Phase II Cervical Cancer Study with Advaxis’ Axalimogene Filolisbac Selected for Poster Discussion Session at the 2016 ASCO Annual Meeting

On April 25, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that the Company’s immunotherapy agent will be featured in a poster presentation and discussion at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Advaxis, APR 25, 2016, View Source [SID:1234511372]). The poster, "ADXS11-001 immunotherapy in squamous or non-squamous persistent/recurrent metastatic cervical cancer: Results from stage I of the phase II GOG/NRG0265 study" (Abstract #5516), was selected as one of 12 abstracts to be featured in the ASCO (Free ASCO Whitepaper) oral poster discussion session on gynecologic cancer, where expert discussants highlight the most clinically applicable and novel posters. The Phase 2 study of lead Lm immunotherapy candidate in HPV-associated cervical cancer, axalimogene filolisbac (AXAL), will focus on how the findings apply to clinical practice and future research.

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The poster session will highlight the GOG/NRG-0265 study, a two-stage phase 2 study led by Warner K. Huh, M.D., Professor and Division Director of Gynecologic Oncology and Senior Scientist at the University of Alabama at Birmingham, evaluating the potential of AXAL as an immunotherapy for patients with pretreated metastatic cervical cancer. The poster will include efficacy and safety results from the completed Stage 1 of the study and preliminary data from Stage 2. The study is being performed in a collaboration between Advaxis and the GOG Foundation, Inc. (GOG), now a member of NRG Oncology.

This year’s ASCO (Free ASCO Whitepaper) annual meeting will focus on "Collective Wisdom: The Future of Patient-Centered Care," and will take place in Chicago, Illinois June 3-7, 2016 at McCormick Place. The poster will be presented at the Gynecologic Poster Session on June 6, 2016 at 1:00 PM CT, and the poster discussion will be from 4:45 – 6:00 PM CT. Please visit www.asco.org for additional information.

About Cervical Cancer

Cervical cancer is the fourth most common cancer in women worldwide. In the United States, nearly 13,000 new cases are diagnosed, and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About Axalimogene Filolisbac

Axalimogene filolisbac (AXAL) is Advaxis’ lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, AXAL showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the Company’s Lm Technology. AXAL has Orphan Drug Designation in the U.S. for the treatment of anal cancer.

About The GOG Foundation, Inc.

PharmaCyte Biotech’s Live-Cell Encapsulation Facility is Commissioned for GMP Manufacture

On April 25, 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 the encapsulation facility for its pancreatic cancer therapy is ready to manufacture PharmaCyte’s biologic product under current Good Manufacturing Practices (GMP) standards (Press release, PharmaCyte Biotech, APR 25, 2016, View Source [SID:1234511375]). The facility will be used to encapsulate the live cells used for PharmaCyte’s pancreatic cancer therapy. The assessment was issued by Chamow & Associates, the biopharmaceutical consulting firm that specializes in the inspection of facilities for GMP compliance.

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Dr. Steven Chamow of Chamow & Associates stated, "Use of the live-cell encapsulation technology is very complex with many manufacturing steps and processes. GMP readiness of a biologic manufacturing facility such as the Bangkok site is no exception. In a relatively short period of time, with the relentless and determined cooperation we received from Austrianova, the facility is ready for GMP manufacture to produce the encapsulated cells that are a major part of PharmaCyte’s pancreatic cancer therapy."

PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented, "We are delighted to announce this exciting milestone in the development of our therapy for pancreatic cancer. This is a major step in generating the overall Chemistry, Manufacturing and Controls (CMC) information, which makes up a large part of the pre-IND package we will be submitting to the U.S. Food and Drug Administration (FDA). We would like to thank Chamow & Associates and Austrianova for completing this process. With the facility ready for cGMP manufacture, we are now in a position to engage with the FDA to discuss our clinical investigational plan and initiate our first clinical trial."

Over the last few months, following an initial on-site audit of the facility by Chamow & Associates, numerous detailed documents were required to be prepared, reviewed and approved by Chamow. These documents include the quality management system manual and a variety of facility-related standard operating procedures (SOPs). In addition, all facility-related equipment has successfully completed the necessary Installation Qualifications (IQ) and Operational Qualifications (OQ).

