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Biotechnology, Health and Business in Canada, the United States and Worldwide

Category Archives: Biotech Trends in 2010

Biotech Trends Update — IP Constituencies: Indian Industry Lobbies to Keep IP Out of Free Trade Agreement with EU

An article in yesterday’s Hindu Business Line says the Indian Drug Manufacturers’ Association is lobbying heavily to keep data protection and other innovator-friendly IP provisions out of the free trade agreement being negotiated between India and the EU. But, with Glenmark and Jubilant on the rise, and with even Biocon carrying the R&D water in its deal with Pfizer, demands for IP protection from domestic constituents are bound to be increasingly loud.

Keep an eye on the progress of the free trade talks, continuing with the India-EU summit this week. Apparently, the main gaps are: the percentage of tradable goods that are tariff-free; a sustainable development clause; and the IP issues noted above. We’ll see how hard India pushes to keep IP out of the picture.

Approval Pathway for Biosimilars and Interchangeable Biological Products: Issues from the FDA’s Public Hearing

On November 2nd and 3rd the FDA held a public hearing to address the challenges it will face in the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This act established an abbreviated pathway for follow-on biologics (a.k.a. biosimilars) that are either “highly similar” or “interchangeable” with previously approved biologics. Many industry stakeholders were in attendance to voice their opinion on the matter including Pfizer, Roche, Merck, Novo Nordisk, Novartis, Amgen, Shire, and TEVA, amongst others. I tuned into these webcasts to extract the salient areas of debate. Read more of this post

Biotech Trends Update — Biosimilars Blur IP Constituencies: Novartis and Pfizer-Biocon are Featured in the Economist

Two 9-figure announcements this week mark a turning point for the biosimilars market, and one highlights the increasingly important role India plays in innovation.

  1. Pfizer linked up with India’s Biocon in a deal that will see Biocon take the lead in development of four biosimilar insulin products that gives Biocon $200 million up front. Coverage of the deal in the Business Standard highlights the country’s overall strength in biosimilars, which fall midway between new molecule development and small molecule generics in terms of the R&D and manufacturing sophistication required. Biocon cites the deal as proof that India can move up the value chain, doing for biosimilars what it did for generics. This is especially true if they continue to attract backing and partnerships from the Pfizers of the world.
  2. Novartis’ generics unit, Sandoz, reported Q3 revenues of $292 million from a single biosimilar product — enoxaparin, a copy of Sanofi-Aventis’ anticoagulant Lovenox — which is not expected to hit blockbuster status in its own right. As we have noted before, the high level of expertise required to make biosimilars creates a high barrier to entry and contributes to the field’s attractiveness to traditional pharmas (e.g., Pfizer, above) as well as to the major generics players. FierceBiotech notes further growth is expected as the first biosimilar antibodies hit the market in 2014-2015.

The Economist picked up the relevant trends in an article today entitled “Attack of the Biosimilars“:

1) “Innovator” pharmas are moving into the biosimilars business, reversing their recent role as the predominant plaintiffs in IP litigation:

“…it is ironic that the next great opportunity for traditional drugs firms is to do to the biotechnology interlopers exactly what the generics firms have done to them: shred their profit margins with cheaper copies…”

2) India in moving up the innovation value chain, increasing that country’s incentive to protect IP more forcefully:

“And as if to remind the world that new ideas don’t all come from America, it is the Indian firm that will design and manufacture the original drugs; Pfizer will only market them.”

Bottom line: biosimilars are at least as big a business as predicted. This success is another challenge to the concept that pharma’s patent cliff challenge will be met by more in-licensing from small biotechs or by increased R&D spending. Revenue is revenue, and biosimilars are poised to generate lots more of it.

Biotech Trends Update — Personalized Medicine: Duncan’s Personalized Health Manifesto is Primarily Preventative

Image from flickr user Steve Rhodes. Some rights reserved.Journalist David Ewing Duncan’sPersonalized Health Manifesto” was published this week by the Ewing Marion Kauffman Foundation. The most interesting thing about the manifesto* is that it assumes that the technical hurdles to generating and understading a full set of personalized health data have been overcome, and focuses on how that information can be deployed most effectively.  Duncan says that “a widening gap exists in integrating and implementing this promising new epoch of personalized health.” There are two main themes in the manifesto: integration and prevention.

Integration comes from Duncan’s view about how the flood of personalized data should be analyzed by researchers and physicians:

“A balance between specialization and integration needs to be restored,with an emphasis on the whole human organism as much as its parts…”

Prevention is, for Duncan, the natural best use of personalized data:

“Shifting to a health care system based as much on healthy wellness as illness is achievable…”

Both are laudable long-term goals, but I am not convinced of the need for urgent action on either point.

Specialization is (as Duncan acknowledges) what has enabled us to discover personalized markers and to analyze them on a allele-by-allele basis. We are a long way from making meaningful predictions about systemic effects on complex traits based on the available information. A shift too early away from specialization could prevent us from ever developing the underlying science sufficiently to make reliable predictions.

