US drug giant Merck & Co (NYSE: MRK) says that the Food and Drug Administration has accepted for review its New Drug Application for Saflutan (tafluprost), an investigational preservative-free prostaglandin analogue ophthalmic solution.
Merck submitted an NDA to support the proposed use of Saflutan for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. The drug is believed to help increase the fluid drainage that occurs through the root of the iris in the eye (this fluid is also known as aqueous humor). Saflutan is currently approved in several European countries, including the UK, Spain and Italy. Additional launches in other countries are expected, pending regulatory approvals.
Enjoying this article? Have the leading Biopharma news & analysis delivered daily on email by signing up for our FREE email newsletter here.
“Merck has been providing new therapies to help treat eye diseases for more than 50 years,” said Joseph Markoff, global director, Scientific Affairs, Ophthalmology, at Merck. “The acceptance of the NDA submission for tafluprost is an important milestone in our effort to bring forward an additional therapeutic option for patients with primary open-angle glaucoma or ocular hypertension."
On April 15, 2009, Merck and Santen Pharmaceutical entered into a worldwide licensing agreement for tafluprost. Merck has exclusive commercial rights to the product in Western Europe (excluding Germany), North America, South America, Africa, the Middle East, India and Australia. Santen retains commercial rights in most countries in Eastern Europe, northern Europe and in countries in the Asia Pacific region, including Japan. Santen will have the option to co-promote Saflutan in the USA, if approved.
Credit Suisse analysts have a net present value for Saflutan in the USA of $0.16/share or 0.4% of total NPV for Merck, based on 70% probability on peak sales of $500 million.
Clobazam filed for LGS, with trade name Onfi
Separately, Danish drugmaker Lundbeck (LUND: DC) said that the FDA has accepted for review NDA for the investigational compound clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome (LGS), a difficult-to- treat form of childhood-onset epilepsy, in patients two years and older. The filing was assigned a standard review and an action letter is anticipated in the fourth quarter 2011. Additionally, Lundbeck announced Onfi as the proposed trade name for clobazam in the USA.
The NDA submission is based on a clinical development program that evaluated the safety and efficacy of Onfi as add-on therapy in patients with LGS. Positive results from the largest clinical Phase III trial ever conducted in patients with LGS were presented at the December 2010 annual meeting of the American Epilepsy Society (AES).
http://www.thepharmaletter.com/file/102679/...lundbecks-clobazam.html -----------
der gewinner hat viele freunde, der verlierer nur gute!
1 |
2 |
3 |
4 |
|
6 |
7
Thread abonnieren
