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Posts from the ‘Competitive Intelligence’ category

New developments in chronic lymphocytic leukemia (CLL)

By on April 7, 2009

Chronic lymphocytic leukemia (CLL) is a malignant type of cancer that involves white blood cells, or lymphocytes, in the bone marrow and then invades
the blood. 

High-power magnification of a peripheral blood...Image via Wikipedia

Approximately 15,000 people are diagnosed with the disease annually in the USA and about 5,000 will die from the disease.  CLL is distinguished from CML, which involves myeloid white blood cells instead of lymphocytes.  In both cases, one of the defining symptoms of the disease is an excess of white blood cells, either of the lymphocytes or myeloid cells.  CLL can either be an excess of T-cell or B-cell lymphocytes, although 90-95% if cases involve B-cells.

Standard treatments for CLL usually includes chemotherapy such as fludarabine, cladribine, chlorumbucil, bendamustine, cyclophosphamide, doxorubicin or vincristine. 

Several of these can be used in combination with monoclonal antibody therapy such as rituximab (Rituxan) or alemtuzumab (Campath), for example, sequential therapy using fludarabine, high-dose cyclophosphamide and rituximab.  Alemtuzumab is often reserved for patients who have not responded to other treatments.

At the recent American Society of Hematology (ASH) meeting, a number of therapies emerged as potential new agents for the treatment of CLL. 

One of these, fostamatinib, was presented in the plenary session. Friedberg described how inhibition of SYK by fostamatinib (R788, Rigel), an oral inhibitor, was well tolerated and demonstrated significant clinical activity.  Trials are also ongoing in other B-cell related diseases such as NHL and rheumatoid arthritis.  Data from the latter are expected in August/September this year and the company will seek a development partner.

Another interesting compound is ofatumumab (Arzerra), a humanised CD20 monoclonal antibody developed by Genmab and GSK similar to Genentech's rituximab.  Phase III results are expected this year in refractory disease (to fludarabine) and front-line CLL.  It is a biosimilar, but interestingly, Genmab prefer to describe it as a 'bio-better' i.e. greater potential efficacy and better safety/immunogenicity profile.  This is a bit of fluff-puff though, because the golden rule of marketing is be first to market or be better, so one would hope that follow-on drugs to market would offer some meaningful differentiation rather than just being a me-too, otherwise why bother?

A number of marketed compounds are also completing trials in CLL in a bid to expand their franchise.  These include lenalidomide (Revlimid) from Celgene, and rituximab (Rituxan) from Genentech.  Lenalidomide data in CLL was presented at ASH.   Most of the CLL patients were elderly, i.e. older than 70 at diagnosis.  The protocol looked at continuous therapy with a starting dose of 5 mg, followed by slow dose escalation.  Results showed an overall response rate of 54%, 40% had stable disease and 6% progressed on therapy.  What was interesting was that 47% achieved a complete response (CR) and 38% a partial response (PR).  Grade 3/4 adverse events included neutropenia/thrombopenia (26%). Infectious complications were seen in 3 patients.  Overall, it looks as though Revlimid may be a reasonable well tolerated and effective drug in this patient population.

Rituximab
has proven to be a very effective therapy for NHL in combination with
standard chemotherapy (R-CHOP), so there was little surprise that data
were positive in front-line and refractory CLL in combination with FC
compared to FC alone.  Although there appeared to be a slight increase
in adverse events such as febrile neutropenia, infections were
manageable and similar in both arms.

There are also a number of compounds in development for CLL that are not yet approved for any indication and most are still far too early in development (phase I or II) to determine whether they will be useful therapies yet or not.  These include ABT-263 (Abbott), cenersen (Eleos), alvocidib (sanof-aventis), ALXN-6000 (Alexion), atacicept (EMD Serono), CAL-101 (Calistoga), CAT-8015 (MedImmune), cell permeation (MaxCyte), CNF-2024 (Biogen Idec), dacetuzumab (Genentech), forodosine (BioCryst), GCS-100 (Prospect), GS-9219 (Gilead), ISF35 (Memgen), lumiliximab (Biogen Idec), MDX-1342 (Medarex), milatuzumab (Immunomedics), obatoclax (Gemin X Biotechnologies), polyphenon E (Polyphenon), PRO-131921 (Genentech), SPC-2996 (Santaris), TRU-016 (Trubion) and motexafin gadolinium (Pharmacyclics). 

