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FDA Authorizes Sale of the IQOS 3 Tobacco Heating System Device in the United States

RICHMOND, Va.–(BUSINESS WIRE)–
Altria Group, Inc. (Altria) (NYSE: MO) announces today that the U.S. Food and Drug Administration (FDA) authorized commercialization of the next generation of the IQOS tobacco heating system device, IQOS 3, in the U.S. FDA authorization follows review of the IQOS 3 Premarket Tobacco Product Application (PMTA) submitted by Philip Morris International Inc. (PMI). Philip Morris USA (PM USA), under an exclusive agreement with PMI, commercializes the IQOS system in the U.S. with three HeatStick variants. Unlike cigarettes, the IQOS system heats but does not burn tobacco.

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IQOS 3 offers several enhancements to the IQOS 2.4 currently being sold in select U.S. markets, including a longer battery life, faster re-charging time, a side opening mechanism, and magnetic closure.

“Altria’s 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future and we’re excited to build on our first-mover advantage with the enhanced IQOS 3 device which has performed successfully in international markets,” said Jon Moore, President and Chief Executive Officer of PM USA.

IQOS is currently available in the Atlanta, Georgia, Richmond, Virginia and Charlotte, North Carolina markets. With PMTA authorization of IQOS 3, PM USA expects to begin quickly marketing the IQOS 3 device to U.S. adult smokers once the regulatory and U.S. importation logistics have been satisfied.

To secure market authorization under a PMTA, U.S. federal law obligates an applicant to demonstrate that marketing of a new tobacco product is appropriate for the protection of public health and requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.

Note to Editor:

On March 30, 2020, PMI submitted a supplemental PMTA to the FDA for the IQOS 3 tobacco heating system device. The original IQOS 2.4 device was authorized by the FDA for commercialization in the U.S. on April 30, 2019.

On July 7, 2020 the FDA authorized the marketing of the IQOS 2.4 tobacco heating system as a modified risk tobacco product with a reduced exposure claim. IQOS 2.4 is the first next-generation inhalable tobacco product to be authorized as a modified risk tobacco product. The IQOS 3 PMTA authorization is independent of the MRTP authorization for the IQOS 2.4 device. PMI expects to file a MRTP application with the FDA for IQOS 3 seeking authorization of a reduced exposure claim.

Altria’s Profile

Altria’s wholly-owned subsidiaries include Philip Morris USA Inc. (PM USA), U.S. Smokeless Tobacco Company LLC (USSTC), John Middleton Co. (Middleton), Ste. Michelle Wine Estates Ltd. (Ste. Michelle) and Philip Morris Capital Corporation (PMCC). Altria holds equity investments in Anheuser-Busch InBev SA/NV (AB InBev), JUUL Labs, Inc. (JUUL) and Cronos Group Inc. (Cronos Group).

The brand portfolios of Altria’s tobacco operating companies include Marlboro^®, Black & Mild^®, Copenhagen^® and Skoal^®. Ste. Michelle produces and markets premium wines sold under various labels, including Chateau Ste. Michelle^®, Columbia Crest^®, 14 Hands^®and Stag’s Leap Wine Cellars^™, and it imports and markets Antinori^®, Champagne Nicolas Feuillatte^™, Torres^®and Villa Maria Estate^™products in the United States. Trademarks and service marks related to Altria referenced in this release are the property of Altria or its subsidiaries or are used with permission.

More information about Altria is available at altria.com, or follow us on Twitter, Facebook and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005919/en/

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IQOS 3 Device (Photo: Business Wire)

Philip Morris International Announces U.S. Food and Drug Administration Authorization of IQOS 3 for Sale in the United States

NEW YORK–(BUSINESS WIRE)–
The U.S. Food and Drug Administration (FDA) today confirmed that IQOS 3, Philip Morris International’s electrically heated tobacco system, is appropriate for the protection of public health and has authorized it for sale in the United States. FDA’s decision follows an assessment of a premarket tobacco product application (PMTA) filed with the agency in March 2020.

The IQOS 3 device contains a number of technological advancements, compared to a previously authorized IQOS device, including longer battery life and quicker recharge between uses.

