Archive for the ‘Business’ Category

PostHeaderIcon Rambus asked about shredded records in Nvidia case


Thu Oct 6, 2011 4:27pm EDT

* Rambus says relevant documents were all produced

* Appeals judge says Rambus doesn’t know what was shredded

* Other judge: ITC may use wrong standard to take cases

By Diane Bartz

WASHINGTON, Oct 6 (Reuters) – Chip technology company
Rambus Inc (RMBS.O) was quizzed in court about destroyed
documents and its own use of its patents as graphics chip maker
Nvidia Corp (NVDA.O) sought relief from expensive licensing
fees.

The two sides squared off on Thursday before the U.S. Court
of Appeals for the Federal Circuit over whether Nvidia
infringed Rambus patents for controlling and managing the flow
of computer data to and from a chip’s memory.

The U.S. International Trade Commission, which hears patent
cases involving imports, had previously found Nvidia infringed
Rambus chip patents and issued an order barring the importation
of any chip made with the infringing technology.

Nvidia licensed the Rambus technology at royalty rates of
between 1 percent and 2 percent depending on the type of memory
controller involved, to allow its chips to enter the country,
but the legal battle has continued.

The ITC had found that Nvidia infringed three patents but
did not infringe two others. Both sides appealed to the circuit
court and the arguments were consolidated.

Part of the battle has centered on whether Rambus destroyed
documents to avoid having them used against it in litigation.

Rambus has acknowledged document destruction but said it
was part of ordinary business practices.

Judge Kathleen O’Malley, part of a three-judge panel that
heard the case, took issue with an attorney for Rambus who said
the company produced the documents that were requested and that
all relevant documents were preserved.

“You admit you have no idea what was destroyed! You have no
record of what was destroyed!” she said.

“Remember, you saved the ones that helped you and destroyed
the ones that hurt you,” O’Malley said at another point.

The appeals court previously ruled in cases between Rambus
and Micron Technology (MU.O) and Hynix Semiconductor
(000660.KS) that Rambus destroyed documents inappropriately.
The cases have been remanded back to lower courts for further
consideration.

The battle is a key one for Nvidia, whose core business
relies on the sale of specialized graphics cards.

Judge Raymond Clevenger on Thursday repeatedly asked
whether Rambus had proved that it used the patents that it was
seeking to defend.

Companies may not sue at the International Trade Commission
unless they show that they are using the patent domestically.
Rambus licensed the patents, and used that to proceed with the
lawsuit.

Clevenger said district courts cannot order production or
importation of infringing products to cease since the Supreme
Court said in a 2006 decision that an injunction should not
necessarily follow a finding of infringement. “It’s a factor we
should think about,” he said.

Rambus and others go to the ITC to file patent complaints
because the trade commission, unlike U.S. district courts, can
bar the importation of devices made with infringing
technology.

The case against Nvidia and others that was before the
International Trade Commission is number 337-661. The U.S.
Court of Appeals for the Federal Circuit case numbers are
2010-1483 and 2010-1556.
(Reporting by Diane Bartz; Editing by Tim Dobbyn)

© 2011 REUTERS (www.reuters.com)

PostHeaderIcon Funding Your Social Venture

From smSmallBusiness.com

MANY SOCIAL VENTURES—even the ones that eventually become self-sustaining—may never yield enough of a financial return to attract traditional backers or investors. As a result, a social entrepreneur’s task of raising financing poses unique challenges.

[smSmallBiz]

For one thing, social ventures are often structured as nonprofits, which means they can’t offer an ownership stake in exchange for capital, like a traditional business might. After all, “a nonprofit doesn’t have equity,” says Rick Aubry, a social entrepreneurship professor at Stanford University’s Graduate School of Business. However, some social enterprises are mimicking equity-like structures to work around the ownership issue, he says.

That’s what Scojo Foundation intends to do. Since 2001, the New York nonprofit has sought to reduce poverty through the sale of affordable reading glasses in poor communities. Today, Scojo is changing its name to VisionSpring and — much like a company going public might do — releasing a prospectus to attract philanthropic investors.

