FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

Safety

The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.”

According to the CDC, every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women.

Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the U.S. In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 through 26 years.

The effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study.

Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.

The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition.

The FDA granted approval of this supplement to the Gardasil 9 Biologics License Application to Merck, Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.

BBK Worldwide Repositions as The Patient Experience Company™ and Unveils New Brand Platform

Health, Technology

Patient Recruitment Pioneer Leverages Its Communications and Technological Expertise to Enhance the Clinical Trial Patient Journey

 

For 35 years, BBK Worldwide has been on the crest of the wave with regard to the development and evolution of the patient recruitment industry. Today, the company announces its new marketplace position as The Patient Experience Company. BBK’s promotion of its trendsetting commitment will be reflected in a redesigned company brand, including logo mark and website (bbkworldwide.com). The website details the services and technology-driven solutions devoted to educating consumers, engaging participants, unburdening sites, and supporting sponsors—the combination of which is essential for a company dedicated to enhancing the patient experience.

“Backed by efficacy data and market research, we’ve encapsulated everything we’ve learned to become The Patient Experience Company,” comments Joan F. Bachenheimer, founding principal and CEO, BBK Worldwide. “A critical component of an experience is ‘choice.’ Our technological platform, combined with our creative communications expertise, makes it possible for us to respond to stated preferences—whether expressed by site staff, patients, caregivers, CRAs, or sponsors—and more specifically, to meet the needs of individuals within those subsets. We are dedicated to the type of support that creates a positive synergistic effect.”

BBK leverages its experiential insights through ongoing Patient Voice and Site Voice initiatives. “Our research shows that even the most compliant of participants may still feel a sense of disenfranchisement,” comments Matt Kibby, principal and president, BBK Worldwide. “Engagement is not the same as experience.”

“Every phone call, office visit, and in-person interaction contributes to the overall participant experience,” explains Bonnie A. Brescia, founding principal and corporate development officer, BBK Worldwide. “Our orientation pays homage to the fact that nothing surpasses attention from medical and nursing providers with regard to creating a positive study experience for a participant. Our products and services are designed to alleviate administrative burden, enabling providers to spend more time with their patients.”

The company has a long history of appreciation for sponsor, CRO, patient, caregiver, and healthcare consumer needs. The Patients to Find the Cure® has been BBK’s tagline since its inception. Delivering the best experience at each key touch point in the patient journey guides BBK’s innovative approach to solving recruitment and engagement challenges.

BBK’s announcement coincides with the Annual Meeting of the Drug Information Association in Boston, June 24–28, 2018. Reporters interested in speaking with BBK can visit booth #1607, or they may contact Elizabeth Gargill by phone at 617-630-5513 or by email at egargill@bbkworldwide.com.

Parallax Health Sciences Granted Patent Rights in India for its Breakthrough Diagnostic Technology

Health

Delivers Comprehensive Investor Update on Intellectual Property Rights & Expanded Portfolio

Parallax Health Sciences, Inc. (“Parallax” or the “Company”) (OTC-Pink: PRLX), and its wholly-owned subsidiaries Parallax Health Management, Inc. (“PHM”), Parallax Behavioral Health, Inc. (“PBH”), the owner of RoxSan Pharmacy, Inc. and emerging leader in Remote Patient monitoring technology, today announced that it has been granted Indian Patent No. 279743  stemming from its Indian Patent Application No. 785/MUMNP/2009 entitled “A Portable Apparatus for Improved Sample Analysis” filed October 25, 2007.  The patent which covers discloses and claims the handheld TargetAnalyzer™ device, which is capable of housing and analyzing two assay cassettes. The claimed device optionally features wired or wireless data transfer and multiple data acquisition components including a keypad, a touch-pad, a barcode wand and / or a finger print reader. This patent expands Parallax’s global ownership of the invention disclosed in its issued US Patent No.8,920,725. The same patented technology that enables Parallax’s exclusive diagnostic platform has been issued in China as patent CNZ200780039901X. As well as in Hong Kong through Parallax’s Application Serial No: 10103654.9, filed October 25, 2007 and issued as HK1137813, and a Macao Application No: MOJ/1298, that has been granted to the company as MOJ/001298, The invention has been continued in the U.S. through the issuance of a patent filed November 25, 2014 and issued as US Patent No.9,170,258. The entire portfolio remains open for continued filings both foreign and domestically.

“We are in a period of Intellectual Property assessment, expansion and acquisition at Parallax and the foresight of founders and their inventions are foundational and enabling in areas of human diagnostics and remote patient monitoring systems,” stated Nathaniel Bradley, President of PHM. “Our ownership of foundational and International patent rights allows us to exclude others and create value for our stakeholders more rapidly and with greater uncontested scale. We are in the process of expanding our already extensive holdings through both strategic portfolio acquisitions and organic portfolio expansion.”

Parallax Health Sciences reiterates its patent ownership and exclusive license right within the fields of human diagnostic testing, healthcare and remote patient care (RPC) as represented in its current and ongoing patent filing process and prosecution both in the United States and through applications made in countries that have both customer populations and Parallax business interests abroad.

