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Lawmakers bring Life Science Discovery Fund to an end, not with a bang but a whimper

The fund established a decade ago by then-Gov. Christine Gregoire and the legislature with the lofty goal of supporting innovative research in this state to promote life sciences competitiveness, enhance economic vitality and improve health and health care has been terminated by the Legislature. And an oft-quoted line of poetry may best sum up the outcome: "not with a bang but a whimper."

The Life Science Discovery Fund (LSDF) was defunded by the Legislature at the insistence of the Republican Senate and at the eventual acquiescence of both the Democratic House and Democratic governor who had touted its importance to the state's future. In the rush to final budget passage, the fate of LSDF drew little attention except from the disappointingly few who understood its to the future of the state's economy.

Those who recognize the quote in the lead paragraph above as from T.S. Eliot's "The Hollow Men" should be forgiven for a quick sense of how appropriate the description "Hollow men" might be for the members of the Legislature.

And how appropriate also for that body might be the poem's line, "headpiece filled with straw."

The "whimper" is in the still unexplained rollover by both Democrats in the House and the governor himself after they had fought fiercely for LSDF funding and owned the vision space as it related to the importance of biotech and biopharma start-ups to the state's future.

The final budget was passed by the Legislature and signed by Gov. Jay Inslee last week after a conference committee had hammered out the details of issues in conflict, including the future of LSDF.  

In the end, House Democrats gave in and allowed a GOP-demanded shift of LSDF's treasury balance of $11 million to the state general fund and the stripping it of any revenue from any source over the coming biennium.  

I confidently (and obviously misguidedly) told friends and business associates the governor would use his line-item veto power to eliminate those LSDF death-knell provisions and turn GOP opposition to state support of entrepreneurs and biotech startups into campaign issues for Democrats next year.

Didn't happen. For reasons yet unexplained, the governor failed last week to employ the veto power he used a year ago to save the fund and thus become the political darling of those who saw LSDF as this state's message to the life sciences world about Washington's commitment to its future role in economic development in this state.

But for all the lamenting from those focused on how this state stacks up against competing states and the message LSDF's demise sends to entrepreneurs in other states, it needs to be remembered that LSDF's legacy is in the life science startups it funded and that are now growing and creating jobs.

And appropriately, one of the grant recipients, Seattle-based Omeros Corp., could possibly become a springboard for biopharma startups in the future because of its unusual program funded with a $5 million LSDF grant and, in an leading-edge partnership, $20 million from Paul Allen's Vulcan Capital in 2010.

Those potential spinouts could come from Omeros' G-protein coupled receptor (GPCR) program, a potentially lucrative focus in what is viewed as one of the most valuable families of drug targets.

GPCR's relate to key physiological processes in the body in which molecules bind to the receptors. GPCR relates to drugs that act on brain-cell receptors, unlocking them to drug development with such drugs representing 30 to 40 percent of marketed pharmaceuticals. Examples of the wide range of GPCR-drugs are antihistamines, opioids, alpha and beta blockers, serotonergics and dopaminergics.

 

The Omeros focus is on what are known as orphan GPCRs, those whose brain-cell receptors lack a certain DNA factor. There is a broad range of indications linked to orphan GPCRs, including cardiovascular disease, asthma, diabetes, pain, obesity, Alzheimer's disease, Parkinson's disease, multiple sclerosis, schizophrenia, learning and cognitive disorders, autism, osteoporosis, osteoarthritis and several forms of cancer.

 

A key Vulcan executive said at the time of the partnership announcement that the Omeros GPCR focus could accelerate new pipeline development across a broad range of highly attractive drug targets and can make a significant impact on the pharmaceutical industry.

 

Dr. Greg Demopulos, CEO of publicly traded Omeros, says the GPCR focus of his company is designed to promote the life science industry in this state in a way that is provided by other states that are spending millions to move life science to the fore in their economic development focuses.

 

But if the Omeros effort is successful in turning out startups to focus on various diseases that could relate to and be impacted by the GPCR research, the result would be a private-sector successor to, or funder of life science discovery since Vulcan Capital and LSDF have a right to receive a percentage of net proceeds generated by the GPCR program.

