One Trend-Buster: A High-Flying Pharma Sector Stock — Vertex — on Hep C Candidate-Trials. . . .

September 26, 2008 · Leave a Comment


. . .Meanwhile [as Merck prepares to let us all know how much the woes of Vytorin/Zetia will affect it (and Schering) in the future], Needham Securities just this morning upgraded Vertex to a “Buy” — from “Hold” — and Vertex is up another almost 5 percent today, trading at $34.50, as I write this. That bumps the post-public secondary offering gain (priced at $25.50) to almost 36 percent in eight days. Wow.

Sweet! — add about 20 percent — to the above chart, for Vertex. [The background -- on this action -- is here.]

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One Trend-Buster: A High-Flying Pharma Sector Stock — Vertex — on Hep C Candidate-Trials. . . .

September 26, 2008 · Leave a Comment

. . .Meanwhile [as Merck prepares to let us all know how much the woes of Vytorin/Zetia will affect it (and Schering) in the future], Needham Securities just this morning upgraded Vertex to a “Buy” — from “Hold” — and Vertex is up another almost 5 percent today, trading at $34.50, as I write this. That bumps the post-public secondary offering gain (priced at $25.50) to almost 36 percent in eight days. Wow.

Sweet! — add about 20 percent — to the above chart, for Vertex. [The background -- on this action -- is here.]

Categories: Bad for Schering Boceprivir Good for Vertex Telaprevir

On the Day AFTER Schering Reports Q3 Results, Merck Will Update 2008 to 2010 Guidance

September 26, 2008 · Leave a Comment


This ought to make Schering’s call interesting. Merck has elected to let Schering-Plough “go first” — in announcing Third Quarter 2008 results. Then, the next morning, on October 22, 2008, Merck will announce its results and update the guidance it suspended, and withdrew after the SEAS trial top-line results were announced — back on July 21, 2008.

Schering won’t be able to hide behind Richard Clark’s Italian-cut, pin-striped, double-breasted, big-shouldered suits much longer, now. From Merck’s release:

. . . .During the [9:00 a.m. EDT, October 22, 2008] call, Richard T. Clark, chairman, president and chief executive officer, Peter N. Kellogg, executive vice president and chief financial officer, and Kenneth C. Frazier, executive vice president and president, Global Human Health, will provide an overview of Merck’s financial performance for the quarter plus 2008 and 2010 financial guidance. . . .

Interestingly, per the above, Merck will conduct its call during the NYSE trading day – suggesting either that (1) Merck will want the markets to be able to react, in real time, to some fundamentally important news (more likely, in my estimation) — or, (2) Merck does not expect the call to be Earth-shatteringly-material (less likely, IMO). Either way, Schering has scheduled its for before NYSE market open (per its usual practice), on October 21, 2008. It should all be rather droll — so circle both mornings in red, on your calendars. I know I have.

And what of those Cholesterol Joint Venture Agreement Amendments Schering apparently never bothered to file with the SEC, as required by Instruction 2 to Item 601 on SEC Regulation S-K?

Wow. Pop-up some Jiffy-Pop popcorn!

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On the Day AFTER Schering Reports Q3 Results, Merck Will Update 2008 to 2010 Guidance

September 26, 2008 · Leave a Comment

This ought to make Schering’s call interesting. Merck has elected to let Schering-Plough “go first” — in announcing Third Quarter 2008 results. Then, the next morning, on October 22, 2008, Merck will announce its results and update the guidance it suspended, and withdrew after the SEAS trial top-line results were announced — back on July 21, 2008.

Schering won’t be able to hide behind Richard Clark’s Italian-cut, pin-striped, double-breasted, big-shouldered suits much longer, now. From Merck’s release:

. . . .During the [9:00 a.m. EDT, October 22, 2008] call, Richard T. Clark, chairman, president and chief executive officer, Peter N. Kellogg, executive vice president and chief financial officer, and Kenneth C. Frazier, executive vice president and president, Global Human Health, will provide an overview of Merck’s financial performance for the quarter plus 2008 and 2010 financial guidance. . . .

