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

Thursday, 17 March 2011

Siegfried sales grow in 2010

Siegfried reported sales growing 11% to CHF314.4m in 2010. The company said its API sales grew by 14.1% to CHF252.2m while sales of formulated drug products remained constant.
Chem Manager

Amgen is to buy Pfizer's Dun Loaghaire, Ireland, manufacturing plant and will manufacture products for Pfizer

RTE

Socma and EFCG call for FDA inspections

Socma’s Bulk Pharmaceutical Task Force (BPTF) and European Chemical Industry Council’s Fine Chemicals Group (EFCG) are calling on the FDA to mandate inspections of non-US API manufacturing sites. The two organisations said the FDA should collect a fee for the cost of inspection and the maintenance of a database of inspected sites.
Socma

Tuesday, 8 March 2011

CIA and UKTI seek exhibitors for Chemspec Europe

The UK Chemical Industries Association and UK Trade & Investment are seeking companies for the UK pavillion at Chemspec Europe in June. Grants are available to potential exhibitors.
Contact Neil Harvey for more details

Monday, 7 March 2011

Evonik has acquired Boehringer Ingelheim Pharma's Resomer polymer technology for use in medical and pharmaceutical formulations

Chemistry Views

Brian Scanlan will succeed Michael Major as president and chief executive of Cambridge Major Laboratories

Milwaukee-Wisconsin Journal Sentinel

Helsinn to build cytotoxic plant

Helsinn Advanced Synthesis is to build a cytotoxic plant in Biasca, Switzerland. The CHF20m plant will have two production areas. One will have three reactor units capable of producing 10kg batches an the other will have larger reactor units to produce 20kg batches. Helsinn expects to begin commissioning projects for the plat in Q1 2012.
Cleanroom Technology

Monday, 28 February 2011

Fujifilm acquires Merck Biomanufacturing Network

Fujifilm has acquired Merck's Biomanufacturing network for $490m. The network consists of the former Avecia facility in Billingham, UK, and Diosynth RTP in Research Triangle Park, NC. Merck has committed to certain continued development and manufacturing activities with Fujifilm.
Bloomberg

Angel Biotechnology made its first pre-tax profit of £0.19m on revenues of £2.95m during 2010

Proactive Investors

Samsung to establish biomanufacturing jv with Quintiles

Samsung and Qunitiles have established a joint venture to provide biopharmaceutical contract manufacturing services in South Korea. Samsung will own 90% of the joint venture company and Quintiles 10%. The jv company will construct its biopharmaceutical manufacturing plant in the Incheon Free Economic Zone in South Korea and be equipped with cutting-edge technologies and 30,000L of mammalian cell culture bioreactor capacity. Groundbreaking is expected in the first half of 2011 and full-scale operation is expected to commence in April 2013.
Bloomberg Business Week

David Anton has been promoted to chief technology officer and senior vice president, process development and manufacturing at Codexis

Silicon Valley / San Jose Business Journal

Wednesday, 23 February 2011

Carbogen Amcis to restructure

Carbogen Amcis plans to restructure its three sites in Sqitzerland. Following the restructuring, the Aarau site will focus more strongly on development; the Hunzenschwil site on the pilot production of early phase projects and the Bubendorf site on large-volume production and the manufacturing of highly active agents. The company said that 60 of its 350 staff will be made redundant.
Carbogen Amcis

Viropro has acquired Alpha Biologics for $21m

Business Weekly

An affiliate of Sun European Partners has acquired NextPharma Technologies

PharmaBiz

Monday, 21 February 2011

Alphora to invest $4m

Alphora is investing $4m during 2011 expanding its facilities and capabilities for API technology development. The company said the expansion is to meet growing demand from customers. The company, which recently increased its R&D capacity by 50% by securing new research facilities, is adding isolation technology for its high potency API development services and will add a fourth cGMP kilo lab.
Contract Pharma

Thursday, 17 February 2011

Pfenex links with Boehringer Ingelheim

Pfenex will use its Pfenex Expression Technology to engineer production strains and processes for Boehringer Ingelheim's proprietary molecules, and molecules from Boehringer Ingelheim's contract manufacturing customers. The companies said the partnership will enable preclinical and clinical development to progress much more quickly and efficiently.
San Diego Union-Tribune

Angel Biotechnology will establish a new manufacturing facility in Newcastle, UK

The Herald

SAFC has completed the first projects at its large scale High Potency facility in Verona, WI

SAFC

Wednesday, 16 February 2011

Endeavour Speciality Chemicals has added compounds for oncology research and novel thioamides to its building blocks and reactive intermediates range

