Zydus plans to buy US drug cos for $60 mn

Pharma company Zydus Cadila plans to acquire a US-based generic pharma company. The Ahmedabad-based firm signed an asset purchase agreement with a US-based pharma company for a cash deal of $60 million. The deal also includes purchase of two generic drugs - Micro-K and Potassium Chlroide ER capsule products.

On Friday, it said Zydus Pharmaceutical USA Inc, through its subsidiary Zynesher Pharmaceuticals USA LLC has entered into an agreement to acquire the assets of the US based Nesher Pharmaceuticals Inc , a generic arm of KV Pharmaceutical. The parent company is based at St Louis, Missouri. The financial details of the agreement were not disclosed by Zydus Cadila in its statement.

KV Pharmaceutical an NYSE listed company said in its filing to US Securities and Exchange Commission, that in consideration for the divested assets of Nesher Pharma, Zydus agreed to pay $60 million cash. As per the agreement at the closing of the transaction, the buyer will deposit $7.5 million of the purchase price in an escrow arrangement for post-closing indemnification purposes. The transactions is expected to be closed during the second quarter of the Company's 2012 fiscal year.

KV Pharmaceuticals further disclosed to the exchange that the agreement consists sales of two products - Micro-K 8mEq and 10 mEq and the company's generic products, including Potassium Chloride ER Capsule products. The broadbased assets purchase agreement includes assets and assumption of certain liabilities, Nesher's existing and pipeline ANDAs, certain manufacturing facilities and a full fledged research and development lab.

According to Zydus Cadila, Nesher has considerable expertise in niche therapies which have development or production barriers, such as controlled release medications or Drug Enforcement Agency's (DEA) controlled substances. With this, Zydus will now be able to manufacture and distribute generic controlled substances in the US market, which otherwise cannot be imported. The market for controlled substances medications in the US is estimated at $7 bn.

The acquired ANDA pipeline comprising 8 existing filings and 5 products under development present a tremendous market potential as they belong to high growth, niche segments which have a combined estimated market size of over $ 2.1 bn. The aggrement allows certain products of KV Pharma to be manufactured by Zydus's US-subsidiary, Zynesher Pharma.

Zydus Cadila, Bayer Healthcare to form marketing JV

Pharmaceutical firm Zydus Cadila today said it will form a joint venture with Germany's Bayer Healthcare to sell drugs in India.

The 50:50 joint venture -- Bayer Zydus Pharma -- will operate in key segments, including women's healthcare, metabolic disorders, diagnostic imaging, cardiovascular disease, anti-diabetic treatments and oncology, the company said in a statement.

Commenting on the development, Zydus Cadila Managing Director Pankaj Patel said: "We have always believed in partnering growth, have keenly explored new opportunities and look at synergies in the market place."

The two partners will leverage on each other's strengths, look at future possibilities and create a common platform to pool in expertise, he added.

"With this step, Bayer Healthcare aims to significantly accelerate its capabilities to better serve the fast growing Indian market," Bayer Healthcare AG Jorg Reinhardt said.

The JV will start operations with Bayer Healthcare's pharmaceutical division, contributing to its existing sales and marketing business in India to the new company, while Zydus will pool in its women's healthcare products, diagnostic imaging business and other products.

Besides Bayer Healthcare's existing products in India, the new company also intends to focus on sales and marketing of future patented pipeline products, it added.

Both Bayer Healthcare and Zydus will supply the JV with products from their respective manufacturing operations at existing locations.

Ahmedabad-based Zydus Cadila is one of India's leading pharmaceutical firms with eight facilities supporting product launches not just in India but also in the regulated markets of US, Europe and Latin America.

Zydus Cadila to market Maxisal in India, Nepal: US firm

US-based Amarillo Bio-sciences Inc (ABI) today said Indian pharmaceutical major Zydus Cadila will be marketing its dietary supplement Maxisal domestically and also in Nepal. "We are delighted that Zydus Cadila has agreed to market Maxisal and are hopeful that success in India and Nepal will lead them to expand Maxisal into some of the nearly 50 other countries in which they currently market products," ABI President and CEO Joseph Cummins said in a statement.

The US biotechnology firm has signed a supply agreement with the city-headquartered pharmaceutical group to market Maxisal in India and Nepal, a statement from ABI said. Maxisal enhances salivary function, promotes oral comfort and helps relieve dry mouth.

