Industry Organization (BIO) rejected PCMA's analysis, in part by arguing that PCMA underestimates the cost of manufacturing biologic drugs, especially for those companies that have never done it before.

The Food and Drug Administration (FDA) long has had a process in place to approve of generic versions of drugs made of chemical compounds, of which exact copies can be made.

This is clearly not true. This IS true, however... ahem To date there is one biogeneric which was the exception according to the FDA:

The FDA, however, made it quite clear that Omnitrope was not therapeutically equivalent to Genotropin (in the manner of a generic version of a chemically-based drug), and that its decision to approve the product does not "establish a pathway" for the approval of other follow-on biologics. Moreover, the FDA stated that Congress must enact new legislation before it will be able to approve almost any other so-called copies of recombinant biotech therapies.

Err.

"There's a great deal of savings that can be achieved," Waxman said. Although he would not name a specific amount or range of savings in dollars, he said, "There are some pretty dramatic figures." New York Democratic Sens. Charles Schumer and Hillary Rodham Clinton will introduce a companion to his bill, Waxman said.

My guess is the legislature is being told by generics lobbyists that the outrageous cost of biotech drugs can potentially be brought down to the generic pharmaceuticals range. Unlikely as of now (nonetheless, be careful what you wish for).

So just what will this bill do? If it is to work, it needs to increase funding to the FDA and provide authority to the FDA to approve generic biologics. To do the latter, it must make the inevitable trade off.

- Dare you skip clinical trials for biologic generics you need to deal with the obvious consumer backlash/lawsuits/cost increase when it's discovered they double the chance of heart attack, etc, but never underwent clinical trials!

- Or, the cost of generics is nearly as expensive after they fund clinical trials and FDA approval.

We shall see...

Going To The Dogs

Working for a healthier world!

In a week when the feds cracked down on some of those quick-loss diet companies with hefty fines for making false claims about their untested pills, it seemed just a bit odd that the FDA approved the first diet drug for dogs.

Heh.

Wyeth, Proteins, and The New Book "Science Business"

I said before about the book Science Business skepticism of biotechnology I was " curious to see how he draws the line between pharma and biotech considering the way in which big pharma often "picks the winners" through licensing and acquisitions. That blurred line also affects what you're actually looking at when you consider the performance of biotech "in aggregate." " Again I have not read the book. However...

This article exemplifies my would be point well:

Wyeth Pharmaceuticals Listed as the Best 10 Pipeline for the Third Consecutive Year by R&D Directions Magazine
Monday January 29, 11:50 am ET

Wyeth Named the Best Central Nervous System Pipeline MADISON, N.J., Jan. 29 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth, (NYSE: WYE - News), announced today that the January issue of R&D Directions magazine has selected Wyeth as The Best Central Nervous System (CNS) Pipeline as part of the magazine's annual "Top 10 Pipeline Report."

Currently, Wyeth has 19 compounds in their CNS drug pipeline under development as potential treatments for patients with neurological conditions including schizophrenia, bipolar disorder, depression, Alzheimer's disease, neuropathic pain, fibromyalgia and acute stroke.

Wyeth is the only major pharmaceutical company exploring three technical platforms for Alzheimer's disease therapeutics: small molecules, biotechnology proteins and vaccines. As part of its "War on Alzheimer's Disease," Wyeth has 11 compounds in development including beta-amyloid inhibitors (in partnership with Elan Pharmaceuticals), gamma secretase inhibitors, plasminogen activator inhibitors and cognitive enhancers. Alzheimer's Disease is a devastating neurological disorder that is expected to affect more than 80 million people worldwide by 2040.

More here:

Meanwhile, another factor driving startups is the need for new companies in emerging areas such as energy, telecommunications and life sciences, which is a combination of medical devices and biotechnology.

“The big trend was the leap in life sciences” VC money, up 20% to $7.2 billion last year, from $6 billion in 2005, Mr. Lefteroff said.

The driver behind this trend is huge pharmaceutical companies that are looking to grow as they face patent protection loss on their most lucrative products.

