Jazz Pharmaceuticals is jamming

Published in Drug Discovery News

DUBLIN—Rapidly expanding its orphan-drug portfolio and planning for $1 billion in revenue in 2014, Irish company Jazz Pharmaceuticals is in the process of acquiring Italian drug firmGentium, and has acquired anti-narcolepsy drug ADX-N05 from Aerial BioPharma, based in North Carolina.

The Gentium acquisition, announced in mid-December, is worth roughly $1 billion, with Jazz making a tender offer of $57 per share to Gentium holders (a 26-percent premium on the volume-weighted average share price over the previous 60 days). Jazz will pay for the deal with a combination of cash on hand, a $500 million incremental term loan from Barclays and the remainder under its existing senior secured credit agreement with Barclays. The company estimates its borrowing costs at 3 to 3.5 percent interest.

The deal will bring into Jazz’s stable a promising drug, Defitelio (defibrotide), which treats severe hepatic veno-occlusive disease (VOD) in children and adults receiving hematopoietic stem cell transplants. In October, Defitelio was approved by European regulators for sale in the European Union, and is protected under orphan-drug exclusivity laws there through 2023.

Hematopoietic stem cell transplantation (HSCT) is more common in Europe than the United States, with 35,200 EU patients in 2013, compared with 19,500 U.S. patients, and 7,600 in the rest of the world. About 10 percent of HSCT patients develop severe VOD, which can involve multiple organ failure; untreated, it has an 80-percent mortality rate within 100 days.

Defitelio is also designated as an orphan drug by the U.S. Food and Drug Administration (FDA); it is not approved yet, but is in Phase 3 clinical trials and has fast-track status for FDA approval pending the results of those trials. There are no other drugs approved in the United States for VOD, according to Jazz disclosure materials.

In addition, Defitelio is being studied to treat graft vs. host disease, which could boost its sales potential significantly, the company anticipates.

Defitelio joins a handful of other orphan drugs in Jazz’s portfolio, addressing hematology and oncology, pain, psychiatric needs and sleep disorders. The company’s major earner in that last category was Xyrem (sodium oxybate), which brought in $154 million of the $230 million the company grossed in the third quarter of 2013. While the results of previous acquisitions and expansions mean Xyrem’s share of overall company revenue is dropping, the drug’s earning power remains on the rise. The Q3 total was 15 percent higher than the previous quarter, and 150 percent higher than the same quarter a year earlier.

In the wake of the deal, Bloomberg News reported that Jazz could be a very attractive acquisition target, with high growth and expanding potential. An advisory from Leerink Swann Research analyst Jason Gerberry said the opportunity “appears reasonably attractive, and potentially durable,” with an initial market size of up to $100 million.

A mid-January acquisition, ADX-N05, will expand Jazz’s presence in the sleep sector. Carrying worldwide development rights (except certain parts of Asia) and patent protection through 2027, the deal cost $125 million in cash, plus up to $272 million in future milestone payments, as well as ongoing royalties to both drug creator Aerial BioPharma and New Jersey-based SK Biopharmaceuticals, which holds the remaining Asian development rights.

The drug treats narcolepsy, which has in the United States about 25,000 patients with inadequate control of their condition; a major growth opportunity will come if ADX-N05 is also approved to treat obstructive sleep apnea, which offers a potential U.S. market of between 150,000 and 275,000. 

At a Jan. 13 presentation at the JP Morgan Healthcare Conference in San Francisco, Jazz chairman and CEO Bruce Cozadd presented slides saying the company expects between $867 million and $877 million in total revenue for 2013, but projects surpassing $1 billion in 2014.

Labor Relations: Blacklisting companies that ship work overseas

Published in the Portland Phoenix

Seeking to protect nearly 20,000 Maine jobs from being sent overseas, labor and union activists lobbied the state legislature last Thursday, with solid support and some modest, but expected, opposition. The bill they supported, LD 1710, would pressure companies that have customer-service call centers in Maine to keep their work in the United States.

Sponsored by Troy Jackson, a Democratic senator from Allagash who is running to replace Congressman Mike Michaud (who is himself running to replace Republican Governor Paul LePage), the bill would require call-center companies to notify the state before relocating call centers from Maine to foreign countries. (It does not require notification if a company moves elsewhere in the US.) And it would require all state-agency call centers to be in Maine.

Notification would have negative effects beyond bad publicity. The bill declares all companies that send Maine call-center jobs overseas ineligible for any “direct or indirect state grant, state guaranteed loan or tax benefit” for a period of five years after
the relocation.

Companies that, at the time of relocation, were receiving state benefits would have to repay to state coffers the unused amounts.

