TheChek News Flow

Ariad Pharmaceuticals Inc Iclusig is commercially available for patients with Refractory Philadelphia-Positive Leukemias in the U.S.

- Announced the commercial availability of Iclusig(ponatinib) for adult patients with refractory chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the United States. ARIAD has begun shipping Iclusig to Biologics, Inc., its exclusive specialty pharmacy, which is now filling prescriptions from physicians and distributing the cancer medicine to patients.

- Last month, the U.S. Food and Drug Administration (FDA) approved revised U.S. Prescribing Information (USPI) and a communications Risk Evaluation and Mitigation Strategy (REMS) for Iclusig that allowed for the immediate resumption of its marketing and commercial distribution. The USPI includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers. Iclusig is now indicated for the treatment of adult patients with:

- T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia, or
- Chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ acute lymphoblastic leukemia for whom no other tyrosine-kinase inhibitor therapy is indicated.
The starting dose of Iclusig remains 45 mg daily.

- On November 1, 2013, there were approximately 640 patients receiving Iclusig obtained through commercial channels in the U.S. Since then, Iclusig was made available through emergency and single-patient investigational new drug (IND) applications, which were reviewed and approved by the FDA on a case-by-case basis. The FDA has approved more than 370 INDs since early November, and more than 300 patients have received Iclusig at no cost through this process. ARIAD expects most of these patients, many of whom received a three-month supply of Iclusig, to transition from the IND program to commercial therapy by the end of the first quarter of 2014. The Iclusig IND program is now closed to new patients with Philadelphia-positive leukemias.

- In addition to providing specialty pharmacy services, Biologics will help transition patients from the Iclusig IND program to commercial product. Biologics will further support the ARIAD Patient Access and Support Services (ARIAD PASS) program by managing ARIADs reimbursement and patient access services and co-pay support programs by conducting benefits investigations and prior authorizations to assess and assist with patient eligibility. Iclusig is currently priced in the U.S. at approximately $125,000 per year. The new annual cost of Iclusig is approximately a 17 percent premium to second-generation TKIs.

Turkey Central Bank (TCMB) Survey of Expectations

- Cuts 2014 GDP forecast from 3.7% to 3.2%
- Maintains End-2014 Inflation:at 7.4%

{http://www.tcmb.gov.tr/yeni/eng/}

The UK regulator plans to crack down on fund companies that splash out on lavish events and gifts for financial advisers in an attempt to win business.

Yesterday the Financial Conduct Authority said it had discovered cases of fund providers offering hospitality or gifts to advisers that were of “unreasonable value”.

“[This] could have led to a channelling of business to that provider,” the UK watchdog said.

Gina Miller, founding partner of SCM Private, the UK investment house, said such practises are widespread and penalise smaller groups that either cannot afford or would not choose to offer the same perks.

She said: “It is all very well to cement or reward a relationship, but the extravagance of some entertainment is eye-watering. You have to question whether it influences what an adviser offers clients.”

It is not uncommon for big fund companies to invite advisers to events such as the Monaco Grand Prix, three day golfing tournaments in Scotland or cruises on superyachts, according to Ms Miller.

And this is by no means a UK phenomenon; Italian fund house Pioneer Investments, for example, invited French clients to the Champions League football final in London last June.

French group Carmignac Gestion also paid for a large number of UK financial advisers to attend a private Rolling Stones concert in Paris in late 2012.

There is broad agreement among smaller fund providers that they are losing business as a result.

The head of an independent financial adviser network recently told Ms Miller that although SCM Private’s funds rank highly in terms of performance, her fund company “does not wine and dine advisers enough to retain [the IFA network’s] business”.

“[Fund selection] is not about best advice, it is about best entertainment,” she said.

Hector McNeil, co-chief executive of Boost ETP, the exchange traded fund boutique, shares her concerns. He said: “[Corporate entertainment] is a bit like product kickbacks and lacks transparency. I think it is only a matter of time before it is banned or prohibited.”

However, Jason Hollands, a managing director at BestInvest, one of the UK’s largest adviser networks, believes such fears are overblown. “I have not been invited to any sports events, concerts or trips in the past year,” he said.

