On August 27, 2019 The Pancreatic Cancer Action Network (PanCAN), the leading pancreatic cancer patient advocacy organization, and CDISC, the global nonprofit dedicated to developing and advancing clinical research data standards of the highest quality, reported a collaboration to establish the first-ever data standards specifically for pancreatic cancer (Press release, PanCAN, AUG 27, 2019, View Source [SID1234539026]).

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Pancreatic cancer has the lowest survival rate among all major cancers. In nearly every country, pancreatic cancer is the only major cancer with a single-digit five-year survival rate. Every day, more than 1,250 people worldwide will be diagnosed with pancreatic cancer, and an estimated 1,180 will die from the disease. It is estimated that in 2020, 480,000 new cases will be diagnosed globally.

CDISC and PanCAN will develop global, nonproprietary clinical metadata standards that build upon existing CDISC standards to create a Therapeutic Area User Guide (TAUG), which describes how to use CDISC standards to represent data in research studies pertaining to specific diseases. CDISC TAUGs provide examples and guidance on implementing CDISC standards to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.

The TAUG is intended to facilitate increased ease of global health data sharing and will include core precision medicine-focused concepts in pancreatic cancer. The suite of CDISC standards – from planning and data collection to organization, analysis and reporting – capture how to structure commonly collected data and outcomes measurements in observational, academic and regulated clinical trials.

The project is being funded through a two-year grant awarded to CDISC by PanCAN.

"Standardizing clinical research data is especially critical with a disease like pancreatic cancer – time is of the essence for patients participating in clinical trials," said PanCAN Chief Data Officer Sudheer Doss, PhD. "With the creation of these new industry-wide standards, which will lead to higher quality data capture, improved efficiencies and cost-savings, data sharing and collaboration within the pancreatic cancer scientific community will be enhanced. This can accelerate clinical advancement and improved patient outcomes. We are pleased to partner with CDISC on this important initiative to benefit patients."

Pancreatic cancer is a devastating disease that is too often diagnosed far too late to respond to currently available treatments," said CDISC President and CEO David R. Bobbitt, MSc, MBA. "CDISC is very pleased to partner with PanCAN to develop the first data standards to drive more meaningful and efficient critical research that will facilitate new treatments. Our work with PanCAN will bring clarity to data."

The TAUG for pancreatic cancer will be freely available via the CDISC website. A machine-readable version designed to facilitate automation in research studies will be available via the CDISC Library API, which all members of the pancreatic cancer research community will be able to access. The anticipated timeline for completion is two years.

On August 27, 2019 Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, reported that its board of directors has appointed Chris Smith as Chief Executive Officer effective September 9, 2019 (Press release, Ortho-Clinical Diagnostics, AUG 27, 2019, View Source [SID1234539027]). Chris will succeed Robert Yates who is stepping down as CEO. Mr. Yates will continue to serve as Ortho’s non-Executive Chairman as a member of the board of directors.

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"I am delighted to lead Ortho as its next CEO," said Mr. Smith. "This is an exciting time for the company and I am thrilled to have the opportunity to work with such a talented group of professionals around the world. I look forward to building upon Ortho’s rich history of customer-focused innovation while taking the business to its next chapter of growth as a global diagnostics leader."

"It has been an honor to serve as Ortho’s CEO," said Mr. Yates. "Ortho is strongly positioned for sustainable and predictable growth, with more efficient operations and talented next-generation leaders. I am excited that we were able to recruit Chris who brings the executive leadership, experience and capabilities to continue Ortho’s transformation and value creation."

Stephen Wise, Managing Director and Global Head of Healthcare for The Carlyle Group, which invested in Ortho Clinical Diagnostics in 2014, said, "We are thrilled to welcome Chris as Ortho’s next CEO. Chris brings over 30 years of healthcare sector experience and has a proven track record driving value creation for multinational businesses. We look forward to a long-term partnership with Chris that we believe will create significant value for Ortho."

Mr. Wise continued, "We are grateful to Robert for his significant contribution to Ortho’s success through his strong leadership in recommitting the entire organization to predictable growth and operational efficiencies. His continued guidance as non-Executive Chairman of the board of directors will ensure a seamless transition for Ortho."

In addition to serving as Ortho’s non-Executive Chairman, Mr. Yates will continue to serve as a senior advisor to The Carlyle Group.

Mr. Smith brings a wealth of leadership and operating experience to Ortho. He most recently served as the CEO of Cochlear Limited, a publicly-traded global medical device company headquartered in Australia, from 2015 through 2018. Under his leadership, Cochlear Limited reached annual sales in excess of AU$ 1 billion dollars while the market cap of the company more than doubled to over AU$ 10 billion dollars (US$ 7.5 billion). Mr. Smith also served as the President of Cochlear Americas for more than a decade. Prior to Cochlear, Mr. Smith held several senior executive roles including CEO in Residence for Warburg Pincus and Global Group President of Gyrus Group Plc., a surgical products company.