According to the prospectus, VisionSpring wants to raise $5 million by the end of the year to deliver almost 650,000 pairs of glasses to people in Asia, Latin America and Africa. The company also plans to train more than 5,000 village-based entrepreneurs on the sale of those glasses. Similar to a Wall Street prospectus, the document outlines risk factors, from currency fluctuations to natural disasters. Investors will receive quarterly reports. But unlike a traditional offering, VisionSpring’s investors are only promised a “social” return on investment rather than lucrative financial returns.

VisionSpring co-founder Jordan Kassalow, a practicing optometrist, says the prospectus was borne out of frustration. He decided “enough is enough” after watching “everyone work so hard cobbling together funding throughout the year, rather than doing what we should be doing (helping disadvantaged individuals see better).” The company worked with the Nonprofit Finance Fund, a community development financial institution that helps nonprofits secure funding, on the prospectus.

VisionSpring’s story illustrates the difficulties that a nonprofit social enterprise can face when it comes to funding. But even for-profit social businesses have trouble, too. For starters, such companies typically don’t have the potential for market-rate returns, as they often cater to impoverished communities within developing nations. Not to mention, many social ventures have long incubation periods — meaning that years can go by before they will become profitable, let alone sustainable.

Despite these challenges, there are a number of like-minded investors willing to consider the social as well as the financial impact of a business. And, in exchange for that support, some investors may accept little or no compensation. Here’s a look at some of your funding options.

Social Investment Funds

Social investment funds, like the Nonprofit Finance Fund, pool together various sources of funding, such as donations from wealthy individuals, foundations, financial institutions and corporations. These funds differ from regular investment funds as they generally anticipate lower than market-rate returns. Their larger motive tends to be advancing social causes instead.

Additionally, some investment funds are aimed at specific disadvantaged regions or populations. For example, the Acumen Fund, a nonprofit global venture fund based in New York, trains its funding eyes on locations in India, Pakistan and East Africa. Yasmina Zaidman, a spokeswoman at Acumen, says that the fund’s social investors are less interested in reaping financial rewards. Instead, she says, “they are looking to invest in philanthropic ventures; the return they’re looking for is the social impact.”

Foundations

A number of foundations including Ashoka and Skoll Foundation provide seed-stage and growth-stage grants (that don’t need to be paid back) to social ventures. The Draper Richards Foundation for Social Entrepreneurship, for example, provides early-stage grants of $300,000 over three years to social entrepreneurs.

Grants can be tough for for-profit social enterprises to secure. However, foundations also can give loans though “program-related investing” or PRI. These type of investments are legally considered charitable although the foundation doesn’t have to accept below-market rates. A for-profit social enterprise can ask for a loan at little or no interest. “The expectation is that [the money] will be paid back at much more beneficial terms for the recipient” than regular lenders might require, says Aubry, the Stanford professor.

Banks and Corporations

Some community banks may loan you the money to get your social venture started. These banks typically earmark federally-backed funds to lend to ventures with community development or social missions. An example of a bank that offers such loans is ShoreBank based in Chicago.

[Social-venture-funding]
Getty Images

Do-gooder corporations often have similar community development missions. For example, Deloitte & Touche and Pfizer both offer support to the Nonprofit Finance Fund. Typically, corporations block off a portion of their budgets to donate funds (or products or services) to socially responsible endeavors. Meanwhile, a number of corporations including Citigroup and Google have set up foundations, which also offer grant money or other aid to social ventures.

Angels and Venture Capitalists

For-profit social enterprises can seek out cash infusions from angel investors or venture capitalists that have a social bent. These investors typically want market-rate returns in exchange for their financial support. They’re partial to entrepreneurs with plans to do good in the world — and usually, they’re willing to wait a little longer (than traditional angels or VCs) to reap returns. For example, The Investors’ Circle, a network of angel investors and VCs, says it invests “patient” capital in companies that address social and environmental issues.

