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Pharma/fine chemicals roundup—19 May 2015

12:52 AM MDT | May 19, 2015 | By DEEPTI RAMESH

API business of Dr. Reddy’s reports rise in sales

The pharmaceutical services and active ingredients (PSAI) business of Dr. Reddy’s Laboratories (Hyderabad, India) reports a 11.6% rise in sales in the company’s fiscal fourth quarter, ended 31 March 2015, compared with the year ago quarter, to 7.41 billion Indian rupees ($117 million). For the full fiscal year ended 31 March, the PSAI business reports a 6.1% rise in sales compared with the previous fiscal year, to Rs25.45 billion. Earnings figures for the PSAI business have not been disclosed.
Europe accounted for about 41% of the company's PSAI sales in the full fiscal year, North America accounted for 18%, India accounted for 13%, and the rest of the world accounted for 28%, Dr. Reddy’s says. During the fiscal year, 77 drug master files were filed globally, including 12 in the United States and 16 in Europe, Dr. Reddy’s says.

SAFC expands ADC manufacturing capacity at St. Louis

Sigma-Aldrich (St. Louis) says that SAFC Commercial, its custom-manufacturing and services business unit, has completed expanding its St. Louis facility to support commercial-scale antibody-drug conjugate (ADC) manufacturing. The facility is in final validation and expected to go online in the third quarter.
SAFC's offers include cell-line engineering and media, linkers, and payloads along with significant conjugation expertise using both highly active and nonpotent compounds. The St. Louis expansion complements other recent additions in ADC capabilities, including the announcement of SAFC's ADC ExpressSM service for preclinical ADC and bioconjugation services and a collaboration with industry leader Baxter BioPharma Solutions for formulation and fill/finish services, Sigma-Aldrich says.
“The ADC market is a growing market and is expected to expand over the next few years,” says Gilles Cottier, president of SAFC. “This strategic expansion is the latest in a series of enhancements in our ADC offering designed to support this important therapeutic area and to help our customers to seamlessly scale ADC production from preclinical to commercial phases. Our offer can bring customers' molecules to the clinic faster with the ease of working with one supplier from start to finish.”
Designed to meet SafeBridge category-4 compound handling to safely accommodate usage of highly active compounds, the St. Louis expansion creates commercial-scale manufacturing capacity for ADCs and other targeted therapies.

Rx-360 establishes working group in India

Rx-360 (Washington, DC), an international supply chain consortium, says that it has formed the Rx-360 Asia Working Group-India. The working group will be led by Anish Swadi, v.p./business development at Hikal; Huzefa Hussain, manager/quality assurance at Amgen; and Prashant Wani, senior supplier auditor at Eli Lilly & Co. Rx-360 is a not for profit consortium led by volunteers from the pharmaceutical and biotech industry including both manufacturers and suppliers, and it aims to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain.
Rx-360 has had a working group at Shanghai for almost 2 years. Given the size of India's pharma market and its importance as a manufacturer and exporter of active pharmaceutical ingredients (APIs) and drug products to North America and Europe, it was important to also develop a presence in India, Rx-360 says. The working group will focus on identifying and mitigating root causes of quality problems and supply chain security.

Germany-based investment firm to help finance Siegfried's acquisition of BASF's businesses

Siegfried (Zofingen, Switzerland) says that investment company RAG-Stiftung Beteiligungsgesellschaft (Essen, Germany), will participate in a hybrid bond of Siegfried in order to finance Siegfried’s previously announced acquisition of BASF's certain pharma ingredients businesses for €270 million ($308 million). The bond entitles RAG-Stiftung to convert the amount within 5 years into Siegfried shares, which represents about a 7% stake in Siegfried. It is expected that the stock will come from Siegfried’s own holding. A capital increase is not planned, Siegfried says. "RAG-Stiftung Beteiligungsgesellschaft is a stable partner with a long-term focus and it fully supports the Siegfried group’s strategy," says Siegfried CEO Rudolf Hanko. Siegfried said earlier this month that it will acquire BASF’s custom synthesis business and parts of its active pharmaceutical ingredients (APIs) business. These include APIs such as ephedrine, pseudoephedrine and caffeine. The transaction also includes BASF’s production sites at Evionnaz, Switzerland; Minden, Germany; and Saint-Vulbas, France.

Novasep announces new appointments

Novasep (Pompey, France), a supplier of manufacturing solutions to the life science industries, announced two new appointments to its executive committee. Pierre-Louis Mikus joins as chief legal officer and Bertrand Waymel is promoted to group human resources director. “We are delighted to welcome Pierre-Louis and Bertrand to the executive committee,” says Michel Spagnol, CEO of Novasep. “They will have key responsibilities at an exciting stage in Novasep’s development towards becoming a leading full service supplier to the life sciences.” Mikus has more than 10 years’ experience in the pharmaceutical industry, notably as v.p./legal, R&D and technical operations for the Ipsen group. Prior to joining Novasep, he practiced law at the offices of HBC Avocats, advising companies in the life sciences sector. Since joining Novasep in 2012, Waymel has taken on increasing responsibilities within the company. He began as a human resources director for the synthesis business unit. Two years later he also took on the role of human resources manager for the corporate management team.












 
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