Interestingly, per the above, Merck will conduct its call during the NYSE trading day – suggesting either that (1) Merck will want the markets to be able to react, in real time, to some fundamentally important news (more likely, in my estimation) — or, (2) Merck does not expect the call to be Earth-shatteringly-material (less likely, IMO). Either way, Schering has scheduled its for before NYSE market open (per its usual practice), on October 21, 2008. It should all be rather droll — so circle both mornings in red, on your calendars. I know I have.

And what of those Cholesterol Joint Venture Agreement Amendments Schering apparently never bothered to file with the SEC, as required by Instruction 2 to Item 601 on SEC Regulation S-K?

Wow. Pop-up some Jiffy-Pop popcorn!

Categories: Merck Schering Plough Confidential Treatment Joint Vent

MDL 1938: The RICO Violations — Amended Consolidated Complaint Counts

September 26, 2008 · 1 Comment


Yesterday, we looked at the newly-detailed “mechanisms of delay and/or negation” of the ENHANCE study results, all as allegedly carried out by Schering’s senior management. Today, we take a peek at the newly-detailed, and amended civil RICO (Racketeering) counts — beginning with paragraph 257 on page 80, et seq. [Here's a link to the full PDF complaint file -- Warning: very large download!]:

. . . .257. The predicate acts committed by Defendants were and are similar, continuous, and related. From at least 2004 to the present, Defendants were aware that they had no scientific basis to claim that Zetia and Vytorin, compared to Zocor alone, reduced or slowed the growth of arterial plaque. However, notwithstanding this knowledge, Defendants heavily promoted, and continue to promote, Zetia and Vytorin’s purported distinct mechanism of action as an advantage in treating high cholesterol, claiming overall health benefits as a result, including cardiovascular benefits. Defendants’ marketing of Vytorin consistently focused on reducing the health risk associated with high cholesterol, including plaque formation leading to heart disease, heart attack, and stroke. Defendants’ advertisements explained the nature of cholesterol, the difference between good and bad cholesterol, the fact that excessive LDL cholesterol levels cause arterial plaque formation, and the adverse health risks associated with excessive plaque, including heart disease, heart attack and stroke. Defendants have consistently marketed Zetia to payers, consumers, and physicians as a drug that lowers LDL cholesterol in a “different” manner, stressing that lowering LDL is important because LDL causes plaque to build up in arteries. Defendants’ website for Zetia is titled “A different way to fight cholesterol” (emphasis in original). It states, “ZETIA works differently,” going on to contrast Zetia with statins. Neither the Zetia nor the Vytorin website explained that the “different” or distinct ways these drugs work produces no cardiovascular benefits for the patients taking them. Defendants uniformly omitted all mentions of the ENHANCE study, which would have negated Defendants’ claims about the purported benefits of Zetia and Vytorin. This consistent message of a “different” approach to lowering cholesterol and the uniform omission of all mentions of the ENHANCE study illustrate how Defendants’ predicate acts of mail and wire fraud were similar, continuous, and related.

258. The victims of Defendants’ predicate acts of mail and wire fraud number at least in the hundreds of thousands, and may number in the millions based on the number of Zetia and Vytorin prescriptions and their volume of sales. The cholesterol-reduction market is the single largest pharmaceutical category in the world. Unlike Zocor, which is now subject to competition from generic simvastatin, Zetia and Vytorin command name-brand prices. Generic versions of Zocor sell for 75 cents to $1 per day at most retail pharmacies, and as little as 10 cents per day at discount pharmacies. Prescriptions for Vytorin and Zetia, on the other hand, each cost roughly $3 per day. Notwithstanding their high costs relative to available generic statins, Zetia and Vytorin represent nearly 20 percent of the American market for cholesterol-lowering drugs. In 2007, 800,000 prescriptions for Zetia and Vytorin were written weekly in the United States. Given this high volume of prescriptions, the number of victims of Defendants’ predicate acts of fraud number in the tens to hundreds of thousands.

259. Defendants’ fraudulent scheme involved the repetition of similar misrepresentations, which were made to hundreds of thousands of consumers, physicians, and health insurers.

260. Defendants’ scheme was calculated to ensure that Plaintiffs and the Classes would pay for Zetia and Vytorin despite the ready availability of less expensive, safer and effective alternatives.

