30 julio 2014

PM01183 . Updates From Ongoing PM01183 trials ( and Pivotal Trial Start in Ovarian, Endometrial and Small Cell Lung Cancers ) may Catalyse a Lucrative ex-Europe deal . ( EDISON Investment ) .



Jul 30th 2014 - Edison Investment Research today published a report on Zeltia entitled "Deep Sea Treasures".



Analysts :

*.- Lala Gregorek .

*.- Dr Mick Cooper .


In summary, the report says:

Zeltia is a holding company that is increasingly focused on the potentially high-growth marine oncology activities of PharmaMar. This subsidiary has a unique business model and has built a pipeline of first-in-class cancer drugs for development with strategic partners. Yondelis, its first product, sold in Europe since 2007, is approaching regulatory catalysts in the US and Japan. Other catalysts include Phase III Aplidin data (expected in 2015) and deal potential for PM01183 (shortly to begin pivotal trials). Approval(s), data and/or deal news should increase our €904m valuation.

Yondelis : A foundation for profitability
Net Yondelis sales of €73m in FY13 underpin profitability, with potential for growth in Europe and beyond. Filings in soft tissue sarcoma in Japan (H214) and in the US around mid-2015 could lead to approvals in 2015/16, significantly boosting revenue through royalties from partners and near-term milestones. Japan approval would trigger a Taiho milestone, with up to $20m potentially due from Janssen.


Hidden potential : Aplidin and PM01183
Aplidin has secured a strong haem-oncology partner in Chugai (ahead of Phase III multiple myeloma data in 2015), which should enable higher penetration in the eight EU countries covered, without needing additional investment from Zeltia. Updates from ongoing PM01183 trials (and pivotal trial start in ovarian, endometrial and small cell lung cancers) may catalyse a lucrative ex-Europe deal.


Financials : Focused investment and reducing debt
Revenue growth teamed with stable operating expenditure (ex-R&D) should enable Zeltia to grow its bottom line; we forecast EBITDA improvement from €23.8m in FY13 to €35.2m in FY14. R&D spending for FY14/15 will increase with investment in pivotal trials (Aplidin and PM01183) and the Sylentis glaucoma study. Increased operating cash flow should result in a continuing reduction in net debt.


Valuation : €904m SOTP, PM01183 prospects ignored
Our €904m (€4.07/share) valuation is based on a sum-of-the-parts DCF to 2025 (rNPV for the biopharma business; DCF for the chemicals division). It suggests the current market cap is largely supported by Yondelis, with limited value ascribed to earlier-stage assets, such as PM01183, which could drive significant value as part of a life cycle management strategy. Japan/US approval decisions for Yondelis in STS represent near-term upside as would Aplidin data or a PM01183 partnership.

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Taiho Pharma and Sumitomo Dainippon both invest in Remiges BioPharma Fund ... And now a pair of Asian pharma companies is bankrolling a rare operation: a brand new VC organization--Remiges Ventures--that plans to go hunting for biotech startups in the U.S. and Europe.

A New VC player debuts with global plans to invest $150M in biotech startups .

July 24, 2014 | By John Carroll .


Over the last few years there's been something of a shakeout among biotech venture investors. There are fewer big players, but with IPOs taking flight again, established venture groups are rolling out new funds collectively worth billions of dollars.



And now a pair of Asian pharma companies is bankrolling a rare operation: a brand new VC organization--Remiges Ventures--that plans to go hunting for biotech startups in the U.S. and Europe.

Taiho, a subsidiary of Otsuka, and Sumitomo Dainippon Pharma each committed $30 million to the new venture operation, which has offices in Cambridge, MA, and Tokyo. Taro Inaba--a veteran VC operator who had helmed Mitsui Ventures--is running the VC, which now has collected $70 million of a planned $150 million fund. Inaba has been a board member at a number of biotechs, including San Diego-based Actimis and Edison Pharmaceuticals. Walter Olesiak, another Mitsui veteran, is listed in SEC documents as a general partner.

In its release, Taiho said that the cancer drug developer is jumping in with plans to make the venture operation a kind of central command for scouting new collaborations around the world.

Noted the company: "Taiho hopes to use the investment in Remiges Fund as the platform for open innovation--an outreach for innovative technologies. Through Remiges' well-connected US-Japan cross border investment team, Taiho will be tapping into the US/Europe biotech start-up community and catalyze the company's R&D to deliver innovative cancer treatment to patients."

They may not have the biggest new fund this year, but it's evidently unique as a pure biotech VC startup. Remiges will be joining a growing group of venture players with new funds to play with. Just yesterday, Sofinnova closed a big $500 million fund, following closely on Versant's $300 million effort and Essex Woodlands' progress on a $750 million package. Add in Arch and Abingworth's plans along with other funds announced in 2013 and FierceBiotech roughly tallies the prospective total at close to $4 billion in a little more than a year.

El miedo al ébola alimenta la expansión del virus en África .

La epidemia de ébola que afecta desde principios de año a África occidental y que se ha cobrado ya al menos 672 víctimas mortales, tiene un peligroso efecto secundario: el miedo, que alimentado por la falta de información contribuye en buena medida a que el brote esté siendo tan difícil de controlar. Ante una situación que no mejora, sus síntomas van a peor: los más recientes, un ataque a personal de Médicos sin Fronteras (MSF) o el cierre de fronteras de Liberia.

No es algo nuevo. El pasado mes de abril, un centro de MSF en Macenta, al sur de Guinea, fue atacado a pedradas por una multitud enfurecida. Hace unos días, en el pueblo de Kolo Bengou, donde se cree que hay varias personas infectadas, un grupo de jóvenes armados con piedras y cuchillos bloqueaba el paso al personal sanitario, según informa The New York Times. “Por todos los sitios que han pasado esas personas la comunidad se ha visto afectada por la enfermedad”, aseguraba uno de ellos, culpando del brote a quienes habían acudido precisamente a socorrerlos.

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