Posts

Posted on

Foundation Building Materials, Inc. Enters Into Definitive Agreement to Be Acquired by American Securities LLC

Foundation Building Materials, Inc. Enters Into Definitive Agreement to Be Acquired by American Securities LLC

FBM Shareholders to Receive $19.25 Per Share in Cash

SANTA ANA, Calif.–(BUSINESS WIRE)–
Foundation Building Materials, Inc. (“FBM” or the “Company”) (NYSE: FBM), one of the largest specialty building products distributors of wallboard, suspended ceiling systems, metal framing and complementary and other products in North America, today announced that it has entered into a definitive agreement under which an affiliate of American Securities LLC, a leading private equity firm, will acquire all outstanding shares of FBM for $19.25 per share in an all-cash transaction valued at approximately $1.37 billion, including outstanding debt.

An affiliate of Lone Star Funds (“Lone Star”), a global private equity firm, acquired FBM in 2015 and has maintained a majority ownership since the Company’s initial public offering in 2017. Upon completion of the transaction, FBM will become a privately held company.

The transaction, which was unanimously approved by the FBM Board of Directors, represents a premium of approximately 27% to the closing price of FBM common stock on November 13, 2020, the last trading day prior to the transaction announcement.

“We are pleased to announce this transaction with American Securities, delivering immediate cash value to our shareholders at a significant premium,” said Ruben Mendoza, President and CEO of FBM. “American Securities has a proven track record of investing in building products and distribution businesses, and shares our commitment to providing superior products and services to our customers. Having founded FBM nearly a decade ago, I am confident American Securities is the right partner for our company’s next phase, as we work to advance our strategic priorities and continue building long-term value for the Company. This transaction is truly a testament to the hard work and dedication of our more than 3,400 employees, and I’m excited to partner with the team at American Securities to further accelerate our success.”

“The FBM Board, led by the Special Committee and with the assistance of independent financial and legal advisors, conducted a thorough review of opportunities to enhance shareholder value, and unanimously concluded that entering into this agreement with American Securities represents the best way to maximize value,” said Chris Meyer, Chairman of the FBM Board. “This transaction with American Securities is a great outcome for FBM, and I thank Ruben and the rest of the management team for leading FBM to this critical point in the Company’s history. We look forward to FBM’s continued success with its new partner.”

“FBM’s strong national brand and reputation as the distributor of choice for leading building product suppliers make it a compelling investment for American Securities,” said Kevin Penn, a Managing Director of American Securities. “FBM has built meaningful relationships with its loyal customer base, and its focus on customer service underpins its leading market position. We look forward to working with the FBM team to build on the Company’s leadership and grow its global presence while further strengthening its relationships with its customers and partners.”

Approvals

Following execution of the merger agreement, FBM’s majority shareholder, which owns approximately 52% of the Company’s outstanding shares of common stock, approved the transaction by written consent. No further action by FBM’s shareholders is needed or will be solicited in connection with the merger.

The transaction is expected to close in the first quarter of 2021, subject to customary closing conditions, including receipt of clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the Competition Act (Canada).

Advisors

RBC Capital Markets is serving as financial advisor to FBM, and Gibson, Dunn & Crutcher LLP and Davies Ward Phillips & Vineberg LLP are serving as legal counsel. Evercore is serving as financial advisor to the Special Committee of FBM’s Board, and Richards, Layton & Finger PA is serving as legal counsel. Weil, Gotshal & Manges LLP is serving as legal counsel to American Securities.

About Foundation Building Materials

Foundation Building Materials, Inc. is a specialty building products distributor of wallboard, suspended ceiling systems, metal framing, and complementary and other products throughout North America. Based in Santa Ana, California, the Company employs more than 3,400 employees and operates more than 170 branches across the United States and Canada. Learn more at www.fbmsales.com or follow us on LinkedIn, Twitter, Instagram or Facebook.

About American Securities

Based in New York with an office in Shanghai, American Securities is a leading U.S. private equity firm that invests in market-leading North American companies with annual revenues generally ranging from $200 million to $2 billion and/or $50 million to $250 million of EBITDA. American Securities and its affiliates have approximately $23 billion under management. For more information, visit www.american-securities.com.

Cautionary Note Regarding Forward-Looking Statements

This communication contains forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from the results expressed or implied by the forward-looking statement. The Company has made these statements in reliance on the safe harbor created by the Private Securities Litigation Reform Act of 1995 (set forth in Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act). In some cases, forward-looking statements can be identified by words such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or the negative or similar expressions. All of the Company’s forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that the Company is expecting, including: the outbreak of the novel coronavirus COVID-19, or the COVID-19 pandemic; the length and severity of the COVID-19 pandemic and its impact on the global economy, the Company’s business, operations and financial results; the impact of cost-saving initiatives on the Company’s financial and liquidity position; federal, state and local government initiatives to mitigate the impact of the COVID-19 pandemic, including additional restrictions on business activities, “shelter-in-place” orders, guidelines and other restrictions; risks associated with transactions generally, such as the inability to obtain, or delays in obtaining, required regulatory approvals; the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; the outcome of any legal proceedings that may be instituted following announcement of the transaction; failure to retain key management and employees of the Company; issues or delays in the successful integration of the Company’s operations with those of the acquirer, including incurring or experiencing unanticipated costs and/or delays or difficulties; failure or inability to implement growth strategies in a timely manner; unfavorable reaction to the transaction by customers, competitors, suppliers and employees; future levels of revenues being lower than expected and costs being higher than expected; conditions affecting the industry generally; local and global political and economic conditions; conditions in the securities market that are less favorable than expected; and other risks described in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and Quarterly Reports on Form 10-Q.

The forward-looking statements contained in this communication are based on historical performance and management’s current plans, estimates and expectations in light of information currently available to the Company and are subject to uncertainty and changes in circumstances. There can be no assurance that future developments affecting the Company will be those that we have anticipated. Actual results may differ materially from these expectations due to changes in global, regional or local political, economic, business, competitive, market, regulatory, public health and other factors, many of which are beyond the Company’s control, as well as the other factors described the Company’s filings with the SEC. Additional factors or events that could cause the Company’s actual results to differ may also emerge from time to time, and it is not possible for us to predict all of them. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove to be incorrect, the Company’s actual results may vary in material respects from what we may have expressed or implied by these forward-looking statements. You should not place undue reliance on any of the Company’s forward-looking statements. Any forward-looking statement made by the Company in this communication speaks only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable securities laws. The Company qualifies all of its forward-looking statements by these disclaimers.

Additional Information and Where to Find It

The Company will prepare an information statement on Schedule 14C for its stockholders with respect to the approval of the transaction described herein. When completed, the information statement will be mailed to the Company’s stockholders. You may obtain copies of all documents filed by the Company with the SEC regarding this transaction, free of charge, at the SEC’s website, www.sec.gov or from the Company’s website at https://investors.fbmsales.com/.

FBM Contact Information:

Investor Relations:

John Moten, IRC

Foundation Building Materials, Inc.