And shifting to a preventative healthcare system is not a goal I view as being unique to personalized medicine. As genomic testing becomes widely available, and patients begin to process their data, complex traits continue to present a challenge for them and their doctors — now that I know I have an increased risk of heart disease, I should shift my diet and increase my exercise. But these are things preventative healthcare advocates have been recommending for decades; and there is no evidence that I’ve seen that suggests the genetic information about increased risk is more motivational than family history, or peer behaviour, or any other non-personalized factor.

Bottom line: I’m no expert on manifestos, but while there’s nothing in this one I feel strongly opposed to, it doesn’t move me to action either. Read the whole thing (it’s not very long) and form your own (personalized) view.

* Other than his decision to call it a manifesto.
Image from flickr user  Steve RhodesSome rights reserved.

Biotech Trends Update — Biosimilars: FDA Meeting Formally Announced, EMA Working on Rules for (a few) Antibody Biosimilars

Reuters reports that the European Medicines Agency (EMA), which has already approved 13 biosimilars, is expecting to publish guidelines in November on biosimilar antibody therapeutics. EMA Executive Director Thomas Lonngren said that clinical trials will be required for antibody biosimilars (as they are for the products EMA has approved to date), but that requirements were likely to be less onerous than in the United States.

Reuters says that the small number of requests (six) received by EMA so far “reflects the difficulties of making such copycat medicines [antibodies]” but with the earliest therapeutic antibodies coming off patent (in Europe) in 2014, I expect these initial inquiries are just the tip of the iceberg. Of couse, biosimilars are hard (as we’ve noted); but a lucrative opportunity of that scale will not go untapped.

Meanwhile, as expected based on the draft notice leaked in September, the FDA is holding public meetings on the implementation of the Biologics Price Competition and Innovation Act (i.e., the biosimilars legislation). The full Federal Register notice (pdf) is up, and Mark Sernak at eyeonfda.com has extracted the questions posted for comment.

In addition to a long list of scientific and technical questions, there are a couple of inquiries that I’d highlight from a corporate law perspective:

  1. Which types of related entities may be ineligible for a period of 12-year exclusivity for a subsequent BLA, given the “potential transfer of BLAs from one corporate entity to another and the complexities of corporate and business relationships”; and
  2. Whether the existing fee structure under the Prescription Drug User Fee Act (PDUFA) should be considered as a model in establishing a user fee structure for biosimilar applications.

Interested in attending or in submitting a comment? The FDA’s meeting information page is here, and it includes webcast access for November 2 and November 3.

Biotech Trends Update — IP Constituencies: Endo’s Qualitest Purchase Shows Full Integration of Innovator and Generic Strategies

Endo Pharmaceuticals (NASDAQ: ENDP) announced yesterday morning that it will spend $1.2 billion to buy U.S. generics company Qualitest Pharmaceuticals. Endo also has an active pipeline of “innovative” products in development, emphasizing the industry trend we’ve been following of a narrowing distinction between innovator and generics companies.

Endo began its modern existence after being spun out of DuPont Merck in 1997, where it had been that company’s generics division. Instead of continuing in as a pure generics company, though, Endo in-licensed Lidoderm in 1998 and since then has mixed generics and innovative programs with wanton disregard for the traditional industry divide. In fact, Endo’s planning seems to be focused more on product classes than on patent status. The Qualitest purchase, for example, was framed as an expansion of their pain franchise. Another example of Endo’s non-traditional aggregation is pairing the Bioniche license for Urocidin (an innovative bladder cancer product in Phase III) with their purchase of HealthTronics (a urology services and equipment company).

As companies like Endo look to replace revenue from expiring patents, don’t expect them to do it in traditional ways or by sticking to traditional silos. Check out other examples here, or point me to others in the comments.

Biotech Trends Update — Biosimilars: FDA Meeting in November to Discuss BCPI Act Implementation

Adam Feuerstein at TheStreet.com reported this morning on a draft FDA notice for a planned November meeting on implementation of the Biologics Price Competition and Innovation Act, which was passed as part of the healthcare reform legislation.

The BPCI Act (42 U.S.C. 262(k)(8)) provides for the FDA to author guidance “with respect to the licensure of a biological product” — pretty broad, so we’ll have to stay tuned for the actual meeting notice. However, the legislation provides some hint in permitting “product class-specific guidance” specifying criteria that will be used to determine whether a biological product is highly similar to a reference product in such product class.

If the FDA decides to move ahead with product class guidance, it would likely specify the criteria that will be used to determine whether a biological product meets the standards for “interchangeability”.

In other cases, the FDA may determine that “the science and experience [to date] … with respect to a product or product class … does not allow approval of a [biosimilar] for such product or product class.”

Bottom line: following the FDA’s November meetings, biosimilars will be one step closer in the U.S.

P.S. Adam Feuerstein cites Alec Vachon (@HEALTH_NOTES) on Twitter for breaking the story Friday. Not sure why I haven’t found him before, but Alec is now added to my Biopharma-IT-Health Twitter list.

