Pharma industry scores overseas, suffers local setbacks this year – Retrospection – Express Pharma Pulse

Pharma industry scores overseas, suffers local setbacks this year

Gireesh Chandra Prasad G I gives a low-down on the major events during the past one year

The domestic pharmaceutical industry, which had a home run in the US market with generic launches and recouped some nearly-lost export opportunity under compulsory licence this year, saw on the home turf the promised price decontrol remaining subjudice, and the law eventually catching up with them on the overcharging issue.

The fourth largest pharma industry in the world in terms of volume also witnessed the first pharmaceutical exclusive marketing right (EMR) grant to Novartis’ cancer drug Glivec and two high-profile overseas acquisitions in its transition phase to the product patent regime.

Mumbai-based Wockhardt became the largest Indian company in UK by acquiring CP Pharma for pound sterling 10.85 million. CP Pharma, the largest supplier to UK’s National Health Service has a current sales turnover of pound sterling 31 million.

Ahmedabad-based Zydus Cadila made inroads into the European generic market, the second largest after the US, by acquiring the formulation business of Alpharma France, the French affiliate of one of the world’s largest generic drugmakers for a consideration of 5.5 million euros. This acquisition earlier in the year also facilitated the company’s access to UK, Germany and the Netherlands markets.

The tie-up New Delhi-based multinational Ranbaxy Laboratories’ arm Ranbaxy Fine Chemicals Ltd inked with Mallinckrodt baker Inc in September to market the latter’s scientific laboratory products in India and Glenmark Pharma’s collaboration with Canada’s Apotex in July for supplying a new generation bulk drug in the cardiac segment are also two milestones of this year.

Cipla, Ranbaxy and Hyderabad-based Matrix Labs scored when they inked an agreement with the Clinton Foundation HIV/AIDS Initiative for supplying anti-retrovirals at one third to half their current price, in Africa and the Caribbean where the Foundation is working with governments and other organisations on integrated healthcare and prevention programmes. The triple-drug therapy offered thus costs just 36.38 cents a day for a person.

The Ranbaxy-Glaxo R&D tie-up, Orchid Chemicals and Pharmaceuticals Ltd’s cyclosporin supply agreement with US-based Apotex, Roche Scientific’s marketing agreement with New Delhi-based Taksal Pharma and Lupin’s promoters’ dilution of stake in the company were the other major corporate developments.

Indian drug makers took the fight to the rival’s camp with a slew of abbreviated new drug application (ANDA) approvals claiming a share of the US market with the New Delhi-based multinational Ranbaxy Laboratories Ltd remaining at the vanguard.

Ranbaxy and Dr Reddy’s Laboratories received the USFDA approvals to market anti-depressant Nefazodone HCL five dosage forms, the generic equivalent of Bristol Mayers Squibb’s brand Serzone which enjoys an annual sales turnover of US dollar 261 million.

Ranbaxy also got the USFDA nod to manufacture and commercialise type-two diabetes drug Metformin HCL oral solution under the brand name Riomet, anti-bacterial for paediatric patients Amoxcillin oral tablets for oral suspension (Dispermox) two dosage forms, severe recalcitrant nodular acne drug Isotretinoin capsules 30 mg, cephalosporin antibiotic Cefadroxil oral suspension three dosage forms (patented by Warner Chilcott Inc and claiming annual sales of US dollar 37.7 million), Amoxicillin and Clavulanate Potassium for oral suspension (equivalent of Glaxo’s Augmentin claiming USD 272.5 million combined annual sales), Cefprozil, Fluconazole and Glanciclovir two dosage forms besides other tentative approvals.

India’s only New York Stock Exchange listed drug maker Dr Reddy’s Laboratories (DRL) received the US Food and Drug Administration’s (FDA) approval for its new drug application (NDA) for AmVaz (Amlodipine Maleate), a version of Pfizer’s anti-hypertension treatment Norvasc in early November. DRL, now preparing for the drug’s launch in the US, is also readying for a Europe launch upon expiration of the supplementary protection certificate in March 2004.

When Dr Reddy’s notified GlaxoSmithKline (GSK) of its ANDA application for Rosiglitazone Maleate tablets three dosage forms under Para IV, the latter filed a law suit in the New Jersey district court against the Hyderabad-based company alleging patent infringement. Rosiglitazone Maleate goes into GSK’s type two diabetes money-spinner Avandia commanding US dollar 1.1 billion annual sales. Dr Reddy’s also filed lawsuits against US pharma icon Pfizer in New Jersey district court regarding its Sertraline HCL ANDA.

Lupin received USFDA approvals for semi-synthetic broad spectrum cephalosporin antibiotic Cefotaxime sterile vials for injection, the generic version of Claforan marketed by Abbot Labs Inc and for Cefuroxim Axetil tablets. The domestic market witnessed the launches of Wockhardt’s indigenous human insulin Wosulin, Novartis’ imunosuppressant drug Mytortic, Natco’s anticancer drug Zoldonat and Bharat Biotech’s blood clot buster recombinant Streptokinase among others. Mumbai-based Nicholas Piramal India Ltd announced last week its plans to commence clinical trials of semi-synthetic anti-cancer drug called NP102.

The country’s pharma sector regained a nearly-lost opportunity to export certain drugs under compulsory license to countries not having the wherewithal to manufacture these on their own, when India, US and Brazil agreed on a compromise formula to settle the issue ahead of the Cancun WTO ministerial in June. Indian companies, however, feel the requirement of different colour and packaging compared with that for drugs meant for commercial marketing will add to the cost of the generics.

The benevolent price control regime promised in the 2002 drug policy remained subjudice in the Supreme Court on a special leave petition filed by the Union Government challenging an earlier Karnataka High Court order quashing the policy. The national drug pricing body sent a clear signal to the industry this year directing pharma companies to pay half the amounts they allegedly overcharged on seven controversial bulk drugs. At present, Ranbaxy is the only company to comply with the government’s directive.

The Union Government also initiated efforts to centralise drug licensing and introduce a law to govern nutraceuticals this year besides to bring in stringent punishment for those involved in spurious drug trade.