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

Monday, 8 June 2009

Corden PharmaChem to close Cork facility

Corden PharmaChem is to close its Little Island, Cork, Ireland, facility later this year. The company has blamed the current API market conditions, limited potential for the development and commercialisation of new products, the scale of the plant and the significant capital investment necessary for it.
Irish Examiner

Cambrex regains compliance with NYSE listing requirements

Cambrex

Johnson Matthey sees fine chemicals growth

In its year ended 31 March Johnson Matthey saw sales for its Fine Chemicals and Catalysts division grow 15% mostly due to favourable exchange rates. The division's Fine Chemicals businesses, Macfarlan Smith, Pharmaceutical Materials and Services and Research Chemicals which will report as a separate unit next year, contributed £220 (36%) of the division's revenue and 68% of the operating profit. Matthey reported that sales of some products were strong, but manufacturing costs, particularly the cost of energy, rose and that revenue from contract research was adversely affected by the lack of venture capital funding for a number of our smaller customers.
Manufacturing Chemist

Johnson Matthey receives grant for CHP installation at New Jersey facility

Globe St

Dishman expects is Chinese operation to start production in August

DNA India

Tuesday, 2 June 2009

Strem Chemicals has received ChemStewards certification from SOCMA

Strem

SAFC Pharma's St Louis HPAPI conjugates facility receives SafeBridge certification

SAFC

SAFC in supply chain deal with Cherokee

Cherokee Pharmaceuticals will provide analytical testing, storage, packaging and distribution services for raw materials sourced by SAFC as part of a partnership agreement. The partnership will combine SAFC's global sourcing and production capabilities and with Cherokee's analytical laboratories, large-scale cGMP manufacturing, warehousing and distribution facilities.
In-Pharma Technologist

IDT Biologika has established an office in Virginia to serve US customers

Manufacturing Chemist

Lonza negotiating Genome Valley agreement

Further to previous reports Lonza said it is currently negotiating with the Andhra Pradesh Industrial Infrastructure Corporation Ltd for the acquisition or lease of 30 acres of land in Genome Valley. Lonza plans to establish an R&D and manufacturing facility on the site.
Lonza

Thursday, 28 May 2009

Wacker expands cyclodextrin capacity

Wacker has expanded its cyclodextrin facility in Eddyville, IA. The $21m investment has boosted capacity for alpha and beta cyclodextrins by 50% and doubling capacity for gamma cyclodextrin, with the new facility capable of producing 7500 tonne/year of cyclodextrin.
In-Pharma Technologist

Wacker boosts biologics

Wacker is boosting biologics production capacity at its Jena site. Following the completion of a process development and quality control facility in December 2008 a further extension will double the production area and add a downstream purification site. The new facility is expected to be on-stream by 2010
Wacker

Lonza will use its proprietary microreactor technology to produce both clinical trials and large-scale commercial materials for an un-named big pharma

Reuters

Emerson Process Management will provide engineering and design services and digital automation systems for Lonza's biopharma plant in Singapore

Manufacturing Chemist

Lonza invests in India

Lonza will invest $150m in a two-stage project in Genome valley, Hyderabad, India. The first phase of the development, which is due to be operational in 2011-2013, is for R&D labs for 100 people, a small-scale multi-purpose manufacturing plant for biopharmaceuticals, and a small-scale bio-therapeutic media manufacturing plant. The second phase of the development, which is due to be operational in 2014-2015 includes expanded media manufacturing capacity for bio-therapeutic media, additional R&D lab capacity for biologics for 200 researchers, and expanded large-scale manufacturing plant for biopharmaceuticals.
Fierce Biotech

Sunday, 24 May 2009

Hovione invests in R&D unit

Hovione will invest €2m ($3m) in a new R&D unit in Lisbon. The facility, which will be the base for the company's drug R&D efforts, will focus on the design, development and characterisation of nano- and micro-particles for novel delivery applications.
Outsourcing Pharma

The number of peptides in clinical studies has doubled in the last decade

Tufts CSDD

Tuesday, 19 May 2009

The US Senate has confirmed Margaret Hamburg as FDA Commissioner

Wall Street Journal

Americal Pacific Fine Chemicals saw revenues decline 9% in its Q2 2009

Ampac

Lonza will manufacture a subset of Morphotek's antibody pipeline including lead candidate farletuzumab

Morning Star

Avecia Biotechnology will manufacture Giuliani SpA's oligonucleotide therapeutic for Crohn's disease

MMD Newswire

Lonza expands in Singapore

Lonza is investing CHF30m ($27.03m) in a new cell therapy manufacturing facility in Singapore. Construction will commence next year and production by mid-2011.
Reuters

