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BIO 2011: Ernst & Young Global Biotechnology Report 2011

One of the “Super Sessions” at the forthcoming 2011 Biotechnology Industry Organization (BIO) international convention is a presentation of the highlights of Ernst & Young’s 25^th Annual Biotechnology Industry Report.

The 97 page report, available online, offers a useful summary of metrics around financing, deals and sector performance.

As the report notes, one of the key issues that biotech companies continue to face is access to funding in order to sustain innovation. Many biotechnology executives I spoke to at the recent American Society of Clinical Oncology (ASCO) meeting in Chicago confirmed how difficult access to capital remained.

The E&Y report confirms this anecdotal evidence. In their report they note that the 80/20 rule that we are all familiar with applied to biotechnology funding in 2010, with 20% of US companies obtaining 82.6% of the capital!

Given this ratio, it’s not hard to see why so many small biotech companies have struggled for funds. However, what would have been more interesting to learn about is what were the characteristics of the 20% that led them to successfully obtain more than 80% of the funding? In other words what are the learnings for emerging biotech companies seeking capital?

The report also notes that biotech’s share of available VC funding fell from 18% in 2009 to 12.2% in 2010, as VC’s invested in other market segments such as media and technology. One only has to look at the recent market interest in LinkedIn to see that investing in web 2.0 companies is back in fashion again, although with the subsequent share price drop it might be considered to be a little akin to Tulip mania.

Another key funding point that the E&Y report picks up on, is that many VC’s now invest in tranches with milestone or contingency based payments. The result of this “risk sharing” is a lowering of available working capital. The consequence for biotech companies is that less upfront R&D investments can be made. Instead they may be forced to go after fewer indications and not pursue all available opportunities.

Ernst & Young also interviewed several biotech CEOs about how they planned to sustain innovation, and two strategies emerged:

Prove that what you are doing benefits patient outcome
Do more with less i.e. improve efficiency

They are not mutually exclusive, and as the report points out, these are the challenges faced by all life science companies.

It will be interesting to see at BIO 2011 how industry executives view the current state of the biotechnology industry and how innovation can be sustained.

BIO 2011: my top 10 sessions at the BIO International convention in Washington DC

I am excited to be attending, for the first time, the Biotechnology Industry Organization (BIO) international convention that takes place in Washington DC in just over a week’s time from Monday June 27 to Thursday, June 30^th.

This meeting has something for everyone interested in the biotechnology industry whether it be deal making, partnering, licensing, drug discovery or personalized medicine. There are 16 specialized tracks where industry experts provide insight and best practices.

In addition, there are numerous networking and social events plus an exhibit hall that showcases the world’s biotech regions and how they are promoting innovation.

At meetings where there are parallel sessions, I apply “the law of two feet” (thanks to Podcamp for this) that says if you are not getting what you want from the session, it’s OK to walk out and go to another one.

My top 10 sessions at BIO reflect my personal interests in innovation, science and new product development:

Tuesday June 28

How will we afford Personalized Medicines?
The Biomarkers Consortium: Facilitating the Development and Qualification of Biological Markers
Personalized Oncology: The emergence of Personalized Medicine Strategies in Oncology Clinical Development and Deal Making
Navigating the New Law on Licensing Biosimilars

Wednesday June 29

Lessons from a Mature Public-Private Partnership. The Alzheimer’s Disease Neuroimaging Initiative
Emerging Markets. The Future of Growth for Biologics?
The Role of Imaging Biomarkers in Early Phase CNS Drug Development
The Promise of MicroRNA-based Therapeutics in Cancer

Thursday Jun 30

After the Fall. Venture Capital and the Biotech Funding Landscape
Regulatory Issues for Tissue Engineered Products

If you have plans to be at BIO 2011 do say hello after one of the sessions or receptions. You can reach me at the meeting via twitter (@3NT). See you in DC!

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Prostate Cancer Market to expand from $1B to $5B by 2015

The market for prostate cancer therapies is set to expand from $1 billion currently to $5 billion by 2015, according to analysts reported by this morning’s Washington Post/Bloomberg news. This is perhaps no surprise given the recent approval of abiraterone acetate (Zytiga®) from Ortho Biotech (JNJ).

