FiercePharmaAsia—Takeda earnings, GSK’s Bangladesh plant, Novartis-Laekna deal

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Takeda, GlaxoSmithKline, Novartis, Laekna and CANbridge made our news this week. (Google)

Analysts are worried that Takeda's lack of up-and-coming assets is more problematic than the Velcade decline. GlaxoSmithKline is closing a Bangladesh plant and laying off 1,000 as it streamlines emerging markets operations. Laekna obtains Novartis' cancer drugs afuresertib and uprosertib. CANbridge Life Sciences recruits a Pfizer veteran to lead its drug development efforts. And more.

1. Lack of blockbuster candidates at Takeda? Don’t worry, Shire has it covered

Takeda’s April-to-June revenue was flat compared to last year, and it expects once-blockbuster Velcade’s decline will expand to 40% for the full year. But analysts are more worried about a lack of late-stage assets to buoy future revenue. That underscores the importance of its pending $62 billion acquisition of Shire. For 2018 alone, Shire is awaiting two key FDA decisions.

2. GlaxoSmithKline closes Bangladesh manufacturing, cuts 1,000 workers

GlaxoSmithKline will close an outdated facility in Bangladesh and lay off 1,000 employees there. The closure is part of an emerging markets revamp championed by CEO Emma Walmsley in 2017. The goal is to run its pharma business in emerging markets as “an integrated operation” with “the right commercial structure,” according to a spokesperson.

3. Novartis licenses out unwanted GlaxoSmithKline cancer drugs to Chinese biotech

Novartis sold rights to two GlaxoSmithKline-developed cancer drugs to Shanghai-based biotech Laekna. The two drugs, afuresertib and uprosertib, have been tested in humans for several cancer types. The exact dollar amount of the deal was not revealed. Laekna says it “has mapped out” several clear registration paths for new drug applications.

4. Beijing’s CANbridge brings on Pfizer rare disease leader as CMO to help bring new drugs to China

CANbridge Life Sciences hired May Orfali, M.D., as chief medical officer. She was previously executive director of global product development at Pfizer, responsible for drug development across several rare disease assets. The appointment follows a licensing agreement CANbridge signed with Puma to market HER2 cancer drug Nerlynx in China.

5. Systematic data fabrication: Chinese police seek to arrest 18 in vaccine scandal

Chinese government officials investigating Changchun Changsheng Life Sciences’ vaccine production malpractice—which led to anger and fear over vaccine safety and efficacy—found that the company breached the approved manufacturing process and “systematically fabricated production and testing records” to cover it up.

6. After its recent funding round, HiFiBiO pens Takeda R&D collaboration

Fresh off a $37.5 million series B, HiFiBiO Therapeutics has signed a deal with Takeda. The two companies will work together to discover antibodies against Takeda’s targets using HiFiBiO’s single-B-cell screening platform. Likely areas include gastrointestinal diseases and cancers, among others.

7. Otsuka’s guadecitabine fails phase 3 AML trial

A phase 3 acute myeloid leukemia trial of guadecitabine, which Otsuka acquired in its $886 million takeover of Astex, has missed its coprimary endpoints. The drug failed to beat Otsuka’s own Dacogen in achieving statistically-significant improvements in complete response or overall survival. That leaves Otsuka looking to ongoing trials in other indications to save the drug.

8. Wockhardt builds $40M plant in Dubai to produce ‘superbug’ fighters

India’s Wockhardt has inaugurated a 10,000-square-meter, $40 million facility in Dubai. The project includes production of aseptic dry powder and filling, as well as warehousing, product testing and product stability. It will make Wockhardt’s novel antibiotics that fight the emerging threat of superbugs.

9. Clinical Innovations expands into China with new subsidiary

Salt Lake City-based Clinical Innovations, which makes obstetric and neonatal care devices, has launched a new subsidiary called CI Medical Instruments in Shanghai. The unit will be led by Kevin Han, who previously served with Boston Scientific, Johnson & Johnson Medical and GE.

10. FDA hits Japanese API maker with warning letter over lab data

The FDA slapped Japanese API maker Yuki Gosei Kogyo with a warning letter. An inspection at the company’s facility last November found the company didn’t report out-of-specification results for further review.