Of course, any entrepreneur who works with an angel or a VC gets more than money. Angels and VCs work closely with entrepreneurs to shape the company, sometimes taking board seats or management positions. A social angel or VC isn’t any different, but will work within your mission to eke out market-rate returns, says David Berge, founder and managing member of Underdog Ventures, a social venture capital firm in Island Pond, Vt. “A social VC is going to be predisposed to like what you’re doing,” he adds.

(“Starting Up,” a weekly column written by Diana Ransom for smSmallBiz.com, follows entrepreneurs through the early stages of launching a business. Write to her at dransom@smartmoney.com.)

Other recent Starting Up Columns

© 2011 Wall Street Journal (www.wsj.com)

PostHeaderIcon Quantifying the benefits of HS2

The creation of a high-speed rail line from London to the north of England will produce quantifiable benefits to society, the government believes.

The additional minutes business travellers spend at their desks have a value: this is deemed to be equivalent to the money they earn in this period.

It carried out more surveys, asking whether people would be prepared to pay, for example, £20 more to cut a long train journey by one hour. It also examined data on the actual popularity of different train fares when faster and slower trains were available between the same destinations.

Alighting on a value of £5.77 an hour for leisure travellers (in 2009 prices), it was then a short hop to calculate the total benefit to them of switching to high-speed rail travel.

But HS2 Action Alliance notes that this figure has been reached by updating data from 2003.

Since leisure travellers now have faster internet connections on their mobile devices, the campaigners argue, leisure travellers enjoy their time on board trains more and might not be prepared to pay as much to cut journey times.

Similar surveys have helped the government to establish how much passengers would cough up to travel on less crowded trains. This too has been totted up and added to the projected benefits of HS2.

The campaigners argue that the government is drawing too stark a contrast: the models suggest that either HS2 is introduced, or very little investment in transport will take place.

They would rather explore cheaper ways to cut crowding, such as lengthening current trains.

But the government believes that they have significantly underestimated future demand for rail travel; HS2 is necessary to protect not only economy growth but also quality of life, the DfT spokesman said.

"While upgrading existing lines would provide a short-term fix, it does not provide the long-term capacity we so vitally need," he added.

The government predicts that HS2 trains will stick more reliably to their timetables than the average train.

This matters because passengers value being on time very highly – every minute they are delayed wipes out the value of three minutes' journey time, according to more surveys.

There is evidence to back the predictions, the DfT spokesman said, highlighting the reliability of HS1 – the high-speed link between London and the Channel Tunnel.

But HS2 Action Alliance argues that reliability will not be as good as predicted, again diminishing the projected benefits.

© 2011 BBC News (www.bbc.co.uk)

PostHeaderIcon UPDATE 1-Long USD bets rise to 11-month high in latest week


Fri May 17, 2013 4:12pm EDT

NEW YORK, May 17 (Reuters) - Currency speculators increased
their bets in favor of the U.S. dollar to the highest in 11
months in the latest week, according to data from the Commodity
Futures Trading Commission released on Friday.
    The value of the dollar's net long position rose to $32.27
billion in the week ended May 14, the highest since mid-June,
2012, from $26.83 billion in the previous week.
    Speculators boosted bets against most other currencies,
including the Japanese yen, the euro and sterling, while short
positions on the Swiss franc more than doubled in the latest
week.
    Speculators also sharply reversed bets in favor of the
Australian dollar, with short positions reaching as high as
13,450 contracts in the latest week.
    To be short a currency is to bet it will decline in value,
while being long is a view its value will rise.
    The Reuters calculation for the aggregate U.S. dollar
position is derived from net positions of International Monetary
Market speculators in the yen, euro, British pound, Swiss franc,
Canadian and Australian dollars.

