Certriad just wasn’t valuable enough

It was just yesterday that I posted a short news article on the website about AstraZeneca and Abbott pulling the plug on their dyslipidemia drug Certriad (click here to read that), pretty much because the FDA had some questions about it, it seems they were worried it wouldn’t be quite as popular on the market because of those concerns if it got approved, and so it just wasn’t “commercially attractive” enough for them anymore.

I find myself of three minds about this development, quite frankly.

On the one hand, as a consumer (though I don’t need prescriptions much and hope I can continue that well past my middle age years), I’m not sure how I feel about the tactic of two companies putting their drugs together into a single combo pill as (presumably) a way to extend some patent protection time and keep getting name-brand-level payments for drugs that might otherwise be generic.

On the other hand, as a journalist who has focused on healthcare and medical areas most of my career, and now earns my living reporting on the business aspect of pharma and biotech, I understand the need for such companies to keep money flowing into their accounts, both to support the people who work for them and to fund important R&D (and, hopefully, take out ads in ddn, to be honest).

On the third hand (meaning I just borrowed one of my chief editor’s limbs or I’m a mutant), why does this drug have to be abandoned because it’s no longer quite as potentially profitable? With money already put into the effort, isn’t it worth the time and expense to address the FDA’s issues, whatever they are, and make some money off Certriad? Isn’t the goal to get useful therapies to patients and wasn’t this drug supposed to be both convenient and helpful for patients with mixed dyslipidemia?

I mean, companies are willing to tackle orphan drugs and neglected diseases even though the payoffs might not be as high, so what made Certriad so unattractive all of a sudden?

Mind you, I’m not pointing fingers at either company, because I don’t know what the contents of the FDA letter were, and last I heard, the companies hadn’t shared that information. But still, I shake my head and wonder why you just drop a drug that combines two already approved products because it just isn’t as “commercially attractive” anymore?

Brilique…yes, Brilinta…not sure

Earlier this week in a Dec. 14 blog post, I noted that European regulators had given the go-ahead to AstraZeneca’s ticagrelor for the prevention of atherothrombotic events in adult patients with acute coronary syndromes. In that post, I noted it was likely the U.S. Food and Drug Administration (FDA) would make a similar move for Brilinta (as the drug will be known in the United States) as the European Commission did for Brilique (as it will be known in Europe).

Well, today’s decision by the FDA shows why it was a wise move I became a journalist and not a market analyst.

While the FDA didn’t exactly say “No way,” it also didn’t say “Yes.” Instead, we have a solid, “We’re not sure yet.”

More specifically, the FDA has issued a complete response letter (CRL) for the New Drug Application (NDA) for ticagrelor in the United States. In the CRL, the FDA has requested additional analyses of data from AstraZeneca’s PLATO trial. The agency did not request additional studies, clinical studies or otherwise, as a prerequisite for approval of the ticagrelor NDA. At this point, it seems to want the numbers crunched a bit more from the studies that have been conducted.

AstraZeneca has noted that it is evaluating the contents of the CRL and will respond to the agency’s request for additional analyses of the PLATO data as soon as possible. The company reports that it remains confident in the NDA submission for ticagrelor and in its ability to respond to the agency’s questions.

“Our highest priority is to provide the requested PLATO analyses to the FDA and progress to completion of the Brilinta NDA review,” says Martin Mackay, president of research and development for AstraZeneca.

And in this corner…Brilique!

It looks like the world’s second-best-selling medication, Plavix, may possibly have some head-to-head competition in the form of Brilique (also known as Brilinta, and known generically as ticagrelor). In the U.S., the FDA extended the time to complete its review of the New Drug Application ticagrelor from Sept. 16 to Dec. 16, but in Europe, the European Commission has granted marketing authorization to the drug for the prevention of atherothrombotic events in adult patients with acute coronary syndromes.