 

Meanwhile, the legislature, in head scratching fashion, didn't strike the Life Science Discovery Fund from existence, merely left it without resources to survivc.

 

But as a friend who has surveyed the legislative process for decades, and been closely involved with the lawmakers, explained: "This is how the legislature operates. They don't outright kill things.  They just turn off the money spigot because that's the way it's handled in the secretive budget process, which is gutless."

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Juno and Omeros: What a difference a year makes in image of state biotech industry

A year ago Washington's biotech industry was beset by the major image hit of the departure of Amgen and the death rattle of once high-flying Dendreon. But the industry's image in this state has shifted in 2015 with positive national attention from analysts, market watchers and investors being focused on a pair of Washington companies, Juno Therapeutics and Omeros Corp.

And the companies themselves have nearly opposite stories. Juno, founded by four MDs and two PhDs less than two years ago and taken public near the end of 2014, was the Nasdaq's biggest biotech IPO of the year, while Greg Demopulos, M.D., founder and CEO of Omeros, jokes that his company has taken 20 years to become an overnight sensation.

Greg Demopulos 

Juno brought together innovative technologies from some of the world's major research institutions, including Seattle's Fred Hutchinson Cancer Research Center, in a technology that genetically engineers T-cells to recognize and kill cancer. That caught the biopharma-investment world in a storm of upbeat reaction.

The "overnight sensation" that Demopulos refers to for Omeros is the first FDA-approved product for use in eye surgery. It's called Omidria, which Omeros is on the verge of launching, that will provide ophthalmologists a product that is FDA-approved, proven sterile and safe, and reimbursable by payers. One analyst observed that physicians should soon be using it as standard of care.

Juno's key executives are already on the health care-conference trail this month, with CEO Hans Bishop presenting this week in Boston at the Cowen and Company annual Health Care Conference, and CFO Steve Harr., M.D., presenting next week in Miami at the 2015 Barclays Global Healthcare Conference.

Juno's IPO debuted the company at $24 a share, with the price soaring 60 percent the first day before closing at $35. The stock has been as high as $61 a share since then but is trading in the mid-$40s this week. Juno raised $265 million from the offering after already having raised $314 million in venture capital investments over the prior year.

Juno's growth has already created a bridge of sorts from the Amgen-Dendreon down period to this year's uptick in the image and fortunes of the state's biotech industry as Juno has been hiring some of Amgen's and Dendreon's former key employees.

Whereas Juno's rise to prominence made the company virtually an overnight success, the path for Omeros has been more challenged, but suddenly equally eye catching for analysts and investors as the stock has jumped from just under $12 per share at the end of October to just over $25 at the beginning of this week. Some analysts are now suggesting the stock will climb to $38 per share.

This is the company that was tabbed by one analyst, after its $10 per share IPO was followed within days by a 38 percent per-share drop, as the "worst performer of all the 42 companies that have gone public in the U.S. this year."  

The reason for the current excitement over Omeros is the debut of Omidria, which is used during cataract surgery and lense replacement to dilate pupils and prevent pain, replacing a solution that eye surgeons presently must order from drug compounders but is not reimbursable and is described as "a highly inefficient and risky way to treat your patients."

"The FDA approval of Omidria is the first of what we expect will be a long line of product approvals for Omeros given our deep pipeline of products, many of which are currently in clinical trials," said Demopulos.

Indeed a second visibility bump for Omeros happened in late 2014 with the second drug in the company's pipeline, positive results from phase 2 trial of a drug called OMS721. The drug would basically address some orphan diseases like Atypical Hemolytic-uremic Syndrome, a disease that primarily causes abnormal blood clots in the kidneys.

But Demopulos is candid in discussing, during the interview last week, the years of challenge he faced in building the company.

"Right now we are considered a company on its way to success, but it took a long time to get to this point," Demopulos said.

"There were a number of times when the company was significantly at risk of not succeeding. You come to a wall and you can't see around it, under it or over it, but you just have to persevere and somehow you end up on the other side of the wall."

