Statement re Proposal from Takeda Pharmaceutical Company Limited (“Takeda”)

Shire notes the announcement made by Takeda and confirms it has received a fourth proposal on 20 April 2018 regarding a possible offer for the Company (the "Fourth Proposal") (Press release, Shire, APR 20, 2018, View Source [SID1234525816]).

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The Fourth Proposal comprises £26 per share in new Takeda shares, to be listed in Japan and in the US through an ADR listing, and £21 per share in cash, representing a potential value of £47 per share and approximately £44 billion for the total issued and to be issued share capital of the Company. Based on Takeda’s current market capitalisation, Shire shareholders would own approximately 49 per cent. of the enlarged Takeda.

The Board of Shire is considering its position with respect to the Fourth Proposal and will issue a further announcement in due course.

This announcement is made without the consent of Takeda.

Person responsible

Stephen Williams, Deputy Company Secretary, is responsible for arranging the release of this announcement on behalf of the Company.

Publication on a website

In accordance with Rule 26.1 of the Code, a copy of this announcement will be made available, subject to certain restrictions relating to persons resident in restricted jurisdictions, on Shire’s website at www.shire.com by no later than noon (London time) on the business day following this announcement. The content of this website is not incorporated into and does not form part of this announcement.

Further information

This announcement is not intended to, and does not, constitute or form part of any offer, invitation or the solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of, any securities whether pursuant to this announcement or otherwise.

The distribution of this announcement in jurisdictions outside the United Kingdom may be restricted by law and therefore persons into whose possession this announcement comes should inform themselves about, and observe, such restrictions. Any failure to comply with the restrictions may constitute a violation of the securities law of any such jurisdiction.

Citigroup Global Markets Limited, which is authorised by the Prudential Regulation Authority and regulated in the UK by the Financial Conduct Authority and the Prudential Regulation Authority in the United Kingdom, is acting for Shire and no one else in connection with the matters described in this announcement and shall not be responsible to anyone other than Shire for providing the protections afforded to clients of Citigroup Global Markets Limited, or for giving advice in connection with the matters described in this announcement or any matter referred to therein.

Goldman Sachs International, which is authorised by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and the Prudential Regulation Authority in the United Kingdom, is acting for Shire and no one else in connection with the matters described in this announcement and will not be responsible to anyone other than Shire for providing the protections afforded to clients of Goldman Sachs International, or for giving advice in connection with the matters described in this announcement or any matter referred to herein.

Morgan Stanley & Co. International plc, which is authorised by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and the Prudential Regulation Authority in the United Kingdom, is acting for Shire and no one else in connection with the matters described in this announcement and will not be responsible to anyone other than Shire for providing the protections afforded to clients of Morgan Stanley & Co. International plc, or for giving advice in connection with the matters described in this announcement or any matter referred to herein.

Disclosure requirements of the Code

Under Rule 8.3(a) of the Code, any person who is interested in 1% or more of any class of relevant securities of an offeree company or of any securities exchange offeror (being any offeror other than an offeror in respect of which it has been announced that its offer is, or is likely to be, solely in cash) must make an Opening Position Disclosure following the commencement of the offer period and, if later, following the announcement in which any securities exchange offeror is first identified. An Opening Position Disclosure must contain details of the person’s interests and short positions in, and rights to subscribe for, any relevant securities of each of (i) the offeree company and (ii) any securities exchange offeror(s). An Opening Position Disclosure by a person to whom Rule 8.3(a) applies must be made by no later than 3.30 pm (London time) on the 10th business day following the commencement of the offer period and, if appropriate, by no later than 3.30 pm (London time) on the 10th business day following the announcement in which any securities exchange offeror is first identified. Relevant persons who deal in the relevant securities of the offeree company or of a securities exchange offeror prior to the deadline for making an Opening Position Disclosure must instead make a Dealing Disclosure.

Under Rule 8.3(b) of the Code, any person who is, or becomes, interested in 1% or more of any class of relevant securities of the offeree company or of any securities exchange offeror must make a Dealing Disclosure if the person deals in any relevant securities of the offeree company or of any securities exchange offeror. A Dealing Disclosure must contain details of the dealing concerned and of the person’s interests and short positions in, and rights to subscribe for, any relevant securities of each of (i) the offeree company and (ii) any securities exchange offeror(s), save to the extent that these details have previously been disclosed under Rule 8. A Dealing Disclosure by a person to whom Rule 8.3(b) applies must be made by no later than 3.30 pm (London time) on the business day following the date of the relevant dealing.

If two or more persons act together pursuant to an agreement or understanding, whether formal or informal, to acquire or control an interest in relevant securities of an offeree company or a securities exchange offeror, they will be deemed to be a single person for the purpose of Rule 8.3.

