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

Thursday, 10 July 2008

Inspectors collaborate

The US, Europe and Australia will share data from manufacturing facility inspections to cover a wider territory and more facilities than they could alone. The pilot programme will concentrate on inspecting facilities in countries such as China and India.
Associated Press

Dow to acquire Rohm & Haas for $18.8bn

Bloomberg

Penn acquired by Minakem

The assets of Penn Specialty Chemicals have been acquired by PennAkem, a wholly-owned subsidiary of the French Minakem Group. The acquisition makes PennAkem the preeminent supplier of furfural and furan derivatives.
Minakem

Rentschler to expand biomanufacturing and exit pharma

Rentschler will invest €14m to expant the biomanufacturing capbilities at its Laupheim site. At the same time it has sold its pharmaceutical manufacturing business to Riemser Arzneimittel, which will expand its contract manufacturing business with the acquisition.
Rentschler

Aquapharm in Dr Reddy's licensing deals

Aquapharm Biodiscovery has signed a new license agreement with Dr Reddy's and has extended an existing deal. The original deal was signed with Dowpharma, which was acquired by Dr Reddy's earlier this year, in 2006. The agreement covers the use of selected strains from Aquapharm's library of novel marine micro-organisms to generate commercial biocatalysts for the manufacture of pharmaceutical intermediates.
Aquapharm

Albemarle to manufacture ibuprofen for Dr Reddy's

International Business Times

Sunday, 6 July 2008

World Bank group invests in Hikal

Hikal has received a $15m equity investment from International Finance Corporation, part of the World Bank group. Hikal said it plans to use the capital to expand its manufacturing and R&D facilities in Jigani, Panoli and Taloja.
Money Control

Wednesday, 2 July 2008

Lonza commits to stem cells

Lonza will produce clinical trial and commercial supplies of Osiris Therapeutics' adult stem cell therapy, Prochymal. Lonza will build new facilities in Walkersville, including the first commercial-scale allogeneic cGMP manufacturing facility and capacity to manufacture cGMP grade cell culture media for therapeutic applications.
Forbes

Monday, 30 June 2008

Plethico plans to cut CMO business

Plethico Pharmaceutical is looking at trimming its Contract Research and Manufacturing Services (CRAMS) business as low margins are being further squeezed out due to higher inflation and surging crude oil prices.
Economic Times

Rentschler Biotechnologie has started operation of its 250-L multi-process mammalian cell production suite

Rentschler Biotechnologie

Emcure inaugurates plants

Indian manufacturer, Emcure Pharmaceuticals, has inaugurated its commercial oncology products manufacturing plant in Hinjewadi. In addition, Emcure's Gennova Biopharmaceuticals subsidiary has inaugurated its trial-scale malaria vaccine manufacturing facility.
Economic Times

Wednesday, 25 June 2008

FDA funding approved

The US House Agriculture subcommittee has approved funding of $2.1bn for the FDA in 2009 - $282m more than the agency originally requested.
Health Imaging

Avid joins PER-C6 network

Avid Biosciences will be the pre-approved contract manufacturer for licensees of DSM and Crucell's PER.C6 cell line located in the western US.
RTT News

Saltigo expects to meet 5% profit goal

Bloomberg

DHS notifies high risk facilities

The US Department of Homeland Security (DHS) is informing the owners that 7000 chemical facilities have been designated as "high risk" in the face of terrorism attack. SOCMA has welcomes the DHS action to secure chemical facilities according to risk under its Chemical Facility Anti-Terrorism Act Standards.
HS Today

Thursday, 19 June 2008

PacificGMP will build biomanufacturing facility in China following merger with Pacific Biopharma

PR Newswire

China grants approval for FDA offices

Reuters

US Senator calls for pharma outsourcing probe

Pharmalot

Eden Biodesign is to build a biomanufacturing facility in US

Eden Biodesign

CEFIC and DSM criticise EU API measures

CEFIC and DSM have said the European Commission's proposals for tackling counterfeit APIs do not go far enough. Responding to the public consultation both parties believe APIs in medicines destined for the EU market must comply with GMP and that there are concerns over some APIs originating from India and China.
In-Pharma Technologist

Dishman builds in China

Dishman Pharmaceuticals has invested $10m in an API and intermediates facility in Shanghai, China. The facility which is due onstream early in 2009 will support Dishman's contract manufacturing business.
Sify

