On February 11, 2020 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that its Chief Executive Officer and President, Patrick J. Mahaffy, will present at the 9th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 26, 2020 at 10:30 a.m. Eastern Standard Time (Press release, Clovis Oncology, FEB 11, 2020, View Source [SID1234554157]). The conference will be held at the Lotte New York Palace in New York City.

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A live webcast of the presentation and Q&A session can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

On February 11, 2020 Biodesix, Inc. reported initiation of the next phase of their biomarker development program with Merck KGaA, Darmstadt, Germany and Pfizer Inc., New York, NY (Press release, Biodesix, FEB 11, 2020, View Source [SID1234554175]). The companies have completed initial discovery and development of a new proteomic test that identifies likely responders to the anti-PD-L1 checkpoint inhibitor (BAVENCIO) (avelumab). Development efforts will now focus on transferring the test into Biodesix’s CLIA lab in Boulder, CO for clinical phase test validation. The new test was developed through retrospective analysis of the circulating proteome of cancer patients treated with the investigational drug candidate, utilizing the proprietary Biodesix Diagnostic Cortex artificial intelligence (AI) platform. Data from the initial test discovery and development program will be presented at an upcoming scientific meeting in 2020.

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The Diagnostic Cortex platform is based on modern AI techniques to design clinically useful tests that are reproducible and robust, and typically use hundreds of different markers. Based on data found in the circulating proteome and genome, Biodesix designs tests that support treatment decisions including patient selection for immunotherapies, novel therapy combinations, and alternative treatment pathways.

"We are pleased to announce this next phase in our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer with the potential to extend treatment options to more patients. This relationship combines Biodesix’s strengths in test discovery and development, artificial intelligence, and their applications to immunotherapy, with the pharmaceutical leadership of Merck KGaA, Darmstadt, Germany and Pfizer," said Scott Hutton, Biodesix CEO. "The successful progression of this project is another example of how our proprietary Diagnostic Cortex AI-based biomarker platform is uniquely suited to advancing clinical research and investigating new indications for existing therapies."

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US, EU, Japan and other countries for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with mMCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased.

On February 11, 2020 Medivir AB (Nasdaq Stockholm: MVIR) reported investors, analysts and the media to an R&D Day in Stockholm, Monday March 2, 2020, at 14:00 to 16:30 CET (Press release, Medivir, FEB 11, 2020, View Source [SID1234554191]).

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The presentations will, among other things, address new clinical results from the phase Ia study with MIV-818 in liver cancer patients. Members of Medivir’s management team and Professor Jeff Evans, Director of the Institute of Cancer Sciences at the University of Glasgow, will give presentations.

The meeting will be held at Helio GT30, Grev Turegatan 30 in Stockholm, on March 2 at 14:00 to 16:30 CET.

To register now, send an e-mail to: [email protected]

A formal invitation with a full program will be sent out and be available on www.medivir.se.

Warm welcome!

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer.

On February 10, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders, reported that the underwriters of the Company’s initial public offering (the "IPO") have exercised in part their over-allotment option to purchase an additional 768,350 American Depositary Shares ("ADSs") of the Company at the IPO price of US$14.00 per ADS (Press release, I-Mab Biopharma, FEB 10, 2020, View Source [SID1234554085]). Each ten (10) ADSs represent twenty-three (23) ordinary shares of the Company.

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After giving effect to the exercise of the over-allotment option, I-Mab has issued and sold a total of 8,175,750 ADSs in the IPO, for total gross proceeds of US$114,460,500.

Jefferies LLC and China International Capital Corporation Hong Kong Securities Limited acted as joint book-runners. China Renaissance Securities (Hong Kong) and Huatai Securities (USA) acted as lead managers for the offering.

A registration statement related to the offering has been filed with the U.S. Securities and Exchange Commission (the "SEC") was declared effective on January 16, 2020. The offering is made only by means of a prospectus forming a part of the effective registration statement. Copies of the final prospectus relating to this offering , when available, may be obtained from (i) Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388 or by email at [email protected] or (ii) China International Capital Corporation Hong Kong Securities Limited, Attn: Rita Li, 29th One International Finance Center, One Harbour View Street, Central, Hong Kong, by telephone at (852) 2872-2000 or by e-mail at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 10, 2020 McKesson Corporation (NYSE:MCK) reported the commencement of an exchange offer for the split-off of its wholly-owned subsidiary, PF2 SpinCo, Inc. ("SpinCo"), which will hold all of McKesson’s interest in Change Healthcare LLC ("Change Healthcare"), as part of McKesson’s previously announced agreement with Change Healthcare Inc. (Nasdaq:CHNG) ("Change") to merge SpinCo with and into Change (Press release, McKesson, FEB 10, 2020, View Source [SID1234554103]).

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"We are very pleased to launch the split-off of our investment in Change Healthcare. We have concluded that now is the appropriate time to distribute our remaining stake in Change Healthcare," said Brian Tyler, chief executive officer, McKesson. "We expect this exchange offer will continue to deliver value to McKesson shareholders by reducing our number of outstanding shares in a tax-efficient manner. This transaction better positions McKesson to focus on our core business and signifies another important step in McKesson’s transformation to become a simpler, more focused organization."

