Forest Laboratories

FDA warns Forest Labs about Bystolic ads

Christe Bruderlin-Nelson — Wed, 10 Sep 2008 03:29:48 -0400

Forest Laboratories Inc. received a warning letter from the FDA near the end of August for failure to show the risks of its high blood pressure medication, Bystolic, when promoting the drug to physicians.

The company ran an eight-page ad in a variety of medical journals favorably comparing the medication to other medications, but without enough research to support their claims. The advertisements omitted and minimized some of the risks associated with the drug--including cardiac failure and chest pain, as well as claimed the drug was superior for use in patients with obesity, diabetes and poor metabolism--without sufficient evidence to do so, according to the FDA.

Share prices also dropped following legal claims on the Bystolic patent.

- catch the Forbes.com story
- read the Pharmalot blog post

Earnings up, earnings down for drugmakers

Tracy Staton — Tue, 22 Jul 2008 10:30:14 -0400

A plethora of drug-and-device results today, from falling profits at Boston Scientific and Schering-Plough to higher earnings and flat sales at Merck. Here's the roundup:

Merck posted net income of $1.77 billion, up from $1.68 billion year-over-year; per-share results were 82 cents compared with 77 cents a year ago. Discounting foreign-currency gains, sales were relatively flat, slipping by just 1 percent to 6.05 billion. The company suffered a 48 percent drop in Fosamax revenues because of generic competition, while Vytorin and Zetia sales fell 9 percent. Singulair revenues--expected to rise--stayed flat. But blood-pressure meds Hyzaar and Cozaar saw sales grow by 11 percent to $941 million.
Schering-Plough's earnings suffered on Organon acquisition costs, ending up at $398 million, or 24 cents a share, compared with $517 million, or 34 cents, last year. Excluding those items, EPS would have come to 45 cents, the company says. Sales jumped by 55 percent to $4.92 billion--with $1.4 billion of that increase coming from Organon, which it bought last November. A standout drug was Remicade, which saw sales leap by 41 percent to $557 million.
Boston Scientific's earnings fell 15 percent to $98 million on restructuring charges and declining stent sales. Drug-coated stent revenues plummeted by 30 percent in the U.S. as Medtronic launched its new drug-coated product; worldwide, they fell 13 percent to $382 milion. Total sales came to $2.02 billion.
Biogen Idec boosted its earnings to 70 cents per share for the quarter, compared with 54 cents a year ago, on revenues of $993 million. That's a 28 percent increase over last year's second-quarter sales. On an adjusted basis, EPS came to 91 cents, beating analysts' estimates of 84 cents.
Forest Laboratories posted EPS of 79 cents per share, down from 83 cents a year ago; the numbers suffered from a charge related to Forest's parting ways with Daiichi Sankyo on Azor marketing. Revenues grew by 4.2 percent to $967 million. Sales of its antidepressant, Lexapro, grew by 6.1 percent to $894 million, while Alzheimer's drug Namenda pulled in $219 million, up 14 percent.

- see Merck's earnings at MarketWatch
- get Boston Scientific's news from the Wall Street Journal
- check out Biogen's numbers at MarketWatch
- read Schering's results, also at MarketWatch
- find Forest's earnings release

ALSO NOTED: Forest takes charge on Azor split; GSK launches Tykerb-Herceptin trials;

Tue, 13 May 2008 06:59:50 -0400

> Forest Laboratories will take a $44.1 million charge on termination of its deal to co-promote the hypertension drug Azor with Daiichi Sankyo. Report

> GlaxoSmithKline launched its large-scale trials pitting Tykerb against Genentech's Herceptin in early-stage breast cancer. Tykerb report

> Worried that antipsychotics are prescribed when they're not needed, Washington State is working on a plan to ensure that the meds are used appropriately in children on Medicaid. Report

> Schering-Plough is getting the country's largest rooftop solar-energy system, according to PPL Renewable Energy, which is installing the panels at Schering's Summit, NJ, campus. Report

> Already a problem in Southeast Asia, counterfeit malaria drugs are flooding African areas already hard hit by the disease, according to a new study. Report

> Daiichi Sankyo posted a 24.3 percent increase in fiscal-year profits to $941.5 million, but revenues fell by 5.3 percent, and it expects smaller profits in the year to come. Report

> Solvay reported a slight rise in first-quarter rise sales and profits. Report

> Following Wal-Mart, Kroger expanded its popular $4 generic drug program. Report

> India's Ranbaxy has flexed its research muscles once again, this time signing a five-year pact with Merck to develop new anti-infectives. Ranbaxy report

> Faced with a patent fight that has frustrated efforts to find a buyer, Trimeris has begun to hand back out $80 million in cash as it winds down its operations. Trimeris report

