ChronicleMIDWEEK
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A new ED drug: Is this a medical breakthrough, or are we punk’d?
Every year at this time we seem to come across an item that causes us to check the calendar and exclaim, “Ho-ho, this must be an early April Fool’s gag.” So it is with the news that a Korean drugmaker plans to file an NDA in that country for a new PDE5 inhibitor as erectile dysfunction Tx. The compound is named udenafil, and its manufacturer says it hopes to initiate North American trials shortly. Nothing wrong with any of that, so far. And then we note that the developer of the product, which claims to be the largest Korean drugmaker, is named Dong-A PharmTech — and that’s where we say, “Very funny. Dong-A, huh? We ain’t buying it.” So we called directory assistance in Seoul and discovered there really is a Dong-A, and it has been around for 73 years and the president’s name happens to be Mr. Dong Hyun Park. We hung up quickly and found an excuse to spend the rest of the day away from the office. More info=>
They tried to get Marcus Welby, but it seems Bob Young is dead
Pfizer’s new stateside DTC ad for antidepressant sertraline (Zoloft) features a novel spokesman: Dr. Jennifer Melfi, psychiatrist to the guilt-ridden mobster Tony Soprano on the hit TV drama, “The Sopranos.” Actually, the individual featured in the Zoloft spots is not Dr. Melfi, but Lorraine Bracco, the actress who portrays the doctor. It seems Bracco had a year-long depressive episode, which qualifies her to ask viewers: “Why live with depression when maybe you can live without it?” The ad prompts its audience to a web site, www.depressionhelp.com, which provides further details of Bracco’s illness. Zoloft is not mentioned in the commercial. More info=>
Oxford University trial allows MS patients to get their goat
Physicians leading Oxford University trials of multiple sclerosis Tx candidate Aimspro (Daval International) this week called the early results “encouraging.” The unique injectable anti-inflammatory Tx is derived from the blood of goats. Daval kingpin Brian Quick says: “It’s a drug we believe, based on empirical and clinical evidence, to have a broad application to fight MS.” The product is not licensed in Canada, or anywhere else. More info=>
Aeterna Zentaris gets Columbian okay for skin use of Impavido
Columbian regulators this week okayed miltefosine (Impavido, Aeterna Zentaris) as Tx for cutaneous manifestations of leishmaniasis. The company, based in Quebec City, said the approval was the first for the skin variation of the disease. In a statement, the drugmaker said: “Impavido… becomes the first orally administered, breakthrough therapy for both visceral and cutaneous leishmaniasis.” More info=>
Canadian court tosses Apotex suit: Sanofi keeps Plavix patent
Apotex yesterday (03/22) lost a local patent challenge to Sanofi-Aventis’s blockbuster CV Rx clopidogrel (Plavix.) The case had been closely watched internationally, as a potential barometer of other related suits filed by Apotex and its brother clonemeisters in the US and other jurisdictions. A ruling in favor of Apotex would have been considered disasterous to Sanofi and its co-marketing partner Bristol-Myers Squibb, which are counting on the product’s strong revenue stream through a scheduled patent expiry in 2011. Plavix rings up Cdn$6 billion in annual revenues. A BMS spokesman said his company is “pleased with the decision of the Canadian court. It confirms our belief in the validity of the important intellectual property rights associated with Plavix in Canada and throughout the world.” More info=>
Colon cancer Tx PTK/ZK on hold, as Berlex, Novartis ponder data
Inconclusive trial results will delay Berlex and Novartis from filing EU and US NDAs for colon Ca Tx PTK/ZK, the companies said this week. The compound had been regarded as a potential blockbuster. A Berlex spokesman tells the International Herald-Tribune newspaper the companies are now eyeing a 2007 NDA, pending forthcoming data. A European analyst observes: “It’s essentially a problem for [Berlex.] PTK/ZK should have been a growth driver.” More info=>
Free ride for India’s generics industry drawing to an end
The government of India yesterday (03/22) began a process of ending laws that, in essence, allow the country’s generic drugmakers to copy patented medicines without paying royalties to the drug’s patent owner. As a member of the World Trade Organization, India is required to uphold intellectual property rights. Under revised legislation, the country’s clonemeisters will now make licensing payments to the developer of a copied Rx. India, which is emerging as a significant player in the global pharma business, supplies an estimated 40 per cent of the world’s generics. More info=>
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