FiercePharmaAsia—Takeda-Shire reach finish line, Hong Kong prerevenue IPO, AstraZeneca’s asset sale

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Takeda, Ascletis, Hong Kong Exchange, AstraZeneca and Luye Pharma made our news this week. (Google)

Takeda and Shire have finally agreed on a debt-loaded $62 billion merger deal, and major cutbacks are already on the way. China's antiviral drugmaker Ascletis has become the first to file for a Hong Kong IPO under the recently relaxed listing rules for prerevenue biotechs. In another round of asset sale at AstraZeneca, China's Luye Pharma gets rights to the Seroquel franchise. 

1. Takeda to vault into Big Pharma with $62B Shire buyout—and megamerger cuts are on the way

Takeda and Shire have officially agreed on the $62 billion—46% cash, 54% stock—buyout deal, which will shoot up Takeda’s revenue into the rank of top 10 pharma companies worldwide. The deal means taking on a hefty debt load for Takeda, and it comes with a $1.4 billion cost reduction plan that aims to cut 6% to 7% of the combined workforce, or around 3,600 employees.

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2. Ascletis files for Hong Kong IPO as floodgates open to prerevenue biotechs

Hong Kong recently changed its rules to allow prereveue biotechs to be listed. Requirements include a minimum evaluation of HK$1.5 billion ($191 million). Hangzhou, China-based Ascletis has become the first biotech to seek an enlistment under the new rule. The company has built a pipeline of hepatitis C therapies licensed from Western developers.

3. AstraZeneca continues yard-sale strategy with $538M Seroquel rights deal

AstraZeneca has offloaded some rights to antipsychotic Seroquel and its extended-release version, Seroquel XR, to China’s Luye Pharma. The deal, with a total value of up to $538 million, covers rights in the U.K., China and other markets, which together generated $148 million in sales from the drugs last year. It follows several other asset sales at AZ to raise billions of dollars.

4. Aurobindo bids $1.6B for Novartis' U.S. dermatology generics: report

After initially eyeing up Sanofi’s European generics business, India’s Aurobindo is now said to have submitted a $1.6 billion offer for Sandoz’ dermatology business. The deal would include manufacturing facilities and other infrastructure, according to Livemint. If successful, it could become the biggest foreign acquisition by an Indian drugmaker.

5. Daiichi Sankyo in pursuit of Novartis’ Rydapt with next-generation FLT3 drug

Daiichi Sankyo said its quizartinib has become the first drug in the FLT3 class to improve overall survival compared with chemo in relapsed or refractory acute myeloid leukemia with FLT3-ITD mutations. The company is filing for approval and will head into competition with Novartis’ Rydapt. It is also in a phase 3 in the first-line setting, with readouts expected in 2020.

6. Boosted by China launch, Merck's Gardasil turns in a big first-quarter performance

Though Merck’s Gardasil sales suffered in the U.S. from the implementation of a two-dose regimen in young adolescents, revenues from the HPV vaccine franchise still grew 24% in the first quarter to $660 million, thanks to its recent launch in China. Some other shots, like shingles vaccine Zostavax, suffered in the face of competitions.

7. Teva expects FDA preapproval inspection of troubled Celltrion plant this year

Teva expects an FDA preapproval inspection could clear a Celltrion plant where the API for Teva’s migraine therapy fremanezumab is made. The plant currently bears an FDA warning letter, which disrupted Teva’s original plan to gain an approval by mid-June. Teva still expects to launch the drug this year. Celltrion said only that it expects to resolve FDA issues in a timely manner.

8. Astellas to pay Aquinox $25M upfront for regional rights to phase 3 inflammatory pain drug

Astellas is paying $25 million upfront and up to $130 million in milestones for the exclusive rights to Aquinox’s rosiptor in Japan and other Asia-Pacific regions. China and India are not covered by the deal. A phase 2 trial of the drug in bladder pain syndrome/interstitial cystitis (BPS/IC) missed its primary endpoint in 2015, but Aquinox moved into phase 3.

9. China's Sinovac Biotech halts hepatitis A vaccine production amid boardroom drama over company

Chinese vaccinemaker Sinovac Biotech recently halted production of its hepatitis A vaccines, citing repeated interruptions from Aihua Pan, chairman of Sinovac Beijing, and Sinobioway Biomedicine, a minority shareholder of the Sinovac Chinese controlled subsidiary. Pan is fighting Sinovac CEO Weidong Yin for control of the company.

10. WuXi STA plant gets FDA nod for 2 APIs, passing its first inspection

WuXi STA’s new plant in Changzhou, China, just passed an FDA preapproval inspection related to two APIs. The CDMO has previously passed FDA inspections at its two Shanghai sites.

11. South Korean company nabs plant that makes generic Botox

South Korean firm PharmaResearch Products said it had invested about $35 million to obtain majority ownership of a facility of compatriot BioCND. The plant makes a generic botulinum toxin type A injection (ReNtox) with the same ingredient used in Botox.

12. Wuxi Vision raises $13M to commercialize cataract devices

Chinese company Vision Pro has raised $13 million in a series B round to advance its intraocular lens business. Its products picked up CE mark designations in Europe before going on to be registered by Chinese authorities in July.