Genzyme

Genzyme's Myozyme approved

Christe Bruderlin-Nelson — Wed, 22 Oct 2008 05:48:41 -0400

An FDA panel of health experts voted to support approval for mass production of Genzyme's Myozyme for the treatment of Pompe disease, a rare muscle disorder that can lead to fatal respiratory problems. The FDA panel members ruled, 16-1, that the drug was effective, and most recommended accelerated approval of Myozyme, so long as Genzyme was diligent with follow-up. Report

FDA panel to weigh Myozyme expansion

Tracy Staton — Mon, 20 Oct 2008 10:27:45 -0400

The FDA questions whether a study submitted by Genzyme is strong enough to merit expanded approval of a drug to treat a rare illness known as Pompe disease; the drug, Myozyme, is up for advisory committee discussion tomorrow. Report

Genzyme, Isis solidify collaboration agreement

Christe Bruderlin-Nelson — Wed, 25 Jun 2008 11:48:02 -0400

Genzyme and Isis Pharmaceuticals completed their agreement for the cholesterol drug candidate, mipomersen. The two companies have been developing an agreement to work together and announced earlier this year that the collaboration will grant Genzyme exclusive rights to the lipid-lowering drug that Isis has in development.

For the honor, Genzyme will pay Isis $175 million in licensing fees. Genzyme earlier paid $150 million for 5 million shares of the company's common stock. Isis will continue to contribute funding for the drug's development.

- see the release
- get the full story at the Boston Globe
- read about the deal at RTT News

ALSO NOTED: Merck's Cordaptive fails to get U.S. approval; Medtronic sub faces FDA-imposed outage;

Tue, 29 Apr 2008 06:59:50 -0400

> In a blow to Merck's 2008 plans, the cholesterol candidate Cordaptive failed to get the FDA's OK; in a "not approvable letter," the agency asked for more data. Release

> The FDA has imposed new requirements on Medtronic's Physio-Control subsidiary after finding new manufacturing problems affecting its external defibrillators; the company faces an extended outage as it fixes the problems. Report

> Five officials from a Chinese pharma were sentenced to prison time for selling a tainted antibiotic that killed 13 people in 2006. Report

> Britain's consumer watchdog has asked GlaxoSmithKline--along with a host of big brand-name companies--for pricing information as part of a price-fixing probe. Report

> As more drug marketing migrates online, pharma companies are struggling to determine their ROI on Internet promos. Report

> The Clinton Foundation and international drug-purchasing consortium Unitaid have struck deals for deeper discounts on more than 40 generic AIDS meds. Report

> The Indian government is mulling plans to cap retail drug margins and penalize drug makers that give pharmacists higher-than-allowed mark-ups. Report

> Pfizer plans to launch its stop-smoking drug Champix in Japan on May 8. Release

> Merck's Indian subsidiary launched its diabetes treatment Januvia in the subcontinent at a price comparable to other diabetes drugs. Report

> Teva got the FDA nod for its generic version of GlaxoSmithKline's Flolan, an IV drug for hypertension. Report'

> In what may signal a major shift in FDA standards, Isis and Genzyme say that they expect to add another year to the development timeline for a closely watched cholesterol therapy in order to produce data demonstrating a reduced risk of heart attacks and related diseases rather than just an ability to lower levels of cholesterol. Report

> Economic development officials in Baltimore are fretting that they're one step behind the pace being set in Montgomery County, where low-cost lab space along with offers of small loans and grants have been luring away emerging drug developers. Report

> Shares of Medarex slipped seven percent this morning as investors digested Friday's announcement that its application for a new cancer drug will be delayed into 2009. Medarex report

And Finally... Feeling thick-headed? Train your brain to be more intelligent. Report

ALSO NOTED: Genzyme can't make Myozyme at Boston plant; Ranbaxy, Orchid forge drug-and-API deal;

Tue, 22 Apr 2008 06:59:50 -0400

> FDA won't let Genzyme make its uber-expensive Pompe disease treatment Myozyme at its Boston plant because of a small difference between the batches of Myozyme Genzyme makes now and the new larger batches it was to produce; the regulatory crackdown will leave the drug in short supply in the U.S. and depress Genzyme's 2008 earnings. Report

