Myriad’s myRisk® Hereditary Cancer Test Finds More Than 12 Percent of Men with Prostate Cancer Carry an Inherited Genetic Mutation

On February 7, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that results from a large 1,162 patient study of the Myriad myRisk Hereditary Cancer test will be featured during the poster presentation at the 2018 Genitourinary Cancer Symposium in San Francisco, Calif (Press release, Myriad Genetics, FEB 7, 2018, View Source [SID1234523799]). The key finding is that more than 12 percent of men with prostate cancer had an inherited (i.e. hereditary) mutation in a cancer-causing gene.

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"As one of the largest studies of hereditary cancer risk assessment ever conducted in prostate cancer, our myRisk Hereditary Cancer test demonstrated that roughly the same percentage of men with prostate cancer carry hereditary cancer-causing mutations as do women with breast cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. "These compelling findings provide a strong reason for expanding the use of genetic testing in men diagnosed with prostate cancer consistent with existing professional medical guidelines."

The key data are summarized below and the abstract is available at: abstracts.asco.org. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #GU18.

Title: Inherited Germline Mutations in Men with Prostate Cancer.
Presenter: Robert Reid, M.D., Virginia Cancer Specialists.
Date: Sunday, February 9, 2018, 12:15 — 1:45 p.m. and 6:00 p.m. — 7:00 p.m.
Location: Poster Board E4; Poster Abstract 357.

The study will be presented by Robert Reid, M.D. from the Virginia Cancer Specialists who served as the lead investigator of this study. The study objective was to evaluate genetic testing using the 28-gene myRisk Hereditary Cancer test in 1,162 men with a personal history of prostate cancer. Of these, 64 percent had a history of prostate cancer, while 36 percent had a history of prostate cancer and at least one additional cancer. The results showed that 12.1 percent of men with prostate cancer were positive for one or more hereditary cancer mutations in the genes tested. Additionally, the positive rate was significantly higher among men with prostate cancer plus one other cancer (14.7 percent). The inherited mutations were found in genes with a well-known prostate cancer risk (i.e., BRCA2) as well as genes historically associated with other cancer types including breast and colon. These findings suggest that hereditary cancer testing in men with prostate cancer may aid in medical management decision making to reduce overall cancer risk.

"We believe hereditary cancer testing can help inform treatment decisions for these men, including whether to pursue active surveillance, increased screening for secondary cancers and potentially for treatment selection with PARP inhibitors or other medicines in the future," said Dr. Lancaster. "Additionally, once men know they carry an inherited mutation, they can encourage their family members to get tested to learn if they’re at increased risk for cancer and potentially help them prevent future cancers."

The National Comprehensive Cancer Network, American Urological Association (AUA) and an academic consensus panel all support hereditary cancer risk assessment for patients with prostate cancer deemed to be high risk due to metastatic disease or high grade cancer with a family history of BRCA associated cancers including breast, ovarian, pancreatic or prostate cancer.

Importantly, the AUA position states that: "Patients with localized prostate cancer who are at highest risk for developing metastatic castration-resistant prostate cancer, may have a higher incidence of germline DNA repair mutations than expected from published reports. The presence of germline DNA repair gene mutations has important implications for the prostate cancer patient in terms of general cancer screening and possible future prostate cancer treatment decisions. Additionally the presence of germline DNA repair mutations is of utmost relevance to the patient’s first-degree family members due to increased cancer risk and screening implications."

About Prostate Cancer
One in nine American men will have prostate cancer during his lifetime. Prostate cancer is the second leading cause of cancer death among American men and is the most commonly diagnosed. The American Cancer Society estimates in its Cancer Facts & Figures 2018 report that 164,690 men will be told they have prostate cancer in 2018. Currently, there are nearly 2.9 million American men living with the disease and every 18 minutes another American man dies from prostate cancer. That’s a little more than 80 deaths per day and 29,430 this year.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 28 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. The myRisk Hereditary Cancer test offers physicians several distinct advantages over other commercial tests, including unsurpassed lab accuracy, industry leading variant classification and exceptional customer service.

Men with prostate cancer can take the Hereditary Cancer Quiz to find out if they might be at risk for an inherited mutation and qualify for myRisk Hereditary Cancer test.

Insmed to Present at the Leerink Partners 7th Annual Global Healthcare Conference

On February 7, 2018 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported that Will Lewis, President and Chief Executive Officer of Insmed, will present at the Leerink Partners 7th Annual Global Healthcare Conference in New York on Wednesday, February 14, 2018 at 11:30 a.m. ET (Press release, Insmed, FEB 7, 2018, View Source [SID1234523796]).

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The presentation will be webcast live and can be accessed by visiting the investor relations section of the company’s website at www.insmed.com. The webcast will be archived for a period of 90 days following the conclusion of the live event.

Johnson & Johnson to Participate in RBC Capital Markets 2018 Global Healthcare Conference

On February 7, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the RBC Capital Markets 2018 Global Healthcare Conference on Wednesday, Feb. 21, at the Lotte New York Palace in New York City (Press release, Johnson & Johnson, FEB 7, 2018, View Source [SID1234523797]). Dominic Caruso, Executive Vice President, Chief Financial Officer will represent the Company in a session scheduled at 1:30 p.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast and podcast replay will be available approximately two hours after the live webcast.

