NuVasive Partners With Biedermann on Spine Solutions

NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has entered into a strategic partnership with Biedermann Technologies GmbH & Co. KG, a company that holds a broad and extensive patent and technology portfolio in the fields of spinal and extremity surgery, based in Donaueschingen, Germany.

Biedermann Technologies is well regarded for its world-class design expertise within many medical device industries and holds one of the most comprehensive and innovative patent portfolios in the field of spinal surgery. Within the terms of the license and services agreement, Biedermann Technologies has granted NuVasive licenses to intellectual property relating to its spinal technology portfolio.

Specifically, certain Biedermann Technologies’ proprietary screw innovations will be integrated into the NuVasive RELINE^® portfolio, offering surgeons a superior solution to treat complex spinal pathologies in both the adult and pediatric populations for open, as well as minimally invasive surgery, with customized screw placement and ability to facilitate various corrective maneuvers based on the clinical needs of the patient. NuVasive’s RELINE system is the only technology on the market to offer a single tulip that accepts three posterior fixation rods of different diameters and is integrated into its proprietary Integrated Global Alignment (iGA^®) platform designed to achieve global alignment across spinal procedures. This combination of Biedermann Technologies’ propriety screw technology and NuVasive’s RELINE system is expected to be commercially available to surgeons in the first half of 2019.

Biedermann Technologies will also provide services to NuVasive in connection with the development of its next-generation RELINE complex spine system to support three foundational clinical pillars: surgical efficiency, operative reliability and procedural versatility.

https://www.prnewswire.com/news-releases/nuvasive-announces-strategic-partnership-with-biedermann-technologies-to-access-intellectual-property-and-co-develop-state-of-the-art-complex-spine-solutions-300727441.html

Activist employers are a ‘wake-up call’ for the next generation of insurers

With two monster vertical healthcare mergers nearing completion, the next generation of managed care companies is likely to face increased pressure from self-funded employers looking to bend the cost curve on their own.

The potential for large, self-insured employers and new employer coalitions to cut into the profits of insurers should be a “wake-up call” for organizations like CVS-Aetna, Cigna-Express Scripts, UnitedHealth and Humana, Leerink analysts Ana Gupte, Ph.D., and Daniel Grosslight wrote (PDF) in a note to investors Friday.

The pair points to large businesses such as Comcast and Walmart as well as the Amazon-JP Morgan-Berkshire Hathaway coalition as new and formidable competitors in the commercial market moving forward.

“We believe MCOs have their work cut out for them, and that meaningful action would likely involve less cross-subsidization of the more lucrative and growing Medicare Advantage (MA) product through self-insured network contracting, and more innovative approaches and investments on both provider contracts and technology-enabled member engagement and analytics,” they wrote.

Comcast has already indicated it is willing to bypass insurers and contract directly with providers. General Motors recently inked a deal with Henry Ford Health System for a new “ConnectedCare” plan option for its employees.

Meanwhile, more than 40 employers have formed the Health Transformation Alliance aiming to “fix our broken healthcare system.”

The nation’s biggest employers are clearly focused on reducing healthcare costs. A survey by Willis Towers Watson released at the beginning of the year showed 97% of employers said overall health program design and costs were an important priority over the next three years, and 85% said they planned to evaluate vendors best positioned to deliver on that strategy. Nearly two-thirds said they were focused on network strategy including utilizing high-performing providers.

What do the big insurers have to lose? Not much when it comes to revenue, because commercial plans make up a much smaller percentage of overall revenue, especially compared to Medicare Advantage. But large employers remain a “key customer base and vocal and powerful constituency” for payers, and account for a large portion of membership.

That will likely prompt more concerted efforts to invest in platforms aimed at bringing down employer costs, especially as more technology companies enter the race for healthcare’s “digital front door.”