> Ranbaxy inked a deal with Orchid Chemicals & Pharmaceuticals for multiple finished dosages and active pharmaceutical ingredients. Release

> A Nevada judge ordered Wyeth to post a $58 million bond and pay $1.6 million in attorney's fees for acting in 'bad faith' during settlement talks in the case of three women who sued over the Prempro hormone replacement therapy. Report

> Two drug companies outsourced chunks of their IT systems: Nycomed hired British Telecommunications and Hewlett-Packard to provide it with IT infrastructure, and Janssen Pharmaceuticals tapped Porthus to manage all its electronic customs programming in Belgium. Report

> Celgene got regulatory approval to sell its thalidomide drug in the EU, for use in combination with two other meds for treating multiple myeloma. Report

> Roche's Japanese unit Chugai upped its full-year profit expectations to ¥29 billion from ¥17 billion after government drug-price cuts came in smaller than expected. Report

> Mylan got the FDA nod for its copycat version of AstraZeneca's blood pressure pill Plendil. Report

> Four of San Diego's biggest research institutions are teaming up to form the San Diego Consortium for Regenerative Medicine, a group aimed at advancing stem cell work. And they're planning a $115 million research "collaboratory" that would open in 2010. Report

> Cambridge, MA-based Stromedix has landed $25 million in a Series B round of venture capital. Report

> The bill on sequencing a genome has fallen from a few billion dollars to about $60,000 in just five years. And now two companies want to use nanotech to knock that price down to just $100. Report

> University of Cincinnati researcher Melissa DelBello is getting some added scrutiny for failing to disclose large sums of money she received from AstraZeneca a year after completing a study of Seroquel for bipolar disease. Report

And Finally... "Chemo brain" symptoms may not be byproducts of fatigue and depression associated with cancer treatment, but side effects of a common chemo drug, 5-fluorouracil, a new study found. Report

FDA probes Roche, Novartis meds

Fri, 11 Apr 2008 06:59:56 -0400

The transplant drug probe is widening. FDA says it's identified 16 cases of an often-fatal neurological disease among patients taking Roche's CellCept drug, used to prevent organ rejection. The agency will review the reports and work on new labeling for the med over the next couple of months; in the meantime, FDA is warning doctors and patients to look out for neurological symptoms. The agency also is looking at similar risks with Myfortic, a drug made by Novartis that has the same active ingredient, though it hasn't received any reports of the disease in those patients.

You'll recall that Roche alerted FDA to the issue in November after receiving reports of progressive multifocal leukoencephalopathy, which attacks the brain and central nervous system; the disease is usually fatal, and survivors are often permanently disabled. Roche independently confirmed 10 cases of the disease in CellCept patients. Some 500,000 patients worldwide have used the drug, however. European regulators have already added cautionary language to the drug's label; Roche has submitted new labeling to the FDA, but the agency is still reviewing it.

- see the communication from the FDA
- read the Washington Post article

ALSO: Genzyme is recalling more than 100,000 vials of Thymoglobulin, a kidney transplant drug, because of a manufacturing problem; no safety or efficacy problems have been found, however. Report

Related Articles:
Roche's CellCept linked to birth defects. Roche report
Aspreva, Roche put CellCept on ice. CellCept report
Aspreva's CellCept fails late-stage superiority study. Aspreva report

ALSO NOTED: Pfizer loses second bid for journal records; Genzyme eyes 170-worker expansion in Ireland;

Wed, 02 Apr 2008 07:59:50 -0400

> A federal judge in Boston denied Pfizer's attempt to get peer reviews and notes from the New England Journal of Medicine; the ruling follows another, similar decision two weeks ago in favor of the Journal of the American Medical Association and the Archives of Internal Medicine. Report

> Genzyme announced plans to expand its manufacturing and research facilities in Waterford, Ireland, planning to hire another 170 people there. Report

> A German patent court revoked Pfizer's protection on Lipitor's active ingredient, but the company says its basic patent on the med remains in force till November 2011. Report

> Wyeth and Progenics Pharmaceutical got Canadian regulators' approval to sell their Relistor drug designed to relieve constipation caused by opiate pain meds. Report

