Akorn, Inc. Enters into Exclusive Vaccine Partnership with Serum Institute of India, Ltd.
Monday, October 29, 2007
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Akorn, Inc. (NASDAQ: AKRX - News) and Serum Institute of India, Ltd. (Serum), a privately-held worldwide leader in vaccines and the world’s largest manufacturer of Measles, and Diphtheria Tetanus Pertussis vaccines, today announced the signing of an Exclusive Memorandum of Understanding (MOU) with an intent to commercialize six vaccines for the U.S. market. The four vaccine products are:
- Measles, Mumps and Rubella Vaccine (MMR)
- Human Diploid Rabies Vaccine
- Recombinant Hepatitis B Vaccine
- Oncology Bladder Cancer Vaccine (BCG)
Serum is presently manufacturing and intends to sell the vaccine products in the United States of America on an exclusive basis. The four vaccine products have a combined current U.S. market size of approximately $1.5 billion.
The MOU describes the intended terms for a partnership between Akorn and Serum, which shall be converted into definitive agreements within 60 days. Serum has agreed to manufacture the vaccines and grant Akorn exclusive marketing rights for the vaccines in the United States of America and its territories for a period of ten (10) years from the date of receipt of biologics license application (“BLA”) approval.
Akorn shall pay Serum an Exclusive Marketing Rights fee for each of the vaccine products for which it decides to conduct clinical trials and shall fund such clinical trials necessary for securing BLA licenses for the vaccines. Akorn may decide not to fund the clinical trials for any vaccine if it finds that the clinical trials are cost prohibitive, but upon doing so, the exclusive right granted by Serum to Akorn for that vaccine will lapse immediately.
The MOU further provides that net revenues will be split equally between Akorn and Serum with Serum bearing all manufacturing costs and Akorn bearing all marketing costs.
Additionally, Serum will be increasing their equity position with Akorn. Within thirty (30) days of the MOU, Akorn shall sell 1,000,000 shares of common stock to Serum at the then current market price in a private placement pursuant to a separate Securities Purchase Agreement.
Serum is the world’s fifth largest vaccine manufacturer and is well recognized within the vaccine community as a worldwide leader in vaccine development and manufacturing. They possess the intellectual property, technical data and manufacturing processes necessary to obtain BLA license approval. Serum currently manufactures vaccines in state-of-the art production facilities and produces approximately 900,000 vaccine doses per day for worldwide consumption. To date, Serum has sold over one billion measles vaccine doses. Over the years, Serum has supplied vaccines to over 130 countries and has relationships with the World Health Organization (WHO), UNICEF, and the Pan American Health Organization (PAHO). Serum has been responsible for immunizing many of the world’s children from debilitating diseases.
Within the next 120 days, Akorn and Serum will host an Investor and Analyst Day to be conducted on the campus of Serum Institute of India, located in Pune, India. This event is intended to introduce the vaccine capabilities of Serum to the United States capital markets. More importantly, this event will introduce the Chairman and Managing Director of Serum, Dr. Cyrus S. Poonawalla. Dr. Poonawalla is the founder and majority owner of Serum Institute of India. His vision is to provide affordable, safe and effective vaccines to help immunize the world’s population. Recently in June 2005, at a ceremony held in New York City, Dr. Poonawalla received the Albert B. Sabin Vaccine Institute Humanitarian Award for his vital contributions over the past 35 years in the field of vaccines.
Dr. Cyrus S. Poonawalla, Serum’s Chairman and Managing Director stated, “We look forward to this opportunity to extend our philosophy of making quality vaccines available at values that would help immunizing agencies fulfill their task.”
Arthur S. Przybyl, Akorn’s President and Chief Executive Officer stated, “Within three to five years, Akorn intends to become a leading provider of affordable, proprietary vaccines in the U.S. marketplace. Akorn expects to continue pursuing generic and specialty pharmaceutical opportunities in its existing Ophthalmic and Hospital Drug business segments. We are privileged to partner with Dr. Poonawalla and his Company, the Serum Institute of India, to exclusively bring his vaccine products into the United States. Serum possesses the intellectual property and manufacturing infrastructure, and Akorn is building a sales and marketing infrastructure that when combined with Serum’s capabilities, represents a powerful effort to commercialize these vaccine products. I believe these four vaccine products are only the beginning and that we will add other vaccines to our partnership portfolio in the future.”
Arthur S. Przybyl, Akorn’s President and Chief Executive Officer will host a conference call to discuss this press release, beginning at 4:00PM (EST), on Monday October 29, 2007. The dial-in numbers will be provided on the Akorn web site by 1:00PM (EST):
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 immunized 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.
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.
Contact:
Akorn, Inc.
Arthur S. Przybyl
President and CEO
(847) 279-6100
or
Serum Institute of India, Ltd.
Cyrus S. Poonawalla, Ph.D.
Chairman and Managing Director
(020)2699-3939
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