Monday, 16 June 2008

FDA considers outsourcing inspections

The US FDA is looking to outsource the inspection of pharmaceutical manufacturing facilities. However, there are concerns after the relative failure of a similar system used for medical devices.
San Diego Union-Tribune

Further production boost for PER-C6

DSM And Crucell have further enhanced the productivity of their PER-C6 human cell line. Just three months after announcing the cells could produce 15g/l they have announced that they can achieve production levels of 27g/l.
Reuters

Thursday, 12 June 2008

Evonik may sell more shares

Hemscott

Daiichi to acquire Ranbaxy stake

Japanese pharmaceutical company Daiichi Sankyo will acquire a controlling stake in Indian generics manufacturer Ranbaxy for $4.6bn. Analysts believe the deal may start a string of western takeovers in the Indian pharmaceutical sector. Ranbaxy is believed to have talked to other companies including Takeda, GlaxoSmithKline and Pfizer. Sources suggest Pfizer may bid for a further stake in Ranbaxy.
AFP
Times of India
Business Standard

pecter slams Administration over FDA cash

Just days after the Bush Administration called on he US Congress to authorise an additional $275m for the FDA, Senator Arlen Specter has criticised the timing in the Administration Request. Specter believes the FDA needs the money asap, but the Administration request would deliver the money in March or April 2009. Specter is highly critical in his letter to Secretary Leavitt.
Wall Street Journal

BASF has developed a new class of enzymes for producing chemically sophisticated chiral molecules

BASF

Avecia has added formulation studies to its portfolio

Avecia

Angel Biotechnology will manufacture GMP clinical trial GMP material for Novolytics

InvestEgate

Arch buys into Benzochem

Arch Pharmalabs has acquired 70% of Benzochem Lifesciences for around $23m. Benzochem specialises in manufacturing oncology products.
In-Pharma Technologist

Administration asks for more cash for FDA

US Health and Human Services Secretary Michael Leavitt has asked Congress to give the FDA an additional $275 million in next year’s budget to enhance the safety of food and medical products.
New York Times

Cobra Biomanufacturing will produce ViroMed’s Master Cell Bank and GMP-grade VM206RY plasmid DNA treatment for clinical trials

Cobra

Cambridge Major has broken ground on its expansion project

WISbusiness
Previously on FINE

Matthey takes stake in Dr Reddy's subsidiary

Johnson Matthey is to buy a 49% stake in Macred India, the subsidiary of Dr Reddy's dedicated to the manufacture of narcotic drugs from opium.
Economic Times

Thursday, 5 June 2008

Johnson Matthey's Fine Chemicals and Catalysts business saw sales increase 13% to £303m

InvestEgate

Central Glass acquires Girindus business

Girindus has sold its Halle-Kuensebeck, Germany, process development, upscaling, cGMP production of active pharmaceutical ingredients as well as the fine chemical business and all related analytical activities to Central Glass Germany.
Girindus

CVC wins Evonik race, IPO planned

CVC Capital Partners has won the race to acquire a stake in Evonik. The private equity house has acquired a 25.01% stake in the German industrial Group for €2.4bn. Wilhelm Bonse-Geuking, CEO of Evonik's parent company, the RAG Foundation, said that RAG plans to IPO Evonik after mid-2010 and before 2013.
CVC
Bloomberg
Hemscott

Tuesday, 3 June 2008

Dow Chemical has settled its litigation against former executives

Reuters

CVC expected to win Evonik race

As the Evonik decision day draws closer, it has been revealed that RAG now plans to sell a 25.01% stake in Evonik, giving the buyer a veto vote. Reports suggest that CVC Capital Partners is the winning bidder. CVC is set to pay €2.4bn for the stake, beating bids from Bain Capital, Blackstone Group and Kohlberg Kravis Roberts.
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Reuters

Sunday, 1 June 2008

Evonik decision due 11 June

Evonik's parent company RAG will decide on 11 June which of the four interested financial buyers will get the 25% stake in the company. Sources suggest the workers union liked the presentations from KKR.
Forbes

Wednesday, 28 May 2008

Jubilant Organosys has completed its acquisition of Draxis Health

Draxis

Safety concerns slow FDA approvals

Janet Woodcock, director of the US FDA's Center for Drug Evaluation and Research, has said that a new focus on drug safety is delaying the approval of some medicines. She said the Agency's hiring programme would help offset the delays.
Reuters

Tuesday, 27 May 2008

Cytovance Biologics will manufacture an antibody for ImmunoGen

Business Wire

FDA awaits China approval

The US FDA is awaiting approval from the Chinese Ministry of Foreign Affairs before it can establish offices in China. The FDA plans to open offices in Beijing, Shanghai and Guangzhou.
Associated Press

Chemtura for sale?

