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Interview: Harvey Berger and Timothy Clackson, Ariad

Ariad’s CEO and president of R&D talk about following their own path in oncology
Harvey Berger & Timothy Clackson

(Harvey Berger, left, and Timothy Clackson, right) 

In the past few years, the pharma industry has been forced somewhat to put aside old differences and learn to work together. Gone are the days of big drugs for big diseases, and instead research is increasingly focused on developing individualised treatments for niche variations of wider conditions, while treatment resistance has become a very public health problem.

It's a changing dynamic that means it makes sense to put away rivalries and work on wider pre-competitive research efforts, as seen in AstraZeneca and Roche sharing early stage clinical data or the EC-backed Innovative Medicines Initiative (IMI).

Companies are also increasingly making collaborations with or acquiring smaller biotechs that are able to focus on individual areas of high unmet need.

In this environment, it takes a brave company to go for it all alone, right through from research to commercialisation, especially for a relative newcomer such as the 22-year old Ariad.

The only way to build a successful sustainable business in biotech is to believe in your product

But it's a decision that is paying off, with 2013 being Ariad's most important and exciting year since its formation, featuring a green light for its first drug – cancer treatment Iclusig (ponatinib) - both in the US and Europe

“History tells us the only way to build a successful sustainable business in biotech is to believe in your products and to use that as the foundation for investing appropriately in commercialisation, not just discovery and development,” explains Ariad's CEO Harvey Berger, who founded the company in 1991.

“I think we can do it faster and better ourselves.”

This firm belief in Iclusig appears to be justified, with the drug receiving FDA approval three months ahead of schedule in December 2012 for its use in two rare types of cancer: chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL).

It has since gone on to make sales of $13.9m in the second quarter of 2013, with more than 450 unique prescribers of Iclusig in the US, where it is recommended for use in patients who have grown resistance to Tasigna (nilotinib) and Gleevec/Glivec (imatinib mesylate) from Novartis and Bristol-Myers Squibb's Sprycel (dasatinib).

“The commercial launch in US has gone extremely well,” enthuses Berger. “It's been well ahead of virtually everybody's expectations, and the drug is being adopted by physicians across medical landscape in the US.”

Firm beliefs
This confidence stems all the way back to the beginnings of Ariad, when Berger left his role as president of R&D at Centocor (now part of Johnson & Johnson) to set up a company that was looking to take advantage of advances in modern organic chemistry and cutting edge computational methods in drug design to focus on targets inside the cell rather than outside.

“That was the original concept that we said we were going to do and we are one of the leaders of the world in achieving those approaches,” says Berger.

It wasn't until 2000 and the decoding of the human genome that Ariad started to focus on oncology, however.

“We made the assessment at the time that the discoveries then and the upcoming discoveries in the human genome would have a greater impact on applications in cancer than probably in any other therapeutics area for at least the next decade,” explains Berger. “And that was absolutely correct.”

After selling off investigational sarcoma treatment ridaforolimus to Merck & Co following an aborted collaboration attempt, ponatinib emerged as the front-runner in the company's pipeline as a treatment for CML.

The drug was then developed with the specific intention of overcoming the failings of other drugs in the field – the first generation treatment Gleevec/Glivec and the second generation treatments Sprycel and Tasigna.

“What we've learnt subsequent to that is that they aren't good enough,” says Berger. “They allow patients to fail, to develop resistance and for permutations to occur.

“We like to think of Iclusig as the last generation in these types of medicine because it really overcomes all the resistance mutations and limitations that are know of the earlier treatments.”

It's the results of strategy to “discover, develop and deliver our medicines without the additional input of pharma partners”, says Berger.

“We are one of the only biotech companies in the cancer field that will have gone from discovery though to approval in US and Europe.”

Going solo
This independent approach is backed by Berger's colleague Timothy Clackson, who has been with the company since 1994 and is now president of R&D.

“There are many examples of companies that have jettisoned research as soon as it has delivered one or two candidates,” he says.

“Our approach has been that we see first the productivity of our discovery group but also the attraction of having very high achieving high quality science in the company that can connect all the way downstream to commercial.”