Patent Cliff Will Not Save Biotech: Abbott Buys Indian Generics Company Piramal Healthcare

I often hear how the upcoming loss of patent protection for current blockbusters creates an insatiable demand at pharma companies for new pipeline products from biotechs. Here’s an example from 2007. Here’s one from last week. This is not true. Upcoming loss of patent protection creates a insatiable demand for revenue, but new products are not the only source of new revenue.

Abbott’s $3.7 billion deal for a unit of India’s Piramal Healthcare last week is a perfect case in point. This deal, which follows Abbott’s license of a slew of products from Zydus Cadila, will feed the company’s new “established products division.” Abbott’s purchase of Solvay in February also built its emerging markets revenue, which now accounts for over 20% of the company’s business.

Abbott is far from alone: Sanofi is the biggest generics manufacturer in Latin America, Pfizer also has an established products division, Novartis is diversifying into eyecare and has long sold generics, Merck is into follow-on biologics and GSK tapped South Africa’s Aspen Pharma for emerging markets growth through branded generics. These alternatives look even better as payors worldwide are setting more demanding standards for reimbursement, the placebo effect is mysteriously strong, and personalized medicine makes clinical trials even more expensive.

My bottom line? Emerging markets and generics opportunities create plenty of growth, thank you very much, with a far lower risk profile than most product in-licenses or biotech acquisitions (even the option deals). As big pharma gets more comfortable with “established products” and biosimilars, biotechs are going to have to demonstrate even higher value. Plenty of companies are being built and funded with that in mind; but anyone counting on pharma’s desperation will be disappointed.

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Trends Update — Synthetic Biology: JCVI’s First Synthetic Cell (or, A Goat Walked Into a Lab)

World, meet "Mycoplasma mycoides JCVI-syn1.0", 1.08-Mbps of synthetic life.

Today’s issue of Science contains an article by scientists at the J. Craig Venter Institute, who have synthesized a Mycoplasma genome from scratch and transplanted it to a recipient cell. Those recipients have since reproduced using entirely the synthetic DNA.

In the quest to create novel organisms from scratch, Mycoplasma have been the tools of choice. Their small genomes suggest that they stick to the minimum genetic requirements for life (though they may contain unexpected complexity). Still, a megabase is a lot of DNA to assemble, so the JCVI gang uses a cool trick that combines long synthesized oligonucleotides by alternating between yeast and bacterial hosts to stitch the oligos into longer and longer segments. The host cells are controlled by, and exhibit the distinct characteristics of, the synthetic genome.

Venter, noting that the strain they made is a Mycoplasma that exists only in goats, is happy to illustrate the containment features:

"Unless a goat walks into the laboratory, or somebody walks out of our laboratory and injects a goat, we’re probably pretty good."

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Grand Challenges Canada to Mobilize $225 Million Over 5 Years For Global Health

A new nonprofit organization called Grand Challenges Canada has been formed to deploy the Canadian government’s $225 million Development Innovation Fund. In a fabulous marriage of theory and practice, Grand Challenges will be run by Peter Singer, who is also the Director of the McLaughlin-Rotman Centre for Global Health. It also draws on an impressive international scientific advisory board.

The program will identify and launch five “grand challenges” over a 5-year period. The first is

“to create a new class of point-of-care (POC) diagnostics that will be easy to use, low cost, multiplexed and able to assess disease stage and provide information on prognosis.”

Information on the RFP, policies and forms to apply for funding are here, and the deadline for this round of applications is July 12, 2010 at 11:59 pm EST.

Grand Challenges Canada is independent, but is being run in partnership with International Development Research Centre (IDRC), the Canadian Institutes of Health Research (CIHR), the McLaughlin-Rotman Centre for Global Health and with support from the Bill & Melinda Gates Foundation.

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BIO Panel on Comparative Effectiveness Research Notes “Silver Lining” of Personalized Medicine

Speakers Daniel Todd, from EMD Serono, and Steve LaPierre, from Boston Scientific, were led by Foley Hoag lawyer Jayson Slotnik in a discussion of the final CER legislation and predictions about implementation. The overall tone was skeptical — the panel noted the potential for CER data to ultimately contribute to CMS coverage decisions, and worried about the cost of prospective randomized trials and about potential impacts on the FDA approval process.

They were, however, optimistic about the role of personalized medicine in the CER implementation. Steve LaPierre expects it to be helpful, and Daniel Todd advocates using the reference to molecular and genetic subtypes in the legislation to push for personalized analysis if a product is selected for a CER study. He calls personalized medicine a silver lining.

The panel also noted positive structural aspects, including helpful governance provisions in the CER legislation. Specifically, they were impressed with the public reporting and audit provisions and the availability of comment periods to allow private sector input.

In looking at how CER will shake out, the panel expected progressive adaptation of the program over the next 3-7 years.

Daniel Todd emphasized the importance of picking a first recommendation to establish credibility. The controversy this year about breast cancer screening recommendations shows the loss of credibility that can come from a debatable result, so they expect CER to ramp up over time.

He also predicted that dissemination of CER results through social media may drive bottom-up adoption of findings, and that defensive medicine may also contribute to adoption.

