On October 25, 2016 Baxter International Inc. (NYSE:BAX) reported results for the third quarter of 2016, and increased its earnings per share outlook for full-year 2016. Baxter’s third quarter worldwide sales totaled $2.6 billion, an increase of 3 percent on a reported basis and 4 percent on a constant currency basis as compared to the prior-year period (Press release, Baxter, OCT 25, 2016, View Source [SID1234515982]).

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"We are pleased with the continued strength across our core franchises as well as our improved financial performance, both of which are reflected in our third quarter results," said José (Joe) E. Almeida. "Given this progress, we are intensifying our focus on portfolio management and innovation to accelerate our efforts to introduce new products and therapies."

Financial Results

During the quarter, Baxter reported income from continuing operations of $127 million, or $0.23 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis. These results included net after-tax special items totaling $184 million, primarily related to business optimization initiatives, intangible asset amortization, debt extinguishment and Baxalta related spin-off costs.

On an adjusted basis, excluding special items, Baxter’s third quarter income from continuing operations totaled $311 million, or $0.56 per diluted share, exceeding the company’s previously-issued guidance of $0.43 to $0.45 per diluted share.

Baxter’s worldwide sales totaled $2.6 billion in the third quarter, an increase of 3 percent on a reported basis and 4 percent on a constant currency basis as compared to the prior-year period. Sales within the U.S. were $1.1 billion, advancing 6 percent, while international sales totaled $1.5 billion, representing a 1 percent increase on a reported basis, and an increase of 3 percent on a constant currency basis. Adjusting for the impact of foreign exchange, generic competition for cyclophosphamide, and 2015 PROTOPAM orders, Baxter’s sales increased 12 percent in the U.S. and rose 6 percent globally in the third quarter.

By business, Hospital Products sales of $1.6 billion in the third quarter increased 2 percent on a reported basis and 3 percent on a constant currency basis. Adjusting for the impact of foreign exchange, cyclophosphamide and PROTOPAM, Hospital Products sales advanced 7 percent from the prior-year period. Hospital Products performance in the quarter benefited from strong sales across the portfolio, driven by increased demand and favorable pricing in the U.S. for the company’s IV solutions, nutritional therapies, pharmacy injectables and IV access administration sets. Strength internationally in the company’s hospital pharmacy compounding services and cytotoxic contract manufacturing business also contributed to growth in the quarter.

Baxter’s Renal sales totaled $977 million in the third quarter, representing a 4 percent increase on a reported basis, and a 6 percent increase on a constant currency basis. Growth was driven by strong sales of peritoneal dialysis products as well as increased demand globally for continuous renal replacement therapies. Contributing to growth in the quarter were the recent launches of Baxter’s new Automated Peritoneal Dialysis (APD) systems, AMIA in the U.S. and HOMECHOICE CLARIA outside the U.S. Both of these systems utilize Baxter’s SHARESOURCE Connectivity Platform, which is the first and only two-way, remote patient management system for home dialysis therapy globally.

Financial Outlook

Based on the company’s strong performance in the first three quarters of the year, Baxter is raising its financial outlook for full-year 2016 including sales growth of approximately 2 percent on a reported basis or 4 percent on a constant currency basis, and earnings from continuing operations, before special items, of $1.88 to $1.91 per diluted share for the full year. Previous guidance called for reported sales of 1 to 2 percent (or 3 to 4 percent constant currency) and earnings of $1.69 to $1.74 per diluted share.

For the fourth quarter, the company expects sales growth of approximately 2 percent on both a reported and constant currency basis. Baxter expects earnings from continuing operations, before special items, of $0.49 to $0.52 per diluted share for the fourth quarter of 2016.

The earnings per share guidance for the fourth quarter and full-year 2016 excludes $0.05 and $0.22, respectively, per diluted share of intangible asset amortization expense; an estimated $0.01 and $0.07, respectively, per diluted share of Baxalta separation-related expense activities; an estimated $0.07 and $0.51, respectively, per diluted share of business optimization charges; and $7.84 per diluted share of asset impairment, debt extinguishment loss, product related reserve adjustments, and Baxalta retained stake gains for full-year 2016. These estimates are based on information reasonably available at the time of this release and future events or new information may result in different actual results. Reconciling for the inclusion of these items results in GAAP earnings of $0.36 to $0.39 per diluted share for the fourth quarter of 2016, and $8.92 to $8.95 per diluted share for full-year 2016.

A webcast of Baxter’s third quarter conference call for investors can be accessed live from a link on the company’s website at www.baxter.com beginning at 7:30 a.m. CDT on October 25, 2016.
Please see www.baxter.com for more information regarding this and future investor events and webcasts.

