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Luis Mora (PharmaMar): “This is the best moment of our history”

 Luis Mora, Managing Director of the Oncology Business Unit at PharmaMar

  1. Which are the strong points of PharmaMar?

We are one of the few biotechs to have a product on the market, another awaiting commercialization and various more at different stages of clinical development.

Since 2007, Yondelis has been on the market, a compound available today in approximately 80 countries. It has approval for soft tissue sarcoma and platinum sensitive ovarian cancer. Yondelis is a milestone for us as it is the first product per cuota on the European market for the treatment of soft tissue sarcoma. It was the first time that a Spanish pharmaceutical compound was approved in Europe and the first time in the world an antitumoral drug of a marine origin was authorized.

We have more than 30 years of experience in marine biomedicine and we are the first company to carry out all the different phases of development of a drug of these characteristics up to commercialization. Thanks to our “know how” and a solid and proven experience, today we are a world reference in our sector.

  1. Today PharmaMar is a global company. How has this internationalization been?

PharmaMar is a biopharmaceutical company focused on oncology, with its head office in Madrid (Spain) and a growing network of affiliates around the world. The internationalization of the company is and has been a constant since our creation in 1986. From the start, we have understood that the access to knowledge around the world is fundamental to establish both scientific and commercial collaborations would lead to both a solid and sustainable growth. Today we are worldwide leaders in the discovery and development of new antitumoral drugs of a marine origin. We have 5 international partners that have allowed our first product, Yondelis, to have been authorized in 80 countries, including the 3 most important oncological markets: Europe, United States of America and Japan.

The process of expansion beyond our frontiers started in 1999 with the opening of an office in the USA. Between 2012 and 2016, the idea of internationalization got stronger; the Company wanting to maintain a direct presence in key countries to be able to continue with both a continued growth and excellence was taken. During this time offices have been opened in Italy, Germany, Switzerland, France, the United Kingdom, Belgium and Austria.

Today the project for expansion in the USA marks our short term activity. We are working to establish our own commercial network that will us to directly sell the compound Zepsyre (PM1183) and other molecules that will arrive in the future. At the end of 2016, Pascal Besman was named Chief Operating Officer for the USA.

  1. What challenges does the company face in the following 5 years?

Yondelis will continue to grow in sales in Europe, the USA and Japan. We should take into account that we are still in the first year of sales for sarcoma in the last two territories.

At the end of 2017 we expect an answer from the European Commission to our request for the commercialization of Aplidin for the treatment of multiple myeloma. If this is positive, the drug will be on the market in 2018. We will also know the data on the clinical trial with Zepsyre (PM1183) for platinum resistant ovarian cancer and, if positive, will serve to request market access.  

At the same time, we are continuing to study the antitumoral activity of Zepsyre in other tumor types, small-cell lung cancer, BRCA 2 breast cancer and endometrial cancer. This year we forecast the entrance of a new compound into clinical development after obtaining good preclinical and in vivo results.

In 2018 Aplidin may be commercialized in Europe. In the same year, the finalization of the recruitment of patients with small-cell lung cancer is forecast. Running parallel to this will be the development of the commercial network in USA for PharmaMar to be able to commercialize Zepsyre directly.

2019 would bring a third molecule to the market, Zepsyre for platinum resistant ovarian cancer and also we could start to know the results of the clinical trial in lung cancer.

In 2020, this data would support the approval from the different regulatory agencies. In PharmaMar we are working with these objective, to have on the market in the next five years (2018-2022) three molecules (Yondelis, Aplidin and Zepsyre) for four or five different indications (soft tissue sarcoma, platinum sensitive ovarian cancer, multiple myeloma, platinum resistant ovarian cancer and small cell lung cancer).

  1. Are we on schedule?

The answer is yes, we are on schedule. As far as clinical trials are concerned, we are complying with the programme, and we hope the results are positive to be able to present the respective dossiers for the request of authorization for commercialization to the corresponding regulatory agencies. The deadlines are perfectly synchronized with the strategy.

  1. Are you going to take on the commercialization of Zepsyre in the US alone?

Our intention is to create our own sales network in the United States. We have our own European experience, so we know what we are going to confront and how to start it up. If final we reach an agreement for the co-promotion with a possible partner, this would be because the economic offer would be very interesting and beneficial. Pascal will be leading the project for expansion. We hope this to be a reality in the short term future.

  1. In economic terms, what is the situation of PharmaMar?

The result of 2016 has been very positive. From a management point of view it has been one of the best in the PharmaMar history.

Last December, we signed with Chugai Pharma (Roche Group) an agreement for the commercialization of Zepsyre (PM1183) in Japan for which we received an upfront payment of 30 M€, to which another 100 M€ more could be added as we reach the corresponding development milestones of the compound as defines in the contract, and to which the commercial royalties will be added.

The money was paid in its totality during the first few days of January 2017, which allowed us to, along with the rest of the revenue; confront all the development projects without any financial difficulty. In fact, in the first term of 2017 we have registered an increase in the total revenue,

in 8% the same period last year, all this having contributed, along with the efficient commercialization cost management, to which the adjusted EBITDA was positive. With respect to the assignment to research and development, in 2016 78M€ were designated, which, in real terms means a 30% increase with respect to 2015. This has allowed us to push the R&D of Zepsyre, the third and most promising of PharmaMar´s molecules in the fight against various types of cancer. If we don´t invest in future, there is no future.

  1. Will you continue with the plans to be listed on Nasdaq Biotech Index?

Yes. In October 2015, we carried out a merger between Zeltia and PharmaMar. We are working in this direction and it will be communicated at the moment the market allows it.

The current international situation doesn´t recommend this as many uncertainties still exist with regards to political policies and their impact Donald Trump could have in the US, together with those of the different elections around Europe such as in Italy, Germany and Holland.

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