Source: Wall Street Journal: By Peter Loftus
Published: Sept 4, 2014 2:57 p.m. ET
U.S. regulators on Thursday approved a new kind of cancer drug from Merck & Co. that is designed to unleash the body’s immune system against tumors and could generate billions of dollars in sales.
The drug, which Merck plans to sell under the brand name Keytruda, is part of a long-anticipated wave of medicines that could transform cancer treatment and forge a large new market for pharmaceutical companies.
The Food and Drug Administration cleared the drug, pembrolizumab, for the treatment of a deadly form of skin cancer, melanoma. The approval followed a swift review of data from a relatively early-stage human trial–an unusual move reflecting the medical community’s keen interest in pembrolizumab.
The infused drug is a new type of immunotherapy, a category of treatments that harness the immune system to fight cancer. It was approved for people who’ve failed to respond adequately to Yervoy, a Bristol-Myers Squibb Co. immunotherapy that works in a different fashion, and certain other drugs.
Pembrolizumab is the first so-called PD-1 inhibitor to hit the U.S. market. The drugs block a protein called programmed death receptor 1, or PD-1, which acts as a brake on certain immune-system cells to prevent them from attacking healthy tissue. Cancer cells can escape destruction by latching onto PD-1; PD1 inhibitors block this interaction at the site of the tumor, releasing the immune system brake and allowing it to destroy the cancer. Yervoy also lifts a brake on the immune system but does so earlier in the immune-cell activation process, which researchers say may cause more collateral destruction of normal tissue than with PD-1 blockers.
Pembrolizumab and other PD-1-targeting drugs–including those developed by Bristol-Myers and Roche Holding AG–have generated excitement among doctors because they appear to induce relatively high rates of tumor shrinkage and prolong average survival beyond historical norms in clinical studies. Researchers say the side effects associated with the drugs appear to be manageable.
“PD-1 is truly a game-changer. It’s active in a way that other drugs are not,” said Lynn Schuchter, a medical oncologist who heads the melanoma program at the Abramson Cancer Center of the University of Pennsylvania and has assisted in clinical trials of the Merck drug. “And what’s been interesting is the activity of PD-1 beyond melanoma. It looks to be active in bladder and renal and lung cancer. So this is bigger than melanoma.”
Some analysts believe total annual sales of cancer immunotherapies could reach about $32 billion by 2025, if more drugs make it to market to treat a range of cancers. Leerink Swann estimates Merck’s new drug alone could generate annual sales of more than $6 billion by then.
A competing PD-1 inhibitor, nivolumab, hit the market in Japan this month, at a price of $143,000 for a year’s worth of treatment for the average Japanese patient. The drug, from Bristol-Myers and Ono Pharmaceutical Co., is expected to be reviewed by U.S. regulators in coming months. Other PD-1 inhibitors are expected to have similarly high price tags, which could fuel more debate about the affordability of new drugs.
Merck didn’t immediately disclose the price for Keytruda on Thursday
Write to Peter Loftus at email@example.com
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eNeura nears the close of a $6.6 million equity funding round in supports of its home migraine therapy device.
Maryland-based migraine devices maker eNeura is closing in on a $6.6 million funding round, with $5.8 million raised so far.
The company has sold equity to 67 investors so far in a round launched on Aug. 18, 2014, according to an SEC report filed last week. There’s no minimum investment for outside investors, according to the report.
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eNeura’s device is the 1st of its kind to use transcranial magnetic stimulation to depolarize neurons on the brain, a process that doctors believe may interrupt migraine activity. Designed for home use, patients place the device against the back of the head, where a magnetic pulse targets the occipital lobe.
The device won FDA approval in May with positive results from eNeura’s double-blind, placebo-controlled studies in more than 200 patients, which found that nearly 38% of eTMS patients were pain-free 2 hours after using the device, compared with only 17% of patients in the control group. About 34% of eTMS patients were pain-free after 24 hours, compared with 10% of the control patients. Researchers reported no device-related serious adverse events.