Mr. Smith currently serves on the board of directors of several companies including Results Physiotherapy, Nyxoah and Akouos, and was a senior external advisor for McKinsey & Co., AngelMD and EQT Partners. He previously served on the board of directors of publicly-listed Xtent Inc. as well as Startek Inc., Universal Biosensors, Gyrus Group Plc, and Acclarent Inc. Mr. Smith holds a Bachelor of Science degree from Texas A&M University.

On August 27, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, reported that a late-breaking abstract detailing results from a phase 2 study of varlitinib in patients with advanced or metastatic biliary tract cancer in China has been accepted for oral presentation at the upcoming 2019 Chinese Society of Clinical Oncology (CSCO) in Xiamen, China on 19 September 2019 (Press release, ASLAN Pharmaceuticals, AUG 27, 2019, FilingView Source [SID1234539052]).

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Dr Carl Firth, Chief Executive Officer of ASLAN Pharmaceuticals, said: "Our study of varlitinib is the largest clinical trial conducted to date on biliary tract cancer patients in China and we are pleased to see the data we have generated welcomed as an important insight into the treatment of BTC by a prestigious academic group like CSCO."

The abstract titled: "JADETREE*: A phase 2A, single arm, multicenter, study of the panHER inhibitor varlitinib plus capecitabine in Chinese patients with advanced or metastatic biliary tract cancer (BTC)", will be presented in an oral session by Dr. Weijia Fang, Associated Chief Physician , M.D., Department of Medical Oncology, Zhejiang University.

Varlitinib is a highly potent pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. At CSCO, new data will be presented from ASLAN’s phase 2A, single arm, multicenter study of varlitinib plus capecitabine in unselected Chinese patients with second line BTC. Patients with advanced or metastatic BTC who failed on prior first line gemcitabine containing regimens were given varlitinib (300 mg twice daily in a 21-day cycle) plus capecitabine (1,000mg/m2 twice daily for 2 weeks followed by a 7-day rest period).

Presentation date: Thursday, 19 September 2019
Presentation time: 3:30pm – 3:40pm CST

*JADETREE: Joint Assessment of Drug Efficacy of Pan-Her inhibition using Varlitinib in second line BTC in China

Ends

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About varlitinib (ASLAN001)

Varlitinib (ASLAN001) is a highly potent, oral, reversible, small molecule pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. These receptors can be mutated or overexpressed in many tumours, which can cause excessive proliferative activity and uncontrolled growth. Therefore, by inhibiting the activation of the HER receptors, varlitinib could inhibit proliferation and control tumour growth. Varlitinib has been granted orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer, and was awarded orphan drug designation for the treatment of biliary tract cancer by the Ministry of Food and Drug Safety in South Korea.

On August 27, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, reported that the Company anticipates that its current cash position, which includes the $6.7 million in net proceeds from the underwritten offering completed August 16, 2019, will be sufficient to complete enrollment in all three patient groups of its two ongoing Phase 2 clinical trials for its lead compound, VAL-083, which the Company believes will occur by the fourth quarter of calendar year 2020 (Press release, DelMar Pharmaceuticals, AUG 27, 2019, View Source [SID1234539011]).

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"To date, we have had steady enrollment in our two Phase 2 trials, and believe that with the additional capital from our recent financing, we will be in the position to complete enrollment of our Phase 2 clinical trial in China for first-line treatment with radiation for newly diagnosed MGMT-unmethylated GBM patients, as well as both arms of our Phase 2 trial with MD Anderson Cancer Center (MDACC) – one for patients with recurrent disease and one for newly diagnosed patients who have undergone chemoradiation with temozolomide, but will now receive VAL-083 as adjuvant therapy," commented Saiid Zarrabian, president and CEO of DelMar. "We believe the complete enrollment of both of these trials is an important inflection point for the Company and we are grateful to now have the capital to reach that milestone. In the meantime, we expect to provide updates on one or more of these open-label Phase 2 GBM trials at the Society of Neuro-Oncology meeting November 20-24, the American Academy of Cancer Research in April 2020 and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in May 2020."

The Company’s Phase 2 trial in China is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care temozolomide (TMZ) plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population. To date, the Company has enrolled 20 of the 30 patients required for the trial, with positive early results previously reported.