A recent union-conducted tally found 19,470 call-center jobs in Maine, with an average annual wage of $31,500, according to Jenn Nappi, assistant business manager of the International Brotherhood of Electrical Workers Local 2327, which represents most FairPoint employees in Maine.

FairPoint, which has about 900 unionized call-center workers in Bangor, Portland, and South China, is not the largest such company in Maine. That firm is LL Bean, which has about 2000 call-center staffers in Portland, Bangor, and Lewiston. Other major call-center players, according to the union research, are Bank of America with nearly 1000 people between Belfast and Brunswick, T-Mobile with 520 people in Oakland, and TD Bank with 500 in Auburn.

Companies often move call centers in search of low-cost labor: In 2009, the Baldacci administration’s economic commissioner John Richardson said Maine’s low wage levels should be considered by call-center firms (see “Maine — the India of the United States?” by Jeff Inglis, at thePhoenix.com/AboutTown).

In 2011, Carbonite, a Boston-based data-storage company, brought 150 call-center jobs from India to Lewiston. But other companies have gone the opposite direction: In February 2012, Bank of America closed a call center in Orono, laying off 200 people. Nappi and the IBEW say those jobs likely went to other Bank of America call centers in the Philippines.

And in September 2013, Sykes Enterprises, a Florida-based helpdesk company, closed a Wilton call center, laying off 150 people. The company has nearly 60 call centers in 25 countries, the IBEW says.

Some of these companies, including T-Mobile, have received tax incentives and other state support in exchange for promises of increased hiring.

“We’re constantly allowing all these companies to have all these great breaks, but we don’t require anything of them,” Nappi says.

There is, however, a possible loophole in the draft law, which allows state aid to go to a company that offshores work if not doing so “would result in substantial job loss in the State or harm the environment.”

Saving lives with testing

Published in Drug Discovery News

MUNICH, Germany—Seeking to commercialize a genetic diagnostic test that can reduce the incidence of suicide in patients taking antidepressants, Boulder, Colo.-based Sundance Diagnostics has licensed technology from Germany’s Max Planck Institute of Psychiatry.

The financials are not being disclosed by the privately held Sundance, said company CEO Kim Bechthold, though she did say Sundance is taking over patent costs and will pay a sales-based royalty to the Planck Institute. The test will be ready within the next month or two, she said, adding that licensing agreements with commercial lab companies around the country are in the works.

Based on research published in Neuropsychopharmacology in 2011, the test looks at a patient’s full genome for 79 markers of risk of emergent suicidal ideation. Initial research identified those markers, but then the Planck researchers, led by Andreas Menke and Elisabeth Binder, sought insight into the predictive power of those markers.

“When they tested their markers against 500 new patients, they could actually predict about 90 percent correct,” Bechthold says. “For a laboratory test, it’s out of this world.”

There are some limitations on the results, including that the test was only applied to Caucasians and people over the age of 18, though Bechthold admitted “every age of child is being prescribed antidepressants.” She also noted that teens are among the least likely to seek additional help for their depression and are also at risk of not telling their parents what their true thoughts and feelings are.

But the promise is so strong, Bechthold said, that Sundance will work to extend the test results to greater numbers and more diverse populations (including people of Asian and African descent), as well as potentially people under 18. The company will also seek approval from the U.S. Food and Drug Administration, which will allow the company to make claims about the test’s predictive power. Bechthold expects that approval within 18 months.

In the Planck Institute research, people at low risk of emergent suicidal ideation were identified correctly 93 percent of the time, Bechthold said. Those at high risk were identified less successfully, but she said even that division could be very useful, allowing physicians to focus their attention on those patients who are likely to be more at risk.

The market is massive: According to the U.S. Centers for Disease Control and Prevention, 11 percent of Americans age 12 and up are already taking antidepressants, and 9 million new prescriptions are written each year in the United States (as of 2006, so current numbers are likely higher). A further 9 million new prescriptions are written worldwide each year. At $200 to $300 per test, Bechthold said, “the potential profit is $1.8 billion.”

And the test is attractive, because no studies have been able to identify clinical indicators for doctors to detect emergent suicidal ideation induced by antidepressant drugs, leaving them operating in the dark even as they write more and more prescriptions. Rather than putting millions at risk every year—it is estimated that between 6 percent and 13 percent of the population is susceptible to antidepressant-induced emergent suicidal ideation—they can screen patients with a rapid cheek-swab test administered in the office. Results come back from the lab within two days, an important factor since 97 percent of patients who develop this adverse reaction do so within the first 29 days.

“This is a window into something [the doctor] simply can’t guess and has no way of knowing,” Bechthold said.

