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PR Newswire

Aridis Pharmaceuticals Expands Patent Portfolio for Several Fully Human Monoclonal Antibodies Against Infectious Disease Targets

SAN JOSE, Calif., Feb. 24, 2016 /PRNewswire/ — Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today that in addition to the previously announced European Patent Office (EPO) patent issuance, the U.S. Patent and Trademark Office has issued Aridis’ patent covering composition-of-matter, method of production and method of treatment for AR-301 (Salvecin).

AR-301, a fully human monoclonal antibody (mAb) that neutralizes Staphylococcus aureus alpha-toxin, is currently being evaluated in a Phase 2a clinical trial across the U.S. and several countries in Europe.  AR-301 is being tested as an adjunctive therapy to standard of care antibiotics to treat hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) and severe community-acquired pneumonia (CAP).  AR-301 was identified and developed through Aridis’ propriety MabIgX technology by generating a hybridoma clone from B-cells of a recovered S. aureus bacteremia patient.  The antibody works by neutralizing S. aureus alpha-toxin, which is a critical factor involved in the establishment and persistence of S. aureus infection.

Additionally, the patents covering Aridis’ human mAbs against the emerging Gram-negative bacterium Acinetobacter baumannii (A. baumannii), “AR-401,” have also received notices of allowance in Europe and the U.S.

Vu Truong, Ph.D., Founder and Chief Executive Officer of Aridis, stated, “We are delighted to have successfully secured expanded patent protection for AR-301 and AR-401.  We are confident that the use of monoclonal antibodies to treat antibiotic resistant pathogens can have a broad impact on reducing healthcare costs by providing additional protection against infections.  The issuance of these patents adds to our already robust intellectual property estate covering our novel therapeutic antibodies, as well as our antibody discovery platform MabIgX®. Furthermore, significant progress has also been made toward the near-term allowance of patent application for Aridis’ novel fully human monoclonal antibody against respiratory syncytial virus (RSV), AR-201.”

About Aridis Pharmaceuticals, Inc.
Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX to produce novel infectious disease focused therapies.  Aridis’ product pipeline includes AR-101 (Aerumab) anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 (Salvecin) anti-Staphylococcus aureus human monoclonal antibody to treat acute pneumonia; Aerucin, a broadly reactive anti-Pseudomonas aeruginosa human monoclonal antibody initially being developed to treat acute pneumonia; Panaecin, a small molecule anti-infective gallium compound with broad spectrum activities against bacteria, viruses, and fungi; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody.

Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties.  Such forward-looking statements include statements relating to the therapeutic applications of Aerumab (AR-101), Salvecin (AR-301), Aerucin, Panaecin, AR-401, AR-201, Aridis’ proprietary formulation and delivery technologies, about Aridis’ strategy, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Aridis’ expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Aridis’ research and clinical studies and its ability to obtain additional financing.  These forward-looking statements represent Aridis’ judgment as of the date of this release. Aridis disclaims any intent or obligation to update these forward-looking statements.

Contacts:

Tiberend Strategic Advisors, Inc. 
Joshua Drumm, Ph.D. (investors) 
jdrumm@tiberend.com 
(212) 375-2664

Andrew Mielach (media)
amielach@tiberend.com 
(212) 375-2694

 

SOURCE Aridis Pharmaceuticals, Inc.

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PR Newswire

Trovagene Enters into Preferred Provider Agreement with Three Rivers Provider Network

SAN DIEGO, Feb. 24, 2016 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced today that it has entered into an Agreement with Three Rivers Provider Network (Three Rivers), a leading national provider network. Based on the Agreement, Trovagene’s Precision Cancer Monitoring® (PCM) services are covered as an in-network participating laboratory provider within the Three Rivers network, which administers benefits for approximately 14 million covered lives in the United States.

“Here at Three Rivers, we are dedicated to providing the best possible experience to both the Provider and Payor,” stated Charlie Jimenez, managed care specialist at Three Rivers Provider Network/World News. “Facilitating a great relationship between both parties is where the true commitment to our patients is procured. In keeping with our focus on high quality patient care and access to innovative and cost-effective solutions, we are pleased to enter into this contract with Trovagene, and look forward to a successful relationship for many years to come.”

“We are proud to become a preferred provider within the Three Rivers network, as we continue to build critical mass with respect to the number of cancer patients with health plan access to our Precision Cancer Monitoring technology,” said Matt Posard, chief commercial officer of Trovagene. “We look forward to working with Three Rivers to improve the outcomes of cancer patients within in their network.”

About Three Rivers Provider Network

Based in Chula Vista, California, Three Rivers  is the fastest growing proprietary provider network in the United States. The Three Rivers network is now comprised of more than 1.5 million provider locations, including greater than 5,000 hospitals and 100,000 ancillary facilities. The Three Rivers network serves a global population in excess of 200 million. Included in the network are: acute care hospitals, surgery centers, network physicians, ancillary facilities, MRI and radiology centers, laboratories, urgent care clinics, home health and DME providers, chiropractors, physical therapy clinics, and mental health providers.

