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

Wednesday, 3 November 2010

Codexis acquires rights to IP

Codexis has acquired the MolecularBreeding technology portfolio from its Maxygen for $20m in cash. Codexis will no longer have to make royalty payments to Maxygen, which spun out Codexis in 2002. Codexis will now be able to apply the technology in new markets, subject to previously agreements signed by Maxygen.
Silicon Valley/San Jose Business Journal

Wednesday, 27 October 2010

Recipharm will manufacture tablets for DuoCort Pharma's orphan drug for the treatment of Addison’s disease

DuoCort Pharma

Swiss Franc and regulators hit Lonza

Lonza said currency exchange to the Swiss Franc was having a impact despite solid sales in Q3. In its Custom Manufacturing business, Lonza said its capacity utilisation and project pipelines continue to increase. In its chemicals manufacturing Lonza has almost 300 projects in the pipeline and is seeing utilisation of almost 75%. In biological manufacturing Lonza has about 240 projects and capacity utilisation just over 75%. The company said the overall positive outsourcing trend it is seeing is counterbalanced by ongoing volatility due to more stringent drug approvals by regulatory authorities, especially in chemical custom manufacturing.
Reuters

Tuesday, 26 October 2010

Fine chems sales grow in Albemarle Q3

Albemarle's fine chemicals business showed sales grow 7% to $138.4m in Q3 2010. The company said this was due primarily to higher volumes and improved pricing.
Albemarle

SAFC sales grow in Q3

Sales at Sigma-Aldrich's ice chemicals business unit, SAFC, grew 12% to $167m in Q3 2010. The company said this was partly due to improved growth in the sale of bulk chemical products for development and manufacturing. Rakesh Sachdev, Sigma-Aldrich's SVP, CFO and Chief Administrative Officer, expects SAFC sales in Q4 to continue to be strong, but said he expected the comparison to last year will be less favourable than earlier quarters as a result of strong sales of adjuvants for the H1N1 vaccine, which occurred in the fourth quarter of 2009. Jai Nagarkatti, Sigma-Aldrich's Chairman, President, and CEO, said that in Q3 SAFC's pharma sales grew in the US but fell in Europe.
Seeking Alpha

Recipharm is to phase out manufacturing sterile products at its Ashton-under-Lyne, UK, facility

Recipharm

Monday, 18 October 2010

Almac has successfully completed and MHRA inspection of its Clinical Services facility in Craigavon, UK

Almac

Reaxa spins out antibody tech

Reaxa has spun out its antibody drug purification technology business. The new company, ADC Biotechnology, will use IP licensed from Reaxa and aims to deliver significant reduction in manufacturing costs for the new generation of cancer drugs based on antibodies.
Manufacturing Chemist

Tuesday, 12 October 2010

Almac invests in biocatalysis

Almac is investing $4m in broadening its biocatalysis R&D expertise. The company said the investment "will be used primarily to focus around discovery of new biocatalytic platforms that can be rapidly implemented and scaled delivering cost effective processes to chiral intermediates".
Almac

SAFC complete Jerusalem expansion

SAFC has completed the expansion of its fermentation capabilities in Jerusalem, Israel. The 5000m2 facility, which is expected to begin production during October 2010, will focus on niche fermentation of APIs and bulk drugs, producing secondary metabolites (antibiotic-like molecules), cytotoxins and large-molecule proteins. 3000m2 of the new facility has been designed to be Biosafety Level 2 compliant which provides the company the capability for manipulation of human pathogens.
GEN

Monday, 11 October 2010

BASF adds microreactors

BASF has added two microreactors at its Ludwigshafen, Germany, site to manufacture chemical products on a small scale. One reactor can produce samples of up to about 20 kilograms, and the other can manufacture quantities ranging from one to 50 tonne. BASF said the microreactors operate continuously and are used for reactions that require high pressure or release high levels of heat. The continuous mode of operation and the short reactor residence time of the reaction media ensure end products of consistently high quality.
BASF

Pharmatek Laboratories has added roller compaction to its solid oral dosage form manufacturing capabilities is San Diego, CA

