SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: January 5, 1998
MEDIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 0-19131
Delaware 52-1555759
(State of Incorporation) (I.R.S. Employer
Identification No.)
35 West Watkins Mill Road, Gaithersburg, MD 20878
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (301) 417-0770
No Exhibits are being filed with this report
CytoGam and RespiGam are registered trademarks of the Company.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following Letter
to Shareholders dated December 23, 1997:
December 23, 1997
To Our Shareholders:
MedImmune recently established and announced strategic alliances with
Abbott Laboratories and SmithKline Beecham. We believe these alliances
significantly enhance our ability to increase revenues, achieve
profitability and accelerate development of products in the pipeline. In
the remainder of this letter, we will describe the nature and potential
benefit of these corporate alliances.
ABBOTT MARKETING COLLABORATION
On December 1, MedImmune established a global alliance for Synagis
(palivizumab; also formerly known as MEDI-493) with Abbott Laboratories,
one of the world's premier health care companies and a leader in
pediatrics. Synagis is a humanized monoclonal antibody being developed for
the prevention of respiratory syncytial virus (RSV) disease in infants and
young children. The Company signed two separate agreements with Abbott.
One was a marketing and distribution agreement outside the United States
and the other a threshold-based co-promotion agreement within the United
States.
The threshold-based co-promotion agreement in the United States represents
a unique model in the biotechnology industry for product commercialization.
In typical "co-promotion agreements", both companies promote the product
and split the profits at a pre-determined ratio. In MedImmune's
collaboration with the Ross Products Division of Abbott, both companies
sell the product in the United States and are responsible for their own
selling expenses; however, significant profits are shared only if both
companies together can achieve sales revenues greater than what MedImmune
believed it could have achieved on its own. MedImmune will continue to
book all revenues generated from the sale of Synagis in the United States
and will be responsible for both manufacturing and the overall marketing
strategy for the product. This threshold-based structure will incentivize
both companies to work effectively together. At its essence, it is a "pay
for performance" agreement.
Market research shows that office-based pediatricians will be critical to
the successful commercialization of Synagis in the United States if and
when licensed by the FDA. The Ross Products Division sales force has an
exceptional presence among the pediatric community including office-based
pediatricians as well as an extensive pediatric and neonatal customer base
in the hospital. In the Scott Levin Survey conducted over the past twelve
years, Ross has been voted the number one pharmaceutical sales force
among pediatricians. The Ross Products Division sales force currently
sells products such as Survanta (beractant), the best-selling surfactant
for respiratory distress syndrome in premature infants, Biaxin
(clarithromycin), a boad-spectrum antibiotic frequently used in children,
and infant nutritional products such as Pedialyte, Similac and Isomil.
Outside the U.S., Abbott International will have the exclusive right to
market and distribute Synagis. MedImmune will manufacture and sell Synagis
to Abbott at a transfer price determined by end-user sales. MedImmune has
received a $15 million payment, and could receive additional payments
totaling $45 million upon achievement of milestones and certain sales
levels by Abbott. We believe that Abbott's extensive pharmaceutical
presence in more than 130 countries and their long-established commitment
to pediatric health care make them ideal for rapid commercialization of
Synagis worldwide.
We believe these two agreements with Abbott will allow the company to
maximize the commercial development opportunity of Synagis on a global
scale.
SMITHKLINE BEECHAM HPV VACCINE ALLIANCE
On December 11, 1997, MedImmune announced that it had entered into a
strategic alliance with SmithKline Beecham (SB) to develop and
commercialize human papillomavirus (HPV) vaccines for prevention of
cervical cancer and genital warts. HPVs are responsible for the
development of cervical cancer, the second leading cause of cancer death in
women on a worldwide basis. Currently, the company is conducting a Phase I
clinical trial with its first HPV vaccine candidate HPV-11. MedImmune
expects to begin clinical evaluation of HPV-18 and HPV-16 vaccine
candidates in 1998. HPV is one of the most important medical problems and
one of significant commercial opportunity in the vaccine field today. The
MedImmune/SB alliance grants to SB exclusive worldwide rights to
MedImmune's HPV technology in exchange for an up-front payment, future
funds and potential developmental and sales milestones which together could
total over $85 million, as well as royalties on product sales.
SB is, of course, one of the most successful pharmaceutical and vaccine
companies worldwide and we consider them an excellent partner for
development and commercialization of our HPV vaccines. We believe this
alliance will solidify a leadership position for both companies in the HPV
field. We think because of this alliance we will be able to move more
quickly and enhance the potential for successful development of a safe and
effective vaccine.
Lastly, in an important milestone for the company, on December 19, 1997, we
submitted a Biologic License Application (BLA) to the U.S. Food and Drug
Administration (FDA) requesting marketing clearance of Synagis. The BLA
submission is the culmination of more than eight years of research and
development work by our employees and collaborators. Submission of the BLA
to the FDA is an important step in the product development process but as
you recognize a great deal of work remains in what can often be a difficult
and complex process.
Our efforts, as we move forward, are directed toward executing in all areas
of our business, focusing on revenue growth and achieving profitability.
We believe the events just discussed will help do that. As always, we
thank you for your continued support and look forward to keeping you
apprised of our progress in the months ahead.
/s/David M. Mott /s/Wayne T. Hockmeyer, Ph.D.
President and Chief Operating Chairman and Chief Executive
Officer Officer
This announcement may contain, in addition to historical information,
certain forward-looking statements that involve risks and uncertainties.
Such statements reflect management's current views and are based on certain
assumptions. Actual results could differ materially from those currently
anticipated as a result of a number of factors, including risks and
uncertainties discussed in the Company's filings with the United States
Securities and Exchange Commission. Successful development and
commercialization of any of the Company's product candidates will require
thorough clinical evaluation and will be subject to regulatory approval
from authorities such as the FDA in the United States. There can be no
assurance that such approvals will be obtained.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/David M. Mott
(NAME AND TITLE) David M. Mott, President and Chief Operating Officer
(Principal financial and accounting officer)
(DATE) January 5, 1998