REM-001 Therapy

REM-001 Therapy consists of three parts, a laser light source, a light delivery device and the drug REM-001 (collectively, REM-001 Therapy). REM-001 is a second generation photosensitizer drug that has undergone late stage clinical development, and which we believe possesses multiple advantages over earlier generation PDT compounds. Our lead indication for REM-001 Therapy is unresectable cutaneous metastatic breast cancer (CMBC), a disease that may affect individuals with advanced breast cancer and for which effective treatment options are limited. For this and similar cutaneous applications, the light delivery device is a simple and easy to use fiber optic wand that the physician employs to directly illuminate the tumor with light.

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pSivida Corp. Reports Second Quarter FY2018 Results; Continues to Achieve Milestones and Timelines

On February 7, 2018 pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, today reported financial results for its fiscal 2018 second quarter and six months ended December 31, 2017 and provided an update on its continued operating progress (Press release, pSivida, FEB 7, 2018, View Source [SID1234523802]).

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Recent Operating Highlights

Submitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Durasert three-year treatment for posterior segment uveitis
Obtained from the FDA a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $2.4 million in connection with the NDA filing
Newly released second Phase 3 study data for Durasert three-year treatment for posterior segment uveitis continued to demonstrate positive efficacy and safety profile at 12 months
Presented Phase 3 data at several medical conferences, including the American Academy of Ophthalmology (AAO) annual meeting and the American Uveitis Society (AUS) winter meeting
Reported positive Phase 1 knee osteoarthritis pain study data indicating that the implant was well tolerated and showed potential for pain reduction through the six-month study period
"We achieved several milestones in the fiscal second quarter and the past few weeks and continue to make material progress in the transformation of pSivida into a fully integrated commercial stage pharmaceutical enterprise," commented Nancy Lurker, President & CEO. "Our highest priority was the NDA submission for Durasert three-year treatment for posterior segment uveitis, which we accomplished in early January. We are also pleased with the continued positive read out of our clinical uveitis data and look forward to presenting these data at upcoming congresses. Meanwhile, we will continue to refine our go-to-market plan in the U.S. and I am confident we have the experienced team and strategy to execute our launch plan with precision."

Fiscal Second Quarter and Six-Month Results

Revenue for the second fiscal quarter ended December 31, 2017 totaled $933,000 compared to $6.0 million for the prior year quarter. The year-ago second quarter included the recognition of deferred collaborative research and development revenue totaling $5.6 million resulting from termination of the Pfizer collaboration agreement. Excluding the Pfizer termination, revenue from feasibility study agreements and royalty income increased to $933,000 for the three months ended December 31, 2017 compared to $387,000 in the prior year quarter. Current period revenues included $196,000 of royalty income received from Alimera Sciences, representing the first quarterly reporting under our July 2017 restructured collaboration agreement. Operating expenses for the three months ended December 31, 2017 increased to $6.7 million from $6.1 million a year earlier, due primarily to professional services costs associated with the NDA filing for Durasert three-year uveitis. Net loss for the quarter ended December 31, 2017 was $5.8 million, or $0.13 per share, compared to net loss of $67,000, or break-even per share, for the prior year quarter.

Revenue for the six months ended December 31, 2017 was $1.3 million compared to $6.2 million for the six months ended December 31, 2016. Excluding the $5.6 million revenue recognized in the prior year period upon termination of the Pfizer agreement, revenues from feasibility study agreements and royalty income increased to $1.3 million for the six months ended December 31, 2017 compared to $664,000 in the prior year six-month period. Operating expenses for the first six months of fiscal 2018 were $13.1 million compared to $13.5 million a year earlier. Higher professional services costs related to the Company’s NDA filing were substantially offset by the absence in the current year-to-date period of severance costs and professional fees related to the Company’s CEO transition and elimination of the position of Vice President, Corporate Affairs and General Counsel in the prior year-to-date period. Net loss for the six months ended December 31, 2017 was $11.8 million, or $0.28 per share, compared to a net loss of $7.2 million, or $0.21 per share for the corresponding fiscal 2017 year-to-date period.

At December 31, 2017, the Company’s cash and cash equivalents totaled $12.9 million.

Anticipated Calendar 2018 Milestones:

FDA acceptance for review of the NDA for Durasert three-year treatment for posterior segment uveitis in calendar Q1
Present 12-month efficacy and safety data from the second Phase 3 clinical study at leading medical conferences
Continue business development efforts and enter into one or more new collaboration agreements with biopharmaceutical companies and other third parties
Expect to complete the GLP safety and pharmacokinetic study for a shorter duration product for posterior segment uveitis
Conference Call

pSivida Corp. will host a live webcast and conference call today, February 7, 2018 at 4:30pm ET. The conference call may be accessed by dialing (877) 312-7507 from the U.S. and Canada, or (631) 813-4828 from international locations. The conference ID is 8399835. A live webcast will be available on the Investor Relations section of the corporate website at View Source

A replay of the call will be available beginning February 7, 2018, at approximately 7:30 p.m. ET and ending on February 14, 2018, at 11:59 p.m. ET. The replay may be accessed by dialing (855) 859-2056 within the U.S. and Canada or (404) 537-3406 from international locations, Conference ID Number: 8399835. A replay of the webcast will also be available on the corporate website during that time.