Ipsen is expanding its relationship with the California biotech, Inspiration Biopharmaceuticals Inc., agreeing to build a commercial organization in Europe to market the U.S. company's portfolio of investigational hemophilia products, which includes a recombinant Factor VIII licensed from Ipsen and Inspiration's lead product, an intravenous recombinant Factor IX.

The French company also announced Aug. 30 that it had appointed a new chief financial officer, updated its sales forecasts for the year, and refocused its R&D pipeline, on the same day that it released its first-half financial results.

The changes come after a strategic review concluded in June by the recently appointed Chairman and CEO Marc De Garidel, who is refocusing the French company's commercial and R&D efforts following a series of product disappointments Also see "Ipsen's New Chief Outlines Growth Plans In U.S., Emerging Markets" - Pink Sheet, 9 June, 2011.).

Specialized Commercial Team To Be Recruited

In an extension of their strategic partnership concluded in January 2010, Inspiration and Ipsen will work together to hire and train a specialized commercial team, which will serve as the exclusive sales organization in Europe for all hemophilia drugs commercialized under the Inspiration brand.

The unit will be active in 53 countries in the EU, Russia and other parts of Europe, and will be set up inside Ipsen's existing commercial organization. All sales by the organization will be booked by Inspiration, with Ipsen booking sales and marketing expenses, rebilling them to Inspiration and recording them in the "other revenues" line of its P&L account. Further financial terms were not disclosed.

Inspiration's lead product, the intravenous recombinant Factor IX, IB1001, is being developed for the treatment and prevention of bleeding in patients with hemophilia B, and marketing applications are expected to be submitted in Europe by the end of the year, and in the U.S. in the first half of 2012. Launch is expected early in 2013. It would be the second recombinant Factor IX product to reach the market, eliminating the reliance of patients on a single supplier, Pfizer Inc., and its recombinant product, BeneFIX, Ipsen said.

The intravenous recombinant porcine Factor VIII product licensed from Ipsen, OB1, is in Phase III, and is intended for the treatment of bleeding in individuals with acquired hemophilia A, and those with congenital hemophilia A who develop inhibitors to the clotting factor.

The strategic partnership agreed upon between the two companies in January 2010 also included Inspiration receiving up to $259 million in milestone payments from Ipsen, with the French company having an option to purchase the company at a later date Also see "Finding Inspiration: Ipsen Builds Fourth Specialist Franchise With Hemophilia Deal" - Pink Sheet, 21 January, 2010.).

Executive Committee Now Complete

During an Aug. 30 earnings call, De Garidel was keen to highlight the moves that already have been made to implement the company's new strategy, which include completing the changes to Ipsen's executive committee with the two new appointments.

Susheel Surpal, a citizen of Ireland and since 2009 financial director of the European medical diagnostics firm, Labco, has been appointed chief financial officer and executive VP, replacing Claire Giraut, who announced in May she was leaving Ipsen on Sept. 1. Nathalie Joannes, a Belgian national and graduate of the University of Pennsylvania Law School, who from 2008 was chief European counsel at Genzyme, has been appointed Ipsen's General Counsel and executive VP.

As part of the new strategy, Ipsen has closed its R&D facilities in Barcelona, Spain, and is continuing to plan the transfer of its U.S. operations to the east coast of that country, a move which is on track to be completed by Jan. 1, 2012, De Garidel said. In the first half of 2011, the Barcelona closure has cost €18.4 million ($26.5 million) and the U.S. transfer €8.7 million.

In France, where Ipsen wants to find a partner for its primary care business, contact has been established with potential partners, De Garidel remarked. In R&D, the company has terminated five research programs, and four more should be stopped by the end of the year. It now has 10 Phase III programs underway: four involve new molecular entities and six involve additional indications for the neurotoxin, Dysport (abobotulinumtoxinA) or the acromegaly therapy, Somatuline (lanreotide).

Sales Up By 5.2%, Net Profits By 21.4%

In the first half of 2011, Ipsen's sales grew by 5.2% to reach €566.6 million, driven by its specialty business, where sales grew by 7.9% to reach €381 million and were led by the cervical dystonia therapy, Dysport, sales of which grew by 17.4% to €105 million in the first half, and Somatuline, sales of which grew by 13.3% to €95 million. Sales of the company's largest product, Decapeptyl (triptorelin), fell by 1.2% to €139.2 million.

In contrast, sales by its primary care business were flat at €185.6 million, with sales of its ginkgo biloba extract, Tanakan, down by 7.3% at €45.2 million.

The strongest growth was seen in emerging markets, where sales grew by 14.4% to reach €131.9 million, and in North America, where sales grew by 25.6% to reach €33.1 million, although from a lower base. In the U.S., Somatuline and Dysport are continuing to drive sales, De Garidel noted.

But sales in the five-largest European countries declined by 3.5% to €273.7 million, led by the company's home market, France, where sales declined by 7%. A tough competitive environment, notably in French primary care, and government austerity measures in Germany and Spain were some of the reasons given by the De Garidel for the decline.

De Garidel updated the company's sales forecasts, predicting that the sales decrease in its primary care business would be in the range of 3%-5% over the full year, rather than in the 8%-10% range. It also has set a target for recurring adjusted operating income, which should be in the range €190 million to €200 million.

In the first half of 2011, Ipsen's operating income rose by 15.1% to €120.8 million, and its consolidated net profit increased by 21.4% to €91.7 million.

- John Davis (j.davis@elsevier.com)

Ipsen Extends Inspiration Deal, Appoints New CFO And Updates Sales Forecast

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