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Biotech Trends Update: Non-Dilutive Financing and Fundraising by Partnering with Nonprofits

As noted in the lead up to BIO, several of the conference sessions touch on industry trends we’ve been following here on the blog. One of these was today’s session entitled “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits,” which we’ve been following as commercialization by non-profit foundations. Our coverage of that trend started off focusing on the financial advantages to companies of finding a commercialization-minded nonprofit partner, but recently we’ve also noted the strategic advantages of these collaborations.

At today’s panel discussion, Genzyme’s Jim Geraghty added to the list of strategic advantages of nonprofit collaborations, echoing Avila’s CEO Katrine Bosely who recently acknowledged the value of the Leukemia and Lymphoma Society’s network of clinician and patient relationships. Geraghty added:

  • access to scientific data that may have benefits to other company programs; and
  • relationships with governments and other clinical gatekeepers.

Most interestingly, Geraghty noted the contribution that nonprofit collaborations can make to employee goodwill and morale in an environment where pursuit of profit can run contrary to the norms that attracted employees to the field of biotechnology in the first place.

The panel also drove home the enormous role the Bill & Melinda Gates Foundation has played in changing the way nonprofits think of their roles in health. Gina Rabinovich from the Foundation was unwavering in stating their commitment not to publications or conference output, but to measurable health outcomes like reducing infant mortality. Kudos.

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Biotech Trends at BIO 2010

As I’m preparing for the BIO conference in Chicago next week, I’m excited to see that several of the biotech trends we’ve been following on the blog are showing up as conference sessions.

  • Interested in “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits”? Get an early start at our trends page on Commercialization by non-profit foundations!
  • Does “Comparative Effectiveness Research and the Government Role” or “Transforming Health Care Through Personalized Medicine” catch your eye? Check out the stories we’ve highlighted on Comparative Effectiveness and Personalized Medicine!
  • Of course, with the new regulatory pathway created by Health Reform legislation in the U.S., Follow-on Biologics (aka Biosimilars) are all the rage at BIO this year.
  • and the whole thing kicks off with Lilly’s General Counsel speaking on “Leveraging IP to Spur Global Biotechnology Innovation, Investment and Jobs” – emphsizing the link between IP Constituencies and Global Innovation that we have been following for some time.

Stay tuned for news from these and other sessions as we hit the conference next week!

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Biotech Trends Update — Commercialization by Foundations: Lymphoma and Leukaemia Society’s Preclinical Program Has Advantages for Companies

In my first post noting the trend of non-profit foundations stepping in to support commercial projects, I held out the  Leukemia & Lymphoma Society (LLS)’s Therapy Acceleration Program as a key example.

LLS recently made another investment from that program, giving $3.2 million to get Avila Therapeutics’ AVL-292 into trials for B-cell cancers (pdf).  In writing about this trend originally, I had emphasized the value for the recipeint companies of a non-dilutive investment in a difficult funding environment; but John Carroll’s article at FierceBiotech on the LLS-Avila deal notes another key advantage of these collaborations:

“The LLS offers a developer like Avila other strategic advantages, says [Avila’s CEO Katrine] Bosley. The society doesn’t just support patients, it also has ‘a network of relationships with clinical investigators.’ The LLS can help make introductions between the biotech and the investigators who can provide important insights on clinical trial protocols.”

The advantage for LLS? As Louis DeGennaro, Ph.D., LLS’s chief mission officer, says:

“Last year we had three partnerships, each of which triggered a clinical trial of an agent that would not have been tested in blood cancers if not for our dollars.”

A win-win situation that you can expect to see more of.

Biotech Trends Update — Social Media for Biotechs: Building Momentum Toward Critical Mass

In December, I wrote a post listing the top 3 reasons biotech companies should use social media and noted that we would be following adoption and use of social media by biotechs as one of our Trends in 2010.

The 2010 Dose of Digital Dosie Awards held voting for finalists this week, including for Best Facebook Page, Best YouTube Channel, Best Twitter Feed and Best Blog (in a number of categories).  The pharma and healthcare social media wiki that Dose of Digital maintains is a growing list, but still doesn’t include very many biotech companies. 

So, why haven’t we seen more social media among biotechs? 

Is it fear of FDA admonishment?  This blog post/video clip from Future of Pharma spends some time blaming the FDA’s evolving social media policy.  If the FDA were the problem, though, pharma companies wouldn’t be moving into social networking either.  But they are.

Is it fear of creating reporting obligations because of casual mentions of adverse events?  Looking at one community shows that a significant number of reportable adverse events could be unearthed; but Dose of Digital doesn’t view this as a risk or an excuse for avoiding social media, and explains why here.

The real answer is simpler: the value of a social network is the network.  Until a critical mass of biotechs seed a social media presence, most other companies will not realize sufficient value in being online themselves.

The critical mass is starting to build: Michael Gilman, the Founder/CEO of Stromedix is on Twitter, as is Richard Pops, the CEO of Alkermes.  On Twitter, they interact with investors, journalists and patient communities; which points out that it’s not just a critical mass of other biotechs that creates social media value. 

