Inspiration Biopharmaceuticals and Ipsen Announce Closing of the IB1001 Sale to Cangene Corporation

  Inspiration Biopharmaceuticals and Ipsen Announce Closing of the IB1001 Sale
  to Cangene Corporation

 Sale process for all assets of Inspiration is complete with total aggregate
                consideration potentially exceeding $1 billion

Business Wire

CAMBRIDGE, Mass. -- February 20, 2013

Inspiration Biopharmaceuticals (Inspiration) and Ipsen (Euronext: IPN; ADR:
IPSEY) 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 Inspiration and Ipsen 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). The total aggregate consideration for
these rights may exceed $300 million; including the upfront payment of $5.9
million, sales milestones totaling $50 million and annual net sales payments
tiered up to a double-digit percentage of global 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 that was 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 HCP 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 previously announced the sale of OBI-1 to Baxter International for
a total aggregate consideration that may exceed $700 million, including $185
million in upfront and milestone payments. 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. The total aggregate consideration for Inspiration’s assets through these
two transactions may exceed $1 billion.

Evercore Partners served as joint financial advisor to Inspiration and Ipsen
on these two transactions. Ropes & Gray served as legal advisor to Inspiration
on the transaction. Murphy & King is Inspiration’s bankruptcy counsel and FTI
Consulting, Inc. is Chief Restructuring Officer for Inspiration.

About Inspiration Biopharmaceuticals

As the only biopharmaceutical company dedicated solely to hemophilia,
Inspiration is committed to improving the care of people with this condition
by broadening treatment choices, expanding global access to care and advancing
innovative therapies. Founded by two families whose sons have hemophilia,
Inspiration is inspired to make a difference in the lives of people impacted
by hemophilia around the world. Inspiration's lead product candidates are
IB1001, an investigational intravenous recombinant factor IX being developed
for the treatment of hemophilia B, and OBI-1, an investigational recombinant
porcine factor VIII being developed for the treatment of serious bleeds in
patients with congenital hemophilia A with inhibitors or acquired hemophilia

For more information about Inspiration Biopharmaceuticals, please visit


Inspiration Biopharmaceuticals
Michel Dahan, +1-617-588-1807
VP Commercial Development & Strategic Planning
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