In its decision the FDA noted that:

• International survey data reviewed by the agency found no evidence of increased uptake of IQOS by youth or young adults, while use patterns available for a previously authorized version of IQOS within the U.S. have not raised new concerns regarding product use in youth and young adults.

Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s Chief Executive Officer, said:

“The agency’s decision to authorize IQOS 3 for sale in the U.S. is another important step forward for the tens of millions of American men and women who currently smoke. In just five years, approximately 11.7 million people around the world have stopped smoking and switched to IQOS, and we believe bringing a more modern version of IQOS to the U.S. will only accelerate switching by adults who smoke.”

He added, “The order is subject to the same comprehensive commercialization requirements set in the April 2019 PMTA marketing orders for IQOS 2.4, which aim to maximize the opportunity for adults to switch from cigarettes, while minimizing unintended use. We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth.”

Editor’s Note:

On July 7, 2020, the FDA authorizedIQOS 2.4 as a modified risk tobacco product (MRTP), finding that an IQOS exposure modification order is appropriate to promote the public health.

The IQOS 3 PMTA authorization is independent of the MRTP authorization for the IQOS 2.4 device. PMI expects to file an application seeking a modified exposure marketing order for the IQOS 3 device.

On April 30, 2019, the FDA authorizedIQOS2.4 for sale in the U.S. through issuance of premarket tobacco authorization marketing orders.

IQOS is available in the U.S. market through an exclusive license with Altria Group, Inc.

Philip Morris International: Delivering a Smoke-Free Future

Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company, and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. In addition, PMI ships a version of its IQOS Platform 1 device and its consumables to Altria Group, Inc. for sale under license in the U.S., where the U.S. Food and Drug Administration (FDA) has authorized their marketing as a modified risk tobacco product (MRTP), finding that an exposure modification order for these products is appropriate to promote the public health. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities, and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI’s smoke-free product portfolio includes heat-not-burn and nicotine-containing vapor products. As of September 30, 2020, PMI estimates that approximately 11.7 million adult smokers around the world have already stopped smoking and switched to PMI’s heat-not-burn product, available for sale in 61 markets in key cities or nationwide under the IQOS brand. For more information, please visit www.pmi.com and www.pmiscience.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005912/en/

Corey Henry

Philip Morris International

T. +41 (0)58 242 4500

E. [email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Tobacco FDA Retail Health

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Atlassian Releases 2nd Annual Sustainability Report, Sets Ambitious Goals to Fight Climate Crisis

SAN FRANCISCO–(BUSINESS WIRE)–
Atlassian Corporation Plc (NASDAQ: TEAM), a leading provider of team collaboration and productivity software, today released its second annual Sustainability Report for the fiscal year 2020 and announced ambitious goals to combat global climate change.

This report, which covers our progress from July 1, 2019, to June 30, 2020, details Atlassian’s progress and trajectory across four sustainability pillars: planet, customers, people, and community.

The report includes deeper disclosures and data across all pillars and includes Atlassian’s diversity, equity, and inclusion reporting, instead of having two separate documents. We believe any sincere sustainability efforts must acknowledge the interlocking impacts of climate change, structural racial and gender inequality, and widening social and economic gaps – and this reflects how our team works. We can’t treat these issues as siloed challenges; they influence and amplify one another.

As we state in the report, we have a long-standing commitment to being a company focused on the long term. This is why we’re as just as committed to sustainability as we are to our products. We think about it as embedding the goal of social and environmental progress in everything we do.

As part of our commitment to combat climate change, Atlassian set a goal to reach 100 percent renewable power across all our operations by 2025, which we achieved in the fiscal year 2020, five years ahead of schedule.

“We are setting ambitious climate goals because we believe in matching our words by stepping up and taking action, said Jessica Hyman, Atlassian’s head of sustainability. “It’s what our staff want. It’s what our customers expect. It’s what our politicians should be doing. And it’s what we must do for the future sustainability of our business.”

In September 2019, at UN Climate Week, we committed to set a target to reach net-zero emissions by no later than 2050. We aligned our goals with a 1.5°C trajectory as part of our commitment to the Business Ambition for 1.5°C campaign, reflecting the most ambitious objectives of the Paris Agreement.