Pharmatek

Elan launches manufacturing business

Elan Drug Technologies launched its Manufacturing Services business at CPhI. The new business provides drug product optimisation, scale-up and commercial scale manufacturing of solid oral dosage forms to pharmaceutical companies.
Elan Drug Technologies

Angel Biotechnology has signed a £100,000 regulatory consultancy contract with Materia Medica

InvestEgate

Lonza receives $35m bond towards $200m expansion in Portsmouth, NH

Fosters Daily Democrat

Jubilant Organosys has changes its name to Jubilant Life Sciences

India Mart

Recipharm has acquired Abbott’s manufacturing site in Parets, Spain for an undisclosed sum

In-Pharm

Saltigo and Reuter Chemische Apparatebau will jointly develop processes for the synthesis of APIs and intermediates

Saltigo

MSD Biologics (formerly Avecia Biologics) will supply ThromboGenics' retinal disorder treatment, microplasmin, for 10 years

Thrombogenics

Wednesday, 29 September 2010

Carbogen-Amcis will work with EirGen Pharma to manufacture highly potent active ingredients and solid oral-dose products for the treatment of cancer

Carbogen-Amcis

UKTI seeks companies for UK pavilion at ChemSpec Middle East

UK Trade & Investment is seeking UK-based companies offering UK origin (or high UK added value) products and services within the fine and speciality chemical industry with the objective of meeting a Middle Eastern client base at ChemSpec Middle East on 29-30 November 2010.
Chemicals NorthWest

OctoPlus will perform formulation development a global pharmaceutical company's product candidate

OctoPlus

Lonza confirms plans to invest in India

Previous announcement

The Hindu Business Line

DSM and Crucell launch newco

DSM and Crucell have launched Percivia LLC, a joint venture focused on the development of "biobetter" proteins and monoclonal antibodies using their PER.C6 technology. The company, which will be based in Cambridge, MA, will also license the PER.C6 human cell line for production of third party monoclonal antibodies and other proteins.
Crucell

Tuesday, 28 September 2010

OctoPlus will provide clinical manufacturing for a French biopharmaceutical company

OctoPlus

KemFine UK sold to Aurelius

KemFine has sold its UK facility in Grangemouth to Aurelius. Financial details have not been disclosed and the deal is expected to close later this year. In February, Aurelius acquired Isochem from SNPE.
The Scotsman

Wednesday, 15 September 2010

Grace to acquire Synthetech

WR Grace is to acquire Synthetech for $19.2 million, less Synthetech’s unpaid debt and transaction costs at closing, and subject to a minimum cash balance of $600,000. The acquisition will expand Grace's pharmaceutical offering by adding expertise in chiral and peptide intermediate synthesis in addition to capacity for the manufacture of specialty single-site and polypropylene catalysts used to produce plastics.
Baltimore Sun

Thursday, 9 September 2010

Diosynth RTP will manufacture the API for Nabi Biopharmaceuticals' NicVAX anti-smoking vaccine

Nabi Biopharmaceuticals

Lonza signs manufacturing deal with GSK

GlaxoSmithKline has selected Lonza to produce early stage monoclonal antibodies from its biopharmaceutical pipeline. Initially Lonza will manufacture clinical trial batches of five compounds currently in Phase I and II. In addition GSK will also have flexible access to Lonza's capabilities for future demand dependent upon progression of molecules through late stage development and commercial launch.
Reuters

Socma welcomes R&D Tax Credit decision

Socma has welcomed the decision by US President Barack Obama to to expand and simplify the R&E Tax Credit and to make it permanent to help encourage future productivity and growth. Socma has advocated for this for a numb roof years, said Socma President and CEO Lawrence Sloan welcoming the plan.
Socma

Tuesday, 31 August 2010

Jubilant signs $33m CRAMS deal

Jubilant Organosys has signed its second major CRAMS deal in a week. The company has signed a $33m, long-term contract with a US life sciences company. R Sankaraiah, Jubilant's Executive Director of Finance, said the company would book $250m orders in this year and $250m-$300m in the next three-four years.
Money Control

