The Race to China

Interesting post from Pharmalot regarding Pharma's move to China...

I understand the drivers behind these types of efforts, something to spruce up yet another bland corporate report,...something for senior management to tout as "the strategy"...reducing the costs of an already ineffective R+D effort, etc, etc...

These drivers will have more and more companies jumping on the bandwagon...

How many of these companies are backing up these efforts with a robust plan for maintaining the quality of the products they intend to produce?...and yes, that includes research efforts...or are they just looking at the cost savings?...

The Baxter Heparin Saga...pick your spin...

There are a lot of different ways to look at this issue...

- Writer's Scare Tatics..."Tampering possible in China"

- Troubleshooting drug safety is scientific challenge...heparin-like molecules

- FDA and manufacturer cooperate to maintain drug supply...Earlier this month, the firm stopped production, but the FDA wanted to keep the existing Baxter heparin in doctors' hands because it did not want to cause a shortage of the life-saving drug. Agency officials said increased production by the other heparin manufacturer can now satisfy the demand.

- FDA doesn't inspect overseas manufacturing sites...The FDA has averaged just 15 inspections in China in each of the last five years

- Lack of FDA oversight on imports...Flood of drugs, little oversight by regulators

- Outsourcing causes quality problems...Baxter’s Heparin Problems May Have China Connection

- Chinese quality control...Baxter tests point to Chinese problem

- Realtime crisis management...Call to action at Baxter

Manufacturer intitiates recall...Baxter Issues Urgent Nationwide Voluntary Recall of Heparin

Before you decide on which drum you think should be beat on, just remeber that these issues are harder to solve than you might think...

Teva earmarks $1bn for India plans

Teva continues to set the pace...it seems a lot of companies stand the possibility of being out-maneurvered...

The world's generics titan, Teva, has reportedly earmarked over $1bn to fuel an ambitious plan to broaden its presence in India.

Over the next two years the firm is intending to use $250m-$300m to build new generic ingredients manufacturing facilities in the country.The first of these planned constructions is imminent, with company preparing to build a large active pharmaceutical ingredient (API) manufacturing facility, on over 100 acres of land near Gwalior, Madhya Pradesh. Production capacity will be in line with Teva's large Indian competitors.Meanwhile, the remainder of the money will be used by Teva to fund the hopeful takeover of some Indian pharma businesses. The Israeli company's plans were revealed by Indian newspaper Business Standard, who reported that Teva has been eyeing major acquisition opportunities in India for the past three years, so far to no avail. Teva already has a presence in India through its Indian subsidiary, Teva India, in addition to a two year old R&D centre in New Delhi, however, a company spokesperson reportedly told Business Standard that: "Teva considers India an interesting geographical region and is looking to broaden its activities in the country".

link to full article

Pfizer plans more off-shoring and outsourcing

More on the off-shoring trend...previous post here

Pfizer is looking to Asia for both R&D and manufacturing outsourcing and to help it cut costs in a bid to mitigate the effects of patent expiries and competition from generic drugs.

Pfizer announced plans to increase its R&D presence in Asia at its Hong Kong investor meeting on Friday, while saying it is also look to double the amount of manufacturing outsourcing to 30 per cent.

The pharma giant has struggled in the past year and the high profile clinical trial failure of its cholesterol-lowering drug Torcetrapib has only matters worse.

Torcetrapib would have enabled Pfizer to defend the patents its cholesterol drug Lipitor (atorvastatin) that are due to expire in 2011, potentially creating a $13bn hole in the company's revenues.

In addition, Pfizer's pipeline has been criticised from many quarters, with even the company's new president of global R&D stating "I'm the first to admit [the drug pipeline] is not as rich as I'd like it to be."

To help combat this Pfizer will look to bolster its Asian R&D, targeting China, India, Japan and South Korea.

New sites in these areas would help the company bolster its share of the Asian pharmaceutical market which is predicted to grow to $200bn by 2017.

link to full article

Offshoring Manufacturing Facilities...

Merck goes to Ireland...

Sanofi goes to China...

Who is going to go to India?...

Indian firm takes over German biologics plant

India just keeps coming...

An Indian firm has taken over the contract biologics manufacturing business of German corporation Siegfried.

