PHARMA MAR (PHM.MC) -- ehemals Zeltia (Seite 67)

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PharmaMar and Boryung Pharm sign a licensing agreement for Zepsyre® (lurbinectedin) in Korea


* SIGNS LICENSING AGREEMENT WITH BORYUNG PHARM TO COMMERCIALIZE THE MARINE-DERIVED ANTICANCER DRUG ZEPSYR (LURBINECTEDIN), IF APPROVED, IN SOUTH KOREA

* TO RECEIVE A NON-DISCLOSED UPFRONT PAYMENT AND TO BE ELIGIBLE FOR ADDITIONAL REMUNERATIONS UPON ACHIEVING REGULATORY AND SALES MILESTONES

* TO RETAIN EXCLUSIVE PRODUCTION RIGHTS AND TO SELL THE PRODUCT TO BORYUNG PHARM FOR COMMERCIAL USE

* ZEPSYRE IS CURRENTLY IN LATE-STAGE CLINICAL DEVELOPMENT FOR PLATINUM-RESISTANT OVARIAN CANCER AND FOR SMALL-CELL LUNG CANCER

http://www.reuters.com/article/idUSL5N1ND3A7

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EMEA

2.1. Pre-authorisation procedure oral explanations

2.1.2. plitidepsin - Orphan - EMEA/H/C/004354

Pharma Mar, S.A.; treatment of multiple myeloma
Scope: Oral explanation
Action: Oral explanation to be held 7 November 2017 at time 11:00

http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/…

[Marenostrum]

Der Putsch-Demon ist Geschichte...

Aus Spanien hört man ein deutliches Aufatmen. Hoffentlich war das bereits die politische Börse mit den kurzen Beinen. Wäre schön. Der PHM-Aktienkurs geht jedenfalls heute wieder deutlich nach oben (aktuell +5%) und damit in die richtige Richtung, die der Unternehmensentwicklung entspricht. Weiter so.

[bonDiacomova]

Antwort auf Beitrag Nr.: 55.401.137 von bonDiacomova am 27.07.17 06:59:14

Q III 2017

verk. yondelis - Las ventas de Yondelis®, ascienden a 64,6 millones de euros

Q I 2017 - 22,5 mil
Q II 2017 - 20,8 mil
Q III 2017 - 21,3 mil

Q I 2016 - 22,8 mil
Q II 2016 - 22,9 mil
Q III 2016 - 21,3 mil
Q IIII 2016 - 20,0 mil

[Marenostrum]

Schon wieder "langweilige" Zahlen von Pharmamar

PHM hat heute seine Geschäftszahlen für die ersten neun Monate in 2017 bekanntgegeben. Die Umsätze sind stabil. Der ausgewiesene Verlust konnte erneut gegenüber dem Vorjahres-Vergleichszeitraum reduziert werden. Forschung und Entwicklung laufen plangemäß und für 2018 darf wieder Einiges an Positivmeldungen (evtl. auch weitere Zulassungen) erwartet werden. Und wenn sich dann auch noch die gegenwärtige "Spanische Grippe" (Katalonien) beruhigt hat, dürfte auch der Aktienkurs wieder deutlich steigen.

Hier die heutige Meldung:

Pharma Mar group revenues totalled €140 million in the first nine months of the year
Group EBITDA improved with respect to the same period last year
The Group net attributable loss improved +13% compared to 2016

Madrid, 24th October, 2017: The Pharma Mar (MSE: PHM) group registered total net sales of €140 million in the first nine months of 2017, a 0.6% increase with respect to the same period last year. Total revenues in the oncology segment (sales plus royalties and licensing revenues) amounted to €75.6 million, 0.2% more to the same period last year (€75.4 million).

Yondelis® sales amounted to €64.6 million, slightly less than in the same period of 2016 due primarily to price erosion in some European countries; Yondelis® royalties from our partners amounted to €3.9 million and licensing revenues to €7.1 million. The consumer chemicals division reported a 2.1% increase in revenues to €60.4 million.

