Monthly Archives: July 2017

TOMI Environmental Solutions and Astro Pak Settle Lawsuit Concerning TOMI’s Patents and IP Rights

BEVERLY HILLS, Calif. and COSTA MESA, Calif., July 31, 2017 (GLOBE NEWSWIRE) — TOMI Environmental Solutions, Inc. (“TOMI”) (OTCQX:TOMZ) and Astro Pak Corporation (“Astro Pak”) announced today they have settled their litigation relating to TOMI’s patents and intellectual property rights.

The parties have agreed that TOMI is the sole owner of ionized hydrogen peroxide decontamination and sterilization technology, patents, and products, which TOMI markets under the brands Binary Ionization Technology® (BIT™) and SteraMist™. TOMI sued Astro Pak and its wholly owned subsidiary SixLog Corporation (“SixLog”) in California federal court for infringing TOMI’s United States Patent Nos. 6,969,487 and 7,008,592 and violating TOMI’s intellectual property rights by, among other things, indicating that TOMI’s technology and patents were proprietary to SixLog and marketing TOMI’s patented equipment with SixLog labels. Astro Pak and SixLog agreed to cease this conduct and pay TOMI a favorable cash payment. Astro Pak also agreed to assign its iHP mark to TOMI, complementing TOMI’s existing trademark and trade name protection. Finally, Astro Pak and SixLog agreed to remove from the web or take steps to remove any assertions or suggestions that they own or developed ionized hydrogen peroxide technology or patents, or that they provide any ionized hydrogen peroxide products or services.

“TOMI’s patents and technology are extremely valuable and ground-breaking, and TOMI is committed to protecting them and enforcing its IP rights,” said Dr. Halden Shane, TOMI’s CEO and Chairman. “This settlement will allow TOMI to focus all its energy and resources on innovation, on growing our business, and on making potential customers aware of the power of TOMI’s technology.”

“TOMI’s patented technology is very powerful and has outstanding efficacy,” said Ken Carroll, Astro Pak’s President. “The company has a very bright future, and we wish them continued success.”

About TOMI Environmental Solutions, Inc.
TOMI Environmental Solutions, Inc. (OTCQX:TOMZ) is a global decontamination and infection prevention company, providing environmental solutions for indoor surface disinfection through manufacturing, sales and licensing of its premier Binary Ionization Technology® (BIT™) platform, which was invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense. BIT™ uses a low percentage Hydrogen Peroxide as its only active ingredient to produce a hydroxyl radical (OH ion), represented by the TOMI™ SteraMist™ brand of products, which produces a germ-killing aerosol that works like a visual non-caustic gas.

TOMI’s products are designed to service a broad spectrum of commercial structures including but not limited to hospitals and medical facilities, cruise ships, office buildings, hotel and motel rooms, schools, restaurants, meat and produce processing facilities (when not in operation), military barracks, police and fire departments, and athletic facilities. TOMI’s products and services have also been used in single-family homes and multi-unit residences.

TOMI also develops training programs and application protocols for its clients and is a member in good standing of The American Biological Safety Association, The American Association of Tissue Banks, Association for Professionals in Infection Control and Epidemiology, Society for Healthcare Epidemiology of America and The Restoration Industry Association.

For additional information, please visit http://www.tomimist.com/ or contact us at info@tomimist.com.

About Astro Pak
Astro Pak has been the leading provider of high-purity cleaning, precision cleaning and passivation services across North America and worldwide since 1959. Astro Pak continues to improve its technologies and cleaning processes for the Medical Device, Semiconductor, Laser, Biopharm and a myriad of other markets, while maintaining our leader position in contract cleaning for the Aerospace and Defense industries. Astro Pak is privately held with headquarters in Costa Mesa, CA.

For more information, please visit www.astropak.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

Certain written and oral statements made by us may constitute “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 (the “Reform Act”). Forward-looking statements are identified by such words and phrases as “we expect,” “expected to,” “estimates,” “estimated,” “current outlook,” “we look forward to,” “would equate to,” “projects,” “projections,” “projected to be,” “anticipates,” “anticipated,” “we believe,” “could be,” and other similar phrases. All statements addressing operating performance, events, or developments that we expect or anticipate will occur in the future, including statements relating to revenue growth, earnings, earnings-per-share growth, or similar projections, are forward-looking statements within the meaning of the Reform Act. They are forward-looking, and they should be evaluated in light of important risk factors that could cause our actual results to differ materially from our anticipated results. The information provided in this document is based upon the facts and circumstances known at this time. We undertake no obligation to update these forward-looking statements after the date of this release

