Date: 2017-09-27
Type of information: Distribution agreement
Compound: Imvamune® smallpox vaccine
Company: Bavarian Nordic (Denmark) U.S. Department of Health & Human Services (HHS - USA)
Therapeutic area: Infectious diseases
Type agreement: supply - distribution
Action mechanism: vaccine
Disease: smallpox
Details:
- • On April 16, 2013, Bavarian Nordic has announced that BARDA (Biomedical Advanced Research and Development Authority), a division of the U.S. Department of Health & Human Services (HHS), has awarded the company a contract valued at up to $ 228 million for the continued supply of Imvamune® smallpox vaccine. The first $ 110 million of the new order is secured, and the remaining portion will be secured based on availability of funds in 2014. Under the agreement, payments of additional $ 37 million will be received, associated with the delivery of the original 20 million dose order. With this order, the U.S. Government will continue to maintain the stockpile of Imvamune® for use in case of a public health emergency. Furthermore, the order will sustain the unique manufacturing capabilities established by Bavarian Nordic that contribute to protecting the public against bioterrorism.
Since 2010, Bavarian Nordic has been delivering Imvamune® to the U.S. Strategic National Stockpile under a contract (RFP-3) for 20 million doses of the vaccine. As of year-end 2012, 14.4 million doses had been delivered. Upon completion of deliveries under this contract later in 2013, deliveries under the new contract will be initiated. The Company expects to deliver 7 million doses in 2013, of which approximately 1.4 million doses relate to the new contract. Subsequently, approximately 6.6 million doses will remain for delivery.
Financial terms:
- The cash flow of up to $ 228 million from the new contract consists of:
-Four performance-based milestone payments in 2013 totaling $ 20 million, triggered by the production of bulk vaccine for the first 4 million doses
-Deliveries in 2013 of $ 29 million, after which deliveries of $ 151 million remain
-Other income in 2013 and 2014 from miscellaneous services totaling $ 28 million
The entire contract value will be recognized pro rata with the deliveries.
Additionally, the conditions of the RFP-3 contract have been changed allowing $37 million in payments that will be recognized during 2013. Upon licensure of Imvamune® in the U.S., the remaining $12.5 million will be received under the original 20 million dose order.
Latest news:
- • On September 27, 2017, Bavarian Nordic announced the award of a sole source contract from the Biomedical Advanced Research and Development Authority (BARDA) for the procurement of freeze-dried Imvamune® smallpox vaccine. The potential value of the initial base and optional awards is in excess of $ 539 million. The initial award in the contract calls for the manufacturing and storage of $ 100 million of Imvamune® bulk. This is the third such award to manufacture vaccine bulk; with the two prior orders totaling $ 233 million. The initial options in the contract are divided between two distinct areas, the first of which is the filling and freeze-drying of Imvamune® from the three bulk awards, with total potential value of $ 299 million. The second part of the contract contains provisions for clinical development, regulatory commitments, and parts of the establishment and validation of fill/finish activities, with potential value of up to USD 140 million. The award also contains options to acquire additional vaccine bulk and/or freeze-dried doses of Imvamune® in the future.
To ensure the production capacity to secure the future Imvamune® stockpile at the U.S. Strategic National Stockpile, Bavarian Nordic will invest approximately $ 75 million over the coming years in the construction of a fill/finish manufacturing line at its facility in Denmark. As part of Bavarian Nordic's long-standing partnership with BARDA, a potential optional award of up to $ 33 million (part of the $ 140 million mentioned above) is dedicated to process transfer, and validation of the new manufacturing line. This strategic investment will allow Bavarian Nordic to recognize the full value chain of the manufacturing process, to maintain control of the product cycle throughout, and the potential to provide these services to third parties in the future.
- • On July 7, 2015, Bavarian Nordic announced that the BARDA has ordered a bulk supply of Imvamune® non-replicating smallpox vaccine, valued at $ 133 million. Under this new order, which is an extension of an existing contract, Bavarian Nordic will manufacture and store a bulk supply of Imvamune® This bulk material could be converted into freeze-dried Imvamune® at a later date, once the freeze-drying manufacturing process has been transferred to a commercial line, and is approved by the U.S. authorities.
- The freeze-dried version of Imvamune® is expected to reduce the life cycle management costs based on a longer shelf life and will replace the liquid-frozen version that is currently stockpiled in the U.S. Strategic National Stockpile (SNS). The freeze-dried version is well positioned to fulfill the U.S. Government's long-term requirements for sufficient non-replicating smallpox vaccine to protect 66 million Americans, comprising those for whom a replicating smallpox vaccine is not recommended and their household contacts.
- • On September 4, 2014, Bavarian Nordic announced that the BARDA has exercised an option valued at $118 million for the continued delivery of Imvamune® smallpox vaccine to the U.S. Strategic National Stockpile (SNS). This is the second option exercised to purchase additional doses of Imvamune® to maintain the stockpile in case of a public health emergency. The two replenishment options are valued at $ 228 million. Furthermore, the order will help sustain the unique manufacturing capabilities established by Bavarian Nordic that contribute to protecting the public against bioterrorism. The cash flow from the option consists of an upfront milestone payment of $18 million and $100 million that will be recognized pro rata with the deliveries of 4 million doses of Imvamune®. The exercise of the option does not change the Company's financial guidance for 2014.
- Bavarian Nordic has been delivering Imvamune® to the SNS since 2010 in a liquid-frozen formulation. In parallel, the company has been developing a freeze-dried formulation of the vaccine under a second contract with BARDA. A freeze-dried formulation is expected to reduce life cycle management costs based on a longer shelf life. Earlier this year, BARDA exercised an option to fund the transfer of the manufacturing process to a commercial manufacturing line with a larger capacity. Data supporting the clinical requirements for emergency use of the freeze-dried vaccine in the U.S. are also currently being finalized and expected to be submitted to the FDA in 2015. These activities will potentially support the production and supply of freeze-dried IMVAMUNE in 2016. Procurement would need to be conducted through a new contract, on which the Company expects to initiate dialogue with the U.S. Government in 2014.
Is general: Yes