Minakem acquires API plant

Minakem has acquired AstraZeneca's multi-purpose APIs plant in Dunkirk. In addition Minakem has a greed a long term contract to supply AstraZeneca with Budesonide, Omeprazole and Esomeprazole. The multipurpose plant is dedicated to the production of corticosteroids.
Contract Pharma

Thursday, 14 May 2009

Lonza and Teva have received EU approval for their biosimilars jv

Reuters

Eden Biodesign successfully completes second MHRA audit at Liverpool facility

Eden Biodesign

Avecia Biologics Tees Valley manufacturing facility has received a Manufacturer’s Licence from the MHRA

Avecia

Avecia launches antibody fragment toolkit

Avecia Biologics has launched a toolkit of technologies for producing antibody fragment therapeutics. The toolkit combines Avecia's high yield microbial expression system with downstream technologies for purification, refold and PEGylation.
Avecia

Sunday, 10 May 2009

Obama wants extra $300m for FDA

US President Barack Obama has called on Congress to authorise and addtional $300m in to boost the FDA budget from $2.06bn in 2009 to $2.35bn in 2010. The President said the budget should strengthen inspections and increase the number of generic drugs on the US market.
Wall Street Journal

CombinatoRx files against Aptuit

CombinatoRx has filed a lawsuit against Aptuit. CombinatoRx alleges that "Aptuit caused harm by willfully ignoring warnings and failing to correct or disclose deficient practices that did not comply with European Union Good Manufacturing Practices as identified by UK regulatory authorities during planned inspections of Aptuit’s manufacturing facility in Kansas City, Missouri". The suit relates to the terminated agreement to manufacture Synavive (CRx-102) for a clinical trial.
CombinatoRx

Althea Technologies has opened its new state-of-the-art, commercial-scale cGMP manufacturing facility in San Diego, CA

Althea

Pharma declines for Saltigo

Lanxess' Saltigo business unit saw "robust" performance in Q1. The unit was less affected by declining demand from customer industries than in Lanxess' other business units. However Saltigo did see some decline in its pharmaceutical intermediates business due to product launch delays.
Lanxess

Wednesday, 6 May 2009

Dow Chemical plans to issue shares worth $1.63bn to fund Rohm & Haas acquisition

Associated Press

Jubilant Organosys in neuroscience drug discovery collaboration with AstraZeneca

Morning Star

Cambrex sales decline

Cambrex reported a sales decline of 2.8% in Q1 2009. The company said that excluding currency impacts sales increased 8.7% primarily due to long standing orders of two APIs, higher volumes of controlled substances and slightly higher custom development revenues. However, the company saw lower sales of generic APIs.
Cambrex

Tuesday, 28 April 2009

Senators want FDA to inspect more foreign plants

US Senators Chuck Grassley and Edward Kennedy have introduced a Bill to require the FDA to inspect more foreign drug manufacturing plants. The Senators say the FDA would get fees for conducting drug plant inspections.
Policy and Medicine

DSM pharma sales decline, profit rises

DSM's pharmaceutical facing business saw first quarter sales decline 5% to €197m, however profit for the business unit rose 3% to €11m. DSM attributed the sales decline to the disposal of a business unit at the end of 2008.
DSM

Albemarle sees sales decline

Albemarle saw sales in its fine chemicals business fall 18% to $120.8m in Q1 2009. The company attributed the decline to reduced sales in its bromine franchise.
RTT News

Sunday, 26 April 2009

SAFC sees sales decline

Sigma Aldrich saw sales for its SAFC fine chemicals business unit decline 5% against last year in Q1. The company saw a decline in orders from pharmaceutical customers during the quarter, but has a strong forward-orders book. SAFC has continued with three key expansion projects: to expand capacity for cGMP fermentation in Israel and new high-potence API capacity in Madison, WI, both of which are due onstream early in 2010, and a new viral products facility in Carlsbad, CA, which is due onstream soon.
Seeking Alpha

Thursday, 23 April 2009

Lonza on target; opens 2000L facility

Lonza has confirmed it is on track to meet its 2009 financial goals. Chief executive, Stefan Borgas, said the company saw robust underlying demand in life science markets remains and an increased outsourcing in biopharma as well as in chemical APIs, but that Lonza was feeling the effect of customer supply chain optimisation.
In addition, Lonza has started-up its high-titre 2000L microbial manufacturing train in Hopkinton, MA. The train is complemented by a highly flexible purification area. Lonza has also revamped the entire Hopkinton site infrastructure.
Reuters
Lonza

