FiercePharmaAsia—Aducanumab Alzheimer’s flop; Keytruda’s Chinese market; Samsung BioLogics probe

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Eisai, Keytruda and Samsung BioLogics made our news this week. (Google)

Biogen's and Eisai's stocks were dealt a huge blow as the phase 3 program of Alzheimer's candidate aducanumab was terminated early for futility. Despite challenges from lower-priced domestic rivals, Merck & Co.'s Keytruda could still see blockbuster sales in China, a group of analysts said. Prosecutors raided Korea Exchange as part of an investigation into Samsung BioLogics’ alleged violation of accounting rules in its 2016 IPO. And more.

1. Biogen hit by 'transformative failure' as it cans aducanumab tests

Biogen and partner Eisai have stopped phase 3 testing of much-hyped Alzheimer’s candidate aducanumab early after a data monitoring committee found it unlikely that the beta-amyloid antibody would significantly slow cognitive and functional impairment, the study’s primary endpoint. Through a co-development and co-promotion deal signed in 2017, Eisai would have shared potential profits with Biogen had the drug been successful. On Friday, Eisai’s stock in Tokyo slumped almost 17%, hitting its daily fluctuation limit.

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2. Analysts: Keytruda has a blockbuster market not factored into Merck’s forecasts—China

Keytruda could reach blockbuster sales in China, given its known profile in lung cancer, the most common cancer type in China, Cantor Fitzgerald analysts estimate. Citing interviews with two Chinese oncologists, the analysts found that doctors are more comfortable using the Merck & Co. drug because of its “bolus of efficacy and safety data.” In comparison, Junshi Biosciences’ toripalimab and Innovent’s Lilly-partnered sintilimab are given at around 50% discounts, but neither has data on how long they can prolong patients’ lives.

3. More trouble for Samsung BioLogics: Prosecutors raid Korea Exchange in IPO probe

South Korea prosecutors raided Korea Exchange offices on March 15, trying to find evidence on whether the exchange gave Samsung BioLogics special treatment for its 2016 initial public offering, Nikkei reported. Stock regulators previously ruled that the CDMO intentionally violated accounting rules regarding how it booked a biosimilar joint venture with Biogen, an accusation Samsung is challenging.

4. Ebola vaccine maker CanSino Bio to raise $160M in Hong Kong IPO

Tianjin, China-based CanSino Bio is looking to raise up to $160 million in its Hong Kong IPO. As the first vaccine share in Hong Kong under the new prerevenue rule, CanSino plans to sell 57.25 million shares in the price range of HK$21 to HK$22 apiece. Trading will begin on March 28. The company made its name in 2017 by winning Chinese approval for its Ebola vaccine.

5. Spectrum’s Neulasta competitor tripped up by manufacturing issues

Spectrum Pharmaceuticals has pulled its biologics license application for Rolontis, a potential challenger to Amgen’s Neulasta. The FDA asked for more information about the chemistry, manufacturing and controls process, which Spectrum can’t get together before the approval deadline. The drug is being manufactured in South Korea by Hanmi.

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