> Rumors of the Lunesta moth's death have been greatly exaggerated: Sepracor intends to use the animated critter in its DTC ads for some time to come. Report

> Bayer denied rumors that it was on the verge of issuing a profit warning. Report

> Older antipsychotics used to pacify nursing home residents may worsen Alzheimer's symptoms, a new study shows. Report

> ProStrakan got clearance to sell its post-operative anti-nausea drug xomolix in Germany, the U.K., and six other countries. Report

> An experimental drug has demonstrated an ability to improve memory and slow the effects of aging in rats. Researchers believe the same drug--S18986--can interact with AMPA in human brains. Report

> The Myelin Repair Foundation has spent $10 million so far to identify 18 new drug leads for multiple sclerosis. Report

> Genzyme is getting some public backing for a $200 million expansion project in the south of Ireland. Report

> Florida lawmakers are looking to cap biotech investment. Report

And Finally... The brouhaha over heparin has cast a spotlight on the use of animal products in therapies. Report

Shire stock jumps on Pfizer rumors

Fri, 14 Mar 2008 07:59:57 -0400

Less than 10 days after CEO Jeffrey Kindler pooh-poohed big acquisitions, U.K. markets are aswirl with rumors that Pfizer is on the hunt for British pharma group Shire. The company's shares leapt this morning on huge trading volume. Never mind the fact that analysts don't think Shire would be a good fit for Pfizer; deal talk has its own psychology. Alan Greenspan might call it irrational exuberance.

Of course, it's not the first time a Pfizer buyout rumor moved markets. Last fall when Biogen Idec went on the block, Pfizer was a rumored suitor; the chattering classes quickly mused that the drugs giant might prefer Genzyme. Frenzied deal talk around the same time linked Pfizer with Sanofi-Aventis and with Wyeth. Why so much speculation? Everyone knows Pfizer has to do something to replace the sales it'll lose when Lipitor goes generic in a few years.

- read the blog item in The Guardian
- see the Citywire article

Related Articles:
Analysts not impressed with Pfizer. Report
Sanofi stock up on Pfizer buyout talk. Report
Lipitor is No. 1, but faces generic threat. Report

ALSO NOTED: Government could force doc disclosures; Barr sues Watson over Seasonique patent;

Thu, 06 Mar 2008 06:59:50 -0500

> The government is considering requiring pharma companies to disclose their doc-consulting deals as part of any settlement agreements. Report | Report

> Duramed, a Barr Pharmaceuticals subsidiary, filed a patent infringement suit against Watson Pharmaceuticals, alleging it had infringed on its patent for the contraceptive Seasonique. Release

> Teva sued the FDA for denying its exclusivity period for its version of the antipsychotic Risperdal, which goes off patent this year. Release

> Genzyme launched its phosphate-binding drug Renvela for use in dialysis patients in the U.S. Release

> Baxter may test its immune booster Gammagard against Alzheimer's after a medical claims analysis indicated the risk of developing the disease could be reduced in patients previously treated with the med. Report

> A new study showed that Novartis' cancer drug Gleevec could harm fetal development if the child was conceived during treatment. Report

> With no "firm" buyout offers coming in, PDL BioPharma has decided to axe 260 workers--on top of the 320 layoffs already announced--and take itself off the market. Report

> After concluding that its late-stage trial of MC-1 failed to hit its primary endpoint, Medicure has announced plans to slash 50 workers and full-time consultants. Report

> The FDA is sending signals that it will start to let deadlines for drug approvals go by the wayside. Report

And Finally... Surgery may effectively cure Type II diabetes, according to a new study in Diabetes Care. Report

ALSO NOTED: Galvus gets EU committee nod; Merck appoints Vanderbilt official to board;

Mon, 17 Dec 2007 06:59:50 -0500

> The European Committee for Medicinal Products gave its blessing to Novartis' new diabetes med Galvus, after the company revised prescribing information to minimize liver-safety problems. The drug will likely be available in Europe during the first half of 2008. Report

> Merck has appointed Dr. Harry Jacobson, vice chancellor for health affairs at Vanderbilt University, to its board of directors, effective Tuesday. Report

> Genzyme said the FDA has broadened the use of its thyroid cancer diagnostic tool Thyrogen to include identification of cancerous residue in patients who have had their thyroids removed. Release

