Today's Top News Tuesday, March 15, 2016 | By John Carroll
The last time I crossed paths with Kevin Judice, he was helping Jeff Stein launch San Diego-based Cidara Therapeutics, an antibiotics developer that lay well outside the perimeters of Judice's home base in the Bay Area. Now Judice, a Genentech veteran and longtime biotech entrepreneur on the West Coast, is gearing up DiCE Molecules, a spinout from a much closer campus at Stanford that's jumping into the spotlight today with the help of a collaboration with Sanofi's ($SNY) Sunrise team that starts with $50 million in early-stage cash and support, with the potential to add billions more for a successful lineup of programs. DiCE is the brainchild of Pehr Harbury, a Stanford professor and biochemist--and MacArthur "genius" award winner--who's been constructing the building blocks of a platform technology, which is exactly Sanofi's sweet spot for cutting-edge deals. The pharma company's top execs have acknowledged that they are not an innovation powerhouse; development is their domain. So one of their biotech strategies--separate from the big plays like Regeneron ($REGN) and Alnylam ($ALNY)--is to go in early, tying up with potentially disruptive startups like Warp Drive Bio, MyoKardia or now DiCE, in search of new drugs that can fit into core therapeutic areas like diabetes, rare diseases, cardiovascular or oncology. Sanofi is essentially putting up the money for DiCE to make its public debut. And the pharma giant has carved out 12 targets for which it will add up to $184 million in development milestones for each successful effort. The grand total on the table: $2.2 billion. Throughout his whole career as a chemist, says Judice, he's suffered from technology envy when it comes to the biologists he works with. In biology, your work is focused on directed evolution. Now he's planning to create a little tech envy of his own. DiCE is all about directed chemical evolution, where it gets its name. One of DiCE's objectives is to prove that it has the technology to interrupt protein-protein interfaces with a small molecule, potentially replacing a wave of antibody blockbusters on the market. In a case like cancer, there may not be a big advantage in coming up with an oral alternative for, say, Avastin, says Judice, but for chronic diseases like inflammation and cardiovascular disease, a pill could be far preferable to the pricey antibodies that command markets. There's also a small galaxy of targets inside the cell, past the cell membranes that bar antibodies. And Judice says that internal cell sphere will present a new challenge, once they're done providing proof-of-concept data to show that they have what it takes to knock some antibodies off the list of chart-toppers. This is not your classic venture-backed biotech. In this case, says Judice, Sanofi is funding the company right after the seed stage, which was provided by angel investors. Early on, DiCE had 10 targets in mind with 5 staffers, says the CEO. Today there are 12 staffers and the company will likely top out at 24 employees. Ideally, there will be another big-payout partnering deal in about a year, says Judice, and that will keep the company funded until it can start handing out dividends. Don't look for DiCE, set up as an LLC, to go public. The company can generate plenty of returns through collaborations while working on its own in-house pipeline, says the CEO. And if one of their own drugs gets to late-stage development, they can work out a licensing deal with a developer. For Judice, that kind of company structure works well for a biotech that, as he describes it, has been under construction while in flight. You keep the company staffing tight, stay focused and forge ahead on selected targets. It's not particularly sexy right now, but Judice isn't selling shares to the investment world, either. "It's fashionable to engage in chest thumping in the biotech world," says Judice. "That's not my style." It is a style that seems to suit Sanofi well, though. A number of pharma giants have innovation centers, says Judice, and "Sanofi's version (Sunrise) is a well-oiled machine." Another plus: The pharma company is also intent on sticking with the collaboration, not engulfing them in the process. "We really believe we're better together," says Kathy Bowdish, who heads the small team of four at Sanofi's Sunrise initiative. Sunrise likes to get in the act about three to 5 years ahead of an IND, she adds. And that made for a nice fit with DiCE. Related Articles:
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Wednesday, March 16, 2016 | By Amirah Al Idrus