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Pharma cos adhere to EHS to attract global business

Globalisation seems to be driving the Indian pharma industry towards better environmental, health and safety (EHS) performances. In order to elevate their global image, several Indian companies are complying with EHS standards to widen their horizons and attract international players.

EHS auditing is becoming a global practice as organisations around the world develop audit standards. Big players across diverse industrial sectors especially from US and European countries are opting for EHS compliance as one of the key mandate in the process of manufacturing outsourcing.

Most pharma companies like Ranbaxy Laboratories, Alembic, Dr Reddy's Laboratories, Cadila Pharmaceuticals, Zydus Cadila, Arch Pharmalabs and USV, among others have ensured a proper EHS management system and other environmental initiatives to attract additional business opportunities in the global arena.

"The Indian pharma world has evolved around industrial development zones set up by various state governments. In earlier years, most of the units could take benefit of the then prevalent lax environmental laws. But now US and European customers are looking beyond our local compliance levels and want companies to adhere to their standards, which are quite exacting and taxing from an investment perspective. This has led to a big challenge for the Indian pharma industry, particularly small scale units, which either have investment concerns or limitations of growth beyond their allotted unit areas in these industrial zones. These developments are bound to result in various units getting disqualified for supplies leading to elimination and consolidation in the pharma world. With quality and cost efficiency as a given, it is only EHS compliance that will stand out for a vendor," says Ajit Kamath, chairman and managing director of Arch Pharmalabs, which has a standalone turnover of Rs 750 crore.

Kamath adds that at a macro level, both China and India have long been viewed as countries with suspect EHS compliance. Companies with orientation of exports to the Western world are faced with no choice but to adhere to EHS. Besides customer audits, many Indian companies have been proactively seeking out ISO14000 and ISO18000 standards to signal EHS compliance.

To be in sync with the green policy of the western world, Indian companies seem to be proactive in adopting a number of green initiatives, including a proper EHS management system.

For Alembic, EHS functions as a major focus are along with other green initiatives like water conservation, replacement of furnace oil by solid fuel bio-mass and stopping the use of ozone depleting chemicals. "Alembic is a 101 year old company and we put a lot of focus in EHS. At present we are working with a number of multinational pharmaceutical companies and this is an important pre-requisite for them in considering Alembic as a partner for their global outsourcing. A good EHS system such as the one we have at Alembic also helps us in terms of an accident free zone, awareness about the safety and periodically training our team and a pollution free environment. Besides, EHS has become a critical area for the leading Indian pharmaceutical companies as more people are investing in it due to the numerous benefits such as safety and health of employees as well as a commitment to the environment. This also results in the enhancement of productivity," says Pranav Amin, director and chief business development officer at Alembic Limited.

According to Amin, an environment-friendly policy could result in additional business opportunities which would affect the top line and bottom-line as an environmentally friendly policy is well respected by pharmaceutical companies all over the world.

The EHS guidelines were created by the International Finance Corporation in 1998. The objective of EHS is to safeguard life, property and the environment. It enables industries to manage risk better, reduce cost and improve health & safety of people in general. Most global pharma companies use environmental, health and safety performance criteria to assess and select contract manufacturers, key API suppliers, contract research and development labs and even logistics centers. This is primarily done to protect the reputation of the global pharma companies while they outsource to India.

Mumbai-based pharma major USV has invested significantly in resources to reduce the ecological footprint of its operations.

The company has put in place the integrated implementation of environmental, occupational health and safety management systems, popularly known as ISO 14001 and OHSAS 18001, at its manufacturing locations in Lote, Baddi and Daman. "In our business, we must also respond to the growing stringency of statutory EHS norms. In this respect, our environmental performance has consistently extended beyond the statutory requirements, like provision of RO plants for recycling of treated effluent to the maximum extent possible, safe solid waste disposal and emission reductions. To increase health and safety awareness across the organisation, we have created a detailed work flow for reporting accidents or incidents, enabling us to better track and analyse these incidents. All our manufacturing plants have fully equipped with occupational health centers. Also, this year all our manufacturing sites have achieved Zero LTA," says Debabrata Gupta, director and chief operating officer at USV.