For example, the HIV Vaccine Trials Network (HVTN), at Fred Hutchinson Cancer Research Center in Seattle, is running a series of ads on Facebook to recruit patients to its trials; one of their sites is using Craigslist and individual patients are reporting about their experiences with the trials on blogs and on Facebook.  The Canadian Breast Cancer Foundation and the McGill University Health Centre are also using social media for outreach.

My bottom line: social media will be an increasingly common tool for biotech companies in business development, corporate communications, patient recruitment and for employee recruitment and development.  The sooner you start the more expertise you’ll have.

Comparative Effectiveness and Personalized Medicine are “Part of the Same Question” Collins Confirms

In a very informative Kaiser Health News interview (via GenomeWeb), Francis Collins says that

“personalized medicine strategy and CER strategy are part of the same question. … There will often be more than one therapeutic intervention, so you have to compare them. But you also want to know what’s different about the individual that might have an influence on that answer.”

Couldn’t have said it better myself.

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Biotech Trends Update: A Personalized Critique of Comparative Effectiveness Misses the Mark

As the U.S. and Canada move to invest and rely more on comparative effectiveness research (CER), lack of personalization has been the loudest and most frequent objection.  That is why we have been following the interaction between comparative effectiveness and personalized medicine as a key industry trend.

Yesterday, an opinion piece in the WSJ by Leonard Zwelling, a professor of medicine and pharmacology at M.D. Anderson, came out strongly in opposition to CER.  Zwelling takes a number of swipes at CER, but most of the time he is focused on the inability of CER to personalize treatment — for a patient’s genes, age or preferences — in identifying a “best” treatment.  For example:

“If decisions based on CER inhibit the progress of personalized medicine—or in any way interfere with a meaningful interaction between doctor and patient to individually tailor the most appropriate therapy—no one is helped.”

Zwelling’s argument sets up more than a few straw men — that CER uses only retrospective data, that it will ignore qualify of life, and that treatment options change too quickly for CER to provide timely advice — but the main problem is that he assumes that CER and personalization are incompatible.

As this blog has noted on many occasions, CER is at its best when coupled with personalized medicine.  This post about KRAS genotyping is a great example.  This point is not lost on the Obama administration, which is aware of and sensitive to the need to account for personalized treatment in CER.  Zwelling himself opens with a quote from relevant legislation that says the current CER funding is supposed to find out

“what works best for which patient under what circumstances.”

The clause “for which patient” is a built-in acknowledgement of the importance of personalized approaches to CER. 

My bottom line: Both comparative effectiveness and personalized medicine are critical to medically effective and financially sustainable medical care and drug development.

Biotech Trends Update — IP Constituencies: India’s Courts Nix Drug Patents while India Courts Innovation

world_map_2002This blog has been tracking increasing innovative activity in India and China as part of our Biotech Trends series, the idea being that as innovative activity increases, the host countries will take a kinder view of property rights.

The trend toward innovation in India is undeniable — as the WSJ’s Venture Capital Blog noted recently, India even has its own version of  Y Combinator, an incubator/early-stage fund.  India also has many notable successes in pharma and biotech innovation, including Jubilant and Glenmark.

Yet, as Ronald Cass notes in a WSJ editorial, the groundswell of Indian innovation hasn’t yet worked its way up through the legal system.  Citing a Delhi High Court decision that allowed generic copies of Merck’s cancer drug Nexavar, Cass infers that India does not “want drug innovation.”

I disagree.  India does want drug innovation.  Like everyone else, India wants lucrative knowledge economy jobs.  But even with a broad desire for policy change, turning a judicial ship is a slow process in a common law jurisdiction. 

My bottom line: It will likely take time, and may take facts more sympathetic than Merck’s, to break with precedent and habit and to develop a more innovation-friendly jurisprudence in India.  Make no mistake, though, that’s the direction India is heading.  Patience, but not complacence, is the order of the day.

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Biotech Trends Update — Personalized Medicine: The Limits of Genomic Analysis

A great report on GenomeWeb yesterday by Andrea Anderson reviews two JAMA papers that failed to show a clinically useful role for SNP genetic testing in predicting heart disease risk.  Instead,

“traditional risk information based on factors such as family history and plasma biomarker levels were better for predicting heart disease.”

Anderson ties these results back to a January paper in the British Medical Journal that found that

“non-genetic factors were more useful for predicting type 2 diabetes than a set of 20 SNPs.”

The GenomeWeb article quotes the lead author of one JAMA paper as finding the results “surprising and a little disappointing;” but I am inclined to think some context is missing, since only the most die-hard genetic determinist should be either surprised or disappointed. 

Two factors suggest that these conditions, and many others, will resist accurate prediction based on genomic sequence analysis:

  1. They are genetically complex.  The prospective studies looked at data sets with between 12 and 101 SNPs.  Simple calculations suggest that the number of genetic permutations is itself staggering, never mind the physiological complexity of multigenic interactions.
  2. There are massive environmental components. Diet and exercise, among many other factors, will have a tremendous impact on clinical outcomes.  These habits are learned, not inherited, and are even “contagious” within social groupings.

