Biovail

Biovail buys Prestwick, gains CNS drugs

Maureen Martino — Wed, 17 Sep 2008 09:35:02 -0400

Canada's Biovail has bought out U.S.-based Prestwick Pharmaceuticals, which recently won FDA approval for Xenazine. The orphan drug is a treatment for chorea, which is associated with Huntington's disease. Biovail has paid $100 million to acquire Prestwick Pharmaceuticals along with related license rights. The company also gets other early-stage products, including Lisuride Sub Q (advanced Parkinson's disease), Lisuride Patch (Parkinson's disease) and D-Serine (schizophrenia). Ovation Pharmaceuticals announced separately that it had acquired rights to commercialize Xenazine in the United States.

The buyout is part of Biovail's recently-announced plan to focus on central nervous system drugs. The company is investing $600 million over the next four years for work on epilepsy, multiple sclerosis and Parkinson's. "The transaction meets all of our acquisition criteria, and represents Biovail's first commercial exposure to specialty markets in central nervous system, or CNS disorders. The acquisition is another important step in the implementation of our New Strategic Focus," said CEO Bill Wells.

- here's Biovail's release for more
- check out Ovation's release

Melnyk switches focus to new company

John Carroll — Tue, 29 Jul 2008 12:10:02 -0400

Eugene Melnyk's decision to back away from his showdown with Biovail's management team lays the stage for him to start a new company--Trimel Biopharma. Melnyk has described the business model for the soon-to-be developer as a "nimble, R&D-focused pharmaceutical company" that will "capitalize on new technologies and new regulatory environments emerging in Canada and the U.S." And he's promised to back the company with millions of his own dollars.

Trimel will be charged with doing everything Melnyk couldn't force Biovail to do, including "difficult to manufacture" generics along with the acquisition of new products and new technologies.

- read the story from the Globe & Mail

Melnyk outlines $100M blueprint for new developer

John Carroll — Thu, 26 Jun 2008 11:33:21 -0400

Fresh from losing an insurgent attack aimed at winning back control of Biovail, the Canadian entrepreneur says he plans to invest $50 million to $100 million of his own money to start a new R&D focused development company--Trimel Pharmaceuticals. But first he faces a looming court fight over the bitter Biovail dispute.

Trimel will be a "nimble, R&D-focused pharmaceutical company" that will "capitalize on new technologies and new regulatory environments emerging in Canada and the U.S.," he told reporters. And Melnyk said that Bruce Brydon would be his new CEO. First though, comes a court fight over Melnyk's failed tactics to win control of Biovail. In the meantime, Biovail says it plans to focus on the development of new therapies for CNS diseases.

- read the report from the Globe and Mail

Biovail focuses on CNS drugs

Maureen Martino — Fri, 13 Jun 2008 12:34:15 -0400

As the battle for Biovail continues, current CEO William Wells emphasized the company's focus on CNS drug development at Goldman Sachs' annual healthcare conference. Biovail is investing $600 million over the next four years for work on epilepsy, multiple sclerosis, and Parkinson's. Wells said the company will "maintain its drug delivery technology but [will seek] to license it or use it for drug development."

Biovail's development plans, however, hardly seem to be the focus these day. Found Eugene Melnyk launched a proxy battle for the company recently and is looking to sweep out its board and senior management. Melnyk has a dissident group of shareholders backing him, while the current management urges shareholders to reject Melnyk's interference. The fight will come to a head at annual shareholder meeting on June 25, when shareholders vote on the company's future management.

- see the CNNMoney article

ALSO NOTED: Acorda shares soar; Lexicon wins fast track; NIH grants $533N in research funds; and much more...

Tue, 03 Jun 2008 06:59:50 -0400

> News yesterday that Acorda Therapeutics' experimental MS drug helped patients walk better sent its shares up 27 percent. Report

> The FDA has provided fast-track status to Lexicon Pharmaceuticals' therapy for carcinoid syndrome. Story

> Cougar Biotech says it presented positive Phase I and Phase II data for CB7630, an experimental therapy for castration resistant prostate cancer. Release

> Arana Therapeutics and Greenovation Biotech have forged a pact to develop up to five anti-cancer antibodies. Report

> China's Genesis Pharmaceuticals Enterprises has raised $30 million in a private placement. Release

> Novartis "stole the show" at ASCO, Forbes says. Between the big Zometa news--that the bone drug may actually prevent breast cancer recurrence--and dramatic data on an experimental med, the Swiss pharma came out of ASCO looking pretty sweet. ASCO report

> Guess who's the new up-and-comer in pharma? Brazil. Report

> It's not a new question, but it's one whose urgency is growing: How long can Pfizer pay its big dividend? Report

> Eugene Melnyk (photo) said he'd do it, and now he has. The founder of Canada's Biovail launched a proxy battle for the company, looking to sweep out its board and senior management. Report

And Finally… The Scripps Transitional Research Institute was one of 14 research groups that will gain $533 million from the NIH over five years. The funds are earmarked to speed the development of new technologies. Report

ALSO NOTED: U.S. hatches $265M regenerative medicine initiative; Merck KGaA budgets €1B for R&D;and much more...

