McKesson Corporation Announces Pricing and Upsizing of Tender Offer

On July 22, 2021 McKesson Corporation (NYSE: MCK) (the "Company") reported the determination of the Full Tender Offer Consideration, as shown in the table below, for its previously announced cash tender offer to purchase up to $500,000,000 aggregate principal amount (the "Offer") of its outstanding 6.00% Notes due 2041 (the "6.00% Notes"), 4.883% Notes due 2044 (the "4.883% Notes"), 7.65% Debentures due 2027 (the "7.65% Debentures"), 4.750% Notes due 2029 (the "4.750% Notes"), 3.950% Notes due 2028 (the "3.950% Notes"), 2.85% Notes due 2023 (the "2.85% Notes") and 3.796% Notes due 2024 (the "3.796% Notes" and together with the 6.00% Notes, the 4.883% Notes, the 7.65% Debentures, the 4.750% Notes, the 3.950% Notes and the 2.85% Notes, the "Notes", and each, a "series" of Notes) (Press release, McKesson, JUL 22, 2021, View Source [SID1234585108]). The Company also announced that it has increased the aggregate principal amount of the Notes it will purchase pursuant to the Offer from $500,000,000 to $922,154,000 (as increased, the "Tender Cap") in order to accept all of the Notes that were validly tendered and not validly withdrawn at or prior to the Early Tender Time (as defined below). Except as described in this press release, all other terms of the Offer as described in the Offer Documents (as defined below) remain unchanged.

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On July 8, 2021, the Company commenced the Offer in accordance with the terms and conditions set forth in the offer to purchase, dated July 8, 2021 (the "Offer to Purchase"), and the related letter of transmittal (the "Letter of Transmittal" and, together with the Offer to Purchase, the "Offer Documents"). Select terms of the Offer are described in the table below:

All Notes validly tendered and not validly withdrawn at or prior to the Early Tender Time will be accepted for purchase. Pursuant to the terms of the Offer, the amount of Notes that will be accepted for purchase is subject to the Tender Cap. Accordingly, because the Tender Cap has been reached in respect of tenders made at or prior to the Early Tender Time, no Notes of any series tendered after the Early Tender Time (regardless of acceptance priority level) will be accepted for purchase. As set forth in the Offer to Purchase, holders who validly tendered and did not validly withdraw their Notes at or prior to the Early Tender Time are eligible to receive the Full Tender Offer Consideration, which includes the Early Tender Payment. In addition, holders that validly tender Notes that are accepted for purchase by the Company will receive accrued and unpaid interest from, and including, the last interest payment date for their tendered Notes to, but not including, the settlement date for such Notes, in each case rounded to the nearest cent ("Accrued Interest").

The conditions to the Offer specified in the Offer to Purchase have been satisfied. Pursuant to the terms of the Offer, the Company has exercised its Early Settlement Right. Payment of the Full Tender Offer Consideration to holders of Notes that were accepted for purchase on the Early Acceptance Date is expected to be made on July 23, 2021 (the "Early Settlement Date").

The Withdrawal Deadline for the Offer was 5:00 p.m., New York City time, on July 21, 2021, and has not been extended for any series of Notes. The Offer will expire at 11:59 p.m., New York City time, on August 4, 2021, unless extended or earlier terminated by the Company, with respect to any or all series of Notes.

Capitalized terms used in this press release and not defined herein have the meanings given to them in the Offer to Purchase.

Barclays Capital Inc. and Citigroup Global Markets Inc. are acting as lead dealer managers for the Offer and Wells Fargo Securities, LLC is acting as co-dealer manager for the Offer. For additional information regarding the terms of the Offer, please contact: Barclays Capital Inc. toll-free at (212) 528-7581 or collect at (800) 438-3242 or Citigroup Global Markets Inc. toll-free at (800) 558-3745 or collect at (212) 723-6106. Requests for the Offer Documents may be directed to Global Bondholder Services Corporation, which is acting as the Tender Agent and Information Agent for the Offer, at (866)-924-2200 (toll-free) or by email at [email protected].

ANI Pharmaceuticals to Discuss Second Quarter 2021 Financial Results on August 6, 2021

On July 22, 2021 ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ: ANIP) reported that the Company will release its second quarter 2021 financial results on Friday, August 6, 2021 (Press release, ANI Pharmaceuticals, JUL 22, 2021, View Source [SID1234585107]).

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Nikhil Lalwani, President and Chief Executive Officer, and Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, will host a conference call to discuss the results as follows:

A replay of the conference call will be available within two hours of the call’s completion and will remain accessible for one-week by dialing 800-695-0974 and entering access code 5412658.