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The Company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition;  our need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technologies or products will be utilized by physicians or other service providers, prove to be commercially successful or improve outcomes for cancer patients. Trovagene does not undertake an obligation to update or revise any forward-looking statement.  Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2014 and other periodic reports filed with the Securities and Exchange Commission.

Contact

Investor Relations

Media Relations

David Moskowitz and Amy Caterina

Investor Relations

Ian Stone

Account Director

Trovagene, Inc.

Canale Communications, Inc.

858-952-7593

619-849-5388

ir@trovagene.com

ian@canalecomm.com

 

Logo – http://photos.prnewswire.com/prnh/20120620/LA28014LOGO

 

SOURCE Trovagene, Inc.

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PR Newswire

Rani Therapeutics Completes Latest Round of Funding; Brings Total Investment to $70M

SAN JOSE, Calif., Feb. 24, 2016 /PRNewswire/ — Rani Therapeutics announced today that it has closed its latest round of funding, bringing the company’s total investment to more than $70 million. New investors include AstraZeneca, Virtus Inspire Ventures, and Ping An Ventures. Existing investors in Rani Therapeutics include Novartis, Google Ventures, Buttonwood, GF Ventures, KPC Pharmaceuticals, InCube Ventures and VentureHealth, among others. The funding will support expansion of the team, new facilities and manufacturing scale up.

Rani, founded in 2012 and spun out of InCube Labs, is developing a novel technology platform to convert injectable drugs such as TNF-alpha inhibitors, interleukin antibodies, basal insulin and GLP-1 into oral pills. In the last year, the company has entered into strategic collaborations with Novartis and Astra Zeneca/MedImmune to test its platform with selected drugs. 

“We developed Rani Therapeutics with a clear vision – give patients suffering from chronic illnesses a convenient, easy and painless alternative to subcutaneous injections,” said Mir Imran, Chairman & CEO of Rani Therapeutics. “Our team has created a breakthrough drug delivery platform supported by a solid patent portfolio and that is what is attracting potential partners and investors.  We are pleased with our progress, and are now laser focused on demonstrating value for a variety of therapies.” 

“Delivering biologics orally would have a tremendous impact on patients, especially for those suffering from chronic diseases that require them to regularly take medications,” said Jiang Zhang, Managing Director, Ping An Ventures. “Rani is developing a revolutionary platform and we are very excited to support the company in this exciting next phase.”

As part of its next stage of growth, Rani recently hired Robert Gaffney as Vice President of Operations to lead the company’s expansion. Gaffney joined from Spinal Modulation, an InCube Labs company acquired by St. Jude Medical in 2015, where he served as Chief Operating Officer. 

About Rani Therapeutics 
Rani Therapeutics has developed a novel approach for the oral delivery of peptides, proteins and therapeutic antibodies which to date can only be delivered through injections. The approach and technology for Rani Therapeutics was developed at InCube Labs, a multi-disciplinary life sciences R&D lab focused on developing breakthrough medical innovations. InCube is led by Mir Imran, a prolific medical inventor, entrepreneur and investor, who has founded more than 20 life sciences companies and holds more than 400 patents. Many of Imran’s innovations have resulted in new standards of care, including the first FDA-approved Automatic Implantable Cardioverter Defibrillator. For more information, please visit: www.ranitherapeutics.com and www.incubelabs.com.

 

SOURCE Rani Therapeutics

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PR Newswire

Sherpa Clinical Packaging announces completion of move to a new GMP clinical Packaging and Distribution facility in San Diego

SAN DIEGO, Feb. 22, 2016 /PRNewswire/ — Sherpa, a clinical packaging company strategically located in the heart of the San Diego biotech community, demonstrates commitment to its clinical trial materials management business by investing in infrastructure. The new state-of-the-art facility is 37,500 ft2 and offers enhanced capabilities and a strict cold chain management infrastructure. The expansion was needed to support the company’s increased demand for Phase 2 and Phase 3 clinical studies and is a result of continued growth serving new and existing clients.

The new facility offers purpose built space for primary and secondary clinical labeling and packaging, GMP storage for refrigerated (2-8oC), frozen (-20oC, -80oC and LN2), and controlled room temperature (20-25oC), and temperature controlled shipping dispatch. The facility also comprises an ISO 8 clean room for primary packaging of solid dose products. Sherpa now also specializes in cold form and thermoform blistering, blister strip carding, pouching and API storage. 

Sherpa was able to successfully move its operations to the new facility without service interruptions. “When they moved to their new facility, we were in the middle of a clinical trial,” David R., of OrthoTrophix reflected, “The transition was seamless and they did not miss a beat.  As a small, virtual company, we rely heavily on our contractors to be an extension of our team.  Sherpa filled that role beautifully for us as they managed the distribution of our drug to clinical sites.”