Okay, that's all 'til I read the book.

Well maybe one more:

“There is much more to come from Wyeth R&D,” Mr. Poussot said.

Sales of biotechnology drugs, which include Prevnar and Enbrel, rose 23 per cent for the year, and now account for almost 35 per cent of pharmaceutical revenue, he said.

Lastly, from the Best of '06

Stem cells

In a grass roots effort to reject the Bush Administration's recalcitrant position on what promises to be the most exciting area of stopping and reversing - and possible curing - the progression of many major diseases, many states took legislative initiatives to accelerate the finding and development of new stem cell-based research and therapies.

Again, am I missing something in saying that the consequence (perhaps unintended) of Bush's embryonic stem cell funding ban seems to have been to simultaneously start a conversation about bioethics while not managing to stifle innovation?

Exxon and Ethanol

Also of note from the Bloomberg article below:

Exxon Mobil helps fund research into cellulosic ethanol at Stanford University in California.

You sure don't hear much about that. 

Carnival of Biotechnology

Over at Biotech Blog. 

More from the Best of '06

Biofuels

According to BIO, processing just 30 percent of U.S. corn stover into biofuels would reduce U.S. greenhouse gas emissions by the equivalent of 90 to 150 million metric tons of carbon dioxide annually. Another study by the University of Tennessee showed that producing 25 percent of America's energy from agricultural resources would generate in excess of $700 billion annually in economic activity, create 5.1 million jobs, and add $180 billion to net farm income by 2025.

For those of you who scoff at this, when I visited Brazil during 2006, I personally witnessed how this country had harnessed biotechnology with their sugar cane crop to become self sufficient in gas. Even President Bush jumped on the biofuels bandwagon in his 2007 State of the Union address when he established America's "Twenty in Ten" goal, or stopping the growth of U.S. carbon dioxide emissions within the next 10 years by requiring the production of 35 billion gallons of renewable and alternative fuels by 2017. This is five times the amount called for in the current law for 2012.

This is true but as I understand it Bush's plan doesn't differentiate ethanol production from cellulosic ethanol production which is the only way you actually get a significant decrease in carbon emissions through the entire production chain.   Bloomberg.com:

Reviving ethanol requires a breakthrough in technology that would make current processes more efficient or cut the cost of so-called cellulosic ethanol, made from corn stalks, wood chips and wild grasses. Switch grass, for example, could yield 1,000 gallons an acre, more than double that of corn, Bernstein said.

More From Hawaii...

I noted they're trying to mirror San Diego's success, now apparently biotech is second only to pineapple:

After reviewing the newest statistics from the U.S. Department of Agriculture, local growers of designer gene crops are declaring that they have become the second biggest crop category in Hawaii.

Best of '06?

CHICAGO – As we're still in January, it's a good time to look back at 2006 and identify some of the key events that shaped the biotech industry in the Midwest and across the U.S.

In order of importance, here's my list:

1. Biofuels
2. Stem cells
3. BIO 2006 in Chicago
4. The reshaping and resurgence of Abbott Labs
5. Biogenerics in the U.S.
6. The internationalization of Indian pharma
7. FDA product approvals
8. Nanotechnology financing
9. The globalization of biotech
10. The convergence of the drugs, devices and diagnostics/imaging industries

Upon reviewing this list, some of you will say these are not new issues and they appeared before 2006. I will of course agree with you. However, a confluence of events during 2006 surrounding each of the topics took place that elevated them to a center stage.

In analyzing the impact of each of the above points, I'm going to start like David Letterman in reverse order.

Worth reading...

Brown Algae and Skin Cancer

The Biotech-weblog:

In animal study, scientists have demonstrated that brown algae polyphenols (BAP) from a type of brown marine seaweed may be used orally and topically for the treatment and prevention of skin cancer due to UVB.

In Clue to Addiction, Brain Injury Halts Smoking

Interesting.

Glaxo Distorted Paxil Data?

