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Pfizer cuts forecasts as generics threats become reality


US drug giant Pfizer has posted solid first-quarter financials but has warned that the near-term future looks a bit bleaker as generic competition takes its toll on the firm’s blockbuster antihypertensive Norvasc® (amlodipine) and antidepressant Zoloft® (sertraline hydrochloride).

The company’s revenues were up 6.2% to US$12.47bn, and while net income was down 18% to US$3.39bn, or US$0.48 per share, the decline was primarily due to restructuring and acquisition costs and the figures were ahead of analysts’ expectations.

Leading the revenue rise once again was the cholesterol-lowerer Lipitor® (atorvastatin), sales of which climbed 8% to US$3.36bn, while Celebrex® (celecoxib) for arthritis climbed 22% to US$598m. The erectile dysfunction drug Viagra® (sildenafil) contributed US$434m (+11%), but the most pleasing performance came from Pfizer’s new epilepsy and neuropathic pain medication Lyrica® (pregabalin), up 106% to US$395m.

As for its even newer products, Pfizer’s novel pill for smoking cessation Champix®/Chantix® (varenicline) brought in US$162m, helped by an unbranded advertising campaign that is developing the market, while cancer drug Sutent® (sunitinib) had sales of US$102m. Caduet®, which combines Lipitor with Norvasc, leapt 89% to US$146m.

However, it is the sales of Norvasc on its own, still Pfizer’s second bestseller, which are causing concern. They fell 10% to just under US$1.1bn, but the damage will be a lot more severe in the coming months as generic versions of the drug become more widely available. Copycat competition is already hurting Zoloft and sales crashed 81% to US$779m.

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Pfizer has reduced its full-year revenue estimates by US$1.2bn to US$47–$48m to reflect the loss of patent exclusivity for Norvasc, which came six months earlier than expected, and has adjusted its earnings forecast to US$2.08–2.15 per share, down from US$2.18–2.25. Chief executive Jeffrey Kindler also noted that “the disappointing revenue performance” of Exubera® (inhaled insulin) for diabetes is continuing and the firm will get more deeply involved in the more extensive market-development activities to support the product, for which no quarterly sales figures were disclosed.

Mr Kindler also noted the firm’s concerns over a decision by a Canadian federal court in a case with Indian drug firm Ranbaxy at the end of January which found Pfizer’s atorvastatin patent to be invalid in Canada, and said 2008 revenues could be significantly hurt if a final decision went against the New York-based company. US sales of Lipitor have experienced a modest decline as patients switch to cheaper generic forms of Merck’s rival product Zocor® (simvastatin), but Pfizer is comfortable that it can regain its previous strength in the market.

Meantime, documents posted on the US Food and Drug Administration’s website, ahead of a review by the agency’s Antiviral Drugs Advisory Committee on 24 April, say Pfizer’s Celsentri® (maraviroc), the first in a new class of HIV/AIDS treatments called CCR5 antagonists, reduces viral levels in patients with the disease.

In the documents, FDA staff state that combined data from two trials involving treatment-experienced patients with CCR5-tropic HIV-1 showed that maraviroc plus optimised therapy was twice as likely to reduce viral loads to undetectable levels compared with optimised therapy alone. However, agency staff noted that while Celsentri did not appear to increase the risk of lymphoma or infections, it was associated with a possible “modest increase in liver-related side-effects”, so they have asked the panel to consider whether there is a need for special labelling or even additional clinical trials.

PharmaTimes 23/4/2007


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