“We expect [managed care organizations] to renew their focus and attention on this constituency with increased investments in provider contracting and member engagement,” the Leerink analysts wrote.

https://www.fiercehealthcare.com/payer/large-self-funded-employers-are-a-wake-up-call-for-next-generation-insurers

Loxo, Blueprint drive forward with RET-targeting cancer therapies

• No therapies are currently approved in the U.S. to specifically treat cancers driven by changes in an oncogene known as RET. Updated clinical results from two drugs in development by Loxo Oncology and Blueprint Medicines, however, suggest that might not be the case for too much longer.
• Data presented over the weekend at the annual meeting of the American Thyroid Association, while early, gave further evidence of the two therapies’ effectiveness in inhibiting RET signaling in patients with two types of thyroid cancer.
• Treatment with LOXO-292 led to a 59% overall response rate (ORR) in 29 patients with RET-mutated medullary thyroid cancer (MTC), and nearly half of 35 evaluable MTC patients on Blueprint’s drug experienced a response, results showed. While adverse events were common, few patients in either study experienced severe side effects.

Targeted therapies are enjoying a renaissance of sorts, with new drugs designed to seek out specific tumor weak spots emerging for the treatment of breast, lung and ovarian cancers, among others.

With LOXO-292 and BLU-667, Loxo and Blueprint are working to add to the list of addressable genetic targets.

Alterations in the RET gene occur in an estimated 1% to 2% of all non-small cell lung cancer cases. By contrast, RET mutations are found in approximately 60% of medullary thyroid cancers, while between 10% and 20% of papillary thyroid cancers test positive for RET fusions, according to Loxo.

These cancers are highly dependent on activation of the RET kinase for their growth, making small molecule inhibitors of RET signaling a promising treatment approach.

Loxo presented data from its LIBRETTO study of LOXO-292 earlier this year at the American Society for Clinical Oncology’s annual meeting. Updated results now include data from seven more patients and show an increased ORR and continued treatment tolerance. Patients enrolled in the study are heavily pretreated, with a median of three prior systemic therapies.

In Blueprint’s ARROW study, treatment with BLU-667 resulted in a 49% ORR among the 35 patients evaluable for response assessment. The biotech noted, however, that the ORR ticked up to 62% among patients treated with higher doses of the drug for at least six months.

Despite the temptation to compare the studies, one Wall Street analyst highlighted that differences in design between the two could confound a cross-trial analysis.

“LOXO-292’s dose escalation permits intrapatient dose escalation, in addition to a traditional cohort approach. This design may confound direct comparison of response rate data between the two trials,” wrote Leerink analyst Andrew Berens in a Oct. 8 note to investors.

Intrapatient dose escalation, Berens explained, could boost the chances a patient responds to treatment as the amount of drug being administered increases. In a study with fixed doses, by comparison, those patients on a lower treatment regimen may be less likely to respond. (Assuming, of course, a clear dose/response correlation.)

Investors didn’t appear to draw any clear conclusions, with shares in both companies opening lower at the start of Monday trading.

Berens, though, sees the latest snapshot as supportive of the role LOXO-292 and BLU-667 could eventually play, if clinical testing continues to prove positive.

“We see both agents continuing to produce compelling efficacy and safety, and believe both will be used in RET driven cancers,” Berens wrote.

https://www.biopharmadive.com/news/loxo-blueprint-drive-forward-with-ret-targeting-cancer-therapies/539109/

Genmab, Seattle Genetics to Present at ESMO 2018

• Data presented from updated analysis of full innovaTV 201 expansion cohort in recurrent or metastatic cervical cancer

Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that updated clinical data from the innovaTV 201 Phase II study evaluating tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer will be presented as a poster at the European Society for Medical Oncology (ESMO) 2018 Congress taking place in Munich, Germany from October 19 to 23, 2018. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target the Tissue Factor antigen, which is expressed on a broad range of solid tumors.

https://www.marketscreener.com/SEATTLE-GENETICS-INC-10808/news/Seattle-Genetics-Genmab-and-Seattle-Genetics-Announce-Tisotumab-Vedotin-Data-to-Be-Presented-at-ES-27388241/

Turning A Rundown Square Into The Nation’s Top Biotech Hub

How did Cambridge, and in particular Kendall Square, become the biotech hub that it is today?

Alexandria Real Estate Equities has been instrumental in the growth of the Kendall Square market since the California company, headed by Joel Marcus, replicated the successes it had on the West Coast in providing office and lab space to the growing biotech industry.

Courtesy of Alexandria Real Estate Equities

100 Binney, Alexandria’s latest Kendall Square development

In the early 2000s, soon after Novartis announced plans to open a facility in Kendall Square, Alexandria started buying office properties in the submarket. By converting the space to labs, the company, which owns 6.3M SF in the greater San Francisco area, was able to fetch twice the rent.

