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La Jolla Pharmaceutical Company Announces Financial Results for the Three and Nine Months Ended September 30, 2017 and Recent Corporate Progress

On October 26, 2017 La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, reported financial results for the three and nine months ended September 30, 2017 and highlighted recent corporate progress (Press release, La Jolla Pharmaceutical, OCT 26, 2017, View Source [SID1234521288]).

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Recent Corporate Progress

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In August 2017, La Jolla announced that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s New Drug Application (NDA) for the investigational drug LJPC‑501, La Jolla’s propriety formulation of synthetic human angiotensin II, for the treatment of hypotension in adult patients with distributive or vasodilatory shock (dangerously low blood pressure with adequate cardiac function) who remain hypotensive despite fluid and vasopressor therapy (catecholamines and/or vasopressin). The review classification for the application is Priority, and the user fee goal date under the Prescription Drug User Fee Act (PDUFA) is February 28, 2018. In its letter to the Company, the FDA stated that it does not currently plan to hold an advisory committee meeting to discuss this application. The NDA for LJPC-501 is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High Output Shock) multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study of LJPC-501 in patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy, which were published by The New England Journal of Medicine in May 2017.

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In September 2017, an analysis from ATHOS-3 entitled, "Baseline angiotensin levels and ACE effects in patients with vasodilatory shock treated with angiotensin II," was presented during the 30th European Society of Intensive Care Medicine Annual Congress. The pre-specified analysis showed that a relatively low angiotensin II state (as measured by the ratio of angiotensin I to angiotensin II) predicted increased mortality in patients with vasodilatory shock, suggesting that a low angiotensin II state is a negative prognostic indicator of outcomes. Furthermore, the analysis showed a statistically significant treatment effect of LJPC-501 compared to placebo on mortality in these patients with a relatively low angiotensin II state (relative risk reduction of 36%; HR=0.64; 95% CI: 0.41-1.00; p=0.047).

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In September 2017, La Jolla announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued favorable Scientific Advice regarding the EU regulatory pathway for LJPC‑501 for the treatment of hypotension in adult patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. Based on this Advice, La Jolla intends to submit a Marketing Authorization Application (MAA) for LJPC-501 in the third quarter of 2018.

"The first nine months of 2017 have been exciting for La Jolla, highlighted by the positive results from ATHOS-3, the publication of these results in The New England Journal of Medicine and the FDA acceptance of our NDA for LJPC-501," said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. "We look forward to building on this momentum with the preparation for the potential commercial launch of LJPC-501, if approved by the FDA, and the initiation of our pivotal study of LJPC-401 in beta thalassemia patients suffering from iron overload."

Results of Operations

As of September 30, 2017, the Company had $120.8 million in cash and cash equivalents, compared to $65.7 million of cash and cash equivalents at December 31, 2016. Cash used in operating activities for the nine months ended September 30, 2017 was $60.4 million, compared to $40.1 million for the same period in 2016. Net loss for the three and nine months ended September 30, 2017 was $26.3 million and $76.3 million, or $1.19 per share and $3.65 per share, respectively, compared to a net loss of $21.3 million and $53.3 million, or $1.23 per share and $3.10 per share, respectively, for the same periods in 2016.

BICYCLE THERAPEUTICS TO PRESENT PRECLINICAL DATA ON LEAD MOLECULE BT1718 AT THE AACR-NCI-EORTC INTERNATIONAL CANCER CONFERENCE

On October 26, 2017 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that the company will present data describing the mechanism of action of BT1718, Bicycle’s lead molecule, which is being developed to target cancers of high unmet need including triple negative breast cancer and non small cell lung cancer (Press release, Bicycle Therapeutics, OCT 26, 2017, View Source [SID1234521249]). The data will be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held in Philadelphia, Pennsylvania from October 26 – 30, 2017.

First Patient Treated in a Phase 1/2a Trial (Oncovirac) of Novel Oncolytic Virus TG6002 in Recurrent Glioblastoma

On October 26, 2017 Transgene (Euronext Paris: TNG), a biotech company that designs and develops viral-based immunotherapies, reported that the first patient with recurrent glioblastoma has been treated at La Pitié-Salpêtrière hospital, Greater Paris University Hospitals,AP-HP (Paris), in the first-in-human clinical trial (Oncovirac trial) of TG6002, a novel oncolytic virus (Press release, Transgene, OCT 26, 2017, View Source [SID1234521244]). TG6002 represents the next generation of oncolytic virus(OV), which is administered intravenously and has multiple functions. It has been engineered to combine oncolysis (the breakdown of cancer cells) with the local
production of 5-FU chemotherapy agent in the tumor. It is also expected to induce an immune response
following the antigen spreading that is caused by the cancer cells’ breakdown.

