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Posts tagged ‘pharma market analysis’

AstraZeneca AZD9291 & Clovis CO-1686 race to market in NSCLC

January 24th, 2014

Daedalus

The pharma competitive landscape is a dynamic one, which is good news for marketing strategy consultants – there’s always the need for an update on competitor activity and insights into how new clinical data may impact the market opportunity for cancer new products.

A modern David versus Goliath story in cancer drug development is unfolding as Clovis Oncology race to market against AstraZeneca; both companies have drugs in early clinical development that appear effective against T790M mutated lung cancer, for which there is currently no approved treatment.

We’ve been following the story from ASCO last year where Clovis presented a poster showing initial responses with CO-1686 to ECCO in Amsterdam where AstraZeneca gave an oral presentation on initial data on their phase 1 trial of AZD9291.

The story continued around the globe at AACR-NCI-EORTC Molecular Targets meeting in Boston then the World Conference on Lung Cancer (WCLC) in Sydney.

There were more insights on CO-1686 and AZD9291 at the recent JP Morgan Healthcare conference in San Francisco.

Despite the jump in Clovis’s share price, we think that AstraZeneca is still ahead, largely due to the fact that Clovis have had to reformulate CO-1686 and only had data for 3 patients with the new formulation at the World Lung meeting in Sydney.

We think Clovis have some catching up to do and need to present more data on its safety and efficacy. This is expected at the European Lung Cancer Conference in Geneva later this quarter.

AstraZeneca, meanwhile, will be presenting the results of their phase 1/2 trial at the ASCO annual meeting.  We would be surprised if this wasn’t an oral presentation, given the impressive initial data seen so far.

What’s more, by then the company will have patients who have been on drug for over a year, so we will have some sense of the durability of response. This is critical.

Cancer drug development is not conducted in isolation, and having an accurate picture of the competitive landscape is key if you want to create an effective positioning and messaging strategy.

We’ll be following the data on CO-1686 and AZD9291 and European Lung and ASCO.

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 AstraZeneca AZD9291 & Clovis CO 1686 race to market in NSCLC

2014 is the year of Immuno-Oncology

January 17th, 2014

Daedalus

One of the hot topic of conversation amongst the VCs at the JP Morgan Healthcare conference in San Francisco this past week was the field of immuno-oncology.

As AstraZeneca CEO Pascal Soriot noted in his JPM meeting presentation, ASCO 2013 was a major tipping point in immunotherapy and the future of cancer treatment.

We have already seen significant excitement in anti-PD1/PD-L1 drugs and their early promise in melanoma, renal and lung cancers.  As Soriot noted though, the future of immunotherapy is most likely in combination with other drugs.

Pharma companies with a broad pipeline of drugs suitable for evaluating combinations will be well positioned to take advantage of this paradigm shift in the treatment of cancer.

Taking a more strategic view, however, the question is how will immuno-oncology change the treatment landscape on a broader scale?  It is possible that many drugs that are currently in front-line use may be relegated to second or third line use if immuno-oncology combinations become the preferred initial treatment option.

One big question many are asking is how durable are the responses with the new immunotherapies, whether they be checkpoint inhibitors, immune stimulants or even chimeric antigen receptor (CAR) T cell therapies?

We have seen the development of resistance in oral TKIs that showed dramatic initial responses e.g. vemurafenib in melanoma, so will patients see a wearing off effect from immunotherapies, and if so, how will the resistance manifest itself? What new strategies will be important to consider going forward?

By using drug combinations, the hope is that you can achieve greater therapeutic index and close off the escape route of resistance, leading to a longer more durable response.   Companies in this space, including Roche, BMS, Merck and AstraZeneca are beginning to explore the opportunities for novel combinations, as this latest example from Merck shows:

Clinical Trials.Gov MK 3475 Lung Cancer Combo Trial 1024x613 2014 is the year of Immuno OncologyThere’s a lot we currently don’t know, but it looks as though this field is set to get much more exciting as companies explore new frontiers rather than sit still.

We’ll soon be publishing a short report on how the strategic landscape for oncology new product development is already changing as a result of the latest developments in immuno-oncology.

We expect to hear more on where the field is going at the forthcoming annual meeting of the American Association for Cancer Research (AACR) in San Diego.

In the meantime you can read more about the latest developments in immuno-oncology on Biotech Strategy Blog. Exciting times!

Macrophage Cell Surface Protein S100A10 may be new target

November 10th, 2011

Daedalus

Sally Church, PhD on Pharma Strategy Blog has written about research on macrophage cell surface protein S100A10 and the role this plays in cancer metastasis and tumor growth.

As Sally notes, “macrophages are critical in driving tumour growth, invasion and metastasis.  Macrophages are like the Pacmen of cells…”  What a great visual metaphor!

Recently published research now shows that the macrophage cell surface protein, S100A10 plays an important role in how macrophages move to the site of tumor growth, a process that is key to tumor development and angiogenesis.

Is S100A10 a potential druggable target? You will have to read Sally’s insightful blog post to learn more.

Top posts on Biotech Strategy Blog

October 31st, 2011

Daedalus

Last week, Biotech Strategy Blog celebrated one year of publication!

