Cognizant joins forces with Zenith to digitise pharma manufacturing

Professional services firm Cognizant has struck a deal to buy Zenith Technologies, a privately-held life sciences manufacturing technology company specialising in digital technologies to manage, control and optimise drug and medical device production.

Cognizant, which said it already works with the top 30 largest life science companies in the world, did not reveal the financial details of the deal to buy Zenith, based in Cork, Ireland.

Under the new arrangements Zenith Technologies’ more than 800 employees will become part of Cognizant’s Life Sciences business unit.

Cognizant said that interconnected “smart factories” have become a strategic priority for pharma, with production systems and processes becoming more complex because of research advances and increased demand for large-molecule biologics.

The combined Cognizant-Zenith Technologies expertise will deliver a range of “Industry 4.0” capabilities, the companies said.

These include factory design consultation, machine sensor and controller instrumentation, supervisory control, and data acquisition, to manufacturing execution systems, batch automation, enterprise resource planning integration and managed services.

The acquisition also makes sense as Zenith’s operating hubs in Ireland, Germany, India, Singapore, the United States and other sites around the world are located near manufacturing facilities of many Cognizant clients.

Zenith’s CEO Joe Haugh said: “Our combined business will drive process excellence through tighter integration of manufacturing processes and systems, the efficient harnessing of information and analytics across the manufacturing value chain, and the adoption of IoT technologies delivering manufacturing 4.0.”

The transaction is expected to close in the third quarter of 2019, subject to satisfaction of closing conditions, including regulatory review.

Founded in 1998, Zenith Technologies operates on five continents, with 16 locations around the globe. Zenith Technologies works with nine of the world’s 10 largest biopharmaceutical manufacturers, implementing and supporting their manufacturing lifecycle software through its consultancy, manufacturing digital and automation systems integration, and manufacturing site services business lines.

Cognizant joins forces with Zenith to digitise pharma manufacturing

Nabriva Asks Type A Meeting at FDA for Intravenous UTI Med

Nabriva Therapeutics plc (NBRV), a clinical-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced today that it has submitted a Type A Meeting Request and Briefing Document to the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated April 30, 2019 for the New Drug Application (NDA) seeking marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

As the FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the CRL, the purpose of the meeting is to discuss and gain clarity on the issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers that were described in the CRL and other matters pertaining to the steps required for the resubmission of the NDA for CONTEPO. The Type A meeting, per regulation, is required to occur within thirty days of FDA’s receipt of the meeting request.

The company will provide an update on the timing of resubmission of the NDA for CONTEPO after receipt of the FDA’s final meeting minutes, which should occur within thirty days after the date of the Type A Meeting.

https://finance.yahoo.com/news/nabriva-therapeutics-submits-type-meeting-110000586.html

Ultragenyx to become largest shareholder of Arcturus

Ultragenyx Pharmaceutical (RARE) and Arcturus Therapeutics (ARCT+37.7%) say they will expand their licensing deal and research collaborationto discover and develop mRNA, DNA and siRNA therapeutics for up to 12 rare disease targets.

In addition to making a $6M cash upfront payment to ARCT, RARE agrees to purchase 2.4M ARCT common shares at $10/share with an option to buy an additional 600K shares at $16 each, making it ARCT’s largest shareholder; RARE General Counsel Karah Parschauer will join ARCT’s board.

The first disclosed indication under the original collaboration between the two companies is Glycogen Storage Disease Type III, and an Investigational New Drug application for the mRNA therapeutic program, UX053, is expected to be filed in 2020.

https://seekingalpha.com/news/3472361-ultragenyx-become-largest-shareholder-arcturus

Gilead deal with Nurix Therapeutics to tackle disease-causing protein

Gilead Sciences Inc. GILD, -0.23% is partnering with Nurix Therapeutics, a biotech working on drugs to destroy disease-causing proteins, the companies announced Wednesday. Under the terms of the multi-year deal, Gilead will have the option to license certain drug candidates from Nurix, and Nurix will have the option to develop up to two programs with Gilead in the U.S., splitting the costs, U.S. sales and losses of those drugs. The deal excludes Nurix’s lead drug program, for which Nurix will retain all rights. Nurix will receive an upfront payment of $45 million and is eligible to receive up to approximately $2.3 billion in additional milestone payments and royalties, the companies said. “There are many molecular targets involved in disease pathways that have traditionally been challenging to manipulate using conventional approaches,” said John McHutchison, Gilead’s chief scientific officer and head of research and development. “Nurix’s innovative protein degradation discovery technology provides Gilead with a new strategy to interrogate these drug targets, as we continue to build a pipeline of small molecule therapeutics for patients with cancers and other diseases.” Nurix’s drug platform targets the ubiquitin system, a natural way the body degrades normal and disease-associated proteins. The company is working on ways to manipulate this system to fight diseases in immuno-oncology and hematology. Shares of Gilead have gained 9% so far this year, while the S&P 500 SPX, -0.03% has gained 16.4%.

https://www.marketwatch.com/story/gilead-strikes-deal-with-nurix-therapeutics-to-tackle-disease-causing-proteins-2019-06-19?mod=newsviewer_click

Mirati downgraded, target hiked at B. Riley

B. Riley FBR has downgraded Mirati Therapeutics Inc from buy to neutral, raising its price target from $ 60 to $ 92.

https://www.finanzen.net/analyse/mirati_therapeutics_neutral-b_riley_fbr_675384

Armata Pharmaceuticals started at Buy by Ladenburg

Target $9

https://www.benzinga.com/stock/ARMP/ratings

Akero Therapeutics IPO: What You Need To Know

A slew of biotech issues hit the Street this week. Here’s a brief on one of them.

The IPO Terms

Akero Therapeutics, Inc, a South San Francisco, California-based clinical-stage biotech, is planning a 5-million share IPO, with the offering estimated to be priced between $14 and $16, according to the S-1/A filing from June 10.

The size of the offering is about $75 million, assuming the issue to be priced at the midpoint of the range.

The company has applied for listing on the Nasdaq under the ticker symbol AKRO.

Akero said it has opted to comply with certain reduced public company requirements, as it qualifies as an “emerging growth company” under the federal securities law.

JPMorgan, Jefferies, Evercore ISI and Roth Capital Partners are the underwriters for the offering.

The Company

Akero, founded in January 2017, focuses on developing transformative treatments for serious metabolic diseases with high unmet medical need, with the accent on non-alcoholic steatohepatitis, or NASH, which currently has no FDA-approved therapies.

Akero’s lead candidate AKR-001, an analog of fibroblast growth factor 21, or FGF21, is being evaluated for NASH. FGF21 is a hormone that regulates metabolism of lipids, carbohydrates and proteins and also protects tissues from various forms of stress.

The FDA has cleared the IND for AKR-001 to conduct a Phase 2a clinical trial in NASH patients. The company has begun screening patients May 28 and expects to complete the collection of data for the primary endpoint in the first quarter of 2020. It also plans to complete repeat liver biopsies and all collection of data for the trial in the second quarter of 2020.

The Finances

Akero reported a wider loss of $81.71 million for the fiscal year 2018 compared to $4.56 million in 2017. For the three months ended March 2019, the company reported a loss of $5.36 million.

https://www.benzinga.com/news/19/06/13931028/akero-therapeutics-ipo-what-you-need-to-know