TG6002: a novel oncolytic virus allowing the targeted production of chemotherapy in the tumor
TG6002 is a next generation oncolytic immunotherapy, which has a double mechanism of action. It has been
designed by Transgene to:
1. induce the breakdown of cancer cells (oncolysis) by tumor-selective viral replication. In preclinical
experiments, TG6002 was able to induce response in the primary tumor and an immune-mediated
regression of distant metastases (immunogenic cell death);
2. allow the local production of chemotherapy (5-FU), a widely used cancer chemotherapy, in the
tumor. TG6002 expresses the proprietary Fcu1 gene in the cancer cells it has infected, leading to
the local conversion of the 5-FC into 5-FU.

First-in-human trial to deliver first readouts in H2 2018
Oncovirac is an open-label Phase 1/2a trial evaluating the safety and tolerability of multiple-ascending doses
of TG6002 administered intravenously in combination with oral 5-FC, a non-cytotoxic pro-drug, flucytosine,
that can be converted in 5-FU. The anti-tumor activity of this novel oncolytic virus will also be monitored.
The study will enroll patients suffering from recurrent glioblastoma, who have failed standard of care
treatment.

Dr. Ahmed Idbaih, M.D., PhD, neuro-oncologist at La Pitié-Salpêtrière Hospital (Paris, France), is the principal
investigator of the study. He is involved in several clinical trials dedicated to primary brain tumor patients. He
also coordinates "GlioTex", a research group focused on glioblastoma and experimental therapeutics at ICM (The
Institut du Cerveau et de la Moelle épinière – Brain & Spine Institute). AP-HP Paris Greater Hospitals, is the
sponsor of Oncovirac, a trial also supported by INCa (French National Cancer Institute). More information on the
trial is available on clinicaltrials.gov (NCT03294486). The first readouts of the study are expected in the second
half of 2018.

Maud Brandely, M.D., PhD, Chief Medical Officer of Transgene, added: "TG6002 is a very promising new
generation of oncolytic virus, which has the potential to be administered intravenously. Based on our
compelling preclinical data, we have established that its replication induces immunogenic cell lysis and the
local production of chemotherapy. We are excited to see this novel immunotherapy with multiple modes of
action enter the clinic and look forward to obtaining results that will allow further development of TG6002
in several solid tumors indications."

Dr. Ahmed Idbaih, M.D., PhD, neuro-oncologist at La Pitié-Salpêtrière hospital, AP-HP, and principal
investigator of the trial, added: "Current treatments of recurrent glioblastoma are insufficient. By combining
the immunogenic lysis of cancer cells with the targeted production of chemotherapy in the tumor, TG6002
has the potential to show anti-tumor efficacy and to avoid systemic side effects of chemotherapy. We are
very pleased to be conducting this first in human clinical trial evaluating this novel immunotherapy that we
believe could improve the overall survival of recurrent glioblastoma patients while preserving their quality
of life."

Exelixis to Present at the Credit Suisse 26th Annual Healthcare Conference on November 7th

On October 26, 2017 Exelixis, Inc. (NASDAQ: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide an overview of the company at the Credit Suisse 26th Annual Healthcare Conference taking place November 6-8 in Scottsdale, AZ (Press release, Exelixis, OCT 26, 2017, View Source;p=RssLanding&cat=news&id=2311868 [SID1234521212]). The Exelixis presentation is scheduled for 5:20 PM EST / 2:20 PM PST on Tuesday, November 7, 2017.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

Integra LifeSciences Reports Third Quarter 2017 Financial Results

On October 26, 2017 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the third quarter ending September 30, 2017 (Press release, Integra LifeSciences, OCT 26, 2017, View Source [SID1234521199]).

