Pfizer Completes Acquisition of Anacor

On June 24, 2016 Pfizer Inc. (NYSE:PFE) reported that it has completed its acquisition of Anacor Pharmaceuticals, Inc (Press release, Pfizer, JUN 24, 2016, View Source [SID:1234513545]). Under the terms of the transaction, each outstanding share of Anacor common stock has been converted into the right to receive $99.25 net in cash (without interest but subject to required withholding of taxes).

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"Now that Anacor is part of Pfizer, we can accelerate our shared commitment to help patients with inflammatory disease, an area of high unmet medical need," said Albert Bourla, Group President, Pfizer Innovative Health. "We believe that Pfizer is in a position to quickly capitalize on the benefits offered by the combination with Anacor, including the potential for a near-term U.S. product launch and subsequent commercialization of crisaborole, a differentiated asset with compelling clinical data. If approved, crisaborole has the potential to be an important first-line treatment option for patients with mild-to-moderate atopic dermatitis and the physicians who treat them."

The transaction is not expected to impact Pfizer’s current 2016 adjusted financial guidance. Pfizer continues to expect the transaction to be slightly dilutive to Adjusted Diluted Earnings Per Share (EPS)(1) in 2017 with accretion to Adjusted Diluted EPS(1) beginning in 2018 and increasing thereafter.

The Offer

The tender offer for all of the outstanding shares of Anacor common stock expired as scheduled immediately after 11:59 p.m., New York City time, on June 23, 2016. Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Pfizer that 39,306,909 shares of Anacor common stock were validly tendered into and not validly withdrawn from the tender offer, including 4,300,427 shares tendered by notice of guaranteed delivery for which certificates were not yet delivered, representing approximately 86.1% of the outstanding shares. All of the conditions to the offer have been satisfied and on June 24, 2016, Pfizer and its subsidiary Quattro Merger Sub Inc. accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.

Following its acceptance of the tendered shares, Pfizer completed its acquisition of Anacor through the merger of Quattro Merger Sub Inc. with and into Anacor without a vote of Anacor’s stockholders pursuant to Section 251(h) of the Delaware General Corporation Law. As a result of the merger, Anacor became a wholly-owned subsidiary of Pfizer. In connection with the merger, all Anacor shares not validly tendered into the tender offer (other than treasury shares held by Anacor and any shares owned by Pfizer, Quattro Merger Sub Inc. or any person who was entitled to and has properly demanded statutory appraisal of his or her shares) have been cancelled and converted into the right to receive the same $99.25 per share net in cash (without interest but subject to required withholding of taxes) as will be paid for all shares that were validly tendered and not validly withdrawn in the tender offer. Anacor common stock will cease to be traded on the NASDAQ Global Market.

Takeda Revises Collaboration Agreement with Amgen, Returning the Development and Commercialization Rights of Molecules / Products for Japan

On June 24, 2016 Takeda Pharmaceutical Company Limited (TSE: 4502) reported revisions on an existing collaboration agreement, under which Takeda had rights to develop and commercialize multiple molecules / products from Amgen’s pipeline for the Japanese market (Press release, Takeda, JUN 24, 2016, View Source [SID:1234513534]). By the revisions, such rights for molecules / products including AMG403 and AMG386 will be returned to Amgen, effective immediately.

Takeda and Amgen will continue to collaborate on the development and commercialization of remaining molecules / products for the Japanese market, including Vectibix (panitumumab), a leading treatment for unresectable advanced or recurrent colorectal cancer.

“Through our work with Amgen, we have successfully delivered Vectibix to the Japanese patients facing a challenging diagnosis while continuing to build our scientific understanding of novel treatment pathways,” said Phil Rowlands, Interim Head, Oncology Therapeutic Area Unit, Takeda. “We look forward to continuing our scientific discovery and to building a portfolio of innovative medicines through our ongoing collaboration with Amgen.”

Takeda will work with Amgen to ensure a smooth transition of these molecules / products, and will cooperate with Amgen to ensure patients who receives study drug that include any of such molecules / products will receive appropriate therapies in Japan.

Takeda Revises Collaboration Agreement with Amgen, Returning the Development and Commercialization Rights of Molecules / Products for Japan

On June 24, 2016 Takeda Pharmaceutical Company Limited (TSE: 4502) reported revisions on an existing collaboration agreement, under which Takeda had rights to develop and commercialize multiple molecules / products from Amgen’s pipeline for the Japanese market (Press release, Takeda, JUN 24, 2016, View Source [SID:1234513534]). By the revisions, such rights for molecules / products including AMG403 and AMG386 will be returned to Amgen, effective immediately.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Takeda and Amgen will continue to collaborate on the development and commercialization of remaining molecules / products for the Japanese market, including Vectibix (panitumumab), a leading treatment for unresectable advanced or recurrent colorectal cancer.

"Through our work with Amgen, we have successfully delivered Vectibix to the Japanese patients facing a challenging diagnosis while continuing to build our scientific understanding of novel treatment pathways," said Phil Rowlands, Interim Head, Oncology Therapeutic Area Unit, Takeda. "We look forward to continuing our scientific discovery and to building a portfolio of innovative medicines through our ongoing collaboration with Amgen."

Takeda will work with Amgen to ensure a smooth transition of these molecules / products, and will cooperate with Amgen to ensure patients who receives study drug that include any of such molecules / products will receive appropriate therapies in Japan.

TESARO Announces Rolapitant Data Presentations at the 2016 MASCC/ISOO Annual Meeting on Supportive Care in Cancer

On June 23, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported nine presentations of rolapitant data at the 2016 MASCC/ISOO Annual Meeting on Supportive Care in Cancer, June 23 to 25, 2016, in Adelaide, Australia (Press release, TESARO, JUN 23, 2016, View Source [SID:1234513532]).