Many of these small biotechs are, however, struggling to raise capital in the current economic climate and may struggle to develop the agents effectively unless they re-focus their efforts on the lead candidate.

Perhaps the most interesting compound in development is Allos Therapeutics pralatrexate, an anti-folate, which is expected to be filed for PTCL later this year under the FDA's Fast Track mechanism and is also potentially being developed in CTCL, NHL, NSCLC and transitory cell carcinoma of the urinary tract.  Succesful data in NHL may also suggest a role in CLL, since therapies that are effective in one often work in the other tumour type too because of the role of B-cells and T-cells in the disease.

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FDA panel recommends Avastin approval for Glioblastoma

By on April 1, 2009

The FDA Oncologic Drugs Advisory Committee (ODAC) met yesterday and unanimously recommended that Avastin offered benefit to patients with previously untreated Glioblastoma multiforme (GBM), a fatal form of brain cancer.  If accelerated approval is granted on May 5th, it will be the first new treatment for the disease in 10 years.

The American Cancer Society estimates that 21,810 malignant
tumors of the brain or spinal cord are diagnosed per year in the United States; approximately 10,000 of these are likely to be Glioblastoma. GBM has a tendency to recur and relapse is common.  There are few non-surgical options available to patients, so it represents an area of high unmet medical need.

What was so compelling about the Avastin data? 

According to Genentech, the non-comparative Phase II data from the BRAIN study involved 167 patients, of who 85 received treatment with Avastin in combination with irinotecan and were compared to Avastin alone in patients who had previously progressed on prior temozolomide and radiotherapy.  Primary endpoints included objective response rate and progression free survival (PFS).  Secondary endpoints included OS and safety.

"In the 85 patients treated with Avastin alone, the trial showed:
  • In 28 percent, tumors shrank to at least half their original size;
  • In those whose tumors shrank, half experienced a response of at least 5.6 months;
  • 43 percent lived six months without their disease getting worse; and
  • Half lived at least 9.3 months after starting treatment with Avastin and 38 percent survived longer than one year."

There were no new adverse events beyond those reported in previous indications for colorectal, lung and breast cancer.

There are few available treatments for patients who have relapsed after treatment with temozolomide (Temodar).  Temozolomide is approved for the first line treatment of GBM and showed significant survival of 2.5 months when used in combination with radiotherapy (RT) compared to RT alone.  It makes approx. $1B in revenues annually.  I'll be curious to see how the phase III frontline trial shapes out, what the comparator arm will be and how well patients do on upfront Avastin.  If the phase II refractory data is anything to go by, the results may look fairly promising.

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#EyeforPharma Live coverage of the Business Intelligence Summit

By on March 18, 2009

Today we will be covering the above meeting via live microblogging from Princeton, New Jersey.  It's an interesting lineup of some of the top business and competitive intelligence professionals in pharma and biotechnology.

You can follow the meeting via the widget below or join us on Twitter and contribute to the discussion remotely by ending your tweets with #eyeforpharma so we can pick up any comments and questions you may have.

Eye for Pharma, the excellent organisers of the meeting are also on Twitter as @eyeforpharma, while this contributor is @MaverickNY.

We hope to see you at the meeting or on Twitter – do join us!

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Eye for Pharma – some interesting meetings this month

By on March 10, 2009

It is a bit of a shock to realise that this is my 200th blog post and 25,000 views since the first one, how time flies!

This month sees a couple of really interesting conferences that I'll be attending, Twittering and live blogging.  Both are from Eye for Pharma.  The first one is on March 18-19th in Princeton and will cover the 2nd Global Business Intelligence Summit meeting, including areas such as drug pipelines, emerging markets and the global economic downturn.

A number of industry speakers in the competitive intelligence field will be speaking on key topics including representatives from Merck, sanofi-aventis, Amgen, Wyeth, Bayer, Genzyme and Shire among others.  It looks to be a very topical and interesting conference overall.

The second meeting I'm looking forward to covering live is also from Eye for Pharma, this time the first Oncology Summit from Boston on March 30-31.  Topics covered include a range of subjects from product commercialisation strategies, regulatory environment, reimbursement, pricing and market access.

I've already interviewed Steve Heller from Johnson & Johnson on how biomarkers can influence and add value to the new product commercialisation of cancer drugs and will be posting the interview here on the blog this week, so watch this space.

