On August 26, 2020 RareCyte reported a new dual biomarker liquid biopsy assay for androgen receptor splice variant 7 (ARv7) and the neuroendocrine marker, synaptophysin (SYP), enabling customers to evaluate both ARv7 and SYP expression on circulating tumor cells (CTCs) with industry leading accuracy and precision in patients with prostate cancer (Press release, RareCyte, AUG 26, 2020, https://www.prnewswire.com/news-releases/rarecyte-announces-first-commercially-available-arv7synaptophysin-ctc-assay-for-blood-based-characterization-of-treatment-resistant-prostate-cancer-301118268.html [SID1234564074]). The ARv7/Synaptophysin Panel Kit was validated based on rigorous requirements set to clinical standards and enables blood-based investigation of two prominent mechanisms by which tumors become resistant to second-line endocrine therapies.

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"Resistance to second-line anti-androgen therapies has emerged as an important clinical challenge," explained Eric Kaldjian, MD, Chief Medical Officer of RareCyte. "New therapies are in development to target the resistance mechanisms. Identification of ARv7 and synaptophysin on CTCs via a non-invasive blood sample will allow investigational monitoring for tumor transformation, as well as confirmation of clinically suspected resistance in multi-center clinical trials."

The assay comprises processing blood to slides with the AccuCyte Sample Preparation System followed by staining with the RarePlex 0919-LB ARv7/Synaptophysin CTC Panel Kit and imaging on a CyteFinder Instrument. Machine learning enabled analysis and scoring maximizes reviewer concordance. In addition, the RareCyte platform enables cell-free DNA analysis on the same sample, providing a comprehensive liquid biopsy assessment of tumor status.

"In prostate cancer, ARv7 has been associated with resistance to certain therapies, and SYP is a commonly used histologic marker for the neuroendocrine phenotype," said Amir Goldkorn, MD, an oncologist at University of Southern California (USC) Norris Cancer Center and associate professor of medicine at Keck School of Medicine of USC. Goldkorn and his collaborators at USC Norris Cancer Center collaborated with RareCyte to validate the assay. "Using the ARv7/SYP assay, it will be exciting to test whether CTCs bearing these markers are associated with unique biological phenotypes or clinical outcomes in men with prostate cancer."

The ARv7/Synaptophysin CTC Panel Kit is now available for purchase; more information on the kit and the RareCyte platform is available at View Source

On August 26, 2020 Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, reported the first patient dosed in the multicenter, single-arm, open-label Phase 1 study assessing the safety, distribution, and dosing of Debio 1124 in patients with advanced, unresectable pulmonary and extrapulmonary small cell carcinoma. This targeted, investigational radiotherapy belongs to the emerging class of Peptide Receptor Radionuclide Therapies (PRRT), having been designed to selectively deliver molecular radiotherapy to tumor cells expressing the cholecystokinin 2 receptor (CCK2R) (Press release, Debiopharm, AUG 26, 2020, View Source [SID1234564073]). Research will leverage a theranostic approach, combining both diagnostic and therapeutic capacities of the compound. This will allow the pre-identification of patients who have the CCK2R receptors necessary to respond to the targeted radiotherapy using an imaging dose of Debio 1124 followed by a therapeutic dose of the same compound for qualifying patients only.

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The advancement of the Debio 1124 program is part of Debiopharm’s expanding radio-oncology pipeline including other radio-pharmaceutical and chemoradiotherapy enhancing compounds. Initially discovered by the Swiss based Paul Scherrer Institute (PSI), before being licensed by Debiopharm, Debio 1124 has shown anti-tumor activity in pre-clinical cancer models. The advancement of Debio 1124 into this clinical study may reveal improved therapeutic results for suffering from pulmonary and extrapulmonary small cell carcinoma.

"We’re very excited to bring the potential benefit of molecular radiotherapy to patients with small cell lung cancer showing expression of CCK2R. PRRT has the potential to impact the tumor while minimizing the off-target effects," explained Carlos Chanquia, Medical Director of Oncology at Debiopharm.

SCLC is a highly aggressive cancer associated with patients over 65 years old with a history of smoking. Without treatment, extensive stage small cell lung cancer (ES-SCLC), representing approximately two-thirds of all cases, is rapidly and invariably fatal.1 Combination chemotherapy induce dramatic but short-lived responses, with median overall survival in the third line setting <6 months. Ongoing research will evaluate if SCLC could potentially benefit from this specifically targeted radiotherapy.

About Debio 1124
Debio 1124 is a new-generation peptide analogue of minigastrin, coupled to the isotope Lutetium 177 (177Lu) designed to selectively deliver molecular radiotherapy to tumor cells expressing the Cholecystokinin B Receptor (CCK2R). The compound can be used as both a diagnostic tool during initial imaging step and subsequently as an intravenous radio-pharmaceutical for treatment. This targeted, theragnostic compound is being researched in various cancer types including advanced Medullary Thyroid Cancer (MTC) and SCLC.

Debiopharm’s commitment to cancer patients
Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

On August 26, 2020 Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Code: 600196.SH, 02196.HK), a leading healthcare group in China, reported its interim results for the year 2020 ("the Reporting Period") (Press release, Fosun Pharma, AUG 26, 2020, View Source [SID1234564072]).

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During the Reporting Period：

The revenue achieved RMB 14,028 million;
The net profit attributable to shareholders of the listed company amounted to RMB 1,715 million, representing a respective increase of 13.1%;
The net profit attributable to shareholders of the listed company after deduction of non-recurring amounted to RMB 1,304 million, representing a respective increase of 11.71%.
Wu Yifang, President and CEO of Fosun Pharma, expressed that "the COVID-19 brings relatively huge influence and uncertainty to the global and China’s economy. In the first half of 2020, with the orderly work resumption, the production and operation resumed in Q2. The operating revenue in Q2 increased by 38.6% compared with Q1. On the basis of properly carrying out the existing business and industrial upgrading, Fosun Pharma is firmly committed to the path of innovation and international development, thereby maintaining the long-term growth of our performance."

Actively promoted innovation transformation and strengthened the global R&D system together with the capacity building of pharmaceuticals

Fosun Pharma continues to be guided by innovation and internationalization, vigorously develop strategic products, improve the "Combination of integrates biosimilars and innovative drugs" R&D system, and further strengthen R&D investment. In the first half of 2020, Fosun Pharma invested RMB 1,689 million in R&D, an increase of 25.02% compared to the same period last year, of which the R&D expenditure was RMB 1,204 million, an increase of 41.81% compared to the same period in 2019. As of the end of the Reporting Period, Fosun Pharma had 248 pipeline innovative drugs, generic drugs, biosimilars and consistency evaluation projects of generic drugs.

In order to strengthen the global R&D system and capacity building of pharmaceuticals, Fosun Pharma established the Global R&D Center in early 2020, which is responsible for the overall management of the Group’s innovative R&D projects. Focusing on China, the United States and Europe to strengthen preclinical drug research, the ability of clinical development and transforming medicine. Currently, Fosun Pharma has already established interactive and integrated R&D systems in China, the United States and India, and created international R&D platforms including biological drugs, small molecular innovative drugs, high-value generic drugs, new technology therapy.

In the Reporting Period, sales of Rituximab injection (汉利康) increased rapidly after the approval of the new production scale (2,000L), with revenue of RMB 224 million in the first half of the year and more than RMB 100 million revenue in June; Avatrombopag maleate tablets (苏可欣), the first licensed drug for selective thrombocytopenia treatment of adult patients with chronic liver disease undergoing diagnostic procedures or surgery had been approved to market. As of the end of the Reporting Period, Fosun Pharma has obtained approval for clinical trial in Chinese Mainland on 10 small molecule innovative products (including 1 improved new drug) and 11 indications; as well as approval for overseas clinical trials for 5 small molecule innovative drugs and 5 indications. In particular, ORIN1001 had launched phase I clinical trials in the U.S. and recognized by the U.S. Food and Drug Administration (”U.S. FDA”) under the Fast Track Development Program. SAT-189 had been approved to phase II clinical trials in the U.S.; and 10 monoclonal antibody products and 8 combination therapies had launched more than 20 clinical trials worldwide; Axicabtagene Ciloleucel (code FKC876, i.e. anti-human CD19 CAR-T cell injection) of Fosun Kite, a joint venture, completed the bridging clinical trial of the Product for the treatment of adult patients with relapsed and refractory large B-cell lymphoma in Chinese Mainland and commenced clinical trials in Chinese Mainland and was granted priority review status for the launch and registration of drugs. During the Reporting Period, the subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharmaceutical Industrial") was approved to conduct clinical trial in Chinese Mainland by the National Medical Products Administration (the "NMPA") for the mRNA-based COVID-19 vaccine candidate which had been approved by BioNTech.

Integrated operation, improved efficiency and steady international development

Fosun Pharma adheres to actively promote the development of innovation field. Meanwhile, Fosun Pharma continues to strengthen the construction and integration of the marketing system, and the marketing mode is transformed towards specialization, branding and digitalization. Fosun Pharma has formed a domestic and foreign marketing network and marketing team matched with the existing products and products to be listed on the market. In particular, domestic marketing has built a strong ability and management system in the field of high-end diagnosis and treatment of hematological tumors. By the end of the Reporting Period, Fosun Pharma had formed a marketing team of nearly 5,800 people, and nearly 1,000 staff for overseas drugs and medical devices are included. In the field of drug and device distribution and retailing, Fosun Pharma gives full play to the advantages of Sinopharm’s distribution network and logistics through cooperation and linkage with Sinopharm Industrial Investment Co., Ltd. to promote the expansion of drug sales channels of Fosun Pharma.

During the Reporting Period, Fosun Pharma achieved RMB 4,071 million operating revenue, accounting for 29.02% of the total. In terms of international expansion, Fosun Pharma not only established subsidiaries and developed its operating capability in mature markets such as the US and Europe, but also developed markets and production capacity through self-development and M&A in emerging markets such as Africa and India. Meanwhile, Fosun Pharma further consolidated its competitiveness in the African market, build marketing platforms in the United States and Europe, promoted in-depth cooperation with multinational pharmaceutical companies, and increased the drug sales scale of Fosun Pharma in the international market.

Fought against COVID-19 with science and technology to practice social responsibility

In the first half of 2020, in the face of the unexpected COVID-19 pandemic, Fosun Pharma fully combined its own business characteristics and global resource advantages, quickly respond to the epidemic and actively assumed social responsibility during the process of fighting the COVID-19.

In order to meet the needs of medical materials for epidemic prevention and control in time, Fosun Pharma joined hands with global member enterprises to ensure the research, development, procurement and production of medical materials. In particular, the independently-developed 2019-nCoV nucleic acid detection kit (PCR) passed the emergency examination and obtained the approval of the National Medical Products Administration (NMPA) and the medical device registration certificate (in vitro diagnostic reagent). A number of COVID-19 test kits have obtained the relevant qualifications and certification from the United States, the European Union, Australia and other countries and regions. In addition, Fosun Pharma also actively cooperates with BioNTech in Germany to develop mRNA vaccine, undertake the production of national negative pressure ambulances, produce and dispatch global supply of ventilators, and provide mobile CT innovative medical equipment to help reduce the risk of multi-department cross-infection caused by patient transfer.

As of the Reporting Period, the cumulative value of cash or medical masks, protective clothing, medical non-invasive ventilators, negative pressure ambulances and other medical equipment and daily necessities donated by Fosun Pharma to the epidemic area had exceeded RMB 30 million. In Wuhan, Wuhan Jihe Hospital, a designated medical institution under COVID-19, cured 515 patients, with a mortality rate of 0 and an infection rate of 0 for medical personnel.

On August 26, 2020 Penumbra, Inc. (NYSE: PEN) reported that its management team is scheduled to present at the Wells Fargo 2020 Virtual Healthcare Conference on Wednesday, September 9, 2020 (Press release, Penumbra, AUG 26, 2020, View Source [SID1234564071]).

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Event: Wells Fargo 2020 Virtual Healthcare Conference
Date: Wednesday, September 9, 2020
Time: 3:20pm EDT / 12:20pm PDT

A webcast of the presentation will be available by visiting the investors’ section of the company’s website at www.penumbrainc.com. The webcast will be available on the company’s website for at least two weeks following the event.

On August 26, 2020 Lannett Company, Inc. (NYSE: LCI) reported financial results for its fiscal 2020 fourth quarter and full year ended June 30, 2020 (Press release, Lannett, AUG 26, 2020, View Source [SID1234564070]).

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"For both the fiscal 2020 full year and fourth quarter, our net sales and profitability exceeded expectations, driven in large part by a strong performance of our base portfolio and 18 and six new product launches during the year and quarter, respectively," said Tim Crew, chief executive officer of Lannett. "Moreover, during the fourth quarter, we increased our cash position by more than $40 million to approximately $144 million at year end, due to initiatives implemented to improve working capital. We intend to use a portion of the cash to pay down, in full, our Term A Loans at their maturity in November of this year.

"Thus far in fiscal 2021, we have implemented and nearly completed a restructuring and cost reduction plan that we estimate will lower our expenses by approximately $15 million, annually, and launched four new products, including Levothyroxine Tablets. Over the course of the coming year, we intend to continue to launch a number of new products and expand our pipeline through in-house development efforts, as well as in-licensing agreements. We are especially excited and optimistic about recent clinical progress related to a number of drug candidates in our portfolio that have very large addressable markets; we believe these products also have durable value and the potential to be catalysts for significant growth.

"We have provided guidance for the upcoming year, which includes the expected contribution from a number of new product launches in the coming year and a full year of contribution from the 18 products we launched in fiscal 2020. Our outlook also reflects recent and anticipated competitive pressure on certain key products, as well as lower operating expenses as a result of our recently announced restructuring and cost reduction plan."

For the fiscal 2020 fourth quarter on a GAAP basis, net sales were $137.9 million compared with $133.8 million for the fourth quarter of fiscal 2019. Gross profit was $39.6 million, or 29% of net sales, compared with $49.3 million, or 37% of net sales. The company recorded asset impairment charges of $18.8 million compared with $5.9 million in the prior-year fourth quarter. Net loss was $9.7 million, or $0.25 per share, compared with $7.6 million, or $0.20 per share, for the fourth quarter of fiscal 2019.

For the fiscal 2020 fourth quarter reported on a Non-GAAP basis, net sales were $137.9 million compared with $133.8 million for the fourth quarter of fiscal 2019. Adjusted gross profit was $48.9 million, or 35% of net sales, compared with $59.8 million, or 45% of net sales, for the prior-year fourth quarter. Adjusted interest expense decreased to $11.3 million compared with $16.0 million for the fourth quarter of fiscal 2019. Adjusted net income was $13.4 million, or $0.31 per diluted share, compared with $14.7 million, or $0.37 per diluted share, for the fiscal 2019 fourth quarter. Adjusted EBITDA for the fiscal 2020 fourth quarter was $35.2 million.

For the fiscal 2020 full year, on a GAAP basis, net sales were $545.7 million compared with $655.4 million for the fiscal 2019 full year. Gross profit was $165.2 million, or 30% of total net sales, compared with $243.6 million, or 37% of total net sales. The company recorded asset impairment charges of $34.4 million compared with $375.4 million for fiscal 2019. Net loss was $33.4 million, or $0.86 per share, compared with $272.1 million, or $7.20 per diluted share, for fiscal 2019.

For the fiscal 2020 full year reported on a Non-GAAP basis, net sales were $545.7 million compared with $655.4 million for the fiscal 2019 full year. Adjusted gross profit was $204.0 million, or 37% of adjusted net sales, compared with $291.4 million, or 44% of adjusted net sales, for the prior year. Adjusted interest expense significantly declined to $52.5 million from $67.0 million for fiscal 2019. Adjusted net income was $45.6 million, or $1.07 per diluted share, compared with $91.8 million, or $2.35 per diluted share, for the fiscal 2019 full year.

Guidance for Fiscal 2021

Based on its current outlook, the company provided guidance for fiscal year 2021, as follows:

GAAP

Adjusted**

Net sales

$520 million to $545 million

$520 million to $545 million

Gross margin %

Approximately 23% to 25%

Approximately 29% to 31%

R&D expense

$29 million to $32 million

$29 million to $32 million

SG&A expense

$59 million to $62 million

$55 million to $58 million

Restructuring expense

$4 million to $5 million

$ —

Interest and other

$53 million to $54 million

$41 million to $42 million

Effective tax rate

Approximately 34% to 35%

Approximately 21% to 22%

Adjusted EBITDA*

N/A

$100 million to $110 million

Capital expenditures

$15 million to $20 million

$15 million to $20 million

**A reconciliation of Adjusted amounts to most directly comparable GAAP amounts can be found in the attached financial tables.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 4:30 p.m. ET to review its results of operations for its fiscal 2020 fourth quarter ended June 30, 2020. The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49903262. The call will be broadcast via the Internet at www.lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s financial status and performance, regulatory and operational developments, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including Adjusted EBITDA, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). Management uses these measures internally for evaluating its operating performance. The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. The company also believes that including Adjusted EBITDA, as defined in the company’s existing Credit Agreement, is appropriate to provide additional information to investors to demonstrate the company’s ability to comply with financial debt covenants. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP.

Detailed reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are included with this release.

Non-GAAP financial measures exclude, among others, the effects of (1) amortization of purchased intangibles and other purchase accounting entries, (2) restructuring expenses, (3) non-cash interest expense, as well as (4) certain other items considered unusual or non-recurring in nature.

*Adjusted EBITDA excludes the same adjustments discussed above, as well as additional adjustments permitted under the company’s existing Credit Agreement.