Proud to fight against cancer

Ipsen’s CEO David Meek took time out of his hectic schedule at this year’s ASCO conference to meet with pharmaphorum’s Richard Staines, and discuss the company’s portfolio of cancer drugs.

Ipsen has been increasing its presence in cancer under the leadership of CEO David Meek, who visited ASCO in Chicago as the company unveiled new data demonstrating its determination to fight against cancer.

Since his appointment Meek has built on the partnership with US biotech Exelixis, which gave the Paris-headquartered biopharma rights to the cancer drug Cabometyx (cabozantinib) outside US and Japan.

The company has also bought rights for the pancreatic cancer drug Onivyde from Merrimack and Shire. pharmaphorum’s senior reporter Richard Staines caught up with Meek at ASCO to get an update on latest trial results and the company’s developing oncology strategy.

RS: What data is Ipsen presenting at ASCO?

DM: We were proud to be part of ASCO 2018, demonstrating our commitment in the fight against cancer and in advancing oncology innovation to bring new clinical benefits to patients.

This year, we presented eight abstracts in advanced renal cell carcinoma (aRCC), liver and metastatic pancreatic cancer.

In advanced hepatocellular carcinoma (aHCC), analyses of CELESTIAL results show that Cabometyx as a second-line treatment significantly extends patients’ lifetime, providing consistent clinical benefits across different patient subgroups (groupings based on age and the duration of prior sorafenib treatment).

In aRCC, a post-hoc analysis of CABOSUN provides clinicians with a measure of the quality of patients’ survival, demonstrating that treatment with Cabometyx is associated with a longer time without symptoms of disease or grade 3/4 toxicity before progression, compared to sunitinib.

Beyond its proven efficacy as a single agent in aRCC, Cabometyx is being investigated in combination with other agents in different types of cancer (aRCC and metastatic pancreatic adenocarcinoma) as part of a broad investigational program that includes phase 2 and 3 trials.

We are also investigating the potential of Onivyde as a combination therapy in untreated metastatic pancreatic cancer, and preliminary results from a phase 1/2 trial suggest promising anti-tumour clinical activity with a well-tolerated dose for patients receiving the treatment.

The data presented at ASCO continues the really strong momentum in oncology that Ipsen is charting, with Cabometyx having beaten standard of care not once but twice in the METEOR and CABOSUN trials. This year, we are particularly excited about the CELESTIAL data, which demonstrated overall survival benefit, and has been the basis of a new filing in second line HCC.

RS: Please could you give me an update on Cabometyx and how do you think the EU launches are progressing?

DM: The last two years has been rich in regulatory milestones in RCC and more recently, we have seen encouraging developments in HCC, as well as other types of cancer.

We are achieving great success with Cabometyx in kidney cancer, which today is available in 18 countries as second-line therapy for advanced renal cell carcinoma.

In May, we succeeded in getting EC approval for Cabometyx in treatment-naive aRCC patients with intermediate- or poor-risk. Many of our affiliates have already begun negotiations with local health authorities to ensure that Cabometyx will be available to patients in 1st line as soon as possible.

Looking ahead, the EMA has validated the filing of a new application for an additional indication for Cabometyx in second-line HCC, based on the positive results of the phase 3 CELESTIAL study. HCC is the most common type of primary liver cancer in adults and for patients diagnosed with the disease in advanced stage, the life expectancy is less than one year. As the unmet needs of patients with advanced HCC have remained unsurmountable for many years, the potential approval of Cabometyx would bring an important addition to the treatment landscape for these patients.

Other multiple lifecycle management options currently moving forward are investigating the combination of Cabometyx with immuno-oncology drugs for the treatment of RCC, which when used together could offer a potentially transformational treatment.

As we know that we do not have the same response to treatments in the pediatric population as in adults, we are also addressing paediatric cancers, and developing Cabometyx as part of a paediatric investigational plan.

RS: Going forward could you tell me more about Ipsen’s strategy in oncology?

DM: Ipsen entered the field of oncology in 1986, and today we are one of the world’s top 20 pharmaceutical companies specialising in oncology, with a portfolio including treatments for prostate cancer, neuroendocrine tumours and cancers of the bladder, kidney, pancreas and breast.

Our oncology portfolio represents over 60% of our sales, reflecting the continued Somatuline momentum (the biggest growth driver in the United States) and increasing contribution from Decapeptyl in prostate cancer, Cabometyx in renal cell carcinoma and Onivyde in pancreatic cancer.