 JAPANESE YEN (Contracts of 12,500,000 yen)
              5/14/13 week         5/07/13 week
    Long          28,882               27,886
    Short        117,289              106,446
    Net          -88,407              -78,560

 EURO (Contracts of 125,000 euros)
              5/14/13 week         5/07/13 week
    Long          52,843               52,517
    Short         99,764               86,050
    Net          -46,921              -33,533

     POUND STERLING (Contracts of 62,500 pounds sterling)
              5/14/13 week         5/07/13 week
    Long          36,975               31,542
    Short        102,330               94,628
    Net          -65,355              -63,086

     SWISS FRANC (Contracts of 125,000 Swiss francs)
              5/14/13 week         5/07/13 week
    Long           9,550                7,291
    Short         24,960               13,526
    Net          -15,410               -6,235

     CANADIAN DOLLAR (Contracts of 100,000 Canadian dollars)
              5/14/13 week         5/07/13 week
    Long          28,352               25,741
    Short         72,769               77,657
    Net          -44,417              -51,916

 AUSTRALIAN DOLLAR (Contracts of 100,000 Aussie dollars)
              5/14/13 week         5/07/13 week
    Long          61,654               61,501
    Short         75,104               54,871
    Net          -13,450                6,630

 MEXICAN PESO (Contracts of 500,000 pesos)
              5/14/13 week         5/07/13 week
    Long         145,339              144,076
    Short          5,020                5,632
    Net          140,319              138,444

  NEW ZEALAND DOLLAR (Contracts of 100,000 New Zealand dollars)
              5/14/13 week         5/07/13 week
    Long          30,436               37,775
    Short          7,220                9,239
    Net           23,216               28,536

© 2011 REUTERS (www.reuters.com)

PostHeaderIcon Brocade: Building a reliable foundation for expanded data center virtualization

In an effort to meet the growth challenges associated with global expansion and distributed business environments, IT organizations are embracing server and storage virtualization to support business strategies that are more fluid, more cost-effective, and better able to support a dynamic workforce. As they do so, however, many organizations are finding that a more holistic data center virtualization strategy is necessary to meet the management, scalability, and reliability issues related to virtualization deployments.

The Brocade® Data Center Fabric (DCF) architecture provides a strategic foundation for transforming today’s IT infrastructures into next-generation, virtualization-enabled data centers.

This architecture allows organizations to manage a growing and dynamic IT environment from the perspective of the application stack—leveraging built-in fabric intelligence and a scalable, open architecture to support reliable, flexible, and cost-efficient data access and delivery.

This Brocade white paper includes:
Virtualization trends and the issues IT organizations face
A holistic Brocade data center virtualization strategy
The specific Brocade products, solutions, and services that enable data center virtualization

© 2011 AMEINFO (www.ameinfo.com)

PostHeaderIcon BRIEF-Blackstone reports 282,500 share stake in JC Penney


Wed May 15, 2013 6:11pm EDT

<span class="articleLocation”>May 15 (Reuters) – Blackstone Group LP :
* Reports 282,500 share stake in J C Penney Co as of
March 31 valued at

$4.27 million — SEC filing

© 2011 REUTERS (www.reuters.com)

PostHeaderIcon Barnes & Noble shares soar on Microsoft report


Thu May 9, 2013 2:54pm EDT

<span class="articleLocation”>(Reuters) – Shares in Barnes & Noble Inc soared 22 percent on Thursday after a report that Microsoft Corp is considering an offer to acquire the tablet and e-book business of B&N’s Nook Media unit.

The technology website TechCrunch reported that Microsoft, which already owns a 17 percent stake in Nook Media, was proposing a $1 billion offer to buy all of Nook’s digital assets.

The report also suggested that Nook would stop selling Android-based tablets entirely by the end of fiscal 2014 in favor of distributing content via other publishers’ platforms.

A source familiar with the documents cited by TechCrunch confirmed their authenticity. The source said the documents dated from March, suggesting that any deal – if one is even pending – was not imminent.

It was not clear from the TechCrunch story whether Microsoft had formally made an offer to B&N or whether B&N had replied.

B&N and Microsoft declined to comment.