Addressing the challenge of successfully building a biotech company in Washington State, Demopulos said it might have been easier to start his company in the Bay Area but that he felt committed to this area. But he singles out the need for the state to take a leadership role if the road to biotech success is to be made easier.

"In order to create a strong biotech community in this state, some things cleary need be done, including restoring the r&d tax credit," Demopulos said. "If we can put that benefit back in place, then we can begin to recruit biotech companies to the Northwest to make it easier to attract talent to the region."

"Currently it's difficult to attract talent, given that there are fewer biotech companies in the Northwest," he said. "Employees coming to the region have concern about future lateral mobility."

"And we don't have a formal life science or biotech initiative like Texas, Wisconsin, Florida and Massachusetts where multi-billion dollar biotech initiatives contribute to the ability to establish companies in those states," he added. "At Omeros, we are trying to support that sort of initiative by putting together a fund, in cooperation with Life Science Discovery Fund and Vulcan to use our profits to spin out biotech startups."

"But if we are really interested in building a biopharmaceutical-Life science industry in this state, then the state has to be willing to provide funding and tax incentives," he said. "It isn't a giveaway program, but rather one with an outcome that's been proven in other states where the benefits are high-paying jobs and additional revenue to the state. But it has to be done in substantial measure or it will likely fail."

Demopulos named his company after his father, Greek orthodox priest The Very Rev. Dr. Alexander Homer Demopulos, known to his flock as Father Homer, who died in 1993, a year prior to the launch of Omeros.

The name for his company (Omeros is Homer in Greek) was not only appropriate recognition of his father's role in his life, it was also ironically appropriate for the path Omeros has followed. Like the ancient Greek hero Odysseus, whose wanderings after the Trojan War the ancient Greek poet Homer immortalized in his epic poem The Odyssey, Omeros had a series of "wanderings" leading up to its 20th anniversary last June and the breakthrough that followed.

And Demopulos is clear that Omeros won't become another promising Washington biotech firm lost to merger or acquisition.

"We have no interest in being acquired," he emphasized. "If that had been part of our plan for the future, we would have built the company in a different way."

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Legislative disinterest in funding assist for life science industry troubling to many

(Editor's noteThis is the first of a two-part series on the state's life science/biopharmaceutical industry with this first article dealing with the challenges of getting the state to provide the financial tools necessary to grow the industry. The second article will deal with a couple of newly emerging companies that will help carry the hopes for the future of the sector in Washington.)

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The apparent legislative disinterest in the state having a financial role in the future of Washington's life science industry isn't a fatal flaw for what has become the nation's sixth largest biopharma cluster. But it will send the wrong signal to biotech entrepreneurs and investors elsewhere in the country and will inevitably mean some startups won't make it across the early-funding challenge that's known as "the valley of death."

 

"Legislative disinterest" means the very real possibility that the 2015 Legislature may turn its back on key funding for startups, who represent the seeds that grow into players and job creators in the industry, by declining to keep the innovative Life Science Discovery Fund (LSDF) alive.

 

If LSDF, created to foster growth of the state's life science sector, went out of existence on its 10th anniversary because the Legislature decided not to fund it anymore, It would represent an ironic measure of the legislature's lack of commitment to the future of that industry in Washington.

 

Key states around the country are going to great financial lengths in their funding commitments to life science, both to foster growth of that industry within those states and also to send "come join us" messages to biotech innovators and investors elsewhere in the country.

 

LSDF was established in 2005 by then-Gov. Christine Gregoire and the state Legislature to guide investment dollars from the Master Tobacco Settlement Agreement into research and development grants to entities that demonstrate the strongest potential for delivering health and economic returns to the state.

 

It was only the intervention of Gov. Jay Inslee, a key proponent of a strong life-sciences sector, that saved LSDF at the end of the 2014 legislative session, but he couldn't prevent the demise of the research & development credit against the state sales and business & occupation taxes.