657-900-3200

[email protected]

Media Relations:

Joele Frank, Wilkinson Brimmer Katcher

Jed Repko or Ed Trissel

212-355-4449

American Securities Contact Information:

Amy Harsch

+1 (212) 476-8071

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Retail Other Retail Other Construction & Property Manufacturing Specialty Construction & Property Other Manufacturing

MEDIA:

Posted on

Fingerprint Cards AB (publ) Unveils Curved Side-mounted Capacitive Sensor for Mobile Devices

Fingerprint Cards AB (publ) Unveils Curved Side-mounted Capacitive Sensor for Mobile Devices

Expands capacitive portfolio with uniquely curved sensor, enabling greater design flexibility while improving user experience.

GOTHENBURG, Sweden–(BUSINESS WIRE)–
Fingerprint Cards AB (Fingerprints™) today announces the launch of a new slim and curved capacitive touch sensor for biometric authentication. Following the success of the FPC1540 sensor, the uniquely curved FPC1542 sensor is set to enable innovation in the latest borderless smartphone designs.

As demand for side-mounted touch sensors grows, the curved sensor offers OEMs enhanced design flexibility while improving user experience with a seamlessly integrated sensor that can double as power button or volume control, or be used to operate the camera shutter and to scroll. The sensor can be coated in a range of colors to complement the aesthetics of the smartphone design.

FPC1542 expands Fingerprints’ portfolio of capacitive sensors, that are now integrated on the front, back and side of over 455 different mobile device models.

“As smartphone design continues to improve user experience, biometrics continues to act as an enabler for innovation and differentiation,” comments Ted Hansson, SVP Business Line Mobile at Fingerprints. “Being a leader in the capacitive sensor market, we have seen a growing demand for sensors that offer maximum design flexibility without compromising on security or functionality. With the launch of this new sensor, we bring something truly unique to mobile OEMs, taking enhanced user experience and optimized designs to the next level.”

Fingerprints will start volume shipments in Q4 and expects the first smartphone using FPC1542 to be launched in Q1 2021.

For more information about Fingerprints’ mobile device solutions, visit the website.

About Fingerprints

Fingerprint Cards AB (Fingerprints) – the world’s leading biometrics company, with its roots in Sweden. We believe in a secure and seamless universe, where you are the key to everything. Our solutions are found in hundreds of millions of devices and applications, and are used billions of times every day, providing safe and convenient identification and authentication with a human touch. For more information visit our website, read our blog, and follow us on Twitter. Fingerprints is listed on Nasdaq Stockholm (FING B).

For further information, please contact:

Ted Hansson, Senior VP Business Line Mobile

Investor Relations:

+46(0)10-172 00 10, [email protected]

Press:

+46(0)10-172 00 20, [email protected]

KEYWORDS: Sweden Europe

INDUSTRY KEYWORDS: Security Hardware Consumer Electronics Mobile/Wireless Technology

MEDIA:

Logo
Logo
Posted on

KKR and Rakuten to Acquire Stakes in Seiyu from Walmart, Focus on Accelerating Digital Transformation of Japanese Retail: Seiyu Positioned to Become Japan’s Leading Omnichannel Retailer

KKR and Rakuten to Acquire Stakes in Seiyu from Walmart, Focus on Accelerating Digital Transformation of Japanese Retail: Seiyu Positioned to Become Japan’s Leading Omnichannel Retailer

  • KKR to purchase majority stake and new Rakuten subsidiary to acquire minority stake in Seiyu
  • Walmart to retain 15% stake and work with KKR and Rakuten to accelerate Seiyu’s digital transformation to become Japan’s leading omnichannel retailer
  • The complementary retail expertise KKR and Rakuten bring, including track records of driving growth in e-commerce and digital marketing platforms across the globe, will help Seiyu become the local, innovative, value retailer of choice
  • This transaction reflects Walmart’s commitment to building strong, local businesses by bringing together the right parties in the right structure to meet unique market needs

TOKYO & BENTONVILLE, Ark.–(BUSINESS WIRE)–
Walmart Inc. (“Walmart”), KKR & Co. Inc. (“KKR”) and Rakuten, Inc., (“Rakuten”) today announced the signing of definitive agreements under which KKR will purchase a majority stake and a new Rakuten subsidiary will purchase a minority stake in Seiyu GK (“Seiyu” or the “Company”) in a deal valuing the business at ¥172.5 billion (approx. $1.6 billion).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201115005157/en/

Under the terms of the agreements, KKR will acquire a 65% stake in Seiyu, and Rakuten will acquire a 20% stake, through a newly created subsidiary focused on retailer digital transformation. Walmart will retain a 15% stake in Seiyu. The new ownership structure enables Seiyu to take advantage of KKR, Rakuten and Walmart’s combined retail expertise and innovation as a standalone company and accelerate its digital transformation to further benefit both Seiyu’s customers and business partners.

KKR, Rakuten and Walmart are committed to supporting Seiyu’s growth and this unique ownership structure reflects a shared belief in Seiyu’s long-term strategy in Japan. Last year, Seiyu launched an ambitious strategy to accelerate growth through a more concerted focus on providing value, fresh produce and digital convenience to customers. The Company has already met or exceeded operational and financial goals across key areas, including market share, customer satisfaction, associate engagement and financial performance. Together, the three companies look to bring complementary strengths to build on Seiyu’s momentum and support its efforts to become Japan’s leading omnichannel retailer.

KKR and Rakuten’s investment in Seiyu is further intended to deliver a range of substantial benefits over time for the Company’s customer base, including:

  • Accelerated investment in digital channels to facilitate app-based shopping, payment and delivery services;
  • Introduction of new options for cashless payment;
  • Improved service experience across both online and offline channels; and
  • Enhanced product offering at everyday low prices to stay ahead of its customers’ shopping needs.

KKR will bring its deep expertise in the Japanese market to Seiyu, in addition to its decades-long track record of investing in the subsidiaries of large corporations and empowering them to unlock their potential as successful, independent companies. KKR will further leverage its sector and operational expertise to enhance Seiyu’s retail transformation efforts and will make available its network of advisors, portfolio companies and specialists to create value.

The new ownership structure builds on previously established collaborations between Rakuten and Walmart, including the popular Rakuten Seiyu Netsuper online grocery delivery service and Rakuten Group’s partnership with Walmart that includes ebook service support in the United States. Rakuten will further accelerate digital transformation of Seiyu and other Japanese retailers through its new subsidiary Rakuten DX Solution, leveraging its 100M+ membership base and technology.

Seiyu will continue to have access to Walmart’s global retail best practices, sourcing network and scale to maintain the price leadership and value it provides to customers.

Seiyu CEO Lionel Desclee will continue to lead the business through a transition period, after which he will take on a new role within Walmart. A new Board of Directors comprised of representatives from KKR, Rakuten and Walmart will be formed to focus decision making locally, and plans to appoint a new CEO following the close of the transaction.