The deal is a further sign of the ambition of Indian firms to break into the burgeoning biopharmaceuticals market, which was identified as a key target growth area for India at the recent Interphex show in Mumbai, and is tipped to generate $5bn (€3.5bn) in revenue in the country by 2010, up from its current figure of $1.5bn.

India's Avesta Biotherapeutics and Research is now the new owner of Berlin-based Siegfried Biologics and its 50 employees, gaining a capability in developing biologics, from cell line generation, upstream process development, through to manufacturing.

Avesta plans to use the facility to make an entry into the world of making good manufacturing practice (GMP)-compliant biopharmaceuticals for the regulated US and European markets.

However, the Bangalore-based firm said it will initially concentrate on manufacturing biologics for the semi-regulated markets of Brazil, Russia, India and China, where small molecule drugs prevail in the market.

link to full article

Global biotech firms on India quest

more on India...

Indian shores turn attractive for clinical trials.

Close on the heels of global pharmaceutical giants, international biotechnology companies are also finding India an irresistible attraction, though for different reasons.

If the low-cost availability of raw materials was the major reason for global generic pharmaceutical majors such as Teva, Mylan and Actavis to have an Indian base, the emerging opportunities in clinical trials is driving the biotech majors towards the country.

Of the top-10 global biotech companies, the biggest two — Amgen and Biogen — have already set up wholly owned subsidiaries in the country.

Others, such as Genentech, Serono, Chiron, Gilead, among others already have their presence in India through marketing partners and are in the process of exploring business opportunities in a big way.

For instance, Biogen Idec, the oldest biotech company in the US, announced the setting up of its wholly owned domestic subsidiary Biogen Idec Biotech India last month. Biogen, which had a sales of $2.7 million in 2006, also indicated its commitment of significant investments in the Indian R&D segment.

link to full article

Luck of the Irish brings new biologics base

The Irish job machine rolls on...

21/05/2007 - Proposals for the construction of a new small-scale biologics manufacturing plant in Ireland courtesy of pharma heavyweight Pfizer emerged late last week.

The company is considering investing in a site in Shanbally, County Cork, right next to its existing active pharmaceutical ingredient (API) plant in Ringaskiddy, at an estimated cost of €175m.

While the plans are still at a very early stage, with the company having only just applied for planning permission at the site, it will come as welcome news to the area which only three months ago was dealt a blow when Pfizer announced it would be cutting jobs and capacity at the Ringaskiddy API plant.

The new facility is due to be used for Phase III clinical trial products and initial product launches, and will follow the trend of many biologics manufacturers by using disposable technologies to ensure maximum flexibility in production.

Although the plans have yet to officially receive the seal of approval and proposals are technically still pending, the move would fit nicely with Pfizer's recent attempts to expand its presence in the growing biologics market.

The fact that the company has also pushed ahead with attempts to gain planning permission before the plant proposal has even been approved internally is perhaps somewhat telling, illustrating the urgency and importance the firm now lays on the role biologics could have in its future.

link to full article

Amgen opens Indian office

Amgen, the world's largest biotechnology company, is betting big on India. The California-based biotechnology company with sales in excess of $12 billion is setting up an office in India with the aim of testing its drugs in the country and exploring opportunities for tie-ups.

"Amgen is currently forming local affiliate companies in Mumbai and Hong Kong that will have the capability to conduct clinical trials in India and East Asia.

Amgen's affiliate in Mumbai will support the company's clinical trials to take place in India," Mary Klem, Associate Director, Amgen, told Hindustan Times in an e-mailed response.

Industry sources said the company, which banks on innovation to develop therapeutic drugs, is also looking at partnerships that might lead to potential takeovers, though the company refused to divulge details on future plans.

"Amgen is contracting with partners in India and China for services to support its R&D (research and development) operations, including research, pre-clinical development, data management support and statistical programming," the e-mail said. Amgen has an annual research budget of $1.3 billion.

link to full article from Hindustan Times

Astra Zeneca's new PR&D centre leverages Indian chemistry expertise

more off-shoring...this time research...

22/03/2007 - AstraZeneca is leveraging the process chemistry expertise accumulated in India's generics industry and universities by opening a $15m (€11.3m) process research and development (PR&D) laboratory next to its existing research centre for tuberculosis in Bangalore.