 

The R&D credit expired at the end of 2014. More than 2,000 companies had used the credit against the B&O tax since it was instituted in 1994, and about 400 have used the sales tax credit. The lost revenues through 2012 totaled about $950 million, but the investment the credits generated came to about $8 billion, and repaid the state several times over in overall tax collections, according to industry sources.

Chris Rivera
WBBA president.

Washington is now is on a short list of companies that don't offer R&D tax credits, and perhaps the only state on that short list that actually hopes to see its life sciences fortunes be an important component of economic success.

 

The budget Inslee has submitted to the Legislature would make a $20 million investment for LSDF and re-establish a $70 million Research and Development Tax Credit program with the governor telling the life sciences industry he is "a strong supporter of the R&D tax credit and sales tax deferral."

 

To be sure, the industry, guided by the Washington Biotech and Biomedical Association and its president, Chris Rivera, himself a former biotech CEO, have friends in Olympia in addition to the governor.

 

But the myopic among lawmakers will point to this region's sixth-largest life sciences ranking and say "well, things are obviously going pretty well for us."

 

The fact that the Seattle area ranks third among cluster-cities in the total of NIH dollars, at $142 million for the most recent year calculated, is viewed as reflecting the fact the region is anchored more by academic and independent research institutions than by local companies.

 

In fact, those academic-independent institutions, like the Gates Foundation, Fred Hutchinson Cancer Research Center, PATH, Institute for Systems Biology and the University of Washington may well be the most prestigious collection of industry research players in the country.

 

But the startups spun out of those institutions need conventional financial support to become full-blown businesses and that has been a challenge for companies in this state.

 

And from a competitive-clusters standpoint, the fact that two of the cluster cities above Seattle on the list are in California, with San Diego third and the Bay Area a far-ahead number one, is something that the lawmakers and policy makers need to be continually focused on.

 

Indeed nothing points up the importance of competitive awareness than the experience of Chris Rivera himself.

 

Rivera recalls that when he sought advice on launching a biotech firm in Seattle that would focus on orphan diseases "I told a key industry leader I needed space, talent and money. The response was 'you won't find those here.'

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So having been involved with firms in Boston and the Bay Area before moving to Seattle in the mid-80s, he headed for California where, in 2005 in South San Francisco, he launched Hyperion Therapeutics, a specialty biopharmaceutical company focused on the development and commercialization of therapies for gastroenterology and hepatology diseases.  

 

Rivera guided his company through the usual ebbs and flows of early growth challenges, including downsizing when the IPO market dried up. He stepped down in 2008 as the company prepared for what turned out to be successful Phase II trials and a $69 million funding in June of 2009 in one of the largest VC raises that year. Hyperion went public in 2012. He remains an investor in the company, but it is a growing Bay Area firm, not the Seattle-area firm it might have been.

 

Thus it wasn't surprising that when the WBBA executive committee went looking for a new president in late 2008, they lured Rivera back to Seattle with one of his goals being to create a strategy to help keep companies in Washington.  

 

"I think we've done a pretty good job of achieving that," he says.

 

Success for Washington's life science industry often seems a matter of two steps forward and two steps back, despite the best efforts of WBBA, whose strategies include a successful mentor program for entrepreneurs.

 

There was some of both forward and back in 2014. The steps back were the departure Amgen, taking with it the jobs of more than 600 biotech employees, and the demise of once-high-flying Dendreon, which had more than 700 employees, leaving perhaps the largest number of jobless biotech employees ever in this area.

 

But the steps forward were the emergence of Juno Therapeutics, a company less than two years old that surged into an IPO in late 2014, and the surge in interest for Omeros Corp., whose CEO Greg Demopulos jokes that it has taken his company 20 years to become an overnight success.

 

Ironically, the hiring mode for Juno, which develops immunotherapy treatments for cancer and has had remarkable results in small clinical trials, has benefitted from the availability of former Amgen and Dendreon employees.

 

Omeros, a Seattle-based biopharmaceutical company focused on developing and commercializing small-molecule and protein therapeutics for large-market as well as a variety of orphan indications, has become the best biotech story of 2015 and we will take a look next week at the company that celebrated its 20th anniversary last June.

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