Judith McKenna, President and CEO of Walmart International, commented, “This past year has been one of the most extraordinary in Seiyu’s rich 57-year history. Our associates have been exceptional, adapting brilliantly to serve customers at a time when they needed it most and outperforming against an ambitious transformation plan. We have been proud investors in this business over the past 18 years and we are excited about its future under the new ownership structure. Today’s announcement is important because its focus is on bringing together the right partners in the right structure to build the strongest possible local business. We look forward to supporting Seiyu’s growth and success, alongside KKR and Rakuten, as a minority investor.”

Hiro Hirano, Co-Head of Asia Pacific Private Equity and CEO of Japan at KKR, said, “KKR is pleased to invest in the success of Seiyu given the important role it plays in the lives of customers across the country. We are also excited by the prospect of working with Seiyu’s associates, who have dedicated themselves to supporting the business in spite of this year’s unprecedented challenges. We will focus on working closely with Seiyu’s management team and associates and leveraging the expertise of Rakuten and Walmart to enhance the customer experience, meet their ever-changing needs, and make shopping more accessible through digitalization. This investment is a true milestone for KKR in Japan and reinforces our commitment to the market as well as our continuing efforts to champion the long-term success of local businesses.”

Kazunori Takeda, Group Executive Vice President and President of Commerce Company, Rakuten, Inc., said, “By building on our successful partnership on Rakuten Seiyu Netsuper and our deep experience in online retail and data-based marketing, we look forward to accelerating digital transformation of Seiyu brick and mortar retail and further merging the best of offline and online retail to offer Seiyu customers the best possible OMO1 customer experience. The planned establishment of Rakuten DX Solution will also allow us to offer digital solutions optimized to transform retail at Seiyu and in new future partnerships with retailers across Japan.”

KKR is making its investment from its Asia private equity fund. The transaction is subject to regulatory approvals and is expected to close in the first quarter of 2021.

About Walmart

Walmart Inc. (NYSE: WMT) helps people around the world save money and live better — anytime and anywhere — in retail stores, online, and through their mobile devices. Each week, over 265 million customers and members visit approximately 11,400 stores under 55 banners in 26 countries and eCommerce websites. With fiscal year 2020 revenue of $524 billion, Walmart employs over 2.2 million associates worldwide. Walmart continues to be a leader in sustainability, corporate philanthropy and employment opportunity. Additional information about Walmart can be found by visiting https://corporate.walmart.com, on Facebook at https://facebook.com/walmart and on Twitter at https://twitter.com/walmart.

About Seiyu:

Established in 1963, Seiyu is a nationwide supermarket chain in Japan with more than 300 retail units. Through its supermarket and hypermarket formats and Rakuten Seiyu Netsuper delivery service, Seiyu offers customers a broad assortment including fresh food, general merchandise, and apparel products across Japan from Hokkaido to Kyusyu. Offering EDLP to our customers, Seiyu contributes to making their everyday life more convenient as a leading, innovative, local value retailer powered by Walmart, its parent company.

About KKR:

KKR is a leading global investment firm that manages multiple alternative asset classes, including private equity, credit and real assets, with strategic partners that manage hedge funds. KKR aims to generate attractive investment returns for its fund investors by following a patient and disciplined investment approach, employing world-class people, and driving growth and value creation with KKR portfolio companies. KKR invests its own capital alongside the capital it manages for fund investors and provides financing solutions and investment opportunities through its capital markets business. References to KKR’s investments may include the activities of its sponsored funds. For additional information about KKR & Co. Inc. (NYSE: KKR), please visit KKR’s website at www.kkr.com and on Twitter @KKR Co.

About Rakuten:

Rakuten, Inc. (TSE: 4755) is a global leader in internet services that empower individuals, communities, businesses and society. Founded in Tokyo in 1997 as an online marketplace, Rakuten has expanded to offer services in e-commerce, fintech, digital content and communications to approximately 1.4 billion members around the world. The Rakuten Group has over 20,000 employees, and operations in 30 countries and regions. For more information visit https://global.rakuten.com/corp/.

About Rakuten DX Solution:

A new Rakuten Group subsidiary planned for establishment in January 2021 to support the digital transformation of brick-and-mortar retailers across Japan and to promote the merger of offline and online retail (OMO) in order to serve customers with a seamless and personalized retail experience.

1OMO: “Online Merges with Offline” refers to breaking down the barriers between online services and offline brick-and-mortar stores in the retail space in order to provide customers with a seamless, personalized experience.

Walmart

Blake Jackson

+1 479 204-1028

[email protected]

Seiyu

Miyuki Moriguchi

[email protected]

KKR

KKR Asia Pacific

Anita Davis

+852 3602 7335

[email protected]

Finsbury (for KKR Japan)

Deborah Hayden, +81 70 2492 0463

Hannah Perry, +81 70 3769 9633

[email protected]

KKR Americas

Kristi Huller, Cara Major, Miles Radcliffe-Trenner

+1 212 750-8300

[email protected]

Rakuten, Inc.

Corporate Communications Department

[email protected]

KEYWORDS: United States Japan North America Asia Pacific Arkansas

INDUSTRY KEYWORDS: Discount/Variety Department Stores Other Retail Finance Banking Supermarket Professional Services Food/Beverage Retail Online Retail

MEDIA:

Logo
Logo
Logo
Logo
Logo
Logo
Posted on

Mirum Pharmaceuticals Announces Data Presented During AASLD Highlighting Durable Improvements in Pruritus and Quality of Life in Children with Alagille Syndrome Treated with Maralixibat

Mirum Pharmaceuticals Announces Data Presented During AASLD Highlighting Durable Improvements in Pruritus and Quality of Life in Children with Alagille Syndrome Treated with Maralixibat

– Results of long-term treatment from the ITCH and IMAGINE II studies presented in late-breaking oral presentation at AASLD

– Data demonstrates significant and durable improvements in pruritus in children with Alagille syndrome through 220 weeks of maralixibat treatment

– Results have been included as supportive data in ongoing rolling NDA submission for treatment of cholestatic pruritus in patients with Alagille syndrome

FOSTER CITY, Calif.–(BUSINESS WIRE)–
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, announced data presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting Digital Experience™. The data were presented by Dr. Benjamin Shneider of Baylor College of Medicine and Texas Children’s Hospital presenting on behalf of the Childhood Liver Disease Research Network (ChiLDReN) in a late-breaking oral presentation titled “Preliminary Analysis of ITCH and IMAGINE II – Outcome of Long-term Administration of Maralixibat in Children with Alagille Syndrome.”

The objective of the studies was to assess pruritus and other markers of cholestasis in patients with Alagille syndrome (ALGS) with up to 220 weeks of treatment with maralixibat. Maralixibat, an apical sodium bile acid transporter (ASBT) inhibitor, has previously been shown to interrupt the enterohepatic circulation of bile acids, reducing pruritus.

Of the children enrolled in the ITCH and IMAGINE II studies, 28 of the 37 patients were on study at 48 weeks with 80% of those experiencing clinically meaningful reductions in pruritus (ItchRO[Obs] reduction ≥1.0 point) which were durable beyond four years (Week 220), with 90% of patients who continued on study experiencing a pruritus response at the end of treatment. The mean reduction in ItchRO(Obs) at week 48 was -1.9 points and deepened to -2.3 points at the end of treatment. Maralixibat treatment improved quality of life and led to improved growth parameters. The long-term data suggest that maralixibat has the potential to be an effective treatment and could serve as an alternative to surgery for ALGS patients, if approved.