MEDIA RELATIONS CONTACT

TOMI
Juliana deRosa
Executive Administrator
jderosa@tomimist.com

Astro Pak Corporation
Amy Primrose
aprimrose@astropak.com

RedHill Biopharma Announces Unanimous Positive DSMB Recommendation for Continuation of the Phase III Study with RHB-104 for Crohn’s Disease

  • The independent Data and Safety Monitoring Board (DSMB) reviewed safety and efficacy data, of which RedHill remains blinded, from the first 222 subjects who have completed week 26 assessments in the Phase III MAP US study
  • To date, over 300 of the planned 410 subjects, have been randomized in the Phase III MAP US study
  • An open-label extension Phase III study (the MAP US2 study) is ongoing in parallel in patients who remain out of remission after 26 weeks of blinded study therapy in the MAP US study

TEL-AVIV, Israel and RALEIGH, N.C., July 31, 2017 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today reported, following a second pre-planned meeting to assess the safety and efficacy data from its ongoing first Phase III study with RHB-104 for Crohn’s disease (the MAP US study) by an independent Data and Safety Monitoring Board (DSMB), that it has received a unanimous positive recommendation from the DSMB to continue the study as planned.

The independent DSMB reviewed safety and efficacy data, of which RedHill remains blinded, from the first 222 subjects who have completed week 26 assessments in the Phase III MAP US study. In December 2016, a first pre-planned independent DSMB meeting reviewed safety data from the MAP US study and provided a unanimous recommendation to continue the study as planned.

Ira Kalfus, MD, Medical Director at RedHill, said: “RHB-104 is a potentially ground-breaking new therapy for Crohn’s disease. The DSMB has reviewed the unblinded interim safety and activity results of the Phase III MAP US study, and we are very encouraged by its unanimous recommendation to continue the study through randomization of all planned 410 subjects, with no changes to the protocol, investigator’s brochure, study conduct or informed consent form. We continue to enroll subjects and expect to complete enrollment in the study in the first half of 2018. I would like to thank the DSMB members for their professional and independent assessment of the study data and for their positive recommendation.”

RHB-104 is a proprietary, orally-administered, potentially ground-breaking, antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties, targeting a suspected underlying bacterial infectious cause of Crohn’s disease, Mycobacterium avium subspecies paratuberculosis (MAP).

The MAP US study is a randomized, double-blind, placebo-controlled first Phase III study evaluating the safety and efficacy of RHB-104 in patients with moderately to severely active Crohn’s disease (defined as CDAI between 220 and 450). The MAP US study is being conducted in up to 150 clinical sites in the U.S, Canada, Europe, Israel, Australia and New Zealand. Additional clinical data will need to be generated to support a U.S. New Drug Application (NDA) for RHB-104. The primary endpoint of the MAP US study is disease remission, defined as a reduction in Crohn’s Disease Activity Index (CDAI) to less than 150 at week 26.

To date, over 300 of the planned 410 subjects, have been randomized in the MAP US study. A third, safety-focused, independent DSMB meeting is expected to be held when 75% of the planned 410 subjects have completed 26 weeks of study participation. Completion of recruitment for the MAP US study is expected in the first half of 2018.

Additionally, an open-label extension Phase III study (the MAP US2 study) is ongoing to further assess the safety and efficacy of RHB-104 in patients who remain out of remission (CDAI ≥ 150) after 26 weeks of blinded study therapy in the ongoing Phase III MAP US study.

The clinical studies with RHB-104 are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.

