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Thursday, October 4, 2018

Allscripts, Appriss Partner on Access to Prescription Med Monitoring, Abuse Data


Allscripts (NASDAQ:MDRX), a global leader in health care technology, today announced a nationwide integration partnership with Appriss Health, provider of the most comprehensive platform for substance use disorder (SUD) in the U.S., to enable point-of-care access directly to prescription drug monitoring program (PDMP) information and Appriss Health’s NarxCare platform via Allscripts ePrescribe, Allscripts Professional EHR™, Allscripts TouchWorks® EHR, Practice Fusion™ EHR and Allscripts Sunrise™ electronic health record (EHR) platforms. The integration, via Appriss Health’s PMP Gateway platform, of information, advanced analytics, tools, and resources into Allscripts’ platforms can help support clinical decision making, improve patient outcomes, and better ensure patient safety.
This partnership will accelerate access and increase utilization for prescribers across all Allscripts’ EHR platforms using Appriss Health’s NarxCare platform. Utilizing this new integration model, when providers sign up and update their EHR or ePrescribe version, the integration will be automatically established from the practice direct to Allscripts, which in turn sends, receives and delivers the data from NarxCare back to the provider in real-time.
“Our vision at Allscripts is to build open, interoperable connected communities of care,” said Tom Langan, CEO, of Payer & Life Sciences at Allscripts. “As the opioid crisis grows, changes and continues to devastate the U.S., we are aggressively moving to provide our clinicians with a solution that offers objective information and insights into a patient’s risk for drug misuse, abuse, overdose, and death, so patients can be provided with the most effective and appropriate care. This integration partnership with Appriss Health is one in a series of important steps we are taking to act on our mission to efficiently deliver the best solutions available to our providers to enable smarter care, with greater precision, for healthier patients and communities.”
Recently, the CDC predicted that more than 71,000 people in the U.S. died from drug overdose death in the 12-month period ending in January 2018.
Appriss Health’s PMP Gateway platform increases utilization of PDMP information, other information, resources and more, up front, for every patient, at every patient encounter. By delivering both PDMP information and NarxCare within the clinicians’ workflow in Allscripts, this one-click process eliminates the need for providers nationwide to manually log into each state PDMP website separately and then enter a patient’s name and demographics. This easy access to real-time information helps providers to better evaluate and intervene as appropriate with their patients.
All Allscripts ambulatory and acute EHR platforms feature electronic prescribing of medications, a central component of the clinical workflow process which both informs and automates the prescribing process in real-time for thousands of prescribers and millions of patients.

Investor Criticizes China Biologic Over Rejected Takeover Bid


An investor in China Biologic Products Holdings Inc. has criticized the biopharmaceutical company for rejecting a $3.9 billion takeover bid, saying it should consider all options to maximize shareholder value and unwind a private placement that created a controlling group of insiders.
York Capital Management said in a letter to China Biologic’s board that several other holders, including Comgest Global Investors and Kite Lake Capital, share its concerns about the company rejecting the $118-per-share proposal.
“There was no sign of any serious engagement with the bidding consortium,” Richard Swanson, York Capital’s general counsel, wrote in the letter dated Sept. 26 that was obtained by Bloomberg. “No effort was made to solicit a higher bid from the consortium or from other bidders, despite media reports of multiple interested parties.”
U.S. and China-based representatives for China Biologic didn’t respond to requests for comment.
China Biologic received the all-cash proposal in August from a consortium led by the company’s former chairman David Gao and several investment firms. The group offered to acquire the shares in the company they didn’t already own at $118 a piece, a 31 percent premium on the closing price on Aug. 16, the day before the offer was made, according to data compiled by Bloomberg.
Four days later, the company’s board rejected the proposal, saying it didn’t reflect the intrinsic value of the company. The board also announced that it would issue 5.85 million shares in a private placement to a consortium that included shareholder PW Medtech and Centurium Capital, a private equity fund run by China Biologic Chairman David Hui Li at $100.90 apiece. The move gave Centurium and its partners a combined stake of about 37 percent in the company, York Capital said in its letter.
“As evidenced by where the shares are trading after the rejection and private share issuance, currently around $80/share, we do not believe that the company’s actions have created any value for minority shareholders,” Swanson said.
Beijing-based China Biologic’s shares fell 1.7 percent to $78.11 at 12:30 p.m. Thursday in New York, valuing the company at $2.6 billion.
The board said the private placement was done to help acquire and develop leading technologies assets, York Capital said, noting that China Biologic has $366 million in cash on its balance sheet.
“There has been no explanation made as to why the company would be in need of additional cash at this particular point in time,” York Capital said.