“Maralixibat has the potential to address the severe pruritus experienced by children with Alagille syndrome, resulting in meaningful improvement in quality of life, meeting a major unmet need for this patient population,” said Benjamin L. Shneider, M.D., principal study investigator and member of the Childhood Liver Disease Research Network, funded largely by the National Institute of Diabetes and Digestive and Kidney Diseases. “Alagille syndrome often leads to progressive liver disease frequently complicated by severe pruritus, often disrupting sleep, interfering with school, and impacting the quality of life for children and their families so greatly that surgical intervention via external biliary diversion or liver transplant are required. These data show that with maralixibat, we have the potential to positively impact children’s health across multiple clinical measures, without resorting to invasive surgeries which can be associated with significant complications and potential mortality.”

To view the presentation and the complete data, please visit the AASLD section within the Events page on Mirum’s website.

“These results from the study confirm the potential for maralixibat to address the consequences of cholestasis in Alagille syndrome, supporting the effects seen in the long term analysis of the pivotal ICONIC study,” said Chris Peetz, president and chief executive officer of Mirum. “As we progress toward completion of our rolling NDA submission, maralixibat is being offered to eligible patients with Alagille syndrome through an expanded access program until it is available for prescribing.”

About the ITCH and IMAGINE II study

The ITCH study is a randomized, placebo-controlled study of maralixibat in children with ALGS. The IMAGINE II study is an open-label study for participants who completed the ITCH study. ITCH and IMAGINE II were conducted by ChiLDReN in the context of a Cooperative Research and Development Agreement between Mirum Pharmaceuticals and the NIDDK. Thirty-seven children were enrolled into the ITCH study. Children receiving maralixibat in the studies also demonstrated improvements in biomarkers of disease, including reductions in cholesterol and bile acid levels. After over 4 years of treatment, maralixibat continues to be generally well tolerated. There were two serious adverse events possibly related to administration of maralixibat leading to drug withdrawal in both patients (hematochezia/anemia and autoimmune hepatitis).

About Alagille Syndrome

ALGS is a rare genetic disorder in which bile ducts are abnormally narrow, malformed and reduced in number, which leads to bile accumulation in the liver and ultimately progressive liver disease. The estimated incidence of ALGS is one in every 30,000 people.1 In patients with ALGS, multiple organ systems may be affected by the mutation, including the liver, heart, kidneys and central nervous system.2 The accumulation of bile acids prevents the liver from working properly to eliminate waste from the bloodstream and, according to recent reports, 60% to 75% of patients with Alagille syndrome have a liver transplant before reaching adulthood.3 Signs and symptoms arising from liver damage in ALGS may include jaundice (yellowing of the skin), xanthomas (disfiguring cholesterol deposits under the skin), and pruritus (itch)2. The pruritus experienced by patients with ALGS is among the most severe in any chronic liver disease and is present in most affected children by the third year of life.4

About Maralixibat

Maralixibat is a novel, minimally absorbed, orally administered investigational drug being evaluated in several rare cholestatic liver diseases. Maralixibat inhibits the apical sodium dependent bile acid transporter (ASBT), resulting in more bile acids being excreted in the feces, leading to lower levels of bile acids systemically, thereby potentially reducing bile acid mediated liver damage and related effects and complications. More than 1,600 individuals have received maralixibat, including more than 120 children who have received maralixibat as an investigational treatment for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). In the ICONIC Phase 2b ALGS clinical trial, patients taking maralixibat had significant reductions in bile acids and pruritus compared to placebo, as well as reduction in xanthomas and accelerated growth long-term. In a Phase 2 PFIC study, a genetically defined subset of BSEP deficient (PFIC2), patients responded to maralixibat with an increase in transplant-free survival. The U.S. Food and Drug Administration has granted maralixibat Breakthrough Therapy designation for the treatment of pruritus associated with ALGS in patients one year of age and older and for PFIC2. Maralixibat was generally well-tolerated throughout the studies. The most frequent treatment-related adverse events were diarrhea and abdominal pain. Until maralixibat is approved and available for prescribing, the medication is available to patients with ALGS through Mirum’s expanded access program. For more information, please visit ALGSEAP.com. For more information about the Phase 3 study for maralixibat in pediatric patients with PFIC, visit PFICtrial.com.

About Mirum Pharmaceuticals

Mirum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. The company’s lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia. The company has initiated a rolling NDA submission for maralixibat in the treatment of patients with cholestatic pruritus associated with ALGS and expects to complete the submission in the first quarter of 2021. Additionally, the company plans to submit a marketing authorization application to the European Medicines Agency for maralixibat in the treatment of patients with PFIC2 in the fourth quarter 2020.

The company is also developing volixibat, also an oral ASBT-inhibitor, in primary sclerosing cholangitis and intrahepatic cholestasis of pregnancy. For more information, visit MirumPharma.com.

Follow Mirum on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the results, conduct and progress of Mirum’s ongoing and planned clinical studies for maralixibat and volixibat, the regulatory approval path for maralixibat, and the potential launch of maralixibat, if approved. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans,” “expects,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general, the impact of the COVID-19 pandemic, and the other risks described in Mirum’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

The content in this release is the sole responsibility of the authors and does not necessarily represent the official views or imply endorsement of the National Institutes of Health.

1Danks, et al. Archives of Disease in Childhood1977

2Johns Hopkins Medicine. hopkinsmedicine.org/health/conditions-and-diseases/Alagille-syndrome

3Vandriel, et al. GALA EASL 2020; Kamath, et al. Hepatology Communications 2020

4Elisofon, et al. Journal of Pediatric Gastroenterology and Nutrition 2010

Investor Contact:

Ian Clements, Ph.D.

[email protected]

Media Contact:

Erin Murphy

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Health Consumer Infectious Diseases Children Pharmaceutical Biotechnology

MEDIA:

Logo
Logo
Posted on

Simon And Taubman Modify Merger Price To $43.00 Per Share In Cash

PR Newswire

INDIANAPOLIS and BLOOMFIELD HILLS, Mich., Nov. 15, 2020 /PRNewswire/ — Simon Property Group, Inc. (NYSE: SPG) (“Simon”) and Taubman Centers, Inc. (NYSE: TCO) (“Taubman”) today announced that they have reached a definitive agreement modifying certain terms of the original merger agreement (the “Original Merger Agreement”), including a modified purchase price of $43.00 per share in cash and other provisions to reduce closing conditionality.  

The modified merger agreement continues to provide that Simon will acquire an 80% ownership interest in The Taubman Realty Group Limited Partnership (“TRG”). The Taubman family will sell approximately one-third of its ownership interest at the transaction price and remain a 20% partner in TRG. 

