The convergence of Pfizer and AB Science in the tyrosine kinase inhibitor market is an interesting conundrum.

The market for tyrosine kinase inhibitors (TKI) is one that I keep an active interest in having worked in new product development and marketing at Novartis Oncology bringing Gleevec to market in CML and GIST.

422014998 ca48bd5939 m Gone to the dogs? New therapies for the treatment of dog cancerImage by Aureusbay via Flickr

I was, therefore, fascinated to read that AB Science, a fifty person, privately held company based in Paris, launched the first targeted cancer therapy for dogs in June this year.   Masivet (masitinib) is a TKI with approval by the European Medicines Agency (EMEA) for the treatment of non-resectable grade 2 or 3 mast cell tumors (mastocytoma) in dogs.  Up to 20 to 25 percent of skin tumors in dogs and cats are mast cell tumors

In clinical trials, Masivet increased the survival time of dogs by 300 days compared to placebo, and after two years the survival rate was 2.5 times that of dogs receiving placebo.  The drug also demonstrated increased progression free survival.  Masitinib is currently under review by the FDA veterinary division for approval in the U.S..

Animal health is big business and a growing market, particularly in the United States were pet owners are willing to pay for drugs and treatments that will maintain the life of their pets.  There are over 130 million dogs and cats in the United States, and 4 out of every ten households own a dog.   

 Gone to the dogs? New therapies for the treatment of dog cancer

It should come as no surprise that major pharmaceutical companies are players in this field.  In 2008, Pfizer’s animal health division had $2.89B of revenue compared to $2.41B from human oncology drug sales.  In June 2009, AB Science did a pan-European launch of Masivet in Europe, but at the same time Pfizer obtained approval in the U.S. for their TKI, Palladia (toceranib), for same indication i.e. the treatment of mast cell cancer in dogs.  AB Science are still waiting on FDA approval for their drug.

Whether AB Science, who have publicly stated that they don’t wish to partner with other pharmaceutical companies, will be successful in the U.S. animal health market when their product is approved by the FDA remains to be seen.  In the U.S., Pfizer Animal Health have first mover advantage, started selling product in July and have the infrastructure, sales force and marketing to capture market share.   It is hard to see how a small company can compete with an industry behemoth.

At Icarus Consultants, amongst other things, we work with pharmaceutical, biotechnology and healthcare companies on developing market entry strategies into the U.S..  What we see are many examples of business plans that are destined to fail.  As John Mullins of London Business School describes in his new book on “Getting to Plan B: Breaking Through to a Better Business Model”, many companies have flawed business plans that are the equivalent of selling Coke to kids in China.  It sounds attractive on paper given the market size – "all we need is 1% of such a large market", but without the resources to distribute or market the product or a deep understanding of which segments to target (and how to reach them), it is a fundamentally flawed business plan.  The same could be perhaps said for AB Science seeking to compete against Pfizer in selling animal health drugs for dog cancer in the United States.

What makes the convergence between Pfizer and AB Science even more fascinating, is that AB Science are developing masitinib for human use as well.  They are currently in phase 3 clinical trials of masitinib in Gastrointestinal Stromal Tumor (GIST) going head to head against Novartis’ Glivec/Gleevec for first line use.   Not only is this market already dominated by Novartis, the leading second-line treatment for patients who eventually develop imatinib resistance is Pfizer’s Sutent (sunitinib).  Other major pharmaceutical companies that have drugs for this indication include BMS with Sprycel (dasatinib).

It will be interesting to watch what happens to AB Science over the forthcoming months as they go it alone against major Pharma companies with very limited resources. 

Will they make a success of it or will they end up going to the dogs?

 Gone to the dogs? New therapies for the treatment of dog cancer