It's a method that allows for greater understanding according to Clackson: “We can learn what the customers want, to put it succinctly. We can contribute directly to the education and interaction with those people in the field.”

That doesn't mean Ariad goes it completely alone, as Clackson explains that a smaller company, such as Ariad, is more suited to focused interactions with academia rather than the wider scale open innovation approach favoured by larger pharma companies with the appropriate infrastructure to work with lots of universities, biotechs and large rival firms.

There's no doubt that if the human genome had been proprietary, it would've impeded scientific progress

“We embrace the general philosophy of open collaboration and have always based our scientific programmes on early collaborations with academic groups,” says Clackson.

This includes working with Dr Brian Druker – one of the leading scientists behind the development of Gleevec.

“Brian collaborated with us through the development of Iclusig and that was a truly symbiotic relationship,” says Clackson.

Berger also welcomed the idea of standing on the shoulders of academic giants, referencing the genome project that allowed the development of Iclusig.

“There is no doubt that if the human genome had been proprietary, it would have impeded scientific progress worldwide,” he explains. “The concept of open access to science is an incredibly important one. And it's really been led by a lot of the academics who have that as a critical part of the likely growth of scientific knowledge.”

The issue for Berger is when it comes to different companies working together on a major scale, as Roche and AZ are doing.

 “There are a lot of challenges in doing that, especially given that pharma companies have never really done that in a major way before. It will be interesting to see how it plays out.”

Commercial challenges
Ariad's own challenges are of a more commercial nature, with the company one of several to come under criticism for the high price of CML drugs in the US in a paper published in the journal Blood and signed by high profile cancer experts.

Berger explains that there is a valid reason for the high price (~$115,000 per year) of Iclusig, claiming that the clinical benefit of the drug made it a cost-effective treatment.

“CML drugs represent real breakthroughs in treatments of patients who would otherwise be very difficult to treat,” he says.

“There's always a debate about cost and benefit and we understand that. We believe that Iclusig is appropriately and fairly priced in the US and is consistent with the pricing of other high value-added cancer medicines.”

As for the future of Iclusig in leukaemia, Ariad is keen to roll out the drug in Europe over the next few months, while regulatory authorities in Switzerland are expected to have assessed the drug by the end of 2013.

Ariad also has plans to file the drug in Canada and Australia, with approvals expected in the first half 2014, while a filing is expected in Japan during the second half of 2014 after data is obtained from ongoing clinical trials. 

And like the US, all marketing activities will be carried out by Ariad itself, with offices cropping up all over the major markets.

It will be some time before the company dips a toe into the emerging markets of China, India etc, with the near-time focus on establishing the company in areas it already has a hold in.

“We have plenty to do ahead of that,” says Berger. “We've taken on a lot of work and I think that's where we'll focus for at least a year and a half.”

The future also includes plans to expand the use of Iclusig, with current trials investigating the kinase inhibitor's use at an earlier stage in its current indications, as well as for other cancers, such as gastrointestinal stromal tumours (GIST).

“We hope that Iclusig will be the gift that keeps on giving both in CML and in other indications,” says Clackson

The pipeline also includes a potential second treatment in the form of AP26113, which is in phase II development as a personalised lung cancer treatment to target patients with either the ALK or EGFR gene mutation.

There are already established products in both these areas, but Ariad's hopes are that it can achieve a similar outcome to Iclusig and create a drug that can treat resistant forms of the disease.

If Ariad can continue to go it alone with AP26113 and match the achievements of Iclusig, it would be an impressive achievement, and a sign that a biotech can still emerge as real player in the commercial pharma world if the innovation is there.

“There are very few biotech companies that have taken as their strategy to discover, develop and commercialise new medicines and retain the rights and really build a sustainable business that is in touch with patients and in touch with the market place,” says Berger.

“We are building a strong commercial presence, but it is one that is built on what distinguishes the company, which in our case is the solid foundation of breakthrough medicines.”

Article by
Thomas Meek

PMGroup editor

14th October 2013

From: Research, Sales



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