Redwood Credit Union Honored as Volunteer of the Year by the Napa County Hispanic Chamber of Commerce

Redwood Credit Union (RCU) was recently honored as Volunteer of the Year at the 7th Annual Blend of Cultures Award Recognition and Gala by the Napa County Hispanic Chamber of Commerce.

The Blend of Cultures awards represent one of many ways the Chamber fulfills its vision of promoting the economic advancement of the Napa County Hispanic population and serving as a bridge between the Hispanic and non-Hispanic community by facilitating business, social, educational, and governmental relationships.

“This yearly event is an opportunity to celebrate and support community partners,” said Lindsay Jones, Redwood Credit Union’s Napa branch manager. “We’re very honored to be recognized for the volunteer work we do in the Napa community.”

Redwood Credit Union supports several community efforts in Napa through sponsorship and/or volunteering with groups such as Community Action Napa Valley, Center for Volunteer and Nonprofit Leadership, and Puertas Abiertas. After the October 2017 wildfires, Redwood Credit Union partnered with Senator Mike McGuire and the Press Democrat to create the North Bay Fire Relief Fund, which collected and distributed more than $32 million dollars to support relief efforts in Napa, Sonoma, Mendocino, and Lake Counties. RCU covered all administrative costs for the fund so that 100% of donations were used to directly support fire survivors.

About Redwood Credit Union

Founded in 1950, Redwood Credit Union (RCU) is a full-service financial institution providing personal and business banking to consumers and businesses in the North Bay and San Francisco. RCU offers complete financial services, including checking and savings accounts, auto and home loans, credit cards, online and mobile banking, business services, commercial and SBA lending, wealth management, financial planning services, and more. The Credit Union also offers insurance and discount auto sales through their wholly-owned subsidiary. RCU has over $4.3 billion in assets and serves over 320,000 Members with full-service branches from San Francisco to Ukiah, more than 30,000 fee-free network ATMs nationwide, and convenient, free online and mobile banking. RCU can be followed on Facebook at facebook.com/redwoodcu and on Twitter at @Redwoodcu. For more information, please call 1 (800) 479-7928 or visit www.redwoodcu.org.

Redwood Credit Union Offers Free Document Shredding Event in Santa Rosa

Redwood Credit Union (RCU) is hosting a free document shredding event for the Sonoma County community on Saturday, August 4, 2018 from 9 a.m. to noon at their administrative offices at 3033 Cleveland Avenue in Santa Rosa. The popular Shred-a-Thon event will feature free document shredding provided by Shred-It and electronic waste (e-waste) collection by Conservation Corps North Bay.

Attendees may bring up to three banker-sized boxes (15”x12”x10”) of confidential documents for shredding, such as old financial statements, canceled checks, and credit card offers. E-waste recycling services will also be available for attendees to dispose of old computers, monitors, printers, cell phones, and other personal electronics.

“People come to us with sensitive documents that, in many cases, they’ve been storing for years and aren’t sure how to dispose of them safely,” said Matt Martin, RCU’s vice president of community and government relations. “It’s so rewarding to watch our members and employees and our communities drive out of the parking lot, knowing we’ve taken care of their best interests.”

Food and monetary donations will also be accepted at the event to benefit Redwood Empire Food Bank, a local nonprofit committed to making adequate nutrition assistance available and accessible to those who need it in Sonoma County.

For additional information about the event, visit www.redwoodcu.org/shred. RCU also offers helpful guidelines on when to shred documents at bit.ly/RCUWhenToShred.

About Redwood Credit Union

Founded in 1950, Redwood Credit Union (RCU) is a full-service financial institution providing personal and business banking to consumers and businesses in the North Bay and San Francisco. RCU offers complete financial services, including checking and savings accounts, auto and home loans, credit cards, online and mobile banking, business services, commercial and SBA lending, wealth management, financial planning services, and more. The Credit Union also offers insurance and discount auto sales through their wholly-owned subsidiary. RCU has over $4.3 billion in assets and serves over 303,000 Members with full-service branches from San Francisco to Ukiah, more than 30,000 fee-free network ATMs nationwide, and convenient, free online and mobile banking. RCU can be followed on Facebook at facebook.com/redwoodcu and on Twitter at @Redwoodcu. For more information, please call 1 (800) 479-7928 or visit www.redwoodcu.org.

