Valeant Pharmaceuticals

Valeant buys DermaTech for $12.5M

Maureen Martino — Fri, 14 Nov 2008 10:22:47 -0500

Valeant Pharmaceuticals announced that it will purchase Austraila's DermaTech for $12.5 million (AU$19 million). DermaTech develops dermatology products that are marketed throughout Austrailia and overseas. Valeant, which develops dermatology and neurology products, said the acquisition compliments its current pipeline and expands the company's presence in Australia.

- here's Valeant's release

Valeant buys Coria for $95M

Maureen Martino — Wed, 17 Sep 2008 10:58:51 -0400

Valeant is shelling out $95 million to acquire Coria Laboratories, a pharmaceutical company focused on dermatology products in the United States. Valeant will purchase all of the outstanding shares of Coria from its parent company, DFB Pharmaceuticals. The move expands Valeant's U.S. business and boosts the company's dermatology franchise.

"Valeant is committed to growing our dermatology franchise and this acquisition is a key step in transforming this business in the U.S. and gaining the critical mass and profitability we need," said J. Michael Pearson, chairman and CEO of Valeant. "The acquisition of Coria provides Valeant with access to a unique product portfolio, which includes both prescription and OTC products, additional pipeline opportunities for the future and a talented dermatology workforce."

- here's Valeant's release for more

GSK, Valeant ink $820M epilepsy deal

John Carroll — Thu, 28 Aug 2008 11:38:43 -0400

Valeant Pharmaceuticals will pocket a $125 million upfront fee from GlaxoSmithKline in exchange for a collaboration deal on the epilepsy drug retigabine. Altogether the pact could be worth up to $820 million if the drug achieves all of its milestones. Valeant retains up to half of the profits from any sales in the U.S. and several other countries. Glaxo also gains the rights to VRX698 and the other back-up compounds from the potassium channel opener discovery program.

Retigabine has already completed two Phase III trials and is in a study for post-herpetic neuralgia, a painful complication of shingles. The developers say they will file for European approval in early 2009.

"There is a significant need for novel anti-epileptic drugs, as almost one-third of patients with epilepsy continue to experience seizures despite treatment with currently available medications," commented Steve Stefano, senior vice president, GSK U.S. NeuroHealth Division. "We believe that retigabine could potentially play a significant role in improving the management of epilepsy and is a welcome addition to GSK's portfolio."

- check out the release

Valeant chops workforce in restructuring

Fri, 02 May 2008 06:59:57 -0400

In an effort to bring expenses in line with revenues, Valeant is cutting 130 workers in the U.S. and Mexico. In addition, headcount will be further reduced by 1,250 positions as it divests its European subsidiaries. The full effects of the layoffs will be felt within the next year. The layoffs will reduce Valean's staff by about half.

"This is the first step in our plan to right size our company and return it to appropriate levels of profitability," said J. Michael Pearson, chairman and chief executive officer. "We understand the impact these changes will have on our employees and we are committed to treating everyone with respect and dignity. While difficult, these changes are in the best interest of the company to generate meaningful change that will produce long-term value."

- here's Valeant's release

ALSO NOTED: Promacta gets priority review; GTx drug hits endpoint; Alexza touts IIa data; and much more...

Mon, 03 Mar 2008 06:59:50 -0500

> Glaxo's Promacta, a bleeding disorder drug, will be given a priority review by the FDA. Release

> GTx announced that an 80 mg dose of toremifene citrate experienced reduced rates of hot flashes in prostate cancer patients on ADT therapy, hitting a secondary endpoint in a late-stage trial. Report

> Alexza Pharmaceuticals announced that its Phase IIa trial for its migraine drug AZ-104 hits its primary endpoint of two-hour pain relief after two doses compared to placebo. Report

> Denmark's Neurosearch reported positive data for its obesity drug. "Neurosearch considers the TIPO-2 results highly supportive for the continued development of Tesofensine both in terms of superior efficacy and safety." Release

> Valeant Pharmaceuticals has sold its Asian operations to Invida Pharmaceutical for $37.8 million. Release

