s sales

Analyst predicts a long delay for Merck's Cordaptive

Tue, 06 May 2008 06:59:55 -0400

There's more bad news--or analysis--for Merck's drug development efforts. After the FDA turned down Cordaptive, Merck's new cholesterol medication, there was much head scratching over why. The drug giant never explained the reasons for the rejection. Now Pharmalot is highlighting a note from a Credit Suisse analyst who believes that the combination of niacin and the chemical component laropiprant--to prevent flushing--may have been doomed by cardiovascular signals emitted by the chemical.

The numbers of patients who demonstrated these signals may have been small, but Merck researchers couldn't explain just why they had them. With plenty of me-too alternatives on the market and an uncertain risk profile, the agency had little reason to provide an approval.

The kicker, for Merck, is that the analyst doesn't see any definitive new data on laropiprant coming from an ongoing study, leaving the drug giant to mount new trials if it wants to make its case to the FDA. And that could delay any approval for years.

- read the report from Pharmalot

ALSO: The axeman cometh to Merck's sales force. The drugmaker plans to lop off about 15 percent in the sales ranks, or 1,200 jobs. Layoff report

Eisai drug flunks Parkinson's trial

Fri, 11 Apr 2008 06:59:57 -0400

Eisai's has halted development of Perampanel (E2007) for Parkinson's after the drug failed a late-stage trial. Compared with placebo, E2007 didn't show a significant difference in the primary endpoint of reduction of "off" time (how long it takes for the signs and symptoms of Parkinson's disease return as the effect of levodopa wears off).

Perampanel is in development for a number of other indications, including neuropathic pain, epilepsy, multiple sclerosis and migraine prophylaxis. Eisai stressed that this trial failure was not indicative of larger problems with the drug. "The decision to terminate the Parkinson's disease program is due to lack of efficacy over placebo seen in the recently completed two Phase III studies only, and is not predictive of activity in the other indications including epilepsy and neuropathic pain."

In three years Eisai will lose patent protection for Aricept, a Alzheimer's drug which accounts for 40 percent of the company's sales. Finding drugs to make up the gap is a top priority for the the company.

- see Eisai's release for more

Amgen's D-mab meets trial goal

Fri, 25 Jan 2008 06:59:57 -0500

Amgen's great pipeline hope--Denosumab--has met all primary and secondary endpoints in a Phase III head-to-head trial against Fosomax. Denosumab, which is administered twice-yearly, is a fully-human monoclonal antibody for the treatment of bone loss. In the year-long study, the relative magnitude of bone mineral density improvement at the total hip was approximately 40 percent greater in the Denosumab versus the Fosomax group. A total of 1,189 women participated in the trial.

According to one analyst, Denosumab "could achieve sales topping $2 billion a year if and when approved for both osteoporosis and cancer patients." It's the only potential blockbuster in Amgen's pipeline nearing FDA approval. Amgen hopes to file an NDA for the drug in 2009.

- see this release for more

ALSO: Amgen's sales fell 2 percent in the fourth quarter to $3.74 billion, but the company managed to eke out a $835 million profit for the period, an increase of 1 percent. Release

Related Articles:
Denosumab: Amgen's salvation? Report
Amgen touts progress in two key programs. Report
Amgen discusses the future with analysts. Report

Big Pharma’s biotech shift means layoffs for chemists

Maureen Martino — Tue, 11 Dec 2007 11:24:52 -0500

Looking back, 2007 will perhaps be remembered as the year Big Pharma moved away from chemical-based drugs and fully embraced the biologics revolution. AstraZeneca, Sanofi, and (most notably) Pfizer--among many others--have announced sweeping changes that involve boosting investment in biotech drugs. The shift is due to a number of factors. Many of the world’s biggest blockbuster drugs are coming off patent in the next few years, and there aren’t many pharmaceuticals in the pipelines to replace them; Generics are expected to cut $67 billion from top drug makers' annual U.S. sales between 2007 and 2012. Additional, biologics are far less susceptible to the generic competition that’s chipping away at Big Pharma’s bottom line.

But with chemical-based drugs out of vogue, there’s a group in the industry that has also found themselves job-hunting: chemists. Traditionally, chemists have responsible for formulating some of the highest earners among Big Pharma’s portfolios. But few blockbuster discoveries have made their way through the pipeline as of late. Biologists, on the other hand, are in demand as Big Pharmas place their bets on biologics. “The shift is exacting a human toll, as big drug companies like Pfizer lay off thousands of chemists, casting a pall over what was once a secure, well-paying profession,” notes the Wall Street Journal. No exact figures on the number of pharma-based chemist jobs lost, but 116,000 were employed last year, down 24,000 from 2003. Meanwhile, 4,000 more biologists were employed in 2006 than in 2003.