Highlights
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Third quarter revenue increased 11.4% to $278.8 million over the same quarter in the prior year, and organic revenue increased 1.5%. The recent storms had a negative impact of approximately $7 million in the third quarter. Derma Sciences contributed $24.1 million of revenue in the quarter;
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Third quarter GAAP earnings per share was $0.04, down from prior year quarter largely due to acquisition and integration related expenses. Third quarter adjusted earnings per share was $0.45, compared to $0.46 in the same quarter in the prior year;
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Third quarter cash flow from operations was $45.2 million, a slight decrease from $46.8 million in the prior year’s quarter due to higher cash outlays for acquisition and integration expenses. Trailing twelve-month free cash flow conversion was 70.8%, compared to 75.6% in the prior-year period;

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The company is revising its full-year 2017 revenue guidance to a new range of $1.165 billion to $1.175 billion, primarily reflecting the addition of the Codman Neurosurgery business acquired from Johnson & Johnson. This results in a full-year 2017 reported revenue growth range of 17.4% to 18.4%;
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The company is lowering its 2017 full-year organic sales growth to about 4%, from its previous guidance of 6.0% to 7.0%, reflecting the impact from storm-related disruptions and lower base business sales growth; and
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The company is revising 2017 full-year GAAP earnings per share to a new range of $0.24 to $0.30 and adjusted earnings per share guidance to a new range of $1.83 to $1.87.

Total revenues for the third quarter were $278.8 million, reflecting an increase of $28.5 million, or 11.4%, over the third quarter of 2016. Sales in Orthopedics and Tissue Technologies increased by 25.5%, which includes the acquired revenues from Derma Sciences and strength in our regenerative and orthopedic total ankle and shoulder portfolios. Sales in Specialty Surgical Solutions increased 3.4% compared to the third quarter of 2016. The increase resulted from strength in global tissue ablation sales driven by the recent launch of CUSA Clarity.
Excluding the revenue contribution from acquisitions and the effect of currency exchange rates and discontinued products, total organic revenues increased 1.5% over the third quarter of 2016. Excluding the impact of the recent storms, organic growth was approximately 4.4%.
"Despite the challenges that we encountered during the third quarter, we were able to mitigate much of the impact on adjusted earnings per share with tighter expense controls, resulting in better than expected cash flows," said Peter Arduini, Integra’s president and chief executive officer. "We are pleased to have closed the acquisition of Codman Neurosurgery and look forward to the increased scale and profitability that this strategic deal enables."
The company reported GAAP net income of $3.2 million, or $0.04 per diluted share, for the third quarter of 2017, compared to a GAAP net income of $20.1 million, or $0.25 per diluted share, in third quarter of 2016. The decline primarily reflects expenses associated with the Derma Sciences and Codman Neurosurgery transactions.
The adjusted measures discussed below are computed with the adjustments to GAAP reporting set forth in the attached reconciliation.
Adjusted EBITDA for the third quarter of 2017 was $63.0 million, or 22.6% of revenue, compared to $58.6 million, or 23.4% of revenue, in the third quarter of 2016. The decrease in adjusted EBITDA margin on a year-over-year basis primarily results from dilution from Derma Sciences.
Adjusted net income for the third quarter of 2017 was $36.1 million, unchanged from the prior year quarter. Adjusted earnings per share for the third quarter of 2017 were $0.45, a decrease of 2.2% over the prior year quarter.
2017 Full-Year Outlook
The company is adjusting its full-year 2017 revenue guidance to a new range of $1.165 billion to $1.175 billion, from $1.125 billion to $1.140 billion, primarily reflecting the addition of sales from the Codman acquisition in the fourth quarter. The company is reiterating Codman’s fourth quarter revenue contribution of $60 million to $65 million, net of divestitures. The company is revising its full-year GAAP earnings per share guidance to a new range of $0.24 to $0.30 from its previous range of $0.49 to $0.55. Adjusted earnings per share guidance is being revised to a new range of $1.83 to $1.87 from its previous range of $1.88 to $1.94, entirely because of storm related disruptions.
Based on third quarter results and the outlook for the remainder of the year, the company is revising its full-year 2017 organic revenue growth to about 4%, down from its previous range of 6.0% to 7.0%, which reflects storm related disruptions of approximately 1.5% and lower growth in the base business of approximately 1%.
"We expect some storm-related disruptions to continue to impact revenues in the fourth quarter as production at our manufacturing facility and local infrastructure in Puerto Rico gradually return to full operating capacity," said Glenn Coleman, Integra’s chief financial officer. "Full-year 2017 organic revenue growth is now expected to be about 4%, which reflects the impact from the storms and slower run rates in our dural repair and SurgiMend product lines."

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 AM ET today, Thursday, October 26, 2017, to discuss financial results for the third quarter and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.
Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (323) 794-2551 and using the passcode 6660907. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available through October 30, 2017, by dialing (719) 457-0820 and using the passcode 6660907. The webcast will also be archived on the website.