Ablative Solutions bags $77M to complete hypertension device trials

Ablative Solutions raised $77 million from the likes of Gilde Healthcare and BioStar Ventures to bankroll clinical trials of its minimally invasive treatment for uncontrolled hypertension.

Specifically, the new capital will support clinical trials for Ablative’s alcohol-mediated renal denervation technology in support of regulatory filings in the U.S. and Europe, the company said in a statement. The procedure is performed using the company’s Peregrine system and is intended to reduce blood pressure in people with hypertension for whom antihypertensive drugs do not work.

The Peregrine System Kit targets sympathetic nerves that run to and from the kidneys along renal arteries and play a key role in the regulation of blood pressure. The system delivers small doses of dehydrated alcohol to the space outside the renal artery to block overactive signaling of the sympathetic nerves. It does so via the Peregrine System Infusion Catheter, which has FDA clearance to infuse diagnostic and therapeutic agents to the perivascular space that surrounds blood vessels. The system is being studied both in patients taking antihypertensive medication and in those who are not.

Michigan Accelerator Fund, Novus Biotechnology and other individual investors joined Gilde and BioStar in the series D round.

“Hypertension creates a significant burden on the healthcare system, increasing the risk of serious cardiovascular events and stroke,” said Geoff Pardo of Gilde Healthcare in the statement. “We see tremendous potential for Ablative Solutions’ approach and believe the team has a solid plan for building the clinical data through the TARGET BP clinical program.”

Ablative Solutions isn’t the only player using renal denervation to attack high blood pressure. Last July, Otsuka announced it would acquire ReCor Medical and its ultrasound ablation system. ReCor’s device is designed to treat hypertension the same way Ablative’s does—by downregulating the activity of the sympathetic nerves.

https://www.fiercebiotech.com/biotech/ablative-solutions-bags-77m-to-complete-hypertension-device-trials

Verily pockets $1B with eyes on partnerships, M&A

Six weeks after canning its Novartis-partnered glucose-sensing contact lens project, Verily is raising a $1 billion round that will power new partnerships, “global business development opportunities” and potential acquisitions.

Silver Lake led the mammoth round and was joined in the investment by Ontario Teachers’ Pension Plan and “other global investment management firms.” The company did not disclose financial terms of the transaction.

“We are taking external funding to increase flexibility and optionality as we expand on our core strategic focus areas,” said Verily CEO Andrew Conrad in a statement. “Adding a well-rounded group of seasoned investors, led by Silver Lake, will further prepare us to execute as healthcare continues the shift towards evidence generation and value-based reimbursement models.”

The financing comes after a year during which Verily inked multiple partnerships. In May, the company joined forces with Gilead Sciences to analyze the effect the latter’s drugs have on the immune cells of patients with inflammatory diseases. In June, Sanofi, Sensile Medical and Verily teamed up to develop an “all-in-one” insulin patch pump, primarily aimed at patients with Type 2 diabetes—nearly two years after Verily and Sanofi created Onduo, their diabetes-focused joint venture. In July, Verily set up a joint venture with ResMed to apply big data analytics to sleep apnea by developing connected software to assist healthcare providers in identifying and managing patients.

Further, despite halting its smart contact lens project—the device was ultimately unable to consistently measure glucose levels in tears that correlated with blood glucose readings—Verily’s partnership with Novartis continues. The pair is working on a responsive, accommodating contact lens for presbyopia—age-related farsightedness—and a smart intraocular lens for improving sight following cataract surgery.

https://www.fiercebiotech.com/biotech/verily-pockets-1b-eyes-partnerships-m-a

Vaccine for Type 1 diabetes? Provention Bio says a human trial is in sight

Type 1 diabetes, in which the immune system attacks insulin-producing beta cells of the pancreas, is caused by both genetic susceptibility and environmental factors, researchers believe. Biotech startup Provention Bio is trying to reduce the environmental risk by way of a vaccine scientists believe can prevent up to 50% of new Type 1 diabetes cases.

Previous epidemiological studies and experiments on animals and human tissues have suggested a possible link between enterovirus (EV) infections and Type 1 diabetes, according to a summary co-authored by Provention’s co-founder and chief scientific officer, Francisco Leon, M.D., Ph.D., which appeared recently in the journal Expert Review of Vaccines. EVs are known to infect the pancreas and cause a diabetes-like disease in animals. Additionally, scientists have prevented diabetes in mice with attenuated virus vaccines or recombinant VP1 viral proteins.

