Investigator-initiated phase II clinical study of remetinostat started in patients with basal cell carcinoma

On August 2, 2018 Medivir AB (Nasdaq Stockholm: MVIR) reported that the first patient has been enrolled and is being dosed with remetinostat gel 1% in an investigator-initiated phase II clinical study in patients with basal cell carcinoma (BCC) (Press release, Medivir, AUG 2, 2018, View Source [SID1234528308]). This clinical study will be conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin. Medivir will be providing remetinostat drug supply for this study, and will have full access to, and the rights to use, all clinical data after the study is complete.

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The primary objective of the study is to assess the effects of topical remetinostat on the overall response rate in a cohort of BCC patients and could establish that remetinostat has the potential for use in other skin-associated cancers in addition to CTCL. Further details of the study can be found at www.clinicaltrials.gov with the reference NCT03180528.

"This study highlights the potential of remetinostat to be used in conditions beyond early-stage cutaneous T-cell lymphoma," said Christine Lind, CEO of Medivir. She continues, "We look forward to the completion of the study and communication of the clinical outcomes."

For further information, please contact:
Christine Lind, CEO, Medivir AB, phone: +46 (0)8 5468 3100
Erik Björk, CFO, Medivir AB, mobile: +46 (0)72 228 2831

About remetinostat
Remetinostat is a histone deacetylase (HDAC) inhibitor. The unique design of remetinostat enables topical application, making it active only in the skin. As soon as it reaches the blood stream, it is degraded, avoiding the side effects associated with other HDAC inhibitors.

Hologic to Webcast Presentation at the Canaccord Genuity 38th Annual Growth Conference

On August 2, 2018 Hologic, Inc. (Nasdaq: HOLX) reported that the Company will present at the Canaccord Genuity 38th Annual Growth Conference in New York, NY on Wednesday, August 8 at 1:30 p.m. Eastern Time (Press release, Hologic, AUG 2, 2018, View Source [SID1234528306]).

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The presentation will be webcast live and may be accessed through a link on the investors section of Hologic’s website at View Source The webcast will be available for 30 days following the event.

PepVax Releases a "Trojan Horse" Drug Delivery Platform

On August 1, 2018 PepVax, Inc., an early-stage biotechnology company, reported the launch of its novel SMARTmid platform for drug delivery of nucleic acid and amino acid-based drugs and cell therapies in pre-clinical development (Press release, PepVax, AUG 1, 2018, View Source [SID1234630790]). With manufacturing and delivery of immunotherapies, cell therapies, and gene therapies getting increasingly complicated and expensive at scale-up, the SMARTmid platform offers a unique solution with our "Trojan Horse" approach to use the patient’s own cells to manufacture the required proteins, T-cells and nucleic acids in vivo for cancers, infectious and genetic diseases.

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Learn more about PepVax here – View Source

The Perfect Solution for Researchers and Early-Stage Biotechnology Companies

Our SMARTmid vector design is our fully synthetic method for producing plasmid vector particles for mammalian cell transduction and is a powerful template in which to build a drug delivery and immuno-adjuvant platform. DNA-based delivery can directly enhance expression levels and enable easy manufacturing of protein-, DNA- and RNA-based treatments in vivo. Moreover, SMARTmid can be used as an immuno-adjuvant to enhance already developed drugs to work more effectively in patients requiring a strong immune response, like checkpoint inhibitors and CAR-T treatments. SMARTmid can also be used as a diagnostic tool for certain cancers and infectious diseases.

Efficiency and Simplicity That Just Works
"Delivering drugs has always been a challenge for drug developers," said Mahesh Narayanan, CEO of PepVax. "Researchers and research companies looking to deliver their biologics intramuscularly or intravenously can use our SMARTmid platform to produce their drugs inside the patient or deliver it without worrying about degeneration or decreased potency."

Focused on Continued Innovation
PepVax is looking to license SMARTmid to established biopharmaceutical companies that are looking for efficient drug delivery in patients as well as developing novel cancer and infectious disease therapeutics. The Company is also looking to enter into research agreements with academia.

Alkermes’ Corporate Presentation to be Webcast at the 38th Annual Canaccord Genuity Growth Conference

On August 1, 2018 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the 38th Annual Canaccord Genuity Growth Conference on Wednesday, Aug. 8, 2018 at 10:30 a.m. ET (3:30 p.m. BST) from Boston (Press release, Alkermes, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361402 [SID1234528866]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Contact:
Sandra Coombs
Investor Relations
+1 781 609 6377

PRA Health Sciences, Inc. Reports Second Quarter 2018 Results and Updates Full Year 2018 Guidance

On August 1, 2018 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended June 30, 2018 (Press release, PRA Health Sciences, AUG 1, 2018, View Source [SID1234528665]).

For the three months ended June 30, 2018, revenue was $722.8 million, which represents growth of 35.4%, or $189.1 million, compared to the second quarter of 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $182.3 million, an increase of 34.2% compared to the second quarter of 2017. On January 1, 2018, the Company adopted Accounting Standards Codification Topic 606, "Revenue from Contracts with Customers," or ASC 606, using the modified retrospective method for all contracts that were not completed as of January 1, 2018. The prior periods were not restated under this guidance and remain as previously reported. The primary impact of applying this new guidance on our statement of operations is that (i) we now recognize reimbursements from our customers for payments to investigators as revenue, whereas these payments and costs were previously recorded on a net basis, and (ii) we include all reimbursed costs in the total project costs when measuring our progress under our research contracts instead of recording these amounts on a separate basis.

