Alex Gorsky, who joined the drugmaker as its No. 2 exec in the US four years ago before rising to the top slot, resigned today, a Novartis spokeswoman confirms. A replacement for the 47-year-old executive, who had previously worked at Johnson & Johnson, is being sought.

Gorsky will “pursue opportunities outside of the company,” the spokeswoman wrote us this evening. “We thank him for his strong leadership of the North American pharma business and wish him every success in his new role. His successor will be announced at a later date.”

UPDATE: Gorsky is going back to Johnson & Johnson. He will be the company group chairman and worldwide franchise chairman for Ethicon, and report to Sheri McCoy, who runs the Surgical Care Group, a J&J spokesman confirms.

His departure comes four months after an executive shuffle in which Joe Jimenez became worldwide pharma ceo, a spot that was previously held by Thomas Ebeling. Jimenez joined Novartis in April from Blackstone, the private equity firm, and was previously on the AstraZeneca board and an exec at HJ Heinz.

The changes occur as Novartis undertakes a cost-cutting campaign that involves cutting about 2,500 jobs and saving $1.6 billion. Before that reorganization was announced, the drugmaker had already disclosed plans to trim 1,250 jobs in the US specifically.

UPDATE: We would like to note that this was an exclusive item first reported by Pharmalot, which may not have been acknowledged elsewhere.

A Chinese facility that has never been inspected by the FDA made the active ingredient in Baxter International’s Heparin blood thinner, which the agency is now reviewing after 350 reports of allergic reactions and four deaths among its users, The Wall Street Journal reports.

An FDA spokeswoman said the plant making the active ingredient “was supposed to be inspected,” but “due to human error, and inadequate information-technology systems, a pre-approval inspection, which would normally be conducted, was not.” Currently, she tells the paper, “preparations are being made to perform an inspection as soon as possible.” The FDA has inspected a Cherry Hill, N.J., facility where the finished version of the drug was made, but adds, but couldn’t provide the name or location of the supplier.

Both Baxter and the FDA said it wasn’t clear that the product from the Chinese supplier is tied to the reactions, the cause of which has not yet been determined. “We honestly don’t know” the cause, the agency spokeswoman told the Journal. An FDA official earlier this week indicated the reactions could even theoretically be tied to the product’s packaging. The drugmaker this week temporarily halted manufacture of multiple-dose vials of its injectable drug.

The disclosure is likely to immediately spark inquiries from Congress and consumer advocates, the Journal writes, noting that lawmakers have already been investigating the safety of drugs imported from overseas. A recent report from the Government Accountability Office found that few foreign factories are regularly inspected, even though they constitute a large portion of ingredients for US drugs.

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The agency is challenging deals worth an estimated $200 million with Barr Labs, Ranbaxy Labs, Mylan Labs and Teva to keep a generic version of the Provigil sleep-disorder pill off the market until 2012. In its suit, the FTC asks the US District Court for the District of Columbia to void the agreements, essentially giving the generic drugmakers a green light to start selling their low-priced copycats.

The FTC contends Cephalon took that step because Provigil is such an important product - the pill generated $800 million last year, or 40 percent of sales. “The prospect of generic competition was a major financial threat to the company,” according to the FTC, which called the payments “purportedly independent business transactions.” But as a result, Cephalon forced patients and other consumers to pay hundreds of millions of dollars more a year than they otherwise would have.

“Cephalon prevented competition to Provigil by agreeing to share its future monopoly profits with generic drug makers poised to enter the market, in exchange for delayed generic entry. Such conduct is at the core of what the antitrust laws proscribe,” says Jeff Schmidt, the FTC’s Bureau of Competition director, in a statement. By making the payments, “Cephalon achieved a result that assertion of its patent rights alone could not.” Here’s the lawsuit.

In a statement, Cephalon defended its action and vowed to fight the suit: “Cephalon stands by the strength and validity of our Provigil patents and the legal basis for these settlements. We are disappointed that the FTC has determined to challenge these agreements as we believe they fully comply with both the spirit and letter of the antitrust laws. As importantly, our settlements confer a meaningful benefit to US consumers by providing for the entry of generic modafinil three years early.”

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In another blow to an ad hoc group of prostate-cancer patients and stock investors, the House Energy & Commerce Committee has decided not to hold a hearing into the controversy over the FDA’s handling of Dendreon’s Provenge vaccine. In a letter sent earlier today to four congressmen who had requested a hearing on behalf of a non-profit called Care To Live, the committee declined to take up the cause. (Here is the letter).

