Akorn, Inc. and Serum Institute of India, Ltd. Announce the Signing of a Definitive Development and Exclusive Distribution Agree
08 Novembre 2006 - 2:40PM
Business Wire
Akorn, Inc. (AMEX:AKN) and Serum Institute of India, Ltd. today
announced that they have entered into a Definitive Development and
Exclusive Distribution Agreement for Rabies monoclonal antibody.
The Agreement finalizes a previously executed Memorandum of
Understanding dated April 4, 2006 with respect to both companies
collaboration in developing and distributing monoclonal antibody
drugs. The term of the Agreement is ten years following the first
commercial sale of products. Recently, Serum has entered into a
Definitive Agreement with a third party that gives Serum the right
to appoint a distributor for the marketing and distribution of
Rabies monoclonal antibody products. Serum has agreed to appoint
Akorn as the exclusive distributor for Rabies monoclonal antibody.
In exchange for Akorn receiving exclusive marketing and
distribution rights to North, Central, and South America, Akorn has
agreed to help fund product development through milestone payments.
These milestone payments include the successful completion of Phase
I, Phase II, and Phase III clinical trials leading to eventual
receipt of CBER approval for a BLA license. BLA approval is
targeted to occur in 2012 and Akorn expects to fund these milestone
payments with cash flow provided from operations. As the exclusive
marketing and distribution partner for Rabies monoclonal antibody,
Akorn will receive 40% of the revenues from product sales in North
America and 50% of the revenues from product sales in Central and
South America. As part of the Agreement, Serum also grants Akorn
the first option right to obtain exclusive marketing rights in
North, Central, and South America for a second monoclonal antibody
product, Anti-D human monoclonal antibody. The terms for Anti-D
would be consistent with the terms and conditions for the Rabies
monoclonal antibody product. Additionally, Serum has granted Akorn
the first option right to expand the Territory to include Europe in
exchange for annual product sales requirements in Europe. The
current market size in North, Central, and South America and Europe
for Rabies monoclonal antibody is approximately $100 million. The
current market size in North, Central, South America and Europe for
Anti-D monoclonal antibody is approximately $500 million. Arthur S.
Przybyl, President and Chief Executive Officer of Akorn stated, �We
are very excited to enter into this Agreement with Serum. This
Agreement represents Akorn�s first biologic development and
distribution product opportunity. In the future, we expect to
continue to build our platform for development and eventual
commercialization of additional biologic and vaccine products with
Serum Institute. �Also, after my recent visit to India, I have
observed that Serum continues to make excellent progress on a new
manufacturing plant dedicated to our anti-cancer injectable and
lyophilized drug products. We expect our ANDA�s filings to commence
in 2007.� Dr. Cyrus S. Poonawalla, Chairman and Managing Director
of Serum Institute of India Ltd., stated, �We look forward to this
product development and distribution Agreement for this biologic
product as a continuing step towards strengthening the long-term
relationship with Akorn.� About Akorn, Inc. Akorn, Inc.
manufactures and markets sterile specialty pharmaceuticals. Akorn
has manufacturing facilities located in Decatur, Illinois and
Somerset, New Jersey and markets and distributes an extensive line
of hospital and ophthalmic pharmaceuticals. Additional information
is available at the Company's website at www.akorn.com. About Serum
Institute of India, Ltd. Serum Institute is the world�s fifth
largest vaccine manufacturer. Its products are being exported to
137 countries across the globe. Serum institute is now the largest
producer of measles and DTP vaccines in the world. An average of
more than one out of every two children in the world has received
at least one vaccine from Serum Institute. Additional information
is available at the Company�s website at www.seruminstitute.com.