In response, Carmignac says that it only hosts one entertainment evening a year out of roughly 200 investment-focused client events. Pioneer says it allocates a modest part of its marketing budget to corporate hospitality and plans to reduce this expenditure soon.

There is growing consensus that rules on what constitutes appropriate corporate entertainment need to be clarified, particularly beyond the UK market.

Christopher Cruden, a fund manager at Insch Capital, a Swiss hedge fund, said: “Where does hospitality cease and bribery begin?”

Gary Mairs, co-founder of UK fund house TCF, added: “There is a fine line between what is over the top and what is acceptable. We think rugby matches or the Grand Prix are unnecessary and are potentially open to people making accusations of abuse.”

Until now, uncertainty around the rules has caused some fund groups to scale down events to include only their most senior clients, or to legitimise them by tacking a business meeting on to it, according to Charlie Hepburn, managing director of Vivid Event Group, the corporate hospitality company.

His company has also seen increased demand for bespoke gatherings between senior fund executives, top clients and their spouses, such as trips to see the northern lights, as opposed to large-scale client events.

Mr Hepburn believes that fund managers are unlikely to turn away from corporate entertainment altogether as a means of maintaining relationships with advisers, despite the regulator’s push against this.

He said: “The [fund] industry is oiled by entertaining, and there is a massive grey area in terms of what you can do. People are still entertaining, but they are just finding new ways to do it.”

Peltz weighing proxy fight with Mondelez, says source Nelson Peltz is seriously weighing a proxy fight against snack food giant Mondelez International, as was first reported by nypost.com Thursday.

The activist investor, who owns a 2.3 percent stake in the maker of Oreos, Fig Newtons and Ritz crackers, is looking to pressure CEO Irene Rosenfeld to increase margins and, perhaps, explore selling the company’s coffee business, an industry source said.Peltz, if he decides to make the move before the Jan. 21 deadline, would nominate himself and perhaps a few other candidates to the board, the source added.

“I think the majority of shareholders would want Peltz and a few of his directors to have seats on the board,” the source said.

Mondelez, split apart from Kraft in 2012, has seen its share rise 30.2 percent in the last year — outpacing the S&P 500’s 25.4 percent rise. Mondelez shares closed Thursday unchanged at $35.70 in heavy trading.

The looming proxy fight seems similar to Peltz’s battle with H.J. Heinz in 2006, when he won five seats on the board — and called on the company to cut costs and sell assets.

Heinz ultimately followed much of his advice. It sold for a high multiple last year to Warren Buffett and 3G Capital.

Mondelez head Rosenfeld has come under increasing pressure.

Three top shareholders, not including Peltz, were losing patience with the CEO after she fell short of the growth targets she set, The Post reported exclusively in November.

There has been a string of disappointing earnings reports since Rosenfeld split Mondelez from Kraft’s slower-growing grocery business a year ago.

Neither Peltz nor Mondelez returned calls.

TOKYO — Apple has been counting on a long-awaited agreement with China Mobile, the world’s largest cellular operator, to reverse its fortunes in China. If the muted reception Friday, when customers were finally able to buy iPhones from China Mobile, is any indication, the companies may have to work harder to whip up enthusiasm.

Instead of the round-the-block lines that have greeted Apple product introductions in China and other countries in the past, only about a dozen customers showed up to buy iPhones at the opening of a store in Beijing — despite the presence of a special guest, the Apple chief executive, Timothy D. Cook.

Mr. Cook’s trip to Beijing was a testament to the importance that Apple has attached to the introduction of iPhones on a mobile network with more than 750 million customers. The agreement to sell the iPhone 5S and 5C was announced in December, after years of negotiations.

Apple was once an iconic brand in China, where its phones have been sold for years by the second- and third-largest mobile operators, China Unicom and China Telecom. But it has lost ground to the market leader in smartphones, Samsung Electronics, and cut-price domestic rivals.

Its market share has fallen into the single digits.

In some ways, Apple’s challenges echo those of other American brands in China, which gained loyal followings during the country’s boom but have more recently been subject to intense scrutiny by the Chinese media, prompting consumers to give another look to alternatives.

“Apple used to be the must-have, aspirational brand for all wealthy and middle-class Chinese consumers,” said Shaun Rein, the managing director of CMR, a market research firm, and the author of “The End of Cheap China.” “But over the last year, there has been a real deterioration of the Apple brand.”