The WSJ profiles Dr. Bob Sliskovic, a 23-year lab veteran who helped create Lipitor, the world’s best-selling drug. Sliskovic lost his job as a highly-paid chemist when Pfizer made the decision to dismantle one of its flagship labs in Ann Arbor, MI earlier this year. Take a look at this article to see how Pfizer's decision to stake its future on biotech is affecting researchers in the industry.

- here's the WSJ article

Related Articles:
Say goodbye to Big Pharma's gilded age. Report
Lines blur as Big Pharma crosses borders into biotech. Report
Top 5 layoffs of 2007. Report
AZ touts biologics pipeline. Report
A look inside Pfizer's biotech center. Report
Pfizer pares down Ann Arbor campus. Report

Allergan injects $370M into Esprit buyout

Wed, 19 Sep 2007 06:59:55 -0400

Allergan is taking some of the money it makes from Botox to buy Esprit Pharma for $370 million in cash. New Jersey-based Esprit makes Sanctura for overactive bladder and is launching Sanctura XR. Allergan says it plans to boost Esprit's sales force, which counts about 160 workers.

Allergan says the buyout makes a lot of sense, as it plans to expand its presence in the genitourinary market. Allergan is conducting early and mid-stage studies of Botox for idiopathic and neurogenic OAB. The company is betting that Sanctura and Sanctura XR can hit up to $400 million in annual sales.

- read the release on the buyout

Related Articles:
Allergan buying Groupe Corneal. Report
Depomed demands $105M from Esprit Pharma. Report
Esprit adds $91M in VC. Report

Lundbeck chair exits as company seeks calm

Mon, 27 Aug 2007 06:59:54 -0400

Denmark's troubled H. Lundbeck, which has been roiled by the failure of two late-stage trials and a delayed rollout of a U.S. sales force, is bidding goodbye to its chairman. Flemming Lindeløv's departure comes as a gesture to "restore calm," says the company. But with two big patents expiring in 2012 and 2014, analysts are looking for more success on the development side. Lundbeck has been under considerable pressure to acquire new therapies or find a bigger pharma company to merge with.

- see this release for more

Related Articles:
Merck, Lundbeck end gaboxadol development. Report
Teva, H. Lundbeck stop work on oral Copaxone. Report
Lundbeck's shares plunge as drug flunks Phase III. Report

What's next for Pfizer?

Mon, 04 Dec 2006 19:01:37 -0500

In the wake of yesterday's announcement that Pfizer would halt development of its potential blockbuster drug Torcetrapib, shares of the company plummeted $2.96, or 10.6 percent, to close Monday at $24.90--that represents a $21 billion market value loss. Now analysts are speculating about how the drug giant plans to turn things around. For one thing, Pfizer will hit the acquisition road to fill gaps in its pipeline with new drugs and new companies. No doubt this will come at a steep price, as potential partners will sense desperation and capitalize on it. But don't expect the drug giant to acquire another large company, especially since many analysts feel Pfizer is already too large. In a meeting with investors prior to the Torcetrapib debacle, company execs said Pfizer would fill gaps in its pipeline with acquisitions in the area of "diabetes, neurology, infectious disease, and oncology that combined have a worldwide market potential significantly in excess of $200 billion."

Pfizer will also have to cut the fat as it did last week when it axed 2,200 jobs from its U.S. sales force. Two months ago the company announced that it would reveal plans in January to make the company more "nimble." And Deutsche Bank analyst Barbara Ryan speculated that the company may lay off as many as 10,000 of its employees. Whatever happens, all eyes will be on CEO Jeffrey Kindler (photo) as he steers the world's largest drug maker through one of the toughest periods it has ever faced.

- read this article from The Street
- here's last week's release on future plans for the company

Related Articles:

Pfizer halts Torcetrapib development. Report
Pfizer told to pack up presentation on Torcetrapib. Report
Pfizer prepares red carpet for market analysts. Report

Press Release: Pfizer to realign U.S. sales organization

Maureen Martino — Tue, 28 Nov 2006 10:20:01 -0500

As Initial Step in Transformation Strategy and Review of All Business Units, Pfizer to Align U.S. Sales Organization to Support Its Key Products and Customer Needs

Pfizer Says Representatives Are Critical Competitive Advantage and Core Asset in Communicating Value of Medicines

NEW YORK, Nov. 28 -- As part of its strategy to most effectively and efficiently meet customer needs as well as match the organization's business needs, Pfizer said today that it will realign its U.S. sales organization.

The company will reduce the U.S. sales organization by approximately 20 percent, while maintaining strong support for all of its in-line products, including Lipitor, Celebrex and Geodon, as well as important new products such as Lyrica, Exubera, Chantix and Sutent.