Woodruff Sawyer’s Award-Winning Women

We’d like you to meet three exemplary women who represent the excellence and caliber of Woodruff Sawyer.

We’ve known for years that these three individuals are experts in their respective fields, bringing incredible knowledge and savvy to their practices. Recently, each of them has been recognized by outside sources for their professional contributions. Please meet Kristy Furrer, Priya Huskins, and Kristina Keck.

Kristy Furrer and Priya Huskins were both awarded the Elite Women in Insurance Award by Insurance Business America. This award is presented to the most inspiring and influential women in insurance, who are remarkable while not being afraid to make waves.

Kristy Furrer is Senior Vice President, Client Success, and has over 30 years experience in the insurance industry, in both brokerage and risk management. In 2000, Kristy founded Woodruff Sawyer’s Risk Management Practice, and is currently Vice Chair of the Board of Directors.

Kristy’s award feature can be found here.

Priya Cherian Huskins serves as Senior Vice President, D&O, and is a frequent speaker and guest lecturer on D&O liability risk and its mitigation. She is a member of the Woodruff Sawyer Board of Directors and is the author and editor of the D&O Notebook. Congratulations to Kristy and Priya.

Priya’s award feature can be found here.

Kristina Keck recently received the Award for Top Advisor by Participant Outcomes given by the publication 401k Specialist—a recognition of innovative professionals who solve for successful outcomes with their clients. Kristina has been with Woodruff Sawyer since 2013, and embodies our company’s maxim to always be Champions for Your Success. As Vice President of Retirement Plans, Kristina has her finger on what clients are struggling with and how to communicate the nuances of saving for retirement.

Women and Excellence at Woodruff Sawyer

As a leader in the insurance industry, Woodruff Sawyer is proud of our highly-experienced and knowledgeable team. Not only are Priya, Kristy, and Kristina examples of our excellence, they also represent the impact and brilliance of the women in our organization. 4 of 7 members of our leadership team are women, effectively responsible for the leadership of our revenue units. In the boardroom, 3 out of 8 board members are women, including Kristy Furrer and Priya Huskins.

We’re proud of our high caliber team and hope you will join us in congratulating PriyaKristy, and Kristina on their achievements.

Sonoma Racewats Hosted NASCAR Weekend and Raised More Than $210,000 for Local Youth Groups

Charitable programs combined to raise more than $212,500 for local youth groups during the Toyota/Save Mart 350 Monster Energy NASCAR Cup Series weekend at Sonoma Raceway, June 22-24.

The majority of the proceeds raised during race weekend will benefit Sonoma County youth organizations through the Sonoma chapter of Speedway Children’s Charities (SCC). SCC has distributed more than $6 million to youth-serving non-profit groups since 2001.

The Children’s Champions NASCAR Banquet, held on Friday, June 22, at Cline Cellars in Sonoma, featured Olympic Gold medalist Jonny Moseley. Moseley served as the Grand Marshal of the Toyota/Save Mart 350 where he gave the official command of, “Drivers, Start Your Engines.” The sit-down dinner also featured a special Q&A session with FOX Sports commentator Michael Waltrip, NASCAR NEXT driver Hailee Deegan and Monster Energy NASCAR Cup Series driver Matt DiBenedetto.

A live auction at the banquet featured exclusive items, including Ride of a Lifetime Experiences with NASCAR drivers Kyle Busch and reigning Monster Energy NASCAR Cup Series Champion Martin Truex Jr., as well as a Danica Patrick Somnium wine package and a “Sip and Spin” with Ram’s Gate Winery. Overall, the banquet and live auction raised $181,450.

In addition, more than $6,000 was raised through various donations during the weekend, including a $5,000 donation on behalf of the Transporter Drivers of Motorsports Association (TDMA), which participated in the 8th annual NASCAR Hauler Parade in Sacramento on June 21.

For more information about the Sonoma Chapter of Speedway Children’s Charities or to make a donation, visit SonomaRaceway.com/SCC or contact Cheri Plattner at (707) 933-3950 or cplattner@SonomaRaceway.com.

Kaiser Permanente Announces $200 Million Impact Investment, Partners With U.S. Mayors and CEOs to Address Housing Stability

Kaiser Permanente, the nation’s largest integrated health system, announced an impact investing commitment today of up to $200 million through its Thriving Communities Fund to address housing stability and homelessness, among other community needs. The organization’s initial focus will be on preventing displacement or homelessness of lower- and middle-income households in rapidly changing communities; reducing homelessness by ensuring access to supportive housing; and making affordable homes healthier and more environmentally sound.

