APRIL/MAY 04 ARCHIVE

30/05/04 Jubilant Organosys acquires generic pharma companies in Europe

Manufacturing Services (CRAMS) & API company, has announced the acquisition of 80% equity stake of the Belgium based Pharmaceutical Services Incorporated n.v. and PSI Supply n.v. (both Companies collectively referred to as 'PSI' and 'acquisition'). Jubilant will acquire the 80% equity stake by paying Euro 13.5 million (~ Rs. 75 crore) in cash.

PSI comes with an attractive financial and operating status and the acquisition will be accretive to Jubilant's performance. PSI has recorded sales of Euro 9.6 million (~Rs. 53 crore) for 12 months ending March 31, 2004. For the stated period the total EBITDA was Euro 2.8 million (~Rs. 15.6 crore).

With this acquisition Jubilant will now have presence across the pharmaceuticals value chain from manufacturing of API's to sale of formulated products. It will enhance the strength of Jubilant's Life Sciences business in the high opportunity European market. PSI has an attractive portfolio of 19 dossiers with 31 more at different stages of filing and development. The company also has entered into various long-term supply contracts for the dossiers and generic drugs.

www.jubilantorganosys.com

30/05/04 Teva Commences Commercial Launch of Generic Zyban®

Jerusalem, Israel, May 30, 2004 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that, pursuant to its July 2003 agreement with Andrx Corporation and Impax Laboratories, Inc., it has begun commercially shipping Bupropion Hydrochloride 150 mg Controlled Release Tablets.

Bupropion Hydrochloride Tablets are the AB-rated generic equivalent of GlaxoSmithKline's Zyban®.  This product is marketed for smoking cessation.

www.teva.com

28/05/05 Andrx Relinquishes Exclusivity Rights To 150mg Generic Zyban

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--May 28, 2004--Andrx Corporation (Nasdaq:ADRX) ("Andrx" or the "Company") announced today that it has relinquished its right to a 180-day period of marketing exclusivity for the 150mg strength of Zyban(R) (bupropion hydrochloride). As a result of this relinquishment, other companies who have submitted Abbreviated New Drug Applications ("ANDAs") for this strength can receive FDA approval to market their products. Impax Corporation's ("Impax") ANDA for this strength has now been approved, and Teva Pharmaceutical Industries Ltd. ("Teva") has begun shipping this product. Under the Company's previously announced Exclusivity Transfer Agreement with Impax and a subsidiary of Teva, Andrx is entitled to a share of the profits derived from Teva's sale of this product for a 180-day period.

www.phx.corporate-ir.net

26/05/04 Par Pharmaceutical Announces Strategic Alliancewith Orchid Chemicals & Pharmaceuticals Ltd.

Spring Valley, New York, May 26, 2004 - Par Pharmaceutical, Inc., the principal subsidiary of Pharmaceutical Resources, Inc. today announced that it has entered into an agreement with Orchid Chemicals & Pharmaceuticals Ltd., based in Chennai, India, to develop and market generic drugs. The companies will initially collaborate on the development of various dosage forms of as many as seven cephalosporin antibiotics. The companies will also seek to identify and develop up to 10 additional non-cephalosporin products.

Under the terms of the agreement, Orchid will be responsible for the development and manufacture of all products. Par will provide regulatory affairs support and submit each Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) on behalf of Orchid. Par will have exclusive rights to market, sell and distribute the products in the U.S. and will receive a share of the net profits generated by all marketed products.

www.parpharm.com

25/05/04 Teva Announces Approval Of Amoxicillin And Clavulanate Potassium For Oral Suspension, 200 mg and 400 mg

Jerusalem, May 25, 2004- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the company's ANDA for Amoxicillin and Clavulanate Potassium for Oral Suspension, 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL. A launch date has not yet been finalized.

Amoxicillin and Clavulanate Potassium for Oral Suspension is the AB-rated generic equivalent of GlaxoSmithKline's Augmentin® for Oral Suspension, a broad spectrum antibiotic.

www.teva.com

18/05/04 New York City files two suits against GlaxoSmithKline for antitrust violations and Medicaid fraud in connection with the antidepressant Paxil and the antibiotic Augmentin

New York May 18, 2004 - The City of New York has filed two complaints - one in Federal court in the Eastern District of Virginia and one in Federal court in the Eastern District of Pennsylvania - against the pharmaceutical company GlaxoSmithKline PLC and its affiliate, SmithKline Beecham Corp., alleging that the City was forced to pay unlawfully high Medicaid prices for the two drugs.

www.nyc.gov/html/law/pressreleases

25/05/04 MHRA Announces Change of Policy Concerning Generic Product Approvals

Following a recent judgment of the European Court of Justice in the 'Novartis' case (Case 106/01), the MHRA has decided to change its policy concerning the assessment of generic equivalents of line extension products.

