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Wednesday, July 17, 2019

CVS to face barriers to entry in home dialysis – UBS

In a note, UBS says CVS Health’s (CVS -1.4%) potential entry into home dialysis may have limited success since patients will still need to work with a nephrologist and must belong to a clinic, requirements that CVS may struggle to match through its pharmacy network.
UBS adds that CVS may also have difficulty extricating itself from non-compete contracts and joint ventures with established dialysis providers.
DaVita (DVA -1.3%) and Fresenius Medical Care (FMS -2.6%) are still down, but above their session lows.
SA Authors rate CVS Bullish and DVA Neutral. The Quant rating for FMS is Neutral.

Eisai anticancer agent Halaven OKd in China for breast cancer

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, ‘Eisai’) announced today that Eisai received New Drug Approval for Eisai’s in-house developed anticancer agent Halaven (eribulin mesylate) for use in the treatment of patients with locally advanced or metastatic breast cancer, previously treated with at least two prior chemotherapy regimens, including an anthracycline and a taxane, from the China National Medical Products Administration (NMPA).
This approval is based on the results of Study 304,1 which was a multicenter, open-label, randomized, parallel group Phase III clinical study, to evaluate the efficacy and safety of Halaven and vinorelbine in 530 women with locally recurrent or metastatic breast cancer, previously treated with chemotherapy regimens, including an anthracycline and a taxane. Halaven demonstrated a statistically significant extension in the study’s primary endpoint of progression-free survival (PFS) over the comparator treatment vinorelbine according to independent imaging review (Hazard Ratio: 0.80; 95% Confidence Interval: 0.65-0.98; p = 0.036).

Musk’s Neuralink close to clinical trials of ‘brain interface’ device

A new brain implant technology from Elon Musk’s tech startup Neuralink could be used as a treatment for neurologic conditions and Parkinson’s disease.
Musk describes Neuralink as a “brain-machine interface” company – and its latest invention is based on “threads” around a thousand times thinner than a human hair that could be injected by a robot into the brain to detect the activity of neurons.
Musk said at a press event, also streamed online, that one goal of the technology is to stave off the “existential threat” of artificial intelligence surpassing human intelligence.
Musk has argued for several years that even if AI is benign, there is a need for a direct interface with a machine to allow humans to keep up with their development.
So far Neuralink’s technology has only been tested in rats and monkeys – Musk has said that the system has allowed a monkey to “control a computer with his brain.”
But according to Neuralink’s president Max Hodak, the technology is close to clinical trials in neurological disorders.
The company will seek FDA approval for a human clinical trial as early as next year in a specially modified version of the device.
This first trial will target patients with complete paralysis due to a break in the upper spinal cord and will involve installing four of its devices in patients’ brains.
There are other potential applications too, such as for Parkinson’s disease, where it could improve on existing deep brain stimulation therapy.
Neuralink thinks the device could be a step forward on existing technology in this field as it would allow 1,000 times more electrodes to interface with the brain than the best FDA-approved device.
Neuralink also thinks that its device will be less risky than current deep brain stimulation techniques, which involve small holes being drilled in the skull.
Musk said at the press event this week: “This has a very good purpose, which is to cure diseases, and ultimately secure humanity’s future.”

Chardan Healthcare Acquisition Corp. to Merge with BiomX Ltd.