“An investigative hearing prior to an agency’s final decision runs the risk of interfering with the normal regulatory process,” wrote John Dingell, who chairs the committee, and Frank Pallone, who chairs the health subcommittee. “As you can understand, as the committee conducts oversight of the FDA or any other agency, it must be careful to balance the need for aggressive oversight with the equally compelling need to avoid the appearance of political interference that favors a particular interest.”

The controversy erupted last spring, after an FDA advisory panel recommended the agency approve Provenge. But then two FDA panel members wrote the agency urging a go-slow approach, and the FDA shortly thereafter decided to delay approval. One panel member was Howard Scher, an oncologist at Memorial Sloan-Kettering Cancer who serves on the advisory board of a venture capital firm that invested in Novacea, which is developing a rival cancer med. The other was Maha Hussain, a University of Michigan oncologist.

The behind-the-scenes machinations caused a firestorm - the two cancer docs say they received threats; the chain of events fueled debate about the use and approval of experimental meds, and some cancer patients and Dendreon investors filed a lawsuit against the FDA. The suit claims the two panel members held undisclosed financial conflicts of interest and alleged a Byzantine power play involving a key FDA official who sought to sway the outcome, although a federal judge recently dismissed most of the suit.

In further explaining their decision, Dingell and Pallone pointed to waivers that were issued to Scher and Hussain, and then cited a recently enacted FDA regulation governing conflicts of interest. You can read here about the new regs, which were proposed last spring. Although that will likely be of little comfort to the Provenge activists, given that the new regulation was passed after the Provenge episode. A committee spokesman writes us to say that no one will be available to discuss the decision.

Scott Riccio, who heads another group that is pressing for Provenge approval, A Right To Live, send us this statement: “We’re saddened for the patients who have already been lost because they couldn’t access such a promising and potentially lifesaving new therapy….

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In 2003, an FDA veterinarian named Victoria Hampshire began examining a growing number of adverse reactions to ProHeart 6, a Wyeth med for treating hookworm in dogs. Little did she know that her curiosity and commitment to her work would lead her into a maelstrom that, ultimately, would generate a Congressional investigation and raise questions about industry influence over the agency; the FDA’s ability to properly investigate allegations against employees, and the agency’s own commitment to serving the public.

After the med was removed from the market, you see, Wyeth launched its own secret investigation into Hampshire; raised conflict-of-interest charges against her at the FDA; and implicitly threatened agency officials that further action would be pursued if Hampshire was allowed to remain in place. Among those involved in a failed effort to allow ProHeart 6 back on the market was former Wyeth ceo Bob Essner. Hampshire was, in fact, removed from her post, but negotiated a transfer and now works as director of device review in the cardiac device division for the FDA’s Center for Devices and Radiological Health.

Last week, Chuck Grassley, a member of the US Senate Finance Committee who led the investigation, to recommend the FDA strengthen various procedures and policies, particularly concerning interactions between agency officials and industry execs. “The FDA accepted Wyeth’s allegations at face value and took actions against Dr. Hampshire that may have adversely affected the drug approval and recall processes,” he wrote to FDA commish Andy von Eschenbach. (Here’s his report and the attachments). We subsequently spoke with Hampshire and asked her to reflect on the episode. Here’s an excerpt…

Pharmalot: This is a very detailed report. To what extent were you aware of the goings on described?
Hampshire: Well, of course, I lived this, but there were parts that were new to me. I was unaware of the gossip and speculation that was used to try to discredit me. They hired people - a public relations firm, a veterinarian - who had no access to the (ProHeart 6) data or played a public health role but they suggested I was taking a stance for my own benefit (Hampshire was accused of a conflict of interest because she had a web site that infrequently accepted orders for veterinary meds, although she used it almost exclusively for helping family and friends, and orders were taken by a third party. The Wyeth investigation involved unsuccessful attempts to purchase prescription meds). I was shocked, to be honest. You know, only 2,500 or so people a year graduate from veterinary schools. It’s a small world, but I didn’t know it was vindicative and evil. And the company stooped to the level of hiring a PR firm to investigate me. I would never have dreamed that would happen to me in my public health role.

Pharmalot: And what about your managers at the FDA?
Hampshire: I thought my managers were cowardly…

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Drugmakers counting a new hot seller for a primary care market ought to think again. New chemical entities aren’t contributing very much these days - the average launch curves for the top 10 new chemical entities shows that 2007 had the weakest result since 2003.

“Fewer of these NCEs are top-performing, contributing much less to growth,” said Diana Conmy, IMS Health’s corporate director of market insights, who spokes at conference covered by The In Vivo blog. As the blog notes, last year was the first time that pharma experienced a decline in the number of primary care blockbusters - 29 in 2007 vs. 33 in 2006 - IMS data show. However, there was an increase in specialty care blockbusters - 30 in 2007 vs. 25 in 2006.