Madison, Wisconsin-based Propeller Health, formerly known as Asthmapolis, has raised $14.5 million in a round of funding led by Safeguard Scientifics with participation from return backer The Social+Capital Partnership. Propeller has also hired Practice Fusionâ€™s Chris Hogg as its first COO, and heâ€™ll head up the companyâ€™s new San Francisco office.
The smart inhaler companyâ€™s devices and companion apps offer geographic mapping of inhaler use and asthma triggers as well as adherence tracking and early warning alerts for COPD patients.
â€œThe funding supports the mission we are already on: to bring sensors to the full variety of the inhaled medications that are used for chronic respiratory disease,â€ Propeller Health CEO David Van Sickle told MobiHealthNews in an interview. â€œWe are already well down that pathâ€¦ but the respiratory pipeline is fairly active. We are seeing new medications, therapies, and form factors.â€
In May Propeller received FDA clearance for its COPD offering. The new platform aims to help users prevent so-called â€œasthma attacksâ€ or similar lung inflammation symptoms caused by COPD. The Propeller Metered-Dose Inhaler measures a patientâ€™s use of their rescue inhaler. That data is automatically compared to a patientâ€™s baseline and to general clinical guidelines, and the app can alert care teams if an attack seems likely.
â€œIn addition software development, as we take on more COPD programs, we have a broad spectrum of demographics that we have to cover with our products and services,â€ Van Sickle said. â€œSo we are building out teams to support the usability and experience of not only kids with respiratory disease but elderly folks with respiratory disease, caregivers, new enterprise teams for care managers which are on their own evolving with the times and new healthcare arrangements.â€
Propeller is also using some of the funds to build out its client services teams and sales staff, which has been relatively small to date, Van Sickle said.
One of the companyâ€™s recently announced customers was an accountable care organization partly owned by Propeller partner Dignity Health: Arizona Care Network, an ACO formed by Dignity Health and Tenetâ€™s Abrazo Health, recently announced that it would offer its chronic obstructive pulmonary disease (COPD) patients the FDA-cleared, wireless-enabled inhaler and companion program developed by Propeller. The deal marked the first ACO deal for Propeller and one of the few publicly disclosed mobile health customer wins involving an ACO.
â€œWe are [seeing interest from other ACOs] but it depends a lot on what type of ACO, right?â€ Van Sickle said. â€œ[It depends on] how far they are along in their own life course and whether they have developed a budget for innovations investment yet. For a while there was just a lot of groundwork that needed to be laid down to make those kinds of investments. Now we are seeing that change a bit.â€
Propeller is seeing a lot of interest in COPD programs, Van Sickle said, partly driven by the market forces in healthcare incentivizing providers to reduce readmissions for COPD patients in particular.
Propellerâ€™s new Chief Operating Officer â€” the companyâ€™s first ever COO â€” was Practice Fusionâ€™s Associate Vice President of Data Sciences. Hogg joined Practice Fusion in early 2013 after the company acquired his consumer-facing startup 100Plus, which was incubated at Practice Fusion and partially funded by Practice Fusion CEO Ryan Howard, but otherwise a separate business pre-acquisition.
â€œChris brings first and foremost a really interesting mix of skills and experience â€” both the academic experience heâ€™s had and the commercial experience in pharma, data analytics, and fielding a digital health company,â€ Van Sickle said. â€œFor me [Chris’ hire] echoes and foreshadows a shift in digital health toward the therapeutic approach and how we need to build digital health interventions that â€” hopefully â€” have a real focus on delivering improvement and outcome and less on engagement for its own sake. Chris has lived and practiced a lot of what we are trying to do and he has the operating mojo that we want to bring to this company. Heâ€™s a great fit and weâ€™re really excited to have him.â€
Comedian Jim Carey narrates this beautiful sequence of Life. I was moved and only wish that all people across our planet could join in a ocean of consciousness for good and peace. Joined in thought and goodwill to extinguish all hate and evil. Joined together to pervade our societies with a blanket of honor, respect, peace and love.
