Evonik IPO reportedly delayed until 2012

Reuters

Oxford BioTherapeutics has licensed CMC Biologics’ CHEF1 expression system for research, development, and commercial use

Oxford BioTherapeutics

Lonza and Fosun to establish jv

Lonza and Shanghai Fosun Pharmaceutical plan to create a jv in Pudong Zhangjiang High-Tech Industry Zone. The two companies will jointly invest CNY100m ($15.6m). Lonza has said that five drugs will be produced by the jv. Capital Vue

Camlin Fine Chemicals has been renamed Camlin Fine Sciences

Bombay Stock Exchange

Oxford BioTherapeutics has licensed Lonza’s GS Gene Expression System for research, development and commercial applications

Oxford BioTherapeutics

CMC Biologics has completed the installation of a 2000L single-use bioreactor at its Copenhagen manufacturing facility

PR Newswire

Fareva acquires Pfizer plant

Fareva has acquired Pfizer's Henrico, VA, plant and will invest $42m in the facility. Fareva will keep the current 500 employees at the facility and planes to add more over the next five years. As part of the agreement, Fareva will manufacture products for Pfizer for six years. Richmond Times-Dispatch

DSM and Sinochem anti-infectives jv

DSM has established a Hong Kong-based 50/50 global joint venture for its business anti-Iinfectives with Sinochem. Under the jv agreement Sinochem has paid €210m for a 50% equity interest in the business group. The new organisation will be called DSM Sinochem Pharmaceuticals Limited. DSM

Sales grow for Siegfried

Siegfried reported a 28.3% rise in sales to CHF173.8m in H1 2011. Siegfried attributed the growth to a significant increase in API sales, particularly in exclusive synthesis. The company said its strategy is on track and it has the necessary funds for implementation of the strategy. Siegfried

BASF has increased prices of APIs and excipients by 10% due to rising costs for raw materials, energy and labour

In-pharma Technologist

New rules for Chinese contract manufacturers

China's State Food and Drug Administration (SFDA) is clamping down on its drug contract manufacturing companies. The SFDA aims to prevent the export of counterfeit products.
Sidley

CABB has completed its acquisition of KemFine

CABB

Contract manufacturing to double in next 10 years

Business information provider Visiongain predicts that global contract manufacturing revenues will double from 2011 to 2021. The company says revenues will reach $64.07bn in 2016 - with a CAGR of 8.7% between 2010 and 2016 - driven by manufacturing of finished dosage forms.
Pharma Times

Aptuit will sell its clinical trials supplies business to Catalent for $410m

Philadelphia Business Journal

BI plant to exit contract manufacturing

Boehringer Ingelheim's Ben Venue laboratories facility in Ohio is to cease contract manufacturing activities and focus on generics operations. Contract manufacturing work will be transitioned to other Boehringer plants over the next few years.
Nasdaq

Dottikon ES will end short hours working at its plants at the end of September 2011 after seeing more new projects

Dottikon

Congress to pass plant inspection law

The US Congress is expected to pass new legislation that will enable the FDA to inspect overseas generic drug manufacturing facilities every two years. Generic drug manufacturers will pay fees totalling $299m/year to fund the inspections in return for speedier approval of products.
New York Times

Jubilant Organosys has signed a $100m manufacturing deal with an undisclosed global firm

The Hindu

Fine chemicals revenues rise at Ampac

Revenues at Ampac Fine Chemicals rose 55% to $30.8m in its Q3 2011 compared to 2010. The company attributed this to increases in revenues from core products in its key therapeutic areas including a 139% rise in revenues from anti-viral products.
Seeking Alpha

Onyx acquired by Ipca Laboratories

Onyx Scientific has been acquired by Ipca Laboratories for £4.6m. The UK-based business will be operated as part of Ipca's Covenance custom manufacturing business unit.
North East Business

Ampac Fine Chemicals will manufacture the API for Chimerix's smallpox drug, CMX001, at its Rancho Cordova, CA, facility

Pharmaceutical Business Review

Lonza has extended the expiration date for its tender offer for 100% of the outstanding shares of common stock of Arch Chemicals to 12 September

