Biotech Marketing | Biotech Strategy Blog

Biotech Strategy Blog now available on Kindle

By Pieter Droppert on October 17, 2011

For those readers who would like to access Biotech Strategy Blog on their Kindle, this is a quick post to let you know it is now available on the Amazon Kindle Store for $0.99/month. You can also continue to read it for free on the web.

Of course, after Amazon takes its cut there is a (very) small royalty fee that ends up coming my way, so I have vested self-interest in promoting this. However, it’s not something I anticipate getting rich from!

In a world of multi-channel marketing, it is good to try out new ideas that may make it easier for people to access content and information.

BIO 2011 International Convention Video Review #BIO2011

Although I had to leave BIO 2011 early due to illness, I did shoot some video during the time I was at the meeting, and have now put this together into a short 2 minute video that you can watch below.

This post wraps up my coverage of the 2011 BIO international convention in Washington DC. Next week, I’ll be writing more about innovative science and new products in the pipeline that have caught my attention.

A happy holiday weekend to everyone in North America.

http://www.youtube.com/watch?v=hM_wmjaqDyc

Avastin for Breast Cancer is not Personalized Medicine

By Pieter Droppert on June 30, 2011

Bevacizumab (Avastin®) should be withdrawn for metastatic breast cancer. That is the unequivocal recommendation of the Oncology Drugs Advisory Committee (ODAC) yesterday.

Despite the passionate patient advocacy in favor of continued approval, withdrawal is the right decision and it is hard to see the FDA overruling ODAC, given the safety issues such as bowel perforations and relative lack of efficacy. The patient advocacy at this week’s public hearing was fundamentally biased, those who died early and who received no treatment benefit are not alive to stand up and share their experiences.

The bottom line is that Genentech were unable to identify the sub-set of patients who might benefit from the drug. They simply did not have the data, and the reality is that treating all potential HER2- patients in the hope of finding the few who might respond is not a rational drug development or marketing strategy, especially when those that don’t respond may do worse on the drug.

Personalized medicine requires a thorough understanding of the science and molecular biology of a disease. Pfizer recently showed an excellent example of this with crizotinib that targets ALK mutations in non small cell lung cancer (NSCLC).

It is disappointing that a scientifically orientated company such as Genentech would continue to try and push Avastin in Breast Cancer when the data is clearly unconvincing to ODAC. But, if we look at how Genentech approached the Lucentis v Off-label Avastin issue in AMD, with a 40x higher cost for using Lucentis, then what we see is that commercial decisions, and maximization of profit has become more important than doing what’s right for patients.

BIO 2011 Presentation Personalized Medicine Payment Sessions

This is a flawed long-term strategy in my opinion. Society cannot afford to pay for treatments that don’t work in many patients or pay for treatments that are excessively priced. We are already seeing “pay for results” being introduced in Europe, notably England and Italy where payors are reimbursing companies only for those patients that respond.

Personalized medicine is the future. This requires targeted therapies that are aimed at patients who we can predict will have a good chance of responding based on our understanding of mutations, molecular biology and biomarkers.

Avastin in metastatic breast cancer is not an example of personalized medicine and should be withdrawn from the market for this indication.

BIO 2011 Network till you drop #BIO2011

By Pieter Droppert on June 28, 2011

Everyone at BIO 2011, the annual international convention of the Biotechnology Industry Organization (BIO) is into networking. Sit next to someone on one of the shuttle buses, in a coffee line or in a meeting hall and a conversation will soon be struck up and business cards exchanged. Business development, partnering and making connections is what this meeting is really about.

With this in mind, there’s a series of receptions, parties and events that take place around BIO. Yesterday late afternoon, I attended a reception on the Kalmar Nyckel, AKA the Delaware Boat. It is a replica of the tall ship that sailed from Sweden to the New World in 1638, and landed 24 settlers in the Delaware Valley, in what is today Wilmington, DE. Today’s replica serves as Delaware’s goodwill ambassador. Hosting a reception on a boat made a change from the standard hotel ballroom.

In the evening the official BIO reception took place at the Newseum. Plenty of food, drinks and music, plus the opportunity to mix, mingle and explore the Newseum. I enjoyed it! You could even try your hand at being a newscaster at one of the interactive exhibits.

This evening I will be at the New Zealand and Italian Embassies for receptions. BIO 2011 – network till you drop!

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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Webcasts of EHA Education Sessions are well worth watching

By Pieter Droppert on June 14, 2011

At the 16^th Congress of the European Hematology Association (EHA) that was held in London this past weekend, the educational sessions were extremely well attended.

The reason for this was the quality of the thought leaders who presented on science and emerging treatments.

The quality of the education sessions and the fact they are repeated twice, so you can avoid schedule clashes, is one of the things I particularly like about both the American Society of Hematology (ASH) and European Hematology Association (EHA) annual meetings.

As I have written before while at EAU in Vienna , I’m not a fan of promotional satellite symposia. As an example on the Thursday before EHA, attendees interested in CML could attend the Novartis symposia in the morning about how nilotinib was better than imatinib, then in the afternoon attend the BMS sponsored symposia to hear how dasatinib was also better than imatinib. Indeed, two of the speakers were identical in both symposia, but with entirely different messages.

Two other satellite symposia also had speakers talking about second-generation tyrosine kinase inhibitors. What, of course, was on everyone’s mind was when to use one second-generation TKI over the other? Also given that imatinib is reimbursed in many countries, while nilotinib and dasatinib are often not yet available in that setting, the issue of how to treat patients second-line with these therapies was also a hot topic.

However, just attending the individual company-sponsored symposia, to me, meant that it was hard to put together a big picture of exactly what to do when. Perhaps a better way to handle it would have been to have one CML satellite symposia sponsored by all the companies with a dog in the race (Novartis, BMS, Ariad, Pfizer). We might have heard what the experts really thought that way. 🙂

The other issue that arose during the meeting is how data is presented when looking strategically at one treatment or trial to another in the same indication. Are you truly comparing apples with oranges?

M Baccarani European Hematology Association Congress London 2011 As Professor Michele Baccarani pointed out, there is a big difference between data that shows a cytogenetic or molecular response “BY” a certain time as compared to “AT” a certain time.

“BY” can include patients who had a response then went in remission, so could present a higher number than “AT” data that shows only those patients who have a response at that cut-off date. This is an important distinction, for example, when comparing data from the BMS DASISION trial and Novartis ENESTnd trials to long-term survival data for imatinib versus interferon-alpha from the IRIS trial.

So, it was left to the EHA education symposia to provide some practical guidance. In an excellent presentation, Hagop Kantarjian M.D. from MD Anderson provocatively presented his CML treatment guidelines, and discussed when you would use one drug over the other along with the importance of routine monitoring to evaluate how well a patient was doing on therapy.

Webcasts from the EHA education sessions will be available online soon and are well worth watching if you were unable to be in London this past weekend.

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!

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:

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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