Lonza acquires Vivante

Lonza has purchased Vivante GMP Solutions to give it a foothold in the viral-based manufacturing market. Lonza said the acquisition advances its strategy to broaden its biologics custom service offering for the growing viral vaccine and gene therapy markets. Vivante, which is based in Houston, TX, produces GMP viral-based therapeutics.
Lonza

Ricerca Biosciences has successful completion of the HPLC prep purification of an API under cGMP conditions

Ricerca

CMC adds disposable manufacturing

CMC Biologics has completed the addition of a state-of-the-art biopharmaceutical disposable manufacturing facility at its Seattle, WA site. CMC Biologics has partnered with Hyclone to supply the multi-purpose, single-use facility with processing equipment, including a 100L and two 500L single-use bioreactors and disposable mixers.
Genetic Engineering and Biotechnology News

Saltigo will increase prices for its 1,2,4 Triazol product range by 10% from 1 September 2010

Saltigo

Contract manufacturing revenues for Ark Therapeutics in H1 totalled £0.406m of which £0.338m was from one customer

Ark Therapeutics

Cedarlane will market and distribute Phenex's high value reagent proteins in Canada and the US

San Diego Union-Tribune

Tuesday, 24 August 2010

Jubilant signs CRAMS deal

Jubilant Organosys has signed a $51m, four-year research and manufacturing deal with an unnamed US company. The company is in discussions to expand the contract, which could be extended by a further five years. R Sankaraiah, Jubilant's Executive Director of Finance, said the deal takes Jubilant;s CRAMS order book over $1bn.
Money Control

Wednesday, 18 August 2010

Aesica invests in high containment

Aesica is investing £3m in a new high containment facility at its Queensborough, UK, site. The facility, which is due to be completed by May 2011, will enable Aesica to manufacture potent drugs typically classed as Safebridge category 3 and significantly extend its current capabilities in the formulation and packaging of liquid and solid dosage forms. In addition, the new facility will also include security measures that will ensure it can manufacture Schedule II controlled drugs such as opiates.
The Northern Echo

SAFC has extended its agreement to distribute Novozymes Biopharma's LONG R3 growth factor for industrial cell culture applications

Sigma Aldrich

Tuesday, 17 August 2010

EMA and FDA plan joint inspections

The European Medicines Agency (EMA) and the US FDA are seeking potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. The agencies are hoping to see whether greater international collaboration can help to distribute inspection capacity allowing more manufacturing sites to be monitored and reducing unnecessary duplication.
EMA

AMRI is the winner of the inaugural Pfizer Route Design Innovation Award for innovative ideas in process chemistry and large scale API production

Albany Times Union

Monday, 16 August 2010

Carbogen hinders Dishman

Dishman's Q1 turnover fell 12% to $43.2m. The company's CFO, VVS Murthy, put the fall down to reduced revenues at its Carbogen subsidiary. However, he expects Carbogen to see an overall 10% rise in sales over the full year.
Money Control

Synthetech's Q1 revenues fell 56% to $2m and the company reported a loss of $727,000 compared to a $1m profit in 2009

San Francisco Business Times

Thursday, 5 August 2010

Revenues at Codexis rose 28% to $24.5m in Q2 compared to 2009, with product revenues rising 102% to $8.5m

Codexis

Senator introduces safe drug manufacturing bill

US Senator, Michael Bennet, has introduced a bill, the US Drug Safety and Accountability Act of 2010, which aims to strengthen manufacturing quality standards, enhance the US FDA’s ability to track foreign manufacturing sites, and increase the authority of FDA to make drug product recalls. Socma welcomed the introduction of the bill and thanked the Senator for "introducing this common sense legislation which will strengthen the FDA and increase public health and safety by providing additional quality controls on drugs and their ingredients."
Senator Bennet
Socma

US consumers don't trust safety of foreign manufactured drugs

A survey conducted by the Pew Prescription Project has shown that US consumers do not trust the safety and freedom from contamination of drugs manufactured overseas. 78% of those polled trusted US made drugs, but only 6% trusted those made in China, 8% India and 30% Ireland. Swiss manufactured products were trusted by 47% and Canada made 60%.
Pharma Times

