HIV

Tough HIV drug ads draw fire

Tracy Staton — Mon, 25 Aug 2008 10:15:01 -0400

There's no question that the HIV drug market is getting crowded. Newer meds like Gilead Sciences' Truvada and Merck's Isentress are on the rise, and GlaxoSmithKline's older drugs--Combivir and Trizivir, for instance--are losing market share. So it's no wonder that drugmakers have unveiled their versions of a political campaign's "attack" ads, pointing out the side effects of competing treatments or aiming to persuade patients to stick with the regimen they're on.

The question is, have the ads gone too far? Some AIDS advocacy groups think so. An activist group officially complained to GlaxoSmithKline about one ad--which pictures shark-infested waters, advising "stick with the HIV medicine that's working for you--saying that it's offensive and designed to make patients afraid of switching. Another advocacy organization says it has complained directly to the Department of Health and Human Services about another GSK ad pointing out the side effects of competing protease inhibitors.

Compared to other advertising, these ads aren't so tough. But traditionally, AIDS-med ads have focused on the positive. And not only are activists concerned that patients could be scared off their doctors' advice. Physicians have expressed worries, too. The drugmakers say that the ads are educational and appropriate, and that patients should make sure to talk to their doctors about the side effects of any new meds.

- read the Wall Street Journal story

HIV drugs may find preventive use

Tracy Staton — Mon, 04 Aug 2008 10:09:00 -0400

Should HIV drugs be used to prevent infection with the deadly virus? Some say yes. Given the fact that vaccine developers have to start all over on their anti-HIV shot, and microbicides haven't shown much promise either, prophylactic use of antiretroviral drugs seems like a logical choice.

Obviously, extending the use of the drugs these experts are looking at--Viread (tenofovir) and Emtriva (emtricitabine)--would be a big boost to their maker, which happens to be Gilead Sciences (though cheaper versions are made for some markets by Indian companies). But--and this is a big "but"--clinical trials have to be run first. A couple of countries already are conducting tests, and others are in the works.

Initial results might come as early as next year, though. And some experts say these drugs are now the most promising tools for HIV prevention, at least as a stop-gap as vaccine research continues.

- check out the story in the New York Times
- see the Financial Times story

Docs back Viread for hepatitis B

Tracy Staton — Thu, 29 May 2008 10:47:38 -0400

Analysts are chatting up Gilead Science's HIV drug Viread as a treatment for hepatitis B. Currently under FDA review for that indication, Viread already has the backing of four out of five doctors, said Thomas Wei, a Piper Jaffray analyst."Feedback from this survey leads us to believe that Viread could enter the market with the best combination of efficacy, safety and resistance data, and coupled with a lower cost, could win the majority market share of the class," Wei wrote in a note to clients.

This is good news for Gilead, which has been fighting off Viread competitors lately. In November, the FDA gave tentative approval for the first generic version of Viread under the President's Emergency Plan for AIDS Relief, and in January, the Public Patent Foundation challenged four patents on the drug. The U.S. Patent Office has since upheld one of those patents, but there's been no ruling yet on the others.

- see the story in Forbes

Did GSK ignore early abacavir warning?

Mon, 12 May 2008 06:59:55 -0400

Back in 2005, Swedish pharma monitors raised a red flag on the HIV fighter abacavir and its possible link to heart attacks, The Independent is reporting. Thirty-four patients taking abacavir had heart attacks, the Uppsala Monitoring Centre told GSK in May 2005, the newspaper says. Nothing was said publicly, however, until April 2008.

You'll recall that last month, The Lancet published a study showing that abacavir patients had almost double the risk of heart attack as did patients taking other AIDS drugs. Independent scientists said at the time that the data wasn't strong enough to prove a causal link, but that the link was too pronounced to ignore. The same scientists also questioned the data GSK used to back up its pooh-poohing of the link. At the time, the company called the study's findings "unexpected."

- read the story in the Independent

Brazil mulls patent-busting on Tenofovir

Mon, 28 Apr 2008 06:59:55 -0400

The Brazilian government recently deemed the anti-HIV med Tenofovir a "public interest." That's code for, "We're thinking about issuing a compulsory license for this drug." Under WTO rules, countries can circumvent patent protection on drugs it needs to combat a public health crisis. Brazil has some 600,000 people living with HIV.

Currently, Brazil treats 31,300 of those patients with Tenofovir at a cost of $1,387 per person. If the country imported a generic version made in India--at a cost of $170 per patient per year--it could save more than $30 million annually.

Gilead Sciences, which makes Tenofovir, had applied for patent protection for the med in Brazil. The country's health ministry formally dissented. The application remains under review by regulators.

