NEWS AND VIEWS FROM THE PHARMACEUTICAL FINE CHEMICAL AND CUSTOM MANUFACTURING SECTOR

Wednesday, 5 May 2010

BioUetikon adds capacity

BioUetikon has installed a single use bioreactor train with 50L, 250L and 1000L capacity tanks. The train also includes complimentary scale GMP buffer and media preparation.
BioUetikon

Cambrex Q1 sales decline

Cambrex's first quarter 2010 sales declined 6.4%, compared to 2009, to $56.2m. Cambrex said the decrease is primarily due to the timing of orders for two APIs manufactured under long-term supply agreements, a customer supply chain disruption for an API manufactured under a long-term supply agreement, and a feed additive for which a contract expired. Additionally, Cambrex said lower pricing of certain generic APIs and a product utilising its drug delivery technology also contributed to the decrease.
Cambrex

Tuesday, 4 May 2010

DSM Biologics has acquired the Rhobust separation technology from Upfront Chromatograpy for use in pharmaceutical applications

PR Newswire

Syngenta is investing some €50m to expand Saltigo's capacity for crop protection agents in Leverkusen, Germany

Saltigo

SynCo Bio Partners will manufacture two additional antibodies for clinical trials for OncoMed Pharmaceuticals

PR Newswire

DSM to build Australian biopharma plant

The Queensland and Australian governments will fund Australia's first biopharmaceutical contract manufacturing facility in Brisbane. The 7000m3 facility to be built and operated by DSM will provide mammalian process development and cGMP clinical and commercial manufacturing services. The new facility is anticipated to be commissioned and operational in 2013.
In-Pharma Technologist

BPTF introduces API quality agreement

Socma's Bulk Pharmaceuticals Task Force (BPTF) has developed a template to help manufacturers and customers standardise API quality agreements and comply with US regulatory requirements.
Socma

Thursday, 29 April 2010

India tries to prevent EU clampdown on manufacturing facilities

The Indian government is lobbying hard in an attempt to prevent European lawmakers introducing legislation to require the European Medicines Agency to carry out pre-inspection of manufacturing facilities. European fine chemicals companies have been lobbying hard for the legislation which is designed to prevent low quality APIs entering the European market.
Economic Times

Wednesday, 28 April 2010

Alnylam Biotherapeutics has shown that the use of siRNA can improve biopharmaceutical manufacturing

Alnylam

Stable Q1 for DSM; outlook tough

DSM said that activity for its Pharmaceutical Products business remained low and Q1 sales were stable compared to last year. The company saw lower API sales following the loss of some products, but this was offset by the completion of the H1N1 vaccine shipments. Looking forward, DSM said it expected the full year results to be lower than in 2009 due to ongoing challenges at in the business unit said there were "some very tough quarters ahead".
DSM

Tuesday, 27 April 2010

Lower fine chemicals volumes at Albemarle

Sales for Albemarle's fine chemicals business grew 13%, compared to 2009, to $136m in Q1 2010. The company attributed this to increased volumes in performance chemicals but saw lower volumes in fine chemistry services.
Albemarle

Monday, 26 April 2010

Codexis launches IPO

Codexis launched its IPO at $13/share - the low end of its projected range of $13-15 - bringing in $78m. In its first two days of trading the shares rose to $14.
San Jose Business Journal

Avecia Biotechnology will provide oligonucleotide manufacturing for a key component of Pfizer's Macugen

Business Wire

SAFC grows 14% in Q1

Sigma Aldrich's fine chemicals business, SAFC showed sales growth of 14.3% to $152m in Q1 2010, continuing the trend seen in H2 2009. The company also took a $6m restructuring charge during the quarter related to the consolidation of some facilities and the elimination of about 100 jobs. SAFC saw double digit growth of its custom pharma products driven by higher demand for HPAPIs and viral vectors met from its recently opened California and Wisconsin facilities. The company has also seen an increase in booked orders.
Seeking Alpha

Lonza remains cautious

Lonza's Q1 demand remained consistent with 2009, but reported that volatility still persists for its custom manufacturing businesses. The company said its pipelines remain strong and it expects higher capacity utilisation this year. Additionally, it is seeing increased levels of partnership discussion in specialty areas such peptides or HAPIs and continuous high level discussions on pipeline outsourcing.
Reuters

BioInvent will stop its contract manufacturing activities to focus on proprietary drug development

