Pharming « Terug naar discussie overzicht

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marlanki schreef op 14 februari 2017 10:19:

[...]

Och, als duidelijk is dat het goedkopere Ruconest beter werkt, en men bovendien er soms minder van hoeft te gebruiken als aangegeven.... Soms is namelijk één vial Ruconest al voldoende een HAE-aanval te stoppen en ook bij profylaxe is uit fase II onderzoek vaak minder per week nodig gebleken, maar dan moet de patiënt geen zwaargewicht zijn ;-)) .

Het hoofdkantoor van Shire zit in Dublin, Ierland. Dat valt dan ook weer niet zo goed bij de huidige regering.

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Madebeliefje schreef op 14 februari 2017 11:54:

[...]

U zegt het goed, maar het belangrijkste is dat Ruconest in Fase 2 zit. Dat betekend dat het middel nog niet officieel approved is door de FDA als profylaxe. Daarom word het door artsen dus niet voorgeschreven, en off label use kan ook niet zonder gegronde reden(zoals bv geen ander medicijn beschikbaar of allergische reactie).

De echte boost in sales in de US van profylactisch gebruik komt pas na de FDA approval. Ik ben alleen onbekend met de verdeling van sales in de US tussen acuut versus profylactisch. Iemand die daar info over heeft?

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kammetje schreef op 14 februari 2017 10:00:

[...]

Wat een pudding verhaal wederom.
Niets anders te doen.

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Cor S schreef op 14 februari 2017 10:01:

KID: wederom onzin!
Daar gaan we weer - op naar de 0,33

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Twinkie schreef op 14 februari 2017 12:00:

[...]

Wie zegt dat het niet verkocht wordt? "Off label" usage. Als men er genoeg vertrouwen in heeft, kan het zomaar voorgeschreven worden. Ook zonder FDA Approval.

FDA heeft net regels opgesteld voor off label marketing & sales.

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husa schreef op 14 februari 2017 12:14:

1717maxi 12:03 - 14.02.2017 1
www.pharming.com/news/
Pharming Group is a Dutch based biopharmaceutical company and one of the oldest publicly traded biotech companies in Europe. The company is focused on the development of recombinant proteins for therapeutic use. Pharming’s main platform is the development of human recombinant proteins through the generation of transgenic animals which express the human protein in their milk.
Its lead product is RUCONEST, a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with Hereditary Angioedema (HAE) in the USA (approved 2014) and Europe (approved in 2010). In Europe Pharming commercializes RUCONEST in Austria, France, Germany, Netherlands and UK and has a distribution agreement with Swedish Oprhan Biovitrum (Sobi) for Scandinavia, Eastern Europe and Italy. In the US, Pharming now distributes the product itself.
End of last year, Pharming struck a deal with Valeant to acquire all North American commercialisation rights for its own product, RUCONEST, including all rights in the US, Mexico and Canada. The deal had a total value of USD 125 million with an upfront fee paid to Valeant of USD 60 million, and future self- funding sales milestone payments up to a further USD 65 million in total.
We feel that with the acquisition of the rights for RUCONEST in North America, the company will propel into profitability much quicker than previously expected. Already in 2017 we expect Pharming to reach a net profit due to an acceleration of sales of RUCONEST. Pharming has taken over the complete sales force for RUCONEST from Valeant and will invest in extending the sales force and medical science liaison (MSL) personnel, both of which are key for a strong uptake of the sales of RUCONEST. MSLs are needed to establish and maintain peer-peer relationships with leading physicians, referred to as Key Opinion Leaders (KOL’s), at major academic institutions and clinics.
Following closing of the Valeant deal (08 December 2016), the Company’s cash position was EUR 34 million which should be sufficient to carry out the further development of its pipeline and the further strengthening of its sales and marketing force. Last December, Pharming successfully raised EUR 104 million with the help of top tier investors from the US and Europe through a combination of new equity, straight debt and convertible bonds. With regaining full commercial rights for RUCONEST in North America, the cash flow for Pharming will dramatically improve and we estimate that Pharming will be profitable as of this year.
Based on NPV based valuation, we believe that Pharming is substantially undervalued at the current share price of EUR 0.32. Using our valuation model and taking into account the future revenues from RUCONEST for both acute and prophylactic use, the company’s current total value should be EUR 660 million, which translates, based on an expected number of outstanding shares of approximately 700 million following conversion of the EUR 45 million 18 months amortising bond and the EUR 12.5 million 5 year convertible bond, into EUR 0.94 per share. This represents a substantial upside from the current share price.

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Madebeliefje schreef op 14 februari 2017 12:24:

Fines for off label promotions:

en.wikipedia.org/wiki/List_of_off-lab...

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husa schreef op 14 februari 2017 12:14:

1717maxi 12:03 - 14.02.2017 1
www.pharming.com/news/
Pharming Group is a Dutch based biopharmaceutical company and one of the oldest publicly traded biotech companies in Europe. The company is focused on the development of recombinant proteins for therapeutic use. Pharming’s main platform is the development of human recombinant proteins through the generation of transgenic animals which express the human protein in their milk.
Its lead product is RUCONEST, a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with Hereditary Angioedema (HAE) in the USA (approved 2014) and Europe (approved in 2010). In Europe Pharming commercializes RUCONEST in Austria, France, Germany, Netherlands and UK and has a distribution agreement with Swedish Oprhan Biovitrum (Sobi) for Scandinavia, Eastern Europe and Italy. In the US, Pharming now distributes the product itself.
End of last year, Pharming struck a deal with Valeant to acquire all North American commercialisation rights for its own product, RUCONEST, including all rights in the US, Mexico and Canada. The deal had a total value of USD 125 million with an upfront fee paid to Valeant of USD 60 million, and future self- funding sales milestone payments up to a further USD 65 million in total.
We feel that with the acquisition of the rights for RUCONEST in North America, the company will propel into profitability much quicker than previously expected. Already in 2017 we expect Pharming to reach a net profit due to an acceleration of sales of RUCONEST. Pharming has taken over the complete sales force for RUCONEST from Valeant and will invest in extending the sales force and medical science liaison (MSL) personnel, both of which are key for a strong uptake of the sales of RUCONEST. MSLs are needed to establish and maintain peer-peer relationships with leading physicians, referred to as Key Opinion Leaders (KOL’s), at major academic institutions and clinics.
Following closing of the Valeant deal (08 December 2016), the Company’s cash position was EUR 34 million which should be sufficient to carry out the further development of its pipeline and the further strengthening of its sales and marketing force. Last December, Pharming successfully raised EUR 104 million with the help of top tier investors from the US and Europe through a combination of new equity, straight debt and convertible bonds. With regaining full commercial rights for RUCONEST in North America, the cash flow for Pharming will dramatically improve and we estimate that Pharming will be profitable as of this year.
Based on NPV based valuation, we believe that Pharming is substantially undervalued at the current share price of EUR 0.32. Using our valuation model and taking into account the future revenues from RUCONEST for both acute and prophylactic use, the company’s current total value should be EUR 660 million, which translates, based on an expected number of outstanding shares of approximately 700 million following conversion of the EUR 45 million 18 months amortising bond and the EUR 12.5 million 5 year convertible bond, into EUR 0.94 per share. This represents a substantial upside from the current share price.