Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘oncology’

"The only way to keep your health is to eat what you don't want, drink what you don't like, and do what you'd rather not."

Mark Twain

Sensible advice indeed, but how many Americans actually follow that wise and sage advice?  As the baby boomer population ages, health and wealth become issues very much to the fore.  The burden on society to pay for years of poor choices and idle, corpulent lifestyles will be significant.  There is still time to act, but the task will be very much like turning a huge battleship in a narrow river; tricky and fraught with challenges.

It's always interesting reading about those in Asian, Indian or African countries moving to the West and learning that their children develop diseases more typically associated with the new land – cardiovascular, obesity, autoimmune and cancer in particular.  Can we learn something from this? 

It tells us that the Western lifestyle, exercise, diet and stress all play a part in contributing to the widespread problem, but for all the education and information out there, nothing really changes.  The number of people it affects is actually quite small in reality.

Plus ça chânge, plus de la même chose.

If you look at poorer countries, the incidence of breast, lung prostate and colorectal cancers are all lower compared to the West.  Cervical cancer is much higher, but now that a vaccine is available, we may one day see the gradual eradication of HPV in populations where it is a major issue.  There are no vaccines for poor lifestyle choices though.

The solution?  Well, I don't have any grand ideas or suggestions for broad Government schemes that will duly flop through lack of impact.

Instead, I'm taking personal responsibility for my own health and lifestyle and getting my emotional wealth and sanity back.  Yup, I bought a new pair of running shoes this week, time to get out on my bike and get some exercise.  I don't smoke, drink in moderation but have got lazy running my own small  business and it's time to get back my health through sensible exercise.

“So many people spend their health gaining wealth, and then have to spend their wealth to regain their health.”

A.J. Reb Materi

Think about it – prevention is better than cure. 

For most cancers there is no cure unless it is detected early enough and surgery is a viable option.  By the time someone is diagnosed with stage IV cancer, the prospects will be pretty bleak.  Not all cancers are lifestyle related, you can get mutations through hereditary means and  genetic changes through natural aging.  There is no doubt that eating and drinking less, exercising more, and not smoking will probably help you in the long run.  Life is too short to spend it being ill or unwell.

Your health is your responsibility – time, once used, is gone for ever.

1 Comment

Hah, having written about Lilly's Alimta in non-small cell cancer over the weekend, I find this morning that they were the secret suitor to ImClone Systems, who recently rejected BMS's bid.

Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion.

Imclone
ImClone have an interesting portfolio of onoclogy drugs, including Erbitux, for the treatment of advance colorectal and head and necks cancers, as well as several promising agents in development. 


In the near term, three other agents have reached at least phase II.  These include IMC-1121B is a fully-human monoclonal antibody that targets the VEGF
receptor to deprive tumour blood vessels of the nutrients they need for
further growth. Proof of concept of this approach was first demonstrated by Genentech's Avastin.  Phase II studies are underway for metastatic melanoma,
renal, liver, ovarian and prostate cancers. Metastatic breast cancer is
in Phase III testing, while Phase III testing in gastric cancer may
begin in 2009.

IMC-A12 is a fully-human monoclonal antibody that targets the insulin-
like growth factor-1 receptor (IGF-1R). Phase II testing is underway in
breast, prostate, pancreatic, colon, liver and head and neck cancers,
as well as sarcoma, with Phase III trials planned in 2009. IMC-A12 has
the potential to work with a variety of other targeted agents.

IMC-11F8 is a potent, fully human monoclonal antibody that targets the
epidermal growth factor receptor (EGFR), the same receptor targeted by
Erbitux.  It is currently in Phase II studies for metastatic colorectal
cancer with one or more Phase III trials planned in 2009.

This move makes a lot of sense for Lilly, as cancer (neuroscience and diabetes being the others), is one of the main therapeutic areas it focuses on.  It already has Alimta and Gemzar on the market, but Gemzar is due to lose it's patent in 2012 and so it was clearly on the hunt for a company with a cancer portfolio to drive future revenue streams.  At $70 per share, the offer is a decent 13% premium over BMS's revised offer of $62 per share that was recently rejected by Icahn and the ImClone board.

