April 30, 2024

Auvi-Q Challenges EpiPen With a New Shape and Size

But as they entered their teenage years in suburban Virginia, they found the advice increasingly hard to follow. The device they carried to inject the medicine, known as an EpiPen, was shaped like a large felt-tip marker and they would frequently forget it. As the twins entered college, they found themselves thinking there had to be a better way.

This week, the brothers’ invention — a slimmer, rectangular device shaped like a smartphone — hit pharmacy shelves nationwide, the culmination of a single-minded quest that began 15 years ago and ended in a $230 million licensing deal with the French pharmaceutical giant Sanofi.

The product, called the Auvi-Q, boldly challenges the superiority of the EpiPen at a time when food allergies among children and teenagers are on the rise. Sanofi and the Edwards brothers clearly hope it will appeal to a gadget-hungry generation with its compact, rectangular design and automated voice instructions that guide a user through the injection process. Both the Auvi-Q and EpiPen contain the drug epinephrine, which can halt a severe allergic reaction known as anaphylaxis.

Evan Edwards said the device was special because it was designed by people who were intimately familiar with patients’ needs. “This wasn’t just an invention,” he said. “This was something that I knew I was going to carry with me every single day.”

Mylan Pharmaceuticals, which sells the EpiPen, has recently stepped up its marketing of the device and this week showed no signs of backing down. In an interview this week, Mylan’s chief executive took issue with claims that up to two-thirds of EpiPen users do not carry their devices, saying the company would take “appropriate action” to challenge the claims.

Heather Bresch, the chief executive, said she welcomed efforts by Sanofi to raise awareness about the dangers of severe allergic reactions. “However, we certainly don’t condone or find it acceptable to do it in a misleading way, and that’s what we believe they’re doing,” she said.

A spokeswoman for Sanofi said the company stood by its claims.

Energized by their idea to create a new epinephrine device, the twins split up to attend college but geared their studies to their single-minded goal. Evan chose engineering, studying at the University of Virginia. Eric pursued a medical path, eventually earning a doctorate in pharmaceutical sciences.

“We would choose our courses out of the undergraduate bulletin,” Eric said. “You take this; I’ll take that.”

One of the courses Evan chose was an invention and design class taught by Larry G. Richards, an engineering professor at the University of Virginia, where students were encouraged to share their ideas with each other. “Evan came to us early in the semester and said ‘I’ve got this really great idea,’ ” Mr. Richards recalled. “He told us the idea and I said, ‘Evan, this is too good to share with the students in the class. You want to protect your intellectual property here.’ ”

Working with Mr. Richards and another professor, Evan continued to refine the idea, earning a grant for college inventors that provided initial start-up financing for their project. After college, the brothers founded a company, Intelliject, to bring their idea to market, relying on early investments from family and friends.

The product evolved as the years passed, retaining its rectangular profile but picking up other features along the way. Eric had the idea of adding voice instructions to help others to use the device even if they had never seen one. A retractable needle was also added later, with the thought that patients would be more comfortable if they didn’t have to see it.

Intelliject licensed the product to Sanofi in 2009, a deal that included an initial payment of $25 million and up to $205 million in future milestone payments and royalties. The Food and Drug Administration approved the Auvi-Q last summer.

The Auvi-Q has created a stir among allergy sufferers, including bloggers and others who have praised its compact design and “cool” factor. The company also cited internal market surveys that show up to two-thirds of patients do not regularly carry their epinephrine injectors, and about half of parents said they feared others would not be able to properly use their child’s injector in the event of an emergency.

“Anaphylaxis is scary enough,” Evan Edwards said, referring to the severe reaction that can be set off by allergens. “But the treatment shouldn’t be.”

Ms. Bresch, the Mylan chief executive, noted that Sanofi did not provide studies showing users would be any more likely to carry the Auvi-Q. She also cited a marketing study conducted in Canada on Sanofi’s behalf that found 84 percent of participants knew how to use their auto-injectors.

“EpiPen has been tried and true for 25 years,” Ms. Bresch said, and argued that her product’s distinctive shape worked to its advantage. “It’s not easily confused with a Blackberry or your phone in your purse or your backpack.”

