FiercePharmaAsia—Sun’s quarterly loss, BeiGene’s $175M public offering, Biocon plant’s extensive problems

Sun Pharma took a hit with a 9.51 billion rupees antitrust settlement over Modafinil, a sleep disorder treatment.

Welcome to this week's FiercePharmaAsia report, which includes stories about a substantial quarterly loss suffered by Sun Pharma, BeiGene's new public offering of $175 million, an 8-page Form 483 the FDA sent to Biocon and a patent lawsuit between a Daiichi Sankyo subsidiary and Novartis.

1. India's Sun Pharma reports quarterly loss after one-off charge

Sun Pharma just reported a tremendous U.S. sales drop in the previous quarter ended June 30. The net loss of 4.25 billion rupees ($66 million), compared with a profit of 20.34 billion rupees at the same time last year, is thanks to a 9.51 billion rupees antitrust settlement. After taking out the one-off charge, which was over a sleep disorder drug called Modafinil, the company’s net profit fell 74% to 5.26 billion rupees.

2. BeiGene announces pricing of $175 million public offering (PR)

Fresh off a potential $1 billion deal with Celgene, Chinese immunotherapy biotech BeiGene announced a follow-on public offering of 2.465 million American depositary shares, each representing 13 of its ordinary shares, with the price of $71 per ADS. The offering is expected to close on Aug. 16, and the proceeds will be used for activities including R&D. BeiGene was listed on Nasdaq last February with 6.6 million ADSs, at a price of $24 per ADS.

3. FDA slams Biocon sterile plant where Herceptin biosimilar is to be produced

The Biocon sterile manufacturing plant was cited by the FDA in a second Form 483. During an inspection earlier this year, the agency found problems across the entire range of processes, including in aseptic processing and filling, environmental monitoring, data recording, cleaning procedures and even in its processes for buying sterile gloves for employees. The plant, which is expected to produce a Herceptin biosimilar, has also been criticized by regulators in Europe.

4. Daiichi's Plexxikon goes after Novartis cancer med Tafinlar in BRAF patent suit

California-based Plexxikon, which became a part of Daiichi Sankyo in a 2011 buyout, is suing Novartis for patent infringement. The lawsuit is around a former GlaxoSmithKline cancer drug called Tafinlar, a competitor drug to Plexxikon and Roche’s Zelboraf. Plexxikon argues that GSK scientists used the knowledge they acquired when talking to Plexxikon about potential partnership, and used it to make Tafinlar.