The Boards of Directors of Simon and Taubman, including the Special Committee of independent directors of Taubman, have approved the terms of the transaction. The modified merger agreement provides that Taubman will not declare or pay a dividend on its common stock prior to March 1, 2021, and then, only subject to certain limitations and conditions.

The merger is expected to close in late 2020 or early 2021, subject to Taubman shareholder approval and customary closing conditions.  Simon and Taubman also have settled their pending litigation in the Circuit Court for the 6th Judicial District, Oakland County, Michigan.

About Simon
Simon is a real estate investment trust engaged in the ownership of premier shopping, dining, entertainment and mixed-use destinations and an S&P 100 company (Simon Property Group, NYSE: SPG). Our properties across North America, Europe and Asia provide community gathering places for millions of people every day and generate billions in annual sales. For more information, visit simon.com.

About Taubman

Taubman Centers is an S&P MidCap 400 Real Estate Investment Trust engaged in the ownership, management and/or leasing of 26 regional, super-regional and outlet malls in the U.S. and Asia. Taubman’s U.S.-owned properties are the most productive in the publicly held U.S. mall industry. Founded in 1950, Taubman is headquartered in Bloomfield Hills, Mich. Taubman Asia, founded in 2005, is headquartered in Hong Kong. www.taubman.com.

Advisors

BofA Securities is serving as financial advisor to Simon and Paul, Weiss, Rifkind, Wharton & Garrison LLP and Latham & Watkins LLP are serving as legal advisors.  Goldman Sachs & Co. LLC is serving as financial advisor to Taubman and Wachtell, Lipton, Rosen & Katz and Honigman LLP are serving as legal advisors. The Special Committee of the Board of Directors of Taubman has retained Lazard as its independent financial advisor and Kirkland & Ellis LLP as its independent legal counsel.

Forward Looking Statements
This communication contains certain “forward-looking” statements as that term is defined by Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements that are predictive in nature, that depend on or relate to future events or conditions, or that include words such as “believes”, “anticipates”, “expects”, “may”, “will”, “would”, “should”, “estimates”, “could”, “intends”, “plans” or other similar expressions are forward-looking statements. Forward-looking statements involve significant known and unknown risks and uncertainties that may cause actual results in future periods to differ materially from those projected or contemplated in the forward-looking statements as a result of, but not limited to, the following factors: the COVID-19 pandemic and related challenges, risks and uncertainties which have had, and may continue to have, direct and indirect adverse impacts on the general economy, mall environment, tenants, customers, and employees, as well as mall and tenant operations (including the ability to remain open) and operating procedures, occupancy, anchor and mall tenant sales, sales-based rent, rent collection, leasing and negotiated rents, mall development and redevelopment activities and the fair value of assets (increasing the likelihood of future impairment charges); future economic performance, including stabilization and recovery from the impact of the COVID-19 pandemic; savings due to cost-cutting measures; payments of dividends and the sufficiency of cash to meet operational needs; changes in market rental rates; unscheduled closings or bankruptcies of tenants; relationships with anchor tenants; trends in the mall industry; challenges with department stores; changes in consumer shopping behavior, including accelerated trends resulting from the COVID-19 pandemic; the liquidity of real estate investments; the failure to receive, on a timely basis or otherwise, the required approvals by Taubman’s shareholders; the risk that a condition to closing of the transaction may not be satisfied; Simon’s and Taubman’s ability to consummate the transaction; the possibility that the anticipated benefits from the transaction will not be fully realized (including Simon’s underwritten capitalization rate and its expectations regarding FFO per share accretion); the ability of Taubman to retain key personnel and maintain relationships with business partners pending the consummation of the transaction; and the impact of legislative, regulatory and competitive changes and other risk factors relating to the industries in which Simon and Taubman operate, as detailed from time to time in each of Simon’s and Taubman’s reports filed with the Securities and Exchange Commission (the “SEC”). There can be no assurance that the transaction will in fact be consummated.

Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found under Item 1.A in each of Simon’s and Taubman’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and the sections labeled “Risk Factors” and “Forward Looking Statements” in each of Simon and Taubman’s periodic reports on Form 10-Q for the fiscal quarters ended March 31, 2020, June 30, 2020 and September 30, 2020. Simon and Taubman caution that the foregoing list of important factors that may affect future results is not exhaustive. When relying on forward-looking statements to make decisions with respect to the proposed transaction, shareholders and others should carefully consider the foregoing factors and other uncertainties and potential events. All subsequent written and oral forward-looking statements concerning the proposed transaction or other matters attributable to Simon and Taubman or any other person acting on their behalf are expressly qualified in their entirety by the cautionary statements referenced above. The forward-looking statements contained herein speak only as of the date of this communication. Neither Simon nor Taubman undertakes any obligation to update or revise any forward-looking statements for any reason, even if new information becomes available or other events occur in the future, except as may be required by law.

Additional Information and Where to Find It
This communication is being made in respect of the proposed transaction involving Taubman and Simon. In connection with the proposed transaction, Taubman intends to file relevant materials with the SEC, including a preliminary proxy statement on Schedule 14A. Promptly after filing its definitive proxy statement with the SEC, Taubman will mail the definitive proxy statement and a proxy card to each shareholder of Taubman entitled to vote at the special meeting relating to the proposed transaction. This communication is not a substitute for the proxy statement or any other document that Taubman may file with the SEC or send to its shareholders in connection with the proposed transaction. BEFORE MAKING ANY VOTING DECISION, SHAREHOLDERS OF TAUBMAN ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE PROPOSED TRANSACTION THAT TAUBMAN WILL FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT TAUBMAN AND THE PROPOSED TRANSACTION. The definitive proxy statement, the preliminary proxy statement and other relevant materials in connection with the proposed transaction (when they become available), and any other documents filed by TAUBMAN with the SEC, may be obtained free of charge at the SEC’s website (http://www.sec.gov) or at Taubman’s website (www.taubman.com).

Participants in the Solicitation
Taubman and certain of its directors, executive officers and employees may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the shareholders of Taubman in connection with the transaction, including a description of their respective direct or indirect interests, by security holdings or otherwise, is included in the Proxy Statement described above filed with the SEC. Additional information regarding Taubman’s directors and executive officers is also included in Taubman’s proxy statement on Schedule 14A for its 2020 Annual Meeting of Shareholders, which was filed with the SEC on July 2, 2020, or its Amended Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on February 27, 2020, as amended on April 29, 2020. These documents are available free of charge as described above.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/simon-and-taubman-modify-merger-price-to-43-00-per-share-in-cash-301173266.html

SOURCE Simon

Posted on

Gilead and Novo Nordisk Present New Data from Proof-of-Concept Trial in NASH

Gilead and Novo Nordisk Present New Data from Proof-of-Concept Trial in NASH

— Results from First Phase 2 Trial Describing a Triple Combination Regimen Targeting NASH Presented at The Liver Meeting Digital Experience —

FOSTER CITY, Calif. & BAGSVÆRD, Denmark–(BUSINESS WIRE)–
Gilead Sciences, Inc. (Nasdaq: GILD) and Novo Nordisk A/S (NASDAQ Copenhagen: NOVO B) today announced results from a Phase 2 proof-of-concept trial. The five-arm trial evaluated combinations of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist, with Gilead’s investigational FXR agonist cilofexor and/or Gilead’s investigational ACC inhibitor firsocostat over 24 weeks in 108 people with non-alcoholic steatohepatitis (NASH). The results were presented at The Liver Meeting Digital Experience™ (TLMdX), November 13–16, 2020 (Late Breaker #L02).

