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PROMETIC ANNOUNCES REALIGNMENT OF ITS CLINICAL PROGRAM PRIORITIES FOR 2018

On February 21, 2018 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic") reported an update regarding its clinical development programs and confirmation of its priorities regarding its lead drug candidates (Press release, ProMetic Life Sciences, FEB 21, 2018, View Source [SID1234524104]).

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PBI-4050 And Follow-On Analogs, PBI-4547 & PBI-4425
"Idiopathic pulmonary fibrosis (IPF) is now priority No.1 for PBI-4050" stated Pierre Laurin, President and CEO of Prometic. "IPF remains to this day a significant unmet medical need affecting hundreds of thousands of patients with an established market value measured in $billions. The clinical efficacy demonstrated so far in multiple phase 2 clinical trials combined with an impressive safety and tolerability profile gives us great confidence in PBI-4050’s ability to efficiently address fibrotic diseases."

Following the outcome of the successful clinical development Type C meeting held with the FDA in early January 2018, the top clinical development program priority is now the phase 3 pivotal clinical trial for PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF). The all comers study will enroll patients with mild-to-moderate IPF, regardless of whether they are on background standard of care with nintedanib (OFEV) or not and will provide efficacy data on both PBI-4050 as a stand-alone agent, and as an add-on to nintedanib, and will be part of the dataset to support a simple, all-inclusive indication for the treatment of IPF. This multinational study, involving multiple sites across the United States, Canada, Australia, the UK and Europe is expected to begin patient enrollment around the 2018 mid-year mark.

Following last year’s confirmation that beneficial clinical effects are sustained during prolonged treatment in subjects suffering from Alström Syndrome in the United Kingdom, further extensions of duration of treatment were announced to Prometic’s on-going phase 2 open label clinical trial. Prometic now announces that it is formally seeking meetings with both the European and the US regulatory authorities to determine the clinical- regulatory pathway for this condition as a stand-alone indication.

Pierre Laurin stated: "We will soon be disclosing further clinical data from the on-going Alström Syndrome clinical trial in the UK which also gives us great confidence to pursue this devastating condition as a stand-alone fibrosis indication to be treated with PBI-4050. Safety and efficacy data collected and demonstrated to date in such a challenging patient population will also contribute to the clinical design and potential treatment for future clinical development initiatives of the Corporation with respect to indications such as heart, kidney & liver fibrosis".

As part of this realignment, the Corporation has terminated PBI-4050 clinical trial in Cystic Fibrosis Related Diabetes ("CFRD") and is evaluating the need to continue other on-going clinical programs with PBI-4050. Prometic is evaluating its clinical development strategy regarding follow-on compounds (i.e. analogs of PBI-4050) which share the same unique mechanism of action with PBI-4050, have demonstrated similar performance in multiple preclinical studies and some of which have outperformed PBI-4050 in specific animal models. Clinical development of those analogs would enable Prometic to target other fibrotic-related indications and create further therapeutic products optionality for our on- going partnering discussions.

These realignments therefore include: The commencing of PBI-4547’s clinical program includes the initiation of the phase 1 clinical trial in Q2 2018 followed by a phase 2 in patients with liver fibrosis and metabolic diseases. It further includes the initiation of PBI- 4425’s clinical program which is scheduled to commence in H2 2018 with specific targeted indications to be communicated in H2 2018.

RyplazimTM For Plasminogen Deficiencies
RyplazimTM (plasminogen) is the first biopharmaceutical expected to be launched commercially pending the review of its BLA (Biologic License Application) submitted to the FDA initially for the treatment of congenital plasminogen deficiency.

The Company will prioritize the expansion of clinical indications for RyplazimTM and leverage the positive clinical experience gained by supplementing plasminogen levels in deficient patients. There are several medical conditions, some of which potentially lethal, associated with "acquired plasminogen deficiencies" and Prometic is designing clinical trials to establish optimal dosing protocols for the potential use of RyplazimTM for the treatment of such conditions, including thrombotic events as well as acute exacerbations in patients with acute respiratory distress syndrome (ARDS) and/or IPF.

