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

Tuesday, 4 September 2012

GE Healthcare has launched a range of modular biomanufacturing facilities


In-pharma Technologist

Piramal Healthcare is rumoured to be in talks to acquire Ind-Swift Laboratories' CRAMS business and facilities


Business Standard

Aesica Partners with University of Bradford

Aesica has partnered with the Centre for Pharmaceutical Engineering Science at the University of Bradford. Aesica will benefit from the University's research facilities and the University will gain access to Aesica's GMP manufacturing facilities.
Manufacturing Chemist

Mike Ironside has been appointed as General Manager, TTC, at Hovione


Hovione

Thursday, 30 August 2012

Sales rise for Siegfried in H1

Siegfried reported H1 2012 sales of CHF178.7m up 2.9% on 2011 and profits rose 29% to CHF40.1m. The company said that sales of drug products rose markedly after the launch of new drugs in the first half year, however it's drug substance business passed lower costs for raw materials on to customers.
In-pharma Technologist

Wednesday, 29 August 2012

Ark to concentrate on contract manufacturing

Ark Therapeutics has announced that it will no longer invest in proprietary drug development, outlicense its development assets and focus on contract manufacturing. The company has attracted some contracts for its viral manufacturing expertise over the last year and recently appointed a new ceo with manufacturing experience. Financial analysts were split on the decision. Canacord Genuity believes that Ark has a substantial opportunity as a partner for companies in viral product development while Nomra Code said that the question remains whether the Ark will be able to attract sufficient manufacturing contracts in the near term to attain profitability of its contract manufacturing services business.
Ark Therapeutics

Angel Biotechnology will develop and manufacture arGentis Pharmaceuticals collagen product for systemic sclerosis


Angel Biotechnology

Conrad Winters has been appointed as Director, Drug Product Development at Hovione


PR Newswire

Thursday, 23 August 2012

Carbogen Amcis returns to profit

Dishman reported sales at Carbogen Amcis of $24m for its first quarter. Janmejay R Vyas, chairman and managing director of Dishman Pharma, said that the company has spent 18 months restructuring the Swiss business and that they plan to consolidate in the near future. He expects that Carbogen Amcis will contribute a profit of $7m to Dishman this year.
Business Standard

Wednesday, 15 August 2012

Boehringer Ingelheim reported sales from biopharmaceutical manufacturing falling from €233m to €214m in H1 2012 in the first half of 2012


Boehringer Ingelheim

New deal for Cambrex leads to expansion

Cambrex will supply phase III and pre-launch quantities an API for an un-named customer. The company expects the agreement to contribute $20m in 2013. In order to meet the demand under the new agreement, Cambrex will invest significant capital over the remainder of 2012 and in early 2013 to expand our multipurpose large scale cGMP assets.
Cambrex

Siegfried Holding will exchange 80,000m2 of land with the City of Zofingen and StWZ Energie AG, and will obtain land bordering its premises for expansion


Siegfried

Ark Therapeutics and EMD Millipore will collaborate to optimise production of viral based bioengineered vaccines and other live viral products for pilot and production scale


Ark Therapeutics

Laureate Biopharma has developed the process and is manufacturing ZZ Biotech's potential therapeutic for ischemic stroke for phase I clinical trials


Laureate Biopharma

Ampac fine chemicals returns to profit

Ampac reported fine chemicals revenues of $36.4m in its Q3 2012 up 18% on 2011, led by strong anti-viral products revenues. The company said its fine chemicals activities returned to profit during the quarter which it attributed to redesigned processes and cost savings initiatives.
Seeking Alpha

Monday, 13 August 2012

Aurobindo Pharma plans to earn 25% of its annual revenues from its custom research and manufacturing business in the next 4-5 years


Economic Times

Gallus BioPharmaceuticals will provide process development and clinical and commercial supply for mammalian cell-based biopharmaceutical products to customers of Theorem Clinical Research


Theorem Clinical Research

Fuji Pharma acquires Thai plant

Fuji Pharma has acquired the Olic pharmaceutical manufacturing plant in Ayutthaya province, Thailand, for $53m from DKSH. Charles Toomey, executive vice-president for healthcare business unit at DKSH, said that contract manufacturing is a non-core competency for DKSH and that Fuji has significant manufacturing expertise.
Bangkok Post

Small sales rise and restructuring at DSM

Sales rose 2% to €182m in Q2 2012 for DSM's pharmaceutical business. The company said that business conditions are likely to remain challenging, although it anticipates that it will make further strategic progress. The company also announced a series of restructuring measures including the termination of biosimilar product development by its Percivia joint venture, which will now focus on the existing PER.C6 technology licensing business.
In-pharma Technologist

Boehringer Ingelheim will manufacture gevokizumab for Xoma and Servier at its Biberach, Germany facility, following the transfer of Xoma's berkeley facility to CMC