Bayer has dipped its toe into Cambridge, MA, teaming up with the Broad Institute on a cancer therapy in 2013 and contributing $25 million Versant's biotech venture fund in 2014. Now, the German pharma is going full throttle, setting up the Bayer East Coast Innovation Center, establishing a regional presence and boosting its ties to the biotech community. The new center will "enable Bayer's teams to deepen relationships and opportunities to influence the discovery and development of new therapeutics," the company said in a statement on Tuesday. An opening date for the center was not disclosed. Bayer's existing relationships in Cambridge include a $252 million deal with Dimension Therapeutics inked in 2014. It will fund the remaining preclinical work on and Phase I/IIa trial for a gene therapy for hemophilia A and potentially take over for Phase III studies. In March last year, Bayer tapped the Broad again, this time for cardiovascular R&D, and in December it wagered $335 million on Cambridge's CRISPR Therapeutics, setting up a joint venture targeting blood disorders, blindness and congenital heart disease. "We want to be a partner of choice in the industry--one that collaborates effectively with not only scientists from the great research hubs in the U.S., but also clinicians, patient advocates and other key players essential to bringing novel medicines to market," said Habib Dable, president of Bayer's U.S. pharma division, in the statement. The company's planned Cambridge site is the latest in a collection of similar efforts in San Francisco, Berlin, Beijing, Osaka and Singapore, where the drugmaker has set up partnering hubs and startup incubators. Bayer is hardly the first Big Pharma to open up shop in Cambridge's biotech hotbed. In 2015 alone, Eli Lilly ($LLY), Bristol-Myers Squibb ($BMY) and Baxalta ($BXLT) all broke ground in Cambridge's Kendall Square. They joined the likes of Pfizer ($PFE), Novartis ($NVS) and Biogen ($BIIB), which have all strengthened their ties there. While the ongoing colonization of the biotech hub is a boon for the Big Pharmas that so desperately want to cozy up to innovators and academics, it could also be its own undoing. As more pharmas move in, the demand for local lab space is skyrocketing, driving rent prices ever higher. This may not faze deep-pocketed pharmas like Bayer, but could eventually price out the innovators that drew them there in the first place. - here's Bayer's statement Related Articles:
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Bayer bets $335M on CRISPR Therapeutics and the future of gene editing
Bayer adds $25M to Versant's new, $300M-plus biotech venture fund
Dimension leaps into gene therapy action with $252M Bayer deal, $30M round Wednesday, March 16, 2016 | By Ben Adams
| | Vectura CEO James Ward-Lilley |
Vectura has secured a friendly merger with SkyePharma that will see its chief executive depart as the combined company looks to a new and expanded future. The deal, worth £441.3 million ($621 million), puts together two similar companies that are both based in the U.K. and develop treatments for asthma and other respiratory conditions. Combined, the new company is estimated to have a market capitalization of just over £1 billion based on each respective valuation, with joint sales of £153.9 million and profits of around £50.5 million, according to the Financial Times. The newly formed firm will be run by Vectura CEO--and former AstraZeneca ($AZN) exec--James Ward-Lilley, while Vectura's chairman Bruno Angelici will keep his role. SkyePharma's chairman Frank Condella will be staying on as Angelici's deputy. But there's no room at the inn for Peter Grant, SkyePharma's CEO, who will be leaving the firm after four years at its helm. Angelici said: "The merger of Vectura and SkyePharma is a key milestone in the execution of our strategy to become a leading specialty pharmaceutical company, focusing on airways-related disease. The addition of SkyePharma's pMDI technology will allow the enlarged group to access the inhaled product market in its entirety and the enlarged group's enhanced cash flow will better position it to consider attractive strategic opportunities which may emerge in the future." Condella added: "The merger of SkyePharma and Vectura is a highly synergistic, value-enhancing transaction that will establish an industry leader in the development of inhalation products." Vectura is offering SkyePharma shareholders 2.7977 new shares for each share held, valuing SkyePharma at £441.3 million--although SkyePharma shareholders can choose to receive a part of the offer in cash, Vectura said in a statement. An all-stock deal would result in SkyePharma shareholders owning about 41.75% of the combined company, but if the £70 million available under the cash alternative is paid in full, Skyepharma shareholders would own about 37.62% of the new firm. The deal comes as SkyePharma announced its preliminary financials today, which showed record sales of £95.9 million in 2015, up 30% on the year-ago period. - read the FT story (sub. req.) Related Articles:
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Vectura will close plant in Germany within the year Wednesday, March 16, 2016 | By Damian Garde
| | Frazier Interim CEO David Socks |