Lonza

Boehringer Ingelheim contract manufacturing unit will use ProBioGen's GlymaxX technology to produce afucosylated antibodies in its CHO-based system

GEN

Neuland Laboratories reported revenues rising 14% to $23.2m for its Q1 2012

Neuland Laboratories

AMRI Q2 revenues rise

AMRI reported that Q2 2011 revenues for its development/small scale contract manufacturing rose 18% to $9.1m and for its large scale contract manufacturing rose 21% to $25.5m over 2010.
Albany Business Review

Roche Colorado acquired

ICIG is to acquire Roche Colorado and its Boulder, CO, manufacturing facility for an undisclosed fee. ICIG will operate the business as part of its Corden Pharma unit and rebrand the facility as Corden Pharma Colorado. The facility will continue to supply Roche with a number of APIs.
In-pharma Technologist

Joint inspection programme reports

The EMA, the FDA and Australia's Therapeutic Goods Administration have concluded their joint inspection pilot programme. During the two pilots the agencies exchanged more than 250 documents relating to 54 different medicines and organised 13 collaborative inspections of clinical trials. As a result, the agencies will continue with their collaboration on inspections and build on the lessons learned during the pilot phases.
Wall Street Journal

SynCo Bio Partners has produced the first product batches from its expanded aseptic filling facility

Manufacturing Chemist

DSM seeks CMO partner in Asia

DSM is seeking a partner in Asia for its pharmaceutical products custom manufacturing unit. The company is looking to serve new clients in Asia and smaller customers to reduce its reliance on its current large pharma customer base.
Outsourcing Pharma

Cambrex's Q2 sales rose 17.6% to $67.5m primarily due to higher custom manufacturing sales and generic API volumes

MSNBC

Wacker's Biosolutions business generated sales of €39.0m in Q2 2011 up €0.7m from 2010

Wacker

DSM pharma sales slow

DSM reported that sales for its pharma-facing business unit fell to €178m in Q2 2011 from €195m in the same period in 2010 and H1 sales fell to €341m from €381m. The company said that its pharma sales and results improved compared to Q1, but it is conscious that overall performance of the cluster remains below acceptable levels. DSM attributed the lower Q2 sales to the weaker US dollar and lower volumes at DSM Pharmaceutical Products.
DSM

Novasep's Freeport, Bahamas, and Chasse sur Rhône, Lyon, France, facilities passed FDA inspections in March and May respectively

Novasep

Currency puts pressure on Lonza

Lonza's sales fell 5% to CHF1,193m in H1 2011, with the company reporting pressures of unfavourable exchange rates. However, the company reported that it had increased its project pipeline in both chemical and biological manufacturing. Additionally the company said its capacity utilisation was around 80% for both parts of its custom manufacturing business.
Reuters

Sigma-Aldrich's SAFC business unit reported sales of $183m in Q2 2011, up 17% on 2010

Seeking Alpha

Laureate Biopharma will develop and manufacture a biosimilar product for a leading generic pharmaceutical company

Laureate Biopharma

Lonza will provide process development and scale-up agreement for the manufacture of Genesis Biopharma's autologous cell therapy product candidate

GEN

WH Partnership will provide specialist engineering support for the next phase of re-commissioning Angel Biotechnology's Cramlington facility

Angel Biotechnology

Albemarle's Fine Chemistry sales rose 31% to $184.8m in Q2 2011 and income more than doubled to $37.4m

Albemarle

Cellectis reaches Lonza milestone

Just over a year after announcing it would use its meganuclease technology to deactivate glutamine synthetase in Lonza's CHO cell line, Cellectis bioresearch claims it has succeeded. Lonza said the achievement will enable it to make further improvements to its GS Gene Expression System and shorten development timelines.
Bioscience Technology

Lonza will produce phase II clinical trial material for Immune Pharmaceutical's human immunoglobulin monoclonal antibody, bertilimum

Immune Pharmaceuticals

Johnson Matthey's Fine Chemicals Division sales rose 15% to £70m in its Q1 2011

Johnson Matthey

Lonza has started its buyout of Arch

Forbes

Ajinomoto and Granules announce API jv

Ajinomoto OmniChem and Granules India Limited have established a joint venture, Granules-OmniChem Private Limited, to provide contract manufacturing of APIs. The company, which will be based in the Pharmacity SEZ zone in Vishakhapatnam, Andhra Pradesh. It will start construction of its $20m manufacturing facility in November 2011, and expects to start production by January 2013.
India Infoline