Adding to the demand for the test may be an additional result of the Planck research. Since 2005, all antidepressant prescriptions in the U.S. have carried a suicide warning, and there is an additional warning targeting patients 25 and under, who have been deemed by the FDA to be at elevated risk as compared to older patients.

National Institute of Mental Health research has shown, however, that there is no age at which risk is higher or lower; the Planck research confirmed that finding in its population, which ranged in age from 18 to 75.

Bechthold said Sundance, which focuses on adverse drug response and genetics, knows that genetic tests are commonplace in treatments for cancers and infectious diseases and is looking forward to bringing the first genetic test into neuropsychiatry. The company will work with Planck on further research in this and other areas.

Press Releases: Unleash the beef

Published in the Portland Phoenix

I’ve got some beefs with the Maine media. The state’s Freedom of Access Act is meant to be used by all Mainers, for all sorts of reasons. But the press has historically been fickle about which issues they’ll issue those requests about.

Of course, the press should have — and did — demand access to the so-called Alexander report, the $1 million hatchet job a conservative crony of Republican Governor Paul LePage did in order to justify failing to expand health-care coverage to tens of thousands of Mainers.

But what about a case described as “the second federal probe into serious allegations against Governor LePage’s administration,” in which “it’s been nine months since these allegations were first made and we know that documents have been destroyed, the FBI is now involved and favoritism may have been played”? No freedom-of-information requests there.

At least not from the media; those quotes are from Ben Grant, chairman of the Maine Democratic Party, explaining why his organization last week made FOAA requests for correspondence between the LePage administration and Department of Health and Human Services and Maine Center for Disease Control officials relating to shredding of documents used to justify the awarding of $4 million in public-health grants.

This is even more galling because it was a press inquiry for public records that started the whole affair. The Lewiston Sun Journal’s inquiry into CDC grants led to the shredding of supporting documents, according to whistleblower complaints filed by former Maine CDC worker Sharon Leahy-Lind.

But rather than dig to the bottom of the affair itself, the Sun Journal has left the opportunity for what should be straight-up investigative news coverage to become politicized by the involvement of the Maine Dems.

This is a disservice to Mainers, who expect their media outlets to engage in investigation without partisanship. Now the press coverage will not be about whether the governor ordered the shredding, but the Republican administration’s response to the Democrats’ request, and the political gamesmanship and tit-for-tat that ensues.

>> Even more craven and spineless were the reporters called to an off-the-record meeting with LePage on January 27. According to Press Herald State House reporter Steve Mistler’s account, the administration didn’t invite the Press Herald, Sun Journal, or the Bangor Daily News’s bureau chief, though apparently another BDN reporter was there.

My problem isn’t with the selective invitation, which is just another example of the governor’s longstanding ill-will toward the press. I’m disappointed that only one of the reporters who was there appears to have objected to the off-the-record nature of the discussion.

When public officials speak on issues to reporters, Mainers have an expectation — of both the public servants and the press — that they should be able to hear or read what was said. This sort of control of access and information has been decried at the highest levels of the media world, against restrictive White House Press Office policies under both George W. Bush and Barack Obama. It has no place there, and none here in Maine either.

>> My last beef isn’t with a reporter, but a politician fearing questioning. It’s a national story that after the State of the Union address last week, New York Republican Congressman Michael Grimm reacted badly to being asked by television reporter Michael Scotto about a federal probe into his campaign’s fundraising activities.

After storming out of the interview, Grimm returned and was caught on camera threatening Scotto, saying “I will throw you off this fucking balcony,” and “I will break you.” Grimm’s non-apology apology claimed he expects “a certain level of professionalism and respect” from reporters. This is very much like the threatened violence and claimed appeal to standards of decency that LePage has at times used when criticizing reporters for doing their jobs well (i.e. asking questions that make politicians uncomfortable and demanding public accountability).

In case it’s not clear, here’s the official notice from the media to all who serve the public: Transparency is part of the job, not a luxury. If you don’t like it, don’t get elected or take a job with a government agency. It’s as simple as that, and we’ll brook no beefs about it. 

Congressional hopefuls: Maine candidates respond to SOTU

Published in the Portland Phoenix

In his State of the Union address last week, President Barack Obama laid out several initiatives for the coming year, focusing on boosting educational and economic opportunities for workers, and suggesting that his administration has felt the public backlash against the use of drones at home and abroad, as well as National Security Agency dragnet surveillance of all Americans.

Every member of Congress issued a statement that was widely publicized, with his or her reaction to the president’s speech; Maine’s delegation was no exception. What you didn’t hear elsewhere, though, is the perspective from those seeking to take their seats in Washington. The overall message: Partisanship is alive and well in Maine, too.

