Showing posts with label names. Show all posts
Showing posts with label names. Show all posts

Sunday, July 21, 2013

UPDATE 1-Optimer shares rise after report names Glaxo, Cubist as potential buyers

buyers@

* Co aims to get as much as $1 bln - report

* Optimer could get $15-$16/shr - analyst

* Shares up 18 pct

(Adds comments from an analyst, details)

April 2 (Reuters) - Shares of Optimer Pharmaceuticals Inc rose as much as 24 percent after a Bloomberg report said GlaxoSmithKline Plc and Cubist Pharmaceuticals Inc were among those interested in buying the antibiotic maker.

Optimer, the maker of diarrhea drug Dificid, aims to get as much as $1 billion in a possible auction, the report said, quoting two unnamed sources. (http://link.reuters.com/cys96t)

The report also named AstraZeneca PLC and Japan's Astellas Pharma Inc as potential buyers.

Robert W. Baird & Co analyst Brian Skorney said the $1 billion target implied a price of about $18 per share, which, he felt, would be difficult to achieve.

"I think we can see a $15 to $16 (per share) deal get done," Slorney said, calling the jump in Optimer's stock price a probable overreaction.

Tuesday's gains in the stock price eclipsed the 13 percent jump it had seen on Feb. 27, when the company first said it would explore a sale after replacing its CEO.

The shares were up 18 percent at $13.84 in afternoon trade on the Nasdaq, well above their closing price of $12.13 on Feb. 27.

"I think bankers are probably leaking some information to try drum up some more enthusiasm to get a higher deal value than what is already on the table," Skorney said.

Analysts have previously identified Pfizer Inc, Viropharma Inc and Cubist as potential suitors for Optimer.

"Anyone who has commercial infrastructure selling hospital-based antibiotics could be a bidder here," Skorney said.

"Astellas is already partnered with Optimer and since they already own most of the worldwide rights, it makes sense to consolidate everything."

Similarly, he said, Pfizer Inc had a number of antibiotics that would go generic over the next couple of years, so bidding for Optimer would make sense for it too.

Skorney said the cost, and the benefit, of the acquisition would be trivial for companies like Glaxo and Johnson & Johnson , but Forest Laboratories and Cubist would have to pay over 10 percent of their current valuation for Optimer.

Optimer spokesman David Walsey was unavailable for comment.

Cubist spokeswoman Julie DiCarlo said the company did not comment on speculation or rumors related to mergers and acquisitions. GSK declined to comment.

Dificid, which treats adult patients who contract infectious diarrhea in hospitals, accounted for $62.4 million in sales in 2012. The company is expected to generate sales of $310 million from the drug by 2017, according Thomson Reuters data.

Optimer is also testing to see if the drug can prevent diarrhea in patients under 18 years and whether it can treat it in patients undergoing bone marrow transplants.

(Editing by Sreejiraj Eluvangal)


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Friday, June 14, 2013

UPDATE 1-Amid revamp, U.S. FDA names acting head of generic drugs office

* Dr Kathleen Uhl to replace Dr Gregory Geba

* Geba abruptly resigned last week

* Generic drug trade group has concerns about revamp

(Adds details of generic drug office realignment)

By Toni Clarke

March 19 (Reuters) - The U.S. Food and Drug Administration has named Dr Kathleen Uhl acting director of its generic drugs division as it implements the biggest revamp of the department in more than a decade.

Uhl replaces Dr Gregory Geba, who resigned abruptly last week after just eight months on the job, saying the reorganization will change the scope and responsibilities of the office in a way that no longer made his position attractive.

Uhl was previously Geba's senior adviser, according to Dr Janet Woodcock, director of the FDA's drugs division, who announced the news in a memo to staff.

In his own farewell memo to staff, Geba said that over the past five months, since the agency began collecting fees from generic drugmakers to speed up drug reviews, the office approved nearly 200 applications and sent back 600 more, reducing the backlog of pending applications to 2,166 from 2,762.

The realignment, whose details are still being finalized, is designed to sharpen the agency's focus and "bolster our resources around pharmaceutical quality," according to a September note to staff from Woodcock.

Generic drugmakers are unsettled by the changes.

In a statement last week, the Generic Pharmaceutical Association (GPhA) said it was "disappointed" to learn of Geba's departure from the office of generic drugs (OGD).

"Today, 80 percent of prescriptions dispensed in America are generics," the organization said, adding that it and its members "rely on the strength and continuity of the OGD on critical matters such as regulations governing the entry to market of new, cost-saving generic versions of critical medicines."

Geba's departure is particularly jarring since it took the FDA two years to find a permanent replacement for the previous director of OGD, Gary Buehler, who left in late 2010 to become vice president for regulatory strategic operations at Teva Pharmaceutical Industries Ltd , the world's biggest generic drugmaker.

"These vacancies and changes hold the potential to distract from the critical mission of the OGD," GPhA said, "and slow the flow of information, guidance, and approvals."