The MHRA will now accept abridged applications for generic equivalents of line extension products which have not been authorised for ten years, if the original product from the same company (or group of companies) has already been authorised for ten years in the Community. The MHRA will accept such applications only if the line extension is essentially similar to the original product, or if the extension differs from the original product in one or more of the ways envisaged under the proviso to Article 10.1(a) (eg differences of therapeutic indication, route of administration, dose, strength or pharmaceutical form). If the line extension is not essentially similar to the original product, the application should generally be made under the hybrid abridged procedure pursuant to the proviso. But the applicant will be able to rely on the data submitted in respect of the line extension, rather than being required to produce their own bridging data. This does not however exclude the possibility that in specific cases it may be necessary for the MHRA to require additional data from the generic applicant.

Companies whose applications have been invalidated or refused on the basis of the previous policy are entitled to re-submit their applications. The MHRA will assess those applications in accordance with the revised policy.

www.mhra.gov.uk

24/05/04 Consumers Reach $75 Million Settlement WithGlaxoSmithKline -Agreement Requires $25 million to be Returned to Consumers Nationwide for Overcharges on Popular Pain Medication

Boston, May 24, 2004 - The Prescription Access Litigation (PAL) project today announced that its attorneys have settled a suit against GlaxoSmithKline Corporation (NYSE: GSK) over charges that it used illegal tactics to maintain its patent on the popular anti-inflammatory drug, Relafen, and to keep a generic, cheaper version off the market.

The $75 million dollar settlement resolves the claims of the "end-payor class" which consists of both consumers and third-party payors (such as health insurers and union health and welfare funds). Once approved by the court, the settlement will result in the creation of a $25 million consumer pool through which individuals may seek reimbursement for Relafen overcharges, and a $50 million pool for third party payors.

www.prescriptionaccesslitigation.org

19/05/04 Teva Comments On The Court Of Appeals Decision Regarding Generic Version Of Vicoprofen®

Jerusalem, May 19, 2004- Teva Pharmaceutical Industries Ltd. announced today that the United States Court of Appeals for the Federal Circuit has vacated a September 2002 summary judgment decision by the U.S. District Court for the Northern District of Illinois regarding a U.S. patent on a combination of Hydrocodone Bitartrate and Ibuprofen. The district court had ruled that the U.S. patent was invalid as obvious. The patent expires on December 18, 2004. The patent was asserted by Knoll Pharmaceutical Company, now a subsidiary of Abbott Laboratories, which markets the combination as Vicoprofen®. The 2002 annual sales of the branded product in the U.S. were estimated to be approximately $108 million. In April 2003, following FDA approval, Teva USA launched its product, Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg. Knoll had appealed the district court's judgment.

The Court of Appeals has remanded the case to the District Court for further proceedings, which will involve Teva's allegations of inequitable conduct, invalidity, and non-infringement.

The Company plans to continue selling its Hydrocodone Bitartrate and Ibuprofen product.

www.teva.com

18/05/04 Sandoz strengthens global production network with three new facilities

Vienna, May 18, 2004 - Sandoz, the world's second largest supplier of generic medicines, is expanding its global production network with the opening of three new plants this month in Poland, India and Romania. The USD 80 million total investment will boost production capacity by three billion tablets and capsules, while creating approximately 500 jobs.

www.sandoz.com

18/05/04 Bentley Pharmaceuticals Receives Approval To Market A Generic Version Of Simvastatin In The U.K.

EXETER, NH, May 18, 2004 -- Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company focused on advanced drug-delivery technologies, which also manufactures and markets generic and branded products in Europe, announced today that its Spanish subsidiary has been granted approval to market a generic equivalent of simvastatin in the United Kingdom through a company focused in the UK.

www.bentleypharm.com

06/05/04 Wockhardt strengthens European presence with German acquisition

Mumbai, May 6, 2004. Pharmaceutical major Wockhardt Limited today announced the acquisition of the German pharmaceutical company esparma, GmbH. The deal, made at a consideration (equity value) of US$ 11 million (Rs. 49 crores), signals Wockhardt's entry into the German market and the strengthening of its presence in the European Union.

Following the acquisition, Europe now becomes the highest contributor to Wockhardt's total sales, at 40%, overtaking sales from India. Sales from Europe have crossed the US$ 100 million mark, now at US$ 110 million (Rs. 490 crores). The total international business now contributes 62% to Wockhardt's turnover, a significant upward trend from a mere 9%, ten years ago.

www.wockhardt.com