Based on those findings and with proceeds from an initial public offering, Provention is now advancing a multivalent group B coxsackieviruses (CVBs) vaccine candidate dubbed PRV-101 into the clinic for Type 1 diabetes, it announced.

Researcher Heikki Hyöty of the University of Tampere in Finland, who co-authored the current review, had previously found that people with markers of EV infections had an increased risk of Type 1 diabetes. He published that evidence in a 2017 paper in the journal Diabetologia.

In that study, Finnish scientists examined 1,673 longitudinal stool samples from 129 children who turned positive for autoantibodies against pancreatic islets—which is known as a pre-symptom phase of Type 1 diabetes—and compared them with 3,108 samples from 282 matched control children. The researchers observed an increased frequency of EV RNA in the children long before the emergence of autoimmunity.

What’s more, Hyöty and colleagues found that CVB1 antibodies in the mothers of the study subjects were associated with about 50% lower rate of autoimmunity in the children.

“This important observation suggests that a vaccine against CVB could prevent a substantial subset of T1D cases,” wrote the authors in the current study.

Still, there isn’t enough evidence to prove the observed CVB-diabetes link is indeed causal. That key question will likely only be answered by a clinical trial. That’s where Provention Bio comes in.

The company has developed PRV-101, a multivalent CVB vaccine made with the same formalin-inactivated whole-virus vaccine technology used in a polio inoculation. In a preclinical proof-of-concept study done by a team at the University of Tampere, a prototype of the vaccine successfully protected against virus-induced diabetes in a mouse model of Type 1 diabetes, the team reported in a Diabetologia paper.

Provention is on track to start human trials of PRV-101 soon, and its executives hope it will be the first vaccine to prevent up to 50% of Type 1 diabetes cases. “In addition to the potential prevention of T1D, this vaccine could have other important beneficial health effects generated by protection against acute CVB infections, which are frequent and cause significant morbidity particularly in young children,” Leon said in the announcement.

https://www.fiercebiotech.com/research/a-vaccine-for-type-1-diabetes-provention-bio-might-have-it

Fujifilm plans $20M U.S. facility for stem cell treatments

A host of companies are developing regenerative treatments that lean on stem cells. Seeing an opportunity, Japan’s Fujifilm will build a U.S. stem cell manufacturing facility not only for its own efforts but also as a CDMO.

The company said today that its Fujifilm Cellular Dynamics Inc. (FDCI) subsidiary will invest about $21 million to build a facility in Madison, Wisconsin, to “industrialize” induced pluripotent stem cell technologies for its pipeline of regenerative drugs and to manufacture iPS cells for others. It expects the facility to be ready by March 2020.

“To meet the growing demand for FCDI’s iPS cell platform, the state-of-the-art production facility will have a flexible cell culturing design to serve production requirements of both industrial quantities of cells, and small, diverse batches,” Seimi Satake, FCDI CEO, said in a statement. “By combining Fujifilm’s experience gleaned from the intricate process of manufacturing photographic film along with FCDI’s knowledge of cell reprogramming, genetic engineering and cell differentiation, the facility is poised to address the complex manufacturing processes of cell therapies.”

Fujifilm pointed to its investment in and work with Australian biotech Cynata Therapeutics as an indication of its experience. The Melbourne-based company is using a technology called Cymerus to manufacture mesenchymal stem cells to treat cytokine release syndrome, a severe immune reaction in some patients taking CAR-T treatments. Additionally, it said FCDI is already manufacturing iPS cell products for research by public institutions, pharma companies and academia.

A couple of other stem cell manufacturing facilities were announced toward the end of last year. Novo Nordisk, which is investigating stem cell treatments that might eventually cure Type 1 diabetes, is building out a facility in Fremont, California, that it has leased from stem cell biotech Asterias Biotherapeutics. Orchard Therapeutics is investing up to $90 million to build a manufacturing facility for its gene therapies program, also in Fremont.

https://www.fiercepharma.com/pharma-asia/fujifilm-plans-20m-u-s-facility-for-burgeoning-interest-stem-cell-treatments

Could Gilead, Amgen and AbbVie follow Bristol-Myers into megadeal territory?

Bristol-Myers Squibb’s Thursday announcement that it would nab Celgene for $74 billion brought “megamergers back to pharma,” as Credit Suisse analyst Vamil Divan put it in a note to clients. And the return has industry watchers wondering which company will be the next to follow suit.