The state-run CCTV has broadcast a series of exposés of supposed quality or ethics lapses by Western brands, including Apple. In one of the most recent examples, Walmart this month recalled donkey meat that it was selling at several outlets after it was found to have been tainted with fox meat.

Apple is just the latest of a number of American technology companies to fall on harder times in China. Google was once a leading search engine in China, but then lost ground to a local rival, Baidu. Motorola was once a power in mobile phones in China, but then lost ground to Nokia of Finland — which, in turn, yielded leadership to Apple, Samsung and others. More recently, Cisco Systems, the maker of telecommunications network equipment, said that sales in China had been hurt by disclosures of surveillance by the United States National Security Agency.

Analysts say that Chinese consumers are likely to base their purchasing decisions more on the price and features of phones and calling plans. And Apple still has enthusiasts, including some of the consumers who visited the Beijing store on Friday.

“This is like manna from heaven!” said Xia Bingyi, a 26-year-old customer from the eastern Chinese city of Jinan. She was one of 10 registrants for an iPhone through China Mobile who won a trip to the Chinese capital to purchase an iPhone on the opening day of the company’s offering.

Ms. Xia already owned an iPhone 4 she bought two years ago, but said she did not hesitate to sign up for a new iPhone 5S once China Mobile began offering the Apple product.

So far, China Mobile is being has been less aggressive on pricing than some analysts had expected. It is offering the unsubsidized, unlocked version of the iPhone 5S at 5,288 renminbi, or $874, the same price that Apple charges in its own stores in China. China Mobile customers can get the phone for free — but only if they commit to a two-year contract at 588 renminbi per month, or almost $100.

China Unicom and China Telecom have made only modest price cuts on their competing iPhone packages since China Mobile announced its Apple agreement in December.

“There won’t be a subsidy war among the three operators because they have already learned that they need to control this,” said Jun Zhang, an analyst at Wedge Partners, an equity research firm.

On Sina Weibo, a microblogging service, some users complained about the pricing of the iPhone 5S by China Mobile, saying they could get smuggled versions for less money.

“The model is the same,” one contributor wrote on Weibo. “I want the cheaper one.”

Even before the deal with Apple, China Mobile said 45 million people were already using iPhones on its network, most of them acquired from Hong Kong or via other unofficial channels. This accounts for more than 60 percent of the iPhones in use in China, according to Craig Yu, research director at Kantar Worldpanel ComTech, a research firm.

Now, in addition to the agreement with Apple, China Mobile has another big advantage over its two rivals — the fast new network it is building, using so-called 4G technology. China Unicom and China Telecom are still relying on the slower, previous generation technology.

But this is a mixed blessing for Apple, because analysts say some China Mobile iPhone sales will come from customers switching from China Unicom or China Telecom. As a result, estimates of iPhone sales by China Mobile, which have ranged from less than 10 million annually to more than 30 million, might overstate the overall benefit to Apple.

An Apple spokeswoman, Carolyn Wu, said the company did not plan to report first-day sales figures.

Previously, China Mobile had reported more than one million advance orders for the phone via its website since the deal was announced.

But Mr. Zhang of Wedge Partners said such online registrations generally result in firm orders in only about one-third of cases, meaning Apple could expect around 400,000 sales.

Over all, including the effect of customers switching from rival networks, Mr. Zhang said he expected Apple to sell about one million more phones a month in China as a result of the deal, on top of the roughly three million it has been selling.

In a market of more than one billion mobile phone customers, those are modest figures. That may help explain why even Mr. Cook seemed to be looking as much to the future as to the present as he traveled to Beijing for the China Mobile introduction.

Analysts said that Apple could probably broaden its potential market in China by making phones with features that appeal more to Chinese consumers, like bigger screens. Handsets like the Samsung Note 3, which has a 5.7-inch screen, compared with the 4-inch screen of the Apple 5S and 5C, have been selling well in China.

In his appearance at the China Mobile store in Beijing, the Apple chief told shoppers and reporters that “today is just the beginning of China Mobile and Apple coming together to deliver the best experience in the world.”

“We never talk about future things,” Mr. Cook said. “We have great things we are working on but we want to keep them secret. That way you will be so much happier when you see it.”