Opening Position Disclosures must also be made by the offeree company and by any offeror and Dealing Disclosures must also be made by the offeree company, by any offeror and by any persons acting in concert with any of them (see Rules 8.1, 8.2 and 8.4).

Details of the offeree and offeror companies in respect of whose relevant securities Opening Position Disclosures and Dealing Disclosures must be made can be found in the Disclosure Table on the Takeover Panel’s website at www.thetakeoverpanel.org.uk, including details of the number of relevant securities in issue, when the offer period commenced and when any offeror was first identified. You should contact the Panel’s Market Surveillance Unit on +44 (0)20 7638 0129 if you are in any doubt as to whether you are required to make an Opening Position Disclosure or a Dealing Disclosure.

Atreca Announces John A. Orwin Appointed President and CEO Atreca Co-Founder Dr. Tito A. Serafini Will Serve as Chief Strategy Officer Lead Anti-Cancer Candidate Slated to Enter Clinical Testing in 2019

On April 19, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that John A. Orwin, formerly CEO of Relypsa, has been appointed President and Chief Executive Officer of Atreca (Press release, Atreca, APR 19, 2018, View Source [SID1234525531]). He will also serve on the Company’s Board of Directors. Mr. Orwin replaces Atreca co-founder Dr. Tito A. Serafini in this role. Dr. Serafini will assume the newly created position of Chief Strategy Officer, responsible directly for research, preclinical development, technology, and intellectual property. Dr. Serafini also will remain on Atreca’s Board of Directors.

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"John Orwin is a seasoned leader with a very strong track record in scaling up clinical-stage companies. He brings core capabilities that will complement Tito’s vision and his ability to drive Atreca’s innovative science and the development and application of its broadly enabling technology platform," stated Brian Atwood, Atreca’s Chairman, and Founder and former President and CEO of Cell Design Labs. "We believe their combined talents and expertise will be highly synergistic, further differentiating the Company from others in the space and accelerating Atreca’s progress."

Mr. Atwood continued, "During Tito’s tenure leading Atreca, the Company went from early concept through the buildout of its Immune Repertoire Capture (IRC) technology, the creation of a discovery engine generating multiple scientific discoveries and a large collection of preclinical assets, and the rapid advancement of a lead candidate, with an anticipated IND filing in mid-2019. We are proud of the corporate culture of excellence Tito established, attracting a fantastic team and leading life sciences institutional investors, and for the considerable accomplishments achieved under his leadership."

"I am enthusiastically committed to Atreca, a company that I believe can both continue to transform the way new therapies are discovered and ultimately deliver life-changing treatment options to patients in need," said Dr. Serafini. "John’s joining the Company as CEO will have a profoundly positive impact on Atreca, given his successful track record scaling R&D companies, building out their clinical development organizations, manufacturing capabilities, and commercial and G&A functions. This is a very exciting time for Atreca, and I am thrilled with the Company’s prospects for continued and accelerated growth."

Mr. Orwin brings over 25 years of diverse experience in the biotechnology and pharmaceutical industries, having held senior positions at leading pharmaceutical and biotechnology companies, including Johnson & Johnson, Affymax, Rhône-Poulenc Rorer, Genentech, and most recently Relypsa. During Mr. Orwin’s tenure at Relypsa, the company launched and commercialized its lead candidate, Patiromer (US brand name Veltassa), and was acquired by Galenica (Vifor Pharma) in a transaction worth over $1.5 billion. Prior to Relypsa, he served as Chief Executive Officer and a member of the Board of Directors of Affymax. Previously, Mr. Orwin was Senior Vice President of the BioOncology Business Unit at Genentech (now a member of the Roche Group), where he was responsible for all marketing, sales, business unit operations and pipeline brand management for Genentech’s oncology portfolio in the United States. He has also held senior marketing and sales positions at Johnson & Johnson, Alza Pharmaceuticals, Sangstat Medical Corporation, Rhône-Poulenc Rorer Pharmaceuticals and Schering-Plough Corporation. Mr. Orwin received an M.B.A. from New York University and a B.A. from Rutgers University.

"Under the collective vision of Tito and his team, Atreca has become the first mover in discovering and advancing candidates based on its unique approach of understanding the active adaptive immune response at the single cell level in patients," commented Mr. Orwin. "The Company has differentiated itself through its foundational technology, its discovery engine, its strategy for advancing candidates, and in terms of productivity, having generated a library of nearly 1,000 antibodies targeting public tumor antigens. I look forward to contributing to the next chapters of the Company’s evolution, including preparations to bring the first candidates into clinical development in 2019 and 2020."

