Stamford based Cara Therapeutics, Inc. (Nasdaq:CARA), began enrolling patients for a Phase 2b trial. The trial is an oral tablet formulation of its “peripherally selective kappa opioid agonist, CR845,” for the treatment of pain associated with osteoarthritis (OA). The Company expects to report top-line data from this trial during the first half of 2017.
“The initiation of this osteoarthritis trial is an important step in establishing the potential clinical utility of CR845 in the treatment of chronic inflammatory pain,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “The biggest challenge in analgesic development today centers on providing effective medications that lack the abuse burden of traditional pain drugs, and it appears from our previous preclinical and human abuse liability data that CR845 could represent a novel, non-addicting approach to the treatment of chronic pain.”
Werth Foundation to benefit coastal and marine research
NEW HAVEN — Lately there’s a new buzzword dominating the conversation on the campus of Southern Connecticut State University: Science.
Science education is at the heart of two major September announcements at SCSU. The first concerns the largest donation to the university in its 120-year history — a $3 million gift to boost scientific research for students and faculty on the Crescent Street campus.
On September 9 SCSU President Mary A. Papazian said the donation from the Woodbridge-based Werth Family Foundation will be made incrementally over ten years. The sum includes a $1.5 million endowment for Southern’s Center for Coastal & Marine Studies, which will be renamed in the family’s name.
An additional $750,000 ($75,000 annually) will help to pay for the center annual expenses, including both equipment and stipends for students to support their research.
While a $3 million donation to Yale might not even merit a press release (in 2005, an anonymous $100 million gift to the graduate School of Music — which has fewer than 200 students — provided free tuition for all students in perpetuity), Papazian calls the Werths’ gift to SCSU “immensely transformational.”
Peter Werth, president of Woodbridge pharmaceutical developer ChemWerth, established the family foundation with his wife Pam in 2007. Papazian says the foundation has supported the marine studies center — which performs environmental research, particularly on Long Island Sound — for about seven years.
“In recent years Southern has seen impressive programmatic and enrollment growth in the sciences,” Papazian said, “and this gift will take scientific research and experiential opportunities for our students to a while new level.
The center will be housed in a new structure — a four-story, 103,608-square-foot building that will cost some $60 million and function as a “focal point” for SCSU’s science programs. Although work began on the structure in July, the “official” groundbreaking with Gov. Dannel P. Malloy and assorted other grandees was scheduled for September 20.
The yet-to-be-named structure will house teaching and research labs for physics, earth science, environmental science, molecular biology and chemistry. It will include a supercomputing lab for research in theoretical physics, bioinformatics and computer science.
HARTFORD — Connecticut United for Research Excellence (CURE), the state’s life and health-care sciences network, has welcomed to its membership a Chinese bioscience company. HLK Biotechnology Co. Ltd. aims to collaborate with CURE to act as a portal between the Connecticut and Chinese life-sciences industries.
“Our goal is to bridge the West and the East in order to bring efficacious and safe medicines to patients in both countries,” said HLK co-founder and president Jun Xu. “After two years in China, we know how to navigate the hurdles of doing business in that country, with regard to working with government agencies and regulators. In addition, HLK has very strong technical capabilities in CMC and formulation development, and a wealth of knowledge at different stages of drug discovery and development.”
Originally from Hunan Province, Xu is now a U.S. citizen and Connecticut resident. Her business partner, Zeren Wang, is originally from Shanghai, but is now also a U.S. citizen, living in Southbury. Both came to the U.S in the 1990s for academic training and later worked in research and development at Boehringer Ingelheim’s U.S. headquarters in Ridgefield.
According to CURE co-chair Peter R. Farina, formerly senior vice president of development at Boehringer Ingelheim U.S., “As the Chinese economy continues to develop, access to the Chinese market is becoming increasingly important to life-sciences companies. It is challenging for Westerners who want to develop drugs in China to know where to start or who to contact. Jun and Zeren understand U.S. pharma standards and practices and can work with U.S. firms to develop compounds for the Chinese health-care market using state-of-the-art pharmaceutical technology.”