Dr. Brian Salmons, the Chief Executive Officer of Austrianova, said, "We are exceedingly pleased that we were able to have our unique state-of-the-art live-cell encapsulation facility assessed as ready for GMP manufacture by Chamow & Associates. Both of the teams from Austrianova and Chamow worked together seamlessly and virtually nonstop to ensure that the facility is ready for GMP manufacture of PharmaCyte’s biologic product. We did so to enable PharmaCyte to reach the clinic with its novel therapy for pancreatic cancer at the earliest opportunity."

The Austrianova facility will be used to encapsulate the genetically engineered live human cells that, together with low doses of the cancer prodrug ifosfamide, make up PharmaCyte’s pancreatic cancer therapy. PharmaCyte’s cancer therapy attacks the pancreas tumor with "targeted chemotherapy," resulting in significant tumor shrinkage, the ability to convert some tumors from inoperable to operable, a reduction in the pain associated with the disease and an improvement to a patient’s overall quality of life.

PharmaCyte’s upcoming clinical trial in advanced inoperable pancreatic cancer involves placing the genetically modified live cells near the blood supply to the pancreas. The cancer prodrug ifosfamide is then given at one-third the normal dose. The prodrug is converted to its active form at the site of the tumor. In an earlier Phase 1/2 clinical trial, this "targeted chemotherapy" demonstrated far greater efficacy than the then "gold-standard" of care with no meaningful side-effects from the chemotherapy. Patients enrolled in PharmaCyte’s clinical trial will have non-metastatic, locally advanced and inoperable pancreatic cancer. They will be eligible for the trial if their tumors are either stable or progressing after 4-6 cycles of treatment with either of the two most commonly used chemotherapies for these cancers – the two-drug combination of Abraxane plus gemcitabine or the four-drug combination known as FOLFIRINOX. PharmaCyte’s therapy will be compared in such patients with the current "standard of care," which consists of the combination of the anticancer drug capecitabine plus radiation.

Stemline Therapeutics Announces Oral Presentation of SL-401 Phase 2 BPDCN Data at the 2016 ASCO Annual Meeting

On April 25, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that its SL-401 Phase 2 clinical data update was selected for oral presentation on June 4, 2016 at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Press release, Stemline Therapeutics, APR 25, 2016, View Source [SID:1234511376]).

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Details on the presentation are as follows:

Title:
Results from Phase 2 registration trial of SL-401 in patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Lead-in completed, Expansion stage ongoing.
Presenter: Naveen Pemmaraju, M.D., MD Anderson Cancer Center
Abstract No.: 7006
Session: Hematologic Malignancies- Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date/Time: Saturday, June 4, 2016; 5:00 – 5:12PM CT
Location: Arie Crown Theater

Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "We are honored that ASCO (Free ASCO Whitepaper) has selected our Phase 2 data update for an oral presentation at this year’s annual meeting. We are also privileged to be working with world-class collaborators and institutions on this important trial and look forward to Dr. Pemmaraju’s presentation and data updates at the meeting."

Laboratory Corporation of America® Holdings Announces 2016 First Quarter Results and Raises 2016 Guidance

On April 25, 2016 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported results for the quarter ended March 31, 2016 (Press release, LabCorp, APR 25, 2016, View Source;p=RssLanding&cat=news&id=2160874 [SID:1234511377]).

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"We are off to a terrific start to the year, highlighted by robust organic revenue growth and double-digit adjusted EPS growth in the quarter," said David P. King, chairman and chief executive officer. "Broad-based demand for the services of LabCorp Diagnostics and Covance Drug Development is evidence of our customers’ enthusiasm for our differentiated offering. We continue to carry out our mission to improve health and improve lives through focus on three key strategic objectives – delivering world class diagnostics, bringing innovative medicines to patients faster and changing the way care is provided."

