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.

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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.

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.

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

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.

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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.

On February 21, 2018 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the Company will host a webcast conference call to report its fourth quarter and year end 2017 financial results and provide an update on the company’s business and outlook on Tuesday, March 6, 2018 at 4:30 p.m. (ET) after closing of the market (Press release, PTC Therapeutics, FEB 21, 2018, View Source [SID1234524105]).

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The call can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 4299793. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for two weeks.

On February 21, 2018 Ophthotech Corporation (Nasdaq:OPHT) reported that it will report its fourth quarter and full year 2017 financial and operating results on Tuesday, February 27, 2018 (Press release, Ophthotech, FEB 21, 2018, View Source [SID1234524103]). Following the announcement, Ophthotech’s management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company’s financial results and provide a general business update.

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To participate in this conference call, dial 800-239-9838 (USA) or 323-794-2551 (International), passcode 9171013. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 9171013.