Group EBITDA improved an 18% in the first nine months of 2017 to -€4.6 million, compared with -€5.6 million in the same period of 2016. This was due mainly to containment of operating expenses (R&D, marketing and commercial, administration, etc.), which fell 2.3% in the first nine months. This improvement in operating costs was achieved without modifying the existing operating plan or the clinical trial programs. Enrolment continues for the Phase III trial with Zepsyre® in small cell lung cancer, which is expected to complete enrolment next year. Also, the Committee for Medicinal Products for Human Use (CHMP) is expected to give their opinion by year-end to the Marketing Authorization Application (MAA) for Aplidin® in Europe for the treatment of multiple myeloma. And the outcome of the Phase III trial with Zepsyre® in platinum-resistant ovarian cancer is expected early next year.

As a result, the Group reported a net attributable loss of -€14.53 million in the first nine months of 2017, compared with -€16.6 million in the same period of 2016.

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an overall survival of 21.3 months

With regards to progression free survival, in this study Yondelis® reached 5.9 months
improving the 4.6 months of another recently approved drug for this indication

Madrid, October 24th , 2017.
Yondelis® (trabectedin) provides a long term clinical benefit to patients with soft tissue sarcoma...
... Y-IMAGE Phase IV study that evaluated the clinical practice of Yondelis®

With regards to overall survival, Yondelis® reached 21.3 months in this
observational Phase IV study improving the 12.5 months and the 13.5 months
observed in the phase III pivotal studies of these drugs.

In the Y-IMAGE study, more than half the patients didn´t show signs of worsening,
in fact, 15% reported less pain and asthenia, 22% felt well during remission of the
illness and during the treatment with trabectedin. The disease control rate (overall
response, partial response and stabilization of the disease) was 65.6%, including 3
total responses and an objective response rate (overall response and partial
response) in 26.6% of cases.

https://www.pharmamar.com/wp-content/uploads/2017/10/PR_-Y-I…

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...yo scheint anzulaufen und gegen Ende des Monats sollten noch die Quartalszahlen bekanntgegeben werden, bin positiv gespannt.

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Presentation selected for “Best of Day” session

Final data on phase I/II in small-cell lung cancer with Zepsyre®
presented at the IASCLC 18th World Conference on Lung Cancer in Japan

Madrid, October, 18th 2017

Dr. Emiliano Calvo, Director of the START Madrid Group, and the Director of
Clinical Research at START Madrid-CIOCC, Hospital Madrid Norte Sanchinarro,
presented final data of the abstract 9249 titled “Activity and Safety of the
Combination of PM 01183 and Doxorubicin in Relapsed SCLC; Final results
of a Phase Ib trial”.

As Dr Calvo said “what we have seen is an exceptional Progression Free Survival
benefit, and in patients treated with PM1183 in combination with doxorubicin we
saw 21 of 27 patients experience some tumor reduction. And this while better
managing patient tolerability. In fact, when we look at the toxicities by number of
cycles, we can see that they are easily and successfully managed in the day to day
life of patients with growth factors and early cycle dose reductions.”

https://www.pharmamar.com/wp-content/uploads/2017/10/PR_Worl…

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World Lung Conference in Japan - SCLC

The study has been selected as an oral presentation.
The Final Phase I/II activity and safety data of the combination
of lurbinectedin (PM1183) and doxorubicin in relapsed small-cell lung cancer

This study shows that patients treated with PM1183 in combination with
doxorubicin (Phase I/II clinical trial) reached a progression free survival (5.3
months) which compares favorably with historical data of topotecan as a single
agent (the PFS varies between 3.1 and 3.5 months). The objective response rate, a
37% is observed in patients in a combination between PM1183 and doxorubicin
compares to historical data of topotecan in relapsed disease of between 17% and
24%. In platinum sensitive patients, the progression free survival observed in
patients treated with PM1183 in combination with doxorubicin increases up to 6.2
months. https://www.pharmamar.com/wp-content/uploads/2017/10/PR_Worl…




PharmaMar reicht Marktzulassungsgesuch für Aplidin in der Schweiz ein
Das behördliche Verfahren für ein onkologisches Arzneimittel in
der Schweiz ist von jenem der Europäischen Arzneimittel-Agentur
(European Medicines Agency, EMEA), bei welcher PharmaMar das
entsprechende Gesuch Ende 2016 eingereicht hatte, unabhängig.
http://www.finanznachrichten.de/nachrichten-2017-10/41884711…

[pischtie_hufnagel]

Vielen Dank für die Infos, ...schaut momentan nach gap-close bei um die 2,9...aus, baue hier nun wieder erste Positionen auf.