My bottom line: In an age when genomic sequences are becoming increasingly accessible, it should be reassuring to know that even your medical future is not written in stone.  We always suspected as much. Now we have the genetic data to prove it.

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Biotech Trends Update — Commercialization by Foundations: $500k to AVI BioPharma from DMD Organizations

Continuing a trend by nonprofits to invest directly in commercialization of relevant products, CureDuchenne and the Foundation to Eradicate Duchenne each awarded grants of $250,000 to AVI BioPharma, Inc. (NASDAQ: AVII) to support continued research and development of the Company’s drug candidates for the treatment of Duchenne Muscular Dystrophy (DMD).

One interesting note here is the collaboration between foundations, something we also saw in an ALS project in December.   This is a great way for smaller foundations to maximize their impact on the (expensive!) drug development process.

Both foundations, run by parents of kids with DMD, are focused on commercial products:

“CureDuchenne is very happy to support AVI BioPharma as it advances these treatments to boys with DMD as soon as possible.”

“The exon-skipping strategies being developed by AVI offer the greatest prospect for meaningful clinical therapies.”

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Biotech Trends Update: Costs Savings from Personalized Medicine Sought by PBMs, Employers, Pharma Face Legal and Privacy Hurdles

When AstraZeneca announced a companion diagnostics collaboration recently, their head of oncology development said the goal was to get “the right treatment, to the right patient, the first time,” a nice turn of phrase* that is becoming a chorus in the healthcare industry.

This week, giant PBM Medco purchased DNA Direct, saying “[o]ur whole thing at Medco is to get people on the right drug the first time.”  DNA Direct uses its research on 2,000 available tests to help physicians, health insurance companies and patients understand how to use personalized medicine.  This is a good move — we said last month that education is key to expanding the personalized medicine market

AstraZeneca, Medco and other providers, employers and insurers would all like to use information on individuals’ health risks in order to reduce their costs, and as the Wall Street Journal reports, they are willing to provide incentives to their employees to mitigate those risks.  However, some of these efforts conflict with barriers put in place by the Genetic Information Nondiscrimination Act (GINA), which prohibits the intentional acquisition of genetic information about applicants and employees, and imposes strict confidentiality requirements on data that is acquired. (H/T @genomicslawyer)

In addition to legal barriers (some still being erected), AMA and other advocacy groups have also reportedly expressed concern.  I agree there is risk inherent in putting the decision of what the “right drug” is in the hands of manufacturers or payors, neither of whom is neutral in the outcome.  Medco, in particular, does not seem a neutral player here (at least based on their approach to Plavix and Effient, though I invite comments if I’m misinterpreting that study).

Still, a solution is required.  As I have been saying for over a year, personalized approaches to treatment have the potential to benefit all participants in the healthcare system, as the KRAS-Erbitux story has proven.  As Procter & Gamble said when investing in Navigenics’ funding round this week, “Personalized genetic testing can have significant meaning in helping consumers focused on prevention and wellness live better, healthier lives.” 

My bottom line:  A large part of the problem here is the low level of trust from the public, which even limits governments’ ability to act.  That’s particularly unfortunate, because government is the closest thing we have to a neutral funding source for comparative effectiveness and personalized medicine research (despite also being a payor). This is a problem much bigger than just personalized medicine, but until trust is restored, valuable cost savings and health benefits will go unrealized.

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* A concept I’ve been trying to call “personalized effectiveness” — tell your friends.

Biotech Trends Update: Teva’s BLA for Neupoval is Accepted at the FDA

Teva’s decision last year to submit a full biologic license application (BLA) for Neupoval looks positively prescient today.  Teva’s product is already sold in the EU as a biosimilar to Amgen’s Neupogen, but a U.S. biosimilars pathway is stalled along with the rest of health reform and today, the FDA accepted Teva’s BLA, clearing the way for a review of Teva’s clinical data and potentially for approval of the product.

FDA approval isn’t Teva’s only hurdle, though.  Amgen’s U.S. patents on Neupogen don’t expire until 2013, and the two companies are currently litigating the issue of whether Teva’s product infringes those patents.  Furthermore, the Dow Jones article quotes Credit Suisse analyst Michael Aberman who points out that in the EU Teva’s product only has 5% market share, competing against both the original Neupogen and Amgen’s longer-acting Neulasta.

Investors’ reaction? Teva shares were up 1.4 percent, Amgen shares were off minutely.

My bottom line: If you want to read tea-leaves to predict the approach other biosimilar products will take (and I do), watch the Neupoval BLA closely.  The calculus undertaken by other potential market entrants will weigh Teva’s success and costs with this approach against the costs of any Congressional requirement for data exclusivity period and any FDA requirement for clinical trials in an eventual biosimilars regime.

Follow our coverage of North American biosimilars news on this Biotech Trends in 2010 page.

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Biotech Trends Update: Jubilant’s R&D Success Continues Drive Toward Innovation in Asia

world_map_2002One of the biotech trends we’re following in 2010 is the increasing innovative activity in India and China.  Both are booming not only as low cost manufacturing centers but also as innovative hubs adding R&D expertise and specialized know-how.

