U.S. advisers doubt Teva Parkinson’s drug claim
Azilect is already approved as a Parkinson’s therapy, but it is the first time a drugmaker has sought approval for slowing the degenerative disease of the nervous system, instead of merely masking its symptoms.The panel of experts convened by the Food and Drug Administration were unanimous in their skepticism about the result of Teva’s latest trial.”This is really going to be the flagship… and we have to be very solid in this and set a very high standard,” said Dr. Robert Clancy, one of the panel members and a neurologist at the Children’s Hospital of Philadelphia. “And this is close, but it’s not good enough.”The advisory panel’s concerns were similar to those of FDA staff reviewers, that were published last week.Azilect, generically known as rasagiline, is marketed by Israel-based Teva and, in several countries, with Danish partner Lundbeck.It already has FDA approval to treat symptoms of Parkinson’s Disease, such as trembling limbs, stiffness, slow movement and impaired balance. Teva is seeking an expansion of Azilect’s label to include the slowed progression claim.The FDA will make a final decision on the label but usually follows the advice of its advisory committees.In Teva’s latest trial, Parkinson’s appeared to deteriorate more slowly in patients who started taking Azilect earlier than in those who began later. But while the 1 milligram (mg) dose appeared to slow the progression, the 2 mg dose did not, overshadowing the results of the 1 mg trial under review.Much remains unknown about Parkinson’s, including its causes, which has many researchers struggling to find a cure or develop ways to measure the development of the disease.That complicated evaluation of Teva’s trial of Azilect as it is hard to tell whether the drug was hiding the symptoms or affecting the disease itself.”If you tell people in labeling that a drug has effect on disease progression, you want to be sure that it does indeed have an effect on disease progression,” Dr. Russell Katz, head of the FDA’s neurology products division, told the advisers.Anywhere from 500,000 to 1.5 million Americans are estimated to have the disease, and nearly 60,000 are diagnosed each year, according to the Parkinson’s Action Network.That network, joined by five other major groups representing the Parkinson’s patient community, had submitted a written statement to the FDA advisory panel ahead of the vote.Acknowledging various concerns raised by researchers about the conclusiveness of Teva’s trial, the groups said they were encouraged by the evidence but realized the data was not yet definitive and additional information was required.”Azilect is clearly the furthest ahead, but this is an area of incredible research and need,” Michael J. Fox Foundation Chief Executive Todd Sherer told Reuters ahead of the advisers’ vote.Azilect received FDA approval in 2006 for use as a single drug therapy in early Parkinson’s and, in more advanced patients, in addition to levodopa, a standard treatment for the disease that alleviates the symptoms.Teva’s drug works by blocking the breakdown of dopamine, a neurotransmitter chemical.The company declined to comment on the advisory panel’s vote, which came after the regular close of the U.S. stock market. Teva’s shares were little changed in afterhours trade from their $39.29 close.
The Taliban in Afghanistans once impregnable Panjshir Valley
Last month driving up Afghanistanâs magnificent Panjshir valley, you couldnât help thinking if the resurgent Taliban would ever be able to break its defences, both natural and from the Tajik-dominated populace. With its jagged cliffs and plunging valleys, Panjshir has been largely out of bounds  for the  Taliban, whether during the civil war or in the past 10 years when it has expanded a deadly insurgency against western and Afghan forces across the country. But on Saturday, the insurgents struck, carrying out a suicide bombing at a provincial reconstruction team base housing U.S. and Afghan troops and officials.
They were halted outside the base, but according to the provincial deputy governor they succeeded in  killing two civilians and wounding two guards when they detonated their explosives. The Taliban claimed responsibility, saying the first suicide bombing in a decade was a message to Western forces that they were not secure anywhere in the country. They said the  bombers came from within Panjshir, which if true would worry people even more because that would suggest the penetration was deeper and there could be more attacks.
The Long War Journalâs Bill Roggio wrote that the bombing was a propaganda coup for the Taliban. Panjshir is the home of the legendary Northern Alliance commander Ahmad Shah Massoud who was assassinated by two days before the Sept 11, 2001 attacks. Under Massoudâs leadership the Panjshir Valley held out against not only against the Taliban, but famously the Soviet before them.
All along the drive by the side of the rushing Panjshir river on way to Massoudâs hilltop mausoleum, the relics of the war against the Russians have been preserved : rusted tanks on roadsides and an overturned  armoured personnel carrier in the river. There were giant Massoud posters everywhere and because it was the anniversary of his assassination at the hands of a pair of men who pretended to be journalists, the ceremonial gates to the valley were draped in black.
And yet there were concerns even then . Security was tight at each of the gates on the narrow and winding highway through the tall mountains, and the Afghan police who stood guard said if Panjshir had been spared the kind of attacks the Taliban had mounted in the rest of Afghanistan,  it wasnât for lack of trying . They had already carried out attacks in neighbouring Nuristan province and according to a local Afghan police commander responsible for security at one of the checkpoints, American helicopters had been spotted in the area a few days before the anniversary, firing rockets over a hilltop. It wasnât clear who they were targeting, the commander said.