PharmEng to close plant

PharmEng will not be able to file its annual audited financial statements by the filing deadline of April 30, 2009. The company will also close its Sydney, Nova Scotia manufacturing facility effective May 8, 2009.
Market Wire

Wednesday, 22 April 2009

The US Senate Finance Committee has approved Kathleen Sebelius nomination as secretary of health and human services

Associated Press

Mixed reception for UK Budget

The UK Chemical Industries Association said the UK Budget "will be a major disappointment to chemical and pharmaceutical businesses across the UK". Chief Executive, Steve Elliott is "particularly angry that existing money has not been redirected to help temporary lay-offs and short time working".
Elliott also welcomed the £750m Strategic Investment Fund to support emerging technologies and high tech manufacturing. This fund was also cautiously welcomed by the BioIndustry Association, which said "it is essential that the fund is now implemented rapidly" to ensure that companies in the sector can benefit.
Chemical Industries Association
BioIndustry Association

Hovione opens Ireland plant

Hovione has opened the API manufacturing site in Cork, Ireland, which it agreed to acquire from Pfizer in December 2008. Hovione will continue to perform some manufacturing for Pfizer, which has manufactured Lipitor at the site for more than 10 years. However, the facility will mostly be used to address Hovione's own production needs.
Hovione

The US Senate Finance Committee has approved Kathleen Sebelius nomination as secretary of health and human services

Wall Street Journal

Tuesday, 21 April 2009

Excelsyn wins Queen's Award

Excelsyn has won the Queen’s Award for Enterprise 2009, in the International Trade category, in recognition of a near-trebling of its export earnings, which now account for 82% of sales.
Daily Post

AMRI relocates Bothell, WA, R&D laboratory - new facility has space for expansion

AMRI

CIA calls for UK Government to re-skill chemical workers during recession

CIA

Thursday, 9 April 2009

BASF has completed its acquisition of Ciba

Forbes

CIA and ICC sign MoU

The Chemical Industries Association and Indian Chemical Council have signed a memorandum of understanding to encourage the development of trade between the UK and India.
CIA

DSM selected as Shire's manufacturing partner following close of Maryland plant

DSM

Monday, 6 April 2009

Shire closes plant outsources manufacturing

UK pharma company Shire is phase out manufacturing at its Owings Mills, MD, facility over the next three years. Shire plans to outsource the manufacturing to a North Carolina-based manufacturer as the company moves away from in-house manufacturing.
Baltimore Sun

BASF-Ciba acquisition approved by US and Chinese authorities

BASF

Piramal Healthcare relocates custom manufacturing

Piramal Healthcare has closed its API contract manufacturing facility in Huddersfield, UK. Piramal will move the manufacturing jobs to its Morpeth, UK, and Ennore and Ahmedabad, India sites. The move will cost &3163;10m but the company expects to see profits in its custom manufacturing business improve by 6-8% by 2010-11.
Business Standard

Thursday, 2 April 2009

Dow Chemical completes Rohm & Haas acquisition

Wall Street Journal

Lonza’s antibody drug conjugate facility in Visp, Switzerland has received a SafeBridge “Potent Compound Safety Certification"

Lonza

SOCMA changes name

SOCMA has changed its name to the Society of Chemical Manufacturers and Affiliates. Previously known as the Synthetic Organic Chemical Manufacturers Association, SOCMA believes the change formally broadens the scope of its activity to reflect service to the batch, custom and specialty chemical industry. Following changes to its charter all categories of SOCMA membership are now available to companies involved in batch, custom and specialty rather than just synthetic organic chemical manufacturing.
Pharmaceutical Business Review

Shasun has closed its Annan, Scotland, manufacturing plant

In-Pharma Technologist

Johnson Matthey to close Irish plant

Johnson Matthey plans to close its fine chemical manufacturing facility in Ireland and consolidate manufacturing of prostaglandin products at its US facility. The company said that in the quarter to the end of March its Fine Chemicals & Catalysts Division's sales excluding precious metals were ahead of the same period last year helped by favourable exchange translation and that good sales of active pharmaceutical ingredients offset some weakness in catalysts and chemicals.
Reuters

Tuesday, 24 March 2009

Consortium wins manufacturing technology grant

A consortium of US and UK companies has been awarded an $11m phase 2 contract by the US Defense Threat Reduction Agency (DTRA) - Joint Science and Technology Office, Transformational Medical Technologies Initiative (TMTI), to develop technology for accelerated monoclonal antibody and vaccine manufacturing. The consortium combines Xcellerex’s microbial process development and single-use manufacturing technologies with Dowpharma’s Pfenex expression technology, deltaDOT’s analytical technology and BioPharm Services' systems integration, data management/process economics, and simulated event modeling technology. The consortium won a phase 1 grant in July 2007 (FINE Newsletter, 19 July 2007).
Boston Globe

