Pharma Mar SA: 1 director

A director at Pharma Mar SA bought 600 shares at 77.430EUR and the significance rating of the trade was 54/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly sh...

For PHARMA MAR SA, the environment deterioration entails a downgrade t...

PHARMA MAR SA (ES), a company active in the Pharmaceuticals industry, now shows a lower overall rating. The independent financial analyst theScreener just confirmed the fundamental rating of 4 stars out of 4, as well as the stock market behaviour of the title as moderately risky. However, environmental deterioration penalises the general evaluation, which is downgraded to Neutral. As of the analysis date April 14, 2020, the closing price was EUR 4.34 and its expected value was estimated at EUR 4...

PharmaMar - Zepsyre misses in Ovarian, SCLC still promising

PharmaMar recently announced that Zepsyre® failed to show a progression-free survival (PFS) benefit over Topotecan and pegylated liposomal doxorubicin (PLD) in the 443-patient CORAIL study in platinum-resistant ovarian cancer. Zepsyre is currently in a Phase III trial in small cell lung cancer (SCLC) patients with protocols for pivotal studies in endometrial and breast cancer being finalised.

PharmaMar - Aplidin and Zepsyre milestones coming up

PharmaMar investors await two key events that are expected in the next few months. The European Committee for Medicinal Products for Human Use (CHMP) should announce a recommendation regarding Aplidin’s marketing application in the EU for refractory multiple myeloma in combination with dexamethasone by the end of the year. Also, Phase III results from the 443-patient CORAIL study studying Zepsyre® in platinum-resistant ovarian cancer patients is expected early next year.

A mixed set of results in 1H17

PharmaMar has published its 1H17 results. See our main takeaways on this report.

Preparing for ovarian Phase III data

Data from the 443-patient Phase III CORAIL study of Zepsyre® (lurbinectedin, PM01183) in platinum-resistant ovarian cancer is expected in H217 (most likely Q4). Patients are receiving either Zepsyre® or pegylated liposomal doxorubicin (PLD) or topotecan, and progression free survival (PFS) is the primary endpoint. In a previous Phase II, Zepsyre® was able to demonstrate a statistically significant PFS benefit over topotecan (5.7 months vs 1.7 months, p=0.005) in 33 platinum-resistant ovarian can...

We see value in self-commercialisation

At its recent R&D day in New York, PharmaMar flagged endometrial cancer as a likely fourth indication for lurbinectedin (data to be presented at ASCO). It confirmed that it is on track to achieve the key milestones of an approval decision for Aplidin for multiple myeloma in Europe, and Phase III results for lurbinectedin in ovarian cancer this year, with the most likely timing in Q4. The company emphasised its goal of commercialising lurbinectedin itself in the US market, prompting us to adopt s...

Strong newsflow expected in 2017

PharmaMar is approaching two key milestones in H217: an approval decision for Aplidin for multiple myeloma in Europe; and Phase III results for lurbinectedin in ovarian cancer. The Chugai licence deal for lurbinectedin in Japan has strengthened the company’s financial position (pro forma net debt €32m) and seen it put increased emphasis on its preferred strategy to either self-commercialise or co-promote lurbinectedin in the US. Separately, a US manufacturing patent granted last year has extende...

Japan licence deal highlights PM1183 potential

PharmaMar has capped off a strong performance in 2016 by signing a licence deal with Chugai for lurbinectedin (PM1183) in Japan, including €30m upfront and over €70m in potential milestones. The outlook for 2017 is similarly promising, including a potential EMA approval decision for Aplidin in multiple myeloma, Phase III data for lurbinectedin in ovarian cancer, and potential initiation of a pivotal trial of lurbinectedin in a third indication (BRCA-associated breast cancer). We have substantial...

Japan licence deal highlights PM1183 potential

PharmaMar has capped off a strong performance in 2016 by signing a licence deal with Chugai for lurbinectedin (PM1183) in Japan, including €30m upfront and over €70m in potential milestones. The outlook for 2017 is similarly promising, including a potential EMA approval decision for Aplidin in multiple myeloma, Phase III data for lurbinectedin in ovarian cancer, and potential initiation of a pivotal trial of lurbinectedin in a third indication (BRCA-associated breast cancer). We have substantial...