Consolidated Results

Net revenue for the quarter was $2.30 billion, an increase of 29.5% over last year’s $1.77 billion. The Covance acquisition contributed $687.3 million in net revenue during the quarter, compared to $267.2 million in the first quarter of 2015 following the date of closing on February 19, 2015, driving an increase of 23.7% year over year due to strong demand and the inclusion of Covance’s financial results for the entire quarter. LabCorp Diagnostics contributed the remainder of the increase of $102.8 million, or 5.8%, primarily due to solid organic growth and tuck-in acquisitions, partially offset by the impact from currency.

Operating income for the quarter was $301.9 million, compared to $132.4 million in the first quarter of 2015. The Company recorded restructuring charges and special items of $29.3 million in the quarter, compared to $138.7 million during the same period in 2015. Adjusted operating income (excluding amortization of $44.3 million, restructuring and special items) for the quarter was $375.5 million, or 16.4% of net revenue, compared to $302.2 million, or 17.1%, in the first quarter of 2015. The increase in adjusted operating income was primarily due to strong revenue growth and productivity, partially offset by personnel costs and bad debt. The decline in margin was primarily due to the mix impact from the inclusion of Covance’s financial results for the entire quarter.

Net earnings in the quarter were $160.2 million, or $1.55 per diluted share, compared to $3.1 million, or $0.04 per diluted share, last year. Adjusted EPS (excluding amortization, restructuring and special items) were $2.02 in the quarter, an increase of 14.8% compared to $1.76 in the first quarter of 2015. The Company’s results included a net gain in the quarter of $0.05 per diluted share on the sale of investment securities from its venture fund.

Operating cash flow for the quarter was $123.0 million, compared to negative $86.9 million last year. The Company’s operating cash flow in the first quarter of 2015 was negatively impacted by $153.5 million in non-recurring items relating to the acquisition of Covance. Excluding these items, operating cash flow was $66.6 million last year. The increase in operating cash flow was primarily due to improved earnings. Capital expenditures totaled $71.4 million, compared to $33.8 million in the first quarter of 2015. As a result, free cash flow (operating cash flow less capital expenditures) was $51.6 million, compared to negative $120.7 million in the first quarter of 2015. Excluding non-recurring items, free cash flow was $32.8 million last year.

At the end of the quarter, the Company’s cash balance and total debt were $696.3 million and $6.4 billion, respectively. During the quarter, the Company invested $93.3 million in tuck-in acquisitions.

The following segment results are presented on a pro forma basis for all periods as if the acquisition of Covance closed on January 1, 2015 and exclude amortization, restructuring, special items and unallocated corporate expenses. Reconciliations of segment results to historically reported results are included in the Condensed Pro Forma Segment Information tables and notes.

Pro Forma Segment Results

LabCorp Diagnostics

Net revenue for the quarter was $1.59 billion, an increase of 7.2% over $1.48 billion for the first quarter of 2015. The increase in net revenue was the result of organic volume growth (measured by requisitions), Beacon LBS, price, mix and tuck-in acquisitions, partially offset by currency. The increase in net revenue of 7.2% includes the benefit from Beacon LBS of 1.0%, and unfavorable foreign currency translation of 0.6%. Total volume (measured by requisitions) increased by 4.0% (organic volume of 3.4% and acquisition volume of 0.6%). Revenue per requisition increased by 2.7%.

Adjusted operating income (excluding amortization, restructuring and special items) for the quarter was $310.3 million, or 19.5% of net revenue, compared to $289.6 million, or 19.5% of net revenue, in the first quarter of 2015. The increase was primarily due to volume, price, mix and productivity, partially offset by personnel costs and bad debt. Improvement in productivity was driven by Project LaunchPad, the Company’s business process improvement initiative, which remains on track to deliver net savings of $150 million through the three-year period ending in 2017.

Covance Drug Development

Net revenue for the quarter was $703.1 million, an increase of 12.6% over $624.6 million for the first quarter of 2015 due to broad-based demand. The stronger U.S. dollar negatively impacted year-over-year revenue growth by approximately 160 basis points. Excluding the impact from currency and the expiration of the Sanofi site support agreement, net revenue increased 17.9% year over year.