This week, the Indian company Jubilant and Endo Pharmaceuticals announced that they are expanding thier partnership following early and rapid success by Jubliant’s team.  Jubilant has been developing pre-clinical candidates for Endo’s oncology pipeline.  As Endo’s R&D VP says, they are executing on a “strategy of building Endo’s pipeline using a virtual discovery approach” as a complement to their in-licensing strategy.

Jubilant has been running with these types of “virtual discovery” deals, including its collaboration with AstraZeneca that we noted at the time (even as AZ is shedding in-house capacity today), a successful partnership with Lilly and tie-ups with academic institutions including Duke University and UAB.

FierceBiotech reports that Biocon’s Kiran Mazumdar-Shaw predicts a $5 billion Indian biotech business in 2011 that will “double to $10 billion by 2015″ based on “opportunities in clinical trials, manufacturing and more.” 

The greater the contribution R&D makes to India’s growth, the better positioned the country (and the region) will be in the coming years to lead the global industry forward.

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Biotech Trends Update — Personalized Medicine: The Case for Diagnostics Focuses on Cost and Effectiveness

A report in FierceBiotech today distilled the views of three life science VCs on trends to watch in 2010.  Along with other worthwhile observations (and I’d encourage you to read the whole thing) was this bullet pointing out the value of personalized medicine in addressing comparative effectiveness concerns:

“Interest in molecular diagnostics is heating up. It’s one of the most attractive areas because physicians are increasingly demanding test that can tell them which treatments have the best chance of working before expensive medicines are issued. And diagnostics fit well with the healthcare reform efforts. Bloch adds that any technology that improves the efficacy of how care is delivered will be attractive to investors.”

The business case is eminently obvious.  Earlier this week AstraZeneca announced a collaboration with Dako Denmark A/S that will see Dako developing companion diagnostics for products in AstraZeneca’s oncology pipeline.  Key quotes from the announcement highlight the companies’ focus on “health care costs” and “reimbursable products”:

“Targeted treatment with personalized medicine is the future, and … is also a significant contributive factor in cutting health care costs” (Dako CEO)

“This agreement … will enable us to develop novel, reimbursable products that … predict which patients are most likely to respond to treatment, ensuring that we are giving the right treatment, to the right patient, the first time.” (AZ Head of Oncology Development)

The economic case for personalized medicine was one of this blog’s top biotech trends in 2009 and looks to continue at a strong pace through 2010.  To reach its full potential, though, the industry will have to convince policy makers and clinicians that personalized medicine can live up to its promise.

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Biotech Trends Update — Commercialization by Foundations: JDRF, J&J and DexCom Collaborate on Artificial Pancreas

One of the industry trends we’re following in 2010 is the increasing commercialization activity by non-profit foundations. The Juvenile Diabetes Research Foundation has been taking active and creative approaches to funding treatments for their constituents.  Last month, JDRF in Canada partnered with a government funding agency to create a clinical trials network in Ontario; and today, an AP story at PharmPro reports that JDRF in the U.S. is bringing together two corporate partners to develop an artificial pancreas.

JDRF has been funding work on an artifical pancreas since about 2006; but this latest initiative moves the focus over to commercialization

Johnson & Johnson’s Animas Corp. unit (responsible for insulin pumps), and glucose monitor maker DexCom will work together on a device about the size of a cell phone that would be worn outside the body, with initial patient testing potentially beginning in less than a year.

JDRF is putting $8 million towards the project over the next three years, but they did not disclose either the amounts of the corporate commitments or the allocation of revenues from the project.

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Biotech Trends Update — IP Constituencies: Innovators and Generics Continue to Blur Pharma Lines

Two stories noted by the WSJ’s Health Blog highlight the trend we’ve been following of blurring lines between branded/innovator pharma and generics companies:

The biggest development I’d cite is Pfizer’s deal to sell 40 generics made by India’s Strides Arcolab and South Africa’s Aspen.  This deal seems to go a step farther than other innovator/branded deals with generics in that it treads on U.S. soil.  The Pfizer Established Products Business Unit has in-licensed more than 200 products and has an overall portfolio of approximately 600.

“Generics” companies are not sticking to their traditional role either.  Noting Teva’s projected growth and market cap, Jacob Goldstein says that “[i]t’s no longer correct to think of generics manufacturers as scrappy little competitors nipping at the heels of big pharma,” especially where 30% of their revenue comes from branded drugs. 

Add those to increasing innovation in India and China and in collaborations with companies there, and the whole global industry is starting to look a bit more homogeneous.

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Biotech Trends Update — Personalized Medicine: A Big Market, If We Can Just Figure Out How to Get People to Use It

Late last year, a PwC report made the rounds with a big headline number — $232 billion — as the size of the personalized medicine market.  FierceBiotech called it a “tipping point,” for personalized medicine.  George Church called us “the first genomic generation” in Newsweek, and Francis Collins’ new book “offers practical advice on how to utilize these discoveries for you and your family’s current and future health and well-being” (at least according to its publisher).