ImPress PR

Robinson Brothers has invested £300,000 in a calorimetry lab for scale-up process safety

Pharma

Profits fall at Dishman

Dishman Pharmaceuticals reported a its net profits fell 94% during its Q3 ended 31 December 2010, while turnover increased 4% to $51m. The company said performance was affected by a lower-than-expected performance at its Carbogen Amcis subsidiary.
Business Standard

FDA to outsource foreign plant inspections

The US FDA is looking to increase the number of overseas plant inspections through the use of third-party inspectors, according to John Taylor, the agency’s acting principal deputy commissioner. The agency is looking to reduce the average of nine yeas between plant inspections overseas.
Bloomberg

Angel Biotechnology has signed a five year pricing agreement with Materia Medica with a potential value of over £4.5m

Angel Bio

Q4 2010 sales at Cambrex rose 8% to $63.5m as a result of order timing and higher API sales

In-pharma Technologist

Monday, 14 February 2011

Merck's BioManufacturing Network will manufacture large scale GMP clinical supplies of Nuron Biotech's NU100 recombinant human interferon beta

Merck

Record quarter for SAFC

Sigma-Aldrich's SAFC business unit reported recede sales of $171m in Q4 2010. Sales for the unit in the full year 2010 were $647m up 9% on 2009. Rakesh Sachdev, Sigma-Aldrich cep, president and director said the company is "pleased with the higher level of SAFC's booked orders for future delivery as that is an indicator of future growth for that business". He added that "we expect our SAFC Pharmaceutical business to improve further in 2011" as a result of new added capacity in Wisconsin and California. Additionally, Sachdev said that despite the challenges facing the SAFC Custom Pharma business in Europe the SAFC Custom Pharma business in the US and the international markets is doing quite well.
Seeking Alpha

Novasep has partnered with instrAction to develop and operate or supply optimised large-scale chromatography processes to purify taxane-based APIs

In-pharma Technologist

DSM Biologics has achieved 11.5g/L tiers using its XD process technology with a CHO cell line producing an Fc-fusion protein

DSM

Wednesday, 9 February 2011

Boehringer to manufacture Elan antibodies

Boehringer Ingelheim will provide technical development, clinical manufacturing and all related regulatory filing support services for antibodies discovered by Elan.
RTE

The assets of Phoenix Chemicals in Arran and the Wirral, UK, are for sale by the administrators

Winter Hill

DSM Biologics will provide process development and cGMP manufacturing for NKT Therapeutics lead product iNKT mAb

DSM

Tuesday, 8 February 2011

Ampac adds new facility

Ampac Fine Chemicals has added a second semi-works facility in Rancho Cordova, CA. The company said the facility was part of several capital improvements in progress during 2011 and became fully operational in January. This facility offers a state of the art, remotely operable facility that is designed to safely run hydrogenations, hazardous chemistry and potent compound processes.
Ampac

Dalton Pharma will provide cGMP API manufacturing and fill/finish services for Oncovir’s collaboration with the Cancer Vaccine Acceleration Fund

Dalton

ScinoPharm will provide commercial manufacturing for Clinical Data's vilazodone hydrochloride API

ScinoPharm

KaloBios Pharmaceuticals will use BioWa and Lonza's Potelligent CHOK1SV cell line for the development and production of its Humaneered antibodies

Genetic Engineering News

Almac has opened analytical labs at its new headquarters in Pennsylvania

Outsourcing Pharma

Monday, 7 February 2011

Former Biogen Idec President and CEO, James Mullen, has been appointed as CEO of Patheon

Research Triangle News

Large scale manufacturing underpins AMRI revenues

Contract revenues rose 4% at AMRI to $163.2m in 2010. Of this revenues for development/small scale manufacturing fell 4% to $36.5m and revenues for large scale manufacturing grew 13% to $71.0m.
Albany Business Review

Pharma products boost Codexis revenues

Codexis' revenues grew 29% to $107.1m in 2010. The growth was driven by a 77% increase in sales of pharmaceutical products, from $18.6m to $32.8m, and increases in collaborative R&D and government grants. The company reported a net loss of $8.5m a reduction on the loss of $20.3m in 2009. Codexis forecasts revenues of over $120m in 2011.
Codexis

Nitto Denko has acquired Avecia Biotechnology, the DNA- and RNA-based therapeutics manufacturer

Mass High Tech

AMRI's Burlington, MA, facility has received approval from the Italian Medicines Agency for the manufacture of octreotide for a customer in the EU