New clinical data on prostate cancer clinical trial results is expected at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago this weekend from many of the prostate cancer therapies in development such as MDV3100, TAK700, ARN-509, cabozantinib (XL184), ipilimumab, custirsen (OGX-11), BPX-101, alpharadin, denosumab (Xgeva®) and Prostvac-VF.

Indeed, one could argue that prostate cancer is becoming a competitive marketplace. Any emerging biotechnology company that is not already developing a prostate cancer drug is likely to find it a hard market in which to create a blockbuster. By the time any drug comes to market, there will be incumbents with effective products who have captured market share.

Prostate cancer is an exciting market to watch from a marketing strategy and patient perspective, as several companies potentially bring new products to market over the next few years.

However, the bottom line is that patients will live longer as a result of all the innovation that is taking place. Not only that but physician education and awareness of how to treat this disease is also likely to improve as they seek out knowledge on new therapies and treatments. This to many will make a major difference. At the recent American Urological Association (AUA) annual meeting, the sessions on treatment of prostate cancer were standing room only. There is clearly a demand for knowledge out there as the treatment paradigms change.

At the other end of the spectrum, there is also innovation taking place in terms of improved diagnosis and treatment of prostate cancer. Whether we should screen all men for PSA remains a controversial topic, although use of risk calculators do appear to offer less false positives. Indeed, calculating risk is going to be one of the key areas that primary care physicians and urologists need to focus on, particularly in the light of the PIVOT trial data that was presented at AUA, showing radical prostatectomy (with risks including incontinence and erectile dysfunction) was not better than watchful waiting in low-risk, early stage disease.

However, a presentation I am looking forward to at ASCO 2011 is on circulating tumor cells (CTC) and whether these can be a prognostic or even a predictive biomarker. Both the phase III MDV3100 and abiraterone acetate clinical trials captured CTC data. It will be exciting news at ASCO 2011 if circulating tumor cells that require only a blood sample offer an improvement over PSA not only for detection of prostate cancer, but in monitoring the disease over time.

I will be at ASCO 2011 this weekend, and look forward to writing more on prostate cancer from the conference!

How people are using social media to find health information

By Pieter Droppert on May 12, 2011

The findings from a telephone survey of 3001 adults show that social media and the internet are increasingly important for finding health information.

This has important implications for the marketing professionals in the biotechnology and pharmaceutical industries who struggle to come to grips with social media in the absence of any FDA guidance.

The Pew Internet & American Life Project published today their survey on “The Social Life of Health Information, 2011.” It makes for interesting reading. Some of the statistics I found of interest, relating to the United States, include:

74% of adults use the internet
59% of adults (80% of internet users) have looked for online health information around a disease or major health topic
25% of adults (34% of internet users) have read someone else’s commentary or experience about a health issue on an online news group, website or blog
19% of adults (25% of internet users) have watched an online video about health or medical topics (See my previous post on using social media such as video to recruit for clinical trials)
13% of adults (18% of internet users) have consulted online reviews of particular drugs or medical treatments

As this insightful report notes, “people use online social tools to gather information, share stories, and discuss concerns.”

Pharmaceutical and biotechnology companies will have to come to terms with addressing the increasing desire of patients for information, presented in a way that is fair balanced and non-promotional.

The power of social media to potentially change the paradigm of how medical data is gathered was also highlighted in the recent paper published in Nature Biotechnology.

This paper presented an analysis of data collected on the website PatientsLikeMe for those suffering from amyotrophic lateral sclerosis (ALS). While such data will never replace a randomized, blinded drug study, I think that patient community data could have a role to play in areas around Quality of Life (QoL) assessments and post-marketing surveillance.

Increased fast internet access is driving social media and the demand for quality health information. This trend is only set to continue.

Wicks, P., Vaughan, T., Massagli, M., & Heywood, J. (2011). Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm Nature Biotechnology, 29 (5), 411-414 DOI: 10.1038/nbt.1837

American Urological Association Annual Meeting 2011 Satellite Symposia

By Pieter Droppert on May 12, 2011

I am off to Washington DC tomorrow for the annual meeting of the American Urological Association (AUA).

