On April 26, 2019 PharmaMar (MSE:PHM) has reported an agreement with Hong Kong listed Luye Pharma Group Ltd. (HKG:2186) to develop and commercialize the marine-inspired anti-tumor compound, lurbinectedin (Zepsyre) in Small Cell Lung Cancer (SCLC), and potentially in other indications in China, Hong Kong and Macao (Press release, PharmaMar, APR 26, 2019, View Source [SID1234535426]).

Under the terms of this agreement, PharmaMar will receive an up-front payment of US $5 million followed by additional payments for regulatory and sales milestones, as well as double-digit royalties. This income may be increased if other therapeutic indications are approved.

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Luye Pharma will commit to develop lurbinectedin in SCLC in China, while PharmaMar will retain exclusive production rights for the compound.

José María Fernández Sousa-Faro, PhD, President of PharmaMar, commented, "PharmaMar is delighted to team-up with Luye Pharma Group Ltd. for China, a leader in the above mentioned space with an outstanding track record in Oncology, that has successfully brought innovative cancer medicines to Chinese patients."

Rongbing Yang, President of Luye Pharma Group Ltd., said about this new licensing deal: "This agreement with PharmaMar enables us to address the treatment of this type of disease in China, which is much more widespread than in the US and Europe.Oncology is one of the core therapeutic areas for Luye Pharma’s long-term development. We will continue to increase investment to further enrich our oncology pipelines and enhance our competitiveness in this field of treatment, through external partnerships with more innovative companies such as PharmaMar and also through our in-house R&D innovation".

2 According to data from the World Health Organization (WHO), China has the highest number of cancer cases in the world, due to population ageing, tobacco and pollution. China is also the country with the highest mortality rate in Asia for lung cancer. This type of tumor affects a larger number of people than in the U.S., Europe and Japan combined. The WHO estimates that by 2020, 800,000 new cases of lung cancer will be diagnosed and will cause nearly 700,000 deaths. It is estimated that SCLC represents approximately 18% of all lung cancers in China.

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On April 26, 2019 BioInvent International AB (OMXS: BINV) reported that it has received a €0.75 million milestone payment under its collaboration with Mitsubishi Tanabe Pharma Corporation in connection with enrollment of the first patient in a Phase II clinical trial of an antibody identified from BioInvent’s proprietary n-CoDeR antibody library (Press release, BioInvent, APR 26, 2019, View Source [SID1234535427]).

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The license agreement with Mitsubishi Tanabe Pharma covers development of antibodies from the n-CoDeR antibody library.

"It is very satisfying to see that our high quality recombinant human antibody library n-CoDeR is not only delivering candidates for BioInvent’s proprietary programs, but is also proving beneficial for our partners in developing their own pipeline," said BioInvent CEO Martin Welschof.

Under the terms of the agreement, payments are due to BioInvent when certain clinical milestones are achieved and royalty payments are due when a product is sold on the market. Enrollment of a first patient in a Phase II clinical trial is a milestone that triggers a payment to BioInvent.

On April 26, 2019 Andarix Pharmaceuticals, a leader in the discovery and development of targeted peptide therapy for cancer reported that it has been granted the US trademark for Tozaride by the United States Patent and Trademark Office (Press release, Andarix Pharmaceuticals, APR 26, 2019, View Source [SID1234535413]).

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About Tozaride
Tozaride is a novel, best-in-class cancer therapy based on a radio-labeled somatostatin peptide analogue. Early clinical studies of Tozaride demonstrated that it is well tolerated and may produce prolonged stable disease and improved overall survival in advanced lung cancer patients whose disease has continued to progress after failing other therapies. Tozaride targeted radiotherapy represents a new treatment paradigm which is expected to yield significant clinical benefit for both lung cancer (SCLC, NSCLC), and pancreatic cancer patients. Along with its companion diagnostic that helps identify patients most likely to respond – those with enough expression of the peptide’s target – Tozaride could provide another treatment option for patients who are not eligible for, or who have not responded to current therapies.