According to the BBC:

GlaxoSmithKline Plc was accused on Monday of distorting clinical trial results of its antidepressant Seroxat, or Paxil, and covering up a link with suicide in teenagers.

The BBC plans to air a Panorama program later saying the drug company attempted to show that Seroxat worked for depressed children despite failed clinical trials and that Glaxo-employed ghostwriters influenced "independent" academics.

Here's the BBC story.

I haven't directly looked at the data for this drug or for Vioxx because I try make at least some minimal effort at having a life. But speaking broadly about these situations, it seems to me any drug that actual works physiologically is going to show increased health risks over time. That doesn't really strike me as news. The problem seems to be that these companies are trying to hide the negative data and getting into trouble. Even if they're technically following the laws and regulations (which I have not looked at) they're obviously bumbling the PR aspect. That being said GSK denies it:

Only when all the data became available, at the end of the research programme, and were analysed together was an increased rate of suicidal thinking or attempted suicide revealed in those paediatric patients taking Seroxat.

GSK brought this analysis to the attnetion of the regulatory authorities, including in the UK.

I guess we'll see.

Genentech seems to be much smarter about handling this phenomena.

Genentech Inc. warned doctors that people using Lucentis, a treatment for the leading cause of blindness among the elderly, may face an increased risk of stroke.

As I understand it there was already a stroke warning on the bottle, but they decided to send the letters anyway.

(h/t: bioethics.com)

Enzon

More on the Enzon IND:

Santaris Pharma wins milestone payment from Enzon Pharmaceuticals after US FDA grants IND approval...

New Fangled Kids

In my day it cost big bucks in college for this!

For three weeks, she and a few dozen of her seventh-grade classmates at Matthew Gage Middle School in Riverside, are harvesting genes in bacteria and identifying their own DNA

Never did like lab anyway, well the lab book. 

GM Canola to Kill Frans Fat?

Can we get a rush order on this?  Not for me, for... a "friend" of mine who lives in Canada. 

Canola crops could be genetically modified to eliminate the arteryclogging trans fats partly responsible for WA's emerging obesity crisis, according to a leading farm consultant and WA biotechnology experts.

Biotech for Energy Needs

This is in the UK, but it's interesting because while Bush put forth ethanol as an alternative energy plan, it won't make much different in terms of carbon emissions unless it's cellulosic ethanol.  Carbon may not be Bush's concern. 

Green Biologics (GBL), an Oxfordshire (UK) biotechnology company, has received £560,000 (US$1.1 million) in funding to support the development of its fuel biobutanol product—Butafuel—from cellulosic biomass. The Department of Trade and Industry-led Technology Program is providing £250,000 (US$494,000), and shareholder investors and business angels are providing the rest.

Hawaii Takes a Page from San Diego

Or tries to anyway:

At the time, this sleepy, southern California Navy town was gripped in recession. It depended largely on military funding and with the end of the Cold War, defense contracts were drying up and its future looked bleak. It desperately needed to reinvent itself and it did so brilliantly by morphing from a military/tourism-based economy to a life sciences hub in a matter of two decades.

In short, San Diego can serve as a great role model for Hawaii, and while the Aloha State is nowhere close to San Diego in our evolution as a biotech center, we are on the road.

There are life-sciences companies in this state with potential blockbuster products in the pipeline. Hawaii Biotech, for example, is working on cutting-edge recombinant vaccines for West Nile virus, pandemic flu and dengue fever. Any of these could generate hundreds of millions of dollars or more in sales, and the company is considering a manufacturing facility on Oahu. Our own company, Cardax Pharmaceuticals, is developing a cardiovascular drug that, if approved, could be a major factor in the $30 billion cardiovascular drug market. Other local companies such as Tissue Genesis, Hoana Medical and Cellular Bioengineering are ramping up with leading-edge technologies that also could help put Hawaii on the life sciences map.

