On January 7, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that it will be present at the following investor events in the first quarter 2019 (Press release, Innate Pharma, JAN 7, 2019, View Source [SID1234532549]):

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– LifeSci Advisors 1×1 Meetings surrounding the J.P. Morgan Annual Healthcare Conference– San Francisco, January 7-10, 2019

– Oddo BHF Forum – Lyon, January 10-11, 2019

– Degroof Petercam’s Healthcare Seminar – Brussels, January 31, 2019

– Leerink Partners Annual Global Healthcare Conference – NYC, February 27 – March 1, 2019

– Credit Suisse Global Healthcare Conference – London, March 5-6, 2019

– Oppenheimer Annual Healthcare Conference – NYC, March 19-20, 2019

Innate Pharma is committed to meet on a regular basis with the financial community. All corporate information on the Company, such as its financial statements or its corporate presentations, is available on the Company’s websitein the Investors’ section (www.innate-pharma.com/en/investors).

On January 7, 2019 Takeda Pharmaceutical Company Limited (TOKYO:4502) (NYSE:TAK) ("Takeda") reported the completion of its acquisition of Shire plc ("Shire"), becoming a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan (Press release, Takeda, JAN 7, 2019, View Source [SID1234532548]).

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Takeda now has an attractive, expanded geographic footprint and leading position in Japan and the U.S., bringing its highly-innovative medicines to approximately 80 countries/regions with dedicated employees worldwide. Takeda’s R&D efforts are focused on its four therapeutic areas of Oncology, Gastroenterology (GI), Neuroscience and Rare Diseases, with targeted R&D investment also committed to Plasma-Derived Therapies (PDT) and Vaccines. Takeda’s strengthened, highly innovative R&D engine enables the company to have a more global, robust and modality-diverse pipeline as well as to focus on breakthrough innovation. The combined annual revenue of the company, exceeding $30 billion USD, is mainly derived from the key business areas of Oncology, GI, Neuroscience, Rare Diseases and PDT.

"We are delighted that the acquisition was approved by an overwhelming majority of our shareholders at Takeda’s extraordinary general meeting on December 5th, 2018. We are also pleased to have completed the acquisition several months earlier than expected, which was enabled through the hard work of our respective organizations and the smooth receipt of regulatory clearances," said Christophe Weber, President and Chief Executive Officer of Takeda. "We appreciate the support of our employees, partners and shareholders throughout the process. This marks a significant moment in Takeda’s history and is an exciting step forward as we accelerate our transformation journey to deliver highly-innovative medicines to patients around the world with expanded scale and geographical footprint."

Weber continued, "The execution of our integration begins today, and we are confident in our ability to execute a smooth integration under the leadership of our experienced and diverse Takeda Executive Team with a strong track record. The Operating Model we established in September last year has set a clear framework for our integration plans, and we have a highly skilled and dedicated integration team leading the process."

In order to fund the acquisition, Takeda has secured permanent financing with highly competitive rates, resulting in an overall blended interest rate for Takeda’s total debt of approximately 2.3%. The company is confident that it will retain its investment grade credit rating and return to a net debt to EBITDA ratio of 2.0x or less within three to five years following completion.

Weber will present at the J.P. Morgan Healthcare Conference at 3:30 p.m. PST on January 8, 2019.

On January 7, 2019 Forbius, a clinical-stage company developing biologics for the treatment of cancer and fibrosis, reported that the first patient was dosed in a Phase 1 clinical trial with AVID200 (Press release, Forbius, JAN 7, 2019, View Source [SID1234532547]). The trial will evaluate safety, pharmacokinetics, pharmacodynamics, and antitumor effects of escalating doses of AVID200 in patients with solid tumors.

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"Our goal is to significantly expand the number of cancer patients who benefit from checkpoint blockade and other immunotherapies. AVID200 was designed to have the potency and isoform selectivity to effectively counteract the highly immunosuppressive effects of TGF-beta in the tumor microenvironment and reverse resistance to immunotherapy," commented Dr. Maureen O’Connor-McCourt, CSO of Forbius.

AVID200 selectively neutralizes TGF-beta 1 & 3 with best-in-class pM potency, thus neutralizing the principal immunosuppressive TGF-beta isoforms. AVID200’s optimal selectivity was also designed to circumvent cardiac and other safety issues that have limited the applicability of older-generation, non-selective TGF-beta inhibitors.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to immunotherapeutics such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

AVID200’s immuno-oncology mode of action focuses on the reversal of both immunosuppression and fibrosis in the tumor stroma. In syngeneic mouse tumor models, AVID200 treatment led to T-cell activation, increased immune cell infiltration, and increased efficacy of immune checkpoint agents.

On January 7, 2019 McKesson Corporation (NYSE:MCK) reported that it will release financial results for its third fiscal quarter ended December 31, 2018 on Thursday, January 31, 2019, following the market close at approximately 4:00 PM Eastern Time (1:00 PM Pacific Time) (Press release, McKesson, JAN 7, 2019, View Source [SID1234532546]). The company has scheduled a conference call for 5:00 PM Eastern Time (2:00 PM Pacific Time), during which John Hammergren, chairman and chief executive officer, Brian Tyler, president and chief operating officer, and Britt Vitalone, executive vice president and chief financial officer, will review these results.

