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Wednesday, August 10, 2011

Fwd: | 08.09.11 | Will Valeant snap up Medicis?; Yervoy could soon face Roche rival



-------- Original Message --------
Subject: | 08.09.11 | Will Valeant snap up Medicis?; Yervoy could soon face Roche rival
Date: Tue, 9 Aug 2011 13:19:54 -0400 (EDT)
From: FiercePharma <editors@fiercepharma.com>
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To: nbrauchitsch@yahoo.com


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August 9, 2011

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Today's Top Stories:
1. Will Valeant manage to snap up Medicis?
2. Merck, Pfizer among corporate cash stashers
3. Pharma feels threatened by U.S. austerity
4. Yervoy may soon face Roche rival
5. Genentech unloads buildings to Gilead

Spotlight:
Study: Revlimid interaction may explain side effects

Also Noted:
KV Pharma completes generics-unit sale; Gedeon Richter wins dispute over buyout; Much more...

News From The Fierce Network:
1. QIAGEN submits PMA for companion Dx
2. Roche deals API plants in SC, CO
3. Gene regulates the timing of our tickers


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> e-Patient Connections 2011 Conference - Sept 20-21 - Philadelphia, PA

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Today's Top Stories

1. Will Valeant manage to snap up Medicis?

By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

While announcing second-quarter earnings yesterday, Medicis Pharmaceuticals CEO Jonah Shacknai said he plans to get back to his normal schedule soon following a series of personal tragedies that kept him away from the office. Shacknai has been with his family since he lost both his 6-year-old son--who died after an accidental fall--and his girlfriend under "bizarre" and still unexplained circumstances. Now into the picture steps acquisition-hungry Valeant Pharmaceuticals, which, according to Wall Street Journal sources, has approached Medicis about a possible buyout.

The WSJ notes Medicis stock has been underperforming lately as the investigation into the girlfriend's death continues, thereby making the company a potential bargain. So, Valeant might be able to pursue its goal of dominating the dermatology market by snapping up Medicis at an attractive price. Some Medicis products--such as the acne treatment Solodyn--would be natural additions to Valeant's stable.

The timing might be right for Valeant for other reasons. During the conference call about Medicis' earnings, Shacknai sounded as if he might be open to a change, although he declined comment on the buyout talk. "At a time like this, you do a lot of introspective thinking," Shacknai said (as quoted by 10News). "We have obviously had an extraordinarily difficult time. We have undertaken some tragedies, some losses that one couldn't imagine experiencing in a lifetime."

But then again, Shacknai took great pains to thank his co-workers and board of directors for their support, adding that these difficult weeks have made him appreciate his "cohesive, capable and experienced executive team" even more. He started Medicis himself back in 1988. "I expect to be on my normal calendar in the office doing all the things I had done previously," Shacknai promised during the call.

- check out the WSJ piece
- see the 10News story
- get more from the San Diego Business Journal

Related Articles:
Medicis shares drop on death at CEO's house
Medicis CEO's son dies after last week's accident

Read more about: Valeant, Medicis Pharmaceutical, Jonah Shacknai
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2. Merck, Pfizer among corporate cash stashers

By Tracy Staton Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=116&ms=MzU4NjQ5NQS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTU4OTM1S0&mt=1&rt=0" name="api_addthis_com_oexchange_37Ad5a84dEpFo7YvTn9A" >Twitter | Facebook | LinkedIn

World markets in free fall mode; rioting in London; intransigent U.S. politicians; no wonder investors are rushing to buy gold. Next, they'll be burying cash in coffee cans in the backyard. But actually, big drugmakers are one step ahead of the cash-hoarders. They've already been squirreling their money away.

Billions of Big Pharma cash sits in figurative coffee cans around the world, waiting for executives to feel ready to spend. Some companies are saving up for the right acquisition to come along. Unfortunately for the U.S. economy, some plan to invest their money in emerging markets. Some are in the midst of share buybacks that will return a lot of their cash to shareholders as they try to soothe investors through their patent-cliff fears.

But others are just saving up. And that's natural in the current environment. "Companies feel like they don't have strong confidence that things will be better in the next year," job-market watcher John Challenger told the Star-Ledger. "Why take risks right now?"

Among the cash-rich drugmakers are Merck, which has stashed away an additional $1 billion this year. Johnson & Johnson has added another $3 billion to its stores, the newspaper reports, giving it some $27 billion on hand. Pfizer has beaucoups cash--$24 billion as of last week--especially in the wake of its $2.375 billion Capsugel sale. It's spending some of that money on shareholder dividends.

- see the article from the Star-Ledger
- read the New York Post story 

Related Articles:
Should pharma refocus on customers, not shareholders?
Are drugmakers suffering from complexity?
Should Big Pharma spin off to goose shares?