RTT

ICIG to buy Genzyme API unit

International Chemical Investors Group is to acquire Genzyme's API manufacturing unit. ICIG will maintain operations at Genzyme's Liestal, Switzerland, facility and rename the unit Corden Pharma Switzerland LLC. As part of the agreement, ICIG will enter into a five-year supply contract to provide Genzyme with materials needed for the production of eliglustat tartrate, an investigational treatment for Gaucher disease Type 1 that is currently in phase 3 clinical trials. Additionally, ICIG will supply materials needed for the manufacture of other treatments in earlier stages of development. Financial terms for the agreement, expected to close during Q1, were not disclosed.
Boston Globe

RecipharmCobra Biologics has been granted European patents on its Xer-cise genetic engineering technology

Recipharm

Carbogen Amcis has installed new stability study capabilities at its Hunzenschwil, Switzerland-site to meet ICH guidelines

Contract Pharma

Wednesday, 2 February 2011

Informex returns to New Orleans, 14-17 February 2012

Informex

Fine chems grow for Johnson Matthey in Q3

Q3 sales at Johnson Matthey's Fine Chemicals Division improved 10% over last year. The company said sales of APIs remained good, particularly in North America, and the performance of its Pharmaceutical Services business continued to improve.
Johnson Matthey

Laureate Pharma has changed its name to Laureate Biopharmaceutical Services

Laureate Biopharma

Monday, 31 January 2011

Recipharm sells Oxford facility

Recipharm has sold its decommissioned manufacturing facility in Oxford, UK, to Oxford BioMedica for £1.9m. Recipharm acquired the facility when it bought Cobra Biologics in 2010. Oxford BioMedica will recommission the plant over the next 12 months to provide production capacity for its proprietary LentiVector gene delivery technology.
Recipharm

Lonza is to repurchase one million shares during the next year

Lonza

Phoenix Chemicals has made 36 people redundant at its Wirral, UK, site and 7 redundant at its Annan site

Wirral News
Dumfries and Galloway Standard

New contract as Angel raises cash

Angel Biotechnology will provide pre-GMP services for Pathfinder Cell Therapy's novel cell therapy. Additionally, the company has raised £1.9m in a placing of 553,435,720 ordinary shares.
Angel Biotechnology
Angel Biotechnology

Pfenex will develop a scalable production process for a key Malaria antigen in a $3.1m subcontract from SAIC

Xconomy

Wednesday, 26 January 2011

Lonza robust in 2010

Lonza reported sales in its custom manufacturing business unit increase almost 2% to CHF1.4bn in 2010. The company said this growth was driven primarily by improved capacity utilisation in large-scale biological manufacturing as a result of new product introductions, especially in the second half of the year. The company has almost 300 products in its chemical pipeline and about 260 in its biological pipeline and reported capacity utilisation rates of around 75% for both businesses. Lonza also said that the build-out of its large scale mammalian biopharmaceutical facility in Singapore is on track, with start-up targeted in Q3 2011. Additionally, TL Biopharmaceuticals, its joint venture with Teva, has commenced a clinical phase-I trials with its first biosimilar product.
Looking forward, Lonza expects to continue to benefit from increased outsourcing of manufacturing and development by pharmaceutical and biotechnology companies, which combined with stronger product pipelines, improved capacity utilisation and a more appropriate cost base, provides the company with a good platform for a solid performance in 2011.
Reuters

The Grangemouth-based fine chemicals business KemFine, acquired by Aurelius in November, has been renamed CalaChem

Scottish Enterprise

Strong 2010 for Albemarle fine chemicals

Albemarle's fine chemicals business unit reported record income in Q4 2010, up 39% on 2009 to $26.3m. The company said the improvement was due primarily to favourable pricing and mix as well as favourable sales and production volumes, which were partly offset by higher variable input costs. The unit saw sales of $569m in 2010 up 13% on 2009. Mark Rohr, Albemarle's Chairman, President and CEO, said the company was looking at a number of potential bolt-ons for the business unit.
Seeking Alpha

Tuesday, 25 January 2011

Codexis will supply biocatalysis screening products and services to Dainippon Sumitomo Pharma for use in producing therapeutics in its pipeline

San Francisco Business Times

FDA publishes drug manufacturing guidance

The US FDA has published an industry guidance on the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including APIs or drug substances. The FDA says the guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation guidances for industry.
FDA

Monday, 24 January 2011

ICIG launches WeylChem International

WeylChem International has been launched by International Chemical Investors Group to market the groups custom and toll manufacturing capabilities. In addition, WeylChem will focus on supply chain optimisation between ICIG' fine chemicals businesses in Germany, France, Italy and the US.
WeylChem

Monday, 17 January 2011

Rentschler Biotechnologie will be the sole manufacturer of Faron Pharmaceuticals recombinant human interferon beta-1a

In-pharma Technologist

Phoenix enters administration

Phoenix Chemicals has told its workforce in Annan, Scotland, and Bromborough, England, that it has entered administration. The company is seeking ways to keep its two facilities open.