Lonza and Roslin Cells will combine their capabilities to develop customised cell culture media and processes to produce of pluripotent stem cells

Genetic Engineering News

Ampac revenues rise in Q3

Ampac's fine chemicals businesses reported revenues of $20m in its Q3 ended June, compared to $15.6m in 2009, reflecting an increase in revenues from products in development. However, the operating loss for the quarter grew from $0.8m to $2.5m as a result of higher than anticipated costs associated with validating a process change for a core product and general manufacturing inefficiencies.
Ampac

AMRI plans to double capacity at its Singapore facility

Outsourcing Pharma

Wednesday, 4 August 2010

AMRI revenues rise in Q2

Q2 revenues for AMRI's contract division rose 5% to $40.7m. The small scale manufacturing business revenues rose 1% to $8.2m and the large scale manufacturing revenues rose 10% to $21m.
AMRI

Pfenex awarded anthrax tech contract

The US Department of Health and Human Services has awarded Pfenex $18.8m contract to support the development of a robust Pfenex Expression Technology based production strain and process for the production of bulk recombinant protective antigen (rPA) from anthrax. Pursuant to the contract, Pfenex will identify high producing expression strains capable of producing high titers of stable rPA and then develop commercial cGMP manufacturing process.
Xconomy

Cambrex sales fall

Q2 sales at Cambrex fell 4% to $57.4 million. Cambrex said the decrease is primarily due to lower demand for certain larger products including the effects of a supply chain disruption at a customer's facility, lower pricing on generic APIs and a renegotiated contract extension for certain drug delivery products resulting in lower pricing. However the company saw higher sales volume of controlled substances and generic APIs.
Outsourcing Pharma

Tuesday, 3 August 2010

DSM Pharma sales rise

DSM's Pharmaceutical Products business unit reported 5% sales growth in Q2 2010 compared to 2009. However, profit fell as a result of a challenging business environment and unfavourable product mix. DSM said the drop in results was somewhat compensated by the development of the US dollar.
DSM

Siegfried has outsourced maintenance and utility services at its Zofingen, Switzerland, facility

Siegfried

Aesica raises £20m

Lloyds TSB Corporate Markets has provided £20m to Aesica Pharmaceuticals to support its continuing expansion through organic growth and acquisitions.
Pharmacy Business

Monday, 2 August 2010

SynCo to manufacture second product for Versartis

SynCo Bio Partners has extended its collaboration with Versartis, Inc. SynCo will scale-up a second manufacturing process on behalf of Versartis and provide fill and finish services for the manufacture, testing and release of formulated Drug Product vials.
Pharmaceutical Business Review

Sales at Hovione for the fiscal year ended March 31st 2010 rose 15% over 2009 to $144m

In-pharma Technologist

Aptuit partners with Siena

Siena Biotech has acquired a minority stake in Aptuit’s operations in Verona, Italy. In return, Aptuit will become the provider of choice for Siena’s development pipeline of compounds, focused in three key therapeutic areas, including Alzheimer’s disease, Huntington’s disease and oncology.
Mass High Tech

Fine chems sales rise at Albemarle

Sales for Albemarle's Fine Chemistry business rose 36% to $141.2m in Q2. The company said this was the result of increased volumes in both our performance chemicals and fine chemistry services businesses, and partly offset by product mix.
Business Week

Wednesday, 28 July 2010

CMC Biologics will manufacture ProtAffin's lead product for the treatment of chronic obstructive pulmonary disease at its Copenhagen, Denmark facility

Pharmaceutical Business Review

Novasep is working with Cerenis to further optimise the manufacturing process for its HDL mimetic following €10.7m funding from the French Govt

Novasep

The UK's medicines regulator, the MHRA, has clarified its guidance for API manufacturing site authorisation

MHRA

Daiichi Sankyo will use BioWa and Lonza's Potelligent CHOKS1V cell line for development and production of recombinant therapeutic antibodies