US Senate candidates
Shenna Bellows, Democrat The former executive director of the American Civil Liberties Union of Maine supports Obama’s call to raise the minimum wage to “at least $10.10,” though she notes that Obama’s move only affects workers on federal contracts, and only takes effect in 2015. But she criticized his “lack of a commitment to stop the controversial NSA spying program,” saying he “spoke of the need for privacy without talking about specific measures” to ensure it for all Americans. She also called out Obama’s rhetoric on protecting workers and the environment, contrasting those comments with his administration’s secretive negotiations about the Trans-Pacific Partnership, which leaked documents show is heavily biased in favor of corporate interests.

Erick Bennett, Republican The conservative political consultant who was convicted of domestic assault on his wife in an incident during which a police report says he threatened to kill her was critical of Obama, saying the government had spent too much money on the Affordable Care Act, and so much on the economic bailout that “we could have given a million dollars to every man, woman, and child in this country. That would have eliminated poverty and many other problems we face.” The economy is so bad, he said, that “there are plenty of Americans such as myself that will take whatever work they can to avoid starving.” But he objected to Obama’s proposals to raise workers’ income and provide additional savings methods, saying they were misusing the role of government. And he complained that the latest agreement with Iran, in which that country will for the first time open its nuclear facilities to outside inspectors, was “a bad deal” because it only lasts six months.

US House, 1st District candidates
Isaac Misiuk, Republican The former retail manager and real-estate agent now studying at the University of Southern Maine echoed a popular conservative talking point when he said he “would have liked to hear [Obama] apologize for lying” about people’s ability to keep their health-insurance plans under the Affordable Care Act. He also said it was unfair to ask “the rich to pay more in taxes” than those less well off. He also defended the 40-plus Republican-led US House votes to reverse the ACA, saying the president “has forgotten that Congress holds the ability to repeal laws.”

Richard Murphy, Independent The Army National Guardsman and property manager said the speech showed Obama “will continue to ignore traditional checks and balances found in the United States Constitution,” and criticized the president for “spending millions of taxpayer dollars on vacations when those who contribute to his salary and fund every trip he takes cannot afford to take a vacation themselves.” Murphy said he agreed with the president’s “list of topics of things that needed to be addressed,” but disagreed with Obama on how to go about it, saying the president is “out of touch with American taxpayers.”

US House, 2nd District
Emily Cain, Democrat The state senator from Penobscot County says many of Obama’s ideas “require more detail before knowing what their full impact would be,” but nevertheless says several ideas “have great potential.” One of those is the move to raise the minimum wage for some; Cain calls for Congress to raise the minimum wage for everyone. She also praised the president’s call for gender equity in pay. But she expressed concern that “Congress has proven itself to be polarizing and stubborn at times. That attitude gets us nowhere and does nothing to help the people they are elected to serve.” 

Troy Jackson, Democrat The Aroostook County logger and state senate majority leader state specifically praised Obama’s call to raise wages for federal contract employees. “Many in Congress don’t understand how important a living wage is because they have never had to struggle in a minimum wage job.” Jackson backs raising the minimum wage “to a living wage for all people,” not just federal contractors.

Alden Smith, Democrat The US Navy veteran (and current Navy reservist) agrees with Obama that jobs will go where there is high-quality infrastructure, and supports investment in Maine to attract new business. He supports raising the minimum wage: “The choices between heat and food will be eased a bit. I am sorry to see that the same raise is not applied to our elderly and our disabled veterans.” He supports ending the US military presence in the Middle East, but wants to ensure the Veterans Administration “is structured and equipped to meet the needs of our veterans in the coming years.”

Bruce Poliquin, Republican The former state treasurer was not directly reachable, but posted on Twitter and Facebook his reactions, which included agreeing with the president that “the poor and middle class have been left behind.” Poliquin asked “why opportunities have been shrinking during [Obama’s] economic ‘recovery.’” He objected to “a wasteful spending binge that has piled up an additional $5 trillion of debt with no plan to pay it off,” saying that Obama has “raised taxes on American families and the companies that employ them to among the highest in the industrialized world.”

Kevin Raye, Republican The former state senate president and co-owner of Raye’s Mustard Mill says he is “deeply troubled by the President’s vow to use Executive Orders to circumvent the will of the people’s elected representatives. The President sets a tone and, unfortunately, his divisive approach exacerbates the dysfunction that has become such an impediment to America’s ability to solve problems.”

Blaine Richardson, Independent The retired Navy captain and construction-business owner says Obama “made it very clear . . . that he is unwilling to work with the Congress to progress his agenda. This shows that he is no longer willing to maneuver within the traditional checks and balances found in the United States Constitution.” He heard Obama promote “more big government,” including “more regulations, more laws, more sanctions and more American involvement overseas.”