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

> The U.S. government is creating a $265 million research initiative that will develop new stem cell technology to re-grow the skin, limbs and muscles of soldiers injured in Iraq and Afghanistan. And those advances in turn will be made available to the people burned and maimed in everyday accidents. Report

> With about 40 drug development projects in the pipeline, Germany's Merck KGaA says it will spend about €1 billion on drug research this year. That R&D budget represents about 22 percent of sales and is a big increase on last year's budget of €890 million. Report

> University of Cincinnati researcher Melissa DelBello is getting some added scrutiny after finding herself in Senator Charles Grassley's crosshairs. Report

> Call it the blame game. The U.S. FDA says it's traced contaminated heparin back to 12 companies in China. Chinese officials, however, claim the problem started in the U.S. Report

> To listen to news reports about incoming Biovail CEO Bill Wells, you'd think he was one of the horsemen of the Apocalypse. A director for three years, Wells is set to take over the helm May 1, and analysts say they're expecting him to come in swinging his sword. Report

> A new guerilla marketing campaign for over-the-counter Zyrtec is gaining attention in the blogosphere. Report

> Eye on FDA blogger Mark Senak examines recent goings-on at the FDA will change the agency. Report

And Finally... Companies are using nanotechnology as they pursue genome sequencing for the rock-bottom price of $100. Report

Biovail picks Wells as CEO

Mon, 21 Apr 2008 06:59:57 -0400

Canadian drugmaker Biovail has named a new chief to take the reigns from interim CEO Douglas Squires. William Wells has been appointed Biovail's new CEO, effective May 1, 2008. He's been on the company's board since 2005, and has been lead director since June 2007. The company has been in search of a permanent CEO since last year after Biovail's founder and chief Eugene Melnyk (photo) retired while being investigated for accounting fraud.

"Biovail is a great company with outstanding potential to deliver enhanced value for its shareholders. I look forward to executing the Company's new strategic plan, which is currently being developed by the Board and management," Wells said in a statement. No word yet on when we'll see the details of that plan.

- here's the release
- read the WSJ report

Related Articles:
Melnyk slams Biovail board, calls for change. Melnyk report
Biovail drug launch draws feds' scrutiny. Biovail report
Biovail shares sink after FDA schedules review. Biovail report
FDA hands Biovail a non-approval letter. FDA report
Biovail's Melnyk to step down amid SEC probe. Melnyk report

ALSO NOTED: R&D spending jumps; Bio-Imaging buys out Phoenix Data; Late-stage cancer drugs often successful; and much more...

Tue, 25 Mar 2008 07:59:50 -0400

> In a bid to broaden its clinical trial services offerings, Bio-Imaging has forged a deal to buy out Phoenix Data Systems for $24 million. Report

> Research spending into new drug developments jumped to $58.8 billion last year, according to a new study by PhRMA and Burrill & Co. That represents an increase of $3 billion. Release

> About one-fourth to one-half of new cancer treatments that reach assessment in Phase III randomized clinical trials are eventually proven successful, according to a new report. Release

> Halozyme shares surged yesterday in the wake of some upbeat comments from analysts and reports of insiders buying company stock. Report

> Chelsea Therapeutics is reporting positive results from a preclinical study of an RA therapy. Release

> Ceragenix Pharmaceuticals says it has inked a license agreement with FirstPoint Biotech for the development of CSA-54 and other members of the Ceragenin family of preclinical compounds to treat HIV and sexually transmitted diseases. Release

> Why is Jim Cornelius (photo) smiling? His big promotion to permanent CEO of Bristol-Myers Squibb last year came with a mighty boost in pay. According to the Wall Street Journal's calculations, Cornelius pulled down a $11.3 million pay package, up from $1.5 million in 2006. Report

> Biovail's shares fell to an eight-year low yesterday as more details emerged in the SEC case against the company, its founder and three other executives present and past. Report

> Merck CEO Richard Clark (photo) has his work cut out for him this year. Report

And Finally…The family of a cancer victim is asking for public support in its campaign to persuade GenVec to provide the late-stage therapy TNFerade for compassionate use. But the developer says it's waiting for new data and it can't set up a compassionate use program yet anyway--all supplies of the drug are needed for a trial. Article

Melnyk slams Biovail board, calls for change

Fri, 29 Feb 2008 06:59:58 -0500

Biovail founder--and largest shareholder--Eugene Melnyk (photo) isn't happy with the company's management, and he's going to do something about it. In a scathing letter to shareholders, Melnyk lambastes the current board of directors for, as he says, not helping the company realize the full potential of its drug delivery technology.

After disappointing talks with the current board, Melnyk says he is exploring "various options available to me in connection with my interest in Biovail, including the possibility of joining with a partner or partners to acquire the remaining shares of Biovail, selling all or a portion of my current Biovail shares to a third party, continuing to hold my shares for investment, or seeking changes to the composition of the Board of Directors."