And this isn’t just idle speculation, it’s being reflected in real investments. Cancer Research UK, the Medical Research Council, University College London, and the Wellcome Trust are developing a £500 million new home for their partnership, called the UK Centre for Medical Research and Innovation (UKCMRI), where “genomic technologies will play a key role in the array of research its partners plan to pursue there.”

However, there are real challenges to realizing the 11% annual growth rate PwC predicts.

  1. Health care providers need to learn a whole new language and a whole new set of tools and approaches.  A new year-long project at Valparaiso University aims to meet the new criteria of the nursing curriculum essentials in genetics that are set by the American Association of Colleges of Nursing (AACN), but this is just the tip of the iceberg. (h/t @mikesgene)
  2. Even when health care providers are educated, it doesn’t mean that the market will grow.  For example, there is high awareness (80-90%) of a new genetic test designed to reveal a breast cancer patient’s sensitivity to tamoxifen.  However, according to research from Duke University Medical Center, “[a] greater awareness of the emerging data for this new test corresponded to less likelihood of ordering the test and lower likelihood of changing practice based on test results.” (emphasis added) (h/t @DukeIGSP)
  3. The Genetic Information Nondiscrimiation Act loopholes are still intimidating.  GINA does not expressly cover long-term care and other types of insurance and is focused to some extent on prohibitions on requiring genetic tests (which will be moot when everyone’s full genome is sequenced).  Some efforts to remedy or mitigate GINA loopholes are underway, including:

    However, many patients (and, anecdotally, everyone in the insurance industry) are vociferously refusing genetic testing and sequencing.

  4. FierceBiotech notes that the PwC report itself identifies another caveat: “Big Pharma will have to bury its blockbuster business model in favor of a more “collaborative model.”

My bottom line:  Those who are counting on seeing the growth predicted by PwC will have to make an unprecedented investment in educational and regulatory changes to sychronize with the unquestionably giant strides in product innovation that are occuring daily.

For more on personalized medicine, check out the Biotech Trends in 2010 page.

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Trends Update — Social Media: Upopolis Keeps SickKids’ Patients Connected

One of the fantastic uses for social media in healthcare (a trend we will be following this coming year) is to connect communities of patients to each other and to their friends and families when those connections would be difficult to make or maintain IRL (in real life). 

The Hospital for Sick Children (SickKids) in Toronto started up an initiative to do just that, with the added twist that it’s built entirely for young patients.  It offers  personal profiles, personal blogs, instant chat and child-friendly games, and as spokesperson/nephrotic syndrome patient Zachary Starkman says:

“When I’m here for long periods and I’m not able to get to Marnie’s Lounge (the patient recreation room at SickKids) and chat with my friends, I feel isolated, lonely… This will really help me feel connected with everyone.”

The SickKids network is called/run by Upopolis.  It was founded by Christina Papaevangelou, who watched the struggles of her friend Katy McDonald when she was treated for cancer in 2002.  The network was developed by Kids’ Health Links Foundation, in partnership with TELUS and McMaster Children’s Hospital and runs as a SaaS solution hosted by TELUS.

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Trends Update — Electronic Medical Records: Importance of Telemedicine, Implementation and Data Security

Since the Canadian and U.S. stimuli directed fuding towards electronic medical records (EMR), we’ve been following developments in the area as part of our Biotech Trends series here on the blog and have noted successes and failures.  A few recent stories highlight risks and benefits:

A recent Scientific American story (H/T @mikesgene) turned an analytical eye on the University of Pittsburgh Medical Center‘s implementation, the current iteration of which started in 2004.  Case studies have been an important part of the EMR narrative, and many so far have focused on Kaiser Permanente’s implementation, which is the world’s largest civilian system, so it’s nice to see an in-depth analysis of a different experience.  The article closes with a quote from  National Institute of Standards and Technology (NIST) Director Patrick Gallagher, who says the stimulus effort

“is about using technology to bring health care information together to reduce medical error, reduce the need for testing, put information in front of patients, and put information in front of researchers.”

A FierceHealthIT story reported on an initiative by the American Telemedicine Association, which is running a demonstration program with DocTalker Family Medicine.  DocTalker, founded by Dr. Alan Dappen (partnered with @drval) is providing remote health services to Association members and employees.  It’s being pitched as an employee benefit that can promote worker health and productivity by reducing the need for office visits and providing round-the-clock responsiveness. 

Telemedicine’s role in EMR also features in this story about a pacemaker developed by St. Jude Medical that allows patients and doctors at the Montreal Heart Institute to get data and alerts from the device, which also transmits cumulative data to the doctors in advance of patients’ follow-up visits.

With all of these electronic data floating around, security is key, but it remains an elusive target.  Dan Vorhaus tweeted about a ModernHealthCare.com article that highlights numerous security breaches this Fall.  Microsoft’s purchase this week of Sentillion, which focuses on EMR security, was for an undisclosed sum but you can bet it’s key to Microsoft’s EMR strategy.

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