Kiniksa announced that it will present preclinical data for KPL-404, a monoclonal antibody inhibitor of the CD40 co-stimulatory receptor, at the Keystone Symposia.
Monday, April 8, 2019
Bio-Rad Labs (BIO) Receives U.S. FDA Clearance for IH-500
Bio-Rad Laboratories, Inc. (NYSE: BIO), a global leader of life science research and clinical diagnostic products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Bio-Rad’s IH-500, an automated random access system for blood typing and screening.
The IH-500 system was designed for small- to medium-size laboratories, offering automated blood typing and screening based on gel card technology with minimal user intervention. The system can process Bio-Rad’s entire range of IH gel cards for ABO blood grouping, reverse testing, phenotype, Rh-subgroups, antibody screening, antibody identification, single antigen testing, direct AHG testing (DAT), and crossmatch, to deliver safe and accurate results.
“We are pleased to receive FDA clearance for our IH-500 and look forward to extending our reach in the U.S. transfusion medicine market,” said John Hertia, Bio-Rad Executive Vice President and President, Clinical Diagnostics Group. “This addition rounds out our offering, specifically benefitting mid and smaller volume laboratories using gel technology to test blood in an automated way,” he said.
Zogenix hit after FDA rejects filing
Zogenix Inc. ZGNX, -0.29% shares dropped in the extended session Monday after announcing that the Food and Drug Administration did not accept a marketing application for one of its drugs. Following a brief halt, Zogenix shares fell 25% after hours, following a 0.3% decline to close at $51.85 in the regular session. The developer of rare-disease therapies said the FDA rejected a marketing application for its drug Fintelpa to treat seizures from Dravet syndrome because they were “not sufficiently complete to permit a substantive review.” Zogenix said it would seek immediate guidance from the FDA to respond to issues raised in the rejection.
FDA OKs ViiV Healthcare’s two-drug HIV combo
The FDA approves Viiv Healthcare’s Dovato (dolutegravir and lamivudine) for the treatment of HIV-1 infection in adults who have not received prior antiretroviral treatment, the first fixed-dose two-drug combo regimen available in the U.S. for these patients.
ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (GSK +0.2%), Pfizer (PFE +0.2%) and Shionogi (OTCPK:SGIOY -0.4%).
Apple healthcare opportunity seen growing to as much as $300B+ in decade
A Morgan Stanley analyst sees healthcare as a $15B-$313B revenue opportunity for Apple by 2027
Alexa is moving into healthcare, with Amazon (AMZN) announcing a program allowing select developers to create and launch HIPAA-compliant healthcare skills for the company’s voice assistant. Amazon was one of the technology companies identified by participants in a recent Morgan Stanley survey as potentially having the largest impact on healthcare over the next five years, alongside Google (GOOGL; GOOG) and Apple (APPL). However, analyst Katy Huberty argued that participants may be underestimating the iPhone maker as she believes Apple is building a healthcare ecosystem and is “poised to emerge as a leader in consumer-centric healthcare.”
ALEXA TO TRACK CONSUMER HEALTHCARE: Over the weekend, The Wall Street Journal’s Melanie Evans reported that Amazon is positioning its AI assistant Alexa to track users’ prescriptions and relay personal health information in an effort to involve the technology in everyday healthcare. Five companies including Cigna (CI), Livongo Health and some major hospital systems have developed Alexa features for consumers using federal protocol, the publication added. This follows Amazon’s announcement last week that “the Alexa Skills Kit now enables select Covered Entities and their Business Associates, subject to the U.S. Health Insurance Portability and Accountability Act of 1996, HIPAA, to build Alexa skills that transmit and receive protected health information as part of an invite-only program. Six new Alexa healthcare skills from industry-leading healthcare providers, payors, pharmacy benefit managers, and digital health coaching companies are now operating in our HIPAA-eligible environment. In the future, we expect to enable additional developers to take advantage of this capability.”
APPLE OPPORTUNITY UNDERAPPRECIATED: Apple is building a healthcare ecosystem and is “poised to emerge as a leader in consumer-centric healthcare,” Morgan Stanley’s Huberty told investors in a research note on Monday. The analyst pointed out that the center of gravity is shifting in U.S. healthcare, as wearables, electronic medical records, and proposed regulations are enabling data to flow more freely between silos and stakeholders. Huberty sees healthcare as a large, greenfield services opportunity for Apple, which has the potential to lead digital disruption, much like what iTunes did for music or the App Store did for mobile services. The company’s healthcare strategy appears to aim for an ecosystem that puts the consumer at the center, she contended, noting that the Apple Watch has evolved into a “health monitoring guardian and guru.”