Japanese drugmaker Takeda Pharmaceutical teamed up with biotech venture firm Frazier Healthcare Partners to launch a startup focused on new therapies for urologic diseases, joining a $41 million A round to get the company up and running. The biotech, Outpost Medicine, is getting started with a clinical-stage treatment for stress urinary incontinence, which occurs when physical activity causes patients to lose control of their bladders. Outpost licensed worldwide rights to the oral drug from Takeda on undisclosed terms, rechristening it OP-233 and planning to push it through clinical development. The drug completed a Phase I safety study in healthy women in 2014, and Outpost believes it can eventually treat a sizable unmet need. Stress urinary incontinence, which differs from overactive bladder, affects about 18 million people in the U.S., according to Outpost, and there are no therapies approved to treat it. Common drugs for urinary incontinence have proven ineffective for the disorder, Outpost said. Frazier led Outpost's first-round fundraise, joined by Adams Street Partners, Novo A/S, and Vivo Capital. Frazier Partner David Socks is leading the company as interim CEO, joined by colleague Tachi Yamada in the chairman role. Frazier's Dan Estes is taking a seat on Outpost's board alongside Terry Gould from Adams Street, Peter Bisgaard of Novo and Chen Yu from Vivo. "We believe OP-233 is an exceptional asset around which to form Outpost Medicine," Socks said in a statement. "With leadership from a world-class team and support from a premier group of life science venture investors, we believe Outpost has the essential elements to create a leading company developing therapeutics in urology and gynecology." Frazier is working off of a $262 million fund, closed last year, that the firm plans to invest exclusively in life sciences. The Seattle-headquartered VC is looking mostly at first-time financings, earmarking between $10 million and $25 million for each company as it works to build out its portfolio of promising biotech startups. - read the statement Related Articles:
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VC Frazier Healthcare nails $377M fund with eye on biotech startups Wednesday, March 16, 2016 | By Ben Adams
| | Vedanta CSO Bruce Roberts |
Vedanta Biosciences has appointed a Genzyme veteran as its new chief science officer as it expands into its new HQ in Massachusetts. The biotech firm--founded by Boston-based healthcare company PureTech Health--has taken on immunology expert and former Genzyme group vice president Bruce Roberts as its new CSO. This comes as the firm moves into its new headquarters and R&D facility in Cambridge, MA, which includes a state-of-the-art GMP facility for the production of live bacterial drugs. Vedanta is currently developing a new class of therapies designed to modulate the human microbiome to treat autoimmune, inflammatory and infectious diseases. The microbiome is the genetic makeup of microbes' genes and Vedanta, alongside a slew of other biotechs and pharma firms, is hoping it can create new medicines from modulating the billions of organisms inherent in the human body. Roberts, who will head the new Cambridge site, has 30 years' experience in the biotech and pharma industry. He most recently served as head of neuro-immunology and immune-mediated disease research at Sanofi's ($SNY) biotech arm Genzyme, where he directed preclinical efforts resulting in the introduction of therapeutic antibodies, gene therapies, cell therapies and small molecules. | | PureTech CEO Daphne Zohar |
Daphne Zohar, CEO of PureTech, said: "With the addition of Bruce Roberts as CSO and the move to a new state-of-the-art facility, Vedanta is poised to continue to lead this exciting new field." Last year, Vedanta announced a long-term $241 million deal with Johnson & Johnson ($JNJ) on a new bacterial treatment for inflammatory bowel disease, as more Big Pharma players seek to get into this new and cutting-edge research area. Roberts said: "Microbiome modulation is among the most exciting and rapidly evolving fields in science, and it has tremendous potential to change the way medicine is practiced. I am excited to join one of the leading teams in this field and I look forward to driving Vedanta's technology platform and pipeline forward." - read the announcement Related Articles:
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J&J takes another leap into microbiome R&D with $241M Vedanta pact
PureTech banks $171M in a London IPO to fund its biotech bets Wednesday, March 16, 2016 | By John Carroll
CAR-T drugs have already demonstrated significant promise in human blood cancer studies, but clearly face a big challenge in making the leap into solid tumors, which would greatly increase the technology's market potential. To help overcome the obstacle, scientists closely allied with the leading companies in the field have been working on second-gen strategies. And Dr. Edmund Moon, an assistant professor of medicine at the University of Pennsylvania (allied to Novartis), says he has successfully completed a preclinical study that could help blaze a trail forward. Moon focused on PD-1, a key checkpoint inhibitory receptor that is targeted by two recently approved therapeutics, pembrolizumab and nivolumab, which appear to have limited efficacy in some tumors due to a low count of "tumor-reactive immune cells" needed to mount a successful counterattack against cancer. Read more from FierceBiotechResearch >> | 