Genetic Engineering News

Signs of recovery for SAFC

Sales for Sigma-Aldrich's SAFC business unit showed double-digit growth in Q2, rising to $157m. The company said that several of the SAFC markets that were depressed in 2009 are beginning to show good signs of recovery. Jai Nagarkatti, Sigma-Aldich Chairman, President and Chief Executive Officer, said "I think SAFC pharma business still is not recovered to the extent that we would like to see it recover" and Rakesh Sachdev, Senior Vice President and Chief Financial Officer, added that "we expect the SAFC pharma business to improve in the second half".
Seeking Alpha

Thursday, 22 July 2010

Custom manufacturing sales hit Lonza

Profits for H1 2010 at Lonza were CHF135m up 14% from CHF118m in 2009, however sales fell 2% to CHF1301m. In the custom manufacturing division sales fell almost 7% to CHF658m due to anticipated low capacity utilisation in Portsmouth and Hopkinton in Q1 2010. In the chemical manufacturing business Lonza continued to be affected by customers’ efforts to optimise their overall cost base and net working capital. The company successfully implemented of a number of operational excellence programs which have increased the flexibility and throughput of most of its chemical manufacturing assets and will meet the new customer requirements. Lonza's biological manufacturing business continued to operate at high batch success rates, above the industry average and multiple new products and production campaigns had a positive impact on its mid- and large-scale asset utilisation.
Reuters

Tuesday, 20 July 2010

Reaxa will lead a five-company consortium with a £718,000 Technology Strategy Board grant simpler, cleaner, lower-cost manufacturing processes

Reaxa

Angel posts H1 profit

Angel Biotechnology has reported a profit of £106,000 in the first six months of 2010. The company said it has secured business for the rest of the year and expects to post a profit for the full year.
The Herald

Apicore's Somerset, NJ, API manufacturing facility has successfully completed a US FDA inspection

BusinessWire

Eden to develop Itero biosimilar

Eden Biodesign will provide process development for Itero Biopharmaceutical’s biosimilar recombinant follicle stimulating hormone. The product has been licenced by Eden's parent company, Watson Pharmaceuticals.
San Francisco Business Journal

Thursday, 8 July 2010

Jubilant to focus on life sciences

Jubilant Organosys is to spin off its agri-chem and performance polymer business units into a separate business Jubilant Industries and rename itself Jubilant Life Sciences.
Reuters

Tuesday, 6 July 2010

Socma’s Bulk Pharmaceuticals Task Force (BPTF) has introduced a standardised quality drug agreement for CMOs and their customers

Socma

Girindus will validate a manufacturing process for an oligonucleotide product currently in Phase III clinical trials

Girindus

Aptuit acquires GlaxoSmithKline's medicines research centre in verona, Italy

PM Live

BASF merges Swiss fine chems units

BASF has merged its Evionnaz, Switzerland- based businesses BASF Orgamol Pharma Solutions and BASF Fine Chemicals Switzerland into a single organisation, BASF Pharma (Evionnaz). BASF said the merger reduces complexity at its site and simplifies processes.
In-Pharma Technologist

Thursday, 1 July 2010

Aesica acquires R5, plans more

Aesica has acquired R5, which develops and manufactures new medicines and clinical trial materials, for an undisclosed sum. Chief Executive, Robert Hardy, said the company is currently considering a number of additional takeover targets overseas as part of its expansion plans including a formulation manufacturer in the US and Europe.
North East Business

CPhI to be held in Frankfurt in 2011

The annual trade show will take place on 25-27 October 2011 at the Messe, Frankfurt.
PR Newswire

Synthetech has hired a financial adviser to explore alternatives including selling the company

Portland Business Journal

Saltigo's Leverkusen site has successfully completed an FDA audit

Contract Pharma

DCGI to inspect China plants

India's drug regulator, the Drug Controller General of India (DCGI), is planning to start inspecting manufacturers in China supplying intermediates and APIs to Indian manufacturers.
DWS Pillscribe

Rumour: Dishman to sign manufacturing deals worth $40m with Abbott and Merck

Economic Times