GEN

Tuesday, 31 July 2012

CMC acquires Xoma facility

CMC Biologics has acquired Xoma's large-scale biologics manufacturing operations Berkeley, CA. The 3100m2 facility includes three 2750L stainless steel bioreactors and two purification suites. CMC expects to begin offering contract manufacturing services from Berkeley when the transaction closes.
GEN

Thursday, 26 July 2012

Custom manufacturing "firm" for Lonza

Lonza reported H1 revenues increasing to CHF1.9bn. The company said demand in its custom manufacturing business was firm, resulting in capacity utilisation above 75% in both chemical and biological plants, as well as a strong project pipeline. Lonza said it had provided a full response to the FDA regarding the 2011 warning letter received at its Hopkinton, MA, plant and that corrective action had been taken. Looking to the future, the company said it has initiated an investment in formulated products.
Reuters

Dalton Pharma Services provided API development and manufacturing for a Dengue fever clinical trial in Singapore


Dalton

Quarterly record sales for SAFC

Sigma-Aldrich's fine chemicals business, SAFC, reported sales of $223m in Q2, with organic growth of 8% over 2011. Company president and ceo Rakesh Sachdev said "We were pleased by the improved performance of our SAFC custom pharma business, which saw solid growth in cGMP manufactured products in second quarter 2012." Sanchev said the division had double digit sales growth for custom-manufactured high-potency compounds to pharma customers which he attributed to customers recognising the company's investment in HPAPI capacity in Wisconsin.
Seeking Alpha

Piramal Healthcare will change its name to Piramal Enterprises following its increase in business activities


Economic Times

Thursday, 19 July 2012

Novasep invests in HPAPI manufacturing

Novasep is investing €3m to expand its highly potent API manufacturing capabilities at its Le Mans, France facility. The expansion will allow Novasep to serve the increased demand for manufacturing of novel anti-cancer therapies. The new facility will include the capability to perform cryogenic chemistry at -60C in hastelloy reactors. The company will also add large-scale HPLC chromatography and drying in confined areas to manufacture ADC toxins at commercial scale. The plant expansion is expected to be fully operational by the beginning of 2013.
Novasep

ScinoPharm will manufacture topiramate the API for Vivus' Qsymia, approved by the FDA earlier this week


ScinoPharm

Record Q2 for Albemarle's fine chemicals

Albemarle reported record sales in Q2 2012 at $208.7m up 13% on 2011. The company attributed this to favourable volumes and pricing, partly offset by unfavorable foreign currency impacts.
Seeking Alpha

DSM Pharmaceutical Products will provide process development and cGMP manufacture for one of Recepta Biopharma's lead antibodies in Groningen, The Netherlands


Pharmaceutical Business Review

Israel and Switzerland have requested exclusion from the EU's rules for API importation


In-pharma Technologist

Monday, 9 July 2012

Siegfried to build API plant in China

Siegfried, supported by the Chinese development organisation NETDA, will build an API manufacturing plant in Nantong, China. The facility will meet cGMP standards. Siegfried said the site has space for a second phase, which may include finished dosage form production. The new facility is expected to be on-stream in 2014.
Pharmaceutical Business Review

ScinoPharm invests in cytotoxic manufacturing

ScinoPharm will invest $37.6m in the construction of a high potency cytotoxic injectable plant at Tainan Science Park. ScinoPharm said the new facility will include space for R&D, quality control, washing, sterilisation, manufacturing, filling, lyophilisation, packaging, and storage. The company expects the plant to be completed in 2014.
ScinoPharm

Aesica plans to add 100 jobs at its Queensborough, UK, facility


Aesica

Tuesday, 3 July 2012

Dishman to cancel SEZ project

Dishman is to exit its special economic zone in Ahmedebad, India, and sell the land for $108m. In 2009, Dishman merged its engineering SEZ into its pharma SEZ.
Economic Times

Lonza has extended its XS Technology platformm to two additional microbial systems: pacha pastoris and bacillius subtilis


Lonza

Albemarle expands API capacity

Albemarle has expanded and upgraded its API manufacturing facility in South Haven, MI. The new capacity came online on 1 June. The investment at South Haven matches the solids handling equipment with the reactor capacity and Albemare claims it will enable the company to advance its growing portfolio of custom API products.
In Pharm

Amag moves to contract manufacturing

Amag Pharmaceuticals plans to close its manufacturing facility in Cambridge, MA, and is moving to an outsourced manufacturing model. The company will reduce its workforce by 45 as a result of the disposal.
Aman Pharmaceuticals

Thursday, 21 June 2012

FDA seeks to secure supply chain

The US Food and Drug Administration is seeking 100 companies to volunteer to join the Secure Supply Chain pilot programme. The programme aims to promote the safety of drugs and active drug ingredients produced outside the US. Applicants will need to meet the programme's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country. The FDA hopes the programme will expedite the entry of products meeting the pilot's criteria into the US and allow it to focus its resources on foreign-produced drugs that fall outside the programme and that may not be compliant.
Regulatory Focus