“The new Sherpa facility will help sustain the continued growth of our company,” said Mark Paiz, president of Sherpa Clinical Packaging. “We are excited to be able to provide the diversity and quality of services to a large number of clients in all phases of clinical trials. Sherpa’s mission is to be the customer service leader in the clinical trial materials management business and we offer each client the trusting and reliable relationship that people vested in clinical trials seek.”

About Sherpa

Sherpa Clinical Packaging is a privately owned provider of clinical trial material management services for clinical studies phases I-IV, including packaging, labeling, distribution and returns/reconciliation, for pharmaceutical, biotechnology, medical device and dietary supplement companies. Sherpa is located in San Diego, California and partners with companies locally and globally. Sherpa distributes clinical supplies to hundreds of sites across the US, Canada and abroad. For more information, visit www.sherpaclinical.com or call (858) 997-1491.

 

SOURCE Sherpa Clinical Packaging

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PR Newswire

FDA Accepts For Review Supplemental New Drug Application for XTANDI® (enzalutamide) Capsules in Metastatic Castration-resistant Prostate Cancer with Data from Head-to-Head Studies of Enzalutamide Versus Bicalutamide

TOKYO and SAN FRANCISCO, Feb. 22, 2016 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (Nasdaq: MDVN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI® (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016.

A Type-II variation to update the Summary of Product Characteristics (SmPC) has also been submitted to the European Medicines Agency.

About the TERRAIN trial
The Phase 2 TERRAIN trial enrolled 375 patients in North America and Europe. The trial enrolled patients with metastatic prostate cancer whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analogue therapy or following surgical castration. The primary endpoint of the trial was progression-free survival (PFS), defined as time from randomization to centrally confirmed radiographic progression, skeletal-related event, initiation of new anti-neoplastic therapy or death, whichever occurred first. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily versus bicalutamide at a dose of 50 mg taken once daily, the approved dose in combination with an LHRH analogue.

About the STRIVE trial
The Phase 2 STRIVE trial enrolled 396 CRPC patients in the U.S. The trial randomized 257 patients with metastatic prostate cancer and 139 patients with non-metastatic prostate cancer whose disease progressed despite treatment with a LHRH analogue therapy or following surgical castration. The primary endpoint of the trial was PFS, defined as time from randomization to radiographic (bone or soft tissue) progression, prostate-specific antigen (PSA) progression (defined by Prostate Cancer Working Group 2 criteria), or death due to any cause, whichever occurs first. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken once daily (n=198) versus bicalutamide at a dose of 50 mg taken once daily (n=198), the approved dose in combination with a LHRH analogue.

About XTANDI® (enzalutamide) capsules 
XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

Enzalutamide Mechanism of Action 
Enzalutamide is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this MOA is unknown.

Important Safety Information 
Contraindications XTANDI is not indicated for women and is contraindicated in women who are or may become pregnant. XTANDI can cause fetal harm when administered to a pregnant woman.

Warnings and Precautions  
Seizure In Study 1, conducted in patients with metastatic castration-resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0.9% of XTANDI patients and 0% of placebo patients. In Study 2, conducted in patients with chemotherapy-naive metastatic CRPC, seizure occurred in 0.1% of XTANDI patients and 0.1% of placebo patients. There is no clinical trial experience re- administering XTANDI to patients who experienced a seizure, and limited safety data are available in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold; Study 2 permitted the use of these medications. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Adverse Reactions The most common adverse reactions (≥ 10%) reported from two combined clinical studies that occurred more commonly (≥ 2% over placebo) in XTANDI patients were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.

In Study 1, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In Study 2, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups.

  • Lab Abnormalities: Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).
  • Infections: In Study 1, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death.
  • Falls (including fall-related injuries), occurred in 9% of XTANDI patients and 4% of placebo patients. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.
  • Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.
Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.

Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

For Full Prescribing Information for XTANDI (enzalutamide) capsules, please visit http://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf?v=1

You are encouraged to report negative side effects of prescription drugs to the FDA. 
Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.

About Astellas 
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com/en.

About Medivation, Inc.
Medivation, Inc. is a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their families. For more information, please visit us at http://www.medivation.com

About the Medivation/Astellas Collaboration 
In October 2009, Medivation (NASDAQ: MDVN) and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies are collaborating on a comprehensive development program that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer as well as advanced breast cancer. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.

Forward-Looking Statements 
This press release contains forward-looking statements regarding the supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) capsules, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties. Actual results may differ substantially for a number of reasons, including if the data from STRIVE and/or TERRAIN are not incorporated into the prescribing information for XTANDI and other risks detailed in Medivation’s filings with the Securities and Exchange Commission, or SEC, including its quarterly report on Form 10-Q for the quarter ended September 30, 2015, which was filed on November 6, 2015. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Medivation disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

Logo – http://photos.prnewswire.com/prnh/20140416/84970

 

SOURCE Astellas Pharma Inc.