Adjusted operating income (excluding amortization, restructuring and special items) was $103.3 million, or 14.7% of net revenue, compared to $74.2 million, or 11.9% of net revenue, in the first quarter of 2015. The increase was primarily due to demand, productivity and cost synergies, partially offset by the expiration of the Sanofi site support agreement and personnel costs. The Company remains on track to deliver cost synergies of $100 million related to the acquisition of Covance through the three-year period ending in 2017.

During the quarter, net orders (gross orders less cancellations and reductions) were $830 million, representing a net book-to-bill of 1.18.

Outlook for 2016

The following updated guidance assumes foreign exchange rates effective as of March 31, 2016 for the remainder of the year.

Net revenue growth of 8.5% to 10.5% over 2015 net revenue of $8.51 billion, which includes the impact from approximately 40 basis points of negative currency. This is an increase from prior guidance of 7.5% to 9.5%, which included approximately 100 basis points of negative currency.
Net revenue growth in LabCorp Diagnostics of 4.0% to 5.5% over 2015 pro forma revenue of $6.21 billion, which includes the impact from approximately 20 basis points of negative currency. This is an increase from prior guidance of 3.5% to 5.5%, which included approximately 50 basis points of negative currency.
Net revenue growth in Covance Drug Development of 6.0% to 9.0% over 2015 pro forma revenue of $2.63 billion, which includes the impact from approximately 50 basis points of negative currency. This is an increase from prior guidance of 2.0% to 5.0%, which included approximately 200 basis points of negative currency. Excluding the impact from currency and the expiration of the Sanofi site support agreement, net revenue is expected to increase approximately 9% to 12%.
Adjusted EPS of $8.55 to $8.95, versus prior guidance of $8.45 to $8.85, and as compared to $7.91 last year.
Free cash flow (operating cash flow less capital expenditures) of $900 million to $950 million, an increase of approximately 24% to 31% over the prior year, unchanged from prior guidance.
Use of Adjusted Measures

The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including Adjusted EPS, Adjusted Operating Income, and Free Cash Flow. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is furnishing its Current Report on Form 8-K that will include additional information on its business and operations. This information will also be available on the Company’s website at www.labcorp.com. Analysts and investors are directed to the Current Report on Form 8-K and the website to review this supplemental information.

Ipsen is pleased to announce that its partner Exelixis obtained FDA Approval of CABOMETYX™ (cabozantinib) tablets for patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy

On April 25 2016 Ipsen (Euronext: IPN; ADR: IPSEY) reported that its partner Exelixis, Inc. (NASDAQ:EXEL) received approval from the U.S. Food and Drug Administration (FDA) for CABOMETYX (cabozantinib) tablets earlier today for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy (Press release, Ipsen, APR 25, 2016, View Source [SID:1234511439]). On February 29, 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan.

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RCC is the most common form of kidney cancer in adults. The incidence of advanced RCC is estimated to be around 20,000 new patients per year in Ipsen’s territories.

CABOMETYX, which was granted Fast Track and Breakthrough Therapy designations by the FDA, is the first therapy to demonstrate in a large, randomized phase 3 trial for patients with advanced RCC, robust and clinically meaningful improvements in all three key efficacy parameters — overall survival, progression free survival and objective response rate.

Compared with everolimus, CABOMETYX is associated with a 42 percent reduction in the rate of disease progression or death and 34 percent reduction in the rate of death. Median progressionfree survival for CABOMETYX is 7.4 months versus 3.8 months for everolimus (HR=0.58, 95% CI 0.45-0.74, P<0.0001). Median overall survival is 21.4 months for patients receiving CABOMETYX versus 16.5 months for those receiving everolimus (HR=0.66, 95% CI 0.53-0.83, P=0.0003).

In Europe, the Marketing Authorization Application (MAA) for cabozantinib in advanced RCC has been accepted and granted accelerated assessment. With this designation, the MAA is eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by the EMA).

Exelixis press release is available here: http://bit.ly/24gckfO