Family #1 Portable Apparatus For Sample Analysis

United States Patents
8,920,725 Issued
9,170,258 Issued

China
CN Z200780039901.X Granted

Hong Kong
HK 1137813 Granted

India
IN 785/MUMNP/2009 Granted

Macao
MO J/1298
MO J/001298 – Granted

Family #2 Method to Identify Drugs, Moiety or Diagnostic
United States Patent

  • 12/769,036 Pending

Family #3 Method to Produce a Plurality of Antibodies
United States Patent

  • 13/253,366 Pending

Family #4 Method to Determine Immune Status
United States Patent

  • 14/492,641 Pending

Family #5 Flow Thru Test w/ Pressure Indicator
United States Patent

  • 14/786,272 Pending

Family #6 Remote User Monitoring – QOLPOM ACQUISITION
United States Patents

  • 14/979,889 Pending
  • 14/979,742 Pending

Family #7   PLATFORM FOR OPTIMIZING DATA DRIVEN OUTCOMES – ProEventa Acquisition

  • U.S. Patent  Application  No. 14/212,429 Pending
  • Related International filings, Pending

Additional filed applications being prosecuted and available for continuation and divisional filings:

  • US13/253,366 – Title: “Method of Producing a Plurality of Isolated Antibodies to a Plurality of Cognate Antigens”
  • US12/769,036 Title: “Method of Identifying Drugs, Targeting Moieties or -Diagnostics”
  • US14/492,641 Title: “Method for Determining the Immune Status of a Subject”
  • 14/786,272 Title: Flow Through Testing System with Pressure Indicator

About Parallax Health Sciences, Inc.

Parallax Health Sciences, Inc. (PRLX), headquartered in Santa Monica, CA, is a fully reporting Nevadacorporation. The Company is focused on personalized patient healthcare through its established Pharmacy and Infertility businesses, and through Parallax Health Management, Parallax Behavioral Health and Parallax Diagnostics. For additional information, please visit www.parallaxhealthsciences.com.

About Parallax Health Management, Inc.

Parallax Health Management’s (PHM) QOLPOM Hub – Establishing PHM user accounts directly with patients, doctors, hospitals, treatment centers, rehab centers and tele-health operations with seamless systems integration capabilities, technologies and know how.  We utilize our award winning and patented QOLPOM Hub to deliver a continually improving and live customer experience.   Parallax is the sole source of valuable remote patient monitoring systems and services that enable measurement of outcomes and the maximization of quality of life for end-users and peace of mind for those who love and care for them. Please visit http://parallaxhealthmanagement.com

About Parallax Behavioral Health, Inc.

Parallax Behavioral Health is a wholly owned subsidiary of Parallax Health Sciences, Inc. (“PARALLAX”) that includes RoxSan Pharmacy, Inc. a Beverly Hills, CA based Compound and Fertility Specialty Pharmacy licensed in 37 States in the continental US; Parallax Diagnostics, Inc. a Santa Monica, CAbased point of care diagnostic business and Parallax Health Management, Inc., a technology systems integrations company and home health hub with a first of its kind patented technology to support remote patient monitoring, medication adherence and tele-medicine.

Parallax Behavioral Health is the newest subsidiary within the Parallax Health Sciences portfolio and is a critical business unit to its overarching comprehensive healthcare strategy.

With its patent pending technology (R.E.B.O.O.T), which encompasses predictive, progressive behavior analytics and goal optimization software, and its Mobile App series, PBH is strategically positioned to enable large healthcare corporations to individuals take control of their health outcomes.

Health Organizations for the first time will have the opportunity to “scale” their patient adherence programs while having visibility into its effectiveness and bottom line impact.

Individual users will have a goal wizard, virtual coach and rules engine that will help create a personal path toward wellness.  With personalized analysis, decision support and “goal” mastery feedback, the individual will be primed, guided and motivated to adhere to their treatment plan.  Please visit http://www.parallaxhealth.net 

About RoxSan Pharmacy, Inc.

RoxSan Pharmacy, Inc., a wholly owned subsidiary of Parallax Health Sciences, Inc., is a 63-year-old California-based Pharmacy that specializes in the compounding and fulfillment of prescriptions and infertility treatments. RoxSan Pharmacy is licensed in 42 States in the US. Please visit http://www.roxsan.com

About Parallax Diagnostics, Inc.  (“Parallax Behavior”)

Parallax Diagnostics is a wholly owned subsidiary of Parallax Health Sciences, which has an exclusive license, in perpetuity, to a line of proprietary, FDA approved, Point of Care single platform diagnostic tests focusing on the detection and monitoring of infectious diseases.  Please visit http://www.parallaxdiagnostics.com 

Forward-Looking Statements                    

This release includes forward-looking statements contained within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements regarding Parallax’s expected future financial position, results of operations, cash flows, financing plans, business strategy, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions, are forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond Parallax’s control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in Parallax’s Form 10-K and other report filings with the SEC. Parallax is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

For more information please visit our websites at
www.parallaxhealthsciences.com