On April 19,2018 Novartis reported the appointment of John Tsai, M.D. as Head of Global Drug Development (GDD) and Chief Medical Officer (Press release, Novartis, APR 19, 2018, View Source [SID1234525524]). Dr. Tsai will join Novartis on May 1, 2018, and will be based in Basel, Switzerland. He will report to Vas Narasimhan, M.D., CEO of Novartis and will become a member of the Executive Committee of Novartis (ECN). He succeeds Dr. Narasimhan who became CEO of Novartis on February 1, 2018. Dr. Rob Kowalski, who led GDD ad interim since February 1, 2018, will resume his responsibilities as Head of Global Regulatory Affairs for GDD.

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Dr. Tsai has been Chief Medical Officer and Senior Vice President of Global Medical at Amgen Inc., since May 2017 and oversees all clinical and medical functions across multiple sites worldwide. At Novartis, he will be responsible for advancing the company’s industry-leading pipeline of innovative medicines and biosimilars. Dr. Tsai will also lead the GDD organization’s ongoing transformation embracing the power of advanced data sciences and digital technologies to create a more agile model for drug development.

"I am delighted to welcome John to Novartis," said Dr. Narasimhan. "As we continue to reimagine drug development, his expertise across multiple therapeutic areas, including cardiovascular, oncology and neuroscience combined with his background in electrical engineering will be a source of great strength for Novartis. John has a great track record in nurturing talent across clinical development, medical affairs and development operations and shares our commitment to build an empowered and inspired organization. I also want to express my sincere gratitude to Rob Kowalski for his excellent ad interim leadership of the GDD organization."

Dr. Tsai said: "I feel honored to have the opportunity to lead the Novartis Global Drug Development organization and do my part in bringing forward the company’s strong pipeline of medicines that address some of humanity’s biggest health challenges. I am also excited to work with my colleagues at Novartis to pioneer novel paradigms for drug development with data and digital technologies at the core."

Prior to joining Amgen, Dr. Tsai spent eleven years with Bristol-Myers Squibb (BMS), where he served as Global Head of Clinical Development for marketed products and global clinical operations. He also played a leadership role in advancing the company’s late-stage pipeline across multiple therapeutic areas including cardiovascular, oncology and neuroscience. As the company’s Chief Medical Officer, Europe and prior to that, as Head of U.S. Medical and Vice President of Cardiovascular Medical, Dr.Tsai played a critical role in driving multiple transformation initiatives within the development and medical organizations. Before joining BMS, he was a cardiovascular group leader at Pfizer where he led the strategy development and execution of over 26 pivotal trials for a major cardiovascular medicine. He started his career at GE as an electrical engineer before returning to school to study medicine.

Dr. Tsai holds a medical degree from the University of Louisville School of Medicine and a Bachelor of Science in Electrical Engineering from Washington University in St. Louis. He completed his residency at Kaiser Permanente in San Francisco, California, where he then served as a physician in internal medicine, Chief Resident and as a member of the hospital’s faculty.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "will," "pipeline," "ongoing," "to create," "continue," "commitment," "opportunity," "excited," "to pioneer," or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products express or regarding potential future sales or earnings of the Novartis Group. You should not place undue reliance on these statements. Such forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Nor can there be any guarantee Novartis will be commercially successful in the future, or achieve any particular financial results. In particular, our expectations could be affected by, among other things: regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the significant reorganizations of recent years may not be realized or may take longer to realize than expected; the uncertainties inherent in the research and development of new healthcare products; our ability to obtain or maintain proprietary intellectual property protection on key products; safety, quality or manufacturing issues; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; uncertainties regarding actual or potential legal proceedings; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

On April 19, 2018 The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) in tumors with epidermal growth factor receptor (EGFR) mutations (Press release, BioSpace, APR 19, 2018, View Source [SID1234525545]).

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The mutations, exon 19 deletions or exon 21 L858R mutations, will be detected by an FDA-approved test. The decision was based on data form the Phase III FLAURA clinical trial. Results were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress and published in the New England Journal of Medicine.

The FLAURA trial compared Tagrisso to current first-line EGFR tyrosine kinase inhibitors, erlotinib or gefitinib, in patients who had not received previous treatment for locally-advanced or metastatic EGFR-mutation NSCLC. It met the primary endpoint of progression-free survival, and were consistent across all pre-specified patient subgroups.

