Forest Laboratories, Inc. Announces Amendment to Bystolic(TM) (nebivolol) Agreement

Forest Laboratories, Inc.Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX), announced that it and Mylan Inc. (NYSE: MYL) have amended their January 2006 agreement to commercialize, develop and distribute the novel beta blocker Bystolic(TM) (nebivolol), which is currently approved in the United States for the treatment of hypertension. The companies have agreed that Forest will assume Mylan's commercial rights for Bystolic in the United States and Canada including, but not limited to, the elimination of Mylan's option to co-promote the product. Forest will be responsible for all future Bystolic development expenses as well as all sales and marketing expenses for the product.

Under the terms of this amendment, Forest Laboratories Holdings, Ltd. (Ireland) will make a one-time cash payment of $370 million to Mylan. Forest will continue to pay Mylan its contractual royalties for three years, through calendar 2010, after which Forest will pay an amount consistent with the royalty rates Forest generally pays with respect to its principal products for the supply of active pharmaceutical ingredient (API). Beginning in the first quarter of calendar 2011 Forest will amortize the one-time cash payment over the remaining patent life of the product.

Howard Solomon, Chairman and Chief Executive Officer of Forest, said: "This amendment provides an opportunity for Forest to significantly reduce future royalty expenditures for Bystolic resulting in a favorable impact on the overall economics of Bystolic's commercialization program. We have also recaptured co-promotion rights to the product, allowing us to retain more product value in the future. We have been very pleased with our partnership with Mylan thus far and this is a mutually beneficial proposition for the companies."

About Bystolic
Bystolic (nebivolol) is a novel beta blocker that was approved by the FDA in December 2007 and is approved and marketed in more than 65 countries outside of North America. Mylan licensed the U.S. and Canadian rights to Bystolic from Janssen Pharmaceutical N.V. in 2001, and obtained Janssen's consent to sub-license Bystolic to Forest Laboratories in those territories in an initial agreement completed in January 2006. Bystolic is a cardio-selective beta-1 blocker, with vasodilation properties and a favorable tolerability profile. Upon FDA approval, Bystolic has received five years of marketing exclusivity under the Hatch Waxman legislation. In addition there is an issued U.S. pharmaceutical composition of matter patent that expires in 2021, which may offer additional exclusivity.

About Forest Laboratories and Its Products
Forest Laboratories is a U.S.-based pharmaceutical company dedicated to identifying, developing, and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Campral(R)* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation; and Bystolic(TM) (nebivolol), a beta-adrenergic receptor blocking agent indicated for the treatment of hypertension. In addition to our growing product line, Forest also co-promotes the Daiichi Sankyo, Inc. products Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker; Benicar HCT(R)* (olmesartan medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product; and AZOR(TM)* (amlodipine and olmesartan medoxomil), a calcium channel blocker and angiotensin receptor blocker combination product, all indicated for the treatment of hypertension.

For further information, please visit www.frx.com.

* Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are registered trademarks of Daiichi Sankyo, Inc.; and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.

Most Popular Now

AstraZeneca COVID-19 vaccine Vaxzevria authorised …

AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, has been granted a special approval for emergency use in Japan for active immunisat...

Pfizer and BioNTech to supply the European Union w…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY®, the companie...

Takeda announces approval of Moderna's COVID-19 va…

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced that the Ministry of Health, Labour and Welfare (MHLW) granted special approval under...

Sanofi and GSK initiate global Phase 3 clinical ef…

Today, Sanofi and GlaxoSmithKline plc (GSK) started enrolment in their Phase 3 clinical study to assess the safety, efficacy and immunogenicity of their adjuvanted recomb...

Sanofi and GSK COVID-19 vaccine candidate demonstr…

The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who h...

European Commission approves Venclyxto-based combi…

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with hypomethylating agents, azacitidi...

Novartis reaches milestone delivery of 1 billion c…

Novartis announced that it has delivered one billion courses of antimalarial treatment since 1999. More than 90% of this artemisinin-based combination therapy (ACT) was s...

COVID-19 mRNA vaccines are immunogenic in pregnant…

Pregnant women with symptomatic COVID-19 have a higher risk of intensive care unit admissions, mechanical ventilation and death compared to non-pregnant reproductive age ...

Why are some COVID-19 vaccines working better for …

MSU researcher is studying, raising awareness about the role of sex in the efficacy of vaccines that make use of nanomedicine. If there's one take-home message for the...

Rogue antibodies wreak havoc in severe COVID-19 ca…

The development of antibodies to the COVID-19 virus has been the great long-term hope of ending the pandemic. However, immune system turncoats are also major culprits in ...

New vaccine platform: 'Two-one replicon-and-VLP-mi…

To stop the current SARS-CoV-2 pandemic, vaccines of high quality, safety, and efficacy are required. Scientists of the Paul-Ehrlich-Institut and the Ludwig Maximilian Un...

COVID-19 monoclonal antibodies reduce risk of hosp…

Monoclonal antibodies, a COVID-19 treatment given early after coronavirus infection, cut the risk of hospitalization and death by 60% in those most likely to suffer compl...