Impact investing is a form of investment used to deliver a measurable social benefit. Kaiser Permanente’s impact-investing pledge will deliver national and local social and environmental returns with an initial focus on housing, a significant community health challenge.

Housing stability is a key factor in a person’s overall health and well-being, with homelessness affecting more than 550,000 people every day. By investing in community needs, such as housing, this unique investment strategy is designed to advance Kaiser Permanente’s mission to provide high-quality, affordable health care services and to improve the health of its 12 million-plus members along with the health of the 65 million-plus residents who live in the communities it serves.

“Affordable housing will be a significant focus of Kaiser Permanente’s impact investing portfolio to generate housing stability and improve health outcomes,” said Bernard J. Tyson, chairman and CEO of Kaiser Permanente. “We hope our commitment creates a broader national conversation on homelessness, and encourages other companies to join with us to advance economic, social and environmental conditions for health.”

Kaiser Permanente also has joined the Mayors and CEOs for U.S. Housing Investment, a first-of-its-kind coalition comprised of local government officials and business leaders working to advance key federal housing priorities. Together with mayors from Alexandria, Virginia; Baltimore, Maryland; Charlotte, North Carolina; Oakland, California; and Portland Oregon, Kaiser Permanente will convene stakeholders to discuss national housing challenges at a meeting today in Washington, D.C.

“Many of the communities we serve are grappling with some of the highest rates of housing insecurity and homelessness in the United States. As a family physician, I’ve provided medical care to the homeless, and have seen first-hand the impact that living without a home can have on someone’s health. To improve the health of an entire community we must step beyond the four walls of our hospitals and medical offices to help those most in need,” said Bechara Choucair, MD, Kaiser Permanente’s chief community health officer. “We hope this national commitment to impact investing in housing stability will inspire other companies to share the responsibility of this critical issue growing in the United States.”

There will be additional details shared in the coming weeks about Kaiser Permanente’s investments in local communities across the United States.


About Kaiser Permanente
Kaiser Permanente is committed to shaping the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 12.2 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/share.

Redwood Credit Union Wins Three MAC Awards

Redwood Credit Union (RCU) received three awards for their marketing efforts at a ceremony in San Diego on May 31, 2018. Awarded by the Marketing Association of Credit Unions (MAC), these awards recognize outstanding marketing achievements in the credit union community.

RCU received a gold award in the Community Engagement category for providing significant support to North Bay communities during a time of serious crisis—the October 2018 fires. In partnership with California State Senator Mike McGuire and the local newspaper The Press Democrat, the Redwood Credit Union Community Fund collected and distributed more than $32 million dollars in donations to support immediate needs of fire survivors.

The silver award was given to RCU in the Outdoor category, for its welcoming, house-shaped mortgage loan billboard that read, “Home Sweet Loan.”

In the Product Development category, RCU won the bronze award for RCUpay, Redwood Credit Union’s free person-to-person (P2P) payment service. RCUpay was developed in-house to allow RCU members to pay each other instantly, as well as allowing members to pay anyone with a U.S. bank account.

“I work with a very talented team,” said Robin McKenzie, RCU’s Senior Vice President of Marketing and Communications. “Whether it’s to support members in times of crisis or to help them achieve financial goals, such as a first home, this team pulls together to educate and inform in a fun and fresh way. We’re honored to have received these awards.”

About MAC

The Marketing Association of Credit Unions (MAC) was started in 1986 by a group of credit union marketers and business partners who joined together to exchange ideas, build relationships, and foster professional development.

About Redwood Credit Union

Founded in 1950, Redwood Credit Union is a full-service financial institution providing personal and business banking to consumers and businesses in the North Bay and San Francisco. Services include checking and savings accounts, auto and home loans, credit cards, online and mobile banking, business services, commercial and SBA lending, investment and wealth management services, and more. The Credit Union also offers insurance and discount auto sales through their wholly-owned subsidiary. RCU has over $4.3 billion in assets and serves over 302,000 Members with full-service branches from San Francisco to Ukiah, more than 30,000 fee-free network ATMs nationwide and convenient, free online and mobile banking. For more information, call 1 (800) 479-7928, visit www.redwoodcu.org, or follow RCU on Facebook at facebook.com/redwoodcu and Twitter at @Redwoodcu for news and updates.