Two Biotech IPO's

Molecular Insight Pharma, XTENT:

In addition to five other IPOs, there are also two biotech companies going public this week: Molecular Insight Pharmaceuticals (MIPI), a biotech company focused on fighting disease through molecular medicine; and XTENT (XTNT), which produced custom made drug-eluding heart stents.

As states court biotechs...

Traditional biotech hubs are also competing to retain companies. 

stem-cell institutes

First California ( chuggin' along), then Texas.  Zip.

Stem Cell Storage

FoxNews.com:

The Virgin-branded company will be launched next Thursday and is expected to offer parents the chance to put the umbilical blood of their newborn children into cold storage. Scientists believe that future advances in medical technology will use stem cells to cure diseases such as Alzheimer's and cancer.

Or you could just do it yourself!

Bacteria Harnessed As Micro-Robot Motors

Sweet. 

Scientists at Carnegie Mellon University fixed the bacteria to the micro-capsules and then used chemicals to turn on and off their motion-producing flagella

Mapping the Metabolome

Reported among other places at Network Teks':

Cache22x writes "Scientists at the University of Alberta have published the first draft of the Human Metabolome Project, the chemical equivalent of the human genome. In the same spirit as the human genome project, the information has been made freely available to the scientific community and the general public through the project's website. Knowing the makeup of the metabolome will lead to potentially enormous medical advances as clinicians now have a comparative base for analyzing the metabolite levels found in our bodies."

Wikipedia reference:

In January 2007 scientists at the University of Alberta finished a draft of the human metabolome. They have catalogued and characterized 2,500 metabolites, 1,200 drugs and 3,500 food components that can be found in the human body.

3,500 / 3 = ranch, meat, and cheese!

The Immigrant Technologist

William Kerr and Michael Roberts look at Studying Technology Transfer with China:

Assistant Professor William R. Kerr teaches the required first-year MBA course, The Entrepreneurial Manager, in addition to Executive Education courses at Harvard Business School. One of his core research areas is the role of immigrant entrepreneurs and scientists for U.S. technology development, as well as the subsequent diffusion of new innovations to the immigrants' home countries.

Some interesting points:

My research focuses on technology transfer through ethnic scientific and entrepreneurial networks. Traditional models of technology diffusion suggest that if you have a great idea, people who are ten feet away from you will learn about that idea first, followed by people who are 100 miles away, and so forth in concentric circles. My research on ethnic networks suggests this channel facilitates faster knowledge transfer and faster adoption of foreign technologies. For example, if the Chinese have a strong presence in the U.S. computer industry, relative to other ethnic groups, then computer technologies diffuse faster to China than elsewhere. This is true even for computer advances made by Americans, as the U.S.-based Chinese increase awareness and tacit knowledge development regarding these advances in their home country.

In my experience the Chinese have a strong presence in the biotech and research sectors.  This would seem to apply to biotech if it applies to computers.

One implication concerns immigration levels. It is interesting to note that while immigrants account for about 15 percent of the U.S. working population, they account for almost half of our Ph.D.-level scientists and engineers. Even within the Ph.D. ranks, foreign-born individuals have a disproportionate number of Nobel Prizes, elections to the National Academy of Sciences, patent citations, and so forth. They are a very strong contributor to U.S. technology development, so it is in the United States' interest to attract and retain this highly skilled group. It is one of the easiest policy levers we have to influence our nation's rate of innovation.

Historically, the United States has been very successful at the retention of foreign-born, Ph.D.-level scientists, inventors, and entrepreneurs. As China and India continue to develop, they will become more attractive places to live and to start companies. The returnee pattern may accelerate as foreign infrastructures become more developed for entrepreneurship. This is not going to happen over the next three years, but it is quite likely over the next thirty to fifty years. My current research is exploring how this reverse migration would impact the United States' rate of progress.

Also,

...One of the strongest trends of globalization is that U.S. multinationals are placing larger shares of their R&D into foreign countries. About 5 percent of U.S.-sponsored R&D was done in foreign countries in the 1980s, and that number is around 15 percent today.

See this related report on  "time and cost benefits of clinical drug development in India."