Last week we announced that these goals have been approved by the Science Based Targets Initiative steering committee. It’s incredibly important to go through the process of figuring out exactly how much we need to reduce carbon emissions to meet our commitments.

“We congratulate Atlassian Corporation for setting emissions reduction targets consistent with limiting warming to 1.5°C, the most ambitious goal of the Paris Agreement, said Alexander Farsan, global lead for Science Based Targets at World Wide Fund for Nature. “By setting targets that are grounded in climate science, Atlassian is setting themselves up for success in the transition to a net-zero economy.”

We were one of the first Australian companies to sign the 1.5 campaign, making a massive commitment to transform our business. And with 5,000 Atlassians in multiple offices, countries, and continents, we will have to make big changes to our direct and indirect operations to reach this goal. We’re doing this because we believe in reinforcing our words with action and leaving the planet in a better state for future generations.

Our SBTi validation is an important step in our climate leadership and commitment to science. Here are the key ways we believe we can get there by 2050:

Scope 1-2 – Absolute Emissions Reduction of 50 percent by 2025: This will mostly be achieved through procurement of 100 percent renewable energy and is therefore directly aligned with our RE100 commitment. The other critical element is ensuring any of the buildings we own and operate run on electricity for heating and cooling (as opposed to natural gas or diesel).

Scope 3 – Reduce absolute emissions from business travel 25 percent by 2025: This will be achieved by reducing emissions from business travel, with a big focus on air travel. We’ll need to consider how to shift travel policy and team behavior, in the context of Team Anywhere, in order to achieve our goal. There is also an opportunity to work with airlines to advocate for more renewable aviation fuels.

Scope 3 – 65 percent of suppliers by emissions will have SBTs by fiscal year 2025: This will be achieved through supply chain management. We’ll need to engage with our top suppliers and encourage them to set science-based climate targets. We are in the middle of mapping out our priorities here with our internal teams, and we’re looking forward to the opportunity for innovation in this space.

One of our values at Atlassian is “Open Company, No Bullshit.” One thing we know for certain: we aren’t going to get this right the first time. But we are committed to being open and honest about our journey and sharing what we learn with the business community.

“Our hope is that more companies see this is possible, and take the leap, said Mike Cannon-Brookes, Atlassian co-founder and co-CEO. “The latest climate science says we need reductions to keep warming to 1.5 degrees to avoid the most damaging effects of climate change. Australia needs to do its part. Our future depends on it.”

About Atlassian

Atlassian unleashes the potential of every team. Our team collaboration and productivity software helps teams organize, discuss, and complete shared work. Teams at more than 182,000 customers, across large and small organizations – including Honeywell, Dropbox, Bank of America, Redfin, Verizon, and NASA – use Atlassian’s project tracking, content creation and sharing, and service management products to work better together and deliver quality results on time. Learn more about our products, including Jira Software, Confluence, Trello, Bitbucket, Opsgenie, Jira Service Desk, and Jira Align at https://atlassian.com/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005910/en/

Jake Standish

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Posted on December 7, 2020 3:33 pm

PG&E Reminds Customers of Ongoing Support Available to Help with the COVID-19 Pandemic Impacts

PG&E Reminds Customers of Ongoing Support Available to Help with the COVID-19 Pandemic Impacts

Customer Protections, Financial-Assistance Programs and Other Resources Are Ready and Here to Help During These Trying Times

SAN FRANCISCO–(BUSINESS WIRE)–
As COVID-19 cases rise throughout the state, Pacific Gas and Electric Company (PG&E) continues to offer support in numerous ways for customers navigating the unprecedented pandemic and reminds our customers that we’re here to help.

“We immediately took action earlier this year to provide support for customers financially impacted by the pandemic and all of those protections remain in place as we move into 2021. We are also reminding customers about the various resources and programs we have available to help them lower their energy costs,” said Laurie Giammona, PG&E’s Chief Customer Officer and a Senior Vice President.