The newly inaugurated 8,000sq m facility on AstraZeneca's Hebbal campus can accommodate up to 75 process scientists as well as supporting office and engineering staff. The Bangalore laboratory will both consolidate the existing drug discovery programme for tuberculosis at the site and bolster the UK company's global PR&D network. This consists of one facility apiece in the UK and Sweden, plus a pending UK PR&D laboratory at AstraZeneca's Macclesfield site that is expected to start operating by mid-2009.

The company, whose research pipeline has come under critical scrutiny following a succession of damp squibs in late-stage development, has been investing heavily of late in new R&D resources, partnerships and acquisitions. At the same time, it has been making deep cuts to boost productivity and cost efficiency in its supply chain. The recent announcement that 700 manufacturing and supply jobs would go at Macclesfield contrasted pointedly with the £63.5m (€93.6 million) AstraZeneca is investing in its new PR&D laboratory at the same site.

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Two biotech firms to operate in Penang

more on the "Big World/ Small World" theme...

TWO major biotechnology companies in Penang – Progenix Research Sdn Bhd (PRSB) and Alpha Biologics Sdn Bhd (ABSB) – will be ready for business soon.

Chief Minister Tan Sri Dr Koh Tsu Koon said PRSB would begin operations this month and ABSB in September at Biotechnology Park in Bukit Minyak.

He said these companies, founded by Springhill Management Ltd (SML) - a biotech venture capital company - were the first to set up biotech facilities in Bukit Minyak.

“They have strategically positioned themselves in Penang, helping the state government to stimulate foreign investments in biotechnology industry.

“The state government has been striving to make Penang the hub for biotechnology and life sciences,” he said recently.

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India's biotech queen goes for global crown

BANGALORE, India (AFP) - When Kiran Mazumdar-Shaw founded Biocon India in 1978 with 10,000 rupees (225 dollars) and an office in a rented car garage, no banker was willing to give her a loan.

Back then, no one had heard of biotechnology, which uses micro-organisms such as bacteria or biological substances like enzymes to make drugs and synthetic hormones.

Women entrepreneurs were also rare and finding recruits willing to work under a female boss was difficult.

Mazumdar-Shaw, hailed in 2004 as India's richest woman with a personal fortune of 21 billion rupees, and Biocon, India's biggest biotech firm with 3,000 employees, have come a long way from the garage.

The businesswoman, who will turn 54 on Friday, is now setting her sights beyond the domestic market, despite the company's 29 percent annual growth rate, estimated to touch five billion dollars by 2010.

"I see myself and Biocon as being a biotech company in a leadership position on the global stage," Mazumdar-Shaw told AFP in an interview in Bangalore.

"We are on the right track to getting there," added the entrepreneur, who plans to double research spending every year to discover new drugs and enter the league of giants such as Amgen and Genentech.

link to full article

When India is having trouble finding qualified people, we're all in trouble...

Noted scientist Dr. K Muniyappa has regretted that though the number of colleges offering biotechnology degrees in the country has grown by leaps and bounds during the last some years, the quality of the education imparted in these colleges is a subject for deep concern.

"The Indian biotechnology sector is facing an acute shortage of trained manpower and there is a lack of initiative for development of competent human resources," he said. There is an urgent need for the Union government to earmark a portion of the budget towards quality training of manpower in biotechnology.

The observation by the research institutes and the industry is that the present knowledge among biotech graduates makes them unemployable. In the post-graduate sector, many of the candidates are even unfit for on-the-job training.

"With the growing popularity of biotechnology among the students, there has been a spurt in the number of colleges offering biotechnology degrees, but the quality of training offered is a question," Dr Muniyappa, professor and chairman, department of biochemistry, Indian Institute of Science told Pharmabiz. "

Graduate students contribute the most, if not all to our research output in many disciplines. In India, the emphasis is on training rather than research productivity. This has led pharma-biotech sector to insist for candidates who have either studied or worked abroad only because of the quality of personnel in India are just not employable," Dr Muniyappa, who is also the founding coordinator, National DBT Post-doctoral Programme in Biotechnology and Lifesciences, added.

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