The securities offered in this placement have not been registered
under the Securities Act of 1933, as amended, or state securities
laws, and cannot be offered or sold in the United States absent
registration with the Securities and Exchange Commission (SEC) or
an applicable exemption from the registration requirements. As part
of the transaction, the company has agreed to file a registration
statement with the SEC covering the resale of the shares of common
stock issuable. This news release is neither an offer to sell nor a
solicitation of an offer to buy any of the securities discussed
herein and is being issued under Rule 135c of the Securities Act of
1933. Materials in this press release may contain information that
includes or is based upon forward-looking statements within the
meaning of the Securities Litigation Reform Act of 1995.
Forward-looking statements give our expectations or forecasts of
future events. You can identify these statements by the fact that
they do not relate strictly to historical or current facts. They
use words such as "anticipate," "estimate," "expect," "project,"
"intend," "plan," "believe," and other words and terms of similar
meaning in connection with a discussion of future operating or
financial performance. In particular, these include statements
relating to future steps we may take, prospective products, future
performance or results of current and anticipated products, sales
efforts, expenses, the outcome of contingencies such as legal
proceedings, and financial results. Any or all of our
forward-looking statements here or in other publications may turn
out to be wrong. They can be affected by inaccurate assumptions or
by known or unknown risks and uncertainties. Many such factors will
be important in determining our actual future results.
Consequently, no forward-looking statement can be guaranteed. Our
actual results may vary materially, and there are not guarantees
about the performance of our stock. Any forward-looking statements
represent our expectations or forecasts only as of the date they
were made and should not be relied upon as representing our
expectations or forecasts as of any subsequent date. We undertake
no obligation to correct or update any forward-looking statements,
whether as a result of new information, future events or otherwise,
even if our expectations or forecasts change. You are advised,
however, to consult any further disclosures we make on related
subjects in our reports filed with the SEC. In particular, you
should read the discussion in the section entitled "Cautionary
Statement Regarding Forward-Looking Statements" in our most recent
Annual Report on Form 10-K, as it may be updated in subsequent
reports filed with the SEC. That discussion covers certain risks,
uncertainties and possibly inaccurate assumptions that could cause
our actual results to differ materially from expected and
historical results. Such factors include, but are not limited to,
risks and uncertainties relating to the resolution of the FDA
compliance issues at our Decatur, Illinois manufacturing facility.
Other factors besides those listed there could also adversely
affect our results. Akorn, Inc. (AMEX:AKN) and Serum Institute of
India, Ltd. today announced that they have entered into a
Definitive Development and Exclusive Distribution Agreement for
Rabies monoclonal antibody. The Agreement finalizes a previously
executed Memorandum of Understanding dated April 4, 2006 with
respect to both companies collaboration in developing and
distributing monoclonal antibody drugs. The term of the Agreement
is ten years following the first commercial sale of products.
Recently, Serum has entered into a Definitive Agreement with a
third party that gives Serum the right to appoint a distributor for
the marketing and distribution of Rabies monoclonal antibody
products. Serum has agreed to appoint Akorn as the exclusive
distributor for Rabies monoclonal antibody. In exchange for Akorn
receiving exclusive marketing and distribution rights to North,
Central, and South America, Akorn has agreed to help fund product
development through milestone payments. These milestone payments
include the successful completion of Phase I, Phase II, and Phase
III clinical trials leading to eventual receipt of CBER approval
for a BLA license. BLA approval is targeted to occur in 2012 and
Akorn expects to fund these milestone payments with cash flow
provided from operations. As the exclusive marketing and
distribution partner for Rabies monoclonal antibody, Akorn will
receive 40% of the revenues from product sales in North America and
50% of the revenues from product sales in Central and South
America. As part of the Agreement, Serum also grants Akorn the
first option right to obtain exclusive marketing rights in North,
Central, and South America for a second monoclonal antibody
product, Anti-D human monoclonal antibody. The terms for Anti-D
would be consistent with the terms and conditions for the Rabies
monoclonal antibody product. Additionally, Serum has granted Akorn
the first option right to expand the Territory to include Europe in
exchange for annual product sales requirements in Europe. The
current market size in North, Central, and South America and Europe
for Rabies monoclonal antibody is approximately $100 million. The
current market size in North, Central, South America and Europe for
Anti-D monoclonal antibody is approximately $500 million. Arthur S.