Mark Griffiths has been appointed as Chief Executive Officer at Carbogen-Amcis

Pharma

Lonza to buy Arch

Lonza has made an approved offer of $1.4bn for Arch Chemicals. The deal will give Lonza a word-leading presence in microbial control and will reduce the companies dependence on contract manufacturing.
NYT Deal Book

FDA approves 20 drugs in H1

The US FDA approved 20 new drugs in the first half of 2011. Last year it approved 21 in the whole year. While the agency said that it was meeting more than 90% of approval deadlines, there is a feeling amongst some commentators that this approval rise in approval rate is a blip possibly a clearing of a backlog of applications.
Wall Street Journal

Angel Biotechnology has signed a revised contract to manufacture stem cells for ReNeuron's stroke clinical trial

Business Insider

OctoPlus will provide process development and manufacturing for a Danish pharmaceutical company

Octoplus

Recipharm spins out biologics facilities

Recipharm has established a holding company for its biologics development facilities in Sweden and the UK. The shareholders in the new company, Cobra Biologics Holding which will continue to trade as RecipharmCobra Biologics, are its management team, Zentricity Holding and Recipharm. Recipharm has decided to concentrate on its core business activities.
Recipharm

Unions call for Lonza talks

The Unia and Syna unions, which represent workers at Lonza's Visp site, have called for talks with the company, following its decision to extend working hours. The unions said the move was unacceptable and an affront to personnel and unions. Unia said staff should not have to work longer to ensure Lonza turns a profit and called for immediate talks on the issue.
Swiss Info

Lonza has instigated 43-hour working at its Visp, Switzerland, facility to offset currency pressures on profitability

Lonza

Prosonix secures funding

Prosonix has raised £11.4m in Series B funding to move its pipeline of proprietary mono and multi-component combination respiratory therapies through phase II clinical trials. Ventech led the round with Gilde Healthcare Partners joining existing investors the Entrepreneurs Fund, Solon Ventures and Quest for Growth. David Hipkiss, Prosonix's CEO said "these new funds will allow us to attain key performance and clinical data for our pipeline of advanced fast-to-market respiratory programs that will deliver significant added value and benefits to patients and payors alike."
In-pharma Technologist

Cambridge Major Laboratories Europe will manufacture cGMP material for use in clinical studies for Summit's preclinical antibiotic candidate

Manufacturing Chemist

Senator calls on FDA to tighten outsourcing rules

US Senator Sherrod Brown has called on the FDA to tighten its oversight of outsourcing of API production by US pharmaceutical companies. The Senator said: "When drug companies outsource pharmaceutical ingredients, they also outsource drug safety standards. It's simply unacceptable to allow drug companies to skirt existing regulations by importing ingredients from countries with lax safety standards. Drug company profits cannot come at the expense of consumer safety. Pharmaceutical companies must be able to guarantee the safety of their products and trace the origin of their ingredients.”
Sherrod Brown

Bakhu Pharma has completed the purchase of Phoenix Chemicals' Annan, Scotland, site

News & Star

DSM has introduced new downstream processing technology for for faster and more cost effective production of monoclonal antibodies

PR Newswire

Lonza has introduced a new cell culture medium and feed platform for its GS Gene Expression System that achieves product yields up to 10g/L

Lonza

Fujifilm and Mitsubishi enter partnership

Mitsubishi has acquired a 20% stake in Fujifilm's Fujifilm Diosynth Biotechnologies US and UK business units. Following the deal Mitsubishi and Fujifilm will jointly mange the two business units "to strongly promote the expansion of the biopharmaceutical contract manufacturing business". Fujifilm completed the acquisition of the business from Merck in April.
Fujifilm Diosynth Biologics

CMC expansion almost complete

CMC Biologics has almost completed the expansion of its biomanufacturing production facility in Bothell, WA. The expansion will add a 3000L bioreactor train to increase commercial manufacturing.
Pharmaceutical Business Review

Lonza has launched a service to offer early stage development and manufacturing of novel biologics