GEN

Tuesday, 20 April 2010

Codexis will launch its IPO this week

New York Times

Evonik opens China API facility

Evonik has started production at its new API facility in Nanning, China. The 70m3 capacity plan, which can be doubled in size if required, will primarily supply the Chinese market. The plant has been set up in collaboration with a European pharmaceutical company for which Evonik will produce various active ingredients under a multi-year supply contract and in compliance with cGMP.
Evonik

Inno Biologics is providing manufacturing for two biosimilar products for Avasthagen

Bernama

Almac has completed its £9m of its Pharma Sevices manufacturing facility in Craigavon, Northern Ireland

Almac

Angel Biotechnology will manufacture antibodies for Materia Medica in a £1.5m deal

Pharmaceutical Business Review

Tuesday, 13 April 2010

Angel Bio profit rises in 2009; considers expansion

Angel Biotechnology saw both profit and revenues rise 55% during 2009 compared to 2008. The company reported revenues of £1.48m. Company chairman, Paul Harper said "Angel is well positioned to take advantage of the manufacturing opportunities that are emerging in an evolving business environment and are considering the Company's expansion options in the light of the increased volume of business."
InvestEgate

Dishman CFO, VVS Murthy, says the company is seeking CRAMS revenues of about $10m in 2010-11 from Japan

DNA

Monday, 12 April 2010

Ampac acquires Texas facility

Ampac Fine Chemicals has acquired a fine chemicals manufacturing facility in LaPorte, TX. The $475,000, plus costs, acquisition increases the company's capacity by 30%. The facility, which passed FDA in 2008, was completed in 2001 and significant new equipment was added in the last four years. Aslam Malik, President of Ampac said "this additional capability in Texas, which includes commercial scale hydrogenation, as well as azide, cyanide, and phosgene capabilities, fits well with our areas of established expertise in energetic chemistry and continuous processing."
Ampac

Jantibody Technologies is using Pfenex's expression technology to produce HSP-avidin fusion protein for its Jantibodies platform

Boston BioCom

Thursday, 1 April 2010

Codexis sets its IPO price between $13 and $15

CNBC

SAFC has opened its 4700m2 Verona, WI, facility

Wisconsin State Journal

Lonza will expand carnitine capacity at its Nansha, China, facility

Lonza

Ranbaxy to use Pfenex technology

Ranbaxy will develop an undisclosed biosimilar therapeutic using Pfenex's Pseudomonas-based recombinant protein expression technology. The two companies will develop production strains and the production process for the product.
Business Standard

Monday, 29 March 2010

Ampac confirms manufacturing deal with Codexis

Ampac Fine Chemicals will use Codexis' proprietary biocatalysis technology to develop lower cost, more efficient and lower environmental impact processes for pharmaceutical intermediates and APIs.
PR Newswire

Aptuit has denied it is to sell its stake in Aptuit Laurus to Lonza

Reuters

Lonza will end its sodium gamma hydroxybutyrate manufacturing deal with Jazz Pharma

Reuters

Lonza cuts jobs in Visp

Lonza continues to announce measures to meet the cutbacks announced last year. The company plans to cut fixed costs in Basel and Visp by CHF40m over the next 18 months, which will include 193 jobs at Visp.
Lonza

Wednesday, 24 March 2010

Rumour: Lonza to acquire 51% stake in Aptuit Laurus

Business Standard

Eden Biodesign will offer Millipore's UCOE expression technology to clients for mammalian cell line development projects and cGMP production

Eden Biodesign

The Bangladesh Pharmaceuticals Society has called for companies to upgrade facilities to access global contract manufacturing market

Financial Express

Borgas rebrands fine chemicals

Speaking at the Socma dinner in New York, Lonza CEO, Stefan Borgas, said that the industry needed to consider itself the "fine molecules" sector as the products it makes are no longer just chemicals. He said the future of the industry lay in companies reinventing their current business models and taking a more collaborative approach to innovation.
Icis

Cambrex has acquired biocatalyst producer IEP

Cambrex

Hovione's Cork, Ireland, plant has been inspected by the Irish Medicines Board for its EU GMP Certificate and IMP Licence

Hovione

Wednesday, 17 March 2010

Prosonix has launched its UMAX technology for the production of crystalline, excipient free, highly performing, stable drug particles

Prosonix

Successful audits for Jubilant facilities

Jubilant Organosys' Hollister-Stier's Spokane, WA, facility completed a successful audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) and its Draxis Pharma Montreal, Canada, facility completed a successful audit by the US FDA and Health Canada.
Hollister-Stier

UKTI and Chemspec Europe

UKTI and Chemspec Europe
UK Trade & Investment is co-ordinating a UK pavillion at Chemspec Europe in June. Grants are available to potential exhibiters. Contact Tricia Francis for more details.