Beyond the recent EC approval in advanced RCC, we have submitted to the EMA another variation for the use of Cabometyx in the second-line treatment of advanced HCC. We received in 2017 a marketing authorisation in Europe for Xermelo for the treatment of carcinoid syndrome diarrhoea.

Some of our products also received approvals for new indications in 2017: in the United States, the FDA approved a supplemental indication for Somatuline Depot Injection for the treatment of carcinoid syndrome. In Europe, Decapeptyl received an approval for the treatment of pre-menopausal women with early stage breast cancer.

The investments we have made in oncology are delivering for patients. We now have a portfolio of treatments for eight different cancer types, and are looking at options to expand this, including partnerships and acquisitions. We may not be the largest company focused on oncology, but we are certainly one of the fastest growing. I firmly believe that is because we have an entrepreneurial mind-set at Ipsen. We are a biopharma reaching patients across the globe, yet we think like a biotech and we move at the pace of a biotech.

RS: Can you see more deals such as the Exelixis one, or do you envisage using acquisitions to bolster the pipeline?

DM: Ipsen has always worked in a very connected way to the outside world through academic and biotech collaborations. Aside from Exelixis, we currently have several strategic alliances, with Shire for Onivyde, Galderma for Dysport in aesthetic medicine, and Teijin for Somatuline in Japan.

We have a search and evaluate model to look for potential early and mid-stage assets that could be attractive in building strategic partnerships. Our ambition is to be the partner of choice and we have demonstrated our ability to successfully integrate new assets, set up effective governance and add value both strategically and operationally in the way that we develop new drugs with our partners.

Our latest global licensing and joint development agreement for a pre-clinical oncology drug candidate discovered by researchers in MD Anderson’s Institute for Applied Cancer Science (IACS) with the University of Texas MD Anderson Cancer Center, is a new partnership where there is a strong strategic fit.

Oncology is a key growth driver today, and our primary goal for 2018 and the coming years is to add new assets to our portfolio. We are looking at all the options, including partnerships and acquisitions, that fit with our strategy and that can be successfully integrated into Ipsen.

RS: What about digital health or AI, can you see that playing a role in Ipsen’s cancer research or products?

DM: We are constantly looking at the possibilities to leverage new technologies and build partnerships with digital specialists to bring value to patients and healthcare professionals.

Ipsen’s digital transformation will be paramount in driving innovation. In 2017, we created Spinleapa structure that allows us to test new technologies that can transform our working methods, create innovative services for patients, as well as seek partnerships with start-ups and academic structures.

Spinleap was created with three key missions. Acceleration – We accelerate high value internal projects by using technology. Open innovation – We partner with academics and tech start-ups to build innovative products. Disruption – We explore and test emerging technologies to create new ways to improve patients’ lives.

In the United States we have launched initiatives like the website ‘livingwithnets’to bolster support for patients living with neuroendocrine tumours (NETs), which was recently awarded as a patient initiative by eyeforpharma, to maximise the possibility of better health outcomes for all. This platform, developed in conjunction with patients, addresses the wide range of needs identified: from helping to drive earlier diagnosis, to comprehensive disease area information through to a wide range of support and tools on a more practical level.

About the Interviewee

David Meek, Chief Executive Officer, Ipsen
David Meek was appointed CEO of Ipsen in July 2016. He is also on the Board of Directors of Ipsen. David has over 25 years of experience in the pharmaceutical industry where he has held various global executive positions in major pharmaceutical and biotechnology companies. Prior to joining Ipsen David was Executive Vice-President and President of the oncology division of Baxalta.

David started his biopharma career at Johnson & Johnson and Janssen Pharmaceutica (1989-2004) where he held a variety of senior US sales and marketing positions across therapeutic areas in primary care, specialty care, and oncology.

He then joined Novartis (2005-2012), where he successfully served as the global business franchise head for the company’s respiratory and dermatology franchise in Basel, Switzerland; President and Chief Executive Officer of the pharmaceutical division in Canada; and the head of oncology for Northern, Central and Eastern Europe. From 2012 to 2014, he served as Chief Commercial Officer of Endocyte, an oncology biotechnology company.

Prior to his biopharma career David was an officer in the United States Army. He is a graduate of the University of Cincinnati.

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