The exchange offer represents the next step in McKesson’s planned exit from its investment in Change Healthcare, which will be effected through a "Reverse Morris Trust" transaction. In the exchange offer, McKesson stockholders will have the opportunity to exchange their shares of McKesson common stock for shares of SpinCo common stock, which will be immediately converted into an equal number of shares of Change common stock upon completion of the proposed merger, in each case subject to certain customary terms and conditions. The exchange offer and merger are generally expected to be tax-free to participating McKesson stockholders for U.S. federal income tax purposes except to the extent of any cash received in lieu of fractional shares of Change common stock.

Details of the Exchange Offer:

Holders of McKesson common stock will have the opportunity to exchange some or all of their shares for SpinCo common stock at a 7.0% discount per-share value, subject to an upper limit (as described below).
The discount means that tendering stockholders are expected to receive approximately $107.53 of SpinCo common stock for every $100 of McKesson common stock tendered and accepted in the exchange offer.
The number of shares a McKesson stockholder can receive in the exchange offer is subject to an upper limit of 11.4086 shares of SpinCo common stock for each share of McKesson common stock tendered and accepted in the exchange offer.
If the upper limit is in effect, then the exchange ratio will be fixed at that limit and tendering stockholders will receive less than $107.53 of SpinCo stock for each $100 of McKesson common stock.
McKesson will offer 175,995,192 shares of SpinCo common stock in the exchange offer. The number of shares of McKesson common stock that will be accepted in the exchange offer will depend on the final exchange ratio, the number of shares of McKesson common stock tendered and whether the upper limit is in effect.
SpinCo common stock will not be transferred to participating stockholders following the exchange offer. Such participants will instead receive shares of Change common stock in the merger immediately following the completion of the exchange offer. No trading market currently exists or will exist for shares of SpinCo common stock.
The exchange offer is scheduled to expire at 11:59 p.m., New York City time, on March 9, 2020, unless the exchange offer is extended or terminated.
Holders of McKesson common stock may withdraw their tendered shares at any time before the expiration date of the exchange offer.
Participants in the McKesson Corporation 401(k) Retirement Savings Plan (the "McKesson 401(k) Plan") will receive special directions from the plan administrator of the McKesson 401(k) Plan and to allow sufficient time for the tender of shares by the trustee of the McKesson 401(k) Plan, plan participants must provide the requisite instructions as directed by 4:00 p.m., New York City time, on March 3, 2020, unless the exchange offer is extended or terminated.
Subject to the upper limit, the final exchange ratio used to determine the number of shares of SpinCo common stock that participating stockholders will receive for each share of McKesson common stock accepted in the exchange offer will be calculated by McKesson by reference to the simple arithmetic average of the daily volume–weighted average prices, on each of the three Valuation Dates (as defined below), of McKesson common stock and Change common stock on the New York Stock Exchange and The Nasdaq Global Select Market, respectively, during a period of three consecutive trading days (the "Valuation Dates") ending on and including the second trading day preceding the expiration date of the exchange offer. Based on an expiration date of March 9, 2020, the Valuation Dates are expected to be March 3, March 4 and March 5, 2020. Unless the exchange offer is extended or terminated, the final exchange ratio will be announced in a press release no later than 11:59 p.m., New York City time, on March 5, 2020, and the exchange offer will expire at 11:59 p.m., New York City time, on March 9, 2020, leaving two trading days between the date that the final exchange ratio is announced and the expiration of the exchange offer.

The final exchange ratio, as well as a daily indicative exchange ratio beginning at the end of the third day of the exchange offer period, will also be available at www.dfking.com/McKesson.

Immediately following the completion of the exchange offer, SpinCo will merge with and into Change, whereby the separate corporate existence of SpinCo will cease and Change will continue as the surviving company. In the merger, each share of SpinCo common stock will be converted into one share of Change common stock. Change will issue 175,995,192 shares of Change common stock in the merger.

The exchange offer will be subject to proration if the exchange offer is oversubscribed, and the number of shares accepted in the exchange offer may be fewer than the number of shares tendered.

If the exchange offer is consummated but not fully subscribed, or if the upper limit is in effect and not all of the shares of SpinCo common stock owned by McKesson are distributed pursuant to the exchange offer, the remaining shares of SpinCo common stock owned by McKesson will be distributed in a spin-off on a pro rata basis to McKesson stockholders whose McKesson common stock remains outstanding after the consummation of the exchange offer.

The transaction is subject to customary closing conditions, including required regulatory approvals. Change’s board of directors previously approved the Merger and the Merger Agreement prior to the execution of the Merger Agreement on December 20, 2016. On January 17, 2017, the stockholders of Change approved the Merger, the Merger Agreement and the transactions contemplated thereby.

Upon completion of the merger, approximately 51 percent of the outstanding shares of Change common stock are expected to be held by pre-merger holders of McKesson common stock, and approximately 49 percent of the outstanding shares of Change common stock are expected to be held by pre-merger holders of Change common stock.

The terms and conditions of the exchange offer are more fully described in a registration statement on Form S-4 and Form S-1, including a prospectus forming a part thereof, filed by SpinCo with the U.S. Securities and Exchange Commission (the "SEC") today and a tender offer statement on Schedule TO filed by McKesson with the SEC today.

For more information about the exchange offer, please visit www.dfking.com/McKesson or contact the information agent, D.F. King & Co., at 1-866-304-5477 (toll-free in the United States) and 1-212-269-5550 (outside of the United States).

In connection with the transactions, Goldman Sachs & Co. LLC is acting as financial advisor and Davis Polk & Wardwell LLP is acting as legal advisor to McKesson.