FiercePharmaAsia: PRA and Takeda’s Japan JV, Sun’s shrunken profits, ASLAN’s positive varlitinib data

PRA Health Sciences and Takeda form new Japan JV as CRO integrates more deeply.

Welcome to this week’s FiercePharmaAsia report, which includes stories about a Japan-based JV formed by PRA Health Sciences and Takeda, Sun Pharma’s 5% profit drop in the previous quarter, positive top-line phase 2 data from ASLAN’s varlitinib for the treatment of breast cancer and more.

1. PRA, Takeda form new Japan JV as CRO integrates more deeply

Last September, Takeda announced a plan to move its clinical drug development process, along with about 300 Takeda employees, over to PRA Health Sciences, and thus let the CRO take care of much of its operations in the U.S. and Europe. Now the two have equally invested in a JV in Japan in which PRA will “provide clinical trial delivery and pharmacovigilance services as a strategic partner of Takeda in Japan.”

2. Sun profit squeezed as impact from FDA concerns persist at Halol plant

India’s Sun Pharma just reported a 5% drop in its quarterly profits, even though its U.S. sales of $507 million was a 4% increase—thanks to the launch of Olmesartan, a Benicar generic. One reason behind the decline was the ongoing problems at its Halol plant, which the FDA had first cited in 2014 and then added nine observations to its list of concerns in a December reinspection.

3. ASLAN posts positive top-line varlitinib phase 2 data in breast cancer

Varlitinib, Singapore-based ASLAN Pharmaceuticals’ lead candidate, which has two FDA orphan designations, did well in a combo therapy for the treatment of breast cancer. The drug, when combined with chemotherapy capecitabine in a phase 2 trial, achieved 36.4% tumor shrinkage at week 12, compared with Tykerb-capecitabine combo’s 17.8%.

4. India's Aurobindo responds to White House urging, plans second U.S. plant

Aurobindo Pharma responded to Trump’s calling that pharma companies should bring their manufacturing business to the U.S.—by announcing plans to build a second sterile injectables plant at its New Jersey site. Last August, the Indian drugmaker started on its first U.S. plant there, which will eventually host 400 to 500 employees.

5. China facility of Ausmetics hit with FDA warning letter

The FDA has banned cosmetics and body care products from an Australian company's plant in Guangzhou, China. It cited it with “significant violations” of cGMP regulations, saying that it did not do enough to test its active ingredients and products. But the company said it had decided to cease export to the U.S.

6. Aurobindo adds to manufacturing with biosimilars plant

India’s Aurobindo Pharma is on a deal-making and construction spree recently. It has acquired four biosimilar products from a Swiss company, and among them, three are oncology monoclonal antibodies, including a biosimilar of Roche’s Avastin. It is also building a manufacturing facility in Hyderabad, Telangana, for producing all of those drugs.

7. Another Japanese drugmaker cited in FDA warning letter

For the third time in recent months, the FDA has slammed a Japanese drug company in a warning letter, this time at a sterile drug production facility in Tokyo operated by Sato Pharmaceutical. The agency found the plant was not doing enough to prevent contamination during aseptic filling.