Analysts React To Arrowhead-Janssen Linkup: Downside May Be ‘Misguided’


Arrowhead Pharmaceuticals, Inc. ARWR 17.4% stock tanked 15 percent Thursday after the company announced a new $3.7-billion dealto license its ARO-HBV treatment for chronic hepatitis B to Johnson & Johnson JNJ 0.18% subsidiary Janssen Pharmaceuticals.
Investors clearly weren’t impressed by the new deal, but several analysts are saying it’s not as bad as the market is pricing in.

Terms Of The Deal

The new deal gives J&J exclusive licensing rights on the ARO-HBV program. In return, Arrowhead gets $175 million upon closing of the deal, Johnson & Johnson will take a $75 million stake in Arrowhead at a price of $23 per share, and will be eligible to receive $1.6 billion in payments via an initial tier of milestones and another $1.9 billion in additional payments as the treatment reaches a series of three additional targets.
FBR B. Riley analyst Madhu Kumar told Benzinga the negative market reaction in Arrowhead is the result of investors concluding that Arrowhead is “giving away” its best asset and forfeiting the company’s status as a prime acquisition target. He also said investors are likely “selling the news” and taking profits after the stock gained more than 400 percent year-to-date. Kumar said much of the negative sentiment appears to be misguided.
Cantor Fitzgerald analyst Elemer Piros reiterated his Outperform rating for Arrowhead and raised his price target from $17 to $24. Piros said the cash from the cash from the new deal will help Arrowhead develop its international clinics.
“Overall, we feel the agreement is positive for the company as the support of a large partner could speed up the development timelines, increase market penetration with expertise, and validates the TRiM platform that Arrowhead uses,” Piros wrote in a note.

ARO-HBV Value Estimates

Piper Jaffray analyst Edward Tenthoff reiterated his Overweight rating and raised his price target for Arrowhead from $17 to $25. Tenthoff now estimates ARO-HBV 2025 global royalties of $250 million.
“We view this deal as transformative for Arrowhead dramatically strengthening the balance sheet, finding a strong partner for ARO-HBV, while retaining the rest of TRiM pipeline,” Tenthoffsaid.
Even after Thursday’s sell-off, Arrowhead shares are still up 311 percent year-to-date. The stock traded around $15.56 at time of publication.

Veeva TAM expanded again but valuation is fair, says JPMorgan


JPMorgan analyst Sterling Auty kept his Neutral rating and $95 price target on Veeva after its Analyst Day presentation. The analyst states that the management has increased its total addressable market estimate to over $9B from $8B indicated in last year’s analyst day while also boosting its operating margin projections and outlining a roadmap for more products. Auty noted however that Veeva’s current multiple presents limited room for upside.

Migraine treated without medicine in pilot study


By slightly changing the body’s own molecules using a small inhaler, certain migraine patients can either cut down on medication or do without it completely. This is shown by a pilot study which has been published in the scientific journal Cephalalgia.
Patients who suffer from migraine with aura, which is where they experience either sensory or visual disturbances before the painful headaches begin, have been examined in the study. Eleven patients participated in the pilot study, which will now be followed by a large clinical trial.
One of the authors is MSc in Engineering and PhD Troels Johansen, who carried out the study as part of his PhD at the Department of Clinical Medicine at Aarhus University and the Headache Clinic at Aarhus University Hospital, Denmark.
He explains that migraines occur as part of a chain reaction during which the veins in the brain contract and the blood cannot therefore supply the brain with sufficient oxygen.
“We utilise CO2 and oxygen, which are the body’s natural molecules for mobilising its own defence against migraine attacks. The inhaler expands the blood vessels that supply the brain with oxygen by up to seventy per cent and thereby stops the destructive chain reaction,” says Troels Johansen, adding that the effect of the treatment starts after a few seconds.
The pilot study was carried out from 2016-2017 with eleven patients with migraine with aura. One of the results was that the effect of the pain relief increased significantly with each use of the inhaler. Forty-five per cent experienced an effect the first time, and that number rose to 78 per cent the second time.
“The study shows some very significant physiological effects in the body,” says Troels Johansen, who currently teaches at the Aarhus University School of Engineering. Together with a team of employees, he has put the inhaler into production through the company BalancAir.
Since the pilot project is limited to migraine with aura and only comprised eleven patients, Troels Johansen is now planning to conduct a large clinical trial that will also include migraine without aura and chronic migraine.
Story Source:
Materials provided by Aarhus UniversityNote: Content may be edited for style and length.