Kaiser Permanente COO/CNE honored as outstanding leader

Kaiser Permanente Santa Rosa Medical Center’s Chief Operating Officer/Chief Nurse Executive Vicky Locey, RN, MSN, MBA, CENP, was recently honored for her outstanding leadership.

Vicky was one of eight KP nursing leaders recognized last month at the 2018 National Nursing Leadership Conference in Anaheim.

“I am extremely honored to receive this award,” Vicky said. “My life is blessed with being surrounded by the most amazing nursing leaders, physicians, and staff at Kaiser Permanente Santa Rosa.”

This was the first year this conference has recognized Extraordinary Nurse Leaders, with one selected from each KP region. Vicky was the single award recipient for the Northern California region. There were five categories that Vicky was recognized for, including achievements in quality and as a visionary nurse leader.

Now in its ninth year, the theme of this year’s conference was “Creating a Culture of Excellence,” and was designed to inspire, educate, and empower Kaiser Permanente nurses in creating the future of health care. Attendees learned about best practices, innovation success stories, and nursing achievements across our regions, with Vicky among those showcased.

Congratulations to Our Members in the North Bay Business Journal’s Women in Business List

North Bay Business Journal has announced 15 winners of its 2018 Women in Business honors.

The nominations include those submitted by our readers, previous honorees and our editorial department. Achievements and contributions of the nominees made the selection process difficult. Winners were chosen based on many factors, including leadership roles in the organization, business-related innovations, vision and community involvement.

Undoubtedly, many of this year’s nominees will be named winners in the future.

2018 Women in Business honorees

  • Robin Azevedo, CEO, McRoskey Mattress Company
  • Mary Lynn Bartholomew, area manager, Nelson
  • Sondra Bernstein, owner, Girl & The Fig; Girl & The Fig Caters, Fig Foundation
  • Nancy Corriveau, director of operations, Blentech Corporation, Santa Rosa
  • Michelle Crosbie, director, BPM LLP
  • Genie DelSecco, executive vice president and chief operating officer, Summit State Bank
  • Tiffany Devitt, chief information officer, CannaCraft, Inc.. Santa Rosa
  • Maureen Disbot, Northern California regional vice president, quality and patient safety, St. Joseph Health, Northern California
  • Sherie Hickman, administrator, Novato Community Hospital
  • Judy James, director of government affairs for the North Bay region, Comcast Cable
  • Mishel Kaufman, senior vice president for risk management, Redwood Credit Union
  • Ann Lobdell Hudson, senior vice president and head of retail banking, Exchange Bank
  • Renee Mengali, principal, president, Mengali Accountancy, Inc.
  • Kim Stare Wallace, president, Dry Creek Vineyard
  • Elyse Weinstein, M.D. co-chief, Department of Mental Health, Kaiser Permanente, San Rafael;physician leader TPMG Recruitment Services

The recipients will be recognized at an awards dinner gala on Thursday, June 28, at the Hyatt Regency Sonoma Wine Country hotel in Santa Rosa. The event will take place from 5:30 to 8:30 p.m.

Tickets are $90 a person or $875 a table. To register, visit nbbj.news/wib18 or call Annette Wirick at 707-521-3264. The event is hosted by the Business Journal and Wells Fargo.

Redwood Credit Union Donates Little Free Library

Redwood Credit Union (RCU) recently sponsored a Little Free Library and donated it to Hidden Valley Elementary School where 132 elementary students lost homes in the October fires. The campus itself lost its satellite location, which housed 80 of its elementary-level students.

Embracing the take-a-book/leave-a-book philosophy, several of these stand-alone libraries are going up this spring thanks to the partnership of The United Way of the Wine Country Women United members, the Career Technical Education (CTE) Foundation Sonoma County, and local high schools.

Especially during the summer months, Little Free Libraries are a fun and easy way to promote reading and give students easy access to books. RCU’s sponsored library is fittingly in the shape of a redwood tree—the credit union’s logo. The construction was coordinated by Zeke Gifford, a Green Construction Instructor at Montgomery High School and was built by Montgomery High School students.

“Supporting our community during the recovery and rebuild remains a top priority for Redwood Credit Union,” says Brett Martinez, RCU President & CEO. “The little library is a way for us to reach out to some of our younger fire-impacted survivors and have a positive impact.”

