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

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