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SNC-Lavalin and Holtec International form US-based JV to pursue Nuclear Reactor decommissioning work in the US

Wednesday July 18 th 2018

MONTREAL, July 18, 2018 /CNW Telbec/ - SNC-Lavalin (TSX: SNC) and Holtec International group are pleased to announce a new US-based joint venture company named Comprehensive Decommissioning International, LLC (CDI). The company, headquartered in Camden, New Jersey, has been established to bring the expertise of both companies together to ensure safe, rapid, and economic decommissioning of shuttered nuclear plants.

CDI’s priorities are safety and environmental stewardship as it performs accelerated decommissioning of retired nuclear power plants. Using innovative technologies, CDI is the best equipped company to cut the total time elapsed to release plant sites for unrestricted use to eight years or fewer, pending local regulatory approvals (with the exception of the temporary dry storage installation).

With an aging nuclear power plant fleet and the rise of lower cost means of energy generation in the United States, decommissioning has become a rapid growth market with a forecast value exceeding $14B USD over the next ten years. The safe deconstruction of nuclear power plants requires complex project planning and project management, specialized nuclear skills, proven processes and innovative technologies.

“CDI’s vision is to become the leading decommissioning contractor in this market,” said Pierre Oneid, Holtec’s Senior Vice-President and Chief Nuclear Officer. “Now is the time to invest and the parent companies are bringing their joint skills, technologies and financial strength together to lead the way in decommissioning and spent fuel storage.”

Holtec and SNC-Lavalin both boast long histories of strong financial performance and portfolios of first-to-market technologies. Both companies bring to CDI a legacy of safe nuclear operations, quality performance, and on time project delivery.

“This joint venture expands our existing collaboration with SNC-Lavalin on our small modular reactor, the SMR-160, to the decontamination and decommissioning sector of the nuclear industry. We will leverage our used fuel storage and transport expertise, now in use by 110 nuclear reactors around the world, to pave the way for what we call prompt decommissioning,” said Holtec’s President CEO, Dr. Kris Singh.

“SNC-Lavalin continues to expand its participation in the nuclear value chain, working with its valued partner, Holtec,” said Sandy Taylor, SNC-Lavalin’s President, Nuclear. “Over and above our collaboration with Holtec for small modular reactors, the unique contributions of our respective companies bring a complete solution to reactor decontamination and decommissioning, bringing technology and innovation to fuel management and facilities dismantlement.”

About CDI
CDI provides comprehensive project solutions for the accelerated retirement of nuclear power plants. CDI’s global operations provide expertise and technological innovation to protect the public in an environmentally responsible, safe and ethical manner. The joint venture is committed to the enrichment of the communities in which it operates, employing financially sustainable business practices that ensure the upholding of obligations made as a trusted steward of legacy nuclear materials. www.comprehensivedecommissioning.com

About SNC-Lavalin
Founded in 1911, SNC-Lavalin is a global fully integrated professional services and project management company and a major player in the ownership of infrastructure. From offices around the world, SNC-Lavalin’s employees are proud to build what matters. Our teams provide comprehensive end-to-end project solutions – including capital investment, consulting, design, engineering, construction, sustaining capital and operations and maintenance – to clients across oil and gas, mining and metallurgy, infrastructure, clean power, nuclear and EDPM (engineering design and project management). On July 3, 2017, SNC-Lavalin acquired Atkins, one of the world’s most respected design, engineering and project management consultancies, which has been integrated into our sectors. www.snclavalin.com

About Holtec International
Founded in 1986, Holtec International is an integrated technologies enterprise providing innovative solutions, equipment, and services to the global energy industry. Specializing in spent nuclear fuel management technologies, Holtec has changed the landscape of dry spent nuclear fuel storage by designing, licensing, fabricating, and constructing the first underground spent fuel storage facilities in the world. Holtec also provides design, turnkey delivery, problem resolution, life extension, and life assessment services on the entire range of heat exchangers for the electric power generation industry worldwide, and is revolutionizing Air Cooled Condenser (ACC) technology with its HI-MAX (Holtec International MAXimum reliability ACC) air cooled condensing system. To learn more about Holtec International, visit: www.holtecinternational.com

 

SOURCE SNC-Lavalin

Innovation Pharmaceuticals Signs Drug Product Manufacturing Contract with CoreRx to Formulate and Package Brilacidin for Oral Mucositis in Sachet Form

Tuesday July 17 th 2018

BEVERLY, Mass., July 17, 2018 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals (OTCQB:IPIX) (“the Companyâ€�), a clinical stage biopharmaceutical company, is pleased to report the Company has signed a Drug Product manufacturing contract with CoreRx, a leading Contract Development Manufacturing Organization (CDMO), for formulating Brilacidin into granular form in unit dose sachets. Such drug product packaging in the form of sachets provides patients with a convenient, portable, quick-mixing “instantâ€� Brilacidin oral rinse therapy.