> Elixir Pharmaceuticals has dropped its bid for an $86 million IPO, saying that market conditions aren't right. At the same time, Aldagen, a small biotech company with 18 employees, is making a bid to raise $80 million in an IPO. IPO report

> Roche has racked up more late-stage data backing Actemra as a new therapy for rheumatoid arthritis. Report

Emerging Drug Developer: Resolvyx Pharmaceuticals. Profile

And Finally... The Republic Party's new slogan sounds a little familiar to the folks marketing Effexor XR. Report

ALSO NOTED: Kickback investigators focus on docs; GSK outsourcing digs into U.K. payroll;

Mon, 24 Mar 2008 07:59:50 -0400

> Fresh off their successful investigation into device makers' payments to doctors--which led to a total of $310 million in fines and ongoing disclosure agreements--the feds are turning to the other side of the table. Investigators now plan to target doctors for soliciting those kickbacks or bribes. Report

> GlaxoSmithKline told workers at its Ulverston, U.K., plant were told that their jobs were at risk as the company outsources some of their functions; some 330 jobs will be eliminated at the plant, which now employs 537. Report

> Sun Pharmaceutical got the FDA nod for its generic form of Tessalon, a Forest Laboratories cough medicine. Report

> A new survey shows that pharma's medical affairs departments aren't reporting to marketing as much as they did in the past; in 2002, 43 percent of medical affairs units were under the marketing umbrella, but now only 7 percent are. Report

And Finally... Eye on FDA has an interview with former FDA chief David Kessler, who presided over the agency "during much happier times." Report

Pfizer's Lyrica booms on iffy diagnosis

Mon, 14 Jan 2008 06:59:58 -0500

Is fibromyalgia an ill-gotten label that could only benefit drug companies? Or is it a real disease that needs treatment? Judging by the abrupt rise in prescriptions for the Pfizer drug Lyrica since it was approved for fibromyalgia treatment in June, it's real. But doctors are still arguing. Even the physician who initially identified the problem now say he doesn't think it's a true disorder

Meanwhile, patient advocates are hoping that widespread drug treatment will legitimize the disease rather than vice versa. Just as Prozac brought depression out of the closet, so might Lyrica for fibromyalgia.

That, of course, would only be to Pfizer's benefit. An estimated 10 million American adults suffer from the disorder. That's not quite the 15 million who suffer from depression each year, but it's plenty. Already, worldwide sales of Lyrica grew by 50 percent in 2007, and analysts expect further growth of some 30 percent in 2008--even as Eli Lilly and Forest Laboratories prepare to launch their own fibromyalgia remedies, probably later this year.

- read this article from the New York Times

Related Articles:
Northwestern sells Lyrica rights for $700M. Report
Pfizer touts blockbuster drug for fibromyalgia. Report
Lyrica gains blockbuster status. Report

ALSO NOTED: Canada's drug market slowing; GSK files for Promacta approval;

Thu, 20 Dec 2007 06:59:50 -0500

> The Canadian pharma market has slowed to a growth level of 6 percent to 6.5 percent, down from a five-year average of 8.4 percent. Report

> GlaxoSmithKline submitted an NDA for Promacta, a platelet growth factor designed to treat thrombocytopenic purpura. Report

> Valeant Pharmaceuticals says it will sell its hepatitis C drug Infergen to Three Rivers Pharmaceuticals doe about $91.3 million. Report

> Par Pharmaceutical says its year-end profits will be at least $1.45 per share; previously, the generics maker had said it expected earnings of $1.35 to $1.50. Report

> Idera is pocketing a $40 million up front fee from Merck KGaA and hopes to make an additional $381 million in milestones from licensing its technology for cancer therapies. Report

> In a deal that starts small but has a big upside, Santaris Pharma has forged a $700 million development pact with GlaxoSmithKline to develop new antiviral meds. Report

> Boston-based venture capitalist Roger Kitterman has been able to coax investors to back badly needed therapies with none of the big upside that most would demand. Report

> The Wall Street Journal health blog pokes fun at Bystolic, the newly-approved beta blocker from Forest Laboratories and Mylan, as the ultimate "me-too" drug. Report

And Finally… Harvard Business School researchers have identified four types of healthcare consumers, each of which responds to entirely different marketing approaches. Report

SPOTLIGHT: FDA approves Forest's new beta-blocker

Tue, 18 Dec 2007 06:59:52 -0500

Forest Laboratories got the FDA's nod for its blood pressure remedy Bystolic, which it makes in partnership with Mylan. Report

ALSO NOTED: Japan to get Roche's Tarceva next week; Barr sues two generics makers over Seasonale;