Private equity firms Blackstone Group and Apollo Management LP are said to be in talks to acquire Chemtura. Chemtura is currently reviewing strategic alternatives that could include divestitures, acquisitions or a sale.
Forbes

Lonza has acquired Amaxa AG to enhance its Cell Discovery business

Hemscott

Thursday, 22 May 2008

Unipex Group has acquired the active ingredients and specialty chemicals division of Atrium Innovations for $166m

PR Newswire

Dr Reddy's reveals Dowpharma and BASF costs

Dr Reddy's spent $38m on BASF's Shreveport manufacturing plant and $34m on Dowpharma's UK assets in Mirfield and Cambridge. The figures were revealed as the company revealed that its full year 2007-2008 profit fell almost 50% to $117m.
The Hindu

Wednesday, 21 May 2008

SOCMA certifies facilities

SOCMA has certified the first five facilities to complete the required steps of its Chemstewards programme review cycle. The five facilities, which completed the requirements a year ahead of schedule are: Synthetech in Albany, Oregon; Noramco in Athens, Georgia; Noramco in Wilmington, Delaware; Siegfried USA in New Jersey and ESCO Company in Muskegon, Michigan.
SOCMA

Cobra Biomanufacuring wins vaccine manufacturing award

Cobra Biomanufacturing

Tuesday, 20 May 2008

FDA to get subpoena powers?

Congressman Bart Stupak hopes that FDA chief Andrew von Eschenbach will seek subpoena power as part of the impending drug importation bill. The power will allow the FDA to demand certain documents from regulated companies.
Wall Street Journal

FMC to buy ISP alginates business

CNN

Sill four for Evonik

Four potential buyers are still lined up for the acquisition of a 25% stake in Evonik. KKR, Blackstone Group, Bain Capital and CVC Capital Partners are awaiting a decision by Evonik owner RAg on which two will go forward to the negotiation stage.
Forbes

Nicholas Piramal wants further custom manufacturing investments in the US and western Europe

Money Control

Saturday, 17 May 2008

Evonik to invest €2.5bn in chemicals unit

Hemscott

FDA confirms China plans, will ban exporters

On a trip to China the head of the US Health Secretary, Michael Leavitt, conformed that the FDA will open offices in China. The FDA will station 10 staff at three offices across the country. Leavitt also said the FDA plans similar offices in India. In addition, Leavitt said the US plans to ban Chinese companies that don't meet certification requirements form exporting goods to the US.
China Daily
Wall Street Journal

Chemie Uetikon launches biotech division

BioUetikon, the biotech custom manufacturing division of Chemie Uetikon, has been launched in Ireland. BioUetikon, a spin-out from Dublin City University funded by Chemie + Papier Holding, Chemie Uetikon's parent company, will offer manufacturing services to the biopharmaceutical, medical device and related industries.
Pharmaceutical Technology

Anu's Laboratories sees IPO subscribed eight times

Economic Times

FDA approves BASF excipient

BASF

Thursday, 15 May 2008

FDA NME approvals at all time low rate

Although the US FDA has approved 29 new drug applications in the first four months of 2008 - the highest level since 2000 - it has only approved three NMEs, equalling the record low level.
Pharmalot

Wednesday, 14 May 2008

SynCo Bio Partners has completed the manufacture of ActoGeniX’ AG011 for a Phase II clinical trial

SynCo Bio

Major expansion

Cambridge Major Laboratories plans to build North America's most advanced API facility at its Germantown, WI, headquarters. The 12,000m2 facility will include multiple GMP manufacturing suites capable of producing multi-tonne quantities of API. The company said the facility, which is scheduled for August 2009, is required to meet its large and growing pipeline of late developmental and commercial API’s.
The initial build will house six manufacturing suites with reactors up to 7500L with complete isolation and containment and vessels for hydrogenation and cryogenic reactions. Additional manufacturing suites up to 15 000L can be accommodated in the facility if needs arise.
Small Business Times
Image from Business Wire

FDA asks for cash

Andrew von Eschenbach, the US FDA Commissioner, has asked Congress for an additional $275m above the previously proposed budget. von Eschenbach's request includes a detailed spending plan which includes opening new foreign offices, increasing inspections and constructing new databases to track drug hazards.
New York Times