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Hot oncology drugs that may receive approval in 2009

By on February 25, 2009

There are a number of interesting cancer drugs in development that may receive approval this year.  Many of them are from biotech rather than pharma and focused on niche indications.

First up is Genzyme's Clolar (clofarabine), which was filed as a supplemental application in the US on November 24th with a request for priority approval in adult acute myeloid leukemia (AML).  Clolar is already approved for use in relapsed and refractory ALL in both the US and EU.  Data in elderly AML was also presented at the recent American Society of Hematology (ASH) meeting, with unprecedented response rates in a notoriously hard to treat group with a poor prognosis.  No doubt that data will be used to support the initial filing in the over 60 yo patients.

Another exciting compound is pralatrexate from Allos Therapeutics, which is being investigated in peripheral T-cell lymphoma (PTCL), a form of Non-Hodgkins Lymphoma (NHL).  It is also being tested in other cancers including cutaneous T-cell lymphoma (CTCL), NHL, non-small cell lung cancer (NSCLC) and transitory clear cell carcinomas of the bladder.  Pralatrexate has received orphan drug designation and
fast track designation in the U.S. for the treatment
of patients with T-cell lymphoma and orphan medicinal product designation in Europe
for the treatment of PTCL. There are currently no FDA-approved agents
for patients with PTCL, either in the
first-line or relapsed or refractory
setting. Filing is expected in the first half of 2009 in the US, with possible approval within six months, if
successful.

Both PTCL and CTCL are relatively uncommon and yet several companies are fighting a tight battle to gain early entrance to the markets and also for efficacy data.  Another drug being developed in this area is romidepsin from Gloucester Pharmaceuticals.  Post ASH, it looks as if Allos may have the advantage in PTCL and Gloucester in CTCL.  The two drugs have very different mechanisms of actions, which makes it more interesting.  Romidepsin is an HDAC inhibitor, while pralatrexate is an anti-folate compound.

Novartis' Afinitor (everlimus, RAD001) has already been submitted to the FDA for approval in renal cell cancer.  The initial indication is expected to be in patients who have failed Pfizer's Sutent or Bayer's Nexavar, but may well turn out to be the treatment of choice given the proof of concept shown by another mTor inhibitor in that cancer, Torisel from Wyeth.  Incidently, if the Wy-Pfi merger goes ahead, the company may be forced to choose from either Sutent or Torisel, given the overlap in the cancer type.

Last November, Ortho Biotech submitted a BLA for trabectedin when administered in combination with Doxil (doxorubicin
HCl liposome injection) for the treatment of women with relapsed
ovarian cancer (ROC). If approved, trabectedin combined with Doxil will
provide a new, non-platinum treatment option for these patients in the
United States.

Meanwhile, GSK are seeking an NDA for their PDGF inhibitor, pazopanib in for renal cell cancer in the US and EU, and a BLA in both the US and Europe for Arzerra (ofatumumab), a CD20 monoclonal antibody in co-development with Genmab for relapsed, refractory CLL. 

December was a busy month for submissions as Amgen also submitted a BLA denosumab, an investigational RANK Ligand inhibitor. The indications
for which Amgen is seeking FDA approval are treatment and prevention of
postmenopausal osteoporosis (PMO) in women, and treatment and
prevention of bone loss in patients undergoing hormone ablation for
either prostate or breast cancer. The BLA submission contained data from
six Phase 3 trials involving more than 11,000 patients.

All in all, many of these agents may receive fast track or priority designation from the FDA, so we may well see several new cancer drugs on the market for a wide range of tumours by the year end.  It's a fascinating time in the oncology arena and there may be other cancer drugs that I've missed.  If so, please add them in the comments so we can track them.

 

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Is bigger better for Pharma and Biotech?

By on February 5, 2009

The futurist Eric Garland posed an interesting question in the Ning Competitive Intelligence community

recently, asking in the wake of the Wyeth-Pfizer news what strategic decisions we would like to see taken.  His own take?

"I'd love to see companies:
  • Admitting that giant R&D is insufficiently productive, and working to leverage Open Source research business models
  • Basing its future business model around the fact that the U.S.
    private healthcare system is going to fold in the next few years, and
    thinking up innovative pricing models
  • Focusing on deep expertise in certain diseases, especially chronic disease
  • Pioneering new ways to relate to doctors, accepting that the sales rep/advertising model is close to extinct."