Read more about: Pfizer, Merck, Johnson & Johnson, Big Pharma
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3. Pharma feels threatened by U.S. austerity

By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

All the talk of deficit-cutting in Washington has drugmakers spooked--and has industry lobbyists working overtime. Pharma companies are fighting potential new Medicare drug rebates. Whispers about pulling the direct-to-consumer advertising tax deduction have surfaced again. As the next stage of cuts looms, who knows what other ideas Washington will come up with?

And the U.S. cost moves come amid austerity measures elsewhere, especially in Europe, where even richer countries such as Germany have targeted drug prices for reductions. So, the U.S. threats seem even more dire; after all, prices have tended to be higher there than in other countries, and that's helped drugmakers suffering from price negotiations elsewhere.

But as the Wall Street Journal Health Blog reports, analysts aren't as worried about U.S. austerity. Some of the potential cuts won't affect pharma directly: Medicare spending moves, for instance. If the government cuts reimbursements for cancer-drug therapy, oncologists will feel the hurt first. Sure, doctors may press for discounts up the line, but they can't mandate price cuts.

What's more, some drugmakers are more insulated from government cuts. Roche and Novartis, for instance, Sanford C. Bernstein analysts said (as quoted by the WSJ). Merck, Sanofi and Pfizer may also have a measure of protection.

- read the Health Blog post 

Related Articles:
Lilly chief scolds Germany for new pharma rules
CSL predicts profit drop on lower vax sales

Read more about: Medicare, drug prices, Big Pharma, reimbursement
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4. Yervoy may soon face Roche rival

By Tracy Staton Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=67&ms=MzU4NjQ5NQS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTU4OTM1S0&mt=1&rt=0" name="api_addthis_com_oexchange_VbBW7RIjhBhbaVsA0kJQ" >Twitter | Facebook | LinkedIn

Roche's new melanoma treatment, dubbed Zelboraf, may get an early entry into the market. Sources tell Reuters the experimental drug could be approved as early as next week, months ahead of schedule. Apparently, some recently released data, which showed Zelboraf significantly cut the risk of death when added to chemotherapy, has inspired the FDA to move more quickly on the application.

That would mean earlier-than-expected competition for Bristol-Myers Squibb's Yervoy, the breakthrough melanoma drug approved in March. Yervoy has been a boon for BMS, coming out of the gate with unexpectedly strong sales. Its sticker price of $120,000 hasn't appeared to deter uptake one bit, at least not yet.

The two meds aren't exactly head-to-head rivals: Roche's drug targets a particular gene mutation that affects about half of all melanoma patients, so its potential market is somewhat smaller than Yervoy's, which works by stimulating patients' immune systems. In fact, they could become a melanoma-fighting cocktail if in-process trials prove the combination successful. Analysts have predicted that Zelboraf sales will peak at around $732 million, while Yervoy sales are expected to reach more than $1.4 billion.

- read the Reuters story

Related Articles:
Yervoy hits the market with $95M bang
Novartis, Roche blockbusters shine at ASCO
ASCO spotlight on Yervoy, Zytiga and more

Read more about: Roche, Bristol-Myers Squibb, Yervoy, melanoma
back to top


5. Genentech unloads buildings to Gilead

By Tracy Staton Comment | Forward | < a href="http://links.mkt1985.com/ctt?kn=105&ms=MzU4NjQ5NQS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTEzMTU4OTM1S0&mt=1&rt=0" name="api_addthis_com_oexchange_5CPGejfmuM6GOgy4aR8A" >Twitter | Facebook | LinkedIn

Genentech is selling off a small piece of its Oceanside, CA, campus to Gilead Sciences. The deal involves two buildings and 55 employees, all of whom will keep their jobs, the San Diego Union-Tribune reports. That must be a relief to the Genentech folks, who well know that parent company Roche is in the middle of a cost-cutting push.

According to the Union-Tribune, Gilead will pick up a facility where about 30 scientists work on processes for producing experimental drugs. The other building is a manufacturing plant where 25 employees turn out batches of drugs for clinical trials. Gilead plans to use its new facilities to make batches of an experimental cancer drug--that work is currently outsourced to a contract manufacturer--and to develop a production process for another in-development therapy.

The terms of the deal weren't disclosed, but Gilead said in a statement it expects the transfer to close during the third quarter.

Genentech says the sale isn't the beginning of a wholesale unloading of Oceanside property. "Genentech is totally committed to Oceanside," spokeswoman Robin Snyder told the newspaper. "We want to be really clear about that."