Hovione reposted a 24% rise in sales for the year ended March 2012 to $180m, the sixth consecutive year of sales growth


Hovione

Tuesday, 19 June 2012

Fujifilm Diosynth Biotechnologies to expand facilities in UK

Fujifilm Diosynth Biotechnologies is further increasing its contract process development and manufacturing capabilities through the expansion of its services in mammalian cell line development and process development, and the addition of a new multi-product cGMP facility in Billingham, UK. The company said work has commenced on a state-of-the-art cGMP cell bank and 1000L biologics manufacturing facility based upon single-use technology for both upstream and downstream operations. The cell bank manufacturing facility is expected to be available from Q2, 2013 and the mammalian cell culture biologics manufacturing facility is expected to be validated and fully operational in the second half of 2013.
Fujifilm Diosynth Biotechnologies

CMC Biologics' Bothell, WA, facility has received GMP certification from the UK Medicines and Healthcare products Regulatory Agency


PR Newswire

Codexis has been awarded the annual Presidential Green Chemistry Challenge Award for its simvastatin manufacturing process


Codexis

DSM antibody deal

DSM Pharmaceutical Products will use its XD high cell density process technology to produce antibodies for a major pharma company at its Groningen, The Netherlands, and Brisbane, Australia facilities.
PR Newswire

Evonik IPO suspended


Reuters

Lonza has completed the installation of a new GMP clean room in Houston, Texas, for its vaccines and gene therapy business


Lonza

Piramal negotiating to acquire Cambridge Major

Piramal Healthcare is currently in negotiations to acquire Cambridge Major for around $200m. The report appears to confirm earlier comments by the company. A source lose to the situation, quoted in Financial Express, said "Early stage negotiations are on and it will take a while to conclude the deal." Cambridge Major has not commented on the speculation.
Financial Express

Dalton Pharma Services will manufacture chemicals for use in Clarity Pharmaceuticals’ PET-based companion diagnostics and radio-immunotherapeutics programmes


Pharmaceutical Business Review

Wacker Biotech has completed a feasibility study to produce XL-protein's PASylated therapeutic proteins


GEN

Wednesday, 13 June 2012

Ubichem adds capacity in Hungary

Ubichem has added a new manufacturing site in Budapect, Hungary. Ubichem Pharma Manufacturing's 55,0002 facility will produce starting materials, intermediates and other fine chemical products for pharma and non-pharma applications.
Ubichem

SAFC plans to consolidate its global chiral chromatography screening and small scale purification operations at its Pharmorphix laboratories in Cambridge, UK, by July


SAFC

Evonik IPO may be cancelled


Reuters

Thursday, 7 June 2012

The US FDA has sent warning letters to eight companies for failing to register manufacturing facilities


In-pharma Technologist

Strong sales for Johnson Matthey

Johnson Matthey reported that sales for its fine chemical division rose 16% to £285m and operating profit rose 24% to £69.7m. The company said this was boosted by strong demand and supported by a very strong performance from its API manufacturing businesses. Sales in API manufacturing rose 18% to £206m.
Johnson Matthey

Tuesday, 5 June 2012

Codexis has appointed John J Nicols as President and Chief Executive Officer


Codexis

Siegfried adds sterile filling

Siegfried has acquired Alliance Medical Products in Irvine, CA, to add sterile filling services. Siegfried paid $58m in cash with a contingent earn-out consideration subject to AMP meeting defined profitability goals for the fiscal year ended December 31, 2013.
Siegfried

Profits fall at Angel

Angel Biotechnology has reported revenues of £3.456m for the peered ended 31 March. Profits fell from £1.9m to £1.2m partly as a result of the expenditure prepare its Cramlington facility for its initial MHRA inspection. The company plans to continue consolidating its businesses in the coming year.
Proactive Investors

Tuesday, 29 May 2012

Evonik IPO to proceed

Evonik's owners RAG and CVC plan to go ahead with an IPO of the chemicals unit in June. Reports suggest the firm could raise €5bn after delaying the IPO last year.
Reuters

Albemarle is increasing prices for all grades of ibuprofen by 15%


Fierce Pharma Manufacturing

Angel Biotechnology has successfully completed an MHRA inspection at its Pentlands facility


Angel Bio

Thursday, 24 May 2012

Ian Shott has been appointed as president of AMRI Europe


Albany Business Journal

Codexis and Merck extend collaboration

Merck has extended its catalyst and process development collaboration with Codexis to 2015. Merck will use Codexis' enzyme products to develop more cost- and resource-efficient manufacturing processes for its pipeline of therapeutic candidates. To date Merck has evaluated the use of enzymes across programs in various stages of development and the companies have collaborated to develop enzymes for custom reactions such as for sitagliptin.
Pharmaceutical Business Review

