Amgen Dumps AstraZeneca PLC Pact After Patients Developed Suicidal Thoughts

Published: May 27, 2015

Amgen (AMGN) Dumps AstraZeneca PLC (AZN) Pact After Patients Developed Suicidal Thoughts
May 26, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Amgen is scuttling a major deal with AstraZeneca PLC to develop psoriasis drug brodalumab after a patient involved in a late-stage trial developed suicidal thoughts and behavior.

That development means the drug would likely require restrictive labeling, if it were eventually approved by regulators, and the risk was enough for Amgen to pull the plug on the partnership.

The news is a major blow to both companies, who had predicted the drug could eventually rake in $500 million and $1.5 billion in sales annually.

"During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab," said Sean E. Harper, executive vice president of Research and Development at Amgen, in a statement.

The company said it would no longer be involved in the development of brodalumab, though there was some indication AstraZeneca may continue to advance the program.

“After Amgen transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab,” said Amgen.

Forecasts for the program had been sunny and the latest news came as a stunning blow, said several analysts. In November, Amgen (AMGN)’s announcement that the drug saw Phase III results making it superior in some aspects to main competitor Stelara were seen as a huge boon for the company, said Bret Holley, a biotech analyst with Guggenheim Securities, in a note to investors at the time.

On Nov. 11, Amgen announced top-line brodalumab results from its Phase III AMAGINE-3 trial in moderate/severe plaque psoriasis. That data showed brodalumab demonstrated superior efficacy on all endpoints, including, most notably, superior efficacy of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100).

“We believe the PASI 100 results will be differentiating for brodalumab, based on a striking 36.7 percent for 210 mg and 27 percent for 140 mg brodalumab, versus 18.5 percent for Stelara and 0.3 percent for placebo,” wrote Holley in a note to investors. “With this outcome, we believe Amgen will be able to effectively position high-dose brodalumab versus. Stelara and the anti-TNFs in psoriasis."

Holley said even more importantly, brodalumab's safety profile appeared comparable to Stelara in the top-line results, with an SAE rate of 1.4 percent, 1.6 percent and 0.6 percent for 210 mg brodalumab, 140 mg brodalumab, and Stelara, respectively.

“Based on positive results from Phase III AMAGINE-1 trial of brodalumab in psoriasis, we had expected a positive outcome from AMAGINE-3, but we believe brodalumab's superiority over Stelara is a clear win for Amgen,” said Holley. “Amgen expects results from a third Phase III brodalumab psoriasis trial (AMAGINE-2) by year end 2014, and we believe these results will further underscore the drug's superior efficacy versus Stelara.”

Brodalumab is a joint effort between Amgen and British drugmaker AstraZeneca PLC (AZN). Stelara is produced by Johnson & Johnson and brought $543 million for the company in the third quarter alone, up 47 percent from the previous quarter, a sign the market is ripe for a new, more effective drug.

“Although we continue to see a high likelihood brodalumab will reach more than $2 billion sales in psoriasis, based on a superior profile versus existing psoriasis biologics that continue to emerge, we believe Amgen's current valuation correctly reflects a high level of enthusiasm of the drug and the company's other key, late-stage pipeline candidates, led by evolucumab,” said Holley. “Based on this, we would wait for a pullback in the stock to add significantly to positions.”



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