All very good points indeed and ones I agree with.

If we look at some of the interesting developments in oncology recently, they have come from Genentech, an independent biotechnology company partly owned by Roche.  Small is sometimes better, more nimble and more productive.  Except that Roche are now signalling aggressive hostile action to snap up the remaining 44% they don't own. 

Over the last few years, Genentech have been busily searching out cool technologies and licensing them from smaller biotechnology companies such they they now have an interesting pipeline that makes many big pharma companies green with envy.  Some of them will be long shots, some might make it through to market and make a difference, but the important thing is thinking big picture for the long run. 

I'd like to see more pharma companies look at their pipelines and think about stocking up on licensing some of these technologies and products as opposed to the traditional approach of dinosaur mergers, which are often great for the short rather than the long term.

What else might be a positive step forward?

  • Greater involvement in health and medical education
  • Rekindling sponsorship in basic research and science, which leads to greater innovation and better, more targeted therapies
  • Reducing bureaucracy; as companies get bigger systems and procedures often grind creativity and innovation to a halt
  • Smaller, more nimble business units with greater integration from bench to bedside. Scientists, clinicians and marketers can all learn together and work as fully functioning team rather than being bogged down in silo and turf protection mentality
  • Less 'me-toos' and more risk taking
  • A sharper focus on strategy and not size for the sake of it

What I see is a dearth of innovation, both in drug development but also the science and technology driving it.

Meanwhile, the innovative pricing models that Eric mentions are already happening now, as seen by companies such as Genentech, Celgene and Pfizer in their approach to the UK's NICE pricing negotiations (see yesterday's blog post).  We have yet to see the US move to a more price sensitive market, but the European countries are already leading the way in this area, with a strong focus on demonstrating pharmacoeconomic and quality of life benefit.

As big pharma moves towards less competition and greater consolidation (viz Pfizer, Roche, Merck and sanofi-aventis to name a few), the medium sized pharma and biotechnology companies are taking a more focused approach and looking for biotechnology companies to replenish their pipelines.  With the economy tanking, they should gets good deals and hopefully, some blockbusters for the future.

Sometimes though, the world is not enough, as James Bond found.  When everyone zigs, it might be more successful to zag rather than follow the herd.

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What is competitive intelligence?

By on February 3, 2009

“There are no secrets, only information you don’t yet have.”

Drop.io blog

Sometimes random thoughts on the internet can stimulate us in most unexpected ways, as this quote did with me today.  In many ways, the statement is very true, at least as far as pharma competitive intelligence (CI) is concerned.  Much of the information about products and companies is already out there, hidden in the huge mass that is the world wide web.  Often, it is just a matter of superior search skills to ferret out crucial information or key people who may have access to the data you need.

Four things then become critical:

1.  An in depth knowledge of the subject area in order to process what is important and what is not.
2.  A logical and creative mind to find the information in the first place.
3.  A relevant and useful network of contacts.
4.  An ability to process both linear and non-linear data into valid patterns and trends as a commentary.

Is it an art or a science?

In the final analysis, like marketing, CI is a bit of both and one should never misunderestimate the power of intuition and gut feel.  They sometimes make more sense than logic.

To me, it doesn’t matter if you use cool modern web tools or traditional methods as long as the data gathered is relevant and appropriate.  Sometimes a mix of the two works well in tandem, sometimes one or the other is more useful.

However, there is nothing worse than getting a huge ‘book’ or summary sheets of data upon data and no analysis or interpretation.  That’s NOT what CI is or should be, it’s undisciplined and inexperienced data gathering, much like imitation and processed cheese is very different from a crafted artisanal cheese.  The old chestnut of quality over quantity still applies to CI to this day.

What does competitive intelligence mean to you?

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Digital thoughts and playmaking in Pharma

By on January 29, 2009

Yesterday saw me taking a day trip to Washington DC for the SCIP DC meeting on “New Ways of Knowing 2.0” run by the admirable August Jackson.  This event was a workshop format and included brief overviews from Suki Fuller and Eric Garland.

For those interested, you can follow the synopsis and live Twittering of the event using the #scipdc code in Twitter search.  The discussion was lively and the audience, from a variety of fields, were engaged and interested to learn about new tools and ideas that they could apply to their competitive intelligence work.  There was, inevitably, a large focus on Twitter, what it is and how you can use it effectively.