Plenty of drugmakers could stand to pump up growth, and thanks to U.S. tax reform, they have the funds to do it. Just look at AbbVie, one of tax reform’s biggest winners, which also happens to be moving closer every day to a post-Humira future.

AbbVie certainly isn’t the only one out there with big assets set to wane over the next few years. Amgen is also coming up against biosimilar competition for Neulasta, and Bernstein analyst Ronny Gal has suggested the California company could ease the pain with a buyout of rare-disease focused Alexion. And it’s holding onto $30 billion in cash that it could put toward the cause, Bloomberg notes.

As analysts told the news service, a couple other big players belong on the M&A watch list, starting with Gilead. The Big Biotech has already attempted to mitigate its hepatitis C sales slide with one mammoth deal—its $12 billion pick-up of Kite—but with Kite’s CAR-T sales off to a slow start, it could use another, analysts contend. And they say companies like Clovis Oncology, which is struggling to keep its PARP inhibitor Rubraca competitive against rivals with more marketing muscle, could make a good target.

And then there’s Merck & Co., whose investors seem to be clamoring for some dealmaking action despite the company’s smashing success with PD-1 cancer fighter Keytruda.

Lucky for them, the New Jersey pharma giant’s executives are on board. “Let me start by saying that we’re pleased with the way in which our business is growing now, particularly in the oncology field, but that doesn’t make us comfortable,” CEO Ken Frazier told shareholders on Merck’s third-quarter call in October, adding that, “we have to continue to build our portfolio and build on our pipeline, and that’s why [business development] is an important priority for us going forward.”

Who’s not likely to take a seat the buyer’s table in 2019? Historical megamerger champion Pfizer, according to new CEO Albert Bourla.

“We continue not to see the need for any large-scale M&A activity at this time,” he said on Pfizer’s own third-quarter call.

https://www.fiercepharma.com/pharma/could-gilead-amgen-abbvie-follow-bms-into-megadeal-territory

JMP reiterates Outperform on Esperion after European agreement

JMP Securities analyst Jason Butler reiterated an Outperform rating and $153 price target on Esperion Therapeutics after the company announced a European commercialization agreement with Daiichi Sankyo for bempedoic acid and the BA/ezetimibe fixed dose combination. The analyst views this deal as “strong,” and sees Daiichi Sankyo as a compelling strategic fit “given its established commercial infrastructure and success in cardiovascular diseases in the region.”
https://thefly.com/landingPageNews.php?id=2844005

Achaogen in License Confirmation, Redemption Pact with Gates Foundation

On December 27, 2018, Achaogen, Inc. (the “Company”) entered into a License Confirmation Agreement and a Redemption Agreement with the Bill & Melinda Gates Foundation (the “Gates Foundation”) (together, the “2018 Agreements”) in connection with the amendment of certain provisions of the Grant Agreement (the “Grant Agreement”) and the Letter Agreement (the “Letter Agreement”) each previously entered into between the Company and the Gates Foundation and dated as ofMay 4, 2017.The 2018 Agreements were entered into following the de-prioritization of antibody work by the Company, which was the focus of the Company’s collaboration with the Gates Foundation.Among other things, the 2018 Agreements (a) terminated the Company’s obligations to conduct mutually agreed upon work, including work related the Company’s platform technology to develop and launch a product intended to prevent neonatal sepsis, (b) terminated the obligations of the Company to discover drug candidates intended to prevent neonatal sepsis and the obligation of the Gates Foundation to fund approximately $7.1 million in grants not yet received by the Company and (c) granted the Gates Foundation a non-exclusive license to intellectual property developed by the Company to the Grant Agreement and Letter Agreement in specified developing countries.

The Redemption Agreement also provided for the redemption by the Company of the 407,331 shares of the Company’s common stock (the “Gates Shares”) purchased by the Gates Foundation to a Common Stock Purchase Agreement between the Company and the Gates Foundation dated as of May 4, 2017 (the “Purchase Agreement”) for an aggregate redemption price of $5,737,082. The Company paid for the redemption of the Gates Shares with the unused portion of the restricted cash received by the Company to the original purchase of the Gates Shares under the Purchase Agreement.No unrestricted cash of the Company was used to fund the redemption.

https://marketexclusive.com/achaogen-inc-nasdaqakao-files-an-8-k-entry-into-a-material-definitive-agreement-2/2019/01/