profits

Wyeth pounces on Sandoz's copycat Protonix

Tracy Staton — Wed, 21 May 2008 10:46:11 -0400

Wyeth is going toe-to-toe with Novartis. The Protonix maker--and its partner, Nycomed--filed suit against Novartis' generics arm, saying its copycat drug violates the heartburn med's U.S. patent. Sandoz, you'll recall, filed last month for FDA approval of an injectable form of the drug.

It's just the latest twist in the rapidly lengthening story of copycat Protonix. Last year, Teva Pharmaceuticals launched its version, but stopped shipping to sit down with Wyeth at the negotiating table. No settlement of the companies' patent fight has yet been reached, but in the meantime, Wyeth teamed up with Prasco Laboratories to sell an authorized generic. Soon after, a division of India's Sun Pharmaceuticals released its own version.

Wyeth's sales--both branded and generic--dropped by 66 percent during the first quarter--a painful loss, considering the fact that Protonix once was the drugmaker's biggest seller. It's still defending its Protonix patent, though, and plans to ask for lost profits and damages from both Teva and Sun when the patent case goes to trial.

- see the Wall Street Journal story

Could Clarinex be vulnerable to generics?

Wed, 30 Apr 2008 06:59:55 -0400

Consider this scenario from Fred Hassan's nightmares: The $800 million Clarinex, ostensibly under patent till 2020, falls early victim to generic competition. Early, as in next year. In court documents filed April 16, the Indian generics maker Orchid Chemicals alleges that Clarinex RediTabs was never covered by Schering-Plough's '274 patent. If that's so, then Orchid could launch its version of RediTabs almost immediately, the documents state. And so, apparently, could other copycat drugmakers circling the allergy med.

Schering disagrees with Orchid, of course. And though Orchid has some smart lawyers on the case, so does Schering-Plough. We'll have to wait and see what the court decides.

- check out the Pharmalot story
- see the item at Shearlings Got Plowed

ALSO: Drugmakers are lobbying Congress to change a particular patent rule that allows protection to be canceled if the patent holder misrepresented or concealed info in its application. Generics makers, however, say the penalty is necessary, because without it, branded drugmakers could "cheat and get away with it," making it more difficult for cheaper generic meds to make it to market. Report

Novartis restricts Zelnorm to emergencies

Thu, 03 Apr 2008 07:59:55 -0400

Goodbye cruel world. Novartis is pulling the irritable bowel med Zelnorm off the market almost completely, saying it will supply the drug only for emergency use. And even in emergencies, Zelnorm will only be available to patients who don't smoke, and don't have high blood pressure or diabetes or eight other preexisting conditions. And docs who want it must ask the FDA for authorization.

Talk about going out with a whimper. Zelnorm racked up $560 million in sales in 2006, then was withdrawn in March 2007 after it was shown to boost the risk of heart attck, strokes, and chest pain. Novartis eventually made a deal with the FDA to supply Zelnorm to a limited number of patients because it was the only remedy approved for irritable bowel treatment. Eight months later, bye-bye. FDA says the withdrawal was voluntary; we'll have to wait and see whether Novartis offers an explanation.

- see the FDA's press release
- read the Pharmalot item

Related Articles:
Novartis CEO's pay drops with profits. Report
Novartis shares slide after Zelnorm gets yanked. Report
EMEA committee rejects Novartis' Zelnorm. Report

FTC sues Cephalon for blocking generics

Thu, 14 Feb 2008 06:59:57 -0500

Here's one way generics might pay off. The feds are accusing Cephalon of bribing drugmakers to keep copycat Provigil off the market. According to an FTC lawsuit against the company, Cephalon paid four generics makers $200 million to stop selling their versions of the narcolepsy drug until 2012. With $800 million in annual sales, Provigil accounts for about half of Cephalon's revenues.

Using words like "monopoly," an FTC official said Cephalon agreed to share profits with the generics firms in exchange for their staying out of the fray. "Such conducts is at the core of what the antitrust laws proscribe," the official said. But Cephalon defended its agreements with the other companies, which settled patent litigation. "We believe they fully comply with both the spirit and letter of the antitrust laws," the company said in a statement. And Barr Pharmaceuticals, one of the generics firms, said that it believes the deals are legal and that they serve consumers' best interests.

- find Cephalon's release about the FTC suit
- read the story in BusinessWeek
- check out more details in the Wall Street Journal

Related Articles:
Cephalon to pay $425M settlement. Report
Cephalon takes heat for off-label narcotic promotion. Report

Earnings from Schering, Sanofi, Teva

Tue, 12 Feb 2008 06:59:56 -0500

It's an earnings kind of day today, with two of the brand-name biggies reporting, plus the leading generics maker. Here are the results:

Schering-Plough reported a $3.4 billion loss for the fourth quarter, on charges related to its buyout of Organon BioSciences. Those accounting charges masked a 40 percent year-over-year increase in revenues to $3.72 billion. Products driving the increase include the arthritis med Remicade--which saw sales rise by 35 percent to $455 million--and the nose spray Nasonex.
Despite generic competition that ate into sales of its sleeping pill Ambien, Sanofi-Aventis reported a 31 percent increase in profits to $1.09 billion for the fourth quarter. However, prior year results included an accounting charge of $311.8 million. Strong Plavix sales, which grew by 14 percent year-over-year, helped feed revenues. But sales of the company's top 15 drugs declined 0.3 percent.
Generics maker Teva saw its fourth-quarter earnings jump by 20 percent, beating analyst expectations. Sales of the company's own treatment for multiple sclerosis, Copaxone, grew by 15 percent to become the no. 1 seller in the U.S. among MS meds.