Recipharm to expand

Recipharm plans to use a new €90m loan facility to acquire niche CDMOs, invest in existing facilities and build long term partnerships with major pharmaceuticals companies.
Outsourcing Pharma

Wednesday, 16 May 2012

Lonza will provide process development and scale-up efforts for manufacturing viral vectors for Avalanche Biotechnologies gene therapy


GEN

ReNeuron has contracted Angel Biotechnology to provide GMP stem cell manufacturing services for completion of its stroke clinical trial


Angel Biotechnology

Carbogen Amcis drags on Dishman

Dishman Pharmaceuticals and Chemicals sales for FY 2012 rose 9% to $208m although profits fell 29% to $10m. The Carbogen Amcis business reported a Q4 turnover of $77m with a loss of $3m although the company expects the unit to grow significantly in terms of topline and bottomline in its 2013 year.
Money Control

Codexis granted patent

Codexis has been granted a US patent covering biocatalytic processes for the preparation of fused bicyclic proline compounds. These compounds are used to make key intermediates in the synthesis of leading hepatitis-C therapeutics.
Codexis

Tuesday, 15 May 2012

API Corporation has added the pharmaceutical ingredient manufacturing and sales operations of Mitsubishi Tanabe Pharma Corporation


Mitsubishi Tanabe Pharma

Codexis reported Q1 2012 product revenues of $15.2m up 17% on 2011 driven by increased sales of atorvastatin-related intermediates


Codexis

AmPac sales revenues rise in Q2

American Pacific's fine chemical division reported Q2 2012 sales of $20.6m up 28% from 2011 primarily due to strong revenues of anti-viral products. However, this was offset by lower oncology products revenues.
In-pharma Technologist

Thursday, 10 May 2012

Angel Biotechnology has acquired the Devro Medical collagen manufacturing business for £200,000


BBC

Mixed Q1 for AMRI

AMRI reported mixed results for its manufacturing units in Q1 2012. Sales fell 7% to $9.8m for its development/small scale manufacturing, and rose 6% to 23.2m for the large scale manufacturing business.
AMRI

Wednesday, 9 May 2012

BASF has acquired omega-3 fatty acid maker Equateq


In-pharma Technologist

Pharma weak for DSM

DSM has reported weak Q1 performance in its pharmaceutical facing businesses. However, the company said the first signs of improvement are visible. DSM attributed its 7% growth in sales to a better performance at DSM Pharmaceutical Products and slightly better prices at DSM Sinochem Pharmaceuticals.
DSM

Wacker's Biosolutions unit reported a 9% increase in Q1 sales to €41.2m


Wacker

Tuesday, 8 May 2012

Lonza's Q1 in line with expectations

Lonza reported its business performance was in line with expectations in the first quarter of 2012 and that its custom manufacturing business has continued pipeline development and signed new contracts ranging from pre-clinical to commercial products. The company also reported that capacity utilisation in both chemical and biological manufacturing was 75%.
Lonza

Carbogen Amcis looks east

Dishman Pharmaceuticals & Chemicals is refocussing its Carbogen Amcis subsidiary by expanding from its traditional Europe and the US markets towards Japan and other territories. In addition, Dishman has reduced manpower at Carbogen Amcis bringing down the wage bill significantly. The company said these changes are expected to strengthen Carbogen Amcis' financial performance in the fourth quarter of the fiscal 2012.
Business Standard

Cambrex Q1 sales rise

Cambrex reported a 14% increase in Q1 sales to $70.6m and EBITDA increased by 41% to $15.6m. The company attributed the increase in sales to higher volumes of controlled substances and generic APIs.
Cambrex

Thursday, 3 May 2012

Pfenex anthrax contract renewed

US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) has exercised its option to extend its contract with Pfenex to develop a production strain and process for the production of bulk recombinant protective antigen (rPA) from anthrax. Under the contract Pfenex will continue to develop an rPA-based anthrax vaccine from rPA produced in Pseudomonas fluorescens. To date, Pfenex has demonstrated that a strongly immunogenic, stable and protective form of rPA could be expressed and recovered from the highly efficient fermentation of a strain of P. fluorescens engineered to produce rPA.
Pfenex

Cambrex’s Charles City, Iowa, API manufacturing facility has successfully completes and FDA GMP inspection


Pharmaceutical Business Review

Wednesday, 25 April 2012

Ark plant receives approval

The Finnish Medicines Agency (FIMEA) has extended Ark Therapeutics' GMP certification to include its newest and largest production facility in Kuopio, Finland. The 650m2 facility has been designed for larger scale production from suspension cell cultures utilising state-of-the-art single use systems and includes an automated fill and finish line capable.
Ark Therapeutics