HLK is headquartered in the high-tech industrial zone of Shenzhen, located in Guangdong province, just to the northwest of Hong Kong. Its Web address is hlkpharma.com.
Froshauer to succeed Pescatello at bioscience group
HARTFORD — Former Rib-X Pharmaceuticals president and CEO Susan Froshauer will take the reins at Connecticut United for Research Excellence (CURE), the state’s bioscience industry group, effective April 1.
Froshauer succeeds Paul Pescatello, who will step down after ten years in the top job to devote more time to private business ventures and non-life sciences policy issues. However, he will remain on the CURE board and executive committee and will continue to assist the group’s government-relations efforts as chairman of CURE’s Bioscience Growth Council.
Until 2010, Froshauer headed New Haven’s Rib-X Pharmaceuticals, which she co-founded in 2000. Under her leadership, Rib-X raised more than $160 million in private equity, bridge financing and government grants and built a pipeline of antibiotics to treat serious hospital infections.
Prior to Rib-X, Froshauer was a member of Pfizer’s Strategic Alliance Group, where she was instrumental in the creation of a $200 million investment portfolio that transformed the Pfizer global research and development strategy, helping the company identify new resources for drug discovery.
Currently Froshauer is director of the Technology Exchange Portal for the University of Connecticut’s Office of Economic Development. In that role she assists Connecticut entrepreneurs and organizations with initiatives that train students, create jobs and contribute to economic development.
State government has recently ratcheted up its investment in the life sciences and technology entrepreneurship. For example, it incentivized the Jackson Laboratory to develop a genomic medicine facility in Farmington and created Connecticut’s Innovation Ecosystem, a public-private partnership with hubs in Hartford, New Haven, Stamford and Storrs, to support high-value technology-based start-up and stage 2 companies. In addition, Gov. Dannel P. Malloy has proposed a new $200 million Bioscience Innovation Act and announced a $1.5 million investment in UConn to support STEM (Science, Technology, Engineering and Math) education activities (see related story this issue).
According to CURE, Froshauer will initially focus on expanding the CURE network, fostering connectivity among members, educators, investors and entrepreneurs, helping to build the bridges necessary to transform cutting-edge bioscience research into funded, sustainable start-up biotechs as well as fortifying CURE’s commitment to education.
HARTFORD — The state is continuing its financial backing of its tech sectors, this time establishing a $200 million fund to bolster bioscience.
The Bioscience Innovation Act was proposed by Gov. Dannel P. Malloy to establish the money to strengthen the bioscience sector over ten years. The governor made the proposal in January at the groundbreaking of the new Jackson Laboratory for Genomic Medicine (JAX) in Farmington.
Malloy says the money will help the state attract and invest in more companies, compete for more federal and private funding, and provide well-paying jobs with benefits for state residents. The funding will be administered by Connecticut Innovations Inc. (CII), and would be broken down as $10 million annually for the first two years, $15 million annually for years three and four, and $25 million annually for the remaining six years.
It is proposed that funding not duplicate existing public funding, all investments are thoroughly vetted, and that an advisory board provides oversight.
State grants $2.3 million for Durata’s relocation
BRANFORD — On September 27 Gov. Dannel P. Malloy announced that the state would provide up to $2.25 million in grants to Durata Therapeutics Inc. to support the relocation of its research and development, clinical and regulatory operations from Morristown, N.J. to Branford. In turn the bioscience firm, whose headquarters are in Chicago, has pledged to create up to 80 new, full-time jobs in Connecticut.
Durata will be leasing some 18,000 square feet of space in Branford for research, clinical and regulatory work.
The move is the latest in a series of initiatives that have been announced since Malloy launched his Bioscience Connecticut plan last year. The objective of Bioscience Connecticut is to position the state for sustained economic growth driven by research, development, and commercialization of new technologies and products.
“The goal of Bioscience Connecticut is twofold: creating good paying jobs with good benefits for residents in an industry that is poised for growth,” explained Malloy. “With the addition of Durata Therapeutics, we are further cementing the state as a destination for health and life science companies. Connecticut will continue to cultivate new investment, attract new talent, and work with our entrepreneurs to develop our workforce and strengthen our state’s position as a global leader in this rapidly expanding field.”