Microsoft acquired its stake in the Nook Media unit a little more than a year ago in a deal that valued the entire unit at $1.7 billion. In December the British publisher Pearson Plc bought a stake in the unit at a $1.8 billion valuation.

But Nook Media sales have disappointed since. Revenue dropped 26 percent in the most recent holiday quarter as Nook sold fewer digital readers and tablets and had to cut prices. Just this week B&N slashed the price of its best tablet by one-third as a special promotion for Mother’s Day.

It was not immediately clear why Microsoft would want to buy Nook’s digital assets, unless it wished to make a preemptive strike against Google and shift Nook away from the Android platform. There is already a Nook app for Windows 8 devices.

Microsoft’s recent acquisitions – such as online chat service Skype and business networking site Yammer – have not been content-focused.

Barclays analyst Alan Rifkin, in a note to clients on Thursday, said a lower valuation for the Nook Media unit was appropriate and that $1 billion was even higher than he had modeled.

B&N shares rose 22 percent to $21.70 in afternoon trading. The stock last traded at those levels a year ago, around the time of the Microsoft investment.

The stock is heavily shorted, with almost 36 percent of its float sold short as of April 15. Short sellers borrow stocks and sell them, betting the price will fall. Where short interest is high, that can exacerbate a rally, as people rush in to cover their positions.

Credit Suisse, in a note to clients, said the suggested terms of the Microsoft offer implied that Barnes & Noble was worth about $27 per share.

COLLEGE BOOKSTORE CHAIN

Nook Media also includes a college bookstore chain, but the TechCrunch report suggested the Microsoft offer would include only the e-book, digital reader and tablet assets.

If Microsoft carves the college bookstore chain out of the Nook Media unit, and B&N takes back those stores, Credit Suisse said the valuation of B&N could rise even higher.

While the college bookstore chain has provided B&N with much needed cash, sales have been weak. In the first three quarters of the fiscal year, sales fell 0.3 percent, while operating profit fell 7 percent to $115.8 million.

The college textbook business is undergoing a transformation with the shift to digital, as publishers move away from large, heavy books that last for years to multiple packages with smaller bites of content.

Companies like News Corp and Apple have started to make plays on the digital textbook market as that shift accelerates.

COULD SPEED OTHER SALES

Earlier this year, B&N Chairman Leonard Riggio said he wanted to buy the company’s chain of nearly 700 namesake bookstores. Selling off Nook could simplify that process, especially if it reunited Riggio with the college bookstore business, which he sold to B&N in 2009.

B&N first indicated it might spin off the Nook business in early 2012. The retailer has spent hundreds of millions of dollars on the unprofitable unit, trying to make its devices competitive against devices from Amazon, Apple and Google, among others.

The latest IDC market share data for tablets, released earlier this month, leaves B&N out of the industry’s top five vendors, suggesting its share of the global market is negligible. Microsoft’s new Surface tablets – the first of which hit the market last October – have only a 1.8 percent share.

B&N has typically launched a new edition of the Nook every year. But this year it simply updated its high-definition tablets by adding Google’s app store, which a number of analysts saw as an easy way for the company to launch a “new” Nook.

One uncertainty in any Microsoft bid is how Liberty Media would respond. It holds preferred shares in B&N that, if converted, would represent 17 percent of the company. Liberty was not immediately available to comment.

One analyst following Barnes & Noble said a Microsoft deal, if it happens, would be dramatic but not necessarily surprising.

“We must be careful here because details are lacking, but with devices phasing out, we see sale of the digital assets as an effective sale of the entire Nook business, unless co-ownership or leasing of digital content is arranged,” Stifel analyst David Schick said in a research note.