Science Business: the Promise, the Reality, and the Future of Biotech

I have not read Harvard business professor Gary P. Pisano's new book, so I'll reserve judgment. I'm curious to see how he draws the line between pharma and biotech considering the way in which big pharma often "picks the winners" through licensing and acquisitions. That blurred line also affects what you're actually looking at when you consider the performance of biotech "in aggregate." Interestingly an article at seekingalpha ends with the impressive stock chart of Genentech.

Sounds like an interesting read. Here's a piece of a Q&A:

I argue in the book that "monetization of intellectual property" has been a powerful shaping force in biotech. The idea behind monetization of IP is that you don't need to actually develop a product; you can just develop a piece of IP, and then capture financial returns through licensing or other market arrangement. This has worked wonderfully in semiconductors and software, but monetization of IP only works there because of some very specific conditions. You need to have a very modular knowledge base; that is, you need to be able to break up a "big puzzle" into its relatively independent pieces so that a particular piece can be valued independently; and you have to have well defined intellectual property rights. It is hard to sell stuff where the rights are not well defined. There are all sorts of hazards.

There's a dissenter in the Harvard Business Review (sub req.)

Biotech Cost Ceiling?

NY Times:

Are biotechnology companies reaching the limits of how much they can charge for their drugs? One sign of that is the sluggish sales of drugs for psoriasis.

I'm not sure this is the best example to draw an industry wide conclusion about a cost ceiling.

more: In my opinion this is just as relevant to a biotech price ceiling as the psoriasis situation above is:

After winning the FDA's approval for its new cancer drug Vectibix, Amgen swiftly pegged the price of the new drug at a 20 percent discount on Erbitux, which works in much the same way. Analysts immediately seized on the move as an indication that the biopharma industry is becoming increasingly sensitive to criticisms that new cancer therapies are priced at huge premiums for drug developers. But even at the discount, analysts note, Vectibix will still cost more than $100,000 a year.

Are We Prepared for the Biotechnology Revolution?

Some say no:

I can confidently say that most people are completely ignorant of how different the future will be and how rapidly it is approaching. Our existing laws, social structures, national organizations, and systems of government will have to be restructured to avoid irrelevance.

In no area are these changes more profound than biotechnology. Very soon we will be faced with the world of Do-It-Yourself Biotechnology, what Baris Karadogan correctly calls The Ultimate Empowerment of the Consumer. We will have to deal with new terrorist threats where small groups of people can home-grow biotech and nanotech weapons to wreak massive human destruction. We will be faced with complex social questions our parents couldn't imagine, such as What is a Human Being?

And yet, if these issues get demagogued by political opportunists the technological advances may never come. Or may not happen in the right places at the right times. Over regulation and pushing it underground would seem to me to be a mistake.

Alternatively, is an advantage of Bush's stem cell shenanigans that while it clearly hasn't stopped stem cell research it has at least started a conversation?

Nanotechnology Based Medicines Nearing Commercialization

NANOMEDICINE Conference in March:

Innovations at the intersection of medicine, biotechnology, engineering, physical sciences and information technology are spurring new directions in R&D, commercialization and technology transfer. Basic research in nanomedicine and bionanotechnology is rapidly producing commercially viable products. Governments and industries across the globe are staking their claims by investing billions for research. Clearly, international rivalries are growing and political alliances and battle lines are beginning to gel.

Europe Behind on Agri Biotech?

Smells like politics:

Professor Dr Marc Van Montagu, Chairman International Plant Biotechnology Organisation (IPBO)[i] Gent University and president of the European Federation of Biotechnology, told journalists in Brussels recently that European farmers are lagging behind the rest of the world in terms of access to agricultural biotechnology.

..."Fighting the vicious circle of hunger and poverty is the most urgent task that faces our society, and will require a reformulation of current models of agriculture," he said. But he also believes that the technology has already demonstrated considerable benefits in Europe, despite systematic attempts to deny European farmers the right to use a technology widely used in the rest of the world.

