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PharmaMar

Aplidin and Zepsyre milestones coming up

Update | Pharmaceutical & healthcare | 03 Nov 2017

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.

PharmaMar

Preparing for ovarian Phase III data

Update | Pharmaceutical & healthcare | 19 Jul 2017

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 cancer patients.

PharmaMar

We see value in self-commercialisation

Update | Pharmaceutical & healthcare | 03 May 2017

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 self-commercialisation as our base case valuation scenario, which lifts our valuation by 16% to €1.50bn (vs €1.29bn), or €6.75/share (vs €5.79/share).

PharmaMar

Strong newsflow expected in 2017

Update | Pharmaceutical & healthcare | 16 Mar 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 extended IP protection for lurbinectedin until at least December 2032. These developments have prompted us to adopt co-promotion in the US in our base case valuation scenario and to extend our rNPV model to 2035 vs 2030 previously. Our base case valuation has increased by 29% to €1.29bn (vs €1.01bn), or €5.79/share (vs €4.55/share).

PharmaMar

Japan licence deal highlights PM1183 potential

Outlook | Pharmaceutical & healthcare | 25 Jan 2017

PharmaMar has capped off a strong performance in 2016 by signing a licence deal with Chugai for lurbinectedin (PM1183) in Japan, including EUR 30m upfront and over EUR 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 substantially revised our valuation assumptions, but the end result is that our valuation is little changed at EUR 1.01bn (EUR 4.55/share).

PharmaMar

Myeloma filed, breast results by year end

Update | Pharmaceutical & healthcare | 27 Sep 2016

PharmaMar has delivered impressive progress in 2016, including filing for Aplidin approval for myeloma in Europe, and the launch of small cell lung cancer (PM1183) and lymphoma (Aplidin) pivotal trials. News likely before year-end includes breast cancer Phase II results and full recruitment in the PM1183 ovarian Phase III. H116 accounts released in July showed Yondelis royalties ahead of our forecasts after approvals in US and Japan in Q415; however we were too optimistic about the boost FDA approval would give to European sales, so we have trimmed sales forecasts for Europe. This cuts our valuation to €1.02bn (€4.58/share) from €1.09bn (€4.91/share).

PharmaMar

Aplidin Phase III success

Update | Pharmaceutical & healthcare | 05 May 2016

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 H216). Our valuation increases to €1.09bn (was €1.07bn previously) or €4.91 per share (€4.82), but a successful self-commercialisation of PM1183 in the US (if approved) could lift valuation by 14% compared to our base case.

PharmaMar

ADMYRE results keenly awaited

Update | Pharmaceutical & healthcare | 10 Mar 2016

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.

PharmaMar

PharmaMar hits the boards running

Outlook | Pharmaceutical & healthcare | 16 Nov 2015

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

FDA approves Yondelis in soft tissue sarcoma

Flash note | Pharmaceutical & healthcare | 27 Oct 2015

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, which is likely to continue to be buoyed by this positive news.

PharmaMar

Yondelis approvals in US and Japan pending

Update | Pharmaceutical & healthcare | 25 Aug 2015

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, ahead of these catalysts.

PharmaMar

Repositioning for growth

Update | Pharmaceutical & healthcare | 18 Mar 2015

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 valuation to €1.03bn or €4.65 per share, ahead of a number of key catalysts in 2015.