In this sense, says The Pharma Letter’s Spanish correspondent, it is important to note the last announcements they have made during the last weeks, related to new agreements with Spanish GP Pharm, and Japanese Chugai (TYO: 4519, owned 60% by Roche) to buy and sell, respectively, licenses for commercialization of pharmaceuticals products around the world.
With the first of these agreements, PharmaMar bought the license for Politrate (leuproreline), for prostatic cancer, to distribute exclusively in Italy from October. “The goal of this operation is optimizing the commercial structure they have there, taking into account the synergies between the products and our network of sales,” said Luis Mora, general manager of PharmaMar, adding: “We had said before that we are negotiating with other companies to maximize the value of our commercial structures in countries as Italy, and we are going to continue doing the same”.
In the case of Politrate, the Spanish biotech is expecting to gain entrance into a market valued in 35 million euros ($47.3 million), where there are also other competitors. And, anyway, it is not going to have a big impact over its finances, Mora said, remembering the importance of revenues for a small company who needs cash to continue investigating.
Agreement with Chugai
On the other hand, PharmaMar announced a new agreement with Japan’s Chugai, which acquires the license to commercialize Aplidin (plitidepsin) for the treatment of patients with multiple myeloma in eight European countries (France, Germany, UK, Belgium, Netherlands, Luxemburg, Ireland and Austria.
To acquire these rights, Chugai will pay an upfront of 5 million euros, although it could add 30 million euros more according to development, regulatory and commercial milestones. Also, Zeltia’s affiliate will receive royalties from sales and have revenues of selling the products in the rest of European countries (Spain, Italy and Nordics, mainly) where it is going to sell it through its solid commercial structure. It could be possible from the last quarter of 2015, when the company expects all regulatory process could have finish in Europe. “It is important for us receiving the confidence of a company as Chugai, which has put its trust in a product which is still being developed. It creates a good and serious image from PharmaMar,” explained Jose Luis Moreno, responsible for capital markets at PharmaMar.
Nowadays, the product has shown strong data of safety and efficacy, and PharmaMar has recently initiated the Phase III ADMYRE study to confirm it is a valid candidate to treat patients with multiple myeloma. “If final results are positive, it is important to note that European approval it is recognized by other 40 countries, so we are evaluating agreements with other partners to commercialize Aplidin in all of them", said Mr Moreno.
Once again, expert on financials of PharmaMar could not give an exact estimation of the share of the market they could reach with this product, although they calculate it could be near to 300-400 million euros in Europe (Aplidin would be applied in third/quarter line of treatment), taking into account it will compete with other protosome inhibitors and lenalidomide.
PharmaMar’s pipeline: PM01183 :
As has been said before, all resources that PharmaMar can extract from licensing in both directions and with products with low level revenues are thought as useful for financing big innovations with wide indications. One of these, as Moreno pointed out, is PM1183, a new molecular entity that could be used for treatments of several types of cancers.One proof of that are the results which were presented in American Society of Clinical Oncology annual meeting, held last June in Chicago. In a multicenter Phase II trial, patients with platinum-resistant/refractory ovarian cancer (PRROC) patients received PM1183 in monotherapy, compared with topotecan.
According to data published by PharmaMar, PRROC patients treated with topotecan did not register any objective response, whereas 30% of patients treated with PM1183 exhibited a clinically-significant response. Clinical benefit (objective response or disease stabilization) was observed in 71% of patients treated with PM1183, and in 52% of those who were administered topotecan. Also, median progression free survival in randomized PRROC patients treated with PM1183 was 5.7 months, compared with 1.7 months in patients with topotecan.
Finally, a statistically significant difference of over four months was observed in overall survival between randomized patients treated with PM1183 and those in the control arm. Results could be better because 50% of patients treated with PM1183 are still being monitored for survival. So according to this data, and predictable and manageable safety profile, PharmaMar confirmed that is planning a pivotal Phase III trial with this compound for this indication.