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Vertex Gains Reimbursement for Orkambi & Symkevi in Scotland

Zacks Equity Research

Vertex Pharmaceuticals Incorporated VRTX announced that it has received a reimbursement approval in Scotland for its cystic fibrosis (CF) medicines Orkambi and Symkevi. Following this, approximately 400 eligible CF patients in Scotland will now get access to both these drugs for their immediate treatment.

Vertex’s CF medicines are reimbursed in 17 countries across the world. However, the company has faced some challenges with respect to commercialization of Orkambi in the ex-U.S. markets due to re-imbursement hurdles.

Though Vertex has reached reimbursement agreements for Orkambi in several European countries including Germany, Ireland, Netherlands, Sweden, Italy, Denmark and now Scotland, its negotiations continue with several other countries on the Continent that represent significant potential markets including the United Kingdom and France. The company has generated limited revenues from Orkambi in these countries due to the ongoing pricing discussions on Orkambi’s reimbursement rate.

Shares of Vertex have increased 4.1% so far this year against the industry’s decrease of 1.3%.

We would like to remind investors that Vertex’s three CF medicines, namely Kalydeco, Orkambi and Symdeko (known as Symkevi in Europe) are collectively approved for treating a good number of CF patients in North America, Europe and Australia. Total CF product revenues in the first half of 2019 were around $1.8 billion, reflecting a rise of 28.6% year over year.

Vertex’s newest CF medicine Symdeko has become the main driver of CF revenues within a short span. Approval of Kalydeco and Orkambi for new patient populations is also driving sales growth.

Symdeko/ Symkevi generated sales of $682 million in the first half of 2019, reflecting a massive surge of more than 200% year over year. Symdeko’s uptake is being driven by new patient starts as well as shifts from Orkambi and Kalydeco.

Meanwhile, last month, the FDA accepted and granted a priority review to Vertex’s new drug application (NDA) for its triple combination regimen comprising VX-445 (elexacaftor), tezacaftor and ivacaftor to treat CF patients aged 12 years and above. The regulatory body has set an action date of Mar 19, 2020.

If approved, the triple combination regimen will help Vertex address a significantly larger CF patient population (almost 90% of patients with CF) in the future.

Even though Vertex enjoys a strong position in the CF market, it is likely to face a tough competition from several companies like AbbVie ABBV, Eloxx Pharmaceuticals, ProQR Therapeutics PRQR and Proteostasis Therapeutics, which are also developing medicines to treat CF.

Zacks Rank & Another Key Pick

Vertex currently has a Zacks Rank #2 (Buy). Another top-ranked stock in the healthcare sector is Amgen Inc. AMGN, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Amgen’s earnings estimates have been revised 2.9% upward for 2019 and 4.3% for 2020 over the past 60 days. The stock has inched up 0.4% year to date.

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