About RHB-104:      
Currently in a first Phase III study for the treatment of Crohn’s disease (the MAP US study), RHB-104 is a proprietary, orally-administered, potentially ground-breaking oral antibiotic combination therapy, with potent intracellular, antimycobacterial and anti-inflammatory properties. RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is related to Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. The development of RHB-104 is consistent with the growing awareness of the possibility that a bacterially-induced dysregulated immune system may contribute to the pathogenesis of various autoimmune diseases of unknown etiology. Clinical trials conducted with earlier formulations of RHB-104 include an Australian Phase III study conducted by Pharmacia/Pfizer. RedHill has conducted several supportive studies with the current formulation of RHB-104 and a long-term population pharmacokinetic (pop-PK) study is ongoing as part of the Phase III MAP US study. Additionally, an open-label extension Phase III study (the MAP US2 study) is ongoing to assess the safety and efficacy of RHB-104 in subjects who have completed week 26 assessments in the ongoing Phase III MAP US study and remain with active Crohn’s disease (CDAI ≥ 150) at week 26. RHB-104 is covered by several issued and pending patents. RedHill also completed a Phase IIa, proof-of-concept clinical study, evaluating RHB-104 as an add-on therapy to interferon beta-1a in subjects treated for relapsing-remitting multiple sclerosis (the CEASE MS study), with top-line final results suggesting meaningful positive safety and clinical signals upon 24 weeks of treatment with RHB-104 as an add-on therapy, thereby supporting further clinical development. RHB-104 was granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA for the treatment of nontuberculous mycobacteria (NTM) infections, providing a Fast-Track development pathway, as well as NDA Priority Review and an additional five years of U.S. market exclusivity, if approved. RedHill is in discussions with the FDA regarding the development of RHB-104 development program for NTM infections.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill promotes two gastrointestinal products in the U.S. – Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, and EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s clinical-stage pipeline includes: (i) TALICIA (RHB-105) an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study and an ongoing confirmatory Phase III study; (ii) RHB-104 an oral combination therapy for the treatment of Crohn’s disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis, and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102) a once-daily oral pill formulation of ondansetron with successful top-line results in a Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON – a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) – an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP). More information about the Company is available at: www.redhillbio.com.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal® and EnteraGam®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) the Company’s Expanded Access Program, which allows patients with life-threatening diseases potential access, subject to regulatory and other approvals, to RedHill’s investigational new drugs that have not yet received regulatory marketing approval, if a patient suffers an adverse experience using such investigative drug, potentially adversely affecting the clinical development program of that investigational product or the Company generally; (xiv) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.

Company contact:
Adi Frish
Senior VP Business Development & Licensing 
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

IR contact (U.S.): 
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com

Four Arab countries refuse to withdraw demands on Qatar

The top diplomats of four Arab nations issued a joint statement in Bahrain on Sunday, reaffirming their insistence that Qatar comply with their demands.

The foreign ministers of Egypt, Saudi Arabia, Bahrain, and the United Arab Emirates said that they will continue their boycott of Qatar and will not retreat on their demands, but are ready for a dialogue with Qatar if their demands are met. Bahrain’s Foreign Minister Khaled bin Khalifa read out the joint statement insisting that the four nations will not backtrack on their 13 demands and calling the measures taken against Qatar an act of national sovereignty in compliance with international law.

Source: VOV5

Leader Nguyen Duc Canh’s 85th death anniversary commemorated

Hai Phong City’s Confederation of Labor on Sunday night hosted a ceremony to mark the 85th anniversary of the death of leader Nguyen Duc Canh.

Nguyen Duc Canh was one of the outstanding leaders of the Communist Party of Vietnam, an excellent student of President Ho Chi Minh and the first Secretary of the Hai Phong Party Organization. He was also one of the founders of the Northern Red Federation of Labor, now the Vietnam General Confederation of Labor. Mr Canh was killed by French colonialists at the age of 24 on July 31st, 1932.

Source: VOV5

Russia expels hundreds of US diplomats in tit-for-tat move

Russian President Vladimir Putin on Sunday said the United States must cut two thirds of diplomatic positions in Russia in response to new US sanctions against Russia.

In an interview with Rossia-24 television, Mr. Putin said 755 of approximately 1,000 people working at the US embassy and consulates must end their activities in Russia. Earlier, the Russian Foreign Ministry demanded the US cut its diplomatic presence in Russia by September 1 to 455 people � the same number Russia has in the US.

Source: VOV5

Vietnam participates in world folklore festival in Romania

Vietnam showcased its ethnic minority culture at the 2017 World Folk Culture Festival held in Romania in late July.

Vietnamese artists from the Au Co art troupe introduced typical songs and dances of the Kinh, Thai, and H’mong ethnic groups and those living on the Central Highlands. Their performances were accompanied by traditional instruments such as zither, a bamboo instrument called the T’rung, and the monochord which is found nowhere else in the world.

The 2017 World Folk Culture Festival attracted artists from 11 countries, including France, Italy, India, and Indonesia. It promotes folk music from around the globe.

Source: VOV5

Vietnamese wins World Games’ muay championship title

Bui Yen Ly of Vietnam triumphed in the women’s 51kg muay Thai category at the World Games in Poland on Sunday. Ly defeated Apasara Koson of Thailand in the final.

The World Games, first held in 1981, is an international event involving sport or disciplines not contested at the Olympic Games. With one gold medal, Vietnam now ranks 39th in the medal standings. 102 countries and territories are competing at this year’s tournament.

Source: VOV5