Top posts on Biotech Strategy Blog Top posts on Biotech Strategy BlogTwo of the most read posts on Biotech Strategy Blog in its first year were:

  • Lucentis v Avastin CATT trial results in AMD (briefing at ARVO)
  • Prostate Cancer Intervention versus Observation (PIVOT) trial data (presented in plenary session at AUA)

You can read more on Biotech Strategy Blog about the top posts of the past year. Some of the topics Pieter Droppert has most enjoyed writing about include: radium-223 (Alpharadin) and use of nanotechnology to detect blast injuries.

We look forward to further coverage of news from medical and scientific congresses on Biotech Strategy Blog as it enters a second year.

Pieter will be at the AACR-NCI-EORTC molecular targets and cancer therapeutics meeting in San Francisco in two weeks time.

Analyzing the cost of Seattle Genetics Adcetris (brentuximab vedotin)

August 24th, 2011

Daedalus

Adcetris Logo 300x112 Analyzing the cost of Seattle Genetics Adcetris (brentuximab vedotin)Earlier this summer, the Food and Drug Administration (FDA) Oncology Drugs Advisory Committee (ODAC) announced a positive decision for Seattle Genetics’ Adcetris™ (brentuximab vedotin) in Hodgkin Lymphoma (HL) and Analplastic Large Cell Lymphoma (ALCL).

As Sally Church on Pharma Strategy Blog reported earlier this week, Seattle Genetics has just received fast track approval from the FDA for Adcetris™, a CD30-directed antibody drug-conjugate.

Using the company announced price of $13,500 per dose, Sally in her blog post analyzed the clinical trial data and treatment regimens to come up with a likely cost for a course of treatment in the range of $94,500  – $121,500.

Sally goes on to note that the “overall treatment cost will therefore be typically less than the $120K cost of treatment for BMS’s ipilimumab (Yervoy) in metastatic melanoma.

The clinical data for Adcetris™ is impressive, and patients will most certainly benefit from the availability of this new treatment.  Adcetris™ is the first antibody drug conjugate (ADC) technology to come to market.

You can read more about Sally’s analysis of the Adcetris™ price and other ADC products in the pipeline such as Roche’s T-DM1 on Pharma Strategy Blog.

What role does PTEN loss play in non-melanoma skin cancer?

August 3rd, 2011

Daedalus

Enjoying the sunshine on Miami Beach 300x225 What role does PTEN loss play in non melanoma skin cancer?At ASCO this year, there was a lot of interest in BRAF mutated melanoma, with data being presented in the plenary session on vemurafenib (PLX4032) and ipilimumab.

However, as Sally Church on Pharma Strategy Blog points out, 40% of all new cancer cases are due to non-melanoma skin cancer, with over one million diagnoses each year in the US.

Sally discusses research published in the AACR journal Cancer Research by Mei Ming and colleagues from the University of Chicago on how the tumor suppressor gene phosphatase and tensin homolog deleted from chromosome ten (PTEN) regulates UVB-induced DNA damage.

The research shows that PTEN has a key role to play in human skin cancer formation and progression with low levels of PTEN associated with slower rates of DNA repair after UVB radiation damage.

As Sally notes on her blog, “a greater understanding of the molecular mechanisms underpinning non-melanoma skin cancer potentially means that chemoprevention strategies can be developed down the road.”

You can read more about the role PTEN plays in non-melanoma skin cancer on Pharma Strategy Blog.

Metastatic Melanoma Competitor and Market Analysis

May 13th, 2011

Daedalus

One of the services that Icarus Consultants offers is to monitor competitor activity in a market, therapeutic area or pathway, and advise clients on new developments.

For those interested in metastatic melanoma, this week saw Roche/Genentech make marketing applications to the FDA in the United States and European EMEA for PLX4032 (vemurafenib) in BRAF V600E mutation-positive metastatic melanoma.

Sally Church on Pharma Strategy Blog has more about the Roche/Genentech filing, and has written extensively about BRAF inhibitors and mechanisms of resistance.

If you are interested in learning more about how Icarus Consultants can help you keep track of competitor activity in a pharma market, business or therapeutic area, please contact us.

 

Impact of healthcare reform on US pharma market

April 27th, 2011

Daedalus

Marblehead MA © Pieter Droppert 300x225 Impact of healthcare reform on US pharma marketAs marketing strategy consultants we are often called upon to look at the market opportunity in the United states for a company, a new drug or indication.

In order to do this it’s necessary to keep on top of the regulatory and reimbursement challenges that pharmaceutical and biotechnology companies face in the U.S. market.

Healthcare reform is a topic of active debate, especially with the passing of the Affordable Care Act (ACA) by Congress.  Pieter Droppert on Biotech Strategy Blog looks at what we can learn two years after healthcare reform took place in Massachusetts.

The findings are interesting, access to insurance coverage is not the same as access to healthcare, and the spiraling costs remain the biggest challenge that has to be overcome. You can read more on Biotech Strategy Blog.

The increasing importance of mouse models in drug development

March 25th, 2011

Daedalus

Mice seem to get bad PR; there’s far more people that like cats……..So in the interests of fair balance, we’d like to draw attention to the increasing importance of preclinical mouse models in cancer drug development.

Pieter Droppert on Biotech Strategy Blog discusses how innovations in translational medicine, and improved mouse models of human cancer are having a major impact on bringing new cancer drugs to market.

So, time for some good thoughts about mice (with apologies to cat lovers out there).