Sachets are planned to be used in the continuing clinical evaluation of Brilacidin for the indication to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy.

The CoreRx agreement for Drug Product production aligns with one signed in April with another leading CDMO to, in parallel, bulk produce a commercial-grade supply of Brilacidin. Both of these manufacturing agreements serve to prepare for, and expedite, Brilacidin’s continued clinical development. Brilacidin is a defensin-mimetic drug candidate with unique immunomodulatory, anti-inflammatory, and antibacterial properties.

“CoreRx is pleased to have been selected by Innovation Pharmaceuticals for the development of Brilacidin sachets,� said Todd R. Daviau, President and CEO. “Having a sachet as a convenient oral therapy is long overdue in the treatment of oral mucositis, and we look forward to working with Innovation Pharmaceuticals to develop this new formulation and provide clinical trial supplies for this important indication.�

“Packaging Brilacidin in an easy-to-use sachet would likely substantially enhance its appeal and adoption among patients at risk for oral mucositis,� commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “IV-based oral mucositis therapies present distinct challenges to patients already overwhelmed with the burden of cancer care—requiring visitation to a hospital or a doctor’s office, and up to an hour (or more) to administer the drug. Brilacidin packaged in a sachet, in contrast, allows patients the convenience of taking their medication whether they are at home or elsewhere. Sachets are an optimal way of delivering much-needed treatments to this substantial patient population in need of an effective and easy to administer therapy.�

“This agreement with CoreRx is yet another important milestone positioning Brilacidin as one of the most promising drug candidates in late-stage development for the prevention and treatment of oral mucositis,� said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “CoreRx is now a valued contributor to advancing our Brilacidin development plan.�

About CoreRx Corporation

CoreRx is a Contract Development Manufacturing Organization (CDMO) with a focus on clinical phase drug product development, offering state of the art facilities to support supply chain needs throughout the entire clinical trial process. Integrated offerings provide comprehensive services for the development, manufacturing and testing of solid, liquid and semi-solid dosage forms, from pre-formulation work to final formulation development. More information is available at: www.corerxpharma.com.

Alerts
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http://www.ipharminc.com/email-alerts/

About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases.  Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.  A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM.  Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infections. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene� due to its crucial role in controlling cell mutations, and has successfully completed a Phase 2 trial in ovarian cancer. Prurisol, an oral psoriasis drug candidate acting through immune modulation and PRINS reduction, has now completed a Phase 2b trial and is awaiting statistical analysis.  More information is available on the Company website at www.IPharmInc.com.

Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,� “believes,� “hopes,� “estimates,� “looks,� “expects,� “plans,� “intends,� “goal,� “potential,� “may,� “suggest,� and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

INVESTOR AND MEDIA CONTACT
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com 

Primoris Services Corporation Announces Electrical Distribution Award Valued Over $75 Million for Its Recently Acquired T&D Group

DALLAS, July 17, 2018 (GLOBE NEWSWIRE) — Primoris Services Corporation (NASDAQ:PRIM) (“Primorisâ€� or “Companyâ€�) today announced a new  Master Service Agreement (“MSAâ€�) with a major utility customer with a three-year anticipated value of approximately $75 million.  The contract was secured by Primoris TD, part of the Transmission and Distribution segment.

  • The award is a three-year agreement for system overhead and underground electrical baseload distribution services in Northern Florida.  The MSA expands Primoris TD’s presence in the area.
  • Work will include construction and maintenance of electrical distribution work and ancillary services.
  • Primoris estimates that the expected annual revenue from this contract is $25 million per year over the course of the contract.  While the agreement does not obligate the customer to award Primoris a specific dollar amount, our discussions with the customer and our history with similar clients form the basis for our anticipated value.

ABOUT PRIMORIS
Founded in 1960, Primoris, through various subsidiaries, has grown to become one of the largest publicly traded specialty construction and infrastructure companies in the United States. Serving diverse end-markets, Primoris provides a wide range of construction, fabrication, maintenance, replacement, water and wastewater, and engineering services to major public utilities, petrochemical companies, energy companies, municipalities, state departments of transportation, and other customers. Growing both organically and through acquisitions, the Company’s national footprint now extends nearly nationwide and into Canada. For additional information, please visit www.prim.com.