Sunday, 14 March 2010

AutekBio to establish Chinese biologics facility

AutekBio, SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation will jointly invest $100m to develop a new biopharmaceutical contract manufacturing organisation in China. The joint venture will build an R&D and manufacturing center in southern Beijing with up to 20,000L capacity in multiple trains.
Business Wire

Partnership offers CMC services

Cambridge Major Laboratories has teamed up with Avantium Pharma, Xcelience and Beckloff Associates to offer an expedited CMC solutions program designed to accelerate drug development. The service is available to companies ranging from small biotechs to big pharma.
Fierce Pharma Manufacturing

Lonza will offer Odyssey Thera's Protein-fragment Complementation Assay (PCA) technology to customers and has taken a stake in Odyssey

Odyssey Thera

Wacker refocusses pharma-facing activities; opens biologics plant

Wacker Chemie has restructured its biotech and fine-chemical segment. The Wacker Biosolutions division, formerly known as Wacker Fine Chemicals, will focus on services for the food, pharmaceuticals and agrochemicals sectors alongside its existing portfolio of fine chemicals and chemical intermediates. Additionally, Wacker has opened a new €18m GMP-certified biologics facility in Jena, Germany, to enable the company to accommodate its customers’ rapidly growing demand for biotechnologically manufactured pharmaceuticals.
Wacker
In-Pharma Technologist

Aurobindo company launches CRAMS subsidiary

Indian pharmaceutical company Aurobindo Pharma has launched a subsidiary to provide CRAMS services. AuroSource will partner with global large, mid-sized and emerging biotech and pharmaceutical companies.
In-Pharma Technologist

Tuesday, 2 March 2010

Dishman's Shanghai facility delayed

Dishman Chemicals and Pharmaceuticals Shanghai, China, facility has been further delayed by a couple of months. VVS Murthy, chief financial officer, expects the facility to start functioning from the second half of 2010, maybe August-September 2010. Dishman has invested $10m in the project.
DNA India

AMRI is suing a consultant for $5m alleging he shared information with competitor, ScinoPharm Taiwan

Albany Business Review

SAFC expects to begin manufacturing at its new Verona, WI, facility in April

Wisconsin State Journal

Wednesday, 24 February 2010

Pharma sales decline at DSM

Full year 2009 sales for DSM declines 11% as a result of low demand from pharmaceutical companies, delay in approvals and the loss of some large contracts. In addition the company recognised a non-cash goodwill impairment charge of €154m from its acquisition of Catalytica.
DSM

Aesica plans expansion

Aesica is seeking to acquire manufacturing facilities in the US and Europe and to add high containment capabilities at one of its sites. The company believes that adding US facilities will help it attract contracts from US pharma customers.
In-pharma Technologist

Cabb has received ISO 14001 certification for its Pratteln, Switzerland, facility

Cabb

Monday, 22 February 2010

Recipharm launches new biologics unit

Following its acquisition of Cobra Biomanufatcuring, Recipharm has combined the two biologics manufacturing businesses into an integrated business, RecipharmCobra Biologics.
Recipharm

Saturday, 20 February 2010

EMS Chemie interested in Lonza?

Lonza shares rose on market rumours that EMS Chemie is considering acquiring the company.
Reuters

Thursday, 18 February 2010

AMRI acquires Excelsyn

Excelsyn has been acquired by AMRI for $19m. The Holywell, Wales-based business, which was formerly part of Great Lakes, includes kilo lab, pilot plant and large scale manufacturing capabilities. AMRI Chairman and CEO Thomas D’Ambra said, "The acquisition of Excelsyn further builds out AMRI's global continuum and will increase our ability to penetrate a market space relatively untapped to date, including customers in large pharma based in Europe."
Ian Shott, President and Chief Executive of Excelsyn, acquired the Holywell business in 2004 for a £3m package including debt.
Albany Times Union

Wednesday, 17 February 2010

Pharmatek Laboratories has received Drug Enforcement Agency (DEA) registration to manufacture Schedule IV and V controlled substances

Phharmatek

Inabata & Co will market Ampac Fine Chemicals' API manufacturing technologies in Japan