Hidden Valley students, parents, and administrators joined RCU and United Way of the Wine Country officials in a dedication of the little library on Thursday, May 24th at the school’s main campus at 3534 Bonita Vista in Santa Rosa.

About Redwood Credit Union

Founded in 1950, Redwood Credit Union (RCU) is a full-service financial institution providing personal and business banking to consumers and businesses in the North Bay and San Francisco. RCU offers complete financial services, including checking and savings accounts, auto and home loans, credit cards, online and mobile banking, business services, commercial and SBA lending, wealth management, financial planning services, and more. The Credit Union also offers insurance and discount auto sales through their wholly-owned subsidiary. RCU has over $4.3 billion in assets and serves over 300,000 Members with full-service branches from San Francisco to Ukiah, more than 30,000 fee-free network ATMs nationwide, and convenient, free online and mobile banking. RCU can be followed on Facebook at facebook.com/redwoodcu and on Twitter at @Redwoodcu. For more information, please call 1 (800) 479-7928 or visit www.redwoodcu.org.

BioMarin Receives Standard Approval for Palynziq™ (pegvaliase-pqpz) Injection for Treatment of Adults with Phenylketonuria (PKU), a Rare Genetic Disease

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that BioMarin received standard approval from the U.S. Food and Drug Administration (FDA) for Palynziq™ (pegvaliase-pqpz) Injection to reduce blood phenylalanine (Phe) concentrations in adult patients with phenylketonuria (PKU), who have uncontrolled blood Phe concentrations greater than 600 micromol/L on existing management. Palynziq, a PEGylated recombinant phenylalanine ammonia lyase enzyme, is the first approved enzyme substitution therapy to target the underlying cause of PKU by helping the body to break down Phe.  Palynziq is BioMarin’s second approved treatment for this important condition.

 

PKU is a rare genetic disease that manifests at birth and results in a variety of cumulative toxic effects on the brain. PKU affects approximately 1 in 12,500 live births in the United States each year. PKU is marked by an inability to break down Phe, an amino acid that is found in all forms of protein. Left untreated, high levels of Phe become toxic to the brain and may lead to serious neurological and neuropsychiatric-related issues, impacting the way a person thinks, feels, and acts. Due to the seriousness of these symptoms, infants are screened at birth to ensure that they are diagnosed early and treated to avoid intellectual disability and other complications. Patients living with PKU require life-long management, including adherence to a challenging and severely restrictive daily diet of medical foods and formula that avoids the ingestion of Phe that is present in most foods.

The approval of Palynziq in the United States marks an important milestone for adults living with PKU who will now have access to an effective new treatment option for controlling their blood Phe.

The approval of Palynziq comes during National PKU Awareness Month. During National PKU Awareness Month, local patient organizations are encouraged to organize events to spread PKU awareness and raise funds for academic research.

“BioMarin is thrilled to be able to offer this important new therapy to adults with PKU who are unable to control their Phe levels with existing options. The approval of Palynziq is the culmination of more than a decade of perseverance by BioMarin employees dedicated to bringing treatments to PKU adult patients,” said Jean-Jacques Bienaimé, chairman and chief executive officer of BioMarin.  “We are proud of this medical achievement and appreciate the FDA’s thoughtful review of our application.  We also are grateful to the PKU patients and medical communities for their continued partnership and participation in the clinical program that led to the approval of this effective therapy.”

“The goal in treating PKU is to keep blood Phe levels within the range set in the medical guidelines, as elevation of Phe can be toxic and damaging to the brain. Palynziq provides another much needed tool for us to help adult patients control their Phe levels, which previously had not been achievable for many adults living with the condition,” said Cary Harding, M.D., professor at Oregon Health & Science University and investigator for the Phase 3 studies.

“Palynziq has the potential to be a game-changing therapy for adults in the PKU community who have struggled throughout their lives to control their Phe levels, despite rigorous management,” said Christine Brown, MS, executive director of the National PKU Alliance. “BioMarin has provided unwavering support for the PKU community and continues innovative medical research to advance treatment options for this rare genetic disease.”

Palynziq is expected to be available in the United States by the end of June, and BioMarin will begin the promotion of Palynziq immediately. Palynziq is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Palynziq REMS.