The trial met its primary endpoint by demonstrating that in people with NASH and mild to moderate fibrosis all regimens were well tolerated. The most common adverse events (AEs) were gastrointestinal. Minimal pruritus (itching) was observed in people treated with cilofexor. Across all groups, 5–14% of people discontinued any trial treatment due to AEs. Exploratory efficacy endpoints assessing biomarkers of liver health at 24 weeks in post-hoc analyses showed statistically significant improvements in hepatic steatosis (measured by magnetic resonance imaging proton density fat fraction; MRI-PDFF) and liver injury (measured by serum alanine aminotransferase; ALT) in the combination arms versus semaglutide alone. Although liver stiffness measured by vibration-controlled transient elastography (VCTE) and enhanced liver fibrosis (ELF) score declined in all groups, statistically significant differences between groups were not observed.

“These results offer novel insights around the multiple mechanisms that drive NASH and demonstrate the potential of combination approaches for patients in significant need of a treatment option for this condition,” said Naim Alkhouri, MD, Director of the Fatty Liver Program, Chief of Transplant Hepatology, Arizona Liver Health, Chandler. “We are encouraged that these data showcase the potential for combination approaches to elicit improvements in liver fat content, liver biochemistry, and certain non-invasive tests of fibrosis, all of which have been associated with meaningful histologic improvement in NASH.”

“Gilead is focused on delivering scientific advances that can improve the lives of people with liver disease, both through our own innovation and in partnership with companies with complementary expertise, such as Novo Nordisk,” said Mark Genovese, MD, Senior Vice President, Inflammation Clinical Development at Gilead Sciences. “These data offer new insights into potential therapeutic approaches to treating NASH, a disease which currently has limited treatment options.”

“This trial brings together Gilead and Novo Nordisk’s respective expertise and science to provide important insights into potential new combination therapies involving semaglutide to help people living with NASH,” said Martin Holst Lange, Senior Vice President, Global Development at Novo Nordisk. “We are now carefully evaluating next steps together based on a thorough assessment of data.”

The companies are also presenting preclinical data supporting the development of combination approaches in NASH. In the preclinical trial, semaglutide alone and in combination with cilofexor and/or GS-834356 (an analog of firsocostat) were administered daily for 12 weeks in a murine model of diet-induced NASH (n=15-16/group). The results demonstrated that while semaglutide significantly improved NASH and fibrosis-related endpoints, the addition of either cilofexor or the firsocostat analog further improved liver fat reduction. The combination of all three agents had the greatest impact on changes in the NAFLD Activity Score (NAS).

The safety and efficacy of firsocostat, GS-834356 and cilofexor have not been established. Firsocostat, GS-834356 and cilofexor are investigational compounds and are not approved by the FDA or any other regulatory authority. Semaglutide has not been approved by the FDA or any other regulatory authority for the treatment of people living with NASH, but has been approved for the treatment of type 2 diabetes.

About NASH

NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. The risk of progression to advanced liver disease, including liver decompensation (loss of liver function) and liver cancer, is higher in people with NASH than in the general population and NASH could become the leading reason for liver transplants in most countries. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few management options.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

About Novo Nordisk

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Gilead Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials involving cilofexor, firsocostat and GS-834356 and the possibility that Gilead may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of cilofexor, firsocostat and GS-834356 and other investigational compounds, or that the parties may make a strategic decision to discontinue their collaboration at any time, and as a result, the compounds may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

GILEAD CONTACTS:

Douglas Maffei, PhD, Investors

+1 (650) 522-2739

Darcy Bowman, Media

+353 (87) 382-6777

NOVO NORDISK CONTACTS:

Daniel Muusmann Bohsen, Investors

+45 3075 2175

Mette Kruse Danielsen

+45 3079 3883

KEYWORDS: Europe Denmark United States North America California

INDUSTRY KEYWORDS: Health Hospitals Clinical Trials Research Science Pharmaceutical Biotechnology

MEDIA:

Logo
Logo
Posted on

Azul S.A. Statement on the Successful Settlement of Public Convertible Debentures

Knighthead Capital Management and Certares Management acted as anchor investors of the offering

PR Newswire

SAO PAULO, Nov. 15, 2020 /PRNewswire/ — Azul S.A. (B3: AZUL4, NYSE: AZUL) and its partners celebrate the successful settlement of its public offering of convertible debentures in Brazil.  The settlement took place on Nov 12 and the official settlement announcement can be found on the Azul Investor Relations website.  Financial advisors to the company included Seabury Securities LLC, a US investment banking firm and Itau BBA, a Brazilian investment bank which acted as sole underwriter for the public offer. 

“We want to thank all of our financial partners for their support during this process.  Together with our anchor investors Knighthead and Certares, we are setting the stage for a successful long-term partnership.  Azul’s strategic competitive advantages and unique business model, combined with the strong market recovery in Brazil, lead to us to be optimistic about our future.  The successful conclusion of this public offering ensures that we are in a position to be a long-term winner,” says John Rodgerson, Chief Executive Officer at Azul.

“Since its founding in 2008, Azul has executed one of the most creative and ambitious business plans in aviation,” said Tom Wagner, Founder of Knighthead Capital Management.  “Amidst uncertainty around COVID-19, this transaction provides the airline with one of the best liquidity positions in the global industry.  Brazil has been an excellent and resilient air travel market for several years, and Azul’s strong balance sheet and market position set the stage for its future success.  We are excited to partner with management as the company grows in the years ahead.”

“Azul is a premier airline that has been recognized globally for delivering great customer experiences and consistently strong financial performance,” said Tom Klein Senior Managing Director at Certares.  “That, coupled with Azul’s being strategically positioned for growth and a long term winner in Latin American aviation, makes partnering with its respected management team ideal for Certares.”

About Azul

Azul S.A. (B3: AZUL4, NYSE: AZUL), the largest airline in Brazil by number of flight departures and cities served, offers 916 daily flights to 116 destinations. With an operating fleet of 140 aircraft and more than 13,000 crewmembers, the Company has a network of 249 non-stop routes as of December 31, 2019. In 2020 Azul was awarded best airline in the world by TripAdvisor, the first time a Brazilian Flag Carrier ranked number one in the Traveler’s Choice Awards. Azul was also recognized in 2019 as best regional carrier in South America for the ninth consecutive year by Skytrax. Additionally, in 2019, Azul ranked among the top ten most on–time low-cost carriers in the world, according to OAG. For more information visit www.voeazul.com.br/ir.