Small wonder that the primary care market fell during the last seven months of 2007, contributing a negative 18 percent to overall market growth for the year, the blog writes, while specialty care contributed a positive 118 percent. The growth rates per therapeutic area tell the same story: specialty care grew 10.5 percent, while branded meds grew 2.9 percent - which is slower than the 3.8 percent growth for the overall market.

To underscore her point, In Vivo notes that Conmy believes three of four potential blockbusters to launch this year are specialty meds: UCB’s Cimzia for Crohn’s disease, Bristol-Myers Squibb’s ipilimumab for melanoma and Wyeth’s Pristiq for depression, assuming it ever gets FDA approval. The fourth potential blockbuster on Conmy’s list, the blog writes, is MedImmune’s Numax for respiratory virus.

Hat tip to The In Vivo blog

A minority of US medical schools surveyed have adopted policies on conflicts of interest regarding financial interests held by the institutions, but at least two-thirds have policies applying to financial interests of institutional officials, according to a study in the Journal of the American Medical Association (subscription may be required).

The researchers surveyed deans of all 125 accredited allopathic medical schools in the US between February and December 2006 to assess the extent to which the schools have adopted policies concerning institutional conflicts of interest (ICOI). They received replies from 86, or 69 percent. They found that 38 percent have adopted an ICOI policy covering financial interests held by the institution, 37 percent are working on adopting a policy and 25 percent aren’t working on a policy, or simply didn’t know.

“Although it is encouraging that 38 percent of institutions are in the process of developing policies covering the institutions’ financial interests, wider adoption of ICOI policies covering these interests is imperative in light of the compelling interest of research integrity, protection of human subjects and preservation of public trust,” write the authors, whose work was funded by the Greenwall Foundation.

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Why? Because David Brennan is convinced he can prevail in disputes over the drugmaker’s two biggest meds, Nexium and Seroquel, and so hasn’t had any discussions about settling the cases, he tells Reuters.

“We haven’t discussed anything around settlement. Our position has been we have strong intellectual property and we intend to defend it and stand behind it. Obviously, we have options available to us. We always explore options that are available but it’s clear to us that we have an intellectual property argument to make and we are making it,” he says. However, more cost-cutting is envisioned if AstraZeneca loses the battles.

The drugmaker’s $5.2 billion cash cow, the Nexium heartburn med, could face generic competition in April. Ranbaxy Laboratories, which has first US rights to market a generic, last week received tentative FDA approval. And the Seroquel antipsychotic, a $4 billion seller, may face a generic threat in late March from Teva Pharmaceuticals.

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Two-thirds of all prescriptions filled in the US are generics, the highest-ever rate, according to figures released by the Generic Pharmaceutical Association. That’s up from 63 percent. Meanwhile, Bloomberg News reminds us that more expensive brand-name meds account for about 80 percent of all dollars spent on prescriptions each year.

The figures, compiled by IMS Health, show generic drugmakers are capitalizing on expiring patents and efforts by insurers to rein in health-care costs, Bloomberg notes, while adding that the companies hope to capitalize as drugs with $20 billion in annual sales lose patent protection and the presidential candidates promise to make generic drugs more widely available. Drugs facing generic competition for the first time this year include Merck’s Fosamax osteoporosis med and Johnson & Johnson’s Risperdal antipsychotic.

“We’re poised to do very well,” Kathleen Jaeger, the trade group’s president says during its annual convention. “All the candidates believe that generics are part of the answer.”

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The results were from a study called Avado, which included patients who took Avastin with Taxotere, but the data is too new to be included in the biotech’s application to market Avastin for this use. The benefit was seen among patients on both low and high doses, compared with patients given a placebo along with chemo, according to Genentech. The study also measured whether patients lived longer than those on placebo.

The FDA is expected to decide later this month on whether to approve Avastin - which is already cleared to treat colon and lung tumors - based on a different study. The earlier trial, called ECOG 2100, showed Avastin was able to slow the spread of breast cancer by an additional 5.5 months when used with Taxotere, compared with just chemo. Genentech hopes the latest results will sway the agency, but some analysts are dubious.

In a research report this morning, Jim Reddoch of Friedman Billings Ramsey notes that an FDA advisory panel in December wasn’t convinced of Avastin’s risk-reward profile and voted 5-4 against approval. “They also had issues with (progession-free survival) as an endpoint for approval in first-line breast cancer. The ECOG 2100 trial, the main study in the filing, showed a robust 5.5 month benefit, but no overall survival benefit. Therefore, the PFS results from Avado, absent survival, are unlikely to persuade the FDA to reconsider the recommendation.”

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