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PR Newswire

Ranpirnase Exhibits Anti-Zika Activity

Tamir Continues To Advance Clinical Progress

SAN DIEGO, Feb. 22, 2016 /PRNewswire/ — Tamir Biotechnology, a clinical stage company developing ranpirnase as a novel broad-spectrum anti-viral, announced results today from a pre-clinical investigational study at the Institute of Antiviral Research at Utah State University. The study evaluated the anti-viral activity of ranpirnase in an established cell model of Zika virus infection. Overall, the study revealed that ranpirnase was active in blocking Zika virus relative to a control. In previous cell based studies, ranpirnase exhibited no cytotoxic effects at therapeutically effective dose levels.

“We are very pleased to see that ranpirnase demonstrated strong antiviral activity against Zika in this established model,” noted Tom Hodge, PhD, Director of Antiviral Research at Tamir. Added Dr. Hodge, “We look forward to rapidly bringing ranpirnase to treat Zika infected patients into clinical phases.”

The clinical work with the Zika virus builds on years of work with other virally-caused pathologies such as Ebola. Results from a recent NIH-sponsored study on the Ebola virus gave 100% survival in ranpirnase-treated animals administered with therapeutic levels of the drug post-infection. The virus was undetectable in the serum of ranpirnase-treated mice at eight days post-infection.

Tamir’s clinical program is led by their phase II investigation of a topical formulation of ranpirnase in the treatment of HPV genital warts. This study is expected to begin enrollment in South America in February 2016. There are an estimated 14 million new and recurrent HPV infections per year in the US alone and the global HPV market is estimated to be over $US2B in 2020. Ranpirnase for injection has been safely administered to over 1,000 subjects in previous oncology clinical trials.

Tamir is a clinical stage anti-viral therapeutics company engaged in the development of a new class of prophylactic and therapeutic drugs for the treatment of viral infections and other virally-caused pathologies. Tamir’s current target is the human papilloma virus (HPV), the worldwide leading cause of genital warts. Tamir is also targeting the acute treatment of the Ebola (EBV), Zika, and Dengue viruses.

 

 

 

SOURCE Tamir Biotechnology

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PR Newswire

Trovagene Enters into Preferred Provider Agreement with Fortified Provider Network

SAN DIEGO, Feb. 22, 2016 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced today that it has entered into an Agreement with Fortified Provider Network (Fortified), a direct-contracted preferred provider network administering benefits nationally for over 4 million covered lives. Based on the agreement, Trovagene’s Precision Cancer Monitoring® (PCM) services are covered as an in-network participating laboratory provider for members of Fortified’s network, which includes self-funded employer groups, insurance carriers and regional and local provider networks that process end-user patient claims.

“Offering the best solutions to our members for their healthcare needs is a key goal at Fortified,” stated Kristin Martin, director of network operations of Fortified Provider Network. “With the significant advances in molecular genetics, particularly as it relates to the diagnosis and treatment of cancer, we are excited to facilitate health benefit access to Trovagene’s Precision Cancer Monitoring service for patients in our network that are fighting cancer.”

“Becoming a Fortified Provider Network member is an important milestone for Trovagene, as we expand the number of covered lives with health insurance access to our Precision Cancer Monitoring technology,” said Matt Posard, chief commercial officer of Trovagene. “We continue to execute on our strategy to commercialize our novel liquid biopsy platform, and we look forward to playing a significant role in improving the care of Fortified’s cancer patients with our non-invasive tests for the detection and monitoring of medically relevant oncogene mutations.”

About Fortified Provider Network

Based in Scottsdale, Arizona, Fortified Provider Network is a national direct-contracted preferred provider network that administers benefits for approximately 4 million covered lives. Fortified’s goal is for end-user patients to receive excellent care in the location of their choice from high-quality providers at a reasonable cost. Fortified works to ensure that its valued healthcare providers benefit from attractive reimbursement levels, fast reimbursement terms and superior customer service. 

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The Company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition;  our need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technologies or products will be utilized by physicians or other service providers or that our strategy to commercialize our novel liquid biopsy platform will prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement.  Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2014 and other periodic reports filed with the Securities and Exchange Commission.

Contact

Investor Relations

Media Relations

David Moskowitz and Amy Caterina

Investor Relations

Ian Stone

Account Director

Trovagene, Inc.

Canale Communications, Inc.

858-952-7593

619-849-5388

ir@trovagene.com

ian@canalecomm.com

Logo – http://photos.prnewswire.com/prnh/20120620/LA28014LOGO

 

SOURCE Trovagene, Inc.

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