Alexion's two rare diseases are going to be future star breeds.

Alexion's two rare diseases are going to be future star breeds.

November 19, 2015

Recently, the EU has given positive opinions on Alexion's two ultra-orphan drugs, Strensiq (asfotase alfa) and Kanuma (sebelipase alfa), which has enabled the company to focus more firmly on the business model of rare diseases.

No company, like Alexion, has succeeded in treating only a few hundred serious and life-threatening businesses around the world, although many other pharmaceutical companies are trying to replicate the Alexion model. However, analysis by evaluatePharma shows that Alexion's leading position will feel pressure in the next few years.

The rare disease pattern is encouraged

Alexion 2 rare drugs for the EU's positive opinion: Strensiq (asfotase alfa) for the treatment of pediatric onset of hypophosphatase deficiency; Kanuma (sebelipase alfa) for the treatment of lysosomal acid lipase deficiency, which The two drugs also need to wait for the EU to formally approve. At that time, Alexion will be approved for four indications for three products, after the company's Soliris (eculizumab, eculizumab) has been approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical Hemolytic uremic syndrome (aHUS).

Both Strensiq and Kanuma are long-term enzyme replacement therapies for life-threatening and ultra-rare metabolic disorders, and no other drugs have been approved. According toevaluatePharma, Strensiq sales will exceed $800 million by 2020 and Kanuma will exceed $700 million.

It is worth mentioning that these two drugs were acquired by Alexion through acquisition: Alexion recently acquired Kanuma for Synageva for $8.4 billion; and Strensiq for Enobia for $470 million in 2011. Although Strensiq's development schedule was slower than Kanuma when Alexion acquired, the apparent gap between the two transaction values ​​suggests an increase in the valuation of rare disease drugs.

Future star variety

Alexion is one of the two leaders in the rare disease outside the tumor, and the other is Sanofi's subsidiary, Genzan, which has three enzyme replacement therapies - Cerezyme, Myozyme and Fabryzyme. The total sales revenue is roughly the same as that of Soliris. This type of analysis does not include oncology products, and rare disease drugs are often approved for a variety of rare and non-rare diseases.

However, Alexion's Soliris sales should be at the top of the list by at least 2020. Analysts predict that Soliris is approved for two extremely rare diseases, paroxysmal nocturnal hemoglobinuria and hemolytic uremic syndrome, with annual sales rising 16% over the next five years.

However, although Soliris should be at the top of the list by 2020, Vertex's cystic fibrosis combination Orkambi will be very close to it, with a projected sales income of $5.1 billion in 2020.

Roche's Esbriet is considered by analysts to be the third drug in the rare disease market, with an estimated sales income of $2.4 billion. Roche acquired the product last year by acquiring InterMune for $8.3 billion.

The analysis of the evaluate Pharma has spawned several anomalous cases—Teva's multiple sclerosis drug Copaxone entered the list, while most other MS drugs did not. However, most of the remaining positions are occupied by traditional rare disease indications such as lysosomal storage and muscular dystrophy products.

A noteworthy phenomenon is that many rare disease drug products have a long commercial life cycle that traditional products do not have. For example, Sanofi's Cerezyme was first approved in 1994. Mainly because if a rare disease drug product meets the needs of the population - the United States meets less than 200,000 patients, the EU meets less than 250,000 patients and will receive tax, market exclusivity and regulatory benefits.

An evaluation report emphasizes that rare disease drugs, including cancer indications, accounted for 14% of total drug sales in 2014 and are expected to rise to 19% by 2020. The question now is that the pharmaceutical industry will focus on drug development for rare diseases. How long can this state last? (Bio Valley: Bioon.com)

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