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO2, a CAR T Cell Treatment Targeting BCMA and TACI, in Patients with Relapsed or Refractory Multiple Myeloma

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On October 24, 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 that Manuel Hidalgo, MD, PhD has agreed to serve as the Principal Investigator (PI) for PharmaCyte’s clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, OCT 24, 2016, View Source [SID1234515987]). Dr. Hidalgo is an internationally respected oncologist and a recognized authority in the treatment of pancreatic cancer. Currently, he serves as Clinical Director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center and Chief of the Division of Hematology-Oncology at the prestigious Beth Israel Deaconess Medical Center in Boston and is a member of PharmaCyte’s Medical and Scientific Advisory Board.

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Commenting on his selection, Dr. Hidalgo said, "I am pleased to have been selected to be the PI of this important clinical trial, having been a part of its overall design. I have been involved in numerous successful clinical trials and will be drawing on that experience in this one. I believe that the Cell-in-Box plus low dose ifosfamide combination chemotherapy may well prove to be of great value for the development of new therapies for pancreas and other solid tumor cancers. This novel technology has exceedingly broad application. I am looking forward to working with other clinical oncologists in the U.S. and in Europe to insure that PharmaCyte’s therapy meets the critical unmet medical need the study is designed to address."

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, also commented, "As we close in on an engagement date with the FDA, we are extremely pleased and fortunate that Dr. Hidalgo has agreed to assume the important position of PI for our clinical trial in patients with LAPC. The available treatments of this disease are only marginally effective. Dr. Hidalgo is well known around the world as an expert in successfully developing therapies for pancreatic cancer, the third deadliest of all forms of cancer. Dr. Hidalgo’s acceptance of the role of PI for our clinical trial lends credence to our belief that PharmaCyte’s therapy will be successful in treating patients with LAPC."

In his role as PI, or "general supervisor" for how the trial is conducted, Dr. Hidalgo will be responsible for ensuring that all of the clinical trial study sites conduct their studies in accordance with the clinical trial protocol and that all associated procedures and regulations are followed by those study sites. As PI, Dr. Hidalgo will also play a major role in developing the final clinical trial report that will be presented to the FDA, which summarizes and analyzes the trial results from all of the study sites.

PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane plus gemcitabine. The study will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they become operable.

On October 24, 2016 ApeX Therapeutics, a clinical stage biotechnology company focused on developing novel compounds to treat cancer, reported that it has changed its corporate name to Apexian Pharmaceuticals, Inc (Press release, Apexian Pharmaceuticals, OCT 24, 2016, View Source [SID1234517417]). As part of this name change, the company has also launched a new corporate website at www.ApexianPharma.com and a new Twitter handle @ApexianPharma.

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"Now is the time to acknowledge that our key priorities are increasingly focused on advancing our innovative oncology molecules through the clinic" stated Steve Carchedi, President and CEO of Apexian Pharmaceuticals, "We are committed to developing innovative new medicines to extend and enhance the lives of cancer patients. The name change to Apexian Pharmaceuticals is indicative of the great progress we’ve made in advancing our APE1/Ref-1 targeted drug candidates. Specifically, our recent IND acceptance by the FDA for APX3330 highlights our focus on bringing safe and effective medicines into the clinic."

ApeX Therapeutics recently announced acceptance by the U.S. Food and Drug Administration of an Investigational New Drug Application to evaluate the tolerability and anti-tumor effects of APX3330, a small molecule in development to treat late stage cancer.

On October 24, 2016 Cellectar Biosciences, Inc. (Nasdaq:CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported that it will be presenting data from its Phase 1 clinical trial of CLR 131 in relapsed or refractory multiple myeloma at a poster session of the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting and Exposition in San Diego (Press release, Cellectar Biosciences, OCT 24, 2016, View Source [SID1234515977]).

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Poster: #4485, "Phase 1, Open-Label, Dose Escalation Study of I-131-CLR1404 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)"
Presenter: Sikander Ailawadhi, MD, vice chair, clinical practice, Division of Hematology/Oncology, Department of Medicine at the Mayo Clinic, Florida,
Session/Date/Time: #653 — "Myeloma: Therapy, Excluding Transplantation,"
December 5, 2016, 6:00pm — 8:00pm PT
Location: San Diego Convention Center in Hall GH

"The ASH (Free ASH Whitepaper) conference is an important and prestigious event that provides a unique opportunity to share some of the encouraging data from our ongoing Phase 1 study of CLR 131 for the treatment of relapsing or refractory multiple myeloma," said Jim Caruso, president and CEO of Cellectar Biosciences. "Relapse/refractory multiple myeloma is a difficult to manage hematologic cancer that continues to require new therapeutic approaches and CLR 131 potentially offers patients a novel treatment alternative."

Abstracts are expected to be available at www.hematology.org on November 3, 2016 at 9:00 AM ET. In addition, the abstracts will be published online in the December 3, 2016 supplemental volume of Blood.

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first half of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides patients with a novel approach to treating hematological diseases and may provide patients with an improvement in progression-free survival and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). Its phospholipid ether (PLE) carrier platform was deliberately designed to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.