> AEterna Zentaris and Paladin Labs have inked a sales deal on all rights related to miltefosine for Cdn$9.125 million in cash. Release

> A hedge fund has cut its holdings in CV Therapeutics to 2.1 percent. Report

> Put your cards on the table, ladies and gentlemen. A U.K. minister is calling on drug companies to hand over all their data on antidepressants to the National Institute for Health and Clinical Excellence. Report

> Want to know what happens inside a pharma company during a recall crisis? Check out Sunday's Chicago Tribune, which details the behind-the-scenes scramble at Baxter. Report

> Celebs may help sell magazines but do they really help market drugs? In the wake of Robert Jarvik's public downfall from Pfizer's pitchman-pedestal, advertising experts are wondering. Report

And Finally... Narcoleptics experience a high rate of eating disorders, with binge eating and food craving at the top of the list. Release

ALSO NOTED: Amgen analysts bearish; FDA hands Kyowa not-approvable letter; Valeant plans review; and much more...

Thu, 28 Feb 2008 06:59:50 -0500

> Oh, the curse of duplication. Schering-Plough embarked on a company-wide downsizing yesterday, eliminating hundreds of jobs in nearly all departments, including finance, research, information technology, and marketing. Report

> Faced with what they see as the likelihood of some significant restrictions on the use of Amgen's anemia drugs--as well as new data on risks associated with the drugs--analysts have been turning distinctly bearish on the biotech giant's stock. Report

> Kyowa Pharmaceutical has received a not-approvable letter from the FDA for istradefylline (KW-6002), its investigational drug for the treatment of Parkinson's disease. Release

> Valeant Pharmaceuticals says it will undertake a strategic review after reporting weak results for the fourth quarter. Release

> The U.S. Patent office has upheld the validity of Geron's patent for human embryonic stem cells. Report

> Any attempt to track down the source of problems with the blood thinner heparin are likely to run into trouble following a convoluted supply trail in China. Report

> The FDA has nixed Eli Lilly's plans for a long-acting formulation of its antipsychotic Zyprexa. Report

> GSK's secret vaccine adjuvant is drawing attention. Report

And Finally... The CDC has greatly expanded the population of people it's recommending for an annual flu shot, saying everyone aged six months to 18 should get the an annual jab. Report

ALSO NOTED: Galenica share surge on committee approval; Progen to acquire CellGate; and much more...

Mon, 04 Feb 2008 06:59:50 -0500

> Shares of Galenica jumped 15 percent this morning after the company announced that an FDA advisory committee has endorsed its iron replacement therapy Ferinject/Injectafer. A formal decision is expected in mid-March. Report

> Australia's Progen has inked a deal to acquire CellGate, a U.S. cancer therapy developer, for $1.5 million in shares and the assumption of $1 million in liabilities. In addition to its pipeline candidates Progen also gains the help of CellGate CSO Dr. Laurence Marton. Report

> Acorda Therapeutics has acquired certain assets of Neurorecovery, which focuses on the development and commercialization of neurological drugs that target inflammatory diseases of the peripheral nerves. Release

> Chutes & Ladders: Valeant Pharmaceuticals CEO Timothy Tyson has hit the exit and will be replaced by Michael Pearson. Chairman Robert Ingram will step down as well but remains as a director. Prior to joining Valeant, Pearson had been a director at McKinsey & Company. Release

> BioLineRx has produced positive data from a Phase IIa trial of its schizophrenia drug BL-1020. Thirty-six treatment refractory patients took part in the study, registering statistically significant responses during the six-week study. No side effects like weight gain or motor difficulty were reported. Report

> Pre-emption handed GlaxoSmithKline the victory in a lawsuit over a 13-year-old who committed suicide while taking the antidepressant Paxil. A California judge cited the pre-emption rule in dismissing the suit, saying that the case created a direct conflict between federal labeling requirements and state tort law. Report

