Johnson & Johnson Announces completion of Offer for Ci:z Holdings Co., Ltd.

On January 11, 2019 Johnson & Johnson (NYSE: JNJ) reported that the conditions to its public tender offer for all of the outstanding shares of Ci:z Holdings Co., Ltd. (TYO: 4924) (the "Company") not already held by Johnson & Johnson or its affiliates that was previously announced on October 23, 2018, have been satisfied and the offering period for the tender offer has expired (Press release, Johnson & Johnson, JAN 11, 2019, View Source;johnson-announces-completion-of-offer-for-ciz-holdings-co-ltd-300776682.html [SID1234532626]).

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There were 20,004,934 shares of the Company tendered in the tender offer, representing 41% of the outstanding shares of the Company. Johnson & Johnson will acquire all tendered shares for ¥5,900 per share and will purchase additional shares of the Company through the acquisition of CIC Corporation ("CIC"), the ownership vehicle of the Company’s founder, Dr. Yoshinori Shirono. As of the expiration of the offering period, the shares tendered in the tender offer, together with shares already held by Johnson & Johnson or its affiliates and the shares to be acquired through the acquisition of CIC, will give Johnson & Johnson an aggregate ownership interest in the Company of 89%. The settlement of the tender offer and the acquisition of CIC will be completed by January 17, 2019. Following settlement of the tender offer and the acquisition of CIC, Johnson & Johnson plans to acquire the remaining shares of the Company that were not tendered in the tender offer through a share consolidation under Japanese law during the first half of 2019 and take appropriate actions to delist the Company from the Tokyo Stock Exchange.

Additional information on the tender offer and settlement procedures is available to the Company’s shareholders in the tender offer registration statement for the transaction filed on EDINET in Japan. Copies of an English translation of the tender offer explanatory statement, which includes all the information described in the tender offer registration statement, may be obtained by contacting Johnson & Johnson’s tender offer agent, SMBC Nikko (IBG_M&[email protected]).

Dr. Reddy’s to Release Q3 FY19 Results on February 1, 2019

On January 11, 2019 Dr. Reddy’s Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it will announce results for the quarter ended December 31, 2018 on Friday, February 1, 2019 after the Board Meeting (Press release, Dr Reddy’s, JAN 11, 2019, View Source [SID1234532623]).

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Summary of Events


Event


Date and Time


Medium

Release of financial results


February 1st, after the Board Meeting


Email, Media, Company website, Business wire

Press meet presentation


Will be available on the Company’s website


URL available on Company’s website, www.drreddys.com

Earnings Call


February 1st, 6:30 PM IST / 8:00 AM EST


Hosted by the Company

(Details below)

Playback of Earnings Call


After the earnings call till February 7th


Details below

Transcript of the Earnings call


Will be available on the Company’s website


URL available on Company’s website, www.drreddys.com


Earnings Call

Following the release, the management of the Company will host an earnings call to discuss the Company’s financial performance. (Dial In and other details given below)

Play Back

The play back will be available after the earnings call, through February 7th, 2019. For play back dial in phone No: 022 7194 5757 / 022 6663 5757, and Playback Code is 37176.

Conference Dial-In Numbers

Universal Access Number:


+91 22 6280 1219

+91 22 7115 8120

Local Access Number:

Available all over India


+91 70456 71221

International Toll Free Number:


USA: 1 866 746 2133

UK: 0 808 101 1573

Singapore: 800 101 2045

Hong Kong: 800 964 448


No password/pin number is necessary to dial in to any of the above numbers. The operator will provide instructions on asking questions before and during the call.

Puma Biotechnology and Knight Therapeutics Enter into Exclusive License Agreement to Commercialize NERLYNX® (neratinib) in Canada

On January 11, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that it has entered into an exclusive License Agreement with Knight Therapeutics Inc. (TSX: GUD) that grants Knight the exclusive right to commercialize NERLYNX (neratinib) in Canada (Press release, Puma Biotechnology, JAN 11, 2019, https://investor.pumabiotechnology.com/press-release/puma-biotechnology-and-knight-therapeutics-enter-exclusive-license-agreement-commercia [SID1234532621]).

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Puma Biotechnology filed a new drug submission for NERLYNX with Health Canada in July 2018 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. Under the terms of the License Agreement, Knight will be responsible for all commercial activities and future regulatory submissions for NERLYNX in Canada. Puma will receive upfront and milestone payments up to $7.2 million USD throughout the term of this agreement, as well as double digit royalties on net sales of NERLYNX in Canada.

"Our new agreement with Knight demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "We are confident this new partnership will help patients in Canada access NERLYNX at the earliest opportunity."

"We are excited to partner with Puma to offer a new treatment option to Canadian breast cancer patients," said Jonathan Ross Goodman, Chief Executive Officer of Knight. "While adjuvant trastuzumab-based therapy has been shown to reduce the risk of recurrence in early stage HER2-positive breast cancer, up to 25% of patients treated with adjuvant trastuzumab will have a recurrence. NERLYNX has been shown to significantly reduce the risk of recurrence in those patients who were previously treated with trastuzumab."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

EMMAC Life Sciences PLC: Research Collaboration with Imperial College London

On January 10, 2019 EMMAC, the European independent medical cannabis company, is reported a research collaboration with Imperial College London to deliver a long-term comprehensive research programme designed to inform and shape the future of the medical cannabis therapeutic industry (Press release, EMMAC Life Sciences, JAN 10, 2019, View Source [SID1234554039]). The programme aims to investigate mechanisms of action of cannabis-based medicinal products related to several clinical applications including pain and cancer, as well as characterise cannabis-based medicinal products in disease models with particular focus of chronic pain, spasticity and cancer.