Patients receiving Tagrisso had about 18.9 months on average before the disease got worse compared to 10.2 months for patients receiving traditional treatments.

Tagrisso is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against central nervous system cancers. It has been approved in the U.S. and Brazil for first-line EGFRm advanced NSCLC, and in more than 75 countries, including the U.S., Europe, Japan and China, for patients with EGFR T790M mutation-positive advanced NSCLC. It is also being evaluated as an adjuvant and in combination with other treatments.

It has also been approved in the U.S. for second-line treatment of patients with metastatic EGFRm NSCLC, whose disease has on or after a first-line EGFR-TKI round of therapy and who have developed the secondary T790 mutation. The drug received both Breakthrough Therapy and Priority Review designations from the FDA in 2017 for the first-line setting.

"Today’s FDA approval of Tagrisso in the first-line setting is an exciting milestone for patients and our company," said Dave Fredrickson, executive vice president, Head of the Oncology Business Unit at AstraZeneca, in a statement. "Tagrisso delivered unprecedented median progression-free survival data across all pre-specified patient subgroups, including patients with or without CNS metastases, and could prolong the lives of more patients without their tumors growing or spreading."

The drug is being evaluated in Europe and Japan as a first-line treatment, with regulatory decisions expected in the second half of this year. AstraZeneca has projected that Tagrisso could, at its peak, bring in $4 billion per year.

Lung cancer accounts for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined. It is the leading cause of cancer death for both men and women. About 10 to 15 percent of patients in the U.S. and Europe and about 30 to 40 percent in Asia, have EGFRm NSCLC. They are especially sensitive to EGFR-TKI treatments, but those cancers typically develop resistance to that treatment, leading to disease progression.

"The approval of osimertinib in the first-line setting represents a major advance in the treatment of patients with EGFR mutations and a significant change in the treatment paradigm," stated Suresh Ramalingam, principal investigator of the FLRUA trial, a researcher with the Winship Cancer Institute of Emory University in Atlanta. "Osimertinib provides robust improvements in progression-free survival with no unexpected safety signals compared to the previous generation of EGFR inhibitors."

On April 19, 2018 Oasmia reported that the Private Placement has enabled Oasmia to place 26 new convertible instruments with a limited group of investors at a nominal value of SEK 1,000,000 per convertible instrument through an accelerated book building procedure (Press release, Oasmia, APR 19, 2018, View Source [SID1234556570]).

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The convertible loan is issued with the purpose of replacing the Company’s financing under the Company’s convertible loan 2017:2 in the total amount of MSEK 26, which fell due for payment 18 April 2018. The fallen due loan amount under the Company’s convertible loan 2017:2 will be paid to the convertible loan holders in May 2018 and the fallen due interest was paid in April 2018.

In order to enable the placement, the Board of Directors of Oasmia has, by virtue of the authorisation granted by the Annual General Meeting held on 25 September, 2017, resolved on a directed issue of a new convertible loan in the amount of SEK 26,000,000. The convertible instruments have been subscribed at 100 per cent of the nominal amount and the convertible loan bear an interest rate of 8 per cent per year. The conversion rate is based on the closing price of Oasmia’s shares on Nasdaq Stockholm on 18 April 2018 with premium and will amount to SEK 4.90. The term of the loan is approximately one year with a maturity date on 22 April 2019 if not converted to shares earlier. The terms of the convertible instruments are based on an accelerated book building procedure on 18 April 2018 and the Board of Directors has thereby ensured that the terms of the convertible instruments corresponds to fair market standards.

If the convertible loan is fully converted into shares, the number of shares in Oasmia increases by 5,306,122 from 176,406,372 to 181,712,494 and the share capital increases by SEK 530,612.20 from SEK 17,640,637.20 to SEK 18,171,249.40. In the event of a full conversion into shares, the dilution effect will amount to approximately 2.9 per cent.

Shire notes the announcement made by Takeda (Press release, Shire, APR 19, 2018, View Source [SID1234525813]). The Board of Shire (the "Board") confirms that it has received three conditional proposals from Takeda regarding a possible offer for the Company, on 29 March 2018 (the "First Proposal"), 11 April 2018 (the "Second Proposal") and 13 April 2018 (the "Third Proposal").

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The First Proposal comprised £28 per share in new Takeda shares, to be listed in Japan and in the US through an ADR listing, and £16 per share in cash, representing a potential value of £44 per share and approximately £41 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 50 per cent. of the enlarged Takeda.