About Knighthead

Established in 2008, Knighthead Capital Management’s credit platform combines bottom-up fundamental research with top-down macro analysis to identify investment opportunities across the capital structure.  Led by co-founders Tom Wagner and Ara Cohen, the experienced investment team seeks to achieve superior risk-adjusted returns in distressed investments via fundamental analysis and driving restructuring processes.  The $4.5 billion platform is diversified across Knighthead’s evergreen funds, closed end credit funds, real estate lending, and insurance asset management.

About Certares

Established in 2012, Certares focuses on direct investments in proprietary transactions, leveraging deep sector experience in the travel and hospitality industries, and with a consistent emphasis on partnership with management teams to drive growth. Certares brings together a team with decades of both operational and investment experience in private equity, travel, tourism, hospitality and travel-related business and consumer services. For more information, please visit www.certares.com.

Cision View original content:http://www.prnewswire.com/news-releases/azul-sa-statement-on-the-successful-settlement-of-public-convertible-debentures-301173258.html

SOURCE Azul S.A.

Posted on

MyoKardia Presents Cardiac Imaging Data from 30-Week EXPLORER-HCM Study of Mavacamten

EXPLORER
-HCM
Cardiac Imaging Data Presented at AHA 2020 Scientific Session with Simultaneous Publication in Circulation

Mavacamten
T
reatment
Resulted in
Favorable Effect on
Cardiac Structure
— Significantly Reduced
Hypertrophy
in Patients with Hypertrophic Cardiomyopathy

BRISBANE, Calif., Nov. 15, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) announced results from its cardiac magnetic resonance imaging (CMR) substudy of mavacamten for the potential treatment of hypertrophic cardiomyopathy (HCM) showing that 30-week treatment with mavacamten has a favorable effect on cardiac structure, while maintaining contractile function within the normal range. These data were shared today in an oral presentation titled, “Mavacamten Favorably Impacts Cardiac Structure in Obstructive Hypertrophic Cardiomyopathy: EXPLORER-HCM CMR substudy” (Oral Session 18654), at the American Heart Association’s Scientific Sessions 2020 during the High Profile Clinical Science in CVD session. Data from the EXPLORER-HCM CMR substudy were also published simultaneously in Circulation.

The CMR substudy was conducted as part of MyoKardia’s pivotal Phase 3 EXPLORER-HCM clinical trial in patients with symptomatic, obstructive HCM to assess the impact of once-daily treatment with mavacamten on parameters of cardiac structure and function. Thirty-five patients were enrolled in the CMR substudy and randomized to mavacamten (n=17) or placebo (n=18) and had valid CMR assessments at day 1 and week 30 (end of treatment) which were analyzed centrally in a blinded manner. Statistically significant changes from baseline to Week 30 were observed in the mavacamten group vs. placebo for the primary endpoint of left ventricular mass index (p<0.0001), as well as exploratory endpoints of absolute intracellular myocardial mass index, maximum wall thickness, and maximum left atrial volume index (all p<0.001 for the difference from placebo). From baseline to Week 30, there was no worsening in myocardial fibrosis, another common characteristic of HCM.

“Hypertrophic cardiomyopathy is defined by the thickening of the heart muscle, so to see favorable remodeling of the heart indicating a lessening of hypertrophy within 30-weeks of treatment is a highly encouraging finding for the many patients struggling with HCM,” said Sara Saberi, M.D., Assistant Professor in the Division of Cardiovascular Medicine and member of the Inherited Cardiomyopathy Program at the University of Michigan Medical School, and lead author on the study. “The CMR substudy is the first randomized, controlled clinical trial of HCM patients to show that a once-daily oral therapeutic agent can reduce left ventricular wall thickness and mass, and positively impact several other parameters of cardiac structure and function. Left ventricular hypertrophy and left atrial volumes in particular are predictive of poor prognosis in HCM patients, so it will be exciting to see how mavacamten impacts cardiac function and disease progression as we continue to follow patients over time.”  

Changes in left ventricular hypertrophy and left atrial volumes were observed concurrently with reductions in levels of plasma biomarkers of myocardial stress and injury, consistent with echocardiographic observations from the overall EXPLORER-HCM population. Importantly, the reduction in left ventricular mass index correlated with a reduction in high-sensitivity cardiac troponin I.  

“Data from the CMR substudy complements and extends our observations of mavacamten’s positive benefits on cardiac function and symptom relief, providing us with encouraging evidence that mavacamten treatment may change the course of the adverse cardiac remodeling inherent to HCM. In directly targeting the proteins of the heart muscle that lead to the excessive contraction and impaired relaxation underlying HCM, we have a growing body of data showing that mavacamten is reducing hypercontractility and hypertrophy and reducing harm to the cardiac muscle while maintaining contractile function within the normal range,” said Jay Edelberg, M.D., Ph.D., MyoKardia’s Chief Medical Officer.  

As previously reported, results from EXPLORER-HCM demonstrated that patients treated with mavacamten experienced statistically significant and clinically meaningful improvements in symptoms, functional status and key aspects of quality of life. In addition to meeting the primary and all secondary endpoints, mavacamten was well tolerated with a safety profile similar to placebo. MyoKardia plans to submit a New Drug Application for mavacamten to the U.S. Food and Drug Administration (FDA) in the first quarter of 2021.

About EXPLORER-HCM

The EXPLORER-HCM Phase 3 trial enrolled a total of 251 patients with symptomatic (NYHA Class II or III), obstructive hypertrophic cardiomyopathy. All participants had measurable LVOT gradient (resting and/or provoked) ≥50 mmHg at baseline. Patients were randomized on a 1:1 basis to receive individualized once-daily dosing of mavacamten or placebo. Patients started on a dose of 5mg, with up to two opportunities for dose adjustments (to doses of 2.5mg – 15mg) based on a combination of residual LVOT gradient, drug plasma concentration and left ventricular ejection fraction (LVEF) levels.

The primary endpoint for EXPLORER-HCM was a composite functional analysis designed to capture mavacamten’s effect on both symptoms and function. The composite functional endpoint is defined by either (1) the achievement of a ≥1.5mL/kg/min improvement in peak VO2 accompanied by an improvement of ≥1 NYHA functional class, or (2) the achievement of a ≥3.0mL/kg/min improvement of peak VO2 with no worsening in NYHA functional class. In addition to the endpoints reported today, the EXPLORER-HCM study also assessed mavacamten’s effect on patient-reported outcomes, health-related quality-of-life and symptom severity assessments, changes from baseline to Week 30 in echocardiographic indices, circulating biomarkers, cardiac rhythm patterns and accelerometry.

About
MyoKardia

MyoKardia is a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases. The company is pioneering a precision medicine approach to its discovery and development efforts by 1) understanding the biomechanical underpinnings of disease; 2) targeting the proteins that modulate a given condition; 3) identifying patient populations with shared disease characteristics; and 4) applying learnings from research and clinical studies to inform and guide pipeline growth and product advancement. MyoKardia’s initial focus is on small molecule therapeutics aimed at the proteins of the heart that modulate cardiac muscle contraction to address diseases driven by excessive contraction, impaired relaxation, or insufficient contraction. Among its discoveries are three clinical-stage therapeutics: mavacamten (formerly MYK-461); danicamtiv (formerly MYK-491) and MYK-224.

MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science.

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the clinical and therapeutic benefit and future potential of mavacamten, the ability of our long-term studies to provide further evidence of how mavacamten impacts cardiac function and disease progression over time, the ability of our long-term studies to provide further evidence of mavacamten’s potential to positively impact several other parameters of cardiac structure and function, that mavacamten treatment may change the course of the adverse cardiac remodeling inherent to HCM, and mavacamten’s ability to reduce harm to the cardiac muscle while maintaining contractile function within the normal range, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the development and regulation of our product candidates and any ongoing effects of the COVID-19 pandemic, as well as those set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and our other filings with the SEC. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Michelle Corral
Executive Director, Corporate Communications and Investor Relations
MyoKardia, Inc.
650-351-4690
[email protected]

Hannah Deresiewicz (investors)
Stern Investor Relations, Inc.
212-362-1200
[email protected]

Julie Normant (media)
W2O
628-213-3754
[email protected]



Posted on

ROSEN, A LEADING LAW FIRM, Reminds Golar LNG Limited Investors of Important November 23 Deadline in Securities Class Action – GLNG

NEW YORK, Nov. 15, 2020 (GLOBE NEWSWIRE) — Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Golar LNG Limited (NASDAQ: GLNG) between April 30, 2020 and September 24, 2020, inclusive (the “Class Period”), of the important November 23, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Golar investors under the federal securities laws.

To join the Golar class action, go to http://www.rosenlegal.com/cases-register-1958.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.

The complaint alleges throughout the Class Period defendants made false and/or misleading statements and/or failed to disclose that: (1) certain employees, including the CEO of Hygo Energy Transition Ltd. f/k/a Golar Power Limited (“Hygo”), had bribed third parties, thereby violating anti-bribery policies; (2) as a result, the Company was likely to face regulatory scrutiny and possible penalties; (3) as a result of the foregoing reputational harm, Hygo’s valuation ahead of its IPO would be significantly impaired; and (4) as a result of the foregoing, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than November 23, 2020. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-register-1958.html or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of Rosen Law Firm toll free at 866-767-3653 or via e-mail at [email protected] or [email protected].

NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR’S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors. Attorney Advertising. Prior results do not guarantee a similar outcome.

——————————-

Contact Information:

        Laurence Rosen, Esq.
        Phillip Kim, Esq.
        The Rosen Law Firm, P.A.
        275 Madison Avenue, 40th Floor
        New York, NY 10016
        Tel: (212) 686-1060
        Toll Free: (866) 767-3653
        Fax: (212) 202-3827
        [email protected]
        [email protected]
        [email protected]
        www.rosenlegal.com



Posted on

Arbutus Announces Presentation of Phase 1a/1b Clinical Trial Results for AB-729 in Chronic Hepatitis B Subjects at The Liver Meeting Digital Experience™, The American Association for the Study of Liver Diseases Meeting

Across all single-dose cohorts, mean HBsAg concentrations continuously declined up to week 12 before reaching a plateau
,
suggesting
dosing of AB-729 less frequently than every 4 weeks
may be warranted

        In the 60mg every 4 weeksmulti-dose cohort, HBsAg concentrations continued to decline steadily beyond week 12 with no plateau in response observed to date

          Both HBV RNA and HBcrAgconcentrations declined after single- and multi-dose administration of AB-729

          AB-729 was generally safe and well tolerated

C
onference Call and Webcast Scheduled
for Monday, November 16, 2020 at 8:00 am ET

WARMINSTER, Pa., Nov. 15, 2020 (GLOBE NEWSWIRE) — Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today announced the presentation of updated clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound. The presentation, entitled Safety and pharmacodynamics of the GalNAc-siRNA AB-729 in subjects with chronic hepatitis B infection, was presented by Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., Chief of Division of Gastroenterology and Hepatology, Department of Medicine, The University of Hong Kong, Hong Kong, during a virtual oral session: Hepatitis B: Therapeutics (New) at The Liver Meeting Digital ExperienceTM, The American Association for the Study of Liver Diseases Meeting.              

Summary of presented data

Single-doses of AB-729 studied to date, 60 mg, 90 mg and 180 mg, resulted in comparable mean HBsAg declines at week 12, followed by a sustained plateau phase. During the multiple-dose portion of the trial, 60 mg of AB-729 dosed every 4 weeks resulted in continuous declines in HBsAg, reaching a mean of –1.44 log10 IU/ML at week 16. Data beyond week 16 demonstrate further declines in HBsAg with no plateau seen to date. AB-729 also resulted in meaningful decreases in both HBV RNA and HBcrAg. AB-729 was generally safe and well tolerated. The presentation can be accessed through the Investors section under Events & Presentations of Arbutus’ website at www.arbutusbio.com.

Repeat dosing of AB-729 60 mg every 4 weeks results in continuous HBsAg declines beyond
w
eek 12

  Mean (SE) Week 12

N=7 		Mean (SE) Week 16

N=7 		Mean (SE) Week 20

N=3

Δlog10 HBsAg (IU/mL) 		-1.10 (0.15) -1.44 (0.18) -1.73 (0.12)

Professor Yuen stated “These are the first multi-dose data for AB-729 and show continuous decline of HBsAg throughout the dosing period. Importantly, AB-729 was generally safe and well tolerated. These encouraging data support the continued development of AB-729 as a potential cornerstone of future combination regimens for the treatment of chronic hepatitis B infection.”

Summary of clinical trial design 

AB-729-001 is an ongoing first-in-human clinical trial consisting of three parts:

In Part 1, three cohorts of healthy subjects were randomized 4:2 to receive single-doses (60 mg, 180 mg or 360 mg) of AB-729 or placebo.

In Part 2, non-cirrhotic, HBeAg positive or negative, chronic HBV subjects (N=6) on a background of nucleos(t)ide therapy with HBV DNA below the limit of quantitation received single-doses (60 mg to 180 mg) of AB-729. An additional cohort in Part 2 included 90 mg single-dose of AB-729 in HBV DNA positive chronic HBV subjects.

In Part 3, chronic HBV subjects, HBV DNA negative first and HBV DNA positive later, are receiving multi-doses of AB-729 for up to six months.

About AB-729 

AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. In an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

About HBV

Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts over 250 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.

The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.

Conference Call and Webcast

Arbutus will hold a conference call and webcast on Monday, November 16, 2020 at 8:00 am Eastern Time to provide an AB-729 clinical update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus’ website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 7791835.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 7791835.

About Arbutus

Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, please visit www.arbutusbio.com.

Forward-Looking Statements and Information

This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements regarding the Company’s expectation that AB-729 could be the cornerstone of future combination regimens for the treatment of chronic hepatitis B infection.

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus’ clinical development programs.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Contact Information


Investors and Media

William H. Collier
President and CEO
Phone: 267-469-0914
Email: [email protected]

Pam Murphy
Investor Relations Consultant
Phone: 267-469-0914
Email: [email protected]