Other online commenters wondered if younger children might lose the Auvi-Q because of its size. It is smaller than a deck of cards.

Sanofi has set a price for the Auvi-Q that is comparable to the EpiPen, charging $240 for two auto-injectors and a training device. Lori Lukus, a Sanofi spokeswoman, said the company’s market research indicated that a “large percentage” of insurers would cover the product.

Still, the Auvi-Q faces long odds: several other companies have tried and failed to challenge the dominance of EpiPen. Last year, the manufacturer of the only competing products on the market, the Adrenaclick and Twinject, announced it would stop making them.

One allergy specialist, Dr. Scott H. Sicherer, said the Auvi-Q could provide an alternative for patients who have complained over the years about the EpiPen’s bulky size. He said some have already asked about it.

“People might find it easier to have that in a pocket compared to carrying a giant Magic Marker,” said Dr. Sicherer, a researcher at the Jaffe Food Allergy Institute at Mount Sinai Medical Center in Manhattan.

Still, he noted that he had seen several EpiPen competitors come and go. In the past, when he presented patients with alternatives, “the patients have mostly been more comfortable taking the EpiPen.”

This article has been revised to reflect the following correction:

Correction: February 1, 2013

An earlier version of this article used an outdated company name on first reference. It is Sanofi, not Sanofi-Aventis. The company changed its name in 2011.

Article source: http://www.nytimes.com/2013/02/02/business/auvi-q-challenges-epipen-with-a-new-shape-and-size.html?partner=rss&emc=rss

Investment Into China Declined During 2012

BEIJING — China’s foreign investment inflows fell last year for the first time since the global financial crisis, government data showed Wednesday, slipping 4 percent as a troubled world economy reduced investors’ enthusiasm for deals in emerging markets.

But the nation, with the world’s second-largest economy, after that of the United States, still drew $111.7 billion in foreign direct investment in 2012 after a record $116 billion in 2011 and maintaining the country as one of the top destinations for corporate expansion.

Foreign investment is an important gauge of the health of the global economy and of demand for the output of China’s huge manufacturing sector — though such investment is a small contributor to China’s overall capital flows when compared with exports, which were worth about $2 trillion in 2012.

Analysts said cooling growth in China’s foreign direct investment, or F.D.I., did not suggest that investors’ confidence in the country was waning. Rather, it shows China needs another catalyst to drive inflows after the increase from joining the World Trade Organization hit a natural plateau.

“We will see F.D.I. bouncing around $110 billion to $120 billion for some years,” said Tim Condon, an economist with ING in Singapore. “Hopefully, the current administration is going to intensify reform efforts, such as opening of the capital account. That could be momentous, in terms of attracting more F.D.I.”

A new government led by Xi Jinping, the incoming president, is set to take over in March, and investors are hoping that Beijing will pursue changes it had delayed, including the relaxing of capital account controls, to drive China into the next stage of growth.

Analysts forecast that data to be released on Friday would show China’s annual economic growth had rebounded to 7.8 percent in the fourth quarter of 2012 from 7.4 percent in the third — the weakest pace of expansion since the depths of the financial crisis in early 2009.

In December, F.D.I. in China fell 4.5 percent from a year earlier to $11.7 billion, the Commerce Ministry said at a briefing Wednesday.

China joined the W.T.O. in 2001, and foreign direct investment inflows have more than doubled since. Figures from the Organization for Economic Cooperation and Development show China now takes turns with the United States as the world’s top F.D.I. destination, with the United States pulling ahead of China by a slim margin in 2011.

Shen Danyang, a spokesman from the Commerce Ministry, acknowledged that China had to try harder to attract foreign investors, without elaborating. But he stressed that foreign funds were not leaving in a big way.

“It is true that some manufacturing companies are moving out of China,” Mr. Shen said. “But one point I want to remind you is that, so far, there is no big-scale pullout of foreign investment.”

Data showed European and Asian firms had cut their Chinese investment the most, even though Asian firms remained by far the biggest foreign investors in China.