BioMarin is also committed to bringing Palynziq to adult PKU patients outside of the United States.  In March 2018, the European Medicines Agency accepted BioMarin’s submission of a Marketing Authorization Application for Palynziq.

Clinical Trial Results

Palynziq significantly and substantially reduced blood Phe levels as demonstrated in the pivotal Phase 3 PRISM-2 study, which met the primary endpoint of change in blood Phe compared with placebo (p<0.0001).  During the PRISM-2 double-blind, placebo-controlled, randomized withdrawal period trial (RWP), participants were randomized in a 2:1 ratio to either continue their maintenance Palynziq dosage (20 mg once daily or 40 mg once daily) or to receive matching placebo for a total of 8 weeks.  Palynziq-treated patients maintained their blood Phe concentrations as compared to their randomized withdrawal baseline, whereas patients randomized to matching placebo returned to their pretreatment baseline blood Phe concentrations.

In the Phase 3 program, 57% of patients were taking medical food at baseline and 16% were on a protein-restricted diet at baseline (defined as receiving greater than 75% of total protein intake from medical food).

About Phenylketonuria

PKU, or PAH deficiency, is a genetic disorder affecting approximately 50,000 diagnosed patients in the regions of the world where BioMarin operates and is caused by a deficiency of the enzyme PAH.  This enzyme is required for the metabolism of Phe, an essential amino acid found in most protein-containing foods. If the active enzyme is not present in sufficient quantities, Phe accumulates to abnormally high levels in the blood and becomes toxic to the brain, resulting in a variety of complications including severe intellectual disability, seizures, tremors, behavioral problems and psychiatric symptoms. As a result of newborn screening efforts implemented in the 1960s and early 1970s, virtually all individuals with PKU under the age of 40 in countries with newborn screening programs are diagnosed at birth and treatment is implemented soon after. PKU can be managed with a Phe-restricted diet, which is supplemented by low-protein modified foods and Phe-free medical foods; however, the strict diet is difficult for most adult patients to adhere to to the extent needed for achieving adequate control of blood Phe levels.

To learn more about PKU and PAH deficiency, please visit www.PKU.com. Information on this website is not incorporated by reference into this press release.

About ACMG Guidelines

Practice guidelines issued by the American College of Medical Genetics and Genomics (ACMG) support the need for lifelong management of Phe levels in patients with phenylketonuria or PKU.  The new diagnosis and management guidelines were published online in Genetics In Medicine’s Advance Online Publication (AOP) service.

The guidelines state that treatment of PKU should be initiated as early as possible and must be continued throughout adulthood and “lifelong,” with a goal of maintaining blood levels of Phe for all patients between 120 to 360 micromol/L. Patients treated from the early weeks of life with initial good metabolic control, but who lose that control in later childhood or adult life, may experience both reversible and irreversible neurocognitive and neuropsychiatric consequences.

According to the guidelines “the primary goal of therapy is to lower blood Phe, and any interventions, including medications, or combination of therapies that help to achieve that goal in an individual, without other negative consequences, should be considered appropriate therapy.” Evidence for the guidelines are drawn from two previous independent review processes from the National Institutes of Health (2001) and the Agency for Health Research and Quality (2012). The guidelines can be accessed here.

Conference Call and Webcast to be Held May 24 at 6 PM Eastern

Interested parties may access a live webcast that will accompany the conference call by going here.  A replay of the call will be archived on the site for one week following the call.

U.S. / Canada Dial-in Number: (866) 502-9859
International Dial-in Number: (574) 990-1362
Conference ID: 4298742

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 4298742

About Palynziq

Palynziq substitutes the deficient phenylalanine hydroxylase (PAH) enzyme in PKU with the PEGylated version of the enzyme phenylalanine ammonia lyase to break down Phe. Palynziq is administered using a dosing regimen designed to facilitate tolerability; Palynziq’s safety profile consists primarily of immune-mediated responses, including anaphylaxis, for which robust risk management measures effective in clinical trials are in place.

The dosing and administration of Palynziq follows an induction, titration, and maintenance paradigm.  Treatment is individualized to the lowest effective and tolerated dosage.  Prescribers may consider increasing to a maximum of 40 mg once daily in patients who have not achieved a response with 20 mg once daily for at least 24 weeks.  Prescribers are instructed to discontinue treatment in patients who have not responded after 16 weeks of continuous treatment with the maximum dosage of 40 mg once daily.  Periodic blood Phe monitoring is recommended, and patients should be counseled on how to adjust their dietary intake, as needed, based on blood Phe concentrations.