Even the proud Panjshiris were worrying about the expanding Taliban influence, especially concerned at the time about government attempts to seek reconciliation with them.  One Afghan elder who lost his son in the war against Russians said his village was fully armed to fight  the Taliban. There was no way they were going to accept the Taliban in the Panjshir, he told me.
Another local who ran an eating house by the side of the river said he was worried about the growing number of outsiders in the valley. Many, including a group of people from the southern Kandahar province we met at Massoudâs mausoleum, said they were visiting the  area attracted by its cooler climes.  But there were also others,  including a militia commander surrounded by gun-toting guards who swept up to the restaurant the day we were visiting in a cavalcade of vehicles and demanded food. Those were the ones that worried the owner  Jamaal Mohammed the most.
MIDEAST STOCKS-Most Gulf bourses fall; Egypt gains on valuations
Cairo’s index rose 2.5 percent but is still down 43
percent this year and volumes until recently were near
multi-year lows.Dealers say short-term trading has become the norm given the
uncertain political backdrop and a lack of visibility for
investors.”It’s the same scenario being repeated. The market crashes
and every dip is a buy. Events are quickly reflected in the
market,” said Omar Darwish at CIBC.Market heavyweight Orascom Construction gained 5.6
percent and was also the most traded stock.Commercial International Bank and Orascom Telecom
rose by 2.5 percent and 2.2 percent.In the UAE’s capital, National Bank of Abu Dhabi
fell 1.5 percent, Abu Dhabi Commercial Bank slipped
1.8 percent and Investment Bank dropped 5.9 percent.”Banks will be interesting once the numbers are out because
they will be telling us about the credit quality and loan
growth,” said a trader based in Abu Dhabi. “But it’s too risky
to be buying banks before the numbers.”The index slipped 0.4 percent to its lowest close
since August 2010.”There’s been nothing new on the table recently but we’ve
had a sentiment swing (in world markets). Until you see real
concrete proposals, the market will trade on very small
margins,” the trader added, speaking on European politicians
trying to contain the region’s banking crisis.Dubai’s share index ended little changed, up 0.06
percent with only 33.7 million shares exchanging hands, against
the 50-day average of 68.5 million shares.Drake and Scull gained 1.2 percent, accounting for
a third of all shares traded on the index.Emirates NBD , Dubai’s largest stock by market
value, rebounded as investors picked up the battered stock.Its shares rose 1.1 percent, recovering from Wednesday’s
27-week low. It had slumped after announcing it would take over
struggling Islamic lender Dubai Bank.Elsewhere, Qatar fell 0.3 percent to 8,397 points,
with investors locking in gains following a five-day rise.Qatar National Bank fell 0.5 percent, Qatar
Navigations shed 1.8 percent and Qatar Islamic Bank
slipped 0.5 percent.Bucking the trend, Industries Qatar (IQ) rose 0.9
percent after its third-quarter earnings beat
estimates.”Although the results look alright with growth primarily on
back of more capacity, quarter-on-quarter there is a decent
decline of 14 percent. This ties is with the global trend of
margins tightening,” said Ibrahim Masood, senior investment
officer at Mashreq Bank.In Oman, Bank Muscat, the largest lender by market
value, rose 0.6 percent after reporting a 15.8 percent increase
in third-quarter earnings a day earlier. The bank’s results
topped analysts’ estimates.In Kuwait, logistics firm Agility jumped 6.8
percent to its highest level since May 9.”The market still thinks they are in talks with large armies
even though Agility denied signing a deal,” said a Kuwait-based
trader on condition of anonymity.The stock hit a four-month high on Sunday on speculation
about a contract. On Tuesday, the firm denied reports that it
had won a military contract worth up to $700 million, sending
its shares lower.THURSDAY’S HIGHLIGHTSEGYPT* The index rose 2.5 percent to 4,152 points.ABU DHABI* The benchmark slipped 0.4 percent to 2,478 points.DUBAI* The index edges up 0.06 percent to 1,385 points.QATAR* The index declined 0.3 percent to 8,397 points.OMAN* The index eased 0.06 percent to 5,516 points.KUWAIT* The measure rose 0.3 percent to 5,868 points.BAHRAIN* The measure climbed 0.2 percent to 1,150 points.
Russia’s Shuvalov assumes another of Kudrin’s jobs
Kudrin was ordered by Medvedev to resign last month after
refusing to serve in a government that Medvedev is expected to
head under a job swap in the ruling ‘tandem’ that is set to
return Putin to the presidency next year.Shuvalov, who as first deputy prime minister has a broad
economic remit and oversees Russia’s talks on joining the World
Trade Organisation, has already taken over the responsibilities
held by Kudrin as deputy prime minister.Kudrin, who earned a strong reputation on financial markets
for defending fiscal discipline during his 11-year tenure, had
objected to Medvedev’s calls to boost defence spending, saying
they posed a risk to the stability of public finances.Putin said last week, however, that Kudrin “remains a part
of my team”, a hint he might hire him for an influential Kremlin
job after his expected return to the presidency. Some analysts
have speculated he could become central bank chief.
