Month: October 2016

Cardinal Health Reports First-quarter Results for Fiscal Year 2017

On October 31, 2016 Cardinal Health (NYSE: CAH) reported first-quarter fiscal year 2017 revenue of $32 billion, an increase of 14 percent from the comparable quarter last yea (Press release, Cardinal Health, OCT 31, 2016, View Source [SID1234516111])r. The company also reported a decline in GAAP operating earnings of 14 percent to $535 million and in non-GAAP operating earnings of 9 percent to $669 million. GAAP diluted earnings per share (EPS) decreased 17 percent to $0.96, while non-GAAP diluted EPS decreased 10 percent to $1.24.

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"Our first-quarter results were largely as we suggested they would be, with a healthy increase in revenue and a decrease in our operating earnings largely driven by conditions in the pharmaceutical distribution market," said George Barrett, chairman and CEO of Cardinal Health. "While short-term headwinds, particularly around pharmaceuticals, are quite challenging, our Medical segment had an excellent quarter building on the momentum coming out of fiscal year 2016. From an operating perspective, our metrics were strong in both of our reporting segments, and our strategic positioning is well-aligned with the changing needs of the market."

Q1 FY17 summary

Q1 FY17

Q1 FY16

Y/Y
Revenue
$
32.0
billion

$
28.1
billion

14%
Operating earnings
$
535
million

$
620
million

(14)%
Non-GAAP operating earnings
$
669
million

$
737
million

(9)%
Net earnings attributable to Cardinal Health Inc.
$
309
million

$
383
million

(19)%
Non-GAAP net earnings attributable to Cardinal Health Inc.
$
399
million

$
458
million

(13)%
Diluted EPS attributable to Cardinal Health Inc.
$
0.96

$
1.15

(17)%
Non-GAAP diluted EPS attributable to Cardinal Health Inc.
$
1.24

$
1.38

(10)%
Segment results
Pharmaceutical segment
First-quarter revenue for the Pharmaceutical segment increased 14 percent to $28.8 billion due to growth from net new and existing Pharmaceutical Distribution customers and, to a lesser extent, performance from the Specialty business.
Segment profit for the quarter decreased 19 percent to $534 million. This decrease was driven by generic pharmaceutical pricing and, to a lesser extent, reduced levels of branded inflation and the previously announced loss of a large Pharmaceutical Distribution customer. This was partially offset by solid performance from Red Oak Sourcing.

Q1 FY17

Q1 FY16

Y/Y
Revenue
$
28.8
billion

$
25.1
billion

14%
Segment profit
$
534
million

$
657
million

(19)%

Cardinal Health
Page 2

Medical segment
First-quarter revenue for the Medical segment increased 12 percent to $3.3 billion driven by contributions from acquisitions and net new and existing customers.
Segment profit increased 26 percent to $127 million due to contributions from acquisitions and Cardinal Health Brand products.

Q1 FY17

Q1 FY16

Y/Y
Revenue
$
3.3
billion

$
2.9
billion

12%
Segment profit
$
127
million

$
101
million

26%
Fiscal 2017 outlook
The company does not provide GAAP EPS outlook, because it is unable to reliably forecast most of the items that are excluded from GAAP EPS to calculate non-GAAP EPS. These items could cause EPS to differ materially from non-GAAP EPS. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Full-year Pharmaceutical segment profit is now expected to be down as a percentage in the mid-to-high single digits compared to fiscal year 2016, with the changes coming primarily from generic pharmaceutical pricing and, to a lesser extent, reduced levels of branded inflation. Based on first-quarter results and second-quarter expectations, the company slightly lowered its fiscal year 2017 guidance range for non-GAAP diluted EPS from continuing operations to $5.40 to $5.60 from $5.48 to $5.73, representing growth of approximately 3 to 7 percent from the prior year.

More details about this outlook can be found on the company’s webcast and accompanying slides; see below for details.
Additional first-quarter and recent highlights
•
Onboarded Medical segment customer Kaiser Permanente
•
Expanded the existing distribution agreement between Cordis and Biosensors, enabling Cordis to be the exclusive distributor for Biosensors’ coronary interventional products in Japan
•
Acquired TelePharm, a company that focuses on establishing telepharmacies in rural areas
•
Granted Cardinal Health Foundation funds to 17 community-based non-profit organizations nationwide to combat prescription drug misuse

Selecta Biosciences Collaborators at the National Cancer Institute Present Preclinical Data Showing SVP-Rapamycin Application to Cancer Therapy

On October 31, 2016 Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company developing a novel class of targeted antigen-specific immune therapies, reported that results from preclinical studies involving SVP-Rapamycin, the company’s novel immunotherapeutic, were presented by its collaborators Ira Pastan, MD, Chief of the Laboratory of Molecular Biology, and Ronit Mazor, Ph.D., Postdoctoral Fellow at Center for Cancer Research at the National Cancer Institute (NCI), part of the National Institutes of Health (Press release, Selecta Biosciences, OCT 31, 2016, View Source [SID1234516120]).

