Wockhardt to demerge R&D division

Wockhardt Ltd has informed that the Company has considered in principal to demerge its Research & Development business into a separate entity. The new Company will house the new drug discovery programme and the innovative new technologies being developed by the R&D team. The Company will be a listed Company and is scheduled to come into effect from January 01, 2009.

Wockhardt chairman, Habil Khorakiwala said, "The R&D business has great potential and needs to be a focused entity for carrying out unrelenting research activities for the future. At Wockhardt we recognise this fundamental need and are re-structuring our R&D business to unlock true value for all our stakeholders. This will ease the Company to invite strategic investors interested in the R&D Business."

Wockhardt's board of directors have also in principal given their nod to raise Equity / Equity-linked securities to the tune of US $ 200 million to expand the domestic and international operations.

Wockhardt to launch generic version of anti-depressant Zoloft in the US market

Wockhardt Ltd has announced that the Company will be launching Sertraline tablets in the United States. The Company has received approval from the United States Food & Drug Administration (US FDA) for marketing the tablets containing 25mg, 50mg and 100mg Sertraline Hydrochloride, which is used for treating depression. Sertraline is the generic name for the brand Zoloft, sold in the US by Pfizer.

"With over a dozen new product launches in the last twelve months and the recent acquisition of Morton Grove Pharmaceuticals, Wockhard'’s US business has been making significant progress" said Wockhardt Chairman Habil Khorakiwala. "We are continuing to strengthen the US operations by filing several ANDAs, including technologically challenging products."

Wockhardt's Sertraline tablets will be launched in the US market within the next few weeks. According to IMS, the total market for Sertraline tablets in the US is $1.1 billion equivalent to over 1.4 billion tablets. Wockhardt has several products including injectables in the CNS segment.

In the prescription generic pharmaceutical market, the Company has been consistently growing market shares for all its products. Wockhardt today markets over fifty products in the US.

The Sertraline tablets are manufactured at the US FDA certified formulation plant at Waluj, Maharashtra. The product was developed in-house.

Wockhardt is one of the few Companies with end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API's, the dose forms and marketing through the wholly-owned subsidiary in the US, enabling the Company to capture maximum value.

Today Wockhardt has nearly 2000 people working in Europe and USA, which contributes to 60% of Wockhardt sales. In addition to USA, Wockhardt has a strong presence in the UK, France, Germany and Ireland in Europe. Wockhardt employs 9000 people worldwide belonging to 14 nationalities.

Wockhardt launches Cetirizine tablets in USA

Wockhardt Ltd has announced the launch of Cetirizine tablets in the USA. The Company received the ANDA from the United States Food & Drug Administration (US FDA) for marketing the tablets containing 5mg and 10mg Cetirizine Hydrochloride, which is used for treating various forms of allergy. Cetirizine is the generic name for the brand Zyrtec, sold in the US by Pfizer. The total market for Cetirizine tablets in the US is $1.4 billion. Recently the product has been switched from 'Prescription Only' to OTC status and this is expected to significantly increase the potential for the product.

"Wockhardt is amongst the first Companies to get the US FDA approval for this product as soon as the patent expired. Wockhardt USA Inc. has entered into a strategic marketing alliance with Leiner Health Products to market this product in the private label OTC markets," said the Company's Chairman Habil Khorakiwala.

With the recently acquired Morton Grove Pharmaceuticals, USA and its own subsidiary Wockhardt USA Inc. this product will be marketed in addition to the 56 products that Wockhardt already markets in the US generic pharmaceutical market. Wockhardt is thus emerging as a fully focused generic pharmaceutical supplier of medicines with innovative drug delivery system in sterile injectibles and generic liquid products.

Wockhardt acquires Morton Grove

Wockhardt Ltd on October 24, 2007 has announced the acquisition of Morton Grove Pharmaceuticals Inc., a leading liquid generic and speciality dermatology company in the US having a sales revenue of US$ 52 million.

"Morton Grove is strategic to Wockhardt. It provides entry into the US generic market with a portfolio of 31 products, 13 of which occupy the No. 1 market position. All others are in the Top 3. This represents a clear demonstrable strength in sales and marketing," said the Company's Chairman Habil Khorakiwala. "Wockhardt now has a strong position in the liquid market in USA and UK," added the Company's Chairman.

Morton Grove is a leading liquid generic and speciality dermatology company in the US with revenues of $ 52 million. Approximately one third of its revenues come from the branded Lindane range of dermatological products.