Clinical trials with sub-cutaneous Plasminogen in patients with diabetic foot ulcers and in patients with Tympanic perforations are also currently being conducted in Sweden with expected interim clinical data readouts later this year.

The expenses related to the IVIG non-inferiority phase 3 clinical trial will decrease in 2018 with the completion in H1 2018 of the adults’ cohort required for the FDA BLA filing to be followed by the completion of the pediatric cohort in H1 2019.

Commenting on the financing strategy required to execute on these plans, Bruce Pritchard, Prometic’s CFO noted, "At this stage in its development, the Corporation requires a financing strategy that allows it to maintain adequate capitalization as it continues to build enterprise value with its strong pipeline of therapeutics, but that also recognizes the need for a combination of: generating revenue through product sales; generating revenue from leveraging the asset base, such as licensing technologies for non-core indications or geographies and monetizing priority review vouchers; effective use of debt and synthetic royalty structures and by accessing capital from long-term institutional investors under the best possible conditions". He added, "Each element of this plan is critical, and is being actively pursued by management. Investors should be assured that no single component of the strategy is been seen as mutually exclusive to another. Most importantly, all components need to be readily deployable as required, as we continue to plan to execute a timely secondary listing on NASDAQ".

To maintain its flexibility for strategic fund-raising, Prometic has filed a preliminary short form base shelf prospectus (the "Preliminary Shelf Prospectus") with the securities commissions in each of the provinces of Canada.

Mr. Pritchard went on to explain, "The establishment of a shelf prospectus is common practice among our Canadian and US Peers. Prometic is somewhat unusual for not having one in place. Today’s filing of such a shelf prospectus adds to our armory of financing choices".

The Preliminary Shelf Prospectus, when made final or effective, will allow Prometic to offer up to $250,000,000 of common shares over the 25-month period that the Shelf Prospectus is effective. The Shelf Prospectus will enable Prometic to potentially access new capital as and when needed. The amount and timing of any future offerings will be based on the Company’s financial requirements and market conditions at the time. The specific terms of any future offering under the Shelf Prospectus will be established at the time of such offering. At the time any of the securities covered by the Shelf Prospectus are offered for sale, a prospectus supplement containing specific information about the terms of such offering will be filed with applicable Canadian securities regulatory authorities. The Preliminary Shelf Prospectus filed today with the Canadian securities regulatory authorities has not yet become effective. No securities may be sold, nor may offers to buy be accepted, prior to the time the Preliminary Shelf Prospectus becomes effective. This news release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualifications under the securities laws of any such jurisdiction. A copy of the Preliminary Shelf Prospectus can be found on SEDAR at www.sedar.com or may be obtained upon request to Prometic’s Investor Relations Department using the contact information set out below.

Loxo Oncology Announces Publication of Larotrectinib Clinical Data in The New England Journal of Medicine

On February 21, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, and Bayer AG, Germany, reported a publication in the February 22nd issue of the New England Journal of Medicine (NEJM) for larotrectinib in the treatment of pediatric and adult patients whose tumors harbor tropomyosin receptor kinase (TRK) gene fusions (Press release, Loxo Oncology, FEB 21, 2018, View Source [SID1234524101]).

The NEJM publication provides additional clinical details and patient follow-up from the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting presentation. It includes the first 55 consecutively enrolled adult and pediatric patients with TRK fusion cancers treated across Loxo Oncology’s Phase 1 adult trial, Phase 2 trial (NAVIGATE), and Phase 1/2 pediatric trial (SCOUT) and uses a July 17, 2017 data cutoff.

"Ongoing treatment with larotrectinib continues to demonstrate striking and durable efficacy coupled with minimal side effects, across a diverse patient population," said David Hyman, M.D., the NAVIGATE global principal investigator, chief of the Early Drug Development service at Memorial Sloan Kettering Cancer Center and senior author of the NEJM paper. "The efficacy of larotrectinib warrants screening for TRK fusions alongside other actionable targets in patients of all ages with advanced solid tumors."