The Company is also conducting a Phase 2 trial with MDACC with one arm treating patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled. The second trial arm will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. The Company will provide enrollment and treatment updates as appropriate.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional, DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers, including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source

On August 27, 2019 Lannett Company, Inc. (NYSE: LCI) reported financial results for its fiscal 2019 fourth quarter and full year ended June 30, 2019 (Press release, Lannett, AUG 27, 2019, View Source [SID1234539028]).

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"In fiscal 2019, we made excellent progress rebuilding our business," said Tim Crew, chief executive officer of Lannett. "We feel positive about our company’s future following a number of significant accomplishments. Since January 2018, we have launched 25 products with annualized sales of approximately $100 million, acquired or in-licensed more than 40 ANDAs and paid down approximately $187 million of our outstanding debt, which included $87 million of voluntary payments. In the past year, we have expanded existing strategic alliances and established new ones, and submitted to the FDA nine product applications, all while we implemented and recently completed a net $33 million cost savings plan.

"Financial results for our fiscal 2019 fourth quarter, the first full quarter of the fiscal year without sales of Levothyroxine, exceeded or were at the upper end of our expectations. The quarter did benefit from a few items that were related to timing.

"Looking ahead, we expect to launch a number of new products that will continue to build our business in the near term and have begun adding products to our pipeline that have significant potential in the medium term and beyond."

For the fiscal 2019 fourth quarter, on a GAAP basis, net sales were $133.8 million compared with $170.9 million for the fourth quarter of fiscal 2018. Gross profit was $49.3 million, or 37% of total net sales, compared with $66.5 million, or 39% of total net sales. Research and development (R&D) expenses were $9.4 million compared with $8.3 million for the fiscal 2018 fourth quarter. Selling, general and administrative (SG&A) expenses were $22.2 million compared with $20.6 million. Restructuring expenses were $2.4 million compared with $4.1 million. Asset impairment charges were $5.9 million compared with $25.0 million for the prior year fourth quarter. Operating income increased to $9.4 million from $8.6 million. Interest expense decreased to $20.2 million from $21.2 million for the fourth quarter of fiscal 2018. Net loss was $7.6 million, or $0.20 per share, compared with $11.4 million, or $0.30 per share, for the fiscal 2018 fourth quarter.

For the fiscal 2019 fourth quarter reported on a Non-GAAP basis, net sales were $133.8 million compared with $170.9 million for the fourth quarter of fiscal 2018. Adjusted gross profit was $59.8 million, or 45% of adjusted net sales, compared with $76.0 million, or 44% of adjusted net sales, for the prior-year fourth quarter. Adjusted R&D expenses were $8.6 million compared with $8.3 million. Adjusted SG&A expenses were $17.0 million compared with $17.4 million. Adjusted operating income was $34.1 million compared with $50.3 million for the prior-year fourth quarter. Adjusted interest expense was $16.0 million compared with $16.6 million for the fourth quarter of fiscal 2018. Adjusted net income was $14.7 million, or $0.37 per diluted share, compared with $24.5 million, or $0.64 per diluted share, for the fiscal 2018 fourth quarter.

For the fiscal 2019 full year, on a GAAP basis, net sales were $655.4 million compared with $684.6 million for the fiscal 2018 full year. Gross profit was $243.6 million, or 37% of total net sales, compared with $288.7 million, or 42% of total net sales. R&D expenses were $38.8 million compared with $29.2 million for the fiscal 2018 full year. SG&A expenses were $87.6 million compared with $82.2 million. Restructuring expenses were $4.1 million compared with $7.1 million. The company reported operating loss of $262.3 million, which included asset impairment charges of $375.4 million. This compares to fiscal 2018 full year operating income of $129.7 million, which included asset impairment charges of $25.0 million and a loss on sale of intangible asset of $15.5 million. Interest expense decreased to $84.6 million from $85.6 million. Net loss was $272.1 million, or $7.20 per share, versus net income of $28.7 million, or $0.75 per diluted share, for fiscal 2018.

For the fiscal 2019 full year reported on a Non-GAAP basis, net sales were $655.4 million compared with $684.6 million for the fiscal 2018 full year. Adjusted gross profit was $291.4 million, or 44% of adjusted net sales, compared with $326.2 million, or 48% of adjusted net sales, for the prior year. Adjusted R&D expenses were $36.1 million compared with $29.2 million. Adjusted SG&A expenses were $71.2 million compared with $71.0 million. Adjusted operating income was $184.1 million compared with $226.0 million for the prior year. Adjusted interest expense was $67.0 million compared with $65.4 million for fiscal 2018. Adjusted net income was $91.8 million, or $2.35 per diluted share, compared with $118.2 million, or $3.10 per diluted share, for the fiscal 2018 full year.