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Through a collaboration under a Cooperative Research and Development Agreement (CRADA) between Selecta and NCI, the results were obtained by co-administration of SVP-Rapamycin with an investigational anti-cancer therapeutic, LMB-100. LMB-100 is a next-generation recombinant immunotoxin (rIT) developed in the Pastan Lab that is currently undergoing Phase 1 clinical trials at the NIH Clinical Center in patients with mesothelioma and pancreatic cancer.

Dr. Pastan’s presentation at the Immunogenicity and Bioassay Summit 2016 in Baltimore, Maryland was entitled, "Strategies to Reduce Immune Response to Immunotoxins," and Dr. Mazor’s presentation was entitled, "Induction of Tolerance to Immunotoxins Using Nanoparticle Delivery of Rapamycin." Further, Dr. Mazor presented a poster with the title "Nanoparticle-Encapsulated Rapamycin Prevents Primary and Secondary Immune Responses in Murine Models."

LMB-100 is a next-generation immunotoxin comprised of a mesothelin-targeting antibody fragment linked to an engineered cytotoxic domain of Pseudomonas exotoxin A. The majority of mesothelioma patients treated with an earlier version of LMB-100, called SS1P, experienced dose-limiting immune responses despite the use of potent immunosuppressants. However, the few patients tolerating more than one treatment cycle in this trial showed marked antitumor activity in patients with chemotherapy-refractory mesothelioma.

The co-administration of SVP-Rapamycin with LMB-100 in mice models prevented the formation of anti-LMB-100 antibodies and allowed for the administration of at least four treatment cycles, representing a marked increase in the number of effective doses that could be administrated without the onset of neutralizing antibodies. Further, in a tumor model, the addition of SVP-Rapamycin restored the beneficial effect of LMB-100 on controlling tumor growth.

"These pre-clinical proof of concept data clearly demonstrate the potential benefit of co-administrating LMB-100 and SVP-Rapamycin, two products currently used in clinical trials," said Peter Keller, M.Sc., Chief Business Officer at Selecta. "The program is part of our objective to extend our clinical pipeline by applying our SVP technology platform to oncology treatments. In oncology, the effectiveness of many therapies could be enhanced by antigen-specific mitigation of undesired immune responses."

Selecta is developing SVP-Rapamycin for co-administration with biologic therapies for the antigen-specific mitigation of undesired humoral and cellular immune responses. The company is focused on three strategic areas: enzyme therapy, gene therapy and oncology. SVP-Rapamycin has the potential to be co-administered with a multitude of biologic drugs that have been identified in each of these areas to increase the number of treatable patients and/or enhance efficacy and safety.

Selecta’s lead product candidate, SEL-212, applies SVP-Rapamycin to pegsiticase, a pegylated uricase. SEL-212 is designed to be the first non-immunogenic version of uricase, an immunogenic enzyme that targets uric acid. SEL-212 is in a Phase 2 clinical trial and is being developed for patients with chronic refractory and tophaceous gout.

About LMB-100

LMB-100 is a next generation immunotoxin comprised of a mesothelin-targeting antibody fragment linked to an engineered cytotoxic domain of Pseudomonas exotoxin A. Mesothelin, a cell surface antigen discovered in Ira Pastan’s laboratory at NCI, is overexpressed in mesothelioma, pancreatic, ovarian and lung cancers. Dr. Pastan is a world-renowned expert in the design and development of immunotoxins. A first generation mesothelin-targeted immunotoxin, SS1P, could only be given for 1 cycle because it was immunogenic, but showed marked antitumor activity in patients with chemotherapy-refractory mesothelioma, when combined with drugs to suppress the development of anti-drug antibodies. LMB-100 was engineered to reduce immunogenicity and off target toxicity. LMB-100 is currently in phase 1 clinical studies by CCR investigators at the NIH Clinical Center in Bethesda, Maryland.

