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Shire’s ADHD Portfolio Remains Strong Amid Competition


We issued an updated report on Shire Plc SHPG on Sep 7, 2018.

Shire holds a strong position in the attention deficit hyperactivity disorder (ADHD) market. The growth engine of the company is Vyvanse. We are also encouraged by Shire’s efforts for the label expansion of lead ADHD drug Vyvanse. The label expansion of Vyvanse approved by the FDA for the treatment of moderate-to-severe binge eating disorder (B.E.D.) in adults boosted sales of the company.

Shares of the company have increased 25.1% compared with the industry’s decline of 3.7%.

The company also has in its portfolio-the drug Vonvendi which is approved in the United States and is first and only recombinant von Willebrand factor (rVWF) treatment for adults living with first and only recombinant von Willebrand factor (rVWF) treatment for adults living with von Willebrand disease (VWD).

Vonvendi will be called Veyvondi in Europe and in July 2018, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the granting of marketing authorization of Veyvondi in the European Union (EU) for the treatment of bleeding events and treatment/prevention of surgical bleeding in adults (age 18 or older) with VWD, when desmopressin (DDAVP) treatment alone is ineffective or not indicated.

Shire recently acquired sanaplasma AG, a source plasma collection company headquartered in Switzerland. The acquisition of sanaplasma AG is expected to expand Shire’s access to plasma in the longer term.

Earlier, the acquisition of ViroPharma in 2014 added Cinryze (routine prophylaxis against angioedema attacks in adolescents and adults with hereditary angioedema) and investigational candidate, maribavir (cytomegalovirus infection in transplant patients) to Shire’s portfolio.

Cinryze complements Shire's Firazyr, which is indicated for the on-demand treatment of acute hereditary angioedema (HAE) attacks. Also, the European Commission (EC) has approved a label extension for Cinryze and Firazyr for use in pediatrics. A label expansion for Cinryze in pediatric patients was also approved by the FDA in June 2018.

In August 2018, the FDA approved Takhzyro (lanadelumab-flyo) injection for prophylaxis, to prevent attacks of HAE in patients 12 years of age or older. Takhzyro is a first-of-its-kind mAb preventive treatment for HAE. The drug is a subcutaneous injection that took majority of patients one minute or less to self-administer.

However, the U.S. ADHD market is highly genericized, given the presence of authorized generic versions of Johnson & Johnson’s JNJ Concerta, Novartis’ NVS Ritalin LA, authorized generic and generic Adderall XR, and Shionogi’s Kapvay.

On the other hand, Shire is due to be acquired by Japan-based Takeda Pharmaceutical. In May 2018, Shire accepted a buyout offer from Takeda valuing the company at 47 pounds per share or around 46 billion pounds ($62 billion). Takeda offered 0.839 new Takeda shares or 1.678 Takeda ADSs (valued at 27.26 pounds) and $30.33 (21.75 pounds) in cash for each ordinary share of Shire. The deal is expected to close in the first half of 2019.

Zacks Rank & Stocks to Consider

Shire is a Zacks Rank #3 (Hold) stock.

Another better-ranked stock in the biotech sector is Gilead Sciences Inc. GILD, sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead’s earnings per share estimates have increased from $6.11 to $6.58 for 2018 and from $6.36 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 4% so far this year.

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