Pfizer announced in mid-October that it would undertake a comprehensive review of every aspect of its company-wide operations with the goals of being more agile, effective and capable of best ensuring success today and in the future. In January, Pfizer will present its long-term outlook and its additional actions for transforming the company.

"The changes we are making today will better align our sales organization to our overall customer and business needs. This is an important step toward making Pfizer a more agile and effective company," said Jeffrey B. Kindler, Pfizer's chief executive officer. "Our field force will now be in a much better position to adapt to changes in our product mix and capitalize on the growth opportunities we see for our innovative medicines. While we pursue these opportunities and respond to the accelerating changes in our marketplace, our field force will continue to be a critical competitive advantage in ensuring the success of both our products and our company as a whole. The relationship of our representatives with physicians and health care professionals is one of Pfizer's most important assets. We are committed to giving our representatives all the support and tools they need to make an even greater contribution to our success going forward."

Ian Read, president of Pfizer Worldwide Pharmaceutical Operations, said, "The U.S. sales organization has done an outstanding job this year. At the same time, it is incumbent upon us to look ahead and carefully assess our changing marketplace and all the factors affecting our outlook, so that we can align our organization to properly support our key products and customer needs.

"As we do this, I am confident we will maintain our sales leadership and our representatives will continue their critical work in communicating important medical information to prescribing physicians. Consistent with Pfizer's long-standing values, we will provide affected employees with support services and benefits during their transitions. We will continue to support and reward our top performers," Read said.

Press Release: Teva Announces Agreement With Pfizer

Maureen Martino — Tue, 21 Nov 2006 11:49:24 -0500

Teva Announces Agreement With Pfizer Regarding Idarubicin, Azithromycin, And Epirubicin

Jerusalem, Israel, November 21, 2006 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has reached a comprehensive agreement with Pfizer Inc (NYSE: PFE) regarding idarubicin, azithromycin, and epirubicin and the sale of those generic products. The agreement resolves and dismisses all outstanding patent litigation filed by Pharmacia, a subsidiary of Pfizer against Sicor, a subsidiary of Teva, over Sicor's sales of generic idarubicin, an anti-cancer drug and all patent litigation brought by Pfizer over Teva's sale of generic azithromycin, an antibiotic. Furthermore, the parties have granted each other full releases and Teva will continue to market its generic versions of idarubicin and azithromycin. Teva has agreed to make a payment of up to $70 million to Pfizer, which includes an option in 2007 for Teva to sell its own generic version of epirubicin prior to the August 2007 patent expiry. Additional details were not disclosed.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the expected reintroduction of Tysabri® into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

GSK sees success with RLS campaign

Maureen Martino — Wed, 25 Oct 2006 12:45:23 -0400

GlaxoSmithKline’s marketing campaign for Requip, a restless leg syndrome (RLS) treatment, has garnered the company a good deal of negative attention. Critics say the pharmaceutical giant publicized the disease through pharma rep visits to doctors, magazine and television advertising in order to create a market for the indication. Before the marketing blitz, RLS was a little-know disease. Requip was originally a treatment for Parkinson’s, but when physicians began prescribing it off-label for RLS, GSK seized the opportunity to increase the drug’s sales. “Today, the drug, Requip, is on track to post sales of $500 million this year, making it one of the fastest-growing drugs in Glaxo's portfolio,” notes the Wall Street Journal. Parkinson’s treatment accounts for less than half of those sales.

GSK’s revitalized Requip model isn’t going unnoticed by other pharmaceutical industry players. “Pharmaceutical companies, under pressure to find new sales amid pressure from generic rivals, are seeking to treat an ever-expanding range of illnesses and to find additional illnesses their drugs can be used to treat. As a result, they increasingly need to combat skepticism about a disease, just as Glaxo did with RLS,” report s the WSJ. Other drugs makers, such as Germany’s Boehringer-Ingelheim and Belgium's UCB are also seeking RLS indications for their Parkinson’s drugs. Report (sub. req.)

Schering-Plough pulls its garenoxacin app

Sun, 20 Aug 2006 20:01:36 -0400

Schering-Plough has withdrawn its application to the FDA for approval of the antibiotic garenoxacin, a drug that was developed by Japan's Toyama. Toyama announced the move, which will take a bite out of its projected earnings. Toyama had expected the agency to approve the antibiotic, clearing the way for the Japanese drug developer to start earning revenue on U.S. sales. Schering-Plough dropped the application because it did not have a sub-licensee for the U.S. market, officials said. But Toyama also added that Schering-Plough plans to file again. In order to make up for the lost revenue, Toyama now plans to accelerate licensing talks for the experimental Alzheimer's drug T-817MA, T-5224 for rheumatoid arthritis and the antiviral agent T-705.