Uhl, who obtained a medical degree from the Medical College of Pennsylvania, joined the FDA in 1998 in a clinical pharmacology division. She spent five years as assistant commissioner for women's health and as director of FDA's Office of Women's Health.

In 2010, Uhl became deputy director in the office of medical policy. Woodcock said in her memo to staff that Uhl provided "exemplary leadership" of that office as it underwent a major organizational change by becoming a "Super office," or one that houses subordinate offices.

Part of the current realignment of the generic drugs office involves it too becoming a "Super Office."

(Reporting by Toni Clarke in Washington; editing by Gerald E. McCormick and Matthew Lewis)

((toni.clarke@thomsonreuters.com)(202 898-8340)(Reuters Messaging: toni.clarke.thomsonreuters.com@reuters.net))

Keywords: FDA GENERICS/DIRECTOR


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Monday, June 10, 2013

FDA names Kathleen Uhl acting director, office of generic drugs

March 19 (Reuters) - The U.S. Food and Drug Administration has named Dr. Kathleen Uhl acting director of its Office of Generic Drugs as it initiates a nationwide search for a full-time replacement for Dr. Gregory Geba, who resigned last week.

The announcement was made on Tuesday in a note to staff from Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. Dr. Uhl most recently served as Geba's senior adviser.

(Reporting by Toni Clarke in Washington; Editing by Gerald E. McCormick)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: FDA GENERICS DIRECTOR/


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Wednesday, March 13, 2013

NRA Publishes Enemies List With 506 Names

Late last year, the National Rifle Association’s lobbying arm published a Nixonian enemies list naming organizations and individuals that “lent monetary, grassroots or some other type of direct support to anti-gun organizations” or have otherwise backed efforts to promote gun safety. The list totals 506 names, including major medical associations, law enforcement organizations, former presidents and a long list of celebrities. Here are five examples of the kinds of groups the NRA views as its enemies:

As it turns out, the sort of people tasked with saving the lives of victims of gun violence would rather that America’s trauma centers were not quite so busy. A short list of medical and nursing organizations on the NRA’s enemies list includes the American Academy of Pediatrics, the American Medical Association, the American Association for the Surgery of Trauma, and the American Nurses Association, in addition to Ronald Reagan’s Surgeon General C. Everett Koop.

It turns out that sort of people who devote their lives to preparing our children for adulthood don’t much like to learn that a young life has been cut short by gun violence either. The NRA’s enemies list includes the American Association of School Administrators, the American Federation of Teachers, the Council of Chief State School Officers, the National Education Association, the National Association of School Psychologists and the National Association of Elementary School Principals.

It also turns out that people who put risk their lives to keep our streets and schools safe don’t much like being in the line of fire. The National Association of Police Organizations, the National Association of School Safety and Law Enforcement Officers, and the Police Foundation are all on the NRA’s enemies list.

The NRA may not want Americans to “beat their swords into plowshares and their spears into pruning hooks,” but many people of faith take the Bible’s command seriously enough to earn a place on the gun lobby’s list of enemies. They include the American Jewish Committee, the Central Conference of American Rabbis, the Congress of National Black Churches, the Episcopal Church’s Washington Office, the Friends Committee on National Legislation, the Lutheran Office for Governmental Affairs, the United States Catholic Conference, the United Methodist Church General Board & Church Society, and the United Church of Christ Office for Church in Society.

Above anything, the NRA’s enemies list reveals its capacity to hold a grudge. It includes a long, long list of celebrities, many of which are far from Hollywood’s elite circles. It is not clear why the nation’s top gun organization feels so threatened by Art Garfunkel, for example. Or why Washington’s most heavily armed lobbyists fear a ragtag list of former talk show hosts, washed up actors and what appears to be the entirety of Frank Zappa’s progeny. Gun owners beware! Both Boyz II Men and ‘NSYNC are coming for your guns, and the NRA is very, very afraid.


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Friday, January 11, 2013

Inaugural committee releases donors' names

President Obama's inaugural planning committee on Friday released the names of several contributors to the president's swearing-in festivities.

The committee decided to accept corporate donations this time, after banning them in 2009.

Companies such as AT&T, Microsoft, biotech firm Genentech, Inc., healthcare company Centene Corp., Financial Innovations, Inc., Whittier Trust Co., and Stream Line Circle, LLC appeared on the committee's web site along with the names of several individual contributors.

The Presidential Inaugural Committee did not reveal the amount of the donations nor say when they would release more names.

The web site simply says donors' names will be "regularly" posted and to "check this page for future updates."

In December, the committee noted it would accept unlimited money from corporate and individual contributors but would not accept donations from PACs or lobbyists.

The inauguration is estimated to cost over $100 million thanks to the security needs and the parties that surround the Jan. 21 swearing-in. Most of the money comes from donors.

Obama's second inauguration will be much more toned down than his first with fewer balls, no celebrity concert on the National Mall and one fewer day of festivities.

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