(Reporting by Phil Wahba and Ben Berkowitz; Additional reporting by Liana B. Baker and Bill Rigby; Editing by Alden Bentley, Theodore d’Afflisio and John Wallace)

© 2011 REUTERS (www.reuters.com)

PostHeaderIcon UPDATE 2-Severn Trent shares leap on takeover approach


Tue May 14, 2013 5:40am EDT

* Talks at very early stage

* Consortium being advised by Deutsche Bank

* Severn Trent shares up 18.9 percent

(Adds consortium statement, deadline, advisers)

By Anjuli Davies

LONDON, May 14 (Reuters) – Shares in Severn Trent
surged to all-time highs after the British water company
confirmed it had received a takeover approach from a consortium
including Borealis Infrastructure and the Kuwait Investment
Office.

The group, which said on Tuesday the consortium also
included Britain’s Universities Superannuation Scheme, said the
approach was at an early stage and no proposal had been made.

Shares in Severn Trent, which is being advised by Rothschild
and Citi, were the top gainers on Britain’s benchmark FTSE
100 index, rising as much as 18.9 percent to an all-time
high of 2,170 pence at one stage.

Britain’s other two remaining listed water companies Pennon
Group and United Utilities also rose by 4.3
percent and 4.1 percent.

“United Utilities and Pennon will attract further
speculative interest,” said Securequity sales trader Jawaid
Afsar. “These are cash cows, generating huge amounts of profits
and generating very good dividends, and these make attractive
targets for overseas investors.”

Afsar said he would look to buy United Utilities on any dip
in the company’s share price.

Under British takeover rules the consortium now has until
1600 GMT on June 11 to either make a firm offer for Severn Trent
or walk away.

Magazine Financial News had earlier reported Severn Trent
could be the target of a 5.3 billion pound ($8.1 billion) offer
by Borealis, a Canadian infrastructure investor.

The consortium, which is being advised by Deutsche Bank
and RBC, had indicated it would be willing to
offer between 22.5 pounds and 23 pounds a share for the British
utility, two sources told the magazine.

“The ‘Consortium’ confirm that they recently made an
approach to the Board of Severn Trent with a view to making a
proposal regarding a possible cash offer for the entire share
capital of Severn Trent,” Borealis Infrastructure Management
said in a statement.

Yield-hungry investors have been showing strong interest in
British water and sewerage firms as they seek stable cash flows
and a favourable regulatory structure.

Big investors like pension funds and insurers have been
increasingly investing in companies directly or teaming up with
partners.

“There have been endless speculations that income-hungry
funds would bid for the three remaining listed UK water
companies,” analysts at brokerage Liberum said in a note on
Tuesday.

“But for a potential bid to be made in year three of the
five-year regulatory cycle is surprising, and the bidder will be
taking on considerable regulatory risk if they pay this sort of
premium at this point in the cycle.”

UK water companies have regulated price controls set every
five years by the regulator, with the next one due in 2015.
Bidders can be deterred from making an approach halfway through
a cycle, given the uncertainty over the next review.

Analysts at Liberum noted that based on Severn’s regulated
asset value (RAV) the implied premium of 38 percent in an offer
of 22.5-23 pounds a share would be high by historic standards.

There has been a flurry of deals in the British water sector
in recent months and years, with bankers saying past deals have
been valued at a premium of about 30 percent to the RAV.
($1 = 0.6517 British pounds)

(Additional reporting by Sudip Kar-Gupta, Kate Holton and
Sylvia Westall; Editing by Will Waterman)

© 2011 REUTERS (www.reuters.com)

PostHeaderIcon Australian shares rise, close at fresh five-year high


Tue May 14, 2013 2:23am EDT

(Updates to close)

SYDNEY May 14 (Reuters) – Australian shares edged up 0.2
percent on Tuesday as a weaker Australian dollar lifted
companies with high exposure to the U.S. market, but trading was
subdued ahead of the federal budget announcement later in the
day.

The S&P/ASX 200 index finished the session 10.7
points higher at 5,221, not far from the intraday five-year high
of 5,242 marked last week.

A total of 638.4 million shares traded hands.

Australia will release its annual federal government budget
at 0930 GMT, with expectations of a A$17 billion deficit this
year and A$10 billion in 2013/14.

Stocks with a large exposure to the U.S. markets rallied
after the Australian dollar hit its lowest point in 11
months on Monday.

