UNITED STATES |
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934
For the month of November 2016
Commission File Number 001-37626
Mesoblast Limited
(Exact name of Registrant as specified in its charter)
Not Applicable
(Translation of Registrant’s name into English)
Australia
(Jurisdiction of incorporation or organization)
Silviu Itescu
Chief Executive Officer and Executive Director
Level 38
55 Collins Street
Melbourne 3000
Australia
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F:
Form 20-F ☑ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Yes ☐ No ☑
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Yes ☐ No ☑
INFORMATION CONTAINED ON THIS REPORT ON FORM 6-K
On November 14, 2016, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement, which is attached hereto as Exhibit 99.1, and is incorporated herein by reference.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly organized.
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Mesoblast Limited |
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/s/ Charlie Harrison |
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Charlie Harrison |
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Company Secretary
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Dated: November 15, 2016
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99.1 |
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Press release of Mesoblast Ltd, dated November 14, 2016. |
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Exhibit 99.1
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Mesoblast Announces Successful Interim Futility Analysis In Phase 3 Trial For Acute Graft Versus Host Disease
New York, USA; and Melbourne, Australia; November 14, 2016: Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced that the Phase 3 trial of its intravenous product candidate MSC-100-IV used as front-line therapy in children with steroid-resistant acute graft versus host disease (aGVHD) had been successful in a pre-specified interim futility analysis.
Enrollment in the 60-patient open label Phase 3 trial is ongoing across multiple sites in the United States, trial completion is expected in the first half of 2017, and commercial launch activities are underway.
The independent Data Safety Monitoring Board (DSMB) notified Mesoblast that an interim analysis showed that the predefined Bayesian futility rule used to determine the probability of the trial’s success using the trial’s primary endpoint of Day 28 overall response had been passed. The analysis method determined the likelihood of obtaining a statistically significant treatment effect at study completion, based on the data observed at this interim time point.
There are currently no products approved in the United States for this disease. Japan is the only jurisdiction where this therapy is available, through Mesoblast’s licensee JCR Pharmaceuticals Co. Ltd. Based on guidance from the United States Food and Drug Administration (FDA), Mesoblast believes that positive data from this Phase 3 trial may be sufficient for filing for accelerated approval of MSC-100-IV in the United States. Mesoblast plans to broaden its use in adult patients with high-risk steroid-refractory aGVHD.
“We are pleased that Mesoblast has attained such an important milestone in making its product available for the potential treatment of steroid-refractory acute graft versus host disease, a serious and life threatening condition that has a very urgent need for effective therapies,” said Dr Joanne Kurtzberg, the Jerome Harris Distinguished Professor of Pediatrics and Director of the Pediatric Blood and Marrow Transplant Program at Duke University Medical Center and the lead investigator on the ongoing Phase 3 trial.
“Mortality can reach 85% in patients with liver and gut complications and, outside of Japan, there are currently no approved therapies available. MSC-100-IV is on the cusp of becoming an important new treatment option for these patients,” she said.
The successful outcome of the DSMB interim analysis using the trial's primary endpoint of Day 28 overall response is consistent with previously reported results in a pediatric Expanded Access Program (EAP) in children with steroid-refractory aGVHD. Results from this program, which evaluated MSC-100-IV in 241 children, were presented in February 2016 at the American Society of Blood and Marrow Transplantation annual meeting.