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The initial clinical study, which is currently going through regulatory approval processes, is a feasibility randomised controlled trial of patients undergoing major hepatopancreatobiliary surgery evaluating the efficacy of perioperative cannabinoids on pain, nausea and vomiting. The first stage, conducted with the Imperial Clinical Trials Unit (ICTU) and involving comprehensive patient and public involvement activities, is estimated to be completed by March 2019.

Under the terms of the Collaboration Agreement signed between the parties EMMAC will fund research staff for an extendable 3-year period to explore the basic science opportunities uncovered through clinical trials.

Strategic Highlights

Collaboration Agreement with Imperial College London;
EMMAC to fund research staff for an extendable 3-year period to explore the basic science opportunities uncovered through clinical trials;
Research provides valuable data and intellectual property in relation to the use of cannabinoids to treat acute pain, nausea and vomiting;
EMMAC expected to partner with Imperial on additional cannabinoid research programmes focused across different therapeutic areas;
Partnership with world-renowned institution confirms EMMAC as a European leader in research supporting the growing medical cannabis industry.
Professor Nagy Habib, Professor of Hepatobiliary Surgery at Imperial College London, said: "We are delighted to partner with EMMAC Life Sciences and to collaborate on this exciting research programme. Translational research lies at the heart of our academic aims at Imperial College London and our first collaborative project illustrates the potential scope of cannabinoids to improve the quality of life and outcomes of patients undergoing surgery. As we gain a greater understanding of the therapeutic properties for a range of clinical conditions, this research will inform a portfolio of basic science work packages. This project is therefore the first step of a broad research programme aimed at shaping the global future of medicinal cannabinoid therapeutics."

Antonio Costanzo, CEO of EMMAC, commented: "The strategic partnership with Imperial College London puts EMMAC at the very forefront of research in the UK into the medical benefits of cannabis in relation to pain relief. As an industry, all participants must recognise that significant further research is needed to improve the understanding of the medical benefits of cannabis, with basic science and much greater clinical data under-pinning what we consider to be a huge potential market with enormous public health benefits (for patients and clinicians). We are delighted to partner with Imperial in relation to this important work. Imperial is one of the leading research institutions for science and medicine globally and we are delighted they have chosen EMMAC as their partner as they begin their work in this field. The expectation is that the research partnership with Imperial will be extended throughout Europe, with Imperial working with leading European institutions as the clinical trials commence."

Press Release – Black Diamond Therapeutics Closes $85 Million Series B Financing

On January 10, 2019 Black Diamond Therapeutics, Inc., a biotechnology company developing next-generation precision medicines for cancer, reported the completion of an oversubscribed Series B financing of $85 million co-led by New Enterprise Associates and RA Capital Management (Press release, Black Diamond Therapeutics, JAN 10, 2019, View Source [SID1234532915]). Additional new investors NexTech Invest, The Invus Group and Perceptive Advisors joined founding investor Versant Ventures in the round. Following Black Diamond’s recent debut after operating in stealth mode in Versant’s Basel-based Ridgeline Discovery Engine, the company now has raised $105 million.

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Proceeds from the financing will be used to accelerate the development of Black Diamond’s pipeline and to expand its mutation, allostery and pharmacology (MAP) computational and discovery platform for identifying and targeting allosteric oncogenic mutations. Specifically, the round will allow the company to establish its new corporate headquarters in Cambridge, MA, advance two-to-three existing development candidates into the clinic in the next 24 months, and bolster its platform’s ability to rapidly identify precision medicines for mutant cancers intractable to standard care.

"We are pleased to have such strong support from this syndicate of blue-chip investors who recognize our potential to discover and produce transformative therapies that will help millions of people with cancer based on our unique and powerful MAP platform," said David Epstein, Ph.D., president and CEO of Black Diamond. "We are now well-resourced to advance our lead programs and set the course for clinical success."

In connection with the Series B round, NEA’s Ali Behbahani, M.D., and RA Capital’s Rajeev Shah joined Black Diamond’s Board of Directors. They join existing board members Dr. Epstein and Versant’s Brad Bolzon, Ph.D., and Alex Mayweg, Ph.D.

"Black Diamond has tremendous potential to usher in the next step-change in targeted cancer therapies, and this investment represents a chance to build a new type of precision medicine oncology company," said Dr. Behbahani.

Mr. Shah added, "The approach that Black Diamond is taking offers the potential to reshape and extend the pipeline of precision oncology medicines available to oncology patients, and we see a great growth opportunity here."

Black Diamond’s MAP platform has generated a pipeline of five programs, including three that have progressed compounds through lead optimization or into IND-enabling studies. The fourth and fifth programs are in lead identification. Black Diamond’s first two disclosed programs are targeting groups of EGFR and HER2 allosteric mutants.

Black Diamond’s MAP: a unique platform

Black Diamond’s industry-leading MAP platform identifies and drugs allosteric mutant disease targets. Oncogenes are activated by kinase domain mutations or by allosteric mutations. While kinase domain mutations have been successfully drugged with selective inhibitors and are standard of care in many malignancies, allosteric mutations represent an undrugged and unexplored space.

As genomic profiling and sequencing of cancer patients is becoming standard, Black Diamond’s MAP can pinpoint new druggable mutation baskets from the thousands of lesions identified across genes and patients, and can create high-impact precision medicines. Some of the allosteric mutation baskets represent two-to-15 percent of patients in a given tumor tissue or across tumor sites.