Illumina is Committed to Bringing Lifesaving GRAIL Test to People Globally as European Review Process Enters Second Phase

On July 22, 2021 Illumina, Inc. (NASDAQ: ILMN) reported its commitment to re-acquire GRAIL, a healthcare company focused on multi-cancer early detection (Press release, Illumina, JUL 22, 2021, View Source [SID1234585106]).

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"This acquisition is procompetitive, and we have offered far-reaching structural and behavioral remedies to address any potential concerns. Illumina will continue to work with the European Commission (EC) to ensure that it has the information and assurances necessary to approve this transaction. We look forward to presenting our position during the Phase II process," said Charles Dadswell, General Counsel for Illumina.

Illumina is also challenging the EC’s jurisdiction to investigate the transaction under Article 22 of the European Union (EU) Merger Regulation. The Commission reversed decades of merger policy in asserting jurisdiction under Article 22 of the EU Merger Regulation on April 19, 2021, seven months after the deal was announced. Illumina has filed an action in the General Court of the EU seeking annulment of the EC’s jurisdiction to review the acquisition.

"The Commission’s unprecedented decision to assert jurisdiction to review this transaction between two U.S.-based companies leaves businesses around the world uncertain as to how the EU Merger Regulation will be applied in the future," said Dadswell.

Illumina’s re-acquisition of GRAIL means that millions of citizens across the European Economic Area (EEA) will be able to access life-saving early cancer screening years sooner. "When people have access to early cancer detection, lives will be saved," said Francis deSouza, Chief Executive Officer of Illumina. "If this acquisition does not proceed, GRAIL’s European roll-out will be slower and the cost will be measured in the unnecessary loss of life. Re-uniting GRAIL with Illumina will accelerate availability of the GRAIL test by many years in the EEA and globally, saving tens of thousands of lives, and leading to significant health care cost savings."

TAE Life Sciences Identifies Proprietary Drug Candidates to Support Boron Neutron Capture Therapy (BNCT)

On July 22, 2021 TAE Life Sciences (TLS), a biological-targeting radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported that as part of its growing pipeline of investigational therapies, it has identified several proprietary drug candidates, including TC220 and TC221 (Press release, TAE Life Sciences, JUL 22, 2021, View Source [SID1234585105]).

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"TLS is the only company developing comprehensive, in-house target drugs as well as a neutron technology system called Alphabeam to enable the next-generation in biologically targeted radiation therapy. Today’s news brings us closer to our goal of providing new hope to patients with the most difficult to treat cancers," said Bruce Bauer, PhD, CEO of TAE Life Sciences. "Historically, brain, head and neck, and melanoma cancers have been treated with BNCT and studies have shown improvements in survival compared to other cancer therapies. New boron drugs expand the potential to treat other indications including breast, lung and liver cancers."

Most BNCT clinical studies to date have been carried out using boronophenylalanine (BPA) as the boron target drug. When neutron radiation is applied, the boron atoms react to generate alpha particles that destroy cancer cells. Healthy cells without the boron are spared, resulting in less normal tissue damage. This is a key difference compared to conventional radiation therapy. While historical BNCT clinical outcomes have been encouraging, the availability of better boron-10 drugs and access to an in-hospital neutron system will now provide more opportunities for clinical research and potential improved efficacy of this new cancer therapy.

TC220 and TC221 have similar targeting as BPA, but have several more favorable properties, including:

Delivers more boron selectively to tumor cells compared to BPA in pre-clinical studies.
Much greater solubility than BPA, potentially allowing for of easier administration and delivery of far more boron to tumor tissue. This could be key for improving clinical outcomes.
In pre-clinical studies, TC220 is retained longer in the tumor compared to BPA, making it possible to attain a greater tumor to normal tissue ratio for boron than possible with BPA. This should provide greater flexibility in treatment planning.
As demonstrated by early preclinical data, TC220 and TC221 have shown consistent superior delivery of boron in multiple human tumor xenografts compared with BPA, expanding their potential clinical application.
"It is very exciting to add these two new compounds to our rich pipeline of boron containing drugs and to nominate them as product candidates so quickly," said Kendall Morrison, PhD, Chief Scientific Officer of TAE Life Sciences. "Our early pre-clinical data has shown TC220 and TC221 to have excellent boron delivery properties. The next step will be to identify a contract manufacturer and evaluate the two compounds in stability, pharmacokinetic, toxicokinetic and pre-clinical efficacy studies."