Reblog this post [with Zemanta]
1 Comment

This month is Breast Cancer Awareness Month.


Breast cancer ribbonOver 186,000 new cases of invasive breast cancer are diagnosed every year in the US alone and, sadly, some 40,000 die from the disease, making it the second deadliest cancer amongst women (source: American Cancer Society).

A number of patient advocacy groups are holding walks in aid of research including the American Cancer Society and Susan G Komen for the cure Foundation. Others, such as the National Breast Cancer Organisation are focusing on early detection, since the earlier the disease is found, the better the chance of a cure or long term survival.


There are some fascinating stories of hope and survival on the internet – you can read some of them on
American Cancer Society and on one of my favourite cancer sites for inspiration, Punk Rock Mommy.

Sal in darker pink
And for those of you on Twitter and Friendfeed, why not turn pink like this? 

I've gone pink, have you?

Are you doing anything to support this worthy cause?

This morning I was listening to a short talk on YouTube by Gary Vaynerchuk from WineLibrary at Web2.0.Vlog Soup - Wine Library TVImage by stevegarfield via Flickr 


You can watch it yourself here


It was one of the most inspiring things I've heard this year and it got me thinking more critically. 

Often, we get asked by clients why do we 'only' do a few specialist areas – oncology, hematology, immunology, GI and respiratory medicine.


The answer is very very simple.

Sorry, but I really can't get excited about fungal toenails or suchlike.  Yes, we could have more clients and make more money having a broader focus doing anything under the sun that is related to the pharma industry, but it's what excites me, what I'm passionate about that matters much more. 

The oncology and hematology marketplace is exciting to me, it's interesting; a fascinating, complex area of different sub-diseases, treatments, pathways, mechanisms and targeted therapies.  Our brand equity is heavily invested in knowing this specialist subject well and that's what people ultimately call for; expertise and knowledge.  

If you're going to spend 15-18 hour days working on building a consulting business, or indeed any business, then wouldn't you rather spend it on subjects that you love and are passionate about?  At least, I think so, and it makes the job much more enjoyable, more of a vocation than a job, in fact.

Our time on earth is too short not to do things we really enjoy and if we have a chance to do what we want to do, why not grab it with both hands? 

Reblog this post [with Zemanta]

A new form of chemotherapy that destroys new blood vessels growing
around tumours has produced some promising results in a phase II trial of
patients with inoperable pancreatic cancer.  The data was presented recently at the
European Society for Medical Oncology (ESMO).


The study evaluated the efficacy and safety of three different
doses of cationic lipid complexed paclitaxel (EndoTAG-1) administered
twice weekly, in combination with weekly infusions of
gemcitabine,
compared to gemcitabine alone, in 200 patients with pancreatic
adenocarcinoma.  Gemcitabine is considered the standard of care for this particular cancer.


EndoTAG, developed by MediGene, consists of charged particles that bind preferentially to the
fast-growing endothelial cells in new blood vessels being formed by
tumours.  The drug,
paclitaxel (Taxol), is then released
and reaches the tumours
vessels.  Paclitaxel itself is not very efficient in pancreratic cancer, but this may be a novel approach for getting more chemotherapy into the heart of the tumour where it can do most damage.

After following patients for a year, it was found that 
treatment with such combination led to a substantially extended median
survival time compared to standard therapy.  Patients given gemcitabine
alone survived on average 7.2 months, compared to up to 13.6 months for
patients who received repeated doses of the combination (EndoTAG plus
gemcitabine).

Targeting the formation of new blood vessels and destroying ones
already present is very efficient, and has been quite successful for
other cancers, as Avastin has shown, but not to the same degree in pancreatic cancer.  These results are very promising compared to the never ending doublets and triplets that have been previously tried and compared to gemcitabine therapy alone.  The cancer is usually detected and diagnosed in the advanced stage, making it notoriously difficult to treat.

Reblog this post [with Zemanta]

The absolute last thing you need when you or a family member is seriously ill with cancer is an illegal scam from snake oil salesmen.