ShangPharma starts cGMP facility

ShangPharma has begun operations at its new facility in Fengxian, China. The cGMP multi-purpose pharmaceutical development and manufacturing facility includes a pilot plant with reactor capacities ranging from 200L to 3000L as well as reactors for high temperature, cryogenics, highly toxic and pressurised reactions, including hydrogenation.
Seeking Alpha

Thursday, 13 January 2011

Aurobindo sells subsidiary to Sinochem

Sinopharm is acquiring a 51% stake in Aurobindo Pharma's Chinese subsidiary, Aurobindo (Datong) Bio Pharma Co. Ltd (ADBPL). Sinopharm will later acquire a further 29.5% stake, reducing Aurobindo's holding to 19.5%. Aurobindo will receive $50m for the stake, $23m of which is a repayment of a loan to the subsidiary. Aurobindo's senior manager for investor relations, Tathagato Roychoudhary, said "in the second round of stake sale, Sinopharm will infuse cash into ADBPL to relocate its factory to expand capacity as regulated by the Chinese government".
India Infoline

Wednesday, 12 January 2011

DSM signs enzyme supply agreement with Codexis

DSM Pharmaceutical Products will use Codexis enzymes for commercialisation of sustainable enzyme-based pharmaceutical manufacturing routes developed by its InnoSyn route scouting services.
Codexis

Peakdale Molecular has received the French CIR Research Tax accreditation

Peakdale

Tuesday, 11 January 2011

Raptor engages Cambrex and Patheon

Raptor Pharmaceutical has engaged Cambrex to manufacture of the API and Patheon to produce the commercial product for its DR Cysteamine its nephropathic cystinosis treatment.
Raptor Pharmaceutical

Euticals acquires Archimica

Italian API manufacturer Euticals SpA will acquire Archimica from TowerBrook Capital Partners. The sale price was not disclosed. Towerbrook acquired the Archimica business from Clariant in June 2006 for approximately €70m. Archimica has approximately 550 employees at six production sites in Italy, France, Germany, US and UK.
Wall Street Journal

Monday, 10 January 2011

Lonza's Borgas wary of strong SFr

Lonza's CEO Stefan Borgas has warned that the strong Swiss franc will be a major challenge for the Swiss economy in the next five years. He added that products made in Switzerland will become less competitive on a global scale.
Reuters

Helsinn has sold its Irish plant to IS Pharma for €4.4m

Reuters

Cambrex has appointed Shawn Cavanagh as Executive Vice President and COO, leading Cmabrex's innovator pharmaceutical contract manufacturing operations

Cambrex

AMRI consolidates drug discovery operations

AMRI has merged its discovery R&D and discovery chemistry departments to form a Global Drug Discovery organisation. The company will combine its discovery chemistry and biology functions into a single unit at its locations worldwide.
RTT

Sunday, 9 January 2011

The EMA is concerned about the quality of non-EU manufactured APIs

In-Pharma Technologist

Dishman facility due online in April

Dishman's facility in Shanghai, China, is expected to begin commercial operations in April. Dishman's CFO, VVS Murthy, says the $10m facility will eventually contribute about $20-25m/year in the future from contract manufacturing of APIs for European clients.
DNA India

Alexander Wessels is the new President and Chief Executive Officer of DSM Pharmaceutical Products

DSM

Recipharm has set up its pharmaceutical development services business as an individual company, Recipharm Pharmaceutical Development

Recipharm

The FDA approved 21 new drugs in 2010

Wall Street Journal

Thursday, 16 December 2010

Stason Pharmaceuticals has licenced Lonza's GS Gene Expression System to develop and manufacture antibodies for tissue necrosis therapy

Lonza

DSM Pharmaceutical Products has licenced c-LEcta's alcohol dehydrogenates for screening programs and process development

PR Newswire

Aesica expands into Europe

Aesica is to acquire three pharmaceutical manufacturing facilities from UCB. Aesica will acquire facilities in Monheim and Zwickau in Germany and Pianezza in Italy. In addition Aesica has signed a long-term supply agreement to supply UCB's products. 600 employees will be transferred from UCB to Aesica. Aesica believes acquisition of the UCB sites "will support and enable its future growth and evolution". Financial details of the deal, which is expected to close in Q1 2011, were not revealed.
Manufacturing Chemist

India plans to increase the number of manufacturing plant inspectors for local an overseas facilities

Business Standard