“We are thrilled to welcome Durata Therapeutics to Branford and are grateful to the Governor for helping the company choose Connecticut,” said Branford State Rep. Lonnie Reed (D-102). “Durata promises to create at least 80 substantial jobs, has huge potential for growth and joins a community of Branford life sciences firms dedicated to curing diseases and saving lives.”
A clinical development-stage biopharmaceutical firm founded in 2009, Durata is focused on the growing need for new therapeutics to treat infectious diseases. It acquired the rights to a pharmaceutical drug and two other products through acquisition of Vicuron Pharmaceuticals from Pfizer and is currently in the late stages of development of dalbavancin for acute bacterial skin and skin structure infections (otherwise known as abSSSI), including MRSA.
Total capital investment in Connecticut over the next ten years is estimated to be $13 million. This includes $2 million of state assistance provided by the Department of Economic & Community Development (DECD), which will be used for leasehold improvements; research and development; furniture, fixtures and equipment; relocation costs; and other project-related expenses, and will be disbursed based on job creation milestones. The remaining $250,000 will be provided as a training grant.
Will state’s $300 million biotech gambit deliver promised benefits?
If you ask State Sen. Len Suzio about the recently announced deal between Jackson Laboratories of Maine and the state of Connecticut to build and staff a 173,500-square foot research facility alongside the University of Connecticut Health Center in Farmington, it’s not unlike the story of the emperor’s new clothes.
“That’s an appropriate metaphor that I considered using during debate,” says Suzio, a Meriden Republican who represents the 13th District. “I don’t think it’s appropriate for the state of Connecticut to wager taxpayer money to do this. If we’re going to do so, let’s at least make it a fair deal for the taxpayers. This is radically unfair.”
Connecticut got involved in the Jackson Labs deal after several locations in Florida — including Sarasota, Tampa and Collier — as well as Florida Gov. Rick Scott passed on the deal. However, in Connecticut Gov. Dannel P. Malloy’s administration asked for and obtained approval on October 26 from the General Assembly to borrow $291 million — $192 million in a forgivable, secured construction loan and $99 million in grant support for research and related activities — to finance the research facility on 17 acres of state-owned land. In return, Jackson pledged to contribute $809 million over the next 20 years and seek additional funding via grants, contributions and other sources, bringing the project’s total value to $1.1 billion. The bill passed in the senate by a 24-14 vote, and in the house by a 147-1 tally.
In return, Jackson promised to add 320 jobs in Connecticut within the next ten years and a total of 660 jobs within the next 15 to 20 years. Currently, the company employs 1,400 people: 1,200 at its Bar Harbor, Me. headquarters and 200 in California. The new site in Farmington will host 30 senior scientists or principal investigators who will head up operations that Jackson hopes will translate “newly developed research applications into commercial products and services for personalized medicine, such as complex diagnostics or drug development,” according to an October 26 Jackson press release.
But that’s not the whole story, nor is it being accurately portrayed in press releases and reports being circulated, says Suzio.
“Jackson is not investing over $809 million in the normal sense of the word ‘investing,’” asserts Suzio. “That amount represents all of the money Jackson would potentially spend over the next 20 years. It covers their operating expenses. In the world of banking and accounting, you never talk about operating expenses as a form of ‘investment.’ The proponents of the proposal have been using this to mislead the public.”
Suzio explains that the proposal seems to combine $291 million of the state’s investment, which will be spent up front, with Jackson’s operating expenses, which will be spent over the 20-year life of the deal. “It looks like Jackson is investing three times more than the state is,” he says. “That’s a disingenuous way of comparing the two.”
The assertion by Malloy’s office that for every dollar the state invests, Jackson will invest three dollars Suzio calls “grossly misleading.”
“We’re lending them the money temporarily below our cost of borrowing the money at about five percent and giving it to them for one percent,” says Suzio. “We’re putting up all the risk money and we’re not getting a penny of the commercial value of what they’re creating. It’s incredible to me that we could negotiate such a one-sided deal.”