> The FDA says it's "increasingly likely" that Pfizer's stop-smoking pill Chantix may cause psychiatric symptoms in some patients, including suicidal thoughts and actual suicide. Report

> Pony up, Congress. Stop whipping the FDA for its failures and fork over the cash necessary to fix the problem. That's what editorial writers at the Boston Globe and New York Times said over the weekend. Report

And Finally... For anyone out there who may think that quality does not matter in healthcare: Patients treated at top-rated hospitals nationwide are nearly one-third less likely to die, on average, than those admitted to all other hospitals. Study

ALSO NOTED: Genitope's MyVax misses Phase III endpoint; Report: Pfizer looks at Danish biotechs; and much more...

Fri, 21 Dec 2007 06:59:50 -0500

> Genitope's MyVax, a treatment for follicular B-cell non-Hodgkin's lymphoma, has flunked a Phase III trial. There was no difference in progression-free survival between patients taking the drug and the control substance. On the bright side, however, the company noted that the MyVax arm of the trial "showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumor-specific target and those who did not." Genitope's shares took a beating on the news, dropping 50 percent. The company said that it would work with the FDA to determine the best path for MyVax. Release

> Report: According to the site Copenhagen Capacity, Pfizer is taking a close look at several Denmark-based drug developers. A number of Danish biotechs are working on therapies for obesity, diabetes and cancer, all of which may be of interest to Pfizer. Report

> Bavarian Nordic has gained a $25 million milestone payment as part of its deal with the Department of Health and Human Services to provide 20 million doses the smallpox vaccine Imvamune. Release

> The FDA has extended its review of Genta's advanced melanoma treatment Genasense by 60 days. Release

> Daiichi Sankyo will be marching three of its subsidiaries--Sankyo Chemica., Sankyo Organic Chemicals, and Daiichi Sankyo Chemical Pharma--in order to "management resources on the pharmaceutical businesses." Release

> Valeant Pharmaceuticals is selling the U.S. and Canadian rights to Infergen, a hepatitis C treatment. Three Rivers Pharmaceuticals will acquire the drug for $91 million. Valeant says it's selling Infergen in order to simplify its operations. Release

> Redwood City, CA-based A.P. Pharma is on the hunt for a new CEO. Report

And Finally... A group of scientists have derived four embryonic stem cell lines that could lead to the creation of cells that will not cause immune rejection. Report

ALSO NOTED: ReNeuron confident of trial OK; Valeant licenses Xyrem rights;and much more...

Thu, 11 Jan 2007 19:01:30 -0500

> ReNeuron Group says it is confident that it can gain regulatory approval to start a Phase I stem cell trial of ReN001 after the FDA put a hold on the study on Tuesday. Report

> Valeant Pharmaceuticals has licensed the Canadian rights to Jazz's cataplexy treatment Xyrem. Report

> A group of buyout firms including Texas Pacific have set their sights on a potential offer for Merck KGaA's generic drug unit. Report

> Chelsea Therapeutics is touting the outcome of a European Phase IIb trial of Droxidopa for neurogenic orthostatic hypotension. Release

And Finally… ASCO has touted the development of more targeted cancer therapies as well as a newly approved cervical cancer vaccine as the top advancements in the field for 2006. Sutent, Tykerb, Sprycel and Erbitux have all been held up as examples of effective, targeted cancer drugs. Article

SPOTLIGHT: Valeant sells development programs

Thu, 21 Dec 2006 19:01:33 -0500

Valeant Pharmaceuticals has sold the rights to its HIV and cancer development programs to Ardea Biosciences. Report

Schering-Plough licenses hepatitis B drug

Wed, 13 Dec 2006 19:01:35 -0500

Shares of Valeant Pharmaceuticals and Metabasis Technologies jumped late Wednesday after they announced that Schering-Plough had licensed the experimental pradefovir for chronic hepatitis B. Valeant licensed the drug from Metabasis six years ago. Both companies will earn an up-front payment along with a schedule of milestones.