If you are not able to attend, then you can follow the Twitter coverage on Pharma Strategy Blog where Sally Church (@MaverickNY) will be aggregating the tweets. The conference hashtag is #AUA2011. I also expect to be live-tweeting from the conference.

Like many medical conferences in the United States, the AUA meeting kicks off with independent continuing medical education (CME) satellite symposia on topics of interest.

As a lawyer who has to pay for his own continuing legal education (CLE) credits, I have to confess that I am somewhat cynical that other professionals such as physicians expect to have their CME paid for through free industry-sponsored events. These symposia are certainly not cheap to run.

However, compared with Europe, CME events in the United States are usually well-produced and fair balanced, albeit with a topical theme that obviously relates to the sponsor’s interest.

The two satellite symposia that I will be attending at AUA are Friday evening’s Amgen supported “Managing Skeletal-Related Events in Patients with Prostate Cancer” and the Saturday morning Astellas/Medivation supported “Reason for Hope: Key Advances in the Management of Castration-Resistant Prostate Cancer.”

While at Quintiles, I was lead CRA/European Project Manager for the phase III trial trial of risedronate in elderly women at risk of hip fracture, so I am interested in bone related treatments, and am looking forward to hearing more about denosumab (Xgeva®) and its impact on skeletal related events (SRE).

Oliver Sartor (Tulane) raises some excellent questions in a recent paper published in the Asian Journal of Andrology, “if a patient has a SRE, does it affect the way a patient feels, functions or survives?”

Sartor argues that a better definition of the benefit a drug has on SRE’s would be “a reduction in pain, analgesic consumption or improvement in quality of life (QoL)” instead of the current “feel, function or survive” standard.

He notes that patients with bone-metastatic castrate resistant prostate cancer (CRPC) have a limited life expectancy, so that QoL is a key issue. “An asymptomatic event linked to a future adverse event is less meaningful in a patient with metastatic CRPC.”

Sartor concluded his paper by saying:

“The lack of effect of bisphosphonates or denosumab on patient-reported outcomes including QoL, pain or analgesic consumption continues to be a disappointment for this entire field.”

When we talk about a reduction in SRE’s what does this really mean for the patient? I look forward to hearing what the expert panel at Friday evening’s symposia on this topic and hope it will be addressed.

Moving on to the other satellite symposium, supported by Medivation/Astellas, that I will be attending early on Saturday morning. I expect this symposium will focus on new drugs in the pipeline such as MDV3011 and ARN-509 that target the androgen receptor. Hopefully they will also discuss other therapeutics, such as the recently approved abiraterone acetate (Zytiga®), as well TAK-700, which has a similar mechanism of action to abiraterone, i.e. they both inhibit CYP17 and testosterone production.

I’m looking forward to hearing what the expert panel has to say about the need to take prednisone with abiraterone, and whether there are any issues surrounding long-term usage if abiraterone ends up being used earlier in the pre-chemotherapy setting. Updated data from the COU-AA-301 trial will be presented at AUA on Monday, and I expect a lot of interest from urologists in this.

The satellite symposia are set to be a good warm up act to the start of the main AUA meeting that runs from May 14 to 19 in Washington DC. I’ll be writing more from the AUA 2011 over the next few days.

Sartor, O. (2011). Denosumab in bone-metastatic prostate cancer: known effects on skeletal-related events but unknown effects on quality of life Asian Journal of Andrology DOI: 10.1038/aja.2011.33

BayBio 2011 Annual Conference on Powering Global Innovation

Today and tomorrow, Northern California’s Life Science organization BayBio has their annual meeting. Entitled ‘Powering Global Innovation” it’s a meeting that covers a lot of ground from deal making to partnering, emerging markets and company presentations.

According to their website, they plan to be live streaming to their website. However, if you are interested in following the Twitter discussion (hashtag #baybio2011), you can do so using the aggregator below – just click on the play button to see the tweets:

Biodegradable nanoparticles may be a new treatment to combat MRSA infections

Nanotechnology is leading to innovation in drug delivery, and new ways to treat diseases.