Actions to Protect Customers

PG&E intends on maintaining the following customer protections through April 16, 2021:

• Moratorium on service disconnections for non-payment for residential and small commercial customers;
• Post-enrollment verification and re-enrollment requirements have been suspended for the California Alternate Rates for Energy Program (CARE) and Family Electric Rate Assistance (FERA) Program (FERA);
• Security deposits are being waived for small commercial customers (residential customers are not required to submit security deposits);
• Customers on the Medical Baseline program offering customers with qualifying medical conditions a lower monthly rate on energy bills are not being asked to re-certify through a doctor or other eligible medical professionals for up to one year.

PG&E helped almost 200,000 customers enroll in the CARE program this year providing income-qualified customers with a monthly discount. At the end of October, more than 1.57 million PG&E customers were enrolled in CARE, compared to the 1.39 million enrolled at the end of February prior to the shelter-at- home mandates.

More Energy Saving Resources and Financial Assistance Programs

To take advantage of additional programs, tools and savings opportunities, PG&E recommends customers become more familiar with the following:

• Separate from CARE, income-qualified households with three or more persons can apply for the FERA at pge.com/FERA for an 18% discount on their electric bill.
• Relief for Energy Assistance through Community Help (REACH) provides income- qualified customers with financial assistance during times of hardship. Customers impacted by COVID-19 will be provided with up to an additional $100 in bill payment assistance through April 16, 2021.The program is funded by PG&E through tax-deductible contributions from customers and employees. To donate, clickhere.
• The federally-funded Low-Income Home Energy Assistance Program (LIHEAP) provides financial assistance to help offset eligible household energy costs, including heating, cooling and home weatherization expenses. To learn more, dial 211 or (866) 675-6623 for LIHEAP income guidelines and a list of participating agencies.
• Convenient ways to pay that can help better manage energy costs. Start by logging onto your PG&E online account to monitor energy use and check or compare your rate plan. Explore programs, like Budget Billing to help avoid or manage unanticipated high bills.

Active COVID-19 Protocols

As always, the safety of our customers and employees is PG&E’s most important responsibility. As our field crews perform critical safety and maintenance work as well as follow COVID-19 protocols including wearing face-coverings and respecting social distancing guidelines, we ask our customers to do the same. Your actions can keep our workforce healthy and safe as we continue to maintain and safely operate gas and electric services for our customers.

For more information on PG&E’s response to the virus visit pge.com/covid19/.

About PG&E

Pacific Gas and Electric Company, a subsidiary of PG&E Corporation (NYSE:PCG), is one of the largest combined natural gas and electric energy companies in the United States. Based in San Francisco, with more than 24,000 employees, the company delivers some of the nation’s cleanest energy to nearly 16 million people in Northern and Central California. For more information, visit pge.com and pge.com/news.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005811/en/

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KEYWORDS: California United States North America

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Posted on December 7, 2020 3:32 pm

SHAREHOLDER ALERT: Rigrodsky & Long, P.A. Announces Investigation of Anworth Mortgage Asset Corporation Merger

WILMINGTON, Del., Dec. 07, 2020 (GLOBE NEWSWIRE) — Rigrodsky & Long, P.A. announces that it is investigating Anworth Mortgage Asset Corporation (“Anworth”) (NYSE: ANH) regarding possible breaches of fiduciary duties and other violations of law related to Anworth’s agreement to be acquired by Ready Capital Corporation (“Ready Capital”) (NYSE: RC). Under the terms of the agreement, Anworth’s shareholders will receive 0.1688 shares of Ready Capital common stock per share.

To learn more about this investigation and your rights, visit: https://www.rl-legal.com/cases-anworth-mortgage-asset-corporation.

You may contact Seth D. Rigrodsky or Gina M. Serra cost and obligation free at (888) 969-4242 or [email protected].

Rigrodsky & Long, P.A., with offices in Delaware and New York, has recovered hundreds of millions of dollars on behalf of investors and achieved substantial corporate governance reforms in securities fraud and corporate class actions nationwide.

Attorney advertising.  Prior results do not guarantee a similar outcome.

CONTACT:         

Rigrodsky & Long, P.A.
Seth D. Rigrodsky
Gina M. Serra
(888) 969-4242 (Toll Free)
(302) 295-5310
Fax: (302) 654-7530
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