- see the story at Domain B
- get some background in Forbes

ALSO: The U.S. Trade Rep is keeping Thailand on its naughty list for its new habit of issuing compulsory licenses, which allow the government to circumvent patent protection, on various drugs. The pharma industry had been lobbying to have Thailand downgraded. Release | Report

GSK tests sliding-scale prices

Mon, 17 Mar 2008 07:59:55 -0400

Is sliding scale the way to go in emerging markets? GlaxoSmithKline wanted to know. So the company is testing a radical new pricing plan that would offer meds to patients according to their ability to pay. The pilot pricing programs are now underway in India, South Africa, and Morocco, countries with a growing middle class, plus significant numbers of people in poverty.

The idea is to generate a premium from wealthier patients, the Financial Times reports, to subsidize losses on low-price sales to poor patients. It's a new approach in these so-called "middle income" countries; in the past, drug makers have tended to sell, say, HIV drugs at cut rates in the very poorest countries, but in middle income countries, charged higher prices. That meant only the patients in the highest income brackets could afford to pay.

Now, poor patients would have access to those meds--and GSK is hoping that big sales volume will offset the lower prices. We'll have to keep an eye on this pricing test; more and more drug makers are targeting emerging markets such as India and China for sales growth.

- read the story in the Financial Times
- see the Outsourcing-Pharma piece on emerging markets strategies

Related Article:
Biotech, emerging markets are big VC targets. Report

Three-way HIV combo approved in EU

Tue, 18 Dec 2007 06:59:56 -0500

Call it a trifecta. European regulators have approved Atripla, the combination HIV med that allows patients to get their entire drug cocktail in just one pill a day. The approval is another coup for the three companies that collaborated on the product--Gilead Sciences, Bristol-Myers Squibb, and Merck. Combining the existing drugs efavirenz, tenofovir and emtricitabine, Atripla will soon be available in Germany, Austria and the UK.

Approved by the FDA since July 2006, Atripla has become the most-prescribed treatment regimen for HIV patients just starting drug therapy. Sales of the drug topped $650 million during the first nine months of 2007.

Under the terms of a deal announced last week, Gilead and BMS will lead the commercialization charge in Europe. Merck granted BMS its European rights to the drug. Analysts expect worldwide sales to peak at about $4 billion.

- check out Gilead's release
- read the report from the BBC
- here's an analysis of the HIV drug market from CNN Money

Related Articles:
FDA OKs three-in-one AIDS drug. Report
GSK losing its grip on HIV market. Report
BMS, Gilead expand alliance. Report

Pfizer nets first AIDS patent in India

Tue, 11 Dec 2007 06:59:57 -0500

Pfizer cleared a big milestone in India today: The company became the first to get patent protection for an AIDS drug there. The new patent covers Celzentry, or maraviroc, a new, first-in-class HIV remedy that was approved by the U.S. FDA in August.

Pfizer's victory follows several other attempts, including GlaxoSmithKline's bid for a patent on Combivir; opposition from patient groups prompted GSK to withdraw its application last year.

- read the report from the Economic Times
- see this chart of HIV drug patent applications and their status in the Business Standard

Related Articles:
Selzentry approval marks big win for Pfizer. Report
Investors yawn at Maraviroc endorsement. Report
New HIV drugs offer breakthrough therapies. Report

Who tainted Roche's Viracept?

Mon, 26 Nov 2007 06:59:55 -0500

A new regulatory report gives us a peek at the recall of Roche's HIV remedy Viracept--and it's not a pretty picture. You'll remember that Viracept was withdrawn from the European market in June because impurities were found in the pills; it's now back on the market. Just how the drug was tainted hadn't been publicly acknowledged

According to European regulators, Roche employees didn't clean out a holding tank used to store the starting compounds for Viracept. And when they finally did, they allowed an ethanol cleaning solution to mix with the drug ingredients. Result: a toxic compound that ended up in patients' pills.

Roche has since corrected the problem. But the root cause, the EMEA report concluded, was that employees simply didn't understand the drug's manufacturing process, perhaps because it was purchased from another company. Is this a taste of things to come, given all the drug-buying that's going on in pharma these days? Let's hope not.

- see the report from the EMEA
- read the Financial Times article

Related Articles:
Viracept snafu costing Roche millions. Report
EU puts Viracept on hold. Report

ALSO NOTED: Caraco gets FDA nod for GSK seizure drug; Mylan prices offering of stock;

Wed, 14 Nov 2007 06:59:50 -0500

> Caraco Pharmaceutical got tentative FDA approval for its copycat form of GlaxoSmithKline's Lamictal, a remedy for seizures and bipolar episodes that sold some $1.89 billion in the 12 months ended Sept. 30. Release

> Mylan announced that it has priced its new offering of preferred stock at $1,000 per share and common stock at $14 per share; the company intends to sell 1.86 million shares of the former and 53.5 million of the latter. Release

> Lundbeck reported a 37 percent boost in third-quarter profits to about $170 million, excluding the one-time payment from Takeda Pharmaceutical on the commencement of their co-development deal. Release

