Merck Obtains Exclusive Rights to Market and Distribute MassBiologics' Tetanus-Diphtheria (Td) Vaccine in the U.S.

Merck's Adult Vaccine Portfolio Now Includes 9 of the 10 Vaccines on the U.S. CDC's Recommended Adult Immunization Schedule

BOSTON, MA, USA and WHITEHOUSE STATION, NJ, USA | April 21, 2010 | MassBiologics (MBL) of the University of Massachusetts Medical School and Merck & Co., Inc. (NYSE: MRK) announced today that they have entered into an agreement that provides Merck with exclusive rights to market and distribute MBL's tetanus and diphtheria toxoids adsorbed (Td) vaccine in the United States, with the exception of Massachusetts, where MBL will continue distributing the vaccine. Merck plans to begin distributing the Td vaccine in June 2010. Specific financial details of the agreement were not disclosed.

"Adult vaccination is an important element in Merck's commitment to help people be well, and we are delighted to partner with MBL to add tetanus-diphtheria vaccine to our broad U.S. portfolio of adult vaccines," said Soren Bo Christiansen, M.D., senior vice president and general manager, Adolescent & Adult Vaccines, Merck Vaccines. "This agreement is another example of how Merck engages in partnerships that will enable us to bring the most robust portfolio of products to our customers."

MassBiologics' Td vaccine was licensed by the U.S. Food and Drug Administration (FDA) in 1970. The vaccine is indicated for active immunization for the prevention of tetanus and diphtheria and is approved for use in people seven years of age and older.

The U.S. Centers for Disease Control and Prevention (CDC) recommends that adults 19 years of age and older with an uncertain or incomplete history of receiving the primary vaccination series of three doses of Td vaccine should begin or complete the Td primary vaccination series, and that adults who have not had a Td booster shot in 10 years or more should be vaccinated. Adults 19 years of age and older should receive a booster dose of Td vaccine every 10 years. Tdap (tetanus, diphtheria, and acellular pertussis) vaccine should replace a single dose of Td for adults aged 19–64 years who have not received a dose of Tdap previously, to additionally help protect them against pertussis disease.

Tetanus and diphtheria can be serious diseases

Cases of tetanus and diphtheria have been drastically reduced in the U.S. since the introduction of vaccines, but people can still be at risk for these diseases. The bacteria that cause tetanus are found in soil and can enter the body through any cut or wound. Tetanus is not spread from person to person. Because tetanus bacteria are widespread in the environment, vaccination is an important way to protect against tetanus. Almost all cases of tetanus occur in people who have never been vaccinated or who have not had a tetanus booster shot within the preceding 10 years.

Tetanus, sometimes called "lockjaw," is a bacterial infection affecting the nervous system. It causes severe muscle spasms that can lead to, among other things, "locking" of the jaw so a person cannot open his/her mouth or swallow. Symptoms include stiffness in the neck, rigidity of abdominal muscles, difficulty with breathing and swallowing, and muscle spasms can cause fractures of the spine and long bones. According to the CDC, approximately 1 out of 5 cases of tetanus are fatal.

Diphtheria is rare in the U.S. due to widespread use of diphtheria-containing vaccines; however, these bacteria are still a concern. Diphtheria continues to occur in other parts of the world. Diphtheria is caused by bacteria that can be passed from an infected person to others by coughing or sneezing. Early symptoms of diphtheria include sore throat, mild fever and chills. Usually the disease causes a thick coating at the back of the throat that makes it difficult to breathe or swallow, and may cause serious breathing problems. The most common complications are inflammation of the heart that can lead to abnormal heart rhythms, and inflammation of the nerves, which can cause temporary paralysis of some muscles. Diphtheria bacteria not only affects the throat, but can also infect other areas of the body, such as the nose, eye, and skin.

Important information about tetanus-diphtheria vaccine

The tetanus diphtheria vaccine is contraindicated in patients with hypersensitivity to any component of the vaccine or who have had a severe allergic reaction after a previous dose of this vaccine or any other Td vaccine.

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive the Td vaccine more frequently than every 10 years, even for tetanus prophylaxis as part of wound management.

If Guillain-Barre Syndrome occurred within six weeks after receipt of a previous dose of tetanus toxoid-containing vaccine, the decision to give subsequent doses of the Td vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

The most common local adverse reactions associated with Td vaccine may include erythema (redness), tenderness, and swelling at the injection site. Common systemic reactions may include headache, malaise, and temperature elevations.

Please see the accompanying Prescribing Information for Td vaccine.

About MassBiologics

MassBiologics is the only non-profit FDA-licensed manufacturer of vaccines and other biologic products in the United States and produces tetanus-diphtheria vaccine. MassBiologics traces its roots to 1894, and since then has maintained a mission to improve public health through applied research, development and production of biologic products. MassBiologics has been a part of the University of Massachusetts Medical School since 1997.

About the University of Massachusetts Medical School

The University of Massachusetts Medical School, one of the fastest growing academic health centers in the country, has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $240 million in research funding annually, 80 percent of which comes from federal funding sources. The mission of the Medical School is to advance the health and well-being of the people of the commonwealth and the world through pioneering education, research, public service and health care delivery with its clinical partner, UMass Memorial Health Care. For more information, visit www.umassmed.edu.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. Merck. Be well. For more information, visit www.merck.com.

SOURCE: Merck

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