To reach a BioMarin RareConnections® case manager, please call, toll-free, 1-866-906-6100 or e-mail support@biomarin-rareconnections.com. For more information about Palynziq, please visit www.palynziq.com.  For additional information regarding this product, please contact BioMarin Medical Information at medinfo@bmrn.com.

Indication

PALYNZIQ™ (pegvaliase-pqpz) Injection is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 µmol/L on existing management.

Important Safety Information

BOXED WARNING: RISK OF ANAPHYLAXIS

  • Anaphylaxis has been reported after administration of PALYNZIQ and may occur at any time during treatment with PALYNZIQ.
  • Administer the initial dose of PALYNZIQ under the supervision of a healthcare provider equipped to manage anaphylaxis, and closely observe patients for at least 60 minutes following injection. Prior to self-injection, confirm patient competency with self-administration, and patient’s and observer’s (if applicable) ability to recognize signs and symptoms of anaphylaxis and to administer auto-injectable epinephrine, if needed.
  • Prescribe auto-injectable epinephrine to all patients treated with PALYNZIQ. Prior to the first dose, instruct the patient and observer (if applicable) on its appropriate use. Instruct the patient to seek immediate medical care upon its use. Instruct patients to carry auto-injectable epinephrine with them at all times during treatment with PALYNZIQ.
  • PALYNZIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALYNZIQ REMS. Further information, including a list of qualified pharmacies, is available at www.PALYNZIQREMS.com (site will be live within 24 hours) or by telephone 1-855-758-REMS (1-855-758-7367).

WARNINGS AND PRECAUTIONS

Anaphylaxis

  • Signs and symptoms of anaphylaxis reported include syncope, hypotension, hypoxia, dyspnea, wheezing, chest discomfort/chest tightness, tachycardia, angioedema (swelling of face, lips, eyes, tongue), throat tightness, skin flushing, rash, urticaria, pruritus, and gastrointestinal symptoms (vomiting, nausea, diarrhea).
  • Anaphylaxis generally occurred within 1 hour after injection; however, delayed episodes occurred up to 48 hours after PALYNZIQ administration.
  • Consider having an adult observer for patients who may need assistance in recognizing and managing anaphylaxis during treatment with PALYNZIQ. If an adult observer is needed, the observer should be present during and for at least 60 minutes after administration of PALYNZIQ, and should be able to administer auto-injectable epinephrine and call for emergency medical support upon its use.
  • Anaphylaxis requires immediate treatment with auto-injectable epinephrine. Prescribe auto-injectable epinephrine to all patients receiving PALYNZIQ and instruct patients to carry auto-injectable epinephrine with them at all times during treatment with PALYNZIQ. Prior to the first dose, instruct the patient and observer (if applicable) on how to recognize the signs and symptoms of anaphylaxis, on how to properly administer auto-injectable epinephrine, and to seek immediate medical care upon its use. Consider the risks associated with auto-injectable epinephrine use when prescribing Palynziq. Refer to the auto‑injectable epinephrine prescribing information for complete information.
  • Consider the risks and benefits of readministering PALYNZIQ following an episode of anaphylaxis. If the decision is made to readminister PALYNZIQ, administer the first dose under the supervision of a healthcare provider equipped to manage anaphylaxis and closely observe the patient for at least 60 minutes following the dose. Subsequent dose titration of PALYNZIQ should be based on patient tolerability and therapeutic response.
  • Consider premedication with an H1-receptor antagonist, H2-receptor antagonist, and/or antipyretic prior to administration of PALYNZIQ based upon individual patient tolerability.

Other hypersensitivity reactions

  • Hypersensitivity reactions other than anaphylaxis have been reported in 196 of 285 (69%) patients treated with PALYNZIQ.
  • Consider premedication with an H1-receptor antagonist, and/or antipyretic prior to PALYNZIQ administration based upon individual patient tolerability.
  • Management of hypersensitivity reactions should be based on the severity of the reaction, recurrence of the reaction, and the clinical judgment of the healthcare provider, and may include dosage adjustment, temporary drug interruption, drug discontinuation, or treatment with antihistamines, antipyretics, and/or corticosteroids.