In December, Loxo Oncology initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib, utilizing the same patient population and data cutoff as outlined in the NEJM paper. The rolling NDA submission is expected to be complete in early 2018 and a Marketing Authorisation Application (MAA) submission by Bayer in the European Union is expected in 2018. The larotrectinib program has continued to enroll and treat newly identified patients with TRK fusion cancers, beyond the 55 patients described in the publication. The anti-tumor activity and safety of larotrectinib in these additional patients are consistent with the data reported in the publication, and will be included for supportive analyses in the NDA and MAA submissions. Loxo Oncology expects to present these additional data in the second half of 2018.

"It is exciting to see the NEJM share the larotrectinib experience in TRK fusion cancers with the broader clinical and research communities," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "The class-leading data reported for larotrectinib are a testament to the importance of building selective medicines against all of the actionable targets comprehensive profiling can identify. We hope to build on the success of larotrectinib as our pipeline matures in 2018 and beyond."

Overview of Data Published in NEJM

The published data were based on the intent to treat (ITT) principle, using the first 55 TRK fusion patients with RECIST-evaluable disease enrolled to the three clinical trials, regardless of prior therapy or tumor tissue diagnostic method. The analysis included both adult and pediatric patients, ranging in age from four months to 76 years, who carried 17 unique TRK fusion-positive tumor diagnoses. Tumor types included salivary gland, infantile fibrosarcoma, thyroid, colon, lung, melanoma, gastrointestinal stromal tumor (GIST), and other cancers.

The primary endpoint for the analysis was overall response rate (ORR). Secondary endpoints included duration of response, progression-free survival, and safety. As shown below, as previously reported, the ORR was 75% by central assessment and 80% by investigator assessment.

Central Assessment (%)
(n=55) Investigator Assessment (%)
(n=55)
Overall response rate (95% CI)
(ORR=PR+CR) 75% (61–85%) 80% (67–90%)
Partial response 62 % 64 %*
Complete response 13 % 16 %
Stable disease 13 % 9 %
Progressive disease 9 % 11 %
Could not be evaluated 4 % 0
* Data include one patient who had a partial response that was pending confirmation at the time of the July 17, 2017 data cut-off. The response was subsequently confirmed, and the patient’s treatment and response were ongoing as of the data cut-off date.

Median duration of response (DOR) and median progression-free survival (PFS) had not been reached after median follow-up durations of 8.3 months and 9.9, respectively. At 1 year, 71% of responses were ongoing. As of the July 17, 2017 data cutoff, 86% of responding patients remained on treatment or had undergone surgery with curative intent. The first patient treated with a TRK fusion tumor remained in response and on therapy at 27 months.

Larotrectinib was well tolerated with the majority of all adverse events being grade 1 or 2. Few grade 3 or 4 adverse events, regardless of attribution, were observed with the most common being anemia (11%), alanine or aspartate aminotransferase increase (7%), weight increase (7%), and neutrophil count decrease (7%) (all grade 3 events). There were no treatment-related grade 4 or 5 events, and no treatment-related grade 3 adverse events occurred in more than 5% of patients. Eight patients required larotrectinib dose reductions. Adverse events leading to dose reductions included AST/ALT elevation, dizziness, and neutrophil count decrease, all grade 2 or 3 events. In all cases, patients whose doses were reduced maintained their best response at the lower dose and none discontinued larotrectinib due to an adverse event.

Primary resistance was observed in six patients in the study. Of the six, one patient had been previously treated with another TRK inhibitor and tumor sequencing prior to larotrectinib dosing revealed a solvent front mutation, a known resistance mechanism. Tumor tissue was analyzed for three of the five remaining patients. In all three patients, TRK immunohistochemistry failed to demonstrate TRK expression, potentially implicating a false positive initial TRK fusion test result and therefore explaining the lack of response in these patients.