Melnyk stepped down as chairman in June of 2007 as part of a settlement with Canadian regulators who were investigating insider trading allegations linked to his sale of $1.3 billion in Biovail stock between 2002 and 2004. Melnyk currently owns 11 percent of the company's stock.

- read Melnyk's letter
- see this Financial Post article for more

Related Articles:
Biovail drug launch draws feds' scrutiny. Report
Biovail shares sink after FDA schedules review. Report
FDA hands Biovail a non-approval letter. Report
Biovail's Melnyk to step down amid SEC probe. Report

Biovail shares sink after FDA schedules review

Tue, 20 Nov 2007 06:59:55 -0500

Shares of Biovail took a dive this morning after the company announced that the FDA expects to take six months to review its application for BFV-033, a once-daily version of buproprion, which is sold as Wellbutrin for depression. Biovail says the new formulation has a better safety profile than the currently marketed therapy, but the company has been stymied in gaining an approval. The FDA issued a non-approvable letter last summer, though Biovail says it responded in October after reanalyzing its data. Biovail had been hoping for a quicker response from the agency. So did investors, who took a nine percent bite out of Biovail's stock price in retaliation for the disappointment. Sales of Biovail's extended release form of Wellbutrin plunged 57 percent against generic competition in the third quarter.

- see this Biovail release
- check out the AP report on Biovail

ALSO NOTED: University spins off drug delivery company; Millennium Phase II meets goal; Will the FDA get money to flex muscles?

Wed, 07 Nov 2007 06:59:50 -0500

> The University of Leuven has spun off Formac Pharmaceuticals, banking on new drug delivery technology to tackle poorly soluble molecules. Release | Report

> A Phase II trial of Millennium Pharmaceuticals' MLN1202 met its primary endpoint of reducing C-reactive protein levels in patients at high-risk for atherosclerotic cardiovascular disease. MLN1202 is a novel, humanized monoclonal antibody. Release

> Sure enough, President Bush announced yesterday that he'd like to pump up the power at the FDA, but said not a word on increased funding for the effort. Report

> Norway's SantoSolve raised $7 million in a new venture round, enough money to push its lead pain therapy, 2PX, into a late stage study. Release

> Biovail has acquired marketing rights to two early stage therapies from Pharma Pass II. Report

> Kiadis Pharma's lead product, ATIR, has been granted orphan drug designation by the FDA as a therapy for immune reconstitution and prevention of Graft versus Host Disease (GvHD) following allogeneic bone marrow transplantation. ATIR is currently in phase I/II clinical studies and anticipated to enter clinical phase III studies in 2008. Release

> Apitope Technology has completed dosing six multiple sclerosis patients in a Phase I/IIa trial of ATX-MS-1467. The therapeutic vaccine was found to be safe and well tolerated. Release

> A federal judge dealt a blow to Johnson & Johnson's trademark-infringement suit against the American Red Cross. Report

> Neural stem cells were used to stimulate the learning and memory abilities of mice engineered to mimic the severe disabilities produced by Alzheimer's and stroke. Report

> A chemistry professor at the University of Illinois at Urbana-Champagne says that an iron-based catalyst she developed with a colleague could speed the drug delivery and manufacturing process. Report

And Finally... Here's a little secret about Eli Lilly's U.S. president Deidre Connelly (photo): She likes to go undercover. Report

Biovail to drop analyst from lawsuit

Mon, 10 Sep 2007 06:59:54 -0400

Canada's Biovail has agreed to drop an analyst and his bank from the lengthy list of people and companies it sued last year, alleging a conspiracy to profit by cutting the biotech's stock price. The New York Post reported that David Maris and Banc of America Securities were dropped from its suit, calling it a sign that the company's case is "collapsing." The Post also goes on to claim that its own investigation showed that the analyst had accurately reviewed the work of forensic accountants called in to review Biovail's books. Biovail agreed to pay Banc of America Securities $2 million to cover the cost of litigation.

- read the report from The New York Post

Biovail inks deal for late-stage therapy

Wed, 08 Aug 2007 06:59:55 -0400

Details are sketchy, but Canada's Biovail is reporting this morning that it has licensed the rights to a late-stage therapy for sexual dysfunction. Biovail paid an undisclosed upfront fee and agreed to an undisclosed milestone schedule with an undisclosed company for BVF-324, a therapy that it says has already produced robust Phase II data. Biovail anticipates launching a Phase III trial in the first half of next year. Biovail made the announcement on the same day it reported that new generic competition is digging deep into its revenue.

"This agreement provides Biovail the opportunity to enter the multi-billion-dollar, global sexual-dysfunction market with a novel treatment option that has generated robust Phase II data, and that has intellectual property protection beyond 2020 through a method-of-use patent," said Dr. Douglas Squires, Biovail's CEO. "This exciting product has the potential to address a large unmet clinical need, and to make a significant difference in the lives of millions of men and women."

- see the release for more information

Related Articles:
Biovail trading halted on generic court decision. Report
Biovail shares rebound on reorganization effort. Report
Biovail chairman charged with securities violations. Report

FDA hands Biovail a