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Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $117.0 million, which represents growth of 25.6% at actual foreign exchange rates and 24.4% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and $58.1 million of revenue attributable to our Data Solutions segment, was 12.9% at actual foreign exchange rates and 11.7% on a constant currency basis.

Net new business for our Clinical Research segment for the quarter ended June 30, 2018 was $670.0 million, representing a net book-to-bill ratio of 1.30 for the period. Our calculation of the net book-to-bill ratio excludes the revenue impact of adopting ASC 606, excludes reimbursement revenue and excludes revenue from our Data Solutions segment. Net new business during the quarter contributed to an ending backlog of $3.9 billion at June 30, 2018.

"I am pleased with our second quarter performance, which included double-digit revenue, earnings and net new business growth when compared to the second quarter of 2017" said Colin Shannon, PRA’s Chief Executive Officer. "We continue to stay focused on our client deliverables and our strategic objectives. We are pleased to continue to add new clients and believe we are well-positioned to drive future growth."

Direct costs were $381.7 million during the three months ended June 30, 2018 compared to $300.6 million for the second quarter of 2017. The increase in direct costs was primarily due to an increase in labor-related costs of $36.4 million in our Clinical Research segment as we continue to hire billable staff to ensure appropriate staffing levels for our current studies and our future growth. In addition, our Data Solutions segment resulted in $41.6 million of incremental direct costs when compared to the second quarter of 2017. We also had an unfavorable impact of $5.3 million from fluctuation in foreign currency exchange rates during the three months ended June 30, 2018. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, direct costs were 66.4% of revenue during the second quarter of 2018 compared to 65.6% of revenue during the second quarter of 2017.

Selling, general and administrative expenses were $91.2 million during the three months ended June 30, 2018 compared to $76.2 million for the second quarter of 2017. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, selling, general and administrative costs were 15.9% of revenue during the second quarter of 2018 compared to 16.6% of revenue during the second quarter of 2017.

GAAP net income was $42.0 million for the three months ended June 30, 2018, or $0.64 per share on a diluted basis, compared to GAAP net income of $29.5 million for the three months ended June 30, 2017, or $0.45 per share on a diluted basis.

EBITDA was $102.6 million for the three months ended June 30, 2018, representing an increase of 55.9% compared to the second quarter of 2017. Adjusted EBITDA was $109.7 million for the three months ended June 30, 2018, representing growth of 28.5% compared to the second quarter of 2017.

Adjusted net income was $66.1 million for the three months ended June 30, 2018, representing 27.8% growth compared to the second quarter of 2017. Adjusted net income per diluted share was $1.00 for the three months ended June 30, 2018, representing 26.6% growth compared to the second quarter of 2017.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2018 guidance, to the corresponding GAAP measures is included in this press release.

First Half 2018 Financial Highlights

For the six months ended June 30, 2018, revenue was $1,424.7 million, which represents growth of 39.5%, or $403.2 million, compared to the six months ended June 30, 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $380.6 million, representing growth of 37.3% compared to the six months ended June 30, 2017.

Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $249.9 million, which represents growth of 28.2% at actual foreign exchange rates and 26.4% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and $114.9 million of revenue attributable to our Data Solutions segment, was 15.3% at actual foreign exchange rates and 13.4% on a constant currency basis.

Reported GAAP income from operations was $145.7 million, reported GAAP net income was $81.0 million and reported GAAP net income per diluted share was $1.22 for the six months ended June 30, 2018.

Adjusted Net Income was $122.3 million for the six months ended June 30, 2018, an improvement of 32.8% compared to the same period in 2017. Adjusted Net Income per diluted share was $1.85 for the six months ended June 30, 2018, up 32.1% compared to the same period in 2017.

The Company is updating its full year 2018 revenue guidance to between $2.87 billion and $2.92 billion, representing as reported growth of 47% to 50%, constant currency growth of 18% to 20% excluding the impact of adopting 606 and reimbursement revenue, and constant currency organic growth of 10% to 12% excluding the impact of adopting 606 and reimbursement revenue. We expect GAAP net income per diluted share to between $2.92 and $3.02 and Adjusted Net Income per diluted share to between $4.13 and $4.23. We continue to anticipate an annual effective income tax rate estimate of approximately 24%, which includes the expected impact of the U.S. Tax Cuts and Jobs Act. Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in interpretations, analysis, and additional guidance that may be issued by regulatory agencies as it relates to the U.S. Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.20 and a GBP rate of 1.37. All other foreign currency exchange rates are as of June 30, 2018.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on August 2, 2018, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 9692658. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investors.prahs.com. A replay of the conference call will be available online at investors.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 9692658.

Additional Information

A financial supplement with second quarter 2018 results, which should be read in conjunction with this press release, may be found in Investor Relations section of our website at investors.prahs.com in a document titled "Q2 2018 Earnings Presentation."