For me, I was curious to see how many other Competitive Intelligence professionals are using social media and cloud tools in their workflow and to gather relevant data.  There was also a bonus as several interesting ideas cropped up during the workshop and stimulated my own thinking further.  The first was asymmetry of information, the second was playmaking and how both can influence marketing strategy.  These ideas piqued some long lost thoughts I had from reading some excellent books such as Daniel Pink’s ‘A Whole New Mind’ about how right brain thinking will dominate in the information age and Don Tapscott’s treatise on ‘Grown up Digital’.  If you haven’t read either book, I would highly recommend them.

Much of the discussion yesterday kept circulating back to the impact of Gen X/Y versus Baby Boomers, and how the latter are often stuck in traditional models such as SWOTs, Porter’s 5 Forces etc, whereas those from the Digital Age are more likely to embrace new ideas and the use of technology in ways the Boomers could never imagine:

“The bottom line is this: if you understand the Net Generation, you will understand the future.’ And as
my son often reminds me, the future is now.“

Don Tapscott, Grown Up Digital

The digital age is indeed a-changing the landscape.  Just as breaking news is rapidly changing with community and citizens snapping events as they happen in real time on their iPhones, in many ways, CI is also at the forefront of this vanguard.  August, Suki and Eric demonstrated this with their adoption and use of cool new internet tools to help them find and process relevant information then analyse and shape it into a story or pattern that enables the user to recognise data to support a notion of strategic analysis and intent.  Ultimately, valid reliable information, whether gleaned from traditional market research or online tools, is key because it allows you to forecast and shape the future.

The big question is can you gain a competitive advantage and do it faster and quicker than your competitors?

Internet dog
In the old world, asymmetry of information and hence control of that information was much more prevalent.  In the new world, the internet provides a much faster and more transparent data set for those enlightened enough to recognise the changing order.  CI professionals who can find and utilise this data, essentially re-create a more balanced world since everyone has access to Google and a huge wealth of information accessible in the public domain, including sources such as Twitter.  Out of chaos comes new patterns.

Meanwhile, how does playmaking fit into all this?  I recalled my time as a marketer for a pharma company.  Often, we would analyse the competition and figure out ways to use market research to subtlely try and influence how doctors either perceived competitors on the market or those coming along in the pipeline behind us, then monitor and measure the effects of a particular campaign.  This all takes considerable time and money though.  Yesterday, a member of the audience from Play2run was sharing how his company uses creative models to help companies develop and gain a competitive edge.

“You run plays. Plays are run on you. Every organization and every person
runs plays to increase their relative competitive advantage
in busy marketplaces. Some do it well. Some try to avoid it. Some do it
directly. Some use surrogates. Some run one play at a time. Some run many
simultaneously. Almost all do so on instinct but fewer with the support
of stated objectives, policies and augmenting research.”

Plays2run

You can see more about the system and how it works on the website but the digital world has allowed playmaking and marketing strategies to evolve in a much more sophisticated way than we used to accomplish.  Whether it works effectively or not, I couldn’t say, but it’s a fascinating area to watch and potentially get involved in.

Overall, it was a very enjoyable and thought-provoking workshop, kudos to August, Eric and Suki for making it a worthwhile 450 mile round day trip!

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Work on stuff that matters: is Wy-Pfi a fail?

By on January 26, 2009

Earlier this month I came across a thoughtful blog post from Tim O'Reilly entitled "Work on stuff that matters: first principles" and it has been making me think ever since.  Image representing Tim O'Reilly as depicted in...Image by

Tim O’Reilly / Flickr

via CrunchBaseO'Reilly outlined three important things and I highly recommend reading his post:

1) Work on something that matters to you more than money.
2) Create more value than you capture.
3) Take the long view.

If we apply those simple parameters to the Wy-Pfi merger announced this morning, I'm left with a big feeling of FAIL on all three, it's like the city public internet router going down and hearing the wails of a thousand lost souls.

Money? It's all about near term sales and revenues, baby!

Value?  For Pfizer shareholders, perhaps, but not for Wyeth employees or society in general.

Long view? Umm, tricky one if the pipeline fails and does not deliver.  What then when Lipitor, Effexor and other drugs go off patent between 2011-2015?  What about the societal impact of baby boomers aging, as Eric Garner pointed out while commenting on the previous blog post?

The thing about this deal though, is that the merger will need Government approval and who knows how they will view this in the current economic climate.  They aren't always a given.

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