In an April 3, 2011 online article in Nature Chemistry, researchers from the IBM Almaden Research Center, Institute of Bioengineering and Nanotechnology in Singapore and Zhejiang University in China publish groundbreaking data on how biodegradable nanoparticles could be used to treat infectious diseases such as methillicin-resistant Staphylococcus aureus (MRSA).

The research shows how nanoparticles can selectively disrupt microbial cell membranes, walls and inhibit the growth of gram-positive bacteria, MRSA and fungi.

What makes this research exciting, is that the nanoparticles did not cause haemolysis or break-up of red blood cells. The authors note that nanoparticles for the treatment of infectious diseases could be “synthesized in large quantities and at low cost” and are therefore “promising as anti-microbial drugs.”

The global market for infectious diseases was $90.4 billion in 2009 and is projected to reach $138 billion in 2014. In the United States there are now more deaths from MRSA than there are from AIDS (18,650 MRSA deaths in 2005 compared to 16,000 for AIDS according to a paper in JAMA).

With more than 94,000 MRSA infections a year in the United States, and the increasing resistance of MRSA to existing anti-microbial therapies, treatment of infectious diseases is a major public health concern. Hospital acquired MRSA infections particularly target the elderly and those vulnerable through weakened immune systems.

Innovations in nanotechnology and drug delivery, such as the one published by Nederberg, Zhang, Tan & Xu in Nature Chemistry, open the door to potential new anti-microbial therapies. It will be interesting to see how this research is commercialized and translated into new products and treatments.

Nederberg, F., Zhang, Y., Tan, J., Xu, K., Wang, H., Yang, C., Gao, S., Guo, X., Fukushima, K., Li, L., Hedrick, J., & Yang, Y. (2011). Biodegradable nanostructures with selective lysis of microbial membranes Nature Chemistry DOI: 10.1038/nchem.1012

Of Mice and Men

One of the themes of this blog is innovation in biopharmaceutical new product development. Innovation can take many forms ranging from nanotechnology based drug delivery to a novel scientific mechanism of action. The March 17, 2011 edition of Nature, highlights how innovative preclinical animal models are having an impact on drug development.

In their article on translational medicine, “Cancer lessons from mice to humans”, David Tuveson and Douglas Hanahan, describe how preclinical mouse models helped predict the recent phase III clinical trial results for sunitinib and everolimus in pancreatic neuorendocrine tumor (PNET).

The data was a major breakthrough for this disease. As Sally Church noted on Pharma Strategy Blog, sunitinib doubled the progression free survival (PFS) time and improved OS.

Tuveson and Hanahan in Nature note that “a vast number of potential anticancer drugs are currently in the pipelines of biopharmaceutical companies.” The challenge is not one of a shortage of candidates nor of potential targets, but in deciding which have most promise and where to spend valuable clinical development resources.

The authors conclude that there’s now optimism that genetically engineered mouse models may be able to mimic the progression of human cancer at the cellular and tissue levels. The mouse model of PNET (RIP-Tag2) successfully predicted that sunitinib and everolimus would be effective in treating humans.

Of course, not all human cancers can be modeled and adaptive resistance can subsequently occur in clinical trials, suggesting that preclinical models do have their limitations.

I hope we will see further innovation in mouse models of human cancer as translational medicine develops.

Tuveson, D., & Hanahan, D. (2011). Translational medicine: Cancer lessons from mice to humans Nature, 471 (7338), 316-317 DOI: 10.1038/471316a

Innovation in Nanotechnology will lead to improved drug delivery, diagnostics & imaging

Innovation in drug delivery presents opportunities for biotechnology companies, and is an area I expect we will see major leaps forward through nanotechnology.

Nanotechnology is the application of science and engineering to materials that are between 1 and 100 nanometers (nm) in size. The Environment Protection Agency (EPA) defines nanotechnology as “the creation and use of structures, devices, and systems that have novel properties and functions because of their small size.”

1nm is one-billionth of a meter. To put this in context, 1nm is one seven-thousandth of the width of a red blood cell or one eighty-thousandth of the width of a human hair. These are unimaginably small materials that are engineered to operate at the molecular and atomic level.

What’s more, there are now more than 1000+ consumer products on the market that utilize nanotechnology from the titanium particles in sunscreens to the silver contained in advanced first aid strips/plasters. Nanotechnology will impact more than $2.5 trillion of manufactured goods by 2015.

