Pharma/fine chemicals roundup—12 August 2014
12:56 AM MDT | August 12, 2014 | By DEEPTI RAMESH
Daiichi Sankyo to sell API plant at Akita to Japanese firm
Pharmaceutical company Daiichi Sankyo (Tokyo) says that it has reached an agreement with finished dosage forms producer Alfresa Pharma (Osaka, Japan) to sell the active pharmaceutical ingredient (API) plant at Akita, Japan owned by the Daiichi Sankyo Propharma (DSPP; Tokyo) subsidiary, to Alfresa. Financial details of the agreement were not disclosed. The transaction is expected to be completed on 1 April 2015.
Daiichi Sankyo is in the process of restructuring its pharma ingredient subsidiaries. The company decided in 2012 to reorganize three of its supply chain subsidiaries in Japan — DSPP, Daiichi Sankyo Chemical Pharma (DSCP; Hiratsuka) and Daiichi Sankyo Logistics (DSLG; Tokyo) into two companies by April 2015, in order to build a competitive production system. Daiichi Sankyo currently utilizes DSPP for the production of APIs and dosage forms; DSCP for the production of APIs and intermediates, and DSLG for logistics. Two manufacturing plants of DSPP and DSCP at Odawara, Japan that produce APIs and intermediates were integrated into one plant in April 2013. Following the restructuring, the surviving two companies will be DSCP, focused on API production; and DSPP, which will focus on dosage forms production and logistics. The API plants at Onahama and Tatebayashi currently owned by DSPP will be taken over by DSCP; in addition, DSLG will be merged into DSPP, Daiichi Sankyo says.
FDA announces API facility fees under GDUFA for fiscal-year 2015
FDA has announced the rate for the generic-drug API facility user fees under the Generic Drug User Fee Amendments of 2012 (GDUFA), for fiscal-year 2015. The global API-facility fee target revenue will be about $43.71 million in fiscal-year 2015, FDA says. The total number of API facilities identified through self-identification is 795, FDA says. Of the total facilities identified as API-production facilities, there are 103 facilities in the United States and 692 foreign facilities, FDA says. The domestic API-facility fee is $41,926, and the foreign API-facility fee is $56,926. These fees are for 1 October 2014 to 30 September 2015. GDUFA became effective on 1 October 2012. GDUFA requires industry to pay user fees to supplement the costs of reviewing generic-drug applications and inspecting facilities. The program also ups the number of inspections of US and overseas manufacturers of generic APIs and finished pharmaceuticals. Under GDUFA, an annual API facility fee is owed by each person that owns a facility that produces or which is pending review to produce APIs for a generic drug.
Codexis narrows loss
Codexis (Redwood City, CA), a developer of biocatalysts for the pharmaceutical and fine chemical industries, reports a net loss of $8.47 million in the second quarter of 2014 compared with a net loss of $12.60 million in the second quarter of 2013. Second-quarter sales decreased 5.8%, to $6.57 million.
Biocatalyst product revenue in the second quarter of 2014 was $2.8 million, a 44% decrease from the prior year quarter. The decrease was primarily due to the expected loss of the company's biocatalyst and intermediate sales to customers in the hepatitis C drug marketplace, Codexis says. Biocatalysis research and development revenues in the second quarter of 2014 were $1.7 million compared with $1.6 million for the second quarter of 2013.
“Codexis is now set to deliver a positive cash flow result in 2014, well ahead of our previous expectations. After delivering results in line with our expectations in the second quarter of 2014, and based on our recently announced technology collaboration and licensing agreement with GSK [GlaxoSmithKline], we are revising all of our financial guidance metrics for fiscal year 2014,” says John Nicols, president and CEO of Codexis.
Ranbaxy’s API business reports huge fall in sales
The active pharmaceutical ingredient (API) business of Ranbaxy Laboratories (Gurgaon, India) reports sales of 466 million Indian rupees ($7.6 million) for the April-June 2014 quarter, compared with sales of Rs2.26 billion in the year-ago period, mainly due to the suspension of API shipments from its plants at Toansa and Dewas, India, the company says. Earlier this year, Ranbaxy temporarily suspended shipping APIs produced at its plants at Toansa and Dewas, following an FDA announcement on 23 January prohibiting Ranbaxy from manufacturing and distributing APIs from its Toansa facility for FDA-regulated drug products. API shipments from the Toansa plant to the United States were suspended on 24 January. Ranbaxy voluntarily suspended all API shipments from the Toansa and Dewas plants to evaluate and inspect manufacturing processes and quality control systems. A joint inspection by multiple European agencies was completed at the Toansa API facility in March with no critical observations; the inspection team concluded that there was no evidence that the products manufactured at the Toansa API facility have any product quality or patient safety issues, Ranbaxy says. As a result, on 5 June, the EU authorities reinstated the EU GMP certificate for the Toansa facility.
Onyx chosen by Cancer Research UK to develop and produce APIs for clinical trials
Onyx Scientific (Sunderland, UK), a subsidiary of Ipca Laboratories (Mumbai), says that it has been chosen by Cancer Research UK (London) to support several of its drug development projects. Cancer Research UK’s drug development office will use Onyx’s expertise in process development, solid-state chemistry, analytical and GMP synthesis of active pharmaceutical ingredients (APIs) for use in clinical trials. “Over the last few years, the team at Onyx Scientific has worked with us on several challenging synthetic chemistry projects and provided exceptional value for money, which has led to us to select them for several new projects,” says Nigel Westwood, drug supply manager at Cancer Research UK. “Having sufficient quantities of API available in a timely manner is critical for our drug development activities. Onyx Scientific is a reliable partner that can deal with complex chemistry in a cost effective manner. It therefore makes total sense for our organization to work even more closely with Onyx Scientific as a partner to assist with the process development, solid-state characterization and GMP manufacture of API across several compounds,” Westwood says.
Songwon completes acquisition of specialty chemicals business of Indian pharma firm SeQuent
Songwon Industrial (Ulsan, South Korea) says it has completed the previously announced acquisition of the specialty chemicals business of pharmaceutical company SeQuent Scientific (Bangalore, India). The acquisition includes SeQuent's polymer stabilizer business and production site at Panoli, India, together with the local R&D team. Financial details of the deal have not been disclosed.
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