Claris Lifesciences Limited - India

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Claris和Pfizer合作来提高产品在管制市场的份额
Pfizer ties up with Claris for injectables
Economic Times, 20 May 2009

AHMEDABAD: World No 1 pharma company Pfizer on Wednesday announced a marketing tie-up with Rs 800-crore Ahmedabad-based Claris Lifesciences, that specialises in injectables.

The pact will give the Indian company wider access for 15 of its products in the highly regulated markets of North America, Europe and Australia.

Pfizer will commercialise the products which have gone off-patent in the western markets under its own brand name, thereby giving itself an edge with a wider portfolio of generic drugs.

The pharma MNC's latest tie-up, that comes close on the heels of a similar tie up with another Indian company Aurobindo Pharma, is in tune with its two-year old strategy to enter into partnerships with generic firms. As per its pact with Aurobindo, the MNC will market 60 drugs of the Indian company in 70 countries.

Talking to ET Pfizer's senior vice-president Kelvin Cooper said "The worth of company's off-patent drugs is close to $11 billon and if we do nothing about it, the revenues will continue to decline."
with the global generic business set to rise from $230 billion to $500 billion by 2012, it is a planned strategy to tap this segment, Mr Cooper said. Pfizer, he said, is open to more such tie-ups in the generics space.

Claris managing director Arjun Handa, who saw the partnership through,said Pfizer's marketing muscle would ensure wider reach for his products. On his company's IPO plans, he said, the company eventually plans to go public, but was awaiting for the right time.

The partnership is part of the big pharma's shift to generics markets, he added. Pfizer, whose global annual sales of generic products is around $10 billion, said it evaluated 20-30 companies before finalising the agreement with Claris.

While the financial terms of the deal were not disclosed, the MNC will get marketing rights for 15 injectable products covering a broad range of therapeutic products in areas like anti-infectives and pain.
Claris partners Pfizer to strengthen regulated market presence
Business Daily from THE HINDU group of publications,Thursday, May 21, 2009

Ahmedabad, May 20 Pharmaceutical major Claris Lifesciences Ltd today announced a partnership with global giant Pfizer Inc to commercialise sterile injectable drugs that are off-patent and have lost market exclusivity in the US, Canada, Europe, Australia and New Zealand.

Pfizer, with a turnover of $10 billion in established products annually, had a similar licensing agreement with Aurobindo Pharma Ltd.

It is looking for more companies having good product portfolio and practices on offer so as to strengthen its position in emerging markets and expand its portfolio of medicines in its Established Products Business Unit (EPBU).

This is a new business strategy and its impact on either company's financials would emerge only after a year or two, the Claris chief said. However, it was not part of outsourcing Pfizer’s manufacturing to low-cost Asia and other places.

"It is in-sourcing of new and high-quality products by Pfizer," Mr Kelvin Cooper, Senior Vice-President, Portfolio Development, Established Products, told Business Line here after signing the deal with Mr Arjun Handa, Managing Director and CEO, Claris Lifesciences Ltd.
Claris Lifesciences was able to seal the deal after the US Food and Drug Administration (USFDA), as also other regulators from many other countries, gave acceptance to its sterile injectable manufacturing facility here, comprising five units set up on 100 acres with an investment of $14 million in recent years.

Mr Handa said the company had enough capacities for the present but more investments would be looked at, if necessary.

To begin with, both Aurobindo and Claris would offer 15 products each to Pfizer. Right now, the deal does not cover emerging markets.

It would take six to 12 months to streamline this new business activity and Claris, apart from marketing products through Pfizer, would also be independently doing so in the said markets as usual.

Pfizer said such arrangements would make available 60 products to it for marketing in more than 70 countries of Asia, Latin America, Africa and the Middle East.

Off-patent medicines, including branded generics, represent one of the fastest growth segments in global pharmaceutical market, particularly in emerging markets where costs and access are primary drivers of these medicines' growth.
Pfizer, Claris to market injectables
Business Standard, Thursday, May 21, 2009

Leading pharmaceutical company, Pfizer Inc., has entered into a partnership with Ahmedabad-based Claris Lifesciences Limited to commercialise sterile injectible drugs that are off-patent and have lost exclusivity in the United States, Canada, Australia, New Zealand and Europe. These drugs cover a range of therapeutic areas including anti-infectives, antibiotics other critical care products.

According to Kelvin Cooper, senior vice president, portfolio development, established products, Pfizer, "The agreement represents our strategy to transform Pfizer's off-patent drugs and established products portfolio from becoming a declining business to a growing business. A partnership with Claris will help expand our steriles portfolio and provide patients with a wide offering of high quality affordable medicines. Off-patent medicines, including branded generics, represent one of the fastest growth segments in the global pharmaceutical market."

The research-based biopharma company had visited Claris several times in the last four months before finalising on the company for the tie-up.

