|[February 20, 2013]
Ipsen and Inspiration Biopharmaceuticals Announce Closing of the IB1001 Sale to Cangene Corporation
PARIS --(Business Wire)--
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
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
IB1001 is currently under regulatory review by both the FDA in the US
and the EMA (News - Alert) 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
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
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
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.
The Group expressly disclaims any obligation or undertaking to update or
revise any forward looking statements, targets or estimates contained in
this press release to reflect any change in events, conditions,
assumptions or circumstances on which any such statements are based,
unless so required by applicable law.
The Group's business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
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