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"Delayed chemotherapy-induced nausea and vomiting can be a debilitating side effect of chemotherapy. At this year’s MASCC/ISOO Annual Meeting, which is the premier global event for supportive care in cancer, we are pleased that data will be presented that demonstrate the activity of rolapitant in patients at high risk for CINV, including those who are receiving cisplatin- and carboplatin-based chemotherapy for gynecologic and lung cancers," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "With our Marketing Authorisation Application (MAA) for oral rolapitant under review by the European Medicines Agency (EMA) and our New Drug Application (NDA) for intravenous rolapitant under review by the U.S. FDA, we look forward to globalizing our mission of improving the lives of people bravely facing cancer."

Please visit TESARO at Booth #3 for information about VARUBI (rolapitant) and our pipeline.

Presentation Details:

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer
Abstract: MASCC-0318, Poster Presentation, Thursday, June 23, 2016

Rolapitant for the prevention of nausea in patients receiving moderately or highly emetogenic chemotherapy
Abstract: MASCC-0322, Poster Presentation, Thursday, June 23, 2016

Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients aged <65 versus ≥65 years
Abstract: MASCC-0432, Poster Presentation, Thursday, June 23, 2016

Single ascending dose pharmacokinetics of rolapitant administered intravenously at supratherapeutic doses in healthy volunteers
Abstract: MASCC-0489, Poster Presentation, Thursday, June 23, 2016

Effects of rolapitant administered intravenously on the pharmacokinetics of cooperstown cocktail (midazolam [CYP3A4], omeprazole [CYP2C19], warfarin [CYP2C9], caffeine [CYP1A2], and dextromethorphan [CYP2D6]) in healthy volunteers
Abstract: MASCC-0492, Poster Presentation, Thursday, June 23, 2016

Effects of rolapitant administered intravenously on the pharmacokinetics of digoxin (P-gp) and sulfasalazine (BCRP) in healthy volunteers
Abstract: MASCC-0494, Poster Presentation, Thursday, June 23, 2016

A single-dose bioequivalence study of rolapitant following oral and intravenous administration in healthy volunteers
Abstract: MASCC-0485, Oral Poster Presentation, Friday, June 24, 2016 from 2:00 PM to 3:30 PM

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with lung cancer
Abstract: MASCC-0321, Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from 11:00 AM to 12:30 PM

Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer
Abstract: MASCC-0316, Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from 11:00 AM to 12:30 PM

About VARUBI (Rolapitant)
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full the U.S. prescribing information, including additional important safety information, available at www.varubirx.com.

An intravenous formulation of rolapitant is currently under review by the FDA, with a target action date under the Prescription Drug User Fee Act (PDUFA) of January 11, 2017. An MAA for oral rolapitant is currently under review by the EMA. TESARO licensed exclusive rights for the development, manufacture, commercialization, and distribution of VARUBI (rolapitant) from OPKO Health, Inc.

PharmaCyte Biotech Releases Medical and Scientific Discussion from 2016 ASCO Annual Meeting

On June 23, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the release of 5 video presentations that captured PharmaCyte’s medical and scientific discussion with oncologists interested in participating in PharmaCyte’s Phase 2b clinical trial in advanced, inoperable pancreatic cancer (Press release, PharmaCyte Biotech, JUN 23, 2016, View Source [SID:1234513531]). The discussion session was by invitation only during the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago.

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Portions of the session were videotaped, and the videos can be viewed at: www.PharmaCyte.com/Media

Commenting on the medical and scientific discussion, the company’s Chief Executive Officer, Kenneth L. Waggoner said, "On behalf of PharmaCyte, I would like to express our sincere appreciation to all who participated in this event, particularly those who traveled from Europe and Thailand to make presentations. Special thanks to those oncologists who sacrificed their time at the ASCO (Free ASCO Whitepaper) annual meeting to play such a major role. The discussion period led by Dr. Hidalgo was informative and stimulating. We believe it will prove to be of great value to PharmaCyte as we move forward with our preparations for the Phase 2b trial in patients with locally advanced pancreatic cancer."

In addition to senior management from PharmaCyte, participants in the meeting included Dr. Walter H. Günzburg, PharmaCyte’s Chief Scientific Officer, Dr. Brian Salmons, a member of PharmaCyte’s Medical and Scientific Advisory Board, Dr. Matthias Löhr, from the Karolinska Institute in Stockholm, Sweden and the Chairman of PharmaCyte’s Medical and Scientific Advisory Board, and Dr. Manuel Hidalgo from the Beth Israel Deaconess Medical Center in Boston and a member of PharmaCyte’s Medical and Scientific Advisory Board. Joining PharmaCyte at the discussion were Dr. Stephen Gately and a team from Translational Drug Development (TD2), Dr. Ronald L. Korn from Imaging Endpoints, and, most importantly, a number of leading clinical oncologists from cancer institutions in the United States and Europe.

The meeting began with an introductory slide presentation by Mr. Waggoner. This was followed by presentations from Dr. Günzburg and Dr. Salmons that covered the development of the Cell-in-a-Box technology and the properties of the capsules produced using PharmaCyte’s platform technology. Dr. Löhr, who served as the Principal Investigator for the previous 2 clinical trials using PharmaCyte’s pancreatic cancer therapy, presented the results of the previous Phase 1/2 and Phase 2 clinical trials. Dr. Hidalgo then covered the elements of the design of PharmaCyte’s upcoming Phase 2b clinical trial. Following these formal presentations, Dr. Hidalgo facilitated an hour-long discussion in which the invited oncologists discussed the proposed Phase 2b trial and ways to improve its design.