The publication also details mechanisms of acquired resistance to larotrectinib. Ten patients experienced disease progression while on treatment after a documented objective response or stable disease for at least six months, a phenomenon known as acquired resistance. Nine of the ten patients had assessments of post-progression tumor or plasma samples, and NTRK kinase domain mutations were identified in all of those samples tested. In seven of those assessed, investigators identified solvent front mutations as a convergent mechanism of acquired resistance; other NTRK kinase domain mutations were identified in the remaining two patients tested. Of the 10 patients who developed acquired resistance, 80% continued treatment with larotrectinib beyond progression due to ongoing clinical benefit.

Loxo Oncology and Bayer are developing LOXO-195, a next-generation TRK inhibitor, to specifically address acquired resistance mutations, including all mutations characterized in the study. LOXO-195 is currently being evaluated in a phase 1/2 trial in children and adults.

About Larotrectinib (LOXO-101)
Larotrectinib is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an analysis of 55 RECIST-evaluable TRK fusion adult and pediatric patients, larotrectinib demonstrated a 75 percent independently-reviewed confirmed overall response rate (ORR) and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. Larotrectinib has been granted Breakthrough Therapy Designation Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Loxo Oncology leads worldwide development and U.S. regulatory activities. Bayer leads ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

About TRK Fusion Cancer
TRK fusions are chromosomal abnormalities that occur when one of the NTRK genes (NTRK1, NTRK2, NTRK3) becomes abnormally connected to another, unrelated gene (e.g. ETV6, LMNA, TPM3). This abnormality results in uncontrolled TRK signaling that can lead to cancer. TRK fusions occur rarely but broadly in various adult and pediatric solid tumors, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas. TRK fusions can be identified through various diagnostic tests, including targeted next-generation sequencing (NGS), immunohistochemistry (IHC), polymerase chain reaction (PCR), and fluorescent in situ hybridization (FISH). For more information, please visit www.TRKtesting.com.

Clovis Oncology Receives Positive Trend Vote from CHMP in European Regulatory Review for Rucaparib Ovarian Cancer Treatment Indication

On February 21, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported an update to the ongoing regulatory review for the Marketing Authorization Application (MAA) for rucaparib tablets as monotherapy for the treatment of a limited population of advanced ovarian cancer patients with deleterious BRCA mutation (germline and/or somatic) (Press release, Clovis Oncology, FEB 21, 2018, View Source;p=RssLanding&cat=news&id=2333860 [SID1234524094]). The indication under consideration by the Committee for Medicinal Products for Human Use (CHMP) focuses on a subset of platinum-sensitive disease where there is particular unmet medical need.

Following a Scientific Advisory Group (SAG) – Oncology last week and an oral explanation this week, the European Union’s (EU) European Medicines Agency (EMA) CHMP has communicated a positive trend vote for the rucaparib MAA and their intention to hold a final vote on the treatment indication at their March meeting (March 19-22, 2018).

"We are pleased with this positive trend vote and the potential for a formal positive vote on the later-line treatment indication next month, especially for a patient population with a significant unmet clinical need," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "This potential approval also paves the way to a rapid review and potential CHMP vote for the maintenance indication by year-end in an earlier-line and all-comers population for women with advanced ovarian cancer."

The CHMP application for the treatment indication currently under review was submitted during the fourth quarter of 2016 and was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. Patients received rucaparib orally 600 mg twice daily as monotherapy until disease progression or unacceptable toxicity. Objective response rate (ORR) and duration of response (DOR) were assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The most common Grade 3/4 adverse event was anemia.

Pending an approval for the treatment indication, Clovis plans to submit a variation to the MA based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied. ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) BRCA-mutant (BRCAmut+); 2) HRD-positive (HRD+) inclusive of BRCA-mutant; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3. The variation to the MA will be directed at the broader intent-to-treat or "all comers" population.