FORWARD LOOKING STATEMENTS
This press release contains certain forward-looking statements, including with regard to the Company’s future performance. Words such as “estimated,” “believes,” “expects,” “projects,” “may,â€� and “future” or similar expressions are intended to identify forward-looking statements.  Forward-looking statements inherently involve known and unknown risks, uncertainties, and other factors, including without limitation, those described in this press release and those detailed in the “Risk Factors” section and other portions of our Annual Report on Form 10-K for the period ended December 31, 2017, and other filings with the Securities and Exchange Commission.  Given these uncertainties, you should not place undue reliance on forward-looking statements.  Primoris does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Company Contact                                                                                              
Kate Tholking
Director of Investor Relations
(214) 740-5615
ktholking@prim.com

Eloxx Pharmaceuticals To Report Second Quarter 2018 Financial Results On August 7, 2018 and Host Webcast and Conference Call

WALTHAM, Mass., July 17, 2018 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. (NASDAQ:ELOX), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cystic fibrosis, cystinosis and other diseases caused by nonsense mutations limiting production of functional proteins, today announced that it will release its second quarter 2018 financial results and host a conference call and live audio webcast on Tuesday, August 7, 2018 at 4:30 p.m. ET to discuss the results and provide a company update.

Conference Call Information:
Date: Tuesday, August 7, 2018
Time: 4:30 p.m. ET
Domestic Dial-in Number: (866) 913-8546
International Dial-in Number: (210) 874-7715
Conference ID: 7277449
Live Webcast: accessible from the Company’s website at www.eloxxpharma.com under Events and Presentations or with this link: https://edge.media-server.com/m6/p/d8xgndsz. A replay will be available on the Company’s website approximately two hours after the call.
Conference Call Replay Information:
Domestic Dial-in Number: (855) 859-2056
International Dial-in Number: (404) 537-3406
Conference ID: 7277449

About Eloxx Pharmaceuticals

Eloxx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are designed to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA. As a consequence, patients with premature stop codon diseases have reduced or eliminated protein production from the mutation bearing allele accounting for some of the most severe phenotypes in these genetic diseases. These premature stop codons have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is focused on extending mRNA half-life and increasing protein synthesis by enabling the cytoplasmic ribosome to read through premature stop codons to produce full-length proteins. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. Eloxx’s preclinical candidate pool consists of a library of novel drug candidates designed to be eukaryotic ribosomal selective glycosides identified based on read-through potential. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis and cystinosis. ELX-02 is an investigational drug that has not been approved by any global regulatory body. Eloxx is headquartered in Waltham, MA, with RD operations in Rehovot, Israel.

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

Contact:
Barbara Ryan
barbarar@eloxxpharma.com
(203) 274-2825

 

22nd Century Announces the Immediate Feasibility of the FDA’s Nicotine Reduction Plan

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22nd Century Group, Inc. (NYSE American:XXII),
a plant biotechnology company that is a leader in tobacco harm reduction
and Very Low Nicotine tobacco, yesterday responded to the Advance Notice
of Proposed Rulemaking (ANPRM)
by the U.S. Food and Drug Administration (FDA) to develop a rule that
will require all cigarettes sold in the United States to contain only
minimally or non-addictive levels of nicotine. When the Company’s
response is posted online by the FDA at www.regulations.gov,
the corresponding tracking number will be: 1k2-94b8-wdcp. 22nd
Century’s complete response to the FDA’s ANPRM is currently available
at: www.xxiicentury.com/ANPRM.

22nd Century’s public comments to the FDA’s ANPRM describe how the FDA’s
proposed rule to require that all cigarettes sold in the United States
contain only minimally or non-addictive levels of nicotine is supported
by rigorous independent science. The Company also demonstrates that the
planned mandate is exceedingly practical and urgently needed in the
interests of public health.

The FDA’s stated goal to render cigarettes minimally or non-addictive is immediately
feasible. 22nd Century has produced and delivered tens of millions
of the Company’s Very Low Nicotine Content (VLNC) SPECTRUM® research
cigarettes since 2011 for use in numerous independent clinical studies
funded by more than $100 million from agencies of the United States
federal government. The results of these independent clinical studies
show that upon switching to 22nd Century’s VLNC SPECTRUM® cigarettes,
smokers: (1) reduce their cigarette consumption, (2) experience lessened
withdrawal symptoms, and (3) increase their attempts to quit smoking.
These peer-reviewed and published studies provide a solid scientific
foundation for the FDA’s proposed nicotine reduction mandate. VLNC
cigarettes are so promising that independent researchers
estimate that in the first year after implementation of the FDA’s
rule to limit cigarettes to minimally or non-addictive levels of
nicotine, approximately 5 million people would stop smoking and, in as
few as five years after implementation of the FDA’s plan, more than 13
million people would stop smoking.

In preparation for the prompt implementation of the new FDA rule, 22nd
Century is already growing increased amounts of the Company’s VLN™
tobacco in order to be able to supply a sufficient quantity of the
Company’s proprietary VLN™ tobacco seeds to grow enough VLN™ tobacco for
the entire U.S. tobacco industry in just one growing season.