261. Each of Defendants’ fraudulent mailings and interstate wire transmissions constitutes “racketeering activity” within the meaning of 18 U.S.C. § 1961(1). Collectively, these violations are a “pattern of racketeering activity” within the meaning of 18 U.S.C. § 1961(5). . . .

It just keeps pouring in Kenilworth.

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MDL 1938: The RICO Violations — Amended Consolidated Complaint Counts

September 26, 2008 · Leave a Comment

Yesterday, we looked at the newly-detailed “mechanisms of delay and/or negation” of the ENHANCE study results, all as allegedly carried out by Schering’s senior management. Today, we take a peek at the newly-detailed, and amended civil RICO (Racketeering) counts — beginning with paragraph 257 on page 80, et seq. [Here's a link to the full PDF complaint file -- Warning: very large download!]:

. . . .257. The predicate acts committed by Defendants were and are similar, continuous, and related. From at least 2004 to the present, Defendants were aware that they had no scientific basis to claim that Zetia and Vytorin, compared to Zocor alone, reduced or slowed the growth of arterial plaque. However, notwithstanding this knowledge, Defendants heavily promoted, and continue to promote, Zetia and Vytorin’s purported distinct mechanism of action as an advantage in treating high cholesterol, claiming overall health benefits as a result, including cardiovascular benefits. Defendants’ marketing of Vytorin consistently focused on reducing the health risk associated with high cholesterol, including plaque formation leading to heart disease, heart attack, and stroke. Defendants’ advertisements explained the nature of cholesterol, the difference between good and bad cholesterol, the fact that excessive LDL cholesterol levels cause arterial plaque formation, and the adverse health risks associated with excessive plaque, including heart disease, heart attack and stroke. Defendants have consistently marketed Zetia to payers, consumers, and physicians as a drug that lowers LDL cholesterol in a “different” manner, stressing that lowering LDL is important because LDL causes plaque to build up in arteries. Defendants’ website for Zetia is titled “A different way to fight cholesterol” (emphasis in original). It states, “ZETIA works differently,” going on to contrast Zetia with statins. Neither the Zetia nor the Vytorin website explained that the “different” or distinct ways these drugs work produces no cardiovascular benefits for the patients taking them. Defendants uniformly omitted all mentions of the ENHANCE study, which would have negated Defendants’ claims about the purported benefits of Zetia and Vytorin. This consistent message of a “different” approach to lowering cholesterol and the uniform omission of all mentions of the ENHANCE study illustrate how Defendants’ predicate acts of mail and wire fraud were similar, continuous, and related.

258. The victims of Defendants’ predicate acts of mail and wire fraud number at least in the hundreds of thousands, and may number in the millions based on the number of Zetia and Vytorin prescriptions and their volume of sales. The cholesterol-reduction market is the single largest pharmaceutical category in the world. Unlike Zocor, which is now subject to competition from generic simvastatin, Zetia and Vytorin command name-brand prices. Generic versions of Zocor sell for 75 cents to $1 per day at most retail pharmacies, and as little as 10 cents per day at discount pharmacies. Prescriptions for Vytorin and Zetia, on the other hand, each cost roughly $3 per day. Notwithstanding their high costs relative to available generic statins, Zetia and Vytorin represent nearly 20 percent of the American market for cholesterol-lowering drugs. In 2007, 800,000 prescriptions for Zetia and Vytorin were written weekly in the United States. Given this high volume of prescriptions, the number of victims of Defendants’ predicate acts of fraud number in the tens to hundreds of thousands.

259. Defendants’ fraudulent scheme involved the repetition of similar misrepresentations, which were made to hundreds of thousands of consumers, physicians, and health insurers.

260. Defendants’ scheme was calculated to ensure that Plaintiffs and the Classes would pay for Zetia and Vytorin despite the ready availability of less expensive, safer and effective alternatives.

261. Each of Defendants’ fraudulent mailings and interstate wire transmissions constitutes “racketeering activity” within the meaning of 18 U.S.C. § 1961(1). Collectively, these violations are a “pattern of racketeering activity” within the meaning of 18 U.S.C. § 1961(5). . . .

It just keeps pouring in Kenilworth.

Categories: Sales Marketing Vytorin Zetia Products Liability Litiga