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The dial-in number for individuals wishing to participate on the call is 323-794-2588. Craig Mercer, senior vice president, Investor Relations is the leader of the call and the password is ‘McKesson’. The conference call will also be available live and archived on the company’s Investor Relations website at View Source

On January 7, 2019 Novocure (NASDAQ: NVCR) reported operating statistics and preliminary, unaudited net revenues and cash balances for the fourth quarter and full year 2018 (Press release, NovoCure, JAN 7, 2019, View Source [SID1234532545]). Novocure plans to discuss these results with investors at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco. The company also highlighted anticipated clinical and regulatory milestones, announced national reimbursement in Sweden and confirmed a Contractor Advisory Committee (CAC) meeting date set by the durable medical equipment (DME) Medicare Administrative Contractors (MACs).

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Novocure announces fourth quarter and full year 2018 operating statistics, preliminary net revenues and provides company update

(1) An "active patient" is a patient who is on Optune under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(2) A "prescription received" is a commercial order for Optune that is received from a physician certified to treat patients with Optune for a patient not previously on Optune. Orders to renew or extend treatment are not included in this total.

(3) The preliminary, unaudited results described in this press release are estimates only and are subject to revision until the company reports its full financial results for the fourth quarter 2018 on Feb. 28, 2019.

"We continued to drive Optune adoption in the fourth quarter with full year 2018 preliminary net revenues of $248.0 million, representing annual growth of more than 40 percent. Prescriptions for patients with newly diagnosed GBM grew to approximately 950 in the fourth quarter, driving our 16th consecutive quarter of active patient growth since the initial presentation of our EF-14 data," said William Doyle, Novocure’s Executive Chairman. "Notably, we also expanded our geographic reach with national reimbursement in Sweden and Zai Lab’s recent launch of Optune in Hong Kong."

"At Novocure, we are working to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy," continued Mr. Doyle. "With an application at the FDA for mesothelioma and ongoing or planned phase 3 pivotal trials in brain metastases, non-small cell lung cancer, pancreatic cancer and ovarian cancer, we believe GBM represents just the tip of the iceberg for Tumor Treating Fields. We look forward to providing a full company update and discussing our 2018 financial results on our February conference call."

Fourth quarter 2018 operating statistics and preliminary financial highlights

There were 2,383 active patients on Optune at December 31, 2018, representing 30 percent growth compared to December 31, 2017, and 6 percent growth compared to September 30, 2018.

In the United States, there were 1,637 active patients on Optune at December 31, 2018, representing 24 percent growth compared to December 31, 2017.
In Germany and other EMEA markets, there were 654 active patients on Optune at December 31, 2018, representing 28 percent growth compared to December 31, 2017.
In Japan, there were 92 active patients on Optune at December 31, 2018, representing 4,500 percent growth compared to December 31, 2017.
Additionally, 1,315 prescriptions were received in the quarter ended December 31, 2018, representing 21 percent growth compared to the same period in 2017, and 6 percent growth compared to the quarter ended September 30, 2018. Prescriptions for newly diagnosed GBM continued to grow, with approximately 950 Optune prescriptions in the fourth quarter written for patients with newly diagnosed GBM.

In the United States, 941 prescriptions were received in the quarter ended December 31, 2018, representing 16 percent growth compared to the same period in 2017.
In Germany and other EMEA markets, 322 prescriptions were received in the quarter ended December 31, 2018, representing 15 percent growth compared to the same period in 2017.
In Japan, 52 prescriptions were received in the quarter ended December 31, 2018, representing 5,100 percent growth compared to the same period in 2017.
On a preliminary, unaudited basis, for the quarter ended December 31, 2018, net revenues were $69.6 million, representing 30 percent growth compared to the fourth quarter 2017, and full year 2018 net revenues were $248.0 million, representing annual growth of more than 40 percent compared to 2017.

At December 31, 2018, on a preliminary, unaudited basis, Novocure had $140.6 million in cash and cash equivalents and $105.3 million in short-term investments, for a total balance of $245.9 million in cash, cash equivalents and short-term investments. This represents an increase of $18.2 million in cash and investments since September 30, 2018.

Anticipated clinical and regulatory milestones

FDA approval for unresectable malignant pleural mesothelioma (2019)
Initiation of phase 3 pivotal trial in recurrent ovarian cancer (2019)
Zai Labs initiation of phase 2 pilot trial in gastric cancer (2019)
Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (2020)
Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (2020)
Data from phase 3 pivotal METIS trial in brain metastases (2021)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2022)
Novocure has received initial comments from the FDA on its October 2018 Humanitarian Device Exemption (HDE) application for approval in malignant pleural mesothelioma and is currently preparing its response.

Other company updates

Novocure announced today that it has finalized a pricing and reimbursement agreement for Optune in Sweden. Reimbursement decisions in Sweden are supported by a comprehensive health technology assessment. With defined reimbursement now established in Sweden, Novocure’s efforts will turn to building adoption.

Novocure also announced today that the DME MACs will host a CAC meeting on March 6, 2019. The CAC meeting is intended to provide a formal mechanism for healthcare professionals to be informed of and participate in the development of the local coverage determination (LCD) for Optune for the treatment of newly diagnosed GBM. Following the CAC meeting, the DME MACs will draft and publish a proposed LCD for public comment.

Fourth quarter and full year 2018 financial results conference call

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2018 financial results on Thursday, Feb. 28, 2019 at 8 a.m. EDT. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 3956899.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call.