NOVOGEN LICENSES PHASE II – READY MOLECULE FROM GENENTECH FOR DEVELOPMENT IN GLIOBLASTOMA

On October 31, 2016 Novogen Ltd (ASX: NRT; NASDAQ: NVGN) reported that it has entered into a worldwide licensing agreement with Genentech, a member of the Roche Group, to develop and commercialise GDC-0084, a small molecule inhibitor of the phosphoinositide-3-kinase (PI3K) pathway (Press release, Novogen, OCT 31, 2016, View Source [SID1234516119]).

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The lead indication for GDC – 0084 is glioblastoma multiforme (GBM), which is the most aggressive form of brain cancer, accounting for approximately 15% of primary brain tumours. Median overal l survival is considered to be approximately 12 – 15 months from the time of diagnosis. 1 Therapies targeting the PI3K pathway have been under development by a number of pharmaceutical and biotechnology companies for several years, in various types of cancer. GDC – 0084 is distinguished from most molecules in the class by its ability to cross the blood – brain barrier, potentially making it suitable for cancers of the central nervous system. Genentech has completed a phase I study of GDC – 0084 in patients with r ecurrent GBM, and data was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, IL in June 2016 2 . The study recruited 47 patients at five centres in the United States and Spain, including UCLA, Dana – Farber Cancer Institute, and Massachusetts General Hospital. In addition, GDC – 0084 has an open Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA), and the transaction includes a quantity of pre – manufactured drug substance that is expected to be sufficient to support a proposed phase II clinical trial. Novogen CEO, Dr James Garner, commented, "We are excited that Genentech has entrusted us to take forward this promising investigational medicine in one of the most challenging areas of cancer treatment. This is a transformative step for Novogen, and the a ddition of GDC – 0084 to our portfolio strengthens our position as an emerging oncology biotech company. Our pipeline is now diversified across three distinct technology platforms, and we anticipate it will provide a rich flow of value – driving milestones as the company progresses." He added, "The PI3K inhibitor class is well – validated and is of considerable interest to larger pharmaceutical companies. While a number of development candidates are in clinical trials across a range of cancer types, we believe GDC-0084 is well differentiated and represents an important opportunity to contribute to the treatment of patients with glioblastoma." Under the terms of the agreement, Novogen will pay Genentech an upfront payment of US$ 5 million and performance – related co nsideration linked to regulatory and commercial outcomes. In addition, Genentech will receive royalty payments in – line with industry benchmarks. Genentech will immediately initiate transfer of the IND for GDC – 0084 to Novogen, as well as key manufacturing and analytical processes. Novogen anticipates being able to provide an update to the market in the design, project cost, and timelines of the proposed phase II study early in the new year

Cellectar Biosciences Announces Design for NCI-Supported Phase II Study of CLR 131 in Multiple Myeloma and Other Hematologic Malignancies

On October 31, 2016 Cellectar Biosciences, Inc. (Nasdaq:CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported the study design of its Phase II clinical trial of CLR 131 in patients with relapsed or refractory multiple myeloma (MM), chronic lymphocytic lymphoma/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL), who have been treated with standard therapy for their underlying malignancies (Filing, 8-K, Cellectar Biosciences, OCT 31, 2016, View Source [SID1234516117]). The company previously provided guidance for study initiation in the first half of 2017 and now anticipates initiating the trial during the first quarter of 2017.

The Phase II study, for which the company has received a $2 million non-dilutive grant from the National Cancer Institute, will be conducted in up to 15 centers across the United States. The company expects that all patients will receive a single dose of CLR 131 at 25.0 mCi/m2 infused over approximately 30 minutes, with the option of a second dose approximately 80-160 days later, based upon physician assessment. Concurrently, patients in the trial with MM will be receiving 40mg oral dexamethasone weekly for up to 12 weeks. The primary endpoint for the study is Objective Response Rate (ORR). Secondary endpoints include Progression-Free Survival and other measures of efficacy. In MM patients, efficacy responses will be determined according to the latest International Multiple Myeloma Working Group criteria, while in lymphomas, efficacy will be determined according to the Lugano criteria. The company anticipates initial efficacy data as early as the second half of 2017.

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"We continue to see consistently positive outcomes with CLR 131 and this study will further define its clinical benefits in a single and multi-dose regimen for the treatment of multiple myeloma, the results of which will be instrumental in the design of a pivotal trial," said Jim Caruso, president and CEO of Cellectar. "We believe CLR 131 may also provide therapeutic benefits in a number of orphan-designated hematologic cancers and we designed the Phase 2 study to optimize our understanding of the drug’s clinical utility."

In order to be eligible for the Oct. 31, 2016 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (Nasdaq:CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, today announces the study design of its Phase II clinical trial of CLR 131 in patients with relapsed or refractory multiple myeloma (MM), chronic lymphocytic lymphoma/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL), who have been treated with standard therapy for their underlying malignancies. The company previously provided guidance for study initiation in the first half of 2017 and now anticipates initiating the trial during the first quarter of 2017.