Pharma industry calls for FDA food-drug split

Associated Press

Cobra Biomanufacturing reaches agreement with customer over contract variation

Cobra

Sunday, 22 March 2009

Chemtura files for bankruptcy protection

Reuters

DSM to establish JVs in China

DSM has taken a 10% stake in North China Pharmaceutical Group Corporation Ltd and the two companies are establishing three joint ventures: one for vitamin C and two for anti-infective APIs and intermediates. DSM will hold a 51% share in the two anti-infectives joint ventures.
DSM

Thursday, 19 March 2009

Almac has "topped-off" it new headquaters site in Pennsylvania

Almac

Wacker expects fine chemicals growth in 2009

Wacker's fine chemicals business saw sales fall 13% in 2008, despite higher sales of its biotech products. The company put this down to consolidation and reducing the number of catalogue products it makes. The company expects overall business to fall in 2009, but believes the fine chemicals unit will see growth.
Wacker Chemie

Onyx Scientific, Cyprotex Discovery and Glytech will jointly offer drug metabolite identification and synthesis services

Onyx

Tuesday, 17 March 2009

Novasep to build HPAI facility

Novasep will develop an R&D-phase pilot facility for highly potent active ingredients (HPAIs) as part of a consortium funded by the French government to develop innovative cancer therapies.
Business Wire

Obama announces FDA picks

President Obama has finally announced his picks to head the FDA. The President has nominated Margaret Hamburg as FDA Commissioner and Joshua Sharfstein as deputy commissioner. Hamburg will face a congressional approval committee.
Forbes

Wednesday, 11 March 2009

Obama settles on FDA choices

Wall Street Journal

Dow and Rohm & Haas settle merger disagreement

Fox

Ampac Fine Chemicals has inaugurated its kilogram scale cGMP batch/continuous processing development facility

Contract Pharma

Lonza speeds biologics development timeline

Lonza has developed a cell line construction process that reduces the time taken from DNA sequence to cGMP material to 14 months. The customer-tailored cell line construction process uses rapid methods for generating clonal cell lines and chemically defined, non-animal origin components.
Bio Valley

Monday, 9 March 2009

Dow back in talks with Rohm & Haas

Bloomberg

UKTI seeks companies for ChemSpec Europe

UK Trade and Investment is seeking up to 14 companies for a stand share at ChemSpec Europe in Barcelona. The companies must be of UK origin and offer UK origin products and services within the fine and speciality chemical industry.
For more information contact UKTI

Merck to acquire Schering Plough for $41.1bn

New York Times

DSM and Roquette are to commercialise a bio-based succinic acid production process

MSNBC

Penn Pharmaceuticals has launched a £12m, 5-year expansion programme at its Tredegar, Wales, site

Outsourcing Pharma

US Senators propose clamp down on unsafe drug imports

A bi-partisan group of US Senators has introduced a Bill that will limit imports of drugs into the US. The Bill - The Pharmaceutical Market Access and Drug Safety Act - will only allow drugs - and drug ingredients - to be imported from FDA-inspected plants.
Domain B

Thursday, 5 March 2009

Lonza to manufacture TcL Pharma antibody

TcL Pharma has chosen Lonza to manufacture its lead monoclonal antibody. Lonza will provide strain development using its XS Microbial Expression Technologies through to cGMP manufacture of Phase I clinical material.
Manufacturing Chemist

RFCL-Mallinkrodt Baker deal off

RFCL has called off plans to acquire Mallinckrodt Baker. The two companies failed to agree a common valuatio, analysts expected the deal to be worth $325-350m.
Economic Times

Dow considers selling assets to fund Rohm & Haas deal

ICIS

Tuesday, 3 March 2009

Novacta and CML partner for chiral processes

Novacta Biosystems and Cambridge Major Laboratories will collaborate to develop new manufacturing routes to chiral pharmaceutical intermediates. Novacta will develop biocatalytic approaches to target chiral intermediates which Cambridge Major will scale-up at its facility in the Netherlands.
In-Pharma Technologist

India to be top five pharma hub

The Indian Government is planning to make the country one of the top five global pharmaceutical innovation hubs within four years. It aims to invest $1bn as part of its Vision 2020 - half of which will be public funds half from industry.
Pharma Times