The Federal Trade Commission (FTC)
has charged five companies with making false and misleading claims for
cancer cures and said yesterday that it has reached settlements with several others.  In their press release, the five companies being sued for false and
deceptive advertising will go before administrative law judges and included the following:

Omega Supply

Native Essence Herb Company

Daniel Chapter One

Gemtronics

Herbs For Cancer

Settlements were reached with other companies who paid restitution ranging from $9,000 to $250,000.  In all, over a 100 warning letters were sent out asking companies to address the bogus claims. 

The FTC, the Food and Drug Administration FDA) and Canadian authorities, are launching a consumer education campaign warning about bogus claims for cures.  It includes videos and a wealth of information in a cartoon format, including excellent snippets such as this:

"Natural doesn't always mean effective. Scammers take
advantage of the feelings that can accompany a diagnosis of cancer.
They promote unproven – and potentially dangerous – remedies like black
salve, essiac tea, or laetrile with claims that the products are both
“natural” and effective.  But “natural” doesn’t mean either safe or
effective when it comes to using these treatments for cancer. In fact,
a product labeled “natural,” can be ineffective and even downright
harmful."


Interestingly, one of the lawyers for the five companies was maintaining that the FTC's actions represent censorship.  The reality is that there are no credible scientific evidence that any of the products
marketed by these companies can prevent, cure, or treat cancer, since few if any, have undergone controlled clinical trials. 

Given the high standards maintained by the FDA and other regulatory authorities, the burden of proof lies with the companies to prove their claims or risk being labelled snake oil salesmen at best.

Reblog this post [with Zemanta]

While recovering from Meltdown Monday, one might also have a eye for the future in 2009 onwards in the Pharma industry because tough times lay ahead.  As regulators increase restrictions, reduce profits and look at cost sharing options, the companies are under increasing global pressure to preserve or limit profit margin erosions.

Lately, drug innovation also seems to be coming up short and the latest news from AstraZeneca that Targacept was disappointing in phase IIb clinical trials for Alzheimer's Disease was just another brick in the wall.  Recent activity in the industry has focused on large scale redundancies and scaling back the sales forces.

Companies have also begun investigating further cost reductions and containment efforts have begun with an increasing dependence on outsourcing where possible, in areas such as medical enquiries, manufacturing and R&D.

Targeted acquisitions of smaller biotechnology companies to replenish the pipelines has also begun as a rash of blockbuster patent expiries over the next 5 years will lead to further reductions in profits and pressure on profits.  Competition from manufacturing, generic and copy companies in emerging markets such as China and India is more prominent than ever before.

Even oncology, the rock star of recent years, has begun to struggle with an increasingly fractured market, organ drug indications, pressure on prices, increased competition for patients in trials and generally disappointing pipeline results.  Quite a lot of companies are suddenly finding they have less than stellar compounds in phase III and a raft of agents in development in phase I plus a big hole in the middle. It's hardly surprising therefore, that many of them are searching for generic companies to buy and take up the shortfall with generic oncology drugs.  That's a real turn for books. 

Some big Pharma companies are already well placed, such as Novartis, which created Sandoz as it's generic arm after the Sandoz-Ciba merger.  Tough times require desperate measures, so what out for a raft of other big Pharma companies getting wise to this strategy to protect against revenue drops down the road.

In many ways, the pharmaceutical industry is a microcosm of life in general; time to trim the fat, reduce expenditures, tighten belts and ride out the economic waves while planning for bigger ones behind.  Those who are successful will emerge stronger and leaner for the efforts in the future.  The smart ones will do things more creatively and effectively rather than just doing more for less.

Prudence and innovation are sometimes a virtue in tough economic times.

This news article on 'antidepressants may help fight cancer by boosting body's immune response' caught my idea in Google Reader this morning. After all, some of the big issues faced by patients undergoing treatment are overcoming the feelings of overwhelm, depression, fear and just generally feeling run down.  It's a common problem, but one that is rarely mentioned in the scientific cancer journal articles, where the focus is on efficacy, side effects and survival.  How patients cope and handle their condition can vary enormously.

Oil on canvas

Image via Wikipedia

Sometimes, I wonder if more attention was paid to the mental wellbeing and psychological state of the patients entering clinical trials, would that impact overall survival in a positive way?


Sources
:

eCancerMedicalScience Online


Reblog this post [with Zemanta]
error: Content is protected !!