Chardan Healthcare Acquisition Corp. (NYSE: CHAC, “CHAC”), a special purpose acquisition company (“SPAC”) sponsored by affiliates of Chardan Capital Markets LLC (“Chardan”), announced today that it has entered into a definitive agreement for a business combination with BiomX Ltd. (“BiomX”), a microbiome company developing both natural and engineered phage therapies.
Assuming no redemption of CHAC shareholders, the combined company will have an initial market capitalization of approximately $254 million. Upon closing of the transaction, it is expected that CHAC will be renamed BiomX and remain on the NYSE American Stock Exchange, listed under a new ticker symbol.
CHAC has entered into a mix of commitments including purchase and sale, backstop, and voting agreements with BiomX and with investors — including OrbiMed, RTW Investment, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Takeda Ventures, Inc., MiraeAsset, Seventure Partners’ Health for Life Capital I, SBI Japan-Israel Innovation Fund, as well as RM Global Partners (RMGP) BioPharma Investment Fund — so that the $50 million minimum closing condition for the transaction has been satisfied prior to today’s announcement.
Proceeds from the transaction will provide BiomX with substantial growth capital and the flexibility of a public listing to further accelerate BiomX’s expansion as a leading microbiome product discovery company. BiomX is developing customized phage-based products designed to improve the appearance of acne-prone skin and eradicate harmful bacteria in chronic diseases. The company’s pipeline includes preclinical candidates for acne-prone skin, inflammatory bowel disease (IBD), primary sclerosing cholangitis (PSC), and colorectal cancer (CRC). BiomX’s product for acne-prone skin is anticipated to begin clinical testing by the end of 2019. The combined company will continue to be led by BiomX’s experienced management team headed by Chief Executive Officer Jonathan Solomon.
“We created CHAC to partner with an innovative biotechnology company that would benefit from a public listing, could use our cash resources to implement groundbreaking clinical work, and whose products and technology could lead to significant growth and drive long-term returns for our shareholders,” said Jonas Grossman, CHAC’s President and Chief Executive Officer. “BiomX has all those qualities, along with an experienced management team ready to take the reins of a public company. We believe this transaction leaves BiomX with a strong balance sheet and sufficient cash for the company to reach multiple value inflection points in its leading clinical programs.”   George Kaufman, CFO and Head of Strategy at CHAC, noted, “We believe we have structured a transaction that will deliver value to all stakeholders and creates opportunity for new investors.  We are excited to make use of inherent features of the SPAC in combination with the fundamental qualities of BiomX and supportive shareholders for the benefit of all of our partners.”
CHAC will host a conference call to discuss the proposed business combination with the investment community on July 17, 2019 at 8:30 AM EDT. Investors may listen to the conference call by dialing (877) 705-6003 toll-free in the U.S. or (201) 493-6725 internationally. The conference ID number is 13692693. The conference call webcast will be available at http://public.viavid.com/index.php?id=135425. A related investor presentation with more detailed information regarding the proposed transaction will be furnished today to the SEC, and can be viewed at the SEC’s website at www.sec.gov. A transcript of the investor call, when available, as well as the investor presentation, can also be found on the BiomX website www.biomx.com.

AC Immune launches early-stage ACI-3024 study for Alzheimer’s

AC Immune SA (NASDAQ:ACIU) has announced dosing of the first subject in a Phase 1 study of ACI-3024, an investigational oral small molecule Tau Morphomer inhibitor to address neurodegenerative diseases that are characterized by the presence of pathological Tau aggregates.
This is the first significant advancement in AC Immune’s collaboration with Eli Lilly and Company (NYSE:LLY).
The trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of ACI-3024 in healthy volunteers.

Halozyme bags $5M milestone from argenx on start of efgartigimod study

The first patient has been dosed in a Phase 1 clinical trial evaluating the safety, pharmacokinetics and pharmacodynamics of a subcutaneously administered formulation of argenx SE’s (NASDAQ:ARGX) efgartigimod (ARGX-113) based on Halozyme Therapeutics’ (NASDAQ:HALO) ENHANZE drug delivery technology.
The event triggers a $5M milestone payment to HALO.

Dialysis services providers down on study of CVS Health home dialysis device

DaVita (NYSE:DVA) and Fresenius Medical Care (NYSE:FMS) are down 4% and 3%, respectively, premarket, both on light volume, in apparent response to the commencement of a clinical trial evaluating a home dialysis device from CVS Health (NYSE:CVS) that could pose a competitive threat.
The HemoCare device was designed by DEKA REsearch & Development Corp., a firm headed by Segway inventor Dean Kamen. CVS owns exclusive U.S. rights to the product.
Update: CVS says the trial will enroll up to 70 patients across as many as 10 U.S. sites.