This acquisition will boost the Company's US revenue by providing a complete range of dosage forms right from tablets, capsules, liquids to injectibles. Overall the product range would swell to around 54 products for the US market, of which 23 products are currently being marketed by Wockhardt USA Inc.

Morton Grove Pharmaceuticals is Wockhardt's third international acquisition in the space of last 12 months, having acquired in October 2006 - Pinewood, the largest generic company in Ireland and the largest supplier of liquid generic products in the UK and in May 2007 - Negma, the fourth largest independent pharmaceutical company in France. These acquisitions in Europe propelled the Company into becoming the largest Indian pharmaceutical company in Europe.

The Company has consistently demonstrated value-creation in all its acquisitions. To fast track the same, Wockhardt has recently appointed an external consultant to integrate its various European acquisitions and drive a pan-European strategy.

Shearman & Sterling, LLP acted as the Company's external legal counsel; ABN AMRO Incorporated represented Morton Grove Pharmaceuticals in the transaction and Kirkland & Ellis LLP acted as Morton Grove's legal counsel.

Wockhardt Ltd Q2 Results

Wockhardt Ltd has announced the following Unaudited results for the quarter ended September 30, 2007:

The Company has posted a net profit of Rs 589 million for the quarter ended September 30, 2007 as compared to Rs 902 million for the quarter ended September 30, 2006. Total Income has increased from Rs 3420 million for the quarter ended September 30, 2006 to Rs 3471 million for the quarter ended September 30, 2007.

The Consolidated results are as follows:

The Group has posted a net profit of Rs 1083 million for the quarter ended September 30, 2007 as compared to Rs 740 million for the quarter ended September 30, 2006. Total Income has increased from Rs 4441 million for the quarter ended September 30, 2006 to Rs 7407 million for the quarter ended September 30, 2007.

Wockhardt to market SAMe

Wockhardt Ltd has announced that the Company has signed an in-licensing agreement with the Italy-based Gnosis SpA to market SAMe (S-adenosyl methionine), a process patented product for osteoarthritis. As per ORG-IMS, the India market is worth Rs 270 cores for this product.

"SAMMY will complement our pain portfolio and further strengthen our osteoarthritis portfolio", said the Company's Chairman Habil Khorakiwala. "We bring to India new products which will fill the gaps in the existing products portfolio."

Osteoarthritis (OA) is a condition in which low-grade inflammation results in pain in the joints, cause by wear and tear of cartilage. It is estimated that 80% of the population will have radiographic evidence of OA by age 65, which is alarming considering the increase of ageing population in India. SAMe in addition to its pain relief effect plays an important role in cartilage formation and repairs. Multi-countries clinical data has proven its efficacy and its role in osteoarthritis.

Gnosis SpA is an Italy-based advance biotechnology company specialising in research and development of innovative process in the field of biotechnology.

Wockhardt markets Zindaclin

Wockhardt Ltd has announced that the Company has signed an in-licensing agreement with Crawford Healthcare, UK to market Zindaclin, a patented 'Once-a-day' topical application for Acne. Zindaclin is the first 'Once-a-day' acne antibiotic to be launched in India. According to ORG-IMS, the Indian market is worth Rs 1680 million for this product.

According to the Company's Chairman Habil Khorakiwala, "Zindaclin has proved its effectiveness in Europe and the US. This product will greatly benefit Indian patients with its efficacy and usage pattern”. Adding further he said, “Wockhardt’s India business is registering a huge growth over the years and in-licensing will be a key growth driver for the future".

Acne is the most common inflammatory condition during adolescence, affecting more than 85% of teenagers, but frequently continues into adulthood. Aside from scarring, its main effects are psychological, such as reduced self-esteem and depression.

World-over, topical antibiotics remain the mainstay of medical treatments prescribed for acne. Gone are the days of multiple daily dosages or applying messy complicated formulations. Medical professionals and patients both agree that Zindaclin's real benefit ensures compliance of the full treatment.

This licensing deal follows the launch of Vitix & Viticolor, patented products from LSI & Crawford of UK respectively, for the treatment of Vitiligo in the Indian market.

As in the case of Vitix & Viticolor, Wockhardt will manufacture Zindaclin in India from imported active ingredients. Zindaclin will be launched in the fourth quarter of 2007 by Wockhardt's dedicated dermatology team, SkinUno.

Crawford Healthcare is a UK-based speciality pharmaceutical Company dedicated to providing treatment for a range of skin conditions.

Wockhardt Limited

Wockhardt Limited has informed the Exchange regarding a press release dated September 17, 2007, titled "Wockhardt gets US FDA nod to enter the US$ 2.6 billion Norvasc market".