- see the report on garenoxacin from Asia News

Medicure to pay MGI $19M for Aggrastat

Tue, 08 Aug 2006 20:01:35 -0400

Medicure has agreed to pay MGI Pharma $19 million for the U.S. marketing rights to Aggrastat injection for coronary syndrome. The drug garnered $10.9 million in U.S. sales last year. Aggrastat was launched in 1998 and is available in 82 countries.

- see the press release for more

Praecis shares hammered as sales effort halts

Mon, 19 Jun 2006 20:01:35 -0400

Shares of Praecis Pharmaceuticals got hammered this morning after the drug developer said it would stop looking for a buyer for its prostate cancer drug Plenaxis. In late 2004 the company reported that doctors were reluctant to prescribe the drug out of concerns over insurance reimbursements. Now Praecis says it will wind down U.S. sales of the drug, pull it from the market and not go after international sales.

- here's the AP report on Praecis

Avanir inks $29M deal to buy Alamo

Mon, 22 May 2006 20:01:39 -0400

Avanir Pharmaceuticals has agreed to buy Alamo Pharmaceuticals for $29 million up front and another $40 million in scheduled sales milestones. Avanir gains FazaClo, a marketed schizophrenia drug, and the opportunity to build on Alamo's sales operations with new products of its own. "With this acquisition, we significantly enhance our portfolio by adding a marketed CNS product," said Avanir CEO Eric K. Brandt. "In addition, Alamo's organization will augment our commercialization capabilities by adding an experienced sales force calling on a base of physicians that overlap with our targeted physicians for Neurodex, which is under priority review at the U.S. Food and Drug Administration for the treatment of Involuntary Emotional Expression Disorder."

- read the release for more information

FDA approves Rituxan for rheumatoid arthritis

Tue, 28 Feb 2006 19:01:39 -0500

Genentech and Biogen Idec have received FDA approval to market the blockbuster Rituxan for rheumatoid arthritis (RA). Rituxan was originally approved for lymphoma and earlier this month was approved for a faster growing form of non-Hodgkins lymphoma. Last year the therapy racked up $1.83 billion in sales. Analysts believe that the competitive RA market is likely to add significantly to Rituxan's sales tally. Rituxan may quickly find itself in a market fight with Bristol-Myers Squibb's Orencia, which was recently approved for RA. Some give Rituxan, a drug with a long track record, the edge. In a late-stage trial, 51 percent of patients taking Rituxan and methotrexate had a significant improvement in symptoms. Twelve percent had an improvement of 70 percent or better.

- read this AP report for more information

ALSO: Lonza--which makes the biochemicals used in Rituxan--is another winner in the announcement. Report

ALSO NOTED: German court rules against Pfizer; Diamyd buys Nurel; Genzyme acquires San Diego plant; and much more...

Mon, 21 Nov 2005 19:00:50 -0500

> A German court has ruled that regulators' price caps on Pfizer's Lipitor are legal. Pfizer's sales in Germany have plunged by one-fifth in the first half of this year. Report

> Sweden's Diamyd Medical has agreed to acquire all of the outstanding shares in Nurel, a Pittsburgh-based biotech valued at $1.5 million. Release

> Genzyme of Cambridge, MA, has acquired Cell Genesys' San Diego manufacturing operation for $3.2 million. Release

> Myriad Genetics has extended its research alliance with Abbott studying how genetics affect people's response to medicine. Report

> AMDL has inked a letter of intent to buy two Chinese pharmaceutical companies for more than 13 million shares of company stock. Release

> Bentley Pharmaceuticals has been given approval to market omeprazole for heartburn in Ireland. Report

> Cubist Pharmaceuticals of Lexington, MA, has expanded its US hospital sales organization. Release

> Oragenics has completed a deal to gain up to $1.2 million in equity based financing. Release

And Finally… A new procedure--preimplantation genetic diagnosis--is being used to help women successfully give birth after multiple miscarriages. Article

Pandemic fears grow, government response uncertain

Tue, 18 Oct 2005 20:01:39 -0400

With fears of a possible avian flu pandemic growing, experts say that government planning for flu drugs is inadequate. Drug experts say they don't know what effect Tamiflu--one of the only drugs known to work on H5N1--will have in fighting a mutated virus. In addition, Roche said it needs 12 to 15 months to deliver a new order of Tamiflu. And if European countries proceed with plans to inoculate 20 percent to 40 percent of their populations, the likelihood that an even more dangerous, drug-resistant flu strain could develop increases.

- read this article from The New York Times for more

PLUS: This year's sales of Tamiflu are likely to surge to SFR1.1 billion to SFR1.2 billion, according to Roche. Report