About Biologically Targeted Radiation Therapy (BNCT)

BNCT is a non-invasive, biologically targeted particle therapy that combines a non-toxic compound containing boron-10 and a low-energy, epithermal neutron beam. This combination generates a therapeutic dose at the cellular level that destroys tumor cells while sparing healthy tissues surrounding the tumor. This results in less toxicity for the patient and the potential to escalate the therapeutic dose to the cancer cells. BNCT has the potential to treat undetected metastases in the local region of the tumor in the same treatment session, which is difficult to impossible for conventional radiotherapy because of the logistical patient treatment setup barriers and the amount of radiation that would be delivered to healthy cells. In addition, BNCT may be utilized for several cancers which are resistant to many, if not all, current cancer therapies available, such as glioblastoma multiforme.

PharmaCyte Biotech Provides Update to Nasdaq Listing Efforts and Presents Scientific Publications Supporting Pancreatic Cancer Treatment

On July 22, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCBD), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that three independent industry publications mention PharmaCyte and/or its past clinical trials and their contributions to prior and future work in the treatment of pancreatic cancer (Press release, PharmaCyte Biotech, JUL 22, 2021, View Source [SID1234585104]).

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PharmaCyte’s Chief Executive Officer (CEO), Kenneth L. Waggoner, commenting on the Company’s expected uplist to Nasdaq said, "As we head into the ninth day of a required 10 days of trading following a reverse stock split, we remain above the price requirement necessary to complete our list of criteria for the expected uplist. Our hope is that PharmaCyte will be trading on the highly respected platform and will become a Nasdaq listed company as early as next week."

Waggoner continued, "With a number of recent well-respected scientific review publications supporting the approach that our technology uses as a promising treatment for pancreatic cancer, it is a validation, of sorts, of our approach and technology against the disease by independent scientists."

Three recently published high profile international medical and scientific review articles have highlighted PharmaCyte’s pancreatic cancer treatment. The articles mention (i) the treatment’s use in clinical trials to develop a cellular microencapsulation technology to treat pancreatic cancer; (ii) the use of prodrugs in its treatment; and (iii) the treatment’s role in improving the pancreatic cancer treatment landscape.

First, the respected scientific journal, Drug Discovery Today, published an article by a Spanish academic group, known for their expertise in the field of cellular encapsulation titled, "Cell microencapsulation technologies for sustained drug delivery: Clinical trials and companies." This publication stresses that the Cell-in-a-Box technology has been tested for years at the preclinical level as well as in two previously successful human clinical trials.

The authors summarize the results of the trials, essentially stating that microencapsulated cells that overexpressed cytochrome P450 2B1 (CYP2B1), which metabolizes the chemotherapy prodrug ifosfamide, transformed it into its active metabolites. These microencapsulated cells were implanted in 27 patients with pancreatic cancer. By placing the microencapsulated cells close to the area to be treated, a more focused therapy is obtained and, thus, better results are expected with lower doses of the chemotherapy prodrug ifosfamide.

In the first Phase 1/2 clinical trial using a 1 g/m2/per day dose of ifosfamide, the median survival of patients was doubled and only one of the patients had treatment-related adverse effects. In a second Phase 2 clinical trial, the prodrug ifosfamide per day dose was increased to 2 g/m2/day. The results showed greater severe adverse effects, but the efficacy profile was similar to the results from the Phase 1/2 clinical trial. The publication notes that PharmaCyte is "continuing with these promising clinical trials and are currently conducting the tests required by the regulatory agencies to begin a Phase 2b clinical trial as soon as possible." (Lopez-Mendez et al., 2021, Drug Discovery Today 26, 852-861)

The sentiment expressed by Lopez-Mendez et al. is echoed in another recent review from the World Journal of Gastroenterology, "Room for improvement in the treatment of pancreatic cancer: Novel opportunities from gene targeted therapy," from the Department of Gastroenterology, Addenbrooke’s Hospital, Cambridge, U.K. This particular review specifically states, "The cytochrome P450/ifosfamide system proof of concept from pre-clinical studies has been used to conduct Phase 1 and Phase 2 clinical trials in pancreatic cancer patients with phenomenal success (improvement of 1-year survival by 3-fold and median survival doubled)." (Galanopoulos et al., 2021, World J Gastroenterol 27, 3568-3580)

The third publication supports the activity of PharmaCyte’s pancreatic cancer treatment titled, "Prodrugs and prodrug-activated systems in gene therapy." This publication that appeared in the high impact journal Molecular Therapy states, "At a dose of 1 g/m2, ifosfamide was well tolerated by all patients in the first part of the trial, with regression of tumors in four patients and stable disease in the other participants." (Sheikh et al., 2021, Molecular Therapy 29, 1716-1728)

PharmaCyte’s CEO added, "The positive assessments of our technology and its use in the treatment of pancreatic cancer by the authors of these key publications, underscore how important it is for us to receive the U.S. Food and Drug Administration’s approval to start our clinical trial in locally advanced and inoperable pancreatic cancer."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source