Lonza

Lonza has received the $260,000 payment it was owed by Regenicin

North Jersey

CABB acquires KemFine

CABB has paid €140m to acquire KemFine from 3i. KemFine, which is headquartered in Helsinki and operates a production facility in Kokkola, Finland, had sales of €81m in 2010. Uwe Kolb, partner responsible for CABB's investors Bridgepoint’s investment activities in the German speaking countries, said: "KemFine is a good fit with our recent acquisition of CABB where our aim is to drive further growth through investments in new technology and new capacities, regional expansion projects and further bolt-on acquisitions.”
Bloomberg

Siegfried plan to power its Pennsville, NJ, facility with solar power

NJ.com

Boehringer Ingelheim is expanding its biopharmaceutical fill and finish capabilities in Biberach, Germany

Boehringer Ingelheim

FDA plans new approach to drug imports

The FDA has launched a plan to improve the safety of pharmaceutical products being imported into the US. The plan includes partnerships and data sharing with regulators across the world.
Wall Street Journal

Evonik Industries has increased its production capacity for the pharmaceutical amino acid glycine by 50 percent

Pharmaceutical Business Review

RecipharmCobra Biologics will continue to advance KAHR Medical's KAHR-102 for future pre-clinical and clinical testing

Recipharm

Pfizer applies for QbD pilot

Pfizer is the first company to apply for the European Medicines Agency's (EMA) and the US Food and Drug Administration's (FDA) 'quality by design' pilot programme. The programme aims to achieve increased co-operation in drug evaluations between the agencies.
PM Live

Lonza has launched the refinancing of its existing CHF500m revolving credit facility

Lonza

Intercell's cGMP biologics facility in Gaithersberg, MD, is available for lease

Pharma BioSource Realty

Dishman shifts focus

Dishman Pharmaceuticals and Chemicals Ltd is planning to shift its focus from low-margin to high-margin products in a bid to boost profits. The company is also re-structuring its Carbogen Amcis subsidiary to bring it back on a growth track.
Business Standard

Onyx Scientific will perform GMP manufacturing for a Cancer Research API for a phase I clinical trial

Onyx Scientific

Pfenex to develop processes for SAFC

Pfenex will engineer production strains and processes for SAFC’s contract manufacturing customers. The developed processes will ultimately be transferred to SAFC’s recently expanded fermentation facility in Jerusalem, Israel for cGMP production. The companies will also work together to combine Pfenex’s Reagent Proteins product offerings in the area of vaccine components with SAFC’s expertise and facilities for bioconjugation to support development of conjugate vaccines.
Contract Pharma

Lonza expands in Singapore

Lonza will expand its biopharmaceutical development services platform in Singapore. the CHF10m investment will add 1858m² of state-of-the-art laboratory space and associated equipment. The additional facilities will support cell line construction, upstream and downstream process development, and analytical services. Lonza said the new facility will come on-line in H1 2012.
GEN

Sales fall at Dottikon

Dottikon reported a 30% fall in sales to CHF80.1m for the year ended 31 March 2011 compared to 2010 and a net loss of CHF7.1m compared to income of CHF12.6m the previous year. The company said the main contributor to the sales decline was a 37% fall in sales of pharmaceutical products as a result of several discontinued and delayed customer projects in the late development phase, together with persistent price and currency pressure.
Dottikon

Viropro's Biologics Process Development subsidiary will double the size of its bioprocess and scale-up laboratory in Poway, CA

Viropro

Aesica's facility in Pianezza, Italy, has received accreditation to manufacture and supply non sterile drugs to the Japanese market

Manufacturing Chemist

Laureate Biopharmaceutical Services will manufacture Patrys' lead antibody PAT-LM1 for preclinical and clinical use

Sacramento Bee

Indian API manufacturers are looking for deals in Japan following after Japanese government opens up its pharmaceutical market to generic drugs

Business Standard

Capacity and costs drive outsourcing

A recent survey of the pharma and biopharma community has revealed that 54.% of organisations outsource less than half of their global manufacturing and that 18.2% currently outsource over 90% of their output. Lack of internal capacity and cost savings were the two key reasons for outsourcing.
GPCM