"Pradefovir has the potential to offer improved treatment options for patients with chronic hepatitis B, a serious blood-borne infection affecting some 400 million people worldwide," said Dr. Robert Spiegel, chief medical officer of Schering-Plough Research Institute.

- read the release on the deal
- here's the report on the licensing deal from TheStreet.com

Related Articles:
Valeant hep C drug fails pivotal trial, again. Report
FDA OK's Valeant's Zelapar for Parkinson's. Report
Schering-Plough's turnaround plan may include buyouts. Report

Valeant hep C drug fails pivotal trial, again

Mon, 11 Sep 2006 20:01:36 -0400

Valeant Pharmaceuticals announced that its hepatitis C drug Viramidine performed worse than a standard therapy in its second of two Phase III trials. Volunteers taking Viramidine registered a 40 percent sustained viral response rate compared to 55 percent of the participants taking ribavirin. But researchers noted that volunteers taking a higher dose of Viramidine registered higher response rates without an increase in anemia. And they underscored that Viramidine appeared safer than ribavirin in the study. Valeant CEO Timothy Tyson noted that the data looks a lot like the returns from their first Phase III trial and added that researchers were preparing a higher dose study. In addition, Tyson said that the company would look for a partner to develop the drug if they launch a new Phase III trial next year.

The data arrived just hours after Valeant announced that the SEC had begun a probe into stock trades made this spring around the time it released data from a Phase III trial of Viramidine that sent its stock into a swoon. Investigators are also probing stock option grants and the biotech's efforts to recover bonuses paid to former CEO Milan Panic, who was fired in 2002.

- see the release on the trial data
- check out this report from The Los Angeles Times on the probe

FDA OK's Valeant's Zelapar for Parkinson's

Wed, 14 Jun 2006 20:01:38 -0400

Valeant Pharmaceuticals has won FDA approval for Zelapar as a combinational therapy for Parkinson's eight months after receiving an approvable letter for the therapy. Valeant has offered data that shows that Zelapar in combination with approved Parkinson's drugs reduces the amount of time patients have difficulty functioning. Valeant acquired Zelapar more than two years ago when it bought the U.S. arm of the U.K.'s Amarin. It agreed to pay Amarin $8 million on the FDA's approval of Zelapar.

- here's the AP report on Zelapar

ALSO NOTED: Satraplatin to get expedited survival review; Azilect OK'd for Parkinson's; and much more...

Wed, 17 May 2006 20:00:50 -0400

> Pharmion and GPC Biotech say that an independent monitoring board will conduct an expedited review of survival data from the Phase III trial of Satraplatin. The companies cautioned against reading too much into the expedited review. Report

> The FDA has approved Teva's Azilect for Parkinson's disease. Teva is also planning a large trial on Azilect's influence on the progression of Parkinson's. Report

> Novartis says an FDA panel has issued a favorable opinion on its Alzheimer's drug Exelon. Report

> Seven in 10 doctors say that the recent high-profile safety problems of certain prescription drugs had made them more wary about a drug's side effects and more likely to prescribe a drug that had been out on the market longer. Release

> Baxter and Jerini are reporting progress in their collaboration to develop new therapies for hemophilia. Report

> Shire Laboratories has filed a patent suit against Corepharma. Report

> Valeant Pharmaceuticals has sold a manufacturing facility in Warsaw, Poland. Report

> China Biopharmaceuticals has reached a deal to purchase all of the shares in RACP Pharmaceutical Holdings and its wholly owned subsidiaries, including Shenyang Enshi Pharmaceutical. Release

And Finally… A family cluster of avian flu deaths in Indonesia has raised worries that the disease may have mutated into a more easily transmissible virus. Article

SPOTLIGHT: FDA approves synthetic cannabis

Mon, 15 May 2006 20:01:33 -0400

Valeant Pharmaceuticals has received FDA approval for a synthetic version of cannabis. Cesamet was approved to help control vomiting and nausea for patients receiving chemotherapy. Report

Valeant to out-license programs in restructuring

Mon, 03 Apr 2006 20:01:38 -0400

Valeant Pharmaceuticals is restructuring, with plans to focus on its late-stage drug prospects and pare back expenses while boosting earnings. The restructuring includes plans to out-license pradefovir for hepatitis B and VRX-840773, its HIV compound. Valeant will concentrate development efforts on Viramidine (taribavirin), retigabine and Infergen. The drug developer will also look to cut costs in sales and reorganize its commercial regions to three from four.

