European regulators are still probing the safety of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, delaying an expected update on the medicine until April.
The European Medicines Agency (EMA) initially aimed to give an update on the medicine by March 16 but a spokeswoman said on Friday that the review had not yet been finalised. As a result, an announcement is now due on April 19 or 20.
The delay leaves a question mark over the product, which has seen its prospects clouded by concern about serious heart problems.
But there was also good news for Gilenya as Britain's healthcare cost-effectiveness watchdog NICE, in an about-turn, decided it was ready to recommend its use on the state health service.
Gilenya, the first multiple sclerosis (MS) pill of its kind, is seen by analysts as a potential blockbuster with annual sales of $2 billion by 2015, according to consensus forecasts collected by Thomson Reuters Pharma.
However, that is down on the $2.2 billion seen at the end of 2011 as doctors have grown more cautious about the drug following reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment.
Those cases prompted the EMA to start its review in January, when it also advised doctors to continuously monitor patients for six hours after giving them a first dose. The U.S. Food and Drug Administration (FDA) is also looking into the drug.
Novartis said in a statement it was working with the EU regulator to finalise the label for Gilenya and was also liaising with the FDA on its review.
Gilenya represents a significant change in MS treatment, since existing medicines like beta interferons and Elan and Biogen Idec's Tysabri must be injected.
Rival oral MS treatments in development include BG-12 from Biogen, teriflunomide from Sanofi and laquinimod from Teva.
Britain's National Institute for Health and Clinical Excellence (NICE), whose opinions are also watched closely in other countries, initially said it was unclear if Gilenya was any better than existing treatments.
It changed its mind after Novartis presented data showing benefit in a subgroup of adults with highly active disease, whose relapses had increased or stayed the same compared with the previous year despite them taking beta interferons.
Carole Longson, director of NICE's health technology evaluation centre, said it was now clear Gilenya was a cost-effective option for these patients, provided Novartis supplied the drug at the discounted price it previously suggested.
A NICE spokeswoman said the size of the discount remained confidential. The list price for 28 capsules is 1,470 pounds ($2,300) or just over 19,000 pounds per person for a year.
Novartis and Britain's MS Society welcomed the final NICE decision, which is expected to be officially published next month. ($1 = 0.6376 British pounds)
IFC CEO Philippe Le Houerou said the fund will "lower the risk for the private sector and attract new investors -- essentially creating a market where there was none."
BIST 100 index opens 0.67 percent higher, US dollar/Turkish lira rate stands at around 3.64
Tightening monetary policies will continue to achieve lower inflation levels, Murat Cetinkaya says
Company will manage operations in 65 countries through Turkey, says head of healthcare group
"We might have to extend in order to reach the target... of stock levels," Khalid al-Falih told an energy forum in Abu Dhabi, referring to a deal between OPEC and non-OPEC producers to cut production by around 1.8 million barrels per day.
BIST 100 index opens 0.40 percent higher; US dollar/Turkish lira rate stands at around 3.66
Crude prices plummet to two-and-a-half month low
Businesses in Turkey expect structural reforms following referendum, says rating agency
"We are optimistic that the policy measures we have taken already place us on the path of recovery," OPEC Secretary General Mohammad Sanusi Barkindo said at an energy forum in Abu Dhabi.
The IMF said "hundreds of millions" of people have been lifted out of poverty through economic integration and technological progress, "helping to reduce global income inequality."
In its latest World Economic Outlook report, the IMF cut its 2017 growth forecast for the region comprising the Middle East, North Africa, Afghanistan and Pakistan to 2.6 percent, down from the 3.1 percent projected in January.
BIST 100 index opens 0.20 percent lower, US dollar/Turkish lira rate stands at around 3.69
It is now time to make progress by preserving freedoms, pluralism and solidarity: Turkey's largest business association
Number of unemployed rises by 1.9 percentage points in January year-on-year, says state agency Turkstat
Beijing has said it wants to transition away from a reliance on debt-fuelled investment and towards a consumer-driven economic model, but the transition has proved bumpy.