Clovis announced positive topline results from the ARIEL3 clinical trial in June 2017. The comprehensive dataset from the trial was presented at the 2017 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Conference in Madrid, Spain,i and subsequently published in The Lancet.ii

In the event of a negative vote next month by the CHMP, Clovis is prepared to submit a new MAA for the maintenance indication.

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2017, the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for rucaparib for a second line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data. The FDA granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for rucaparib. Rucaparib is an unlicensed medical product in the EU.

Nippon Kayaku Initiates Phase 2 Study of NK105 in Breast Cancer

On February 21, 2018 Nippon Kayaku Co., Ltd. (Head Office: Tokyo, President: Masanobu Suzuki, "Nippon Kayaku") reported the initiation of a phase 2 clinical study of NK105 in breast cancer (Press release, Nippon Kayaku, FEB 21, 2018, View Source;sid=40697&code=4272 [SID1234524075]).

This study is a randomized trial comparing the same dosage of weekly administration of NK105 versus paclitaxel in terms of efficacy and safety in patients with advanced or recurrent breast cancer.

With the goal of early launch of this product, we expect to make an even greater contribution to cancer patients, their families and medical professionals.

About NK105
NK105 is a novel DDS (Drug Delivery System) formulation encapsulating active ingredient paclitaxel in macromolecular micelles.

Merck and Viralytics Announce Acquisition Agreement, Expanding Merck’s Leading Immuno-Oncology Pipeline

On February 21, 2018 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Viralytics Limited (ASX: VLA, OTC: VRACY) reported that the companies have signed a definitive agreement under which it is proposed that Merck, through a subsidiary, will acquire Viralytics, an Australian publicly traded company focused on oncolytic immunotherapy treatments for a range of cancers by way of a scheme of arrangement (Scheme) for AUD 1.75 cash per Viralytics share (Press release, Merck & Co, FEB 21, 2018, View Source [SID1234524074]). The proposed acquisition values the total issued shares in Viralytics at approximately AUD 502 million (USD 394 million). The cash consideration of AUD 1.75 per share represents a premium of 160% to the one month volume weighted average price (VWAP) of Viralytics shares.

On completion of the transaction, Viralytics will become a wholly-owned subsidiary of Merck, and Merck will gain full rights to CAVATAK (CVA21), Viralytics’s investigational oncolytic immunotherapy. CAVATAK is based on Viralytics’s proprietary formulation of an oncolytic virus (Coxsackievirus Type A21) that has been shown to preferentially infect and kill cancer cells.

CAVATAK is currently being evaluated in multiple Phase 1 and Phase 2 clinical trials, both as an intratumoral and intravenous agent, including in combination with Merck’s KEYTRUDA (pembrolizumab), an anti-PD-1 therapy. Under an agreement between Viralytics and a subsidiary of Merck, announced in November 2015, a study is investigating the use of the CAVATAK and KEYTRUDA combination in melanoma, prostate, lung and bladder cancers.

"Viralytics’s approach of engaging the innate immune system to target and kill cancer cells complements our immuno-oncology strategy, which is focused on the rapid advancement of innovative monotherapy approaches and synergistic combinations to help the broadest range of cancer patients," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "We are eager to further build on Viralytics’s science as we continue our efforts to harness the immune system to improve long-term disease control and survival outcomes for people with cancer."

"This proposed acquisition culminates years of dedicated work by the Viralytics team and represents an opportunity for significant value creation for our shareholders. Viralytics is proud to have progressed its lead investigational candidate CAVATAK to Phase 1 and Phase 2 clinical trials and, we believe that Merck, the leader in immuno-oncology, is best suited to advance CAVATAK for the benefit of patients globally, and to realize its potential," said Dr. Malcolm McColl, managing director and chief executive officer, Viralytics.

The board of directors of Viralytics unanimously recommends that its company’s shareholders vote in favor of the Scheme, subject to there being no superior proposal and an independent expert concluding that the Scheme is in the best interest of the company’s shareholders. It is the intention of Viralytics’s directors to vote all the shares of Viralytics held or controlled by them in favor of the Scheme, subject to those same qualifications. Merck and Viralytics anticipate the transaction will be implemented by the second quarter of 2018. Implementation of the transaction is subject to a Viralytics’s shareholder vote and customary regulatory approvals.

