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Bayer AG

Drug Names(s): SH T00186, BAY86-5300, Yasminelle

Description: YAZ is a combination oral contraceptive that supresses gonadotropins. Although, the primarymechanism of this action is via the inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium (which reduces the likelihood of implantation).

Drospirenone is a spironolactone analogue and binds to both the progesterone and mineralocorticoid receptors (it is an agonist at the former and antagonist at the latter). Preclinical studies in animals and in vitro have shown that drospirenone has no androgenic, estrogenic, glucocorticoid, or antiglucocorticoid activity. Preclinical studies in animals have shown that drospirenone hasantiandrogenic activity.

Deal Structure: In June 2008, Barr entered into supply and licensing agreements with Bayer for generic versions of Bayer's Yaz. Under terms of these agreements, Bayer will supply Barr with the generic products for launch prior to the expiration of the patents protecting these products and Barr will have sole responsibility to market, sell and distribute the products in the U.S. under the Barr Laboratories label.

Bayer will supply Barr with an authorized generic version of Yaz for launch on July 1, 2011, or earlier in certain circumstances. Barr will pay Bayer an undisclosed supply price for the product. Barr also has an additional undisclosed profit split with Gedeon Richter, its development partner for generic Yaz.

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