Global Insight Perspective | |
Significance | The FDA has dealt GSK a huge blow by approving a raft of generic versions of twice-daily Coreg immediate release (IR), which was its fifth best-selling drug in the second-quarter of 2007. The approval also affects French firm Flamel Technologies, which co-developed both the IR and the newer controlled-release (CR) version of the drug. |
Implications | GSK and Flamel launched the once-daily CR version in March in an attempt to maintain patient loyalty ahead of the anticipated scramble of generic firms entering the Coreg market. However, U.S. patients can now choose from 14 generic versions manufactured by the usual suspects. |
Outlook | The future of the Coreg franchise appears bleak, with doctors expected to resort to copycat alternatives of the drug, particularly after a study questioned whether once-daily CR actually improved treatment regimen compliance compared to the older version. |
Flood of New Competitors
Yesterday the U.S. FDA approved the first generic versions of GlaxoSmithKline (GSK)'s cardiovascular drug Coreg. Four strengths (3.125 mg, 6.25 mg, 12.5 mg and 25 mg) of Coreg tablet have been approved. In the U.S. market the drug is licensed to treat high blood pressure, mild-to-severe chronic heart failure (CHF) and left ventricular dysfunction after a heart attack.
The labelling of the new generic products, however, is likely to be different to that on the branded version because sections of GSK's Coreg have got patent/and or exclusivity protection, according to the agency. Gary J. Buehler, director of the FDA's Office of Generics, highlighted that generic drugs "offer alternatives to Americans in choosing their prescription drugs". The FDA said it had green-lighted applications from the following generic drug-makers:
- Actavis (Iceland)
- Apotex (Canada)
- Aurobindo Pharma (India)
- Caraco Pharmaceutical Laboratories (U.S. subsidiary of Sun Pharma)
- Dr. Reddy's Laboratories (India)
- Glenmark Pharmaceuticals (India)
- Lupin (India)
- Mylan Pharmaceuticals (U.S.)
- Ranbaxy Laboratories (India)
- Sandoz (generics unit of Swiss drug-maker Novartis)
- Taro Pharmaceutical Industries (Israel)
- Teva Pharmaceuticals (Israel)
- Watson Laboratories (U.S.)
- Zydus Pharmaceuticals (India)
One of the generic manufacturers, Actavis, said that U.S. distribution of the product will start immediately. Citing IMS Health data, the Icelandic firm said annual sales of carvedilol in the United States were about US$1.7 billion for the twelve months ending June 2007.
Outlook and Implications
Anticipating a raft of generic competition to twice-a-day Coreg IR, GSK rolled out the controlled-release version of the drug in the United States in March (see United Kingdom: 23 March 2007: GSK Launches Coreg CR Extended-Release Capsule in United States). The new once-daily beta blocker was expected to benefit current users of the medicine, particularly by improving treatment regimen compliance. However, this advantage was recently questioned in a head-to-head study of Coreg IR and Coreg CR that was published in the Journal of Cardiac Failure. Patients on Coreg CR did not comply with their usage regimes more than patients administered the immediate-release version, according to the research (see United Kingdom - France: 27 August 2007: New Study Casts Shadow on Future of Coreg CR for GSK, Flamel Technologies). As a result of the study, U.S. doctors are likely to be considering limiting prescription of the CR version, and they now have 14 generic versions of the IR version to choose from.
U.S. approval of the first generic versions is clearly a blow to GSK and its French partner Flamel Technologies, which co-developed both versions of the cardiovascular medicine (see France: 14 March 2007: Flamel Technologies Sees Slight Dip in 2006 Revenue but Stands to Gain from U.S. FDA Approval of Coreg CR). Coreg was GSK's fifth-best selling drug in the second quarter of 2007, with revenue rising 37% year-on-year to £202 million (US$404 million). Full-year 2006 sales of the triple cardiovascular therapy climbed 38% to £779 million.
Before the predictable scramble to enter the Coreg market, Israeli generics powerhouse Teva slapped seven Indian firms with a lawsuit related to carvedilol, Coreg’s active pharmaceutical ingredient (API). Teva sought legal recourse because Ranbaxy and Dr. Reddy's, among others, did not disclose details of their versions of the API despite offers of confidentiality. The main patent on the drug expired in March this year and paediatric exclusivity has just ended this month (see India - Israel: 3 July 2007: Teva Sues Indian Firms over Carvedilol Patent).