Viralytics’s largest shareholder, Lepu Medical Group, which currently holds voting power in 13 percent of the Viralytics’s shares, has informed Viralytics that it intends to vote the shares it holds at the time of the Scheme meeting in favor of the Scheme, in the absence of a superior proposal and subject to the Viralytics directors maintaining their recommendation to vote in favor of the Scheme.

Chairman of Lepu Medical Group, Dr. Pu stated, "Lepu Medical Group acknowledges this is an attractive opportunity for Viralytics and, as such, is supportive of the transaction. In line with its existing strategy, Lepu Medical Group intends to continue to focus on developing immuno-oncology therapies, including in collaboration with companies globally."

Transaction Terms and Implementation Process

The Scheme proposes that Merck acquires 100 percent of the issued shares in Viralytics. Implementation of the Scheme will be subject to customary conditions, including Viralytics shareholder approval, court approval, regulatory approval, an independent expert concluding, and continuing to conclude, that the Scheme is in the best interest of shareholders, and no material adverse change or prescribed event occurring.

More information on the Scheme and conditions is provided in a copy of the scheme implementation agreement which has been appended to this announcement. The agreement also contains exclusivity provisions that are customary in Australia, including "no shop", "no talk" and "no due diligence" provisions, a break fee, as well as a notification obligation and matching right. The "no talk", "no due diligence" and notification obligation provisions are subject to the directors’ fiduciary obligations.

A scheme booklet is expected to be dispatched to Viralytics shareholders in April 2018. The scheme booklet will contain information relating to the Scheme, the independent expert’s report on whether the Scheme is in the best interests of Viralytics shareholders, the reasons for the directors’ unanimous recommendation and details of the Scheme meeting and other matters relevant to Viralytics shareholders’ vote on the Scheme.

Indicative timetable

A number of expected key dates relevant to the proposed acquisition have been outlined below.

Key milestones Date (AEDT)
Announcement of the proposed acquisition

February 21, 2018

First court hearing April 23, 2018
Scheme booklet dispatched to Viralytics shareholders April 27, 2018
Viralytics shareholder meeting to approve the scheme May 28, 2018
Final court hearing June 4, 2018
Implementation date June 20, 2018

Advisors

Credit Suisse Securities (USA) LLC is serving as financial advisor to Merck, and Baker & McKenzie is serving as Merck’s legal counsel. Lazard is serving as financial advisor and McCullough Robertson is serving as legal counsel to Viralytics.

About CAVATAK

Viralytics is developing oncolytic immunotherapy treatments for a range of cancers. The company’s lead investigational product, CAVATAK, is currently being studied in clinical trials for the treatment of melanoma, as well as bladder and lung cancers. CAVATAK is a proprietary formulation of the Coxsackievirus Type A21 (CVA21) that preferentially binds to specific ‘receptor’ proteins highly expressed on multiple cancer types. CAVATAK acts to kill both local and metastatic cancer cells through cell lysis and the potential generation of an immune response against the cancer cells – a two-pronged mechanism of action known as oncolytic immunotherapy.

About Viralytics Limited

Viralytics is focused on the development and commercialization of oncolytic immunotherapies that harness the power of specific viruses to preferentially infect and kill cancer cells. Based in Sydney Australia, the company is listed on the Australian Securities Exchange (ASX: VLA) while Viralytics’s ADRs also trade under VRACY on the US OTCQX International market. For more information, please visit www.viralytics.com.

Merck’s Focus on Cancer

Merck’s goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.

As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the fastest-growing development programs in the industry. We are currently executing an expansive research program evaluating our anti-PD-1 therapy across more than 30 tumor types. We also continue to strengthen our immuno-oncology portfolio through strategic acquisitions and are prioritizing the development of several promising immunotherapeutic candidates with the potential to improve the treatment of advanced cancers.

For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.