AstraZeneca, the drug’s maker, expects to begin selling the pill in the second half of 2011, once price negotiations are completed with member countries of the European Union, and the company plans to market Brilique based on the results of a study that showed it cut the risk of heart attacks, strokes and death linked to heart disease more than Plavix.

Plavix, which is also known by its generic name clopidogrel, is sold by sanofi-aventis and Bristol-Myers Squibb Co. and posted $9.8 billion in revenue last year, second in sales only to Pfizer Inc.’s Lipitor for lowering cholesterol.

The AstraZeneca study indicates that Brilique, known by the generic name ticagrelor, works regardless of the patients’ genetic makeup, compared with Plavix, which isn’t as effective in patients with a certain genetic variation. Reportedly, AstraZeneca’s drug showed a higher risk of spontaneous major bleeding in the study.

Brilique got a thumbs-up from an FDA advisory panel in the United States, so it is expected that the FDA make a similar marketing decision for the drug as did its European counterpart, in just a couple days. The drug will be known as Brilinta in the United States.

Plavix, which is also known by its generic name clopidogrel, is sold by Sanofi-Aventis SA and Bristol-Myers Squibb Co. and had $9.8 billion in revenue last year, second in sales only to Pfizer Inc.’s Lipitor cholesterol-lowering pill.

Leaders, layoffs and losses

It’s been an interesting month in the pharmaceutical industry, with a few of the top pharma’s leaders leaving, more pink slips piling up and stocks morphing in the face of all of the change.

On Nov. 30, Merck & Co. Inc. announced its appointment of President Kenneth Frazier, who as Merck’s former chief counsel was instrumental in helping the pharma overcome its Vioxx litigation, as its new CEO. Frazier will succeed current CEO Richard Clark, who will reach Merck’s mandatory retirement age next year. Clark will continue as chairman of the board. Although analysts are optimistic that Frazier will see Merck through its next big challenge—the expiration of the Singulair patent, which accounts for 11 percent of the company’s sales—and continue Clark’s work on investing in the next generation of blockbusters, the announcement prompted a 4 percent drop in Merck’s shares to $34.64.

Recently retired Pfizer CEO Jeffrey Kindler speaks at the Reuters Health Summit in New York

Days later came the news that Pfizer Inc. Chairman and CEO Jeffrey Kindler abruptly announced his resignation after four years of leadership at the company. Although Kindler said he needed to “recharge my batteries,” analysts have speculated that he was forced out by a board and investors who are unhappy with Pfizer’s languishing stock price, late-stage clinical failures and a strategy emphasizing repeated acquisitions to boost revenue and cut costs as a way to improve the bottom line. The appointment of Ian Reid, Pfizer’s head of global pharmaceuticals, as Kindler’s replacement has also raised analyst concerns about Pfizer’s long-term performance and leadership. With Pfizer’s shares down 9.6 percent over the last year of Kindler’s tenure, shares rebounded on the resignation news, gaining 20 cents to $16.92.

With the holidays upon us, and many analysts taking a look at the highlights of 2010, layoffs are also making headlines. Fierce Pharma recently unveiled its annual top 10 layoffs list, highlighting the 10 largest job cut announcements by company. Counting the year’s total pink slips at more than 50,000 jobs, the list begins with AstraZeneca, which let 8,550 employees go this year, and counts job losses in the thousands at Pfizer, GlaxoSmithKline, Roche, Bayer, Abbott Labs, sanofi-aventis, Takeda, Novartis and Bristol Myers-Squibb. Given how often these companies made the front page of ddn this year with their merger and acquisition activity, these cuts are no surprise, as all of these transactions inevitably mean consolidation of resources.

With new leadership, more modest operations and the pressure of patent expirations, all of this should make for a very interesting 2011 in Big Pharma. As the Yieldpig blog notes, “with the dicey situation in Europe, stubborn domestic unemployment, a housing market that’s bottoming at best, and the great unknown of interest rates, equity portfolios should probably continue to play defense. Big, cheap, pharmas with sick dividend yields should help.”