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5 promises AstraZeneca must keep now Pfizer's gone

This article was originally published in Scrip

Executive Summary

Many at AstraZeneca are likely breathing a sigh of relief at having fended off a Pfizer takeover (for now at least), but the company cannot bask in its so-called victory for long. With several of the company's shareholders criticizing the board's handling of the situation ( scripintelligence.com, 22 May 2014), AstraZeneca has to deliver on the promises it made during negotiations and prove turning down Pfizer's advances was the right decision. While the Pfizer threat is at bay for now, in six months' time the US giant will have the opportunity to bid once more ( scripintelligence.com, 26 May 2014).

So here is a reminder of some of the main promises CEO Pascal Soriot and his team have made.

1. Key 2014 data readouts

In the near-term, AstraZeneca has promised several key data readouts, which will need to be good for the company to garner credibility for its ambitious forecasts and retain investor confidence.

The data the company has specifically highlighted are:

Compound

Indication

Milestone

Date

brodalumab

psoriasis

top-line Phase III

2Q and 4Q

saxagliptin/dapagliflozin

type 2 diabetes

Phase III

13-17 June 2014 (ADA)

MEDI4736

solid tumors

Phase I

30 May-3 June 2014 (ASCO)

AZD9291

non-small cell lung cancer

Phase I

30 May-3 June 2014 (ASCO)

lesinurad

gout

top-line Phase III results

3Q

CAZ-AVI

cIAI

top-line Phase III

3Q

sifalimumab/anifrolumab

SLE

top-line Phase IIb

3Q

oncology portfolio

various tumors

-

26-30 September 2014 (ESMO)

AZD3293

Alzheimer's disease

Phase I

12-17 July 2014 (AAIC)

mavrilimumab

rheumatoid arthritis

Phase IIb

14-19 November 2014 (ACR)

Source: AstraZeneca

2. 19 Phase III trial starts in 2014-15

In another attempt to display pipeline depth, AstraZeneca has promised to start 19 Phase III registration trials for new molecular entities (NMEs) between now and 2015. Between four and five of these are slated to start this year.

3. Return to growth by 2017

Broadly, AstraZeneca has committed to returning to growth "as quickly as possible." Specifically, the company has said it will have 2017 revenues broadly in line with its 2013 revenues (which were $25.7bn), at which point it will return to growth. During the period 2013-17, the company is facing a decline as a result of exclusivity losses on some of its major products.

4. At least 10 new product launches by 2020

One of the most controversial promises the company has made as part of its 10-year plan (originally laid out in 2013) is that it will be able to generate revenues of more than $45bn by 2023. In order to reach these fabled heights, the company needs to come good on its vow to deliver at least 10 new products to the market between 2013 and 2020. AstraZeneca has several promising candidates which could make it to the market in that time.

Among others, in oncology, filings for the company's four olaparib products are expected between 2016 and 2017; leukemia drug moxetumomab pasudotox is expected to be filed in 2018; and MEDI4736 in 2016. In respiratory, lesinurad, benralizumab, PT003 GFF and PT001 GP are all expected to be filed between 2014 and 2016. And in infection, CAZ AVI (cephalosporin/beta lactamase inhibitor) is expected to be filed in 2014 and 2017 in separate indications ( scripintelligence.com, 14 May 2014).

5. Generate revenues of over $45bn by 2023

If all these factors come good, AstraZeneca says revenues of more than $45bn by 2023 are achievable. However, this means making a steep $20bn ascent in just six years from anticipated revenues of around $25bn in 2017.

Some of the company's forecasts (many of which have been roundly criticized as unrealistic) include $3.5bn peak sales for cardiovascular drug Brilinta (ticagrelor); $8bn revenues from the diabetes franchise; $8bn from the respiratory franchise; $6.5bn for Phase III cancer product MEDI4736 and subsequent combinations; and $2bn for ovarian cancer drug olaparib.

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