Ampac Fine Chemicals

Codexis selects Dishman and Ampac Fine Chemicals

Dishman has been selected as the preferred contract manufacturer for Codexis. Dishman will use Codexis' biocatalysis technology to manufacture building blocks, intermediates and APIs for innovator pharmaceutical companies. Dishman will also offer the technology to its own customers. Codexis will also collaborate with Ampac Fine Chemicals to expand the application of its technology.
Codexis

Aptuit has introduced a production screen to better understand API characteristics and speed process scale-up

Aptuit

Dottikon will introduce short working to address capacity utilisation fluctuations in some plants from March 2010

Dottikon

Monday, 15 February 2010

Albemarle to provide manufacturing for PharmaCore customers

Albemarle will provide manufacturing services for PharmaCore customers with projects that require high volume capacity. The alliance will allow seamless technology transfer when customers require higher volumes of APIs and active ingredients.
Albemarle

Piramal Healthcare is considering expanding its biologics capacity in Grangemouth, Scotland, according to chairman Ajay Piramal

Money Control

Saturday, 13 February 2010

Novasep and Provepharm have successfully validated the cGMP manufacturing process for the Proveblue API

Novasep

Aurelius acquires Isochem

German private equity house Aurelius has acquired Isochem from SNPE for €8m. SNPE will take on €50m in debt from Isochem. The deal is subject to approval by the SNPE board. Unions at Isochem are opposed to the deal and are expected to call for a strike. Aurelius was one of five potential acquirers and was given exclusive negotiating rights in December.
Les Echos

Synthetech sales declined 52% in its Q3 2009 vs 2008

Portland Business Journal

Revenues for AmPac Fine Chemicals fell 53% in the quarter ended 31 December 2009 compared to the same quarter 2008

Las Vegas Review-Journal

Cambrex sales decline in Q4

Cambrex sales decreased by 9.9% in Q4 2009 and full year sales were down 5.3% on 2008. The company said the decrease is primarily due to lower volumes of an API that utilises its polymeric drug delivery technology, lower sales of two APIs manufactured under long-term supply agreements and lower custom development revenues.
Cambrex

Year ends with an upturn for SAFC

Sigma-Aldrich's fine chemicals business, SAFC, had its best quarter of 2009 in Q4, meeting the company's expectations of improved sales as the year ended. CFO, Rakesh Sachdev, put this down to "continued demand for adjuvant products for the H1N1 vaccine production and industrial media for pharmaceutical customers, as well as customer efforts to push early stage clinical trials".
Seeking Alpha

Wednesday, 3 February 2010

Dishman restructures Carbogen Amcis

Dishman is restructuring its Carbogen Amcis subsidiary. Staff levels have been cut by 20% and a new CEO - currently working at another company in the sector - will join in March. Q3 sales at Carbogen Amcis fell 27% this year and the company expects to save CHF8m through the restructuring.
Business Standard

Recipharm has declared its offer for Cobra Biomanufacturing "unconditional"

InvestEgate

Angel Biotechnology has raised £1.4m through a placing of shares

IB Times

Tuesday, 2 February 2010

SynCo signs US deal

SynCo Bio Partners will provide process validation and GMP commercial manufacturing services to support the commercial launch of two separate biopharmaceutical products, from an unnamed company, for the US market. The recombinant proteins will be produced in E. coli.
SynCo BioPartners

UKTI and Chemspec USA

UK Trade and Investment is considering running a UK pavilion at the inaugural Chemspec USA show in Philadelphia in May 2011. For further information contact Tricia Francis.

Peakdale Molecular will establish a synthetic chemistry services team of 50 scientists at Pfizer's Sandwich, UK, site

In-Pharma Technologist

Watson acquires Eden

Eden Biodesign has been acquired by Watson Pharmaceuticals for $15m. Watson had previously acquired 36% of the business through a previous acquisition last year. Following the acquisition Eden will continue to offer contract manufacturing services.
Business Week

Tough year for Lonza in 2009; cautiously optimistic for 2010

Lonza's full year results showed a 8.4% fall in sales in 2009 compared to 2008. The company said that clinical results had driven order reductions for its biopharmaceutical manufacturing business. CEO, Stefan Borgas remains optimistic for the future and said the company's previously announced re-engineering would help generate cash flow in 2010.
In-Pharma Technologist

Carbogen Amcis has inaugurated its high containment API facility at Dishman's Bavla, India site

Carbogen Amcis