"The steps we are taking are driven by our goal to deliver a significant increase in earnings over the next three years," said Valeant CEO Timothy C. Tyson. "We continue to expect our revenues to grow at an annual rate of 5 to 10 percent. As we near the completion of our second pivotal, Phase III trial for Viramidine, we are evaluating the best path to advance this development program to regulatory approval."

- here's the release

Valeant's hep C drug misses a primary endpoint

Mon, 20 Mar 2006 19:01:39 -0500

Shares of Valeant Pharmaceuticals were hit after the drug developer announced that a late-stage trial of Viramidine for hepatitis C did not meet a primary endpoint. Viramidine did hit one of its primary endpoints though, as researchers noted data demonstrating the therapy was safer than standard therapy. Researchers highlighted data that patients taking Viramidine had a statistically lower incidence of anemia compared to patients taking ribavirin (5 percent compared to 24 percent). And while the therapy missed a primary endpoint in demonstrating that it is not inferior to ribavirin on an intent-to-treat basis, researchers emphasized that an analysis of the data showed that higher dosing was associated with higher efficacy. "We continue to work toward commercial launch of Viramidine before the end of 2007," said Valeant CEO Timothy C. Tyson.

- here's the AP report for more information

ALSO NOTED: Neuromed raises $25M; MS sufferers plead for Tysabri; Emisphere inks deal with Novartis; and much more...

Tue, 07 Mar 2006 19:00:50 -0500

> Neuromed Pharmaceuticals, a biopharmaceutical company developing chronic pain drugs, announced the completion of a series D financing of $25 million. This fourth round of financing brings Neuromed's cumulative venture capital financing to $74 million. Release

> About two dozen MS sufferers made fervent pleas to an FDA committee to return Tysabri to the market. Report

> Emisphere Technologies inked a deal with Novartis worth up to $30 million in milestone payments for the use of its drug delivery technology. Report

> Ikonisys has closed a $10 million series D private equity financing round. Release

> The jury in the latest Vioxx trial got a close look at Merck documents outlining the company's concerns about the cardiovascular risks posed by the drug long before it was removed from the market. Report

> Speedel announced today that it has reached late-stage preclinical profiling of a new series of renin inhibitors designated as the SPP1100 series. Release

> Valeant Pharmaceuticals has settled a dispute with the Serbian government. Release

> FEI Company and Sweden-based Sidec Technologies today announced that the two companies will collaborate on the commercialization of Protein Tomography solutions and services based on Sidec's proprietary software and intellectual property, and FEI's transmission electron microscopes. Release

And Finally... A new study indicates that physicians' choice of chemotherapy drugs is influenced by payment methods. Article

Valeant to buy hepatitis C therapy for $113.5M

Mon, 28 Nov 2005 19:01:39 -0500

InterMune has agreed to sell the US and Canadian rights to its hepatitis C therapy Infergen to Valeant Pharmaceuticals for $113.5 million and performance payments of up to $22.5 million. Valeant will gain about $6.5 million in inventory from the Brisbane, CA-based InterMune and will hire 50 members of their sales and marketing staff. InterMune says the deal will reduce its operating costs by $50 million and allow it to focus more on a separate hepatitis C drug and another therapy for lung scarring. Infergen posted $22 million in sales last year.

- read this AP report for more information on the deal

SPOTLIGHT: Valeant's Parkinson's drug 'approvable'

Mon, 03 Oct 2005 20:01:33 -0400

Valeant Pharmaceuticals has received an "approvable" letter from the FDA for its Parkinson's drug Zelapar. Valeant said it would meet with the agency to clarify issues addressed earlier but didn't outline what those issues are. Article