Further, Huberty argued that armed with the Apple Watch and the iPhone, Apple is emerging as “an agent of change” in healthcare and a “leader among tech companies entering the space.” While the analyst sees room for contribution from many technology companies in reducing the estimated $1.2T of wasted U.S. healthcare spending while at the same time improving outcomes, she believes Apple’s advantages include its outsized user base, particularly in wearables; a proven services platform; and trust as a steward of data privacy. Investors are aware of Apple’s healthcare efforts, but the analyst believes they “may be missing the big picture and underappreciating the magnitude of the opportunity.” Huberty noted that her firm’s recent survey of 30 meeting participants, three-quarters of them C-level executives from leading healthcare and technology companies, showed that those polled see Amazon, Google and Apple as the technology companies that will have the largest impact on healthcare over the next five years, in that order of concentration of votes. However, they seem to be underestimating what Apple can accomplish, she thinks.
Overall, the analyst told investors that she sees healthcare as a $15B-$313B revenue opportunity for Apple by 2027. Huberty believes there are two clear paths to monetization, namely wearables and services. Sustained 40% growth in wearables alone implies Apple would reach the low end of that $15B-$313B target by 2021, she said, while access to free applications increases the value of Apple’s platform and helps the company sell more devices and its own services. Additionally, the analyst sees iCloud possibly becoming the go-to cloud service for storing individual’s health data. Huberty reiterated an Overweight rating on Apple’s shares.
Can Trevi get through IPO window with old opioid that failed key Phase 2?
The window for biotech IPOs may still be open, but is it open wide enough to accommodate Trevi Therapeutics, with a failed Phase II study for an extended-release version of an old opioid pain remedy?
Trevi filed for an $86 million IPO over the weekend. In it, they apparently revealed for the first time that their drug, nalbuphine ER, failed badly in a mid-stage study that recruited 63 patients and tested it at 2 doses compared to a placebo.
Based on a post hoc analysis, which teased out more promising results by excluding the patients who had dropped out of the study, the biotech is nevertheless undertaking a Phase IIb/III clinical trial in uremic pruritus, with 373 patients to be enrolled with a moderate to severe case of the disease.
Based on a post hoc analysis, which teased out more promising results by excluding the patients who had dropped out of the study, the biotech is nevertheless undertaking a Phase IIb/III clinical trial in uremic pruritus, with 373 patients to be enrolled with a moderate to severe case of the disease.
Here’s their summary of the data:
In the 162 mg arm, patients reported a mean 2.51 point reduction in WI-NRS score from baseline as compared with a mean 1.75 point reduction in the placebo arm (p=0.083), with 44% of the patients in the 162 mg arm constituting responders as compared to 36% of the patients in the placebo arm (p=0.323). In the 81 mg arm, patients reported a mean 2.14 point reduction in WI-NRS score from baseline, with 27% of the patients in the arm constituting responders (p=0.779). A key secondary endpoint of the trial was the proportion of patients reporting at least a 50% reduction in WI-NRS score from baseline. In the 162 mg arm, 33% of patients reported at least a 50% reduction in WI-NRS score as compared to 18% of patients in the placebo arm (p=0.083).
That’s not good. But there was a positive secondary on quality of life. The only mention we could find of a Phase II on Trevi’s webpage dates back to 2016, which they said was positive.
This is the New Haven-based biotech’s only drug, which they are testing for a variety of conditions.
We read on Wikipedia that nalbuphine is the only opioid that is not marketed as a controlled substance. Approved 41 years ago, it’s been generic for decades now.
Trevi is going into the attempted IPO without the big bucks we’re used to seeing. The biotech ended 2018 with $7.2 million in the back, then soon after raised $10 million in a Series C sale of stock. The company has raised $92 million from the sale of shares and notes and also obtained a $15 million loan, which has been paid back.
TPG is the big backer here, with 55% of the stock. NEA follows at 20% with Lundbeckfond Invest in at 8% and Omega Fund in at 6.2%. CEO Jennifer Good has 4.3% of the shares while Chairman David Meeker — ex-Genzyme chief and biotech CEO — has a 3.9% stake in the company.
Concert Pharma Confirms Decision from Patent Trial and Appeal Board
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a final written decision in connection with the inter partes review (IPR) of U.S. Patent No. 9,249,149 (the ‘149 patent). While PTAB found that the claims of the ‘149 patent are not patentable, the IPR decision is appealable to the U.S. Court of Appeals for the Federal Circuit, and Concert remains committed to defending the ‘149 patent. The ‘149 patent remains valid and enforceable until appeals have been exhausted.
“While we’re disappointed in this outcome, we believe we have strong arguments supporting the validity of our patent and intend to appeal the decision as we work to create additional intellectual property protecting CTP-543,” stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “We remain highly committed to the continued advancement of CTP-543 as a potential treatment for alopecia areata. The outcome of this proceeding does not prohibit us from developing CTP-543 for alopecia areata and our development timelines for CTP-543 remain on track. Importantly, today’s decision is specific to certain patent claims covering CTP-543 and does not affect other programs in our portfolio.”
In April 2017, Incyte filed a petition challenging the validity of the ‘149 patent. Documents relating to the IPR can be accessed online at: http://www.concertpharma.com/technology-overview/intellectual-property/
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