Journal Reference:
  1. Cecilia H Fuglsang, Troels Johansen, Kai Kaila, Helge Kasch, Flemming W Bach. Treatment of acute migraine by a partial rebreathing device: A randomized controlled pilot studyCephalalgia, 2018; 38 (10): 1632 DOI: 10.1177/0333102418797285

DNA-encoded checkpoint inhibitor antibodies advance immunotherapy


Wistar scientists and collaborators demonstrate for the first time that through engineering constructs, they can express DNA-encoded monoclonal antibodies (DMAbs) targeting CTLA-4, an important cancer checkpoint molecule that blocks anti-cancer immunity. Using a synthetic DNA platform, they built versions of the anti-CTLA-4 molecule and were able to then deliver the DMAbs and have them generate fully functional anti-CTLA4 molecules in vivo. This proof-of-principle study opens new avenues for the design and delivery of therapeutic checkpoint inhibitors and suggests potentially novel applications of this technology in cancer treatment. Study results were published online in Cancer Research.
Treatment of cancer with checkpoint inhibitors has recently revolutionized cancer immunotherapy. Since the discovery of immune checkpoints, which was recognized as a groundbreaking development for cancer therapy and awarded the Nobel Prize in physiology or medicine this week, checkpoint inhibitors are becoming standard of care for various malignancies, showing unprecedented impact for patients.
Despite the tremendous advancement in cancer therapy brought by monoclonal antibodies targeting checkpoint molecules, manufacturing complexity and repeated dosing may limit a broader use of this technology.
“Our work provides the first demonstration that we can use synthetic DNA technology to produce checkpoint inhibitor molecules in vivo to impact tumor growth in a preclinical setting,” said lead researcher David B. Weiner, Ph.D., executive vice president and director of the Vaccine & Immunotherapy Center at The Wistar Institute, and W.W. Smith Charitable Trust Professor in Cancer Research. “We showed that DMAbs may represent a valuable addition to the cancer immunotherapy toolbox: In our preclinical studies, DMAbs achieved antitumor activity comparable to that of traditional monoclonal antibodies, while being delivered through a simpler formulation that may provide a bridge to expand target populations for checkpoint inhibitors.”
The team developed a synthetic, sequence-optimized DNA plasmid designed to encode anti-mouse CTLA-4 monoclonal antibodies. When injected in the muscle of mice with the aid of an electroporation device to enhance uptake, the anti-CTLA-4 DMAbs resulted in significant and prolonged antibody expression with even a single dose. Importantly, this approach stimulated robust CD8+ T-cell infiltration, achieving tumor clearance across multiple mouse tumor models. The researchers then went on to develop human checkpoint inhibitor molecules and demonstrated their production in mice and their ability to stimulate human T-cell responses associated with antitumor activity.
“Our results open the door for further applications of DMAbs in cancer immunotherapy,” said Elizabeth K. Duperret, Ph.D., postdoctoral fellow in the Weiner Lab and first author on the study. “This platform is rapid and flexible, allowing for further optimization of antibody sequences, including development of novel therapeutic approaches for which conventional monoclonal antibodies are not suitable.”
This work was supported by National Institutes of Health grants F32 CA213795 and SPORE P50CA174523, and funding from the W.W. Smith Family Trust and the Basser Foundation. Core support for The Wistar Institute was provided by the Cancer Center Support Grant P30 CA010815. Additional funding was provided by Inovio Pharmaceuticals.
Co-authors of this study from The Wistar Institute include Aspen Trautz, Regina Stoltz, Ami Patel, Alfredo Perales-Puchalt, and Kar Muthumani. Other co-authors include Megan C. Wise, Trevor Smith, Kate Broderick, Emma Masteller, J. Joseph Kim, and Laurent Humeau from Inovio Pharmaceuticals.
Story Source:
Materials provided by The Wistar InstituteNote: Content may be edited for style and length.

Rigel Pharma Analyst Day saw 85% tavalisse refill rate, says Piper Jaffray


Piper Jaffray analyst Christopher Raymond kept his Overweight rating and $8 price target on Righer Pharmaceuticals after the company’s Analyst Day. He says the presentation indicated utilization of Tavalisse across all lines and a 85% refill rate, suggesting that the drug had higher demand than anticipated. Raymond contends that the launch so far has been successful while also pointing to the company’s “positive progress for fostamatinib in AIHA and other pipeline products”.
https://thefly.com/landingPageNews.php?id=2800113