Key findings in the EAP program were:
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An overall response rate of 65% in all children at day 28 when MSC-100-IV was used either as last-line or front-line therapy after steroid failure |
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An overall response rate of 81% at day 28 when MSC-100-IV was used as front-line therapy following steroid failure |
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An overall response rate of 65% and 62%, respectively, in patients with gastrointestinal and liver disease, who have the highest mortality risk |
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A significantly improved survival at day 100 in children who achieved overall response at day 28 (82% vs. 39%, log rank p-value <0.0001) |
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Mesoblast Limited
www.mesoblast.com |
Corporate Headquarters Level 38 55 Collins Street Melbourne 3000 Victoria Australia
T +61 3 9639 6036 F +61 3 9639 6030 |
United States Operations 505 Fifth Avenue Third Floor New York, NY 10017 USA
T +1 212 880 2060 F +1 212 880 2061 |
Asia 20 Biopolis Way #05-01 Centros Biopreneur 3 SINGAPORE 138668
T +65 6570 0635 F +65 6570 0176 |
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In February 2016, Mesoblast's licensee JCR launched TEMCELL® HS. Inj. in Japan, the first allogeneic cell-based product to receive full approval in the world’s second-largest standalone healthcare market. A four-week, multi-dose treatment course of TEMCELL for an average adult is expected to be reimbursed by the Japanese Government’s National Health Insurance body at a minimum of ¥13,898,880 (approximately US$130,000) or up to ¥20,848,320 (approximately US$195,000) if symptoms persist and additional dosing is required. Under its agreement with JCR, Mesoblast is entitled to receive royalties and other payments at predefined thresholds of cumulative net sales.
About Graft Versus Host Disease
Mesoblast is developing MSC-100-IV for the treatment of aGVHD following an allogeneic bone marrow transplant (BMT). In patients who have received a BMT, donor cells may attack the recipient (the person receiving the transplant), causing aGVHD, resulting in activation of pro-inflammatory T-cells and tissue damage in the skin, gut and liver, which is often fatal.
According to the Center for International Blood and Marrow Transplant Research, there are approximately 30,000 allogeneic BMTs globally per year for diseases including hematological cancers, with 25% of all cases in the pediatric population. Nearly 50% of all allogeneic BMT patients develop aGVHD. Liver or gastrointestinal involvement occur in up to 40% of all patients with aGVHD and are associated with the greatest risk of death, with mortality rates of up to 85%.
Conference Call
Dr Kurtzberg and Mesoblast’s Chief Medical Officer, Dr Donna Skerrett, are participating in a corporate update conference call beginning at 9:00 am Australian Eastern Daylight Time on Tuesday, November 15, 2016 / 5:00 pm Eastern Time on Monday, November 14, 2016.
To access the call, dial 1 800 558 698 (toll-free Australia), 1 855 881 1339 (toll-free US), or +61 2 9007 3187 (outside of the US and Australia).
The conference identification code is 912575.
The live webcast can be accessed via: http://webcasting.boardroom.media/broadcast/58214386d5f1311b35bd36a6
There will be a slide presentation. Please log in approximately 15 minutes prior to the scheduled start time.
About Mesoblast
Mesoblast Limited (ASX:MSB; Nasdaq:MESO) is a global leader in developing innovative cell-based medicines. The Company has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to establish a broad portfolio of late-stage product candidates. Mesoblast’s allogeneic, ‘off-the-shelf’ cell product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular diseases, immune-mediated and inflammatory disorders, orthopedic disorders, and oncologic/hematologic conditions.
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Mesoblast Limited
www.mesoblast.com |
Corporate Headquarters Level 38 55 Collins Street Melbourne 3000 Victoria Australia
T +61 3 9639 6036 F +61 3 9639 6030 |
United States Operations 505 Fifth Avenue Third Floor New York, NY 10017 USA
T +1 212 880 2060 F +1 212 880 2061 |
Asia 20 Biopolis Way #05-01 Centros Biopreneur 3 SINGAPORE 138668
T +65 6570 0635 F +65 6570 0176 |
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This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
For further information, please contact:
Julie Meldrum Global Head, Corporate Communications Mesoblast Limited T: +61 3 9639 6036 E: julie.meldrum@mesoblast.com |
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Schond Greenway VP, Investor Relations Mesoblast Limited T: +1 212 880 2060 E: schond.Greenway@mesoblast.com |
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Mesoblast Limited
www.mesoblast.com |
Corporate Headquarters Level 38 55 Collins Street Melbourne 3000 Victoria Australia
T +61 3 9639 6036 F +61 3 9639 6030 |
United States Operations 505 Fifth Avenue Third Floor New York, NY 10017 USA
T +1 212 880 2060 F +1 212 880 2061 |
Asia 20 Biopolis Way #05-01 Centros Biopreneur 3 SINGAPORE 138668
T +65 6570 0635 F +65 6570 0176 |
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