Fri, 14 Dec 2007 06:59:50 -0500

> Roche's Japanese unit Chugai Pharmaceutical is preparing to launch the lung-cancer drug Tarceva, approved in Japan in October for treatment of the non-small cell form of the disease. Report

> Barr Pharmaceuticals sued Watson Pharmaceuticals and Sandoz for infringing the patent on Seasonale, a birth control product made by Barr's Duramed unit. Report

> The FDA gave its blessing to Kuvan, a BioMarin Pharmaceutical drug designed to treat the genetic disorder phenylketonuria. Report

> Isis Pharmaceuticals promoted B. Lynne Parshall to chief operating officer; she'll also retain her position as CFO and director. Release

> Forest Laboratories announced that several companies are seeking approval to sell copycat forms of its Alzheimer's drug Namenda. Report

> GlaxoSmithKline is sinking $100 million into a neuroscience research center in China that will play a pivotal role in its ongoing drug discovery work. Report

And Finally... For protection, HIV and aggressive cancer cells cloak themselves in carbo-clothing worn by human sperm. Report

ALSO NOTED: Watson gets OK to sell generic pain drug; Merck adds Reuters CEO to its board

Tue, 27 Nov 2007 06:59:50 -0500

> Watson Pharmaceutical got the FDA's blessing to sell its generic version of Combunox, a short-term pain-management drug made by Forest Laboratories. Report

> Merck has added Reuters Group CEO Thomas Glocer to its board. Report

> The FDA has inked a $6 million contract with Ingenuity Systems to help it slice and dice trial data to identify potential drug-safety problems. Release

> Nigerian pharma has grown by leaps and bounds since a new regulatory regime started cleaning up the industry six years ago; now there are 150 drug companies in the country compared with 70 in 2001. Report

> The recently-acquired Organon is getting a taste of Schering-Plough's research 'religion.' Report

> Researchers have created a new breed of mice that are resistant to the most aggressive forms of cancer. Report

> A team of researchers blitzed the C. elegans roundworm with tens of thousands of chemicals and found 115 that prolonged their short lives. But one, the antidepressant mianserin, is now commanding all of their attention. Report

> Scientists have transplanted stem cells that create new blood into the bone marrow of mice, advancing a new process that could eventually cure autoimmune and genetic blood disorders. Report

> Connecticut's decision to funnel $100 million into embryonic stem cell research has fueled a host of research programs in the state. Report

> Scientists at the University of Oxford are preparing clinical trials to test a new way to treat kidney and liver tumors. Ultrasound waves will be directed to tumors, where bubbles will develop and pop, releasing heat and killing cancer cells. Report

> 23andMe is offering people a chance to send in a swab of saliva that can be analyzed for inherited traits and some idea of their personal disease risks--all for a cost of $999. Report

And Finally... Two renowned Texas heart surgeons who've been feuding for 40 years--Dr. Michael DeBakey and Dr. Denton Cooley--have finally buried the hatchet. Report

ALSO NOTED: Levaquin gets FDA thumbs up for UTIs; Angiotech settles patent fight with J&J subsidiary;

Mon, 17 Sep 2007 06:59:50 -0400

> Angiotech Pharmaceuticals says it's settling its patent battle with Conor Medsystems over the paclitaxel stent. Conor is a Johnson & Johnson subsidiary. Release

> In preparation for its acquisition of Merck KGaA's generics drug business, Mylan Laboratories is getting its financial house in order by buying back two issues of notes. Release.

> MedPointe Pharmaceuticals got FDA approval for a new 250 mg strength of its muscle relaxant Soma, aka carisoprodol. Release

> Cardinal Health warned investors that its pharmaceutical sales aren't growing as fast as overall revenues. The $86.9 billion company distributes drugs to retail pharmacies, hospitals, and other healthcare providers. Report

> A stock analyst lowered his price target on Forest Laboratories, but kept its rating at "outperform" on the strength of a court ruling that forced Teva Pharmaceuticals to back off of Forest's biggest revenue-producer, Lexapro. Report

And Finally... What if almost every bit of research about health and risk and healing was bogus? That's what some critics of epidemiological studies contend. The charge was led by eminent statistician Stan Young, who claims studies are so often wrong that equally valid results could be had from a random-number generator. Report.

Forest Labs gets Lexapro protection

Thu, 06 Sep 2007 06:59:57 -0400

How does Forest Labs spell relief? P-A-T-E-N-T. A federal court has validated the company's Lexapro protection, safeguarding that blockbuster antidepressant and antianxiety drug through 2012. The court also intervened to stop Teva Pharmaceuticals from launching a generic version of Lexapro, which is Forest's top seller at $2 billion per year.

- check out the release

Related Articles:
FDA OKs generic Lexapro. Report
Lundbeck chair hits exit. Report
Forest Labs dumps failed stroke drug program. Report