HealthQuest Capital Raises $110M for Debut Fund with Medtech Focus
Bruce V. Bigelow 8/19/14 Xconomy
HealthQuest Capital, founded last year by Sofinnova Ventures partner Garheng Kong, says it has raised $110 million for its debut fund and already has invested in several medical technology and patient care products.
While HealthQuest is staying close to Sofinnovaâ€”sharing its Menlo Park, CA, office and back office resourcesâ€”Kong says the firm has a different strategy.
Where Sofinnova has raised nearly $1 billion for its two most recent funds to invest mainly in biopharmaceuticals, HealthQuest set out to raise just $50 million for its first fund to invest in medical devices, diagnostics, health IT, mobile health, consumer over-the-counter products, and patient care productsâ€”especially where innovation can improve both patient care and healthcare costs. â€œNowadays, innovation has to be cost-effectiveâ€ as well as improve patient outcomes, Kong said, â€œso healthcare companies want to know how much cost youâ€™re taking out of the system.â€
The combination of team and strategy resonated with investors, Kong said, and he closed fund-raising at $110 million for HealthQuestâ€™s inaugural fund. While there was some overlap with Sofinnovaâ€™s investors, he said HealthQuestâ€™s limited partners are mostly different, and include pension plans, endowments, family offices, and individual investors. A HealthQuest spokeswoman declined to say whether Sofinnova itself has invested in the new fund, saying, â€œWe arenâ€™t providing any detail on underlying investors or economics.â€
David Kabakoff, a San Diego-based partner with Sofinnova Ventures since 2007, will continue to play a role in both worlds. Kabakoff, who has had both operational and investment roles in the life sciences, will be making medtech investments for HealthQuest and placing bets on new drug therapies for Sofinnova.
HealthQuest intends to target areas where there are clear unmet clinical needs for innovation as well as undercapitalized geographies. â€œA lot of these companies are quite capital efficient,â€ Kong said. â€œThe deal sets are equally likely to be spread across the country as they are to be in the Bay Area or Boston. Weâ€™re open-minded about where these companies can be and need to be formed. If your business is focused on hospitals, youâ€™re likely to be in Nashville, TN. If youâ€™re focused on orthopedics, youâ€™re probably in Warsaw, IN.â€
The fund was created last fall and has invested in the following companies:
â€”Orlando, FL-based Vestagen Technical Textiles, which specializes in fabrics and apparel for healthcare workers that are comfortable, designed to repel liquids, and engineered with anti-microbial properties to minimize the chances of spreading infections. HealthQuest invested more than $3 million in Vestagen, Kong said.
â€”Burlingame, CA-based First Aid Shot Therapy, which has been developing over-the-counter remedies formulated as a liquid shot to treat everyday conditions such as pain and upset stomach. HealthQuest invested about $15 million in the company, also known as F.A.S.T.
â€”Friendswood, TX-based Castle Biosciences has been developing molecular diagnostic tests to help doctors determine the optimal treatment for patients with uveal melanoma, cutaneous melanoma, esophageal cancer, thymic cancers, mesothelioma and gliomas. HealthQuest led an $11.8 million round that included Mountain Group Capital and Longfellow Venture Partners.
Kong, was previously a general partner at Sofinnova Ventures, and will continue to manage some Sofinnova investments. But as the founder and managing partner at HealthQuest, he will not be making any new investments for Sofinnova. Some of his deals include Cellective Therapeutics (acquired by AstraZeneca), Novamin Technologies (acquired by GlaxoSmithKline), Cempra Pharmaceuticals (Nasdaq: CEMP), Serenex (acquired by Pfizer) and Alimera Sciences (Nasdaq: ALIM). Kong also sits on the board of Laboratory Corporation of America (NYSE: LH) and the Duke University Medical Center Board of Visitors.
Oher members of the HealthQuest investing team are partner Randy Scott, a medical technology entrepreneur based in Gainesville, FL, and venture partner Tom Callaway of Atlanta, GA, who founded a life sciences executive search firm in Atlanta.