PARIS -- (BUSINESS WIRE) -- Regulatory News:
Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) and Inspiration Biopharmaceuticals Inc. (Inspiration) today announced the closing of the sale of the proprietary hemophilia B product, IB1001 (recombinant FIX), to Cangene Corporation (TSX: CNJ) (Cangene). The transaction was announced on February 6, 2013. Ipsen and Inspiration jointly agreed to sell their respective commercialization rights to IB1001 as part of the transaction. Cangene acquired worldwide rights to IB1001, a recombinant factor IX currently under regulatory review in the United States and Europe. This transaction follows the announcement last month that Ipsen and Inspiration had agreed to sell OBI-1 (recombinant porcine FVIII) to Baxter International.
Cangene acquired worldwide rights to IB1001, as well as Inspiration’s rights to two product candidates in pre-clinical development: IB1007 (recombinant FVIIa) and IB1008 (recombinant FVIII). Under the terms of the agreement, Cangene has agreed to pay $5.9 million upfront, up to $50 million in potential additional commercial milestones as well net sales payments equivalent to tiered double digit percentage of IB1001 annual net sales.
IB1001 is currently under regulatory review by both the FDA in the US and the EMA in Europe. The product was placed on clinical hold by the FDA in July 2012. Inspiration has been working to resolve the issues that led to the clinical hold and has discussed its plans to address the clinical hold with relevant regulatory authorities. Inspiration recently received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for IB1001. A Complete Response Letter is issued by the FDA when the Agency determines that an application cannot be approved in its current form.
The letter is consistent with previous discussions with FDA around the presence of host cell proteins (HCP) in IB1001 responsible for formation of anti-HCP antibodies in 26% of clinical trial subjects. Inspiration worked diligently to implement manufacturing process changes for drug substance to significantly reduce the levels of host cell proteins aimed at eliminating host cell proteins responsible for the immunogenic response to HCP in some clinical trial subjects. Preliminary comparability data available to date on drug substance manufactured using the original and the modified processes suggest that the process changes have been successful with no observed deleterious effect on the factor IX protein itself. No additional clinical data was requested under the Clinical Response Letter. Next steps for the development of IB1001 are now determined by Cangene.
Inspiration and Ipsen previously announced the sale of OBI-1 to Baxter International. The United States Bankruptcy Court in Boston approved that transaction on January 24, 2013, and the Federal Trade Commission is currently reviewing the transaction under the Hart-Scott-Rodino Act. Baxter has agreed to pay $50 million upfront, up to $135 million in potential additional development and commercial milestones as well as tiered net sales payments ranging from 12.5% to 17.5% of OBI-1 annual net sales.
On the transaction, Evercore Partners served as common financial advisor to Inspiration and Ipsen; Lazard and Banque Hottinguer & Cie served as financial advisors to Ipsen.
About the partnership agreement between Inspiration and Ipsen and the product portfolio
In January 2010, Inspiration entered into a strategic agreement with Ipsen, leveraging the combined expertise and resources of the two companies, to develop a broad portfolio of hemophilia products and two products in phase III. IB1001, an investigational intravenous recombinant factor IX (rFIX) therapy for the treatment and prevention of bleeding episodes in people with hemophilia B and OBI-1 an investigational intravenous recombinant porcine factor VIII (rpFVIII) therapy for the treatment of patients with i) acquired hemophilia A and ii) congenital hemophilia A who have developed inhibitors against human FVIII.
In August 2011, Ipsen and Inspiration announced the extension of their agreement to create a hemophilia business unit structure that will act as the exclusive sales organization for all hemophilia products commercialized under the Inspiration brand in Europe.
In July 2012 Inspiration announced that IB1001 was placed on clinical hold by the Food and Drug Administration (FDA).
On 21 August 2012, Ipsen and Inspiration renegotiated their 2010 partnership. This agreement aimed to establish an effective structure whereby Ipsen gained commercial rights in key territories. Inspiration remains responsible for the world-wide development of OBI-1 and IB1001. Ipsen paid a bridging facility for an amount of $30 million providing both Inspiration with time to secure independent third party financing and Ipsen with time to assess potential ways forward.
On 31 August 2012, Ipsen paid Inspiration $7.5 million and received a warrant for 15% of Inspiration’s equity.
Ipsen had agreed to pay Inspiration an additional $12.5 million if Inspiration had raised third party financing by the contractual deadline of 30 September 2012. Inspiration did not manage to raise external funding by this contractual deadline.
On 30 October 2012, Inspiration commenced a voluntary reorganization case pursuant to Chapter 11’s provisions of the United States Bankruptcy Code with the objective of leading a joint marketing and sales process. Ipsen is seeking to exit hemophilia through this process.
On 24 January 2013, Ipsen and Inspiration announced that they had entered into an Asset Purchase Agreement for the sale of OBI-1 to Baxter subject to closing conditions.
On 6 February 2013, Ipsen and Inspiration announced that they had entered into an Asset Purchase Agreement for the sale of IB1001 to Cangene subject to closing conditions.
On 20 February 2013, Ipsen and Inspiration announced the closing of the sale of IB1001 to Cangene.
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2012. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by three franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2011, R&D expenditure totaled more than €250 million, above 21% of Group sales. The Group has total worldwide staff of close to 4,500 employees. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
Ipsen’s Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today.
Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from Generics that might translate into a loss of market share.
Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfill their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance.
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