And Finally... Patients who fail to respond to the ovarian cancer treatment Paclitaxel lack a specific protein, according to a new study. Report

ALSO NOTED: Byetta data backs stand-alone app; Watson, Novartis settle suit;

Fri, 07 Dec 2007 06:59:50 -0500

> Amylin Pharmaceuticals says it has the data to back an application to make Byetta a stand-alone therapy for diabetes. Report

> Watson and Novartis have settled their patent wrangle over the Alzheimer's drug Exelon. Report

> We're happy the way we are, thank you very much. That's what Genzyme CEO Henri Termeer (photo) has to say to rumors that the company could be next on the list of Big pharma biotech buyouts. Report

> In yet another sign of monoclonal antibodies' popularity among big drug developers, Wyeth has extend its evaluation of selected Raven Biotechnologies MAb antibodies. Report

And Finally…. Stand and deliver…smiles. A new survey shows parents prefer teachers who make their children happy over teachers with high achievement ratings. Release

SPOTLIGHT: Genzyme earnings skyrocket to $159M

Thu, 25 Oct 2007 06:59:52 -0400

Genzyme says its profit jumped tenfold to $159.3 million on rising sales of meds for rare genetic diseases. Report

Who should Pfizer buy?

Tue, 16 Oct 2007 06:59:55 -0400

Biogen Idec's sudden step onto the sale block has set off a frenzy of buyout talk. Will Pfizer buy it? According to the Wall Street Journal, Pfizer considered a Biogen deal two years ago and passed. What about Biogen's crosstown rival Genzyme, whose stock jumped on the Biogen news because it's a biotech ripe for Big Pharma plucking? It might be a better fit for Pfizer, some analysts say. Pfizer, of course, isn't talking.

- here's more about Pfizer's pass on Biogen two years ago
- check out this speculation about a Pfizer-Genzyme marriage

ALSO: Who will buy Biogen Idec? Poll

Related Articles:
Biogen Idec in play after Icahn makes his move. Report
Boston officials herald big Genzyme expansion. Report
Pfizer-Sanofi match not made in heaven? Report
Pfizer, Wyeth merger bad idea? Report

Read more on: Pfizer | Biogen Idec | Genzyme

Genentech, Roche rise on cancer sales

Tue, 16 Oct 2007 06:59:54 -0400

Here's Exhibit Z in the long list of reasons why Big Pharma wants to make deals with biotech--and why speculation about Biogen and Genzyme is running so high. Roche and Genentech are both reaping a big harvest from their joint cancer drugs this quarter.

Genentech's profit skyrocketed by 21 percent on better-than-expected sales of Avastin, which jumped 37 percent to $597 million. Roche's strong cancer-med growth--including its share of Avastin and Herceptin--made up for a shortfall in Tamiflu sales, pushing the company's third-quarter revenues up by 6 percent to $28.7 billion.

- see Genentech's release from Genentech
- check out this news release from Roche
- read the NYT report on Genentech's earnings
- read the article about Roche's results from the International Herald Tribune

Related Articles:
Moody's downgrades pharma industry. Report
Should Pharma take the M&A cure? Report
M&A activity heats up as biotech IPOs struggle. Report
MAbs are hottest segment of biotech industry. Report

Read more on: Genentech | Roche | Avastin

FDA warns Genzyme on French plant

Wed, 03 Oct 2007 06:59:55 -0400

Clean up your act, Genzyme--or so says the FDA, which found "significant violations" of manufacturing rules at a French plant that produces the company's Thymoglobulin drug for kidney transplants.

Inspectors found higher-than-allowable levels of bacteria in some of the drug's components and concluded that the company didn't investigate those failures rigorously enough. Nor did the company thoroughly investigate the death of two animals during drug-safety tests. The company says it's heeding the FDA warning and already working to address the agency's concerns.

- read the FDA warning letter
- check out the report from the Boston Herald

Related Articles:
Boston officials herald big Genzyme expansion. Report
Manufacturing woes plague launch of Myozyme. Report
Genzyme reports successful late-stage stem cell study. Report
Genzyme shifts focus after hylastan fails trial. Report