Onconova Presents Data on Dual Inhibitor of CDK4/6 + ARK5 at American Association for Cancer Research 2018 Annual Meeting

On April 19, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported an advance in pre-clinical development and the presentation of new data for investigational ON 123300, a novel dual inhibitor of CDK4/6 + ARK 5 with potential application across a variety of cancers (Press release, Onconova, APR 19, 2018, View Source [SID1234525549]).

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CDK inhibitors have emerged as promising and potentially targeted large market cancer therapies. ON 123300 has the potential to overcome many of the limitations of current generation CDK4/6 inhibitors. Onconova believes that ON 123300 may act as a single agent, due to the unique targeting of ARK5, as well as CDK 4 and 6, making it potentially suitable for indications that may not be responsive to the current generation of CDK4/6 inhibitors.

Onconova and HanX Biopharmaceuticals, the Company’s Greater China collaboration partner for ON 123300, recently completed the pre-Investigational New Drug (pre-IND) consultation with the U.S. Food and Drug Administration (FDA). These discussions provided guidance for the manufacturing of ON 123300 and the pre-clinical development plan for the submission of an IND application.

The data from preclinical studies demonstrates that there is a differential metabolism of ON 123300 in male versus female rodents. As a result, the drug exposure is almost 2-3 fold higher in female rats. Based upon preclinical animal liver microsome studies, this differential effect appears to be limited to rodents, and is not observed in preclinical studies with human liver microsomes. Based on the metabolism data from other species, relevant species have been selected along with the dosing strategy to be implemented in GLP toxicological studies to be conducted by HanX. As a part of the pre-clinical development program, Onconova and HanX announced a collaborative program in December 2017, wherein the remaining IND enabling studies will be funded by and conducted by HanX.

Onconova previously reported that ON 123300 was found to be as active as Palbociclib (Pfizer’s Ibrance) in a preclinical Rb + ve xenograft model. Moreover, the molecule may have the potential advantage of reduced neutropenia when compared to Palbociclib based upon this model.

Ramesh Kumar, President and CEO of Onconova, commented, "At the end of March, we received pre-IND guidance from the FDA, which provides a path towards filing an IND and then starting clinical trials. Our partner, HanX, has initiated GMP manufacturing and will be initiating GLP pre-clinical studies based on the guidance provided by the FDA, and we look forward to advancing ON 123300 into clinical development."

Faming Zhang, Ph.D., founder and Chairman of HanX, commented, "We are pleased to have completed the process chemistry and have initiated GMP manufacturing for ON 123300. GLP toxicology studies are planned and we will be undertaking additional preclinical studies to enhance the profile of this novel compound. In collaboration with Onconova, our goal is to simultaneously file the IND in the USA and China, as soon as possible. Once an IND is in place, HanX plans to initiate Phase 1 studies in China and also participate in more advanced global clinical trials."

A copy of the presentation is available by visiting the Scientific Presentations section of Onconova’s website.

Emergent BioSolutions to Release First Quarter 2018 Financial Results and Conduct a Conference Call on May 3, 2018

On April 19, 2018 Emergent BioSolutions Inc. (NYSE:EBS) reported that it will host a conference call on Thursday, May 3, 2018 at 5:00 pm (Eastern Time) to discuss the financial results for the first quarter of 2018, recent business developments, revenue guidance for the second quarter of 2018, and revenue and net income guidance for full year 2018 (Press release, Emergent BioSolutions, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343377 [SID1234525532]).

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This conference call can be accessed live by telephone or by webcast:

Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 93329114

Live Webcast Information:
Visit View Source for the live webcast feed.

A replay of the call can be accessed on Emergent’s website emergentbiosolutions.com under "Investors."

TESARO to Announce First-Quarter 2018 Financial Results on May 3, 2018

On April 19, 2018 TESARO, Inc. (NASDAQ:TSRO) reported that it will announce first-quarter 2018 financial results on Thursday, May 3, 2018, after the close of the U.S. financial markets (Press release, TESARO, APR 19, 2018, View Source [SID1234525550]). TESARO’s senior management team will host a conference call and live audio webcast at 4:15 p.m. ET on May 3, 2018 to discuss the Company’s operating results for the quarter in greater detail, as well as the status of its development programs.

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This quarterly earnings call will be available via phone and webcast. The conference call dial-in information is listed below. To access the webcast, please log on to the TESARO website at www.tesarobio.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

TESARO will host a conference call and live audio webcast to discuss its first-quarter financial results.

WHEN: Thursday, May 3, 2018 at 4:15 p.m. ET
LIVE DOMESTIC & CANADA CALL-IN: (877) 853-5334
LIVE INTERNATIONAL CALL-IN: (970) 315-0307
THIS CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.tesarobio.com

A replay will be available for 30 days at www.tesarobio.com.