Fujifilm Diosynth Biotechnologies has added a 1,000L Xcellerex Single-Use Bioreactor at its North Carolina facility

Fujifilm Diosynth Biotechnologies

Sales at Onyx Scientific grew 27% to £3.6m in the last year

Technology Networks

Matthey sales grow

Johnson Matthey's fine chemicals business division ended the year to 31 March with revenues up 14% to £255m and sales up 11% to £245m. The company said it saw good sales growth in its API manufacturing businesses and expects that the division will continue to grow steadily in 2011/12 as a result of increasing demand for its APIs, new product introductions and the additional capacity following the acquisition of the Conshohocken, NJ plant 2010.
Johnson Matthey

Boehringer Ingelheim will produce Betaferon for Bayer after Bayer closes its production facility in Emeryville, CA

RTT News

Ubichem Research acquired

The majority share of Ubichem Research has been acquired by Lochlomond Holding, a financial investment company. The company is now independent of Ubichem Plc in the UK.
Outsourcing Pharma

SCM Pharma will manufacture Speciality European Pharma's oncology product Plenaxis for commercial supply

Outsourcing Pharma

FDA launches inspections database

The US FDA has launched an Inspections Database. The searchable resource includes names and addresses of inspected facilities, inspection dates, types of FDA-regulated products involved, and final inspectional classification.
FDA

Gallus BioPharmaceuticals will use Xcellerex's FlexFactory GMP manufacturing platform suite at its St Louis, MO, facility

Xcellerex

CIA seeks companies for UK pavilion at CPhI

The UK's Chemical Industries Association is seeking UK-based companies offering products and services within the fine chemical industry for a UK pavilion at CPhI in Frankfurt, Germany, during October.
For more information contact CIA

Almac has dedicated its new North American headquarters

Philadelphia Inquirer

Lactosan will manufacture some enzymes for Codexis and its customers

Codexis

Gallus acquires site, plans expansion

Gallus Biopharmaceuticals has acquired Johnson & Johnson's Centocor biologics campus in St Lousis, MO, following an equity investment by Ridgemont Equity Partners. Ridgemont has taken a majority stake in Gallus. Gallus will retain 160 jobs at the facility and plans to expand the facility’s manufacturing capabilities, including building a clinical services suite and expanding the existing development lab, and add 160 further jobs over the next five years.
Ridgemont
St Louis Today

Lonza expands in Houston

Lonza will build a state-of-the-art cGMP clean room for its viral-based therapeutics business in Houston, TX. The clean room will include large-scale capacity to support late-stage viral vaccine and gene therapy projects. By utilising disposable process systems it will support production and fill/finish operations of up to 2000L.
Lonza

Pfenex has submitted a Biologics Master File (BMF) to the FDA for its cGMP grade carrier protein for vaccine production

Pfenex

Codexis transfers processes to Teva

Codexis has completed the technology transfer of custom biocatalysts for manufacture of three pharmaceutical products to Teva. Two products have been transferred to pilot manufacturing and a third to full scale commercial manufacturing. Codexis' biocatalysts are being used in reengineered process steps in the manufacture of covered generic products
In-pharma Technologist

Fine chemicals revenues decline at Ampac

Revenues for American Pacific's fine chemicals division fell from $43.2m in 2010 to $30m in 2011 for the six months ended 31 March. The company said this was primarily due to a 92% decline in revenues from anti-viral products, which the company expects to resume in the second half of 2011.
AmPac

Successful inspection at CML facility

Cambridge Major Laboratories has undergone a successful FDA inspection at its two manufacturing sites. The inspection of its Germantown, WI, large scale facility is the first at the site. The company also said the FDA has approved the product, which is the first commercial product produced in the large scale facility.
BioSpace

Cristin Grove has been appointed as director, Global Contract Manufacturing at Pfizer CentreSource

Contract Pharma

Lonza to expand cytotoxic manufacturing in Visp

Lonza will invest CHF24m to expand its cytotoxic manufacturing capabilities in Visp, Switzerland. The company will add multi-kilogram scale cytotoxic production capacity, which will allow it to offer clinical and commercial production, to its current gram scale high potency GMP laboratory suites. The expansion is expected to be completed in Q2 2012.
Lonza