Tuesday, 13 May 2008

Albemarle plans fine chems acquisitions

Albemarle's fine chemicals business unit will focus on targeting the pharmaceutical market, said Ron Gardner, vice-president fine chemicals, speaking at the company's Vision 2010 investor meeting. Gardner said the company plans to develop its API and pharmaceutical intermediates businesses. The company also plans to build its capabilities first in Europe and then in India to be nearer to some of its customers and potential customers. The business is already expanding its R&D capabilities in Asia with teams in India and China.
The company is also building its brand image in the sector by working with its customer to publicise the relationships it develops. Albemarle's current pharma pipeline has 38 projects in preclinical development, 51 in phase I, 14 in phase II and 20 in phase III - the most it has ever had in pIII. Gardner said its pipeline was worth more than $100m in sales.
Acquisition will form part of the company's plan to grow the business, said Gardner. The company plans to acquire businesses that deliver $250m in sales to take the fine chemical business unit sales to $1bn by 2010.
As for competition in the arena from China, Gardner said the company was seeing customers that were hesitant to take business to China. In addition he sees the economic environment changing such that Western manufacturers are seen as relatively more attractive as china becomes relatively less competitive.
Albemarle presentation

Biopharma CMO market grows

The global biopharmaceutical CMO market grew 14% to $2.4bn in 2007, according to a report from HighTech Business Decision. For 2008, the market is expected to grow a similar amount.
Contract Pharma

Thursday, 8 May 2008

Jubilant Organosys has acquired pyridine derivatives manufacturer Specialty Molecules Pvt Ltd for $4.8m

Business Standard

Agilent expands nucleic acid capacity, buys Dow technology

Agilent Technologies is expanding nucleic acid API manufacturing capacity at its Boulder, Colorado, facility. Additionally, Agilent has purchased the assets of Dowpharma's Nucleic Acid Medicines business, the second disposal by Dowpharma in the same number of weeks. In Boulder Agilent is adding large-scale nucleic acid synthesis, purification and drying capacity. The new capacity is due on stream by the end of 2008.
Agilent

Dishman expands API capacity

Dishman Pharmaceuticals and Chemicals has commissioned three API facilities for contract manufacturing. The $37.5m facilities are in Bavla, India. Dishman plans to commission a fourth facility dedicated to the production of cytotoxic compounds by the end the year.
India PR Wire

Wednesday, 7 May 2008

Dr Reddy's plans more acquisitions

GV Prasad, executive vice-chairman and CEO of Dr Reddy’s Laboratories, said the company plans to acquire more small companies globally rather than one large deal to push sales in overseas markets. It is looking at acquisitions including custom pharma services in the US and other markets.
Economic Times

Cobra Biomanufacturing raises £1m to upgrade its Oxford facility to meet FDA requirements for commercial virus production

Cobra Biomanufacturing

Anu's to invest in plants

Anu's Laboratories plans to use the proceeds of its forthcoming IPO to build an API manufacturing plant and a pilot plant for contract research and manufacturing in Vishakhapatnam, India.
Economic Times

Tuesday, 6 May 2008

Reaxa launches second generation encapsulated catalyst for use in flow processes

Reaxa

AMRI sees sales rise, completes high potency facility

Revenue for Q1 rose 11% to $53.6m for AMRI. Discovery, development and small-scale manufacturing saw strong growth, but large-scale manufacturing saw a sales decline. In addition, AMRI has completes its new state-of-the-art 150m2 non-GMP High Potency development laboratory suite at its Albany, NY, facility.
AMRI

Friday, 2 May 2008

QSV Biologics will manufacture a recombinant protein under development by Pfizer

Earth Times

Dr Reddy's completes Dowpharma and BASF acquisitions

Centre Daily Times

Cambrex Q1 sales drop 5%

Cambrex

Albemarle to move HQ to Baton Rouge

Albemarle

Pfizer, finally, confirms biologics facility in Ireland

Irish Times

FDA Director back-tracks

The director of the US FDA's Center for Drug Evaluation and Research, Janet Woodcock, refused to support Democrat proposals for tougher regulations on imported drugs and new fees on drug makers. Despite earlier comments that the FDA needs an additional $225m to inspect all foreign manufacturing facilities Woodcock refused to specify how much the agency needs.
Wall Street Journal