In contrast, Reynolds American (a subsidiary of British
American Tobacco) is apparently incapable of matching 22nd Century’s
achievements and meeting a standard for minimally or non-addictive
tobacco cigarettes. In Reynolds American’s July 13, 2018 response to the
FDA’s ANPRM , Michael Ogden, Ph.D., Senior Vice President of RAI
Services (which is part of Reynolds American), explains:

“At the present time… the science lags behind on this important issue
and additional methods, possibly used in conjunction with traditional
breeding practices, would need to be developed. RAIS believes that the
industry is at least 20 years away from producing tobacco at a
commercial scale that would meet the range of low-level nicotine
discussed in the ANPRM.�

Conversely, 22nd Century already has an extensive portfolio of patented
technologies and unique VLNâ„¢ tobacco plants in burley and flue-cured
varieties and is continuing to develop new VLNâ„¢ varieties with improved
agronomic traits. RAIS’ comments on the ANPRM went on to recognize 22nd
Century’s leadership in creating tobaccos with very low levels of
nicotine:

“Commercialization of such products [tobaccos with very low levels of
nicotine] is also made difficult by: (1) the fact that genome editing
technology (CRISPR-cas9) currently does not appear to be available to
tobacco companies; and (2) the various patent restrictions on the use of
certain genetic-engineering techniques (the patents on nicotine
synthesis pathway genes, for example, are held almost exclusively by
22nd Century Group
).�
(emphasis added)

Reynolds American is not the first to suggest that it will take
multi-national tobacco companies 20-years to develop tobacco with very
low levels of nicotine. As reported by Sam Chambers of Bloomberg
Business, Rolf Lutz, Director of Product Policy at Philip
Morris International Inc. estimated “it would cost the company $10
billion to $12 billion to extract nicotine from all the cigarettes it
sells across the European Union.â€� Chambers went on to report: “Lutz said
the cost could be minimized by genetically modifying tobacco plants, but
this would take about 20 years.
� (emphasis added)

“Fortunately, 22nd Century’s VLNâ„¢ technology makes feasible and
eminently achievable the FDA’s stated goal of rendering cigarettes
minimally or non-addictive,� explained Henry Sicignano, III, President
and Chief Executive Officer of 22nd Century Group.

To make VLNC cigarettes a prompt reality for all smokers, 22nd Century
has announced that the Company is willing to license the use of the
Company’s VLN™ technology and VLN™ tobacco seeds/plants to all
interested companies. The availability of this licensing opportunity
from 22nd Century negates any argument by other tobacco companies that
contend it is somehow not possible to comply with the planned FDA
nicotine reduction mandate.

“Big tobacco companies now have a choice: Combat, obfuscate and attempt
to delay the most important public health initiative of the last 100
years… or demonstrate a genuine commitment to improving the health of
their customers,â€� explained Mr. Sicignano. “Now that 22nd Century’s VLNâ„¢
technology is proven and readily available for licensing,
it will
be interesting to see which Big Tobacco companies genuinely care about
smokers… and which are determined to keep their customers addicted to
the deadliest consumer product available on the market.�

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology
which allows it to increase or decrease the level of nicotine in tobacco
plants and the level of cannabinoids in hemp/cannabis plants through
genetic engineering and plant breeding. The Company’s primary mission in
tobacco is to reduce the harm caused by smoking. The Company’s primary
mission in hemp/cannabis is to develop proprietary hemp strains for
important new medicines and agricultural crops. Visit www.xxiicentury.com
and www.botanicalgenetics.com
for more information.

Cautionary Note Regarding Forward-Looking Statements:
This
press release contains forward-looking information, including all
statements that are not statements of historical fact regarding the
intent, belief or current expectations of 22nd Century Group, Inc., its
directors or its officers with respect to the contents of this press
release, including but not limited to our future revenue expectations.
The words “may,â€� “would,â€� “will,â€� “expect,â€� “estimate,â€� “anticipate,â€�
“believe,â€� “intendâ€� and similar expressions and variations thereof are
intended to identify forward-looking statements. We cannot guarantee
future results, levels of activity or performance. You should not place
undue reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should be
considered with any written or oral forward-looking statements that we
may issue in the future. Except as required by applicable law, including
the securities laws of the United States, we do not intend to update any
of the forward-looking statements to conform these statements to reflect
actual results, later events or circumstances, or to reflect the
occurrence of unanticipated events. You should carefully review and
consider the various disclosures made by us in our annual report on Form
10-K for the fiscal year ended December 31, 2017, filed on March 7,
2018, including the section entitled “Risk Factors,â€� and our other
reports filed with the U.S. Securities and Exchange Commission which
attempt to advise interested parties of the risks and factors that may
affect our business, financial condition, results of operation and cash
flows. If one or more of these risks or uncertainties materialize, or if
the underlying assumptions prove incorrect, our actual results may vary
materially from those expected or projected.