Pfizer, which has a global annual sales of $10 billion for established products, recently expanded an agreement with Aurobindo Pharma to supply finished dosage products. Under the terms of the agreements, Pfizer has acquired rights to 55 solid oral dose products and five sterile injectable products in the US, Europe and France.
Pfizer will supply 60 products in more than 70 countries throughout Asia, Latin America, Africa and the Middle East. "As part of the deal, while Pfizer will bring in 30 products, Claris and Aurobindo will bring in 15 products each to be marketed under the Pfizer label. We also aim to make more than 100 products available across North America, Europe, Australia and New Zealand," Cooper added.

While the financial terms of the deal were not diclosed, officials at Claris said the deal would take about six to twelve months to materialise and would add more products if both the companies found suitable molecules. Officials further said that a co-branding is possible if there is a regulatory requirement.

According to Arjun Handa, managing director and CEO, Claris Lifesciences, "It is the era of alliances and partnerships and with the big shifts happening in the global pharmaceutical industry, this relationship will keep Claris at the forefront of change. Through Pfizer, we will get access to extremely competent sales and marketing partner for our regulated markets strategy in order to enhance our existing presence in these markets. We have been a focused company in sterile injectables and this relationship with Pfizer will help us to continue our focus in the segment, while expanding our product lines and market access."
Pfizer in Generics Licensing Deals with Aurobindo, Claris
The Wall street Journal, 20 May 2009

Pfizer Inc. (PFE) said Wednesday that it is investing more heavily in generics and developing countries, as the pressures of health-care reform make lower-cost drugs and overseas markets more tempting opportunities.

The New York drug giant is expanding a partnership with Aurobindo Pharma Ltd. (524804.BY) to sell 60 off-patent drugs and signed a new agreement with Claris Lifesciences Ltd. to market 15 old injectable drugs. Specific terms weren't released. The deals are part of a shift at Pfizer to rely less on one or two blockbuster drugs like its cholesterol fighter Lipitor, with $12 billion in annual sales.

(This story and related background material will be available on The Wall Street Journal Web site, WSJ.com)

The Aurobindo agreement gives Pfizer rights to sell its competitors' old medicines in more than 70 emerging-market countries, after agreements with Aurobindo last year and this past March gave Pfizer licenses in the U.S. and Europe. The Claris partnership expands Pfizer's presence mostly in hospitals in developed countries where injectable drugs for pain and infection are used.

Traditionally, branded drug makers launched medicines in wealthy countries where they could recoup their investments with high prices, and largely ignored off-patent products and countries where they couldn't charge as much. But as its labs produce fewer blockbusters, Pfizer, like other drug makers, is trying to expand in areas with less profit and less risk.

Health-care reform in the U.S. is accelerating the strategic shift. Drug makers joined others in the health sector last week in a pledge to reduce cost increases by $2 trillion over a decade. More generics could be part of the solution: Last year, seven out of 10 U.S. prescriptions were filled with generics, saving the system $181 billion, according to the Generic Pharmaceutical Association, a trade group.

"Health-care reform is making it even more important for us to engage in this market," says David Simmons, general manage of Pfizer's established products business unit.

Pfizer already sells about 380 of its own drugs that have gone off patent. The generics business will grow to $500 billion in the next five years, Pfizer says, and last year it set up a unit specifically to focus on the business for the first time.
Pfizer expects to add $1 billion in annual sales from its generics business by 2012, and more than 50% of that will come from these and other recent licensing deals.

The Aurobindo partnership is a play to grow in emerging markets, where the high cost of branded drugs and perceived quality issues with generics have limited use. By selling generics, which tend to be as much as 80% cheaper than branded products, Pfizer says it hopes to expand access to "billions" and pick up enough sales to help cushion the blow when Lipitor goes off patent in 2011. The deal includes drugs for infections, heart disease and brain disorders.

While growth of drug sales in the U.S. has stalled, sales in the seven largest emerging markets is expected to double in five years, from $91 billion in 2008 to around $170 billion in 2013, according to Sanford Bernstein. Pfizer declined to detail its profit margins in emerging markets, but GlaxoSmithKline PLC (GSK) made 35% profits in emerging markets in this year's first quarter, compared with 65% in the U.S., according to Sanford C. Bernstein & Co.

"In emerging markets we think growth will be double-digit in the next three years and it will really be a volume game," says Jean-Michel Halfon, general manager of Pfizer's emerging markets business unit.

Pfizer plans to ensure the quality of the medicines from its Indian partners by inspecting the drugs before they leave the plants and when they arrive at their destinations.

Other drug companies - notably Novartis AG (NVS), with its Sandoz generics arm - are also getting more serious about off-patent drugs. Last year Daiichi Sankyo Co. (4568.TO) bought a majority stake in Ranbaxy Laboratories Ltd. (500359.BY), an Indian generics maker, for $4 billion.

In emerging markets, Sanofi-Aventis SA (SNY) has [cut long] been a leader; Last fall, it bought Czech-generics maker Zentiva NV for $2.6 billion to shore up its presence in Eastern Europe. A Sanford Bernstein report issued May 4 ranked Pfizer and GlaxoSmithKline close behind, followed by Merck & Co., Inc. ( MRK), Eli Lilly & Co. (LLY) and Bristol-Myers Squibb Co. (BMY).

- By Avery Johnson, The Wall Street Journal

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