In August 2007, IMS Company Profiles interviewed Dr Jorge Gallardo, Chairman and CEO of Almirall and Dr Per-Olof Andersson, Executive Director, R&D at Spain's largest pharmaceutical company. Formerly a private concern, it floated 27% of its shares in mid-2007. Almirall has subsidiaries in Germany, Italy, France, Belgium, Portugal and Mexico. In the future, it will increase its presence in Germany and enter new European markets, such as the UK and Poland, via the acquisition of German prescription dermatology company Hermal.
IMS: "Can you tell us about Almirall's going public earlier this year? I understand that the quotation on the Stock Market has been very successful and that financial analysts have been extremely positive."
Jorge Gallardo: "Well we have been considering going public for some time but, you need to have a reason to go public. And for us, there were two major reasons: one is internationalisation. We have intensified our presence in Europe over the past 5-6 years for several reasons. First, we want to be able to handle our own in-house products in the future: maybe not alone, maybe we will need partners, but at least we want to have strong or relatively strong operations in most countries in Europe. So that's one of the core processes, to become a pan-European company.
"The second reason is that we have to finance our research. We have a pipeline with a potential blockbuster, aclidinium bromide, which can also be combined with other molecules, such as formoterol and inhaled corticosteroids. In addition, we have other products in the pipeline which need resources now, and will need more resources in the future."
Gallardo pointed out that the internationalization strategy, coupled with the need to finance R&D, gave Almirall a compelling reason to go public. In addition, he noted that the company was able to state to investors that it was different, not a typical 'local' company, but a pharmaceutical concern with an international element and a good background in research.
JG: "We have been able to demonstrate three things during the life of our company. First, we are strong in R&D. We have developed seven compounds internationally since we started research in 1970, which is quite an important achievement for a local company. The second differentiation point is that we have already taken steps to expand outside Spain and we have six subsidiaries in Germany, Italy, France, Belgium, Portugal and Mexico. So, we are practically the only Spanish company with a real, relatively strong presence outside of Spain. And thirdly, we have been pragmatic. In 1997, Almirall merged with Prodesfarma. This made the company stronger and able to put more money into research and expand outside of Spain. This was an important step for a family company like Almirall, because many family companies do not want to lose their 100% control. But we went ahead with the Prodesfarma merger, lowering our share in the company from 100% to 68% for the good of the company."
This strategy proved to be a winning one for Almirall, as the combined company grew and was successful. Then, in 2006, Almirall regained control of the company and changed its name from Almirall Prodesfarma back to the original Almirall.
IMS: "You have spoken about Almirall's ambitions to become a pan-European company. In the future, do you think that Almirall will look towards the US and possibly Japan as well?"
JG: "Well it's always possible. It's a question of going step by step. And for me, now, it's Europe that concerns us. The Hermal acquisition is part of this willingness to become a strong European partner. We thought that Hermal was a good opportunity, and that it made a lot of sense to integrate it with Almirall and to profit from the strong German presence it has. Hermal also has a presence in some other European countries, so I think it potentiaties our opportunities in Europe. Afterwards, everything depends very much on the pipeline. We have a deal with Forest for aclidinium bromide for the US, but they have exclusive rights for the monotherapy. However, eventually, for aclidinium combination therapies, it is possible that we could have a co-promotion agreement with them. Whether we would do this depends on many things, so we will see when the moment arrives: we'll look at the situation of the market, at our competitors, at what we have in the pipeline after aclidinium, and then, well, everything is possible."
IMS: "Could you tell us more about your acquisition of Hermal? It was surprising to some observers because dermatology isn't an area that you've been very much involved in, although you have a psoriasis product in the pipeline. Was dermatology something you wanted to move into in the future?"
JG: "I think that Hermal will be complementary to our activities. Hermal is a strong dermatology company in Germany, and they have a lot of experience. They have not only marketed products, but also a number of products in R&D. Dermatology is quite a stable market, where patients are quite loyal to brands. So for us, in Germany where our presence is rather limited, it will be a strong base. We will also bring some of Hermal's products to other affiliates we have around Europe. So Hermal will bring a combination of things to Almirall: a strong base in Germany, expertise in dermatology, and a number of new products."
IMS: "Could you also tell us how things are going generally for Almirall in 2007?"
JG: "Yes, we are fulfilling our budget expectations, although the environment is not so good, especially in Spain where cost-containment measures have been put in place and we have seen price cuts in 2005/6."
IMS then asked Gallardo about Almirall's most important pipeline drug, aclidinium bromide, which is in Phase III trials for chronic obstructive pulmonary disease (COPD).
JG: "So far we have very good results from Phase II which will be published in 2007-8, and we know that we have a product which is safe and active in COPD, and which has a device that is very user-friendly. Phase III recruitment has finished. We expect the results by the second half of 2008.
IMS: "Dr Andersson did mention that it was very user-friendly and emphasized how important it is for you to have a device platform to go with your respiratory pipeline."
JG: "In 2006, when we decided to proceed with the development of aclidinium by ourselves, we needed this technology and that's why we acquired Sofotec. The device was originally an ASTA Medica device, which was acquired by Meda. In 2006, we bought Sofotec (Germany), a company that employs around 120 people. These people specialise in devices and have specialist technology, which is important for our product."
This device has many advantages compared with existing devices, such as Boehringer Ingelheim and Pfizer's HandiHaler, which is used to deliver Spiriva (tiotropium bromide) - the current gold-standard treatment for COPD - although a new, improved device, Respimat, was approved in Europe for use with Spiriva in July 2007 (and is pending approval from the FDA).
Asked whether he thought that aclidinium could become a blockbuster, like Spiriva, Gallardo commented that IMS had forecast $2 billion in peak sales for monotherapy and combination therapies together. Almirall is also developing aclidinium in a fixed combination with formoterol, a beta-2 agonist (Phase II), and an inhaled corticosteroid (preclinical, but should enter Phase II trials in 2008).
These trials were discussed in more detail in a separate interview with Per-Olof Andersson, Almirall's Executive Director, R&D.
PA: "Spiriva is the only long-acting antimuscarinic on the market, but Boehringer Ingelheim has not been able to develop combination products with Spiriva and other agents. If you want it in combination you have to have two separate inhalers. What we have been able to show is that you can combine our antimuscarinic agent [aclidinium] with other agents in our inhaler. And this is, I think, the most important and interesting part of this: that we can actually not only develop a monotherapy but combinations."
Andersson commented that a filing for aclidinium as a monotherapy should take place in 2009, while a filing for the combination with formotorol is scheduled for 2011.
Gallardo also noted that Almirall is seeking a Japanese partner for aclidinium and stated that "advanced negotiations" are ongoing. He added, "For Europe and some other parts of the world, we will wait until results of this Phase III trial are available." Forest is co-developing aclidinium in the US.
IMS: "Finally, how do you see things developing at Almirall over the next 5-10 years?"
JG: "My hope is that the company will grow. Obviously if aclidinium bromide comes to the market and becomes a blockbuster, it could transform the company, in the way that citalopram changed Lundbeck, for example. When you have a product like this, it can change the company and then opens up many opportunities and many possibilities, you know. So that's my hope."
The full transcript of this interview will be available in the November 2007 IMS Company Profile on Almirall, where Per-Olof Andersson talks in detail with Senior Editor Susan Murray about the rest of the company's R&D pipeline.
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