- see the Gilead release
- get the Union-Tribune story

Related Articles:
DOJ subpoenas Gilead on manufacturing
Pfizer, Genentech and APP initiate recalls

Read more about: Genentech, Gilead Sciences, California
back to top


Also Noted

TODAY'S SPOTLIGHT... Study: Revlimid interaction may explain side effects

A new trial found Revlimid interacts with P-glycoprotein in a way that affects blood levels of the drug, and the researchers suggest its dosage may need to be tweaked because of their finding. Report

@FiercePharma: Study finds Revlimid's interaction w/Pgp affects blood levels, so dosing might need tweaks. | Follow @FiercePharma

> KV Pharmaceutical wrapped up the $60 million sale of its generics unit to Zydus Pharmaceuticals and Zynesher Pharmaceuticals. Report

> Contract manufacturer Aenova plans to lease a SkyePharma manufacturing business near Lyon, France. News

> Hungary's Gedeon Richter said Genefar had been ordered to pay it $40 million for breach of contract in a dispute over the failed buyout of Polpharma. Story

> Gastrointestinal specialist Salix Pharmaceuticals saw its second-quarter profit beat analyst estimates on growing sales of its diarrhea drug Xifaxan. Item

> Endo Pharmaceuticals raised its forecast for sales and earnings as it reported Q2 income of $54.6 million on $607 million in sales. Article

> A start-up has released a software tool to help pharmaceutical companies track comments on Facebook, now that the social media site is enabling two-way communication on drugmakers' pages. Release

> Pfizer and AstraZeneca filed separate patent suits against India's Hetero Drugs, one involving a Viagra copycat and the other concerning a generic version of Nexium. Story

> Bachem said it had renewed a longstanding agreement with AstraZeneca to supply the drug Goserelin. Report

> A Maryland oncologist pleaded guilty to using a misbranded drug after administering cancer meds bought outside the U.S. Piece

Biotech News

@FierceBiotech: Is the FDA writing a recipe for the failure of biosimilars in the U.S.? Report | Follow @FierceBiotech  

@JohnCFierce: So Lexicon says its Ph2 study for LX1032 showed signs of efficacy, reducing symptoms of gastro-related tumors. | Follow @JohnCFierce

@MaureenFierce: Several Russian cos. have establish a $ joint venture designed to develop innovative treatments in the country. | Follow @MaureenFierce

> Biogen, Abbott tout promising MS data from PhIIb daclizumab deal. Story

> Array adds $713M cancer drug pact with Genentech to deal roster. Report

Biotech Research News

> Gene discovered that regulates the timing of our tickers. News

> DoD gives NeoStem $1.7M to develop adult stem cells for osteoporosis. More

> Scientists discover possible genetic route to killing pain. Details

> Standford's SPARK hosts ideas so "crazy" they just might work. Story

> Researcher find faulty gene responsible for some ovarian cancers. Report

> Texas Gov. Perry supports adult stem cells after undergoing procedure. Article

Manufacturing News

> At the box office, bad boy pharma on top. Details

> UPS sees new tech, distribution models for supply chain. Story

> Roche deals API plants in SC, CO. Article

> Merck pushes pharma to top jobs-cutter. More

> NSF expands into chemical reference standards. Report

And Finally... Soy tablets do little to stave off bone loss among menopausal women, according to new research, and don't help with hot flashes, either. Report

Events

> Online Pharmaceutical & Healthcare Marketing MBA for Executives

Saint Joseph's University offers an expanded portfolio of globally accessible AACSB-accredited programs ideal for working professionals in the pharma, biotech, medical device, diagnostics and healthcare sectors. Apply now; our September Cohort begins 9/8. Visit sju.edu/epharma or call 800-SJU-EMBA.

> 16th MDRP Summit - Sept. 14-16, 2011 - Marriott Downtown, Chicago, IL

Medicaid Drug Rebate Program Summit is where manufacturers meet with all the government officials including CMS, VA, 340B, DoD, USDOJ and OIG for compliance and operations answers to healthcare reform questions. Register with a 25% off the standard rate by clicking here: www.medicaiddrugrebates.com

> Optimizing Dosing for the Safe and Effective Use of Drugs in Patients with Renal Impairment - September 19-20 - Washington, DC

Patients with renal impairment are at increased risk for developing drug related adverse events. In these patients drug dosage needs to be closely monitored and adjusted to reflect altered pharmacokinetics (PK) and pharmacodynamics (PD) parameters. This conference will explore ways to facilitate drug development and optimize dosing in renal impairment. Register by August 31 and SAVE $150!

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Marketplace

> New Fierce eBook: Between an Industry Rock and a Political Hard Place: The FDA's 510(k) Initiative

This FierceMedicalDevices eBook examines the background situation, current position and the future of the CDRH’s revision of the 510(k) premarket notification process. Click here to download today.

> Capitalizing on the Outsourcing Option - New Fierce eBook

Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now.

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Fwd: K-V Sells Generics To Zydus For $60M

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In This Issue:

08/09/11

Featured Articles

EU GMP Annex 1:2008 And Particle Counting: Part 2
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K-V Sells Generics To Zydus For $60M
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