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Shire Gets FDA Nod for Cinryze Tech Transfer to New Site

Zacks Equity Research
Updated
Shire (SHPG) receives an FDA approval for transferring the product manufacturing technology of its hereditary angioedema drug, Cinryze, to its manufacturing site in Vienna, Austria.

Shire plc SHPG announced that it has received an FDA approval for transferring the product manufacturing technology of its hereditary angioedema (HAE) drug, Cinryze (C1 esterase inhibitor), to its in-house manufacturing site in Vienna, Austria. The company expects to start commercial manufacturing of Cinryze at the given site during the first quarter of 2018.

Notably, the company has been facing consistent supply challenges for Cinryze, which is produced by a single third-party supplier.

In third-quarter 2017, the company’s Genetic disease portfolio sales were down 7.1% to $628.1 million, primarily due to lower sales of Cinryze, having plunged 65.6% to $56.9 million as a result of supply shortage arising from manufacturing interruption.

With the FDA’s approval of the tech transfer, the company will be able to address the supply disruption of Cinryze as demand for the drug has periodically exceeded its supply from the company’s single third-party partner.

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Shire’s shares have underperformed the industry in a year’s time. The stock has lost 13.2%, comparing unfavorably with the industry’s rally of 16.1%.

We remind investors that Cinryze is approved for the treatment and pre-procedure prevention of angioedema attacks in children (aged two years and above) with HAE.  

It is important to mention that Shire acquired ViroPharma in 2014, which added Cinryze to its portfolio. The drug complements Shire's Firazyr, indicated for the on-demand treatment of acute HAE attacks. The buyout of Dyax also added Kalbitor to Shire’s HAE portfolio.

Shire has a dominant position in the rare diseases market, growing faster than the broader biopharmaceutical market. A strong performance of Vyvanse, Lialda and Firazyr should continue to drive its top line in the upcoming quarters. The approval of Xiidra has also boosted the company’s revenues.

Zacks Rank & Key Picks

Shire carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the health care sector are Exelixis, Inc. EXEL, XOMA Corporation XOMA and Sucampo Pharmaceuticals, Inc. SCMP. While Exelixis and XOMA sport a Zacks Rank #1 (Strong Buy), Sucampo carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Exelixis’ earnings per share estimates have been revised upward from 72 cents to 77 cents for 2018 over the last 60 days. The company pulled off a positive earnings surprise in each of the trailing four quarters with an average beat of 572.92%. Share price of the company has soared 52.1% in a year’s time.

XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 over the last 60 days. The company came up with an average beat of 47.92%. The stock has skyrocketed 601.4% in the last 12 months.

Sucampo’s earnings per share estimates have moved north from $1.15 to $1.19 for 2018 in the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.63%. The company’s share price has surged 52.5% in a year.

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