FiercePharmaAsia—Takeda investors’ fear, WuXi’s 6-fold stock jump, Gardasil-made billionaires

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Takeda, WuXi AppTec, Zhifei Biological Products, Eisai and Zai Lab made our news this week. (Google)

Some Takeda shareholders are worried about the firm taking on a huge debt and issuing new shares to finance the $62 billion Shire deal, and they're demanding a vote at the next shareholder meeting. In three weeks on Shanghai Stock Exchange, WuXi AppTec's stock jumped sixfold by Tuesday. Two major shareholders behind China's Zhifei Biological Products have earned places on Bloomberg's billionaires list.

1. Takeda shareholders fear dilution, debt from Shire deal pose ‘high risks,’ demand shareholders vote on it

Not all Takeda shareholders are happy about the $62 billion Shire deal. A group of 12 investors has asked for a vote to decide its fate. Noticing that Takeda will finance more than half of the takeover through newly issued shares, these opposing shareholders worry that might dilute the earnings per share. They want executives to address the “overly high risks” attached to the deal. The company’s stock price has dropped over 20% since late March.

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2. WuXi AppTec warns traders to cool off after 6-fold stock price increase in 3 weeks

When WuXi AppTec officially started trading in Shanghai May 8, it went straight to hitting the daily increase ceiling allowed, and did the same for the following 15 consecutive trading days. Its stock price has jumped from CNY21.60 ($3.36) pre-trading to CNY129.91 on Tuesday, making it the largest-cap CRO. Citing “abnormal fluctuations,” WuXi tried to calm down investors by drawing their attention to the risks.

3. Meet the Gardasil billionaires, spawned from Merck vaccine's advance into China market

Gardasil franchise’s recent Chinese approvals have propelled two Chinese families into Bloomberg’s ranking of the world’s richest people. The chairman of Zhifei Biological Products, the company that holds Chinese rights to the two HPV vaccines, was worth of about $4.6 billion Wednesday. The firm’s former vice chairman also saw his wealth jump to $1.5 billion as the new market potential came into play.

4. FDA stalls Eisai—and its new partner Merck—in quest to widen cancer med Lenvima's reach

The FDA postponed its decision on Lenvima as a treatment for previously untreated liver cancer patients. Now developer Eisai and partner Merck & Co. expect a verdict by Aug. 24. The delay is a reprieve for Bayer’s Nexavar, which Lenvima had beat slightly in a head-to-head showdown. That data promoted Merck to strike a deal worth up to $5.8 billion with Eisai in March.

5. Crescendo cuts psoriasis drug deal with China’s Zai Lab

China’s Zai Lab has obtained worldwide license to an undisclosed drug of Crescendo Biologics’ with applications in inflammatory diseases, and is planning clinical trials next year. This is Crescendo’s first deal outside its core cancer focus. It signed a $790 million platform alliance with Takeda in 2016.

6. Out of the FDA doghouse, Celltrion again seeks Rituxan biosimilar nod

Celltrion said it has resubmitted its application to the FDA for a Rituxan biosimilar and will resubmit its Herceptin copycat next month. Both Teva-partnered drugs were rejected last year because of plant failings that led to an FDA warning letter. Celltrion said it has resolved the agency’s concerns and is scheduled for a reinspection of the site.

7. Sun Pharma's 2019 revenues to fall short on U.S. generics price pressure as manufacturing issues persist

Sun Pharma said it expects 2019 fiscal year’s revenues won’t meet analysts’ expectations due to poor generic sales and rising competition in the U.S. market, which accounts for about 35% of its total revenues. Its full-year 2018 U.S. sales dropped 34% from the previous year, while it’s still trying to get the key Halol plant pass the FDA’s standards.

8. Gilead wins Chinese approval for Epclusa, but the emerging market is getting crowded

Gilead’s Epclusa became the first pangenotypic hepatitis C treatment approved in China. The country has about 10 million HCV patients, but that might not be able to salvage Gilead’s HCV franchise from declining to just $3.5 billion to $4 billion in sales this year, thanks to existing or looming competitions from Merck and AbbVie.

9. Pivotal bioVenture Partners debuts $150M China-focused biotech fund

The Nan Fung Group’s Pivotal bioVenture Partners has raised a $150 million venture fund to help early-stage life science companies located within China, and intends to raise another $50 million later this year. This follows the venture capital firm’s inaugural $300 million fund last year that’s focused on the U.S. and Europe.

10. Study says African, Middle East generics growth likely to buoy India’s drug manufacturers

Pricing pressures and competitions in the U.S. market may have caused losses for generic drugmakers, but Africa and the Middle East could help boost sales, a recent CPhI study suggests. The Gulf Cooperation Council recently signed a free-trade deal that reduces trade barriers and put forward a drug-pricing strategy that’s expected to fuel generics consumption.

11. FDA hits Chinese API maker Jilin Shulan Synthetic Pharma with warning letter

Chinese API maker Jilin Shulan Synthetic Pharma was hit with a warning letter by the FDA, which cited numerous quality-control and data-integrity issues. The plant produces aminophylline used in muscle relaxants and 8-chloro theophylline used in motion-sickness drugs.