FiercePharmaAsia—GSK's, Akebia's anemia nods; Takeda's Xiidra loss and $900M gene therapy deal

GlaxoSmithKline and distribution partner Kyowa Kirin along with Akebia Therapeutics and Mitsubishi Tanabe have won global first nods for their kidney disease-related anemia drugs in Japan to challenge FibroGen and Astellas' roxadustat. Novartis abandoned an application for eye med Xiidra in Europe, dealing a blow to Takeda, from which it bought the drug. Takeda has penned a deal potentially worth $900 million with Carmine Therapeutics focused on gene therapies. And more.

1. GSK's Duvroq, Akebia's Vafseo win global first nods in Japan to challenge Astellas' anemia drug

GlaxoSmithKline’s Kyowa Kirin-partnered Duvroq (daprodustat) and Akebia Therapeutics’ Mitsubishi Tanabe-paired Vafseo (vadadustat) earned simultaneous approvals from Japanese drug regulators to treat anemia due to chronic kidney disease. The two meds can now take on first-to-market Evrenzo (roxadustat) from FibroGen and local collaborator Astellas.

2. Novartis gives up on Xiidra's EU approval, endangering payoff from $3.4B Takeda buyout

Novartis has voluntarily withdrawn an application for Xiidra in Europe after regulators there raised “major objections” that “cannot be resolved within the available time frame.” The Swiss pharma bought the dry eye med from Takeda for $3.4 billion upfront with an additional $1.9 billion in potential milestone payments. Now, due to the EU defeat, Takeda is projecting about $200 million in operating profits loss.

3. Takeda pens $900M biobucks pact with Carmine for non-viral gene therapy work

Meanwhile, Takeda has signed a heavily backloaded deal potentially worth $900 million with startup Carmine Therapeutics. The two will develop gene therapies against rare diseases using the small biotech’s red blood cell extracellular vesicles platform, which is different from the traditional adeno-associated virus path.

4. Fujifilm pairs with Dr. Reddy's, Global Response Aid to make COVID-19 drug Avigan

Readout from a registrational trial testing Fujifilm’s flu drug Avigan in COVID-19 has been delayed, but that didn’t stop the Japanese company from signing licensing deals around the med. It has paired with India’s Dr. Reddy’s Laboratories and Dubai-based Global Response Aid to manufacture and sell the drug as a potential COVID-19 treatment outside of Japan, China and Russia.

5. China approves CanSino's COVID-19 vaccine candidate for military use (Reuters)

CanSino Biologics’ adenovirus-vectored COVID-19 vaccine candidate, co-developed with the Chinese army’s medical research institute, has been approved for military use in China. The vaccine hasn’t gone through phase 3 testing, though early-stage results showed it can induce neutralizing antibody and T-cell responses in healthy volunteers.

6. China's Hua Medicine eyes diabetes partner as dorzagliatin hits trial goal (Release)

China’s Hua Medicine said 24-week top-line results from a China phase 3 trial showed its global first-in-class glucokinase activator dorzagliatin, as an add-on to metformin, worked in Type 2 diabetes patients whose blood glucose couldn't be controlled with metformin alone. The company plans to file an application in China after completing the 52-week follow-up. It’s also looking for one or more partners to sell the drug in China and globally.