The Phase II study, for which the company has received a $2 million non-dilutive grant from the National Cancer Institute, will be conducted in up to 15 centers across the United States. The company expects that all patients will receive a single dose of CLR 131 at 25.0 mCi/m2 infused over approximately 30 minutes, with the option of a second dose approximately 80-160 days later, based upon physician assessment. Concurrently, patients in the trial with MM will be receiving 40mg oral dexamethasone weekly for up to 12 weeks. The primary endpoint for the study is Objective Response Rate (ORR). Secondary endpoints include Progression-Free Survival and other measures of efficacy. In MM patients, efficacy responses will be determined according to the latest International Multiple Myeloma Working Group criteria, while in lymphomas, efficacy will be determined according to the Lugano criteria. The company anticipates initial efficacy data as early as the second half of 2017.

"We continue to see consistently positive outcomes with CLR 131 and this study will further define its clinical benefits in a single and multi-dose regimen for the treatment of multiple myeloma, the results of which will be instrumental in the design of a pivotal trial," said Jim Caruso, president and CEO of Cellectar. "We believe CLR 131 may also provide therapeutic benefits in a number of orphan-designated hematologic cancers and we designed the Phase 2 study to optimize our understanding of the drug’s clinical utility."

In order to be eligible for the study, multiple myeloma patients must have received prior treatment with a proteasome inhibitor as well as an immunomodulatory drug. Patients with lymphomas, CLL/SLL, LPL, and MZL, including patients with mucosa associated lymphoid tissue, must have received treatment with at least two prior lines of therapy. Patients with MCL require treatment with at least one prior line of therapy.

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 quarter of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) 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 in the treatment of multiple myeloma.

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.study, multiple myeloma patients must have received prior treatment with a proteasome inhibitor as well as an immunomodulatory drug. Patients with lymphomas, CLL/SLL, LPL, and MZL, including patients with mucosa associated lymphoid tissue, must have received treatment with at least two prior lines of therapy. Patients with MCL require treatment with at least one prior line of therapy.

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 quarter of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) 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 in the treatment of multiple myeloma.

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.

European Medicines Agency Validates the Marketing Authorization Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma

On October 31, 2016 Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE (link is external)) reported that the European Medicines Agency (EMA) has validated for review Merck KGaA, Darmstadt, Germany’s Marketing Authorization Application (MAA) for avelumab, for the proposed indication of metastatic Merkel cell carcinoma (MCC), a rare and aggressive skin cancer, which impacts approximately 2,500 Europeans a year (Press release, Pfizer, OCT 31, 2016, View Source [SID1234516116]).[1],[2] Validation of the MAA confirms that submission is complete and begins the EMA’s centralized review process.* If approved, avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, could be the first approved treatment indicated for metastatic MCC in the EU. Patients with metastatic MCC face a very poor prognosis, with less than 20 percent surviving beyond five years.[3]

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"While early-stage Merkel cell carcinoma can be generally managed with surgery, there are significant unmet needs in metastatic disease, where treatment options are severely limited," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. "We are pleased that the EMA is initiating its review of avelumab, as this means we are one step closer to bringing a much-needed new treatment option to European patients."

"This is the first of what we hope will be many regulatory milestones for avelumab," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "We are committed to evaluating avelumab in a number of hard-to-treat cancers, and we believe it may have potential to be an important treatment option for patients with metastatic Merkel cell carcinoma."

The avelumab metastatic MCC MAA submission is supported by data from JAVELIN Merkel 200, a multicenter, single-arm, open-label, Phase II study of 88 patients with metastatic MCC whose disease had progressed after at least one chemotherapy treatment.[1] The JAVELIN Merkel 200 study represents the largest data set of any anti-PD-L1/PD-1 antibody reported in this patient population. These data were recently published in the Lancet Oncology.[1]

Avelumab received an Orphan Drug Designation (ODD) from the European Commission for MCC. To qualify for an ODD in the EU, a medicine must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; the prevalence of the condition in the EU must not be more than 5 in 10,000, or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development; and it must be for a disease where no satisfactory treatment is currently available.[4]

The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and over 2,900 patients evaluated across more than 15 different tumor types. In addition to metastatic MCC, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin’s lymphoma, melanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and urothelial (primarily bladder).

*Avelumab is not approved for any indication in any market. This marks the first acceptance of an EU market authorization application to review the safety and efficacy results for the investigational product avelumab.