Following a thorough review of the First Proposal with its advisers and a Board meeting on 8 April 2018, the Board unanimously rejected the First Proposal, concluding that it significantly undervalued the Company, its growth prospects and pipeline.

The Board has since received two further proposals:

·the Second Proposal comprised £28.75 per share in new Takeda shares, to be listed in Japan and in the US through an ADR listing, and £16.75 per share in cash, representing a potential value of £45.50 per share, only a marginal increase to the First Proposal, and approximately £43 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 51 per cent. of the enlarged Takeda; and

·the Third Proposal also comprised £28.75 per share in new Takeda shares, to be listed in Japan and in the US through an ADR listing, and £17.75 per share in cash, representing a potential value of £46.50 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 51 per cent. of the enlarged Takeda.

The Board met again and thoroughly considered the Third Proposal with its advisers and unanimously rejected it, concluding that it continues to significantly undervalue the Company and Shire’s growth prospects and pipeline.

Following the Board meeting on 14 April 2018 which rejected the Third Proposal, at the Board’s request Shire’s advisers entered into a dialogue with Takeda’s advisers to discuss whether a further, more attractive, proposal may be forthcoming and to understand the basis on which such a proposal would be made.

The Board and management of Shire remain committed to enhancing shareholder value and are focused on fully evaluating internal and external opportunities to maximise value for shareholders, including any further proposals from 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.

The use of artificial intelligence and machine learning in drug development has been ramping up and investors are taking keen notice of the growing trend (Press release, BioSpace, APR 19, 2018, View Source [SID1234525546]). This morning London-based BenevolentAI snagged $115 million to give it a total of about $200 million in its coffers.

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BenevolentAI, which is applying artificial intelligence to develop new medicines for hard to treat diseases, said it will use the funds from the financing round to advance its artificial intelligence driven drug development programs. The company also said it will use the financing to broaden the disease areas on which it focuses, and extend its AI platform capabilities even further. Some of the proceeds from the financing round will be used to explore other science-based industries, including agriculture and energy storage, the company said.

Following the latest financing, BenevolentAI said it has a pre-money valuation of $2 billion.

BenevolentAI has 20 drug programs in its pipeline. Currently, BenevolentAI is using its platform to develop treatments for a wide range of unmet patient needs in various areas including Motor Neuron Disease, Parkinson’s disease, Glioblastoma and Sarcopenia.

The latest funding round, which was primarily supported by investors from the United States, is one of the largest in the AI pharmaceutical sector, the company said this morning. The $115 million the company gathered dwarfs the $15 million secured by the China-based AI startup XtalPi Inc. earlier this year.

Kevin Mulaney, founder and chairman of BenevolentAI, said the financial support the company received in its latest fundraising effort reflects the "rapidly growing global interest in the AI pharmaceutical sector" and the company’s position in that field.

"We have come a very long way since we founded the business in 2013. The capabilities of our technology didn’t exist six years ago. We are pioneering this sector and have evolved into a fully integrated, AI enabled drug development company with the ability to deliver better medicines at previously unimaginable speeds – this ultimately means patients will receive the right medicines, at a lower cost, in less time," Mulaney said in a statement.

The U.K. company said its drug-development portfolio shows that its AI platform can cut early-stage drug discovery by four years. Additionally, BenevolentAI said it can potentially deliver efficiencies in the entire drug development process of 60 percent against pharmaceutical industry averages – "significantly disrupting an industry that spends $180 billion a year on R&D."

The company boldly said its artificial intelligence program can "outperform human scientists" in understanding the cause of a disease and is also capable of "quickly generating drug candidates at scale."

"The technology is also able to decipher the molecular process of disease and link these disease signatures within patients to ensure that the best drug candidate is given to the best patient responders – the ‘right drugs in the right patients’," the company said on its website.

The use of artificial intelligence in drug development is becoming more and more common. In July 2017 pharma giant GlaxoSmithKline forged a $43 million deal with AI company Exscientia to spur drug development. GSK said it will be using AI to discover novel and selective small molecules for up to 10 disease-related targets across multiple therapeutic areas. Also in July 2017 the Mayo Clinic and nference launched a startup company called Qrativ that is focused on drug development that will be powered by clinical expertise and artificial intelligence. Innovator Elon Musk launched the biotech company Neuralink that has the lofty goal of linking the human brain with a computer.