> Orion is suing Sun Pharmaceuticals to protect its patent on Stalevo, a treatment for Parkinson's Disease. Report

> OraSure Technologies, which makes diagnostics for HIV and drug use, announced it has settled a patent infringement suit against Schering-Plough. Release

> A recent trial run by BioCryst was negatively impacted by short needles and fat arms. Report

> Sanofi Pasteur is buying into Acambis' program for a novel West Nile vaccine. Report

> Synta Pharmaceuticals' new, $1 billion pact with GlaxoSmithKline for the cancer drug elesclomol (code named STA-4783) is expected to open a spigot of cash for the drug developer. Report

> Nektar Therapeutics got a consolation prize of $135 million from Pfizer--and a fresh shot at signing a new partner--to calm any upset feelings about Pfizer's abandonment of Exubera. Report

And Finally... Book 'em, Danno. A Wyeth sales rep was arrested yesterday for allegedly stealing drug samples and reselling them to pharmacies at a discount. Report

ALSO NOTED: GSK to launch cervical cancer vaccine in EU;Ranbaxy licenses Sirtex cancer remedy;

Mon, 24 Sep 2007 06:59:50 -0400

> GlaxoSmithKline is now ready to launch its vaccine against cervical cancer, Cervarix, in the E.U--and analysts expect revenues of $2 billion to $5 billion there, based on rival Gardisil's performance in the U.S. Report

> Ranbaxy Laboratories inked a licensing deal with Australia's Sirtex Medical to market the colorectal/liver cancer drug Sir-Spheres. Report

> Cardinal Health tapped CEO R. Kerry Clark as chairman, to replace retiring chairman and founder Robert D. Walker. Report

> Pfizer got EU approval for Celsentri (maraviroc), its new, first-in-class HIV fighter. Report

> Bristol-Myers will buy its drug-development partner Adnexus Therapeutics for about $415 million. Report

> Novartis got the E.U. nod for its Exelon patch, a treatment for mild to moderate Alzheimer's. Report

> The EU's drug safety committee recommended approval for Schering-Plough's combination hepatitis C treatment. Report

And Finally... Here's another drug safety dilemma to round out the day's news: Patients often take handfuls of different prescription drugs daily, in potentially deadly combinations, along with OTC chasers for good measure. Report

SPOTLIGHT: Adcock Ingram gets free license for Merck HIV remedy

Fri, 07 Sep 2007 06:59:52 -0400

South African generics maker Adcock Ingram nabbed a royalty-free license from Merck on its anti-HIV drug Stocrin (efavirenz). The South African government has been buying the brand-name drug from Merck for distribution at state-run clinics. Adcock will sell its version at a "significant discount," once it gets approval from that country's drug regulators. Merck gave a voluntary license for efavirenz to Aspen Pharmacare, Adcock's biggest competitor, two years ago; that company still awaits regulatory approval for its version of the drug. Release

SPOTLIGHT: Thailand skirts Plavix patent

Thu, 23 Aug 2007 06:59:52 -0400

Thailand's health ministry has decided to import a generic version of the heart drug Plavix from India, even though the Schering Plough drug is still under patent. Made by M-Cure, the pills will be imported using compulsory licensing, a World Trade Organization waiver that allows developing nations to bypass drug patents when they have no means to pay for branded versions of necessary drugs. Previously, the Thai government had invoked compulsory licensing for two anti-HIV agents. E.U. and U.S. officials protested the Plavix decision. Report

Pfizer goes public with R&D pipeline

Tue, 07 Aug 2007 06:59:58 -0400

It's tough to take over the world when everyone can see your battle plans--or so thought Pfizer before CEO Jeffrey Kindler pledged transparency. Now the company's future can be viewed at its public R&D pipeline site, which was updated yesterday for the first time since it went online in December. Pfizer has 47 Phase II drugs, 11 Phase III drugs and 14 biologics in its pipeline. An unlucky 13 projects were abandoned.

The pipeline also shows 20 cancer hopefuls moving their way up the charts. But it was an HIV drug that jumped out of the pipeline and onto the market yesterday, with the FDA's approval of Selzentry (maraviroc). It's a first-in-class drug that keeps the virus from entering white blood cells. The accelerated approval is specific to patients with a particular strain of HIV-1, known as R5 virus. Development of the drug for other HIV patients continues, according to Pfizer's pipeline site. Unfortunately, the company hasn't revealed much more about maraviroc's development. Is Pfizer's transparency initiative better than tea leaves? Sure, but it's not exactly the keys to the kingdom.

- see this release on Pfizer's pipeline
- read the release on the FDA approval
- here's the report from StreetInsider on Selzentry
- here's a link to the pipeline

Related Articles:
Pfizer's Kindler leaves analysts feeling flat. Report
Management shakeup at Pfizer. Report
CEO McKinnell gets the boot as Pfizer struggles. Report
Troubled Pfizer blueprints biotech venture effort. Report