FiercePharmaAsia—Amgen-BeiGene $2.7B tie-up; AZ's China projects; controversial Alzheimer's drug

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Amgen, BeiGene, AstraZeneca, a new Alzheimer's drug from China, Takeda and Daiichi Sankyo made our news this week. (Google)

Amgen is tapping into BeiGene’s R&D and marketing capabilities in China by paying $2.7 billion for a 20.5% stake in the Chinese biotech. AstraZeneca said it's stepping up its commitment to China with a slew of investments, as CEO Pascal Soriot and other Big Pharma execs dropped in on Shanghai for the China International Import Expo. China has granted conditional approval to a homegrown Alzheimer's disease therapy, but the drug's clinical data are far from convincing. And more.

1. Amgen pays $2.7B to enlist BeiGene as Chinese R&D partner

In a testament to BeiGene’s R&D and marketing capabilities that could quash some recent short-seller questions, Amgen is paying $2.7 billion for a 20.5% stake in the Chinese biotech. BeiGene will help develop 20 cancer drugs from Amgen’s pipeline for the Chinese market and get commercial rights for seven years. Analysts at Jefferies framed the deal as a positive for Amgen “as there is clear, good rationale to get exposure to this rapidly-growing geography.”

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2. AstraZeneca creates $1B Chinese fund, vows to double R&D team

Top execs from AstraZeneca, Roche, Sanofi and GSK tout China investments at import expo

AstraZeneca is teaming up with China International Capital Corporation to launch a $1 billion fund focused on healthcare, upgrading its Shanghai R&D operations to a global hub and establishing a new artificial intelligence center. It also agreed to sell some oncology drugs for Sun Pharma in the country. Besides AstraZeneca CEO Pascal Soriot, top pharma execs from Roche, Sanofi and GlaxoSmithKline also showed up at the China International Import Expo to renew their commitment to China.

3. China approves a new, home-grown Alzheimer's drug—and questions immediately follow

Breaking a 17-year drought, China approved a new Alzheimer’s drug, Shanghai Green Valley Pharmaceuticals’ seaweed-derived oligomannate (GV-971). However, skeptics pointed out that in its Chinese phase 3 study, the drug only showed improvement on a single Alzheimer’s assessment and didn’t beat placebo in others. The company is planning a global phase 3 in early 2020.

4. Takeda's dengue shot 80% effective in massive phase 3 test

Takeda opens €130M plant to produce dengue vaccine it has yet to get approved

In a large phase 3 test in more than 20,000 participants in dengue-endemic countries, Takeda’s dengue vaccine, TAK-003, was found to be 80.2% effective. In those who hadn’t had a prior dengue infection, the vaccine was 74.9% effective in preventing dengue, an important note as Sanofi’s dengue shot Dengvaxia tripped up because of safety problems in dengue-naïve people. The Japanese pharma opened its €130 million plant in Singen, Germany, to make the vaccine.

5. Daiichi sues Seattle Genetics over tech used in high-profile ADC

In 2008, Seattle Genetics granted Daiichi Sankyo a license to use its cytotoxin and linker technology in an antibody-drug conjugate (ADC). Now Seattle Genetics thinks it is the rightful owner of ADC tech used in the HER2-targeting candidate DS-8201, which attracted AstraZeneca in a $6.9 billion deal. In disagreement, Daiichi filed a declaratory judgement action in the District Court of Delaware.

6. Don't wait up. FTC delays Novartis' Sandoz deal with Aurobindo into 2020: report

Aurobindo is finding it difficult to satisfy the FDA, or the FTC

The U.S. Federal Trade Commission has asked for more information on a lawsuit against Aurobindo, delaying its $1 billion Sandoz U.S. generics deal past the planned 2019 closure. Both firms are named in a price-fixing lawsuit 44 U.S. states had filed against 20 generics makers. Meanwhile, the Indian drugmaker said the FDA slapped it with a four-observation Form 483 following inspections of its two API plants in Hyderabad.

7. Takeda bags MD Anderson CAR-NKs, plans 2021 pivotal trial

Takeda has struck a deal with the MD Anderson Cancer Center to access up to four CAR-NK cell therapies, including candidates against CD19 and BCMA. Compared to existing CAR-T drugs, NK cells can be transplanted into another individual, and they are free from some severe side effects.

8. Takeda's emerging markets cull reaches Russia with $660M Stada sell-off

To further pay down debt, Takeda agreed to sell rights to about 20 drugs in Russia, Georgia and several other Commonwealth countries to Stada for $660 million. About 500 current Takeda employees in sales and marketing could jump to the German drugmaker. The deal is the largest acquisition in Stada’s history.

9. Daiichi Sankyo pulls out of U.S. pain market amid oncology pivot, opioid scrutiny

Daiichi Sankyo bowed out of a marketing collaboration with AstraZeneca over opioid-induced constipation treatment Movantik, and it canceled a licensing agreement with Inspirion Delivery Sciences covering opioid drugs MorphaBond and RoxyBond. With that, the company exited the U.S. pain treatment business to focus on oncology and the injectable iron business.

10. Biogen and Samsung expand biosimilar deal to cover Lucentis, Eylea and China

Biogen is getting exclusive rights to Samsung Bioepis’ biosimilar versions of eye drugs Lucentis and Eylea. It's also expanding its hold on three marketed anti-TNF copycats to China. The news came right before Chinese authorities approved the country’s very first copycat to AbbVie’s Humira.

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