Non-Science-Based Labeling

From Bio:

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood today responded to Sen. Barbara Mikulski's (D-Md.) introduction of the Cloned Food Labeling Act saying, "Labels that are misleading to consumers are unlawful. To require the labeling of foods that are indistinguishable from foods produced through traditional methods – as Sen. Mikulski's proposal does – would mislead consumers by falsely implying differences where none exist. It also risks diverting attention from important safety and nutritional information."

No doubt polls would show simultaneous fear and ignorance of cloning and other gm foods.

That being said I would like to know what I'm eating, and tend to err on the side of more info rather than less. I wouldn't have any problem eating cloned grub. I'm far more threatened by burgers and beer, which I enjoy regularly.

More here:

Mikulski's bill requires food distributors to add labels saying "This product is from a cloned animal or its progeny." The labels would be placed on cheese, milk, meat, and other food in supermarkets and restaurants.

More: nanotech equally mysterious to most.

The Economist on The Drug Industry

Ranbaxy, a big Indian generics firm, gobbled up six competitors last year and is now talking with private-equity firms about a bid for the generics arm of Germany's Merck. Ranbaxy's boss, Malvinder Singh, scoffs that Big Pharma "is struggling to come up with true innovation".

He'd better hope we do, though. Where else is Ranbaxy going to get those generic drugs to sell, do you think? From elves?

Ha. 

Lessons From Other Industries

Interesting stuff:

As professionals affiliated with the biotechnology industry, we often forget that many of the struggles faced today have been solved before by other fields and industries. As Ambrose Bierce wrote, "There is nothing new under the sun, but there are lots of old things we don't know." The question is, where to look for inspiration?

Generic v Generic

Aaron F. Barkoff submits: Generic drug makers typically set their litigation sights on brand-name drug companies. Their goal is to invalidate the brand companies' patents and earn the right to market their generic drugs before the patents expire. Increasingly, however, generics are suing each other to protect or gain market share.

Read the rest here.

IND Allowance

BioWa and Medarex.  MDX-1401, human antibody, CD30-positive lymphomas. 

IND approval

Enzon.  HIF-1 alpha antagonist.  

Amgen Data Disappoints

Article on Aranesp here. 

Richard Branson to Launch Stem Cell Bank:

Spare parts for your kids? 

Tough to Grow Biotech Locally

Many cities and regions are trying to grow biotechnology clusters because of the tax revenue, job growth, and generally positive impact on the local economy.  But there are difficulties such as the requisite quality of research in surrounding universities as well as proximity to venture capital.  This account of Sirna's relocation can't be reassuring to local chambers. 

Other Genentech News...

Huge market cap, stock price at 86 bucks.  No threat yet for generic biologics.  And yet:

Says Levinson: "There's nobody that asks, 'can we continue the hot streak' more than myself."

The possible solution:

... Levinson and Desmond-Hellmann are heading out of their comfort zone into a new field: immunology, which focuses on how the body's own defense systems go awry to cause disorders like rheumatoid arthritis, asthma and multiple sclerosis.

Article at Forbes. 

Also their next blockbuster may be a clot-buster.  (boo!  bad joke.)

Motley Fool:

Last week, we asked you to vote in Motley Fool CAPS for the company that you think will be the best drug stock to own in 2007.

Guess who...

More on the stock price: 

On Genentech Cramer said that the reason the stock has dropped is because the risks to the model caused a multiple contraction; but now he thinks that will change. Here is why he has a bear case of $104.00 and a bullish case of $140.00

And finally it's practically old news by now but here' s a nice post on the licensing supreme court case involving Genentech.  


 

Genentech - the anti-dumb!

Genentech seems to have learned from the vioxx fiasco and is adeptly on top of the PR:

Genentech Inc. warned doctors that people using Lucentis, a treatment for the leading cause of blindness among the elderly, may face an increased risk of stroke.

As I understand it there was already a stroke warning on the bottle, but they decided to send the letters anyway.