Property and casualty insurer QBE Insurance climbed
2.3 percent, Brambles soared 3.1 percent while
biotechnology firm CSL Ltd jumped 1.2 percent.

New Zealand’s benchmark NZX 50 index lost early
gains to finish the session 0.6 percent or 25.8 points lower at
4,645.9.

(Reporting by Thuy Ong; Editing by Kim Coghill)

© 2011 REUTERS (www.reuters.com)

PostHeaderIcon UPDATE 3-US FDA approves Glaxo/Theravance drug for COPD lung disease


Fri May 10, 2013 1:32pm EDT

* Theravance shares up 11 percent

* Drug to carry warning against use in asthma

* Drug will compete with AstraZeneca’s Symbicort

(Updates with FDA comment, side effects)

By Toni Clarke

May 10 (Reuters) – The U.S. Food and Drug Administration has
approved a new drug to treat chronic obstructive pulmonary
disease, a condition often associated with smoking that can
include emphysema, chronic bronchitis, or both.

The drug, Breo, is an inhaled treatment made by British
drugmaker GlaxoSmithKline Plc and Theravance Inc
of the United States. It consists of a corticosteroid,
fluticasone furoate, which reduces inflammation, and a novel
long-acting beta-agonist, called vilanterol, which is designed
to open the airways. The product is inhaled through a palm-sized
device called Ellipta.

COPD is the third-leading cause of death in the United
States, according to federal data.

Theravance shares were up 11 percent to $34.78 in afternoon
trading. Glaxo’s U.S. shares rose 1.95 percent to $51.69.

Breo, or Relvar as it would be called if approved outside
the United States, will compete with GlaxoSmithKline’s
twice-daily asthma and COPD drug Advair, a roughly $8
billion-a-year drug that contains the steroid fluticasone
propionate and the long-acting beta-agonist salmeterol.

Analysts on average expect the drug to generate annual sales
of $559 million by 2015, according to Thomson Reuters data.

Breo would also compete with AstraZeneca Plc’s
twice-a-day Symbicort, an inhaled combination of the
corticosteroid budesonide, and the long-acting beta-agonist
formoterol. Glaxo and Theravance are hoping the once-daily
delivery of Breo will make their drug more attractive to
patients.

The drug carries a boxed warning, the most serious possible,
about the risk of long-acting beta-agonists in increasing the
risk of asthma-related death.

“The safety and efficacy of Breo Ellipta in patients with
asthma have not been established and it is not approved for the
treatment of asthma,” the FDA said in a statement.

Potentially serious side effects associated with Breo
include a heightened risk of pneumonia and bone fractures, the
FDA said. The most common side effects reported by patients were
inflammation of the nasal passage, upper respiratory tract
infections, headache and oral candidiasis, also known as thrush.

The approval, which follows a more favorable-than-expected
review by an FDA advisory panel, could increase investor
optimism about another, potentially more profitable, COPD drug
the two companies are developing called Anoro. The drug is an
inhaled combination of vilanterol and umeclidinium, a
long-acting muscarinic receptor antagonist, which works to relax
the airways and improve lung function.

Analysts expect Anoro, if approved, to generate peak annual
sales of nearly $1.4 billion, according to Thomson Reuters.

The approval of Breo comes just weeks after Theravance said
it would split into two publicly traded companies, separating
the more advanced respiratory drugs it is developing with Glaxo
from its other operations. The move fueled speculation that
Glaxo, which owns 27 percent of Theravance, could eventually buy
Theravance’s most lucrative products.

After the split, the company holding the respiratory drugs
franchise will be called Royalty Management Co. The second
company, called Theravance Biopharma, will focus on development
of drugs for rare diseases.

Shares of Theravance rose as high as $35.80 earlier in the
day.

(Reporting by Toni Clarke in Washington; Editing by Matthew
Lewis, Steve Orlofsky and Carol Bishopric)

© 2011 REUTERS (www.reuters.com)