Inflows from the European Union dropped 3.8 percent in 2012 from a year earlier to $6.1 billion, while F.D.I. from the top 10 Asian economies — including Hong Kong, Japan and Singapore — fell 4.8 percent last year to $95.7 billion.

That contrasted with investment from the United States, which rose 4.5 percent on the year to $3.1 billion.

Article source: http://www.nytimes.com/2013/01/17/business/global/investment-into-china-declined-during-2012.html?partner=rss&emc=rss

China Inflation, Output Make Room for Pro-Growth Steps

A flurry of data on Wednesday showed that China’s factories are bearing the brunt of a modest economic slowdown even as consumer spending and investment in assets such as roads and other infrastructure remain resilient.

China’s annual inflation rate fell to 5.5 percent in October from September’s 6.1 percent — the biggest drop in the annual rate from one month to the next since February 2009 — and a further pullback from July’s three-year peak of 6.5 percent.

Premier Wen Jiabao said prices had fallen further since October, adding to the view that the State Council will start to favor more pro-growth policies, although inflation is still too high to expect a quick cut in interest rates from the People’s Bank of China (PBOC).

“All of this suggests that the balance of risk for the PBOC and State Council is likely shifting to growth and away from inflation,” Tim Condon, head of Asian economic research at ING in Singapore, said.

“I don’t have any (easing) in my forecast horizon. A required reserve ratio cut is a possibility, but I expect that they would continue with these fine-tuning measures.”

A senior official from the country’s top economic planning agency signaled caution ahead, saying inflation was likely to stay high in coming months.

China’s leaders have begun talking in recent weeks about “fine tuning” macroeconomic policy to maintain economic growth, which slowed in the third quarter to 9.1 percent, its weakest in more than two years.

The inflation figures soothed investors’ concerns about a sharp slowdown, supporting oil and copper prices and underpinning Chinese shares, although market direction was being largely set by events in Europe.

The 5.5 percent rise in the consumer price index in the year to September was in line with expectations from a Reuters poll.

Producer price inflation also showed a marked slowdown to 5.0 percent in October, a one-year low, from 6.5 percent in September. The median of a Reuters poll had forecast an October reading of 5.7 percent.

Bank of America/Merrill Lynch economist, Ting Lu, said the sets of figures suggested his forecast that consumer inflation would drop to 4.6 percent in December may now be too high.

FINE TUNING

Premier Wen suggested prices had continued to fall.

“Since October, overall domestic prices have been falling noticeably,” Wen was quoted as saying by a government website. “Prices of pork and eggs have fallen, but prices of fruit, dairy products, beef and mutton remain at high levels.”

But Zhou Wangjun, a senior official at the National Development and Reform Commission, saw inflation staying high and said it was too early for Beijing to relax policy.

“We will still maintain the prudent monetary policy and control the amount of money in circulation,” Zhou said, adding that the government will boost supplies of farm products to help put a lid on price rises.

Industrial output rose in October by 13.2 percent from a year earlier, slightly below expectations for a 13.4 percent rise and the weakest pace since October 2010.

Government officials have expressed concern about weakening external demand for goods from China’s factories, even though the sector is on track to expand by an annual 11 percent this year — in line with official targets.

Exports were a net drag on China’s economic growth in the first nine months of this year as the sector felt the chill of a weak global market. October trade figures are due for release on Thursday.

Retail sales rose 17.2 percent, also slightly below expectations for a 17.4 percent rise, but maintaining a steady pace of growth.

Fixed-asset investment in January through October increased 24.9 percent from the same year-earlier period, topping expectations.

Wen and other policymakers have made it clear that stabilizing prices and fighting inflation are the top priority, so analysts rule out an early rate cut or reduction in bank reserve ratios.

Even after the big fall in October, inflation remains well above the government’s 2011 target of 4 percent.

But in a nod to the slowdown in growth, the government has announced selective measures to support the economy.

Article source: http://feeds.nytimes.com/click.phdo?i=0d0a4fbe74417de4a329f980a6a20868