Lux Research predicts that by 2014, 16% of manufactured goods in healthcare and life sciences will include nanomaterials.

To date, the United States leads the way in the fast evolving field of nanotechnology. Between 2001 and 2010, the U.S. Government invested $12.4 billion in nanoscale science, engineering and technology through the U.S. National Nanotechnology Initiative (NNI).

The National Cancer Institute’s “NCI Alliance for Nanotechnology in Cancer” has an excellent website that outlines the potential impact of nanotechnology.

Some of the promising new cancer diagnostics and therapies based on nanotechnology include:

Positron Emission Tomography (PET) imaging agents that can be used to assess the responsiveness of tumors to chemotherapy
Chemically engineered adenovirus nanoparticle that stimulates the immune system. This is in phase 1 trials for chronic lymphocytic leukemia (CLL).
Cyclodextrin-based nanoparticle that encapsulates a small-interfering RNA (siRNA) agent that shuts down a key enzyme in cancer cells
CRLX101, a cyclodextrin-based polymer conjugated to camptothecin is in clinical trials with solid tumor patients
A nanoparticle based magnetic resonance imaging (MRI) contrast agent that binds to αvβ3-intregrin, a protein found on newly developed blood vessels associated with tumor development. This is in early clinical trials
Technology for the detection of cancer biomarkers such as prostate specific antigen (PSA)
Use of carbon nanotubes to improve colorectal cancer imaging.

Emerging companies such as Bind Biosciences are focusing on targeting cancer, inflammatory, cardiovascular diseases and infectious diseases with therapeutic nanoparticles. Their lead product BIND-014 is currently in phase 1 development.

Innovations in nanotechnology will continue to present new product opportunities for biotechnology, pharmaceutical, medical imaging and diagnostics companies, and should be on everyone’s radar.

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Allon Therapeutics announces promising preclinical results for davunetide in Parkinson’s Disease

By Pieter Droppert on February 24, 2011

Earlier this month the Michael J Fox Foundation (MJFF) announced that Vancouver based Allon Therapeutics had been able to improve motor function and brain pathology in a mouse model of Parkinson’s disease (PD).

MJFF funded this research with Allon Therapeutics. The preclinical study results are published in the Journal of Molecular and Cellular Neuroscience.

What makes this data interesting is that it adds further support to the potential efficacy of the company’s lead product, davunetide, in a wide range of neurodegenerative disorders.

Davunetide (AL-108) is a microtubule-interacting peptide based on an eight amino acid sequence, Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln, single letter code NAPVSIPQ (NAP) derived from activity-dependent neuroprotective protein (ADNP). It has been shown to have neuroprotective properties.

Davunetide can be administered by IV or intranasally and crosses the blood/brain barrier. It is effective at promoting neurite growth, restoring transmission between nerve cells and untangling some of the damage seen in neurodegenerative disorders such as Alzheimer’s disease. References to the scientific publications and mechanism of action can be found on the Allon Therapeutics website.

Currently it is being developed for Alzheimer’s disease (AD), schizophrenia cognitive impairment and frontotemporal dementia (FTD). Davunetide is in a phase 3 clinical trial for progressive supranuclear palsy (PSP), a subtype of FTD.

The company’s strategy is to pursue a fast-track to market in a small indication such as PSP. This is makes a lot of sense for a small biotechnology company with limited funding. Successful approval in PSP will significantly increase the value of the company and improve the terms of any future licensing/partnering deals.

The hope for davunetide is that it will prevent disease progression in disorders such as AD and provide neuroprotective prophylaxisis prior to surgery that carries a high risk of memory loss e.g. heart bypass and coronary artery graft surgery (CABG).

While davunetide may not be a cure for AD, being able to slow down disease progression is something that has considerable value. Given that new imaging biomarkers are likely to provide the opportunity to detect AD much earlier, the market opportunity for early treatment is set to increase.

Many families and caregivers would welcome a drug that delays further cognitive decline and memory loss in their loved ones.

On the basis of the promising preclinical results, I think we can expect to see further clinical research on davenutide in Parkinson’s Disease.

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