Ford Equity International Rating and Forecast Report

Ford Equity International Research Reports cover 60 countries with over 30,000 stocks traded on international exchanges. A proprietary quantitative system compares each company to its peers on proven measures of business value, growth characteristics, and investor behavior. Ford's three recommendation ratings buy, hold and sell, represent each stock’s return potential relative to its own country market.. The rating reports which are generated each week, include the fundamental details behind...

Update: Aplidin Phase III success

Positive results from PharmaMar’s ADMYRE Phase III trial of Aplidin in multiple myeloma clear the path for a potential approval in Europe in H217. Separately, PharmaMar continues to accelerate clinical development of PM1183, a follow-on to its marketed anticancer drug Yondelis: a Phase III trial of PM1183 in small cell lung cancer planned for mid-year will add to the ongoing CORAIL Phase III in ovarian cancer (an interim futility analysis after 210 ovarian patients is expected to report in H21...

Update: ADMYRE results keenly awaited

PharmaMar’s increasing investment in its promising oncology pipeline is supported by growing Yondelis revenue that will be further buoyed by recent approvals in the US, Japan and elsewhere, as well as by refinancing of its short-term debt. Phase III data for Aplidin in multiple myeloma, expected later this month, could be a significant catalyst for the stock. Our valuation is unchanged at €1.07bn or €4.82 per share ahead of this.

Outlook: PharmaMar hits the boards running

PharmaMar, the restructured Zeltia, has commenced trading amid positive newsflow, following the recent approvals of anti-cancer drug Yondelis in the US and Japan for the treatment of soft tissue sarcoma. Phase III data for Aplidin in multiple myeloma, expected early in the New Year could be another significant catalyst for the stock. We lift our valuation slightly to €1.07bn or €4.82 per share (from €4.65 per share) ahead of this catalyst.

PharmaMar hits the boards running

PharmaMar, the restructured Zeltia, has commenced trading amid positive newsflow, following the recent approvals of anti-cancer drug Yondelis in the US and Japan for the treatment of soft tissue sarcoma. Phase III data for Aplidin in multiple myeloma, expected early in the New Year could be another significant catalyst for the stock. We lift our valuation slightly to €1.07bn or €4.82 per share (from €4.65 per share) ahead of this catalyst.

Flash note: FDA approves Yondelis in soft tissue sarcoma

The US FDA has approved Zeltia’s Yondelis (trabectedin) for the treatment of soft tissue sarcomas (STS) liposarcoma and leiomyosarcoma. This is positive news for Zeltia and closely follows the approval of Yondelis in all types of STS in Japan late last month. Yondelis will be marketed in the US by Janssen (J&J) and in Japan by Taiho, and the approvals will trigger approx. $20m in milestone payments. The approvals are in line with our expectations and justify the recent strong share price, whic...

Update: Zeltia - Yondelis approvals in US and Japan pending

Zeltia is approaching a number of significant catalysts, with approval decisions for Yondelis in the US and Japan due before the end of the year, and Phase III data for Aplidin expected early in the New Year. Plans to seek an IPO in the US in H216 following the group’s restructure (through a reverse merger whereby its PharmaMar division absorbed the parent company, Zeltia) could strengthen its financial and commercial abilities. We maintain our valuation of €1.03bn or €4.65 per share, ahea...

Update: Repositioning for growth

Zeltia is laying the groundwork for an important 12-18 month period that could provide significant growth and value creation. Plans to restructure the group (through a reverse merger whereby its PharmaMar division will absorb the parent company, Zeltia) and seek an IPO in the US could be transformational in terms of strengthening its financial and commercial abilities. Then there is the potential for the oncology pipeline to provide upside as it enters a catalyst-rich period. We raise our valuat...

Update: Catalysts on the horizon

Zeltia’s Q314 results highlighted ongoing revenue and profit growth with Yondelis remaining the key contributor to revenue and net margin at oncology subsidiary PharmaMar. Looking beyond financials, Zeltia is approaching a catalyst-rich period, which has the potential to re-rate its valuation as PharmaMar’s business matures. These catalysts relate to the wider Yondelis geographic opportunity (filings/approvals in Japan and the US) and development progress with Aplidin and PM01183, with ex-EU...

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