Beginning in the mid-2000s, the company redeveloped the Binney Street corridor as a biotech campus. Now the corridor is home to a raft of biotech names: Biogen, Bluebird Bio, Constellation Pharmaceuticals, Sage Therapeutics, Sanofi Relay Therapeutics and others.

“Kendall Square is to science what New York is to finance, what Paris is to culture, what Washington is to government,” Novartis Institutes for Biomedical Research President Jay Bradner tells Bloomberg.

Alexandria has also made a succession of major acquisitions in the market in recent years, such as One Kendall Square, as well as dispositions.

Bristol Myers-Squibb Co. is the anchor tenant in Alexandria’s latest building, 100 Binney St., which is 100% leased. Even non-life science tech is represented there, with Facebook as a tenant.

Boston Properties Inc. and BioMed Realty Trust Inc., now owned by Blackstone Group, are other major players in the market. But Alexandria is still the largest (after MIT), with 4.8M SF in holdings and 164K SF under development.

With the growth of Alexandria has come the emergence of Cambridge as a biotech hub. Currently more than 60 public companies with a combined market cap of about $170B are headquartered in Cambridge. Vacancies are low and rents are correspondingly high. Vacancy in Cambridge’s 12.1M SF lab market is 2.5%, and sublease space is nearly gone as of mid-2018, Colliers International reports. Tenants continue to struggle to find available space, and yet there will be continued growth. In 2017, biotech in Massachusetts received $3.2B in venture funding, up 3.4% compared with the year before.

As important as Alexandria has been to the development of Kendall Square and the Boston-area tech industry, the company doesn’t put all of its eggs in one market.  According to Alexandria’s Marcus, by 2022 the greater Boston market will not be as dominant in the company’s asset base as it is today. Alexandria is looking to markets like San Diego, Seattle and New York for further growth. In Seattle, for example, the company acquired 701 Dexter Avenue North in the Lake Union South neighborhood this summer for $33.5M as a spot for future development, and also bought an eight-building life science portfolio in Maryland for $146M.

https://www.bisnow.com/national/news/office/how-a-developer-turned-a-rundown-square-into-the-nations-top-biotech-hub-93635

Jason Karp to shut hedge fund Tourbillon, focus on health and wellness

Hedge fund Tourbillon Capital Partners is shutting down after several years of poor returns, making it the third well-known fund to announce plans to close its doors within a week.

“We have recently not delivered the results that you expect of us and what we know we are capable of,” Jason Karp, who has been running Tourbillon for six years, wrote to clients in a letter seen by Reuters.

He said he plans to spend his time focusing on private and public companies within the health and wellness industry.

At its peak, Tourbillon managed roughly $3 billion in assets and Karp was named one of the hedge fund industry’s rising stars in 2012 after stints as co-chief investment officer at hedge fund Carlson Capital and as director of research and portfolio manager at SAC’s CR Intrinsic Investors Group. It currently manages over $1 billion.

A spokesman declined to comment.

Last week, Boston-based hedge fund Highfields Capital, which oversees roughly $12 billion, announced to clients that it would be shutting down. Criterion Capital also said last week that it would be shutting down, the Wall Street Journal reported last week.

Two years ago, Karp spoke for many hedge fund managers when he said the industry, once largely united in its dislike for Donald Trump, now felt fund managers could benefit from the new administration and make more money by judging companies on their earnings.

Now he said he plans to keep investing in the stock market but in “radically different and unconstrained manner.” Fueled by a deeply personal interest in the health and wellness sector rooted in his own experience with autoimmune diseases in his early 20s, Karp said he would spend most of his time on this sector. In part he plans to grow Hu Kitchen, a food products company and restaurant his family launched six years ago.

https://www.streetinsider.com/Hedge+Funds/Jason+Karp+to+shut+hedge+fund+Tourbillon%2C+focus+on+health+and+wellness/14683580.html

JPMorgan Remains bullish on Dynavax (DVAX) Ahead of ESMO Meeting

JPMorgan analyst, Anupam Rama, reiterated an Overweight rating and $27.00 price target on Dynavax Technologies (NASDAQ: DVAX)

https://www.streetinsider.com/Analyst+Comments/JPMorgan+Remains+bullish+on+Dynavax+%28DVAX%29+Ahead+of+ESMO+Meeting/14683150.html