AstraZeneca Files For Label Expansion Of Tagrisso In Japan

AstraZeneca (NYSE:AZN) announced that it filed a regulatory application in Japan to expand the label of its cancer drug, Tagrisso (osimertinib), for the first line treatment of patients with EGFR mutation-positive non-small cell lung (“NSCLC”).

Tagrisso is approved in the United States, European Union, Japan and China as a second-line treatment option for patients with EGFR mutation-positive NSCLC.

AstraZeneca’s shares have outperformed the industry year to date. The stock has rallied 23.3% compared with the industry’s gain of 15.3% during the period.

The submission was based on the phase III FLAURA study, evaluating Tagrisso compared with the standard-of-care EGFR tyrosine kinase inhibitor (TKI) therapy in the first-line lung cancer setting.

The data showed that treatment with Tagrisso reduced the risk of progression or death by more than half compared with the commonly-used EGFR inhibitors for the first-line treatment of patients with EGFR mutation-positive NSCLC. The median progression-free survival (PFS) was 18.9 months for patients on Tagrisso as compared to 10.2 months in the comparator arm. Tagrisso was well-tolerated in the trial with a safety profile, consistent with the previous experience.

Presently, Tagrisso, is under review in both the United States and the EU for the first-line treatment of patients with NSCLC. In October, Tagrisso has been granted a breakthrough therapy designation by the FDA for the aforementioned indication.

Per the press release, lung cancer is a major cause for deaths as it grips both men and women. Per the alarming figures, around 15-20% of patients in the United States and 30-40% in Asia are diagnosed with EGFR mutation. Of the total patients afflicted with the indication, roughly 50% develop resistance to approved therapies such as AstraZeneca's Iressa (gefitinib) and Roche's (OTC:RHHBY) Tarceva (erlotinib). Hence, label expansion of Tagrisso will allow the company to cater to the hugely unmet needs of patients, who are non-sensitive to treatment with currently-available EGFR therapies.

In a separate press release, AstraZeneca announced formation of a strategic joint venture with the Chinese Future Industry Investment Fund (“FIIF”) in order to create a new stand-alone company, Dizal Pharmaceutical, with equal ownership of both parties.

Pursuant to the agreement, Dizal Pharmaceutical will be responsible to discover, develop and commercialize innovative medicines in China. The combined entity will also win exclusive rights to develop and commercialize three pre-clinical candidates from AstraZeneca’s main therapy areas — oncology, cardiovascular and metabolic diseases plus respiratory disorders.

With this collaboration, AstraZeneca aims at strengthening its foothold in China.

Zacks Rank & Key Picks

AstraZeneca carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector are Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Ligand’s earnings per share estimates have moved up from $3.68 to $3.70 for 2018 over the last 30 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 8.22%. Share price of the company has surged 28.1% year to date.

Achillion’s loss per share estimates have narrowed from 65 cents to 63 cents for 2017 and from 74 cents to 67 cents for 2018 over the last 30 days. The company came up with positive earnings surprises in two of the trailing four quarters with an average beat of 4.51%.

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