ADVERSE REACTIONS

  • The most common adverse reactions (at least 20% of patients in either treatment phase) were injection site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reaction lasting at least 14 days, pruritus, nausea, abdominal pain, oropharyngeal pain, vomiting, cough, diarrhea, and fatigue.
  • Of the 285 patients exposed to PALYNZIQ in an induction/titration/maintenance regimen in clinical trials, 31 (11%) patients discontinued treatment due to adverse reactions. The most common adverse reactions leading to treatment discontinuation were hypersensitivity reactions (6% of patients)—including anaphylaxis (3% of patients) and angioedema (1% of patients)—arthralgia (4% of patients), generalized skin reactions lasting at least 14 days (2% of patients), and injection site reactions (1% of patients).
  • The most common adverse reactions leading to dosage reduction were arthralgia (14% of patients), hypersensitivity reactions (9% of patients), injection site reactions (4% of patients), alopecia (3% of patients), and generalized skin reactions lasting at least 14 days (2% of patients).
  • The most common adverse reactions leading to temporary drug interruption were arthralgia (13% of patients), hypersensitivity reactions (13% of patients), anaphylaxis (4% of patients), and injection site reactions (4% of patients).

Blood Phenylalanine Monitoring and Diet

  • Obtain blood phenylalanine concentrations every 4 weeks until a maintenance dosage is established.
  • After a maintenance dosage is established, periodically monitor blood phenylalanine concentrations.
  • Counsel patients to monitor dietary protein and phenylalanine intake, and adjust as directed by their healthcare provider.

DRUG INTERACTIONS

Effect of PALYNZIQ on other PEGylated products

  • In a single dose study of PALYNZIQ in adult patients with PKU, 2 patients receiving concomitant injections of medroxyprogesterone acetate suspension (a formulation containing PEG 3350) experienced hypersensitivity reactions, and 1 of the 2 patients also experienced anaphylaxis.
  • The clinical effects of concomitant treatment with different PEGylated products is unknown. Monitor patients treated with PALYNZIQ and concomitantly with other PEGylated products for hypersensitivity reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation

  • PALYNZIQ may cause fetal harm when administered to a pregnant woman.
  • If PALYNZIQ is administered during pregnancy, or if a patient becomes pregnant while receiving PALYNZIQ or within 1 month following the last dose of PALYNZIQ, healthcare providers should report PALYNZIQ exposure by calling 1-866-906-6100.
  • Monitor blood phenylalanine concentrations in breastfeeding women treated with PALYNZIQ.

Pediatric use

  • The safety and efficacy of PALYNZIQ in pediatric patients have not been established.

Geriatric Use

  • Clinical studies of PALYNZIQ did not include patients aged 65 years and older.

You are encouraged to report side effects to report suspected adverse events to BioMarin at 1-877-695-8826 and the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information, including Boxed Warning, at PALYNZIQ.com/hcp, which will be available in 24 hours.

About BioMarin

BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare disorders. The company’s portfolio consists of seven commercialized products and multiple clinical and pre-clinical product candidates.

For additional information, please visit www.BMRN.com. Information on BioMarin’s website is not incorporated by reference into this press release.

Forward-Looking Statements

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin),  including, without limitation, statements about: expectations regarding the potential impact of this therapy in the PKU community; the expectations about the availability of Palynziq in the United States by the end of June; BioMarin’s ability to support the launch of a new product and ship to specialty pharmacies; BioMarin’s development programs for Palynziq generally; and the potential approval of Palyniziq in jurisdictions outside of the U.S., including the EU. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: actions by regulatory agencies other than the FDA, results and timing of current and planned clinical trials of BioMarin’s products, the risks related to the commercialization of Palynziq, our ability to manufacture sufficient quantities of Palynziq for clinical trials and the commercial launch of Palynziq in the U.S., the market potential for Palynziq as a treatment for PKU in adults; and those other risks detailed from time to time under the caption “Risk Factors” and elsewhere in the Company’s Securities and Exchange Commission (SEC) filings including the Annual Report on Form 10-Q for the quarter ended March 31, 2018, and future filings and reports by the Company. The Company undertakes no duty or obligation to update any forward-looking statements contained in this Current Report on Form 8-K as a result of new information, future events or changes in its expectations. BioMarin® is a registered trademark, and Palynziq™ is a trademark of BioMarin Pharmaceutical Inc.