- see Schering-Plough's release
- check out the news from the Associated Press
- find a link to Sanofi's press release
- read the Sanofi story in the Wall Street Journal
- see the Teva article

Merck joins Fosamax copycats

Mon, 14 Jan 2008 06:59:55 -0500

Merck won't be outdone on Fosamax. The company has struck a deal with an unidentified generics supplier for an authorized, copycat form of the osteoporosis drug. The Merck-blessed generic could go on sale as early as next month.

You'll recall that Fosamax's key patent is due to expire Feb. 6, and two generics makers--Teva Pharmaceutical Industries and Barr Pharmaceuticals--are first in line. Because they were first to ask the FDA for approval for their versions of Fosamax, they have six-month exclusivity. But that exclusivity doesn't apply to Merck itself, which could sell its own generic form or do so with a partner.

This type of arrangement--for an authorized generic--has come under fire as more and more pharma companies have begun to engage. Critics say they destroy the competitive advantage that six-month exclusivity is designed to confer; now, the Federal Trade Commission is studying the deals

- read the Wall Street Journal article

Related Articles:
US Senate to take on authorized generics. Report
Merck expects $1.8B hit on Fosamax. Report
Merck touts Fosamax data. Report
Merck profits jump by 62 percent. Report

Revlimid fuels Celgene sales rocket

Mon, 07 Jan 2008 06:59:56 -0500

Here's what one big drug can do: Celgene announced that it expects fiscal 2007 profits to double to $1.05 per share, as sales of its cancer drug Revlimid skyrocket. And the company projects that Revlimid will be its profit engine for 2008 as well.

Overall revenue for the company shot up by 50 percent to $1.4 billion; Revlimid's sales grew by a whopping 140 percent to $770 million-plus. As the juggernaut rolls forward, profits should grow a further 45 percent to $1.50 to $1.55 per share on a 30 percent hike in sales to $1.8 billion. And Revlimid will account for 60 percent of that figure, or about $1.25 billion.

Analysts are even more bullish on the company: They're projecting 2008 sales of more than $2 billion. The lion's share of that would come from Revlimid, though Celgene will add another blood-cancer treatment to its quiver when its buyout of Pharmion--and its drug Vidaza--closes later this year.

- see the press release from Celgene
- read this report for more

Related Articles:
Celgene goes global with $2.9B Pharmion buyout. Report
Array partners with Celgene, nets $40M upfront. Report
Celgene accelerates program on positive psoriasis data. Report
Revlimid price likely to attract price scrutiny. Report

ALSO NOTED: Merck vaccine prevents cervical cancer in older women; Diabetes sales drive 37 percent increase in Takeda profits;

Mon, 05 Nov 2007 06:59:50 -0500

> Gardasil protects against cervical cancer in women as old as 45, a new study shows; previously, the vaccine was only proven to work in women ages 9 to 26. Report

> Strong sales of its Actos diabetes drug boosted Takeda Pharmaceuticals to a 37 percent hike in half-year profits. Report

> Cardinal Health posted an 11 percent increase in profits to $301.8 million, but trouble in its pharmaceutical supply-chain services unit prompted a change in management. Report

> Prague's Zentiva Pharmaceuticals saw profits fall 31 percent in the first nine months, but it expects full-year sales to come in with 20 percent growth. Report

> The FDA warned consumers against two unapproved products sold as ED treatments; they contain potentially harmful ingredients that can cause low blood pressure, the agency said. Report

And Finally... Besides its obvious effects, the ED remedy sildenafil citrate may also be a love potion. Report

AZ hit with Crestor patent challenge

Thu, 01 Nov 2007 07:59:56 -0400

It's a one-two punch for AstraZeneca today. A Canadian drug maker is challenging AZ's patent on the cholesterol drug Crestor, one of its top sellers at $2 billion--and a linchpin of its profits over the next few years. Meanwhile, the company reported a 15 percent drop in profits because of restructuring and acquisition costs--and increasing generic competition for its products.

Cobalt Pharmaceuticals says it plans to sell a copycat version of Crestor before its patents begin to expire in 2016. AZ has 45 days to protest, and if it does, the FDA can't approve the new version for at least 30 months.

AstraZeneca also faces patent challenges on Nexium, its top-selling acid-reflux drug, and Seroquel, a schizophrenia and depression remedy. And European regulators snatched away patent protection for Symbicort, a successful asthma treatment, in September, opening the way for generic competition by 2010.

- see AstraZeneca's response to Cobalt
- check out the earnings release from AZ
- read the Crestor report from Guardian Unlimited
- read the CNBC article on third-quarter results

Related Articles:
Crestor less safe than competing statins. Report
Top 5 layoffs of 2007--AstraZeneca. Report
AstraZeneca lays out road map for recovery. Report
AstraZeneca announces restructuring and buyout. Report

It's Barr v. Watson in Estrostep face-off

Mon, 29 Oct 2007 07:59:54 -0400

Here's how winning a patent fight could become a setback. The drug in question: Estrostep Fe, the contraceptive pill made by Warner Chilcott. In 2004, Warner agreed to let generics maker Barr Laboratories launch a version of the pill this month--October 2007--six months before its last patent expires. On Friday, Barr got the FDA's nod for its copycat pill TriLegest Fe, planning to launch it immediately.

Meanwhile, Warner made a supply-and-sell deal with Watson Pharmaceuticals for the same drug. Warner will supply a generic version of Estrostep Fe to Watson, which will market and distribute it. Warner will get a share of the profits from this generic version, known as Tilia Fe. So Barr now faces competition from the source.

- see the release from Barr
- check out Warner Chilcott's release
- read about Barr's version of Estrostep Fe and about the Warner/Watson deal at CNN Money