A few hitches 'across the pond' for pharma products

Bristol-Myers Squibb (BMS) and Ranbaxy Laboratories both got some bad news from the United Kingdom this week, with one product denied the chance—at least for now—to enter the market and three others removed from that market.

In the case of BMS, the U.K.'s National Institute for Health and Clinical Excellence (NICE) issueddraft guidance rejecting National Health Service reimbursement for Yervoy (ipilimumab), an immunotherapy designed to be used against advanced melanoma in patients who havereceived prior treatment. Yervoy was approved inEurope this summer and reportedly is the first treatment cleared for use against thedisease that has demonstrated a significant improvement in overallsurvival. Analysts are saying that the drug could generate global sales ofnearly $1.5 billion in 2016.

Because truly long-term benefits are not yet known, and the drug costs about $31,550 adose (and is given in four doses), NICE could not recommend it, with NICE's chief executive Andrew Dillon saying, "We need to be sure that new treatments provide sufficientbenefits to patients to justify the significant cost the NHS isbeing asked to pay."

Although Dillon acknowledged that clinicalresults had shown Yervoy capable be being "very effective for a small percentage of patients," he also noted that the follow-up thus far has been "too short to determinehow long this effect would last." He also added that the main trialsupporting use of Bristol-Myers Squibb's therapy didn't compare it with"drugs currently used to treat people with advanced or metastaticmelanoma."

In explaining NICE's rationale, Dillon said that clinical specialists report that about 30percent of people treated with Yervoy would have improved survival,with possibly "only 10 percent potentially experiencing long-term benefits." In addition, he noted that no patient characteristics or biomarkershave yet been identified to identify the patients who would benefit from the therapy.

Amadou Diarra, general manager of BMS's UK business, said the drugmaker "will be submitting further evidence [in] the hopethat NICE will reconsider this decision so that all patients withmetastatic melanoma can access this potentially life-extendingtreatment."

The treatment was approved by drugs regulators in the UnitedStates in March and was in May recommended for approval inEurope by the European Medicines Agency.

While BMS was blocked at the door, Ranbaxy Labs has been "shown the door" so to speak, and the British arm of the company is now in the process of recalling three drugs from the U.K. market. It's not a fatal blow, as the problem is that drugmakerviolated stipulated safety warning requirements of the country and neglected to make required changes to the patientinformation leaflets accompanying the drugs toinclude updated safety information. As such , Ranbaxy must withdraw one batch each of antiviraldrug Aciclovir, antifungal drug Fluconazole and analgesic Oldaram.

This is the second time Ranbaxy has had to recall products this year and the fifth time in past two years from the UKmarket. The most recent previous recall was three months ago when Ranbaxy had to recall the skin infectiondrug Isotretinoin.