In a joint statement by Senate President Donald E. Williams Jr., Senate Majority Leader Martin M. Looney, Commerce Committee Co-Chairman Sen. Gary D. LeBeau, Higher Education and Workforce Development Co-Chairman Sen. Beth Bye and Public Health Committee Co-Chairman Sen. Terry Gerratana, the Democratic lawmakers noted that “In these difficult times, Connecticut has an extraordinary opportunity to invest in the technologies and jobs of the future, as well as the innovative small business and manufacturing jobs that have kept Connecticut’s economy afloat for decades. Investing in the future of Connecticut’s hard-working families and entrepreneurs is essential to the growth of our economy.”
“I believe that it is an important investment to make in building the future of bioscience in Connecticut,” says Looney of the Jackson proposal. He notes that although there is a burgeoning biotech industry in his hometown of New Haven and other cities in the state, the industry needs to be expanded on a much bigger scale.
“The Connecticut economy was built on pillars including manufacturing and the aerospace and defense industries,” says Looney, a Democrat who represents the 11th District. “They’re no longer the components that they were 50 years ago. We need to be looking to our future and this is a way to do that.”
Looney points out that Connecticut is in a situation similar to where North Carolina was several years ago when state business leaders realized that the Tar Heel State’s economy, built on textiles, tobacco and furniture manufacturing, was no longer viable. “Hence, they built a Research Triangle centered around the major universities in the Raleigh-Durham area,” including Duke and the University of North Carolina/Chapel Hill, says Looney.
“We’re looking to do the same thing: to have a research corridor stretching from Storrs to Farmington to New Haven, with the University of Connecticut, the UConn Health Center and Yale University as the key components,” he adds.
Looney believes that Connecticut can provide the kind of talent needed to staff a facility like Jackson Labs because of its strategic location in the Northeast corridor between Boston and New York. “When the facility is here, we will be gearing up for training in preparation,” he says. “We want to attract high-level, good-paying jobs to Connecticut, like we used to have in manufacturing, which is what these jobs will be. We can’t continue to base our economy on low-paying service jobs.”
Commenting on indirect “spinoff” jobs created by the economic activity generated by the presence of the facility in Farmington, Suzio says a report issued by Jackson Labs entitled “Reinventing Connecticut: A Bioscience Connecticut Collaboration,” claims that Jackson’s mere presence in Connecticut will grow the number of biotech jobs (defined by NAICS code 541711 in the report as research and development in biotechnology), which currently number about 2,030 statewide, to 4,035 in 20 years.
“They’re saying that every biotech job created in the next 20 years in Connecticut is because they’re going to be here,” Suzio says. “How specious that assumption is, how outrageously exaggerated it is.”
However, Suzio, who worked in the biotech industry during the 1980s, has high praise for Jackson’s accomplishments and its place in the bioscience industry.
“They have a wonderful, world-renowned reputation. They deserve credit for what they’ve done in genomics,” says Suzio. “But this is a different field. When you’re dealing with leading-edge technology, you’re dealing with the unknown. It can work out to be spectacularly successful or be a spectacular failure.
“It might be that they do develop something unbelievable that will revolutionize medical care in the form of personalized medicine,” he adds. However, he cautions, “No one knows for sure how successful it will be or how long it will take to develop.”
Jackson Laboratory for Genomic Medicine: The Facts
• $291 million in bond funding from Connecticut ($192 million in secured construction loan plus $99 million in research partnership participation; not including about $115 million in debt service).
• A 17-acre parcel of state-owned land near UConn Health Center in Farmington to locate 173,500-square-foot research facility, which Jackson hopes to expand to a total of 250,000 square feet.
• $809 million in operating expenses to be spent by Jackson Labs over next 20 years.
• Total 20-year capital and research budget of $1.1 billion.
• 320 jobs within first 10 years cited by Jackson Labs.
• 660 jobs within the next 15 to 20 years cited by Jackson Labs.
• By year 2031, 6,800 jobs “associated with” the facility, per Malloy administration, vs. 4,035 jobs projected by the Jackson report.