On April 26, 2019 PharmaMar Group (MSE: PHM) reported total sales of €18.4 million in the first three months of 2019, compared to €19.7 million in the same period of 2018 (Press release, PharmaMar, APR 26, 2019, View Source [SID1234535430]). Sales of Yondelis accounted for €17.1 million, compared to €18.4 million in March 2018. As in previous quarters, price erosion was one of the main factors behind the difference in Yondelis sales figures between quarters.

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During the first three months of 2019, royalty income of €0.9 million was recorded, compared to €1.4 million during the first three months of the previous year. In relation to license revenues, no license revenues were recorded in the first quarter of 2019, which explains the difference in total revenues in this period (€19.4 million, compared to €27.8 million in 2018). After the closing date, a license agreement has been signed with Luye Pharma Group Ltd. for the marketing of Zepsyre (lurbinectedin) in China, with an initial payment of US$5 million as part of the agreement, which will be registered in the second quarter of this year.

Sales in the consumer chemicals sector, which grew by 16.6% in the first quarter, are not included in the Group’s total revenues as the companies forming part of the sector were classified as available for sale/interrupted operations, both in March 2019 and in the same period in 2018.

As a result, at the end of the first quarter of 2019, the group’s EBITDA was €-7.1 million compared to €-2.6 million in March 2018.

At March 31, 2018, the Group’s profit from continuing operations was €-10.4 million compared to €-2.5 million in the first quarter of 2018.

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On April 26, 2019 RhoVac AB ("RhoVac") reported that the company has received a written response from the Food and Drug Administration (FDA), USA regarding to the recently completed pre-IND meeting on development of the company’s drug candidate RV001 (Press release, RhoVac, APR 26, 2019, View Source [SID1234555931]). The subject of the meeting was to obtain agreement with the Agency regarding the scope of currently available data and the necessary data to support an IND submission for the clinical phase 2 trial in prostate cancer patients. Furthermore, the purpose of the meeting was to discuss with the agency and reach concurrence regarding the initial IND study protocol in the identified study population, the proposed endpoints along with the proposed safety monitoring. The FDA has confirmed that no further preclinical studies are required to support clinical development of the company’s clinical phase II trial in USA and that the design and the defined end-points in the study are relevant to document clinical proof of concept in treatment of prostate cancer patients with the company’s drug candidate RV001.

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In alignment with the company’s original development schedule, RhoVac contacted the FDA in early 2019, and in March the company announced that FDA had accepted RhoVac’s request for a pre-IND meeting. A pre-IND meeting is comparable to a Scientific Advice Procedure in the EU, which RhoVac concluded in mid-2018. Following confirmation of the pre-IND meeting, the company submitted a Briefing Package which FDA has now evaluated and the response to our questions is based on this background information.

In conclusion, the FDA agrees that, in relation to USA, no further preclinical studies are required in support of a clinical phase II trial in prostate cancer patients. The identical study protocol is currently under review in Denmark with subsequent review in other European countries. The FDA also commented that the company’s approach in developing the quality specification for the drug candidate RV001 complies with relevant regulatory guidelines. In the response relating to the proposed clinical trial, the FDA agrees that the definition of the patient population, which we plan to recruit for the clinical study, is well-defined and that the clinical end-points set in the study are relevant in order to document clinical proof on concept.

Comments from RhoVac´s CEO, Anders Ljungqvist

-A pre-IND meeting may be a face-to-face meeting at FDA in Washington DC, a telephone conference or a written response. Based on the questions and the background information we forwarded the FDA, FDA assessed to have adequate background to be able to respond in writing. It is gratifying that the FDA confirms that we have correctly interpreted the regulatory guidelines in USA enabling us to continue our clinical development of RV001 based on the same strategy as used within the EU. A big thank you to employees and external consultants for a very professional and valuable work.