Przybyl, President and Chief Executive Officer of Akorn stated, "We
are very excited to enter into this Agreement with Serum. This
Agreement represents Akorn's first biologic development and
distribution product opportunity. In the future, we expect to
continue to build our platform for development and eventual
commercialization of additional biologic and vaccine products with
Serum Institute. "Also, after my recent visit to India, I have
observed that Serum continues to make excellent progress on a new
manufacturing plant dedicated to our anti-cancer injectable and
lyophilized drug products. We expect our ANDA's filings to commence
in 2007." Dr. Cyrus S. Poonawalla, Chairman and Managing Director
of Serum Institute of India Ltd., stated, "We look forward to this
product development and distribution Agreement for this biologic
product as a continuing step towards strengthening the long-term
relationship with Akorn." About Akorn, Inc. Akorn, Inc.
manufactures and markets sterile specialty pharmaceuticals. Akorn
has manufacturing facilities located in Decatur, Illinois and
Somerset, New Jersey and markets and distributes an extensive line
of hospital and ophthalmic pharmaceuticals. Additional information
is available at the Company's website at www.akorn.com. About Serum
Institute of India, Ltd. Serum Institute is the world's fifth
largest vaccine manufacturer. Its products are being exported to
137 countries across the globe. Serum institute is now the largest
producer of measles and DTP vaccines in the world. An average of
more than one out of every two children in the world has received
at least one vaccine from Serum Institute. Additional information
is available at the Company's website at www.seruminstitute.com.
The securities offered in this placement have not been registered
under the Securities Act of 1933, as amended, or state securities
laws, and cannot be offered or sold in the United States absent
registration with the Securities and Exchange Commission (SEC) or
an applicable exemption from the registration requirements. As part
of the transaction, the company has agreed to file a registration
statement with the SEC covering the resale of the shares of common
stock issuable. This news release is neither an offer to sell nor a
solicitation of an offer to buy any of the securities discussed
herein and is being issued under Rule 135c of the Securities Act of
1933. Materials in this press release may contain information that
includes or is based upon forward-looking statements within the
meaning of the Securities Litigation Reform Act of 1995.
Forward-looking statements give our expectations or forecasts of
future events. You can identify these statements by the fact that
they do not relate strictly to historical or current facts. They
use words such as "anticipate," "estimate," "expect," "project,"
"intend," "plan," "believe," and other words and terms of similar
meaning in connection with a discussion of future operating or
financial performance. In particular, these include statements
relating to future steps we may take, prospective products, future
performance or results of current and anticipated products, sales
efforts, expenses, the outcome of contingencies such as legal
proceedings, and financial results. Any or all of our
forward-looking statements here or in other publications may turn
out to be wrong. They can be affected by inaccurate assumptions or
by known or unknown risks and uncertainties. Many such factors will
be important in determining our actual future results.
Consequently, no forward-looking statement can be guaranteed. Our
actual results may vary materially, and there are not guarantees
about the performance of our stock. Any forward-looking statements
represent our expectations or forecasts only as of the date they
were made and should not be relied upon as representing our
expectations or forecasts as of any subsequent date. We undertake
no obligation to correct or update any forward-looking statements,
whether as a result of new information, future events or otherwise,
even if our expectations or forecasts change. You are advised,
however, to consult any further disclosures we make on related
subjects in our reports filed with the SEC. In particular, you
should read the discussion in the section entitled "Cautionary
Statement Regarding Forward-Looking Statements" in our most recent
Annual Report on Form 10-K, as it may be updated in subsequent
reports filed with the SEC. That discussion covers certain risks,
uncertainties and possibly inaccurate assumptions that could cause
our actual results to differ materially from expected and
historical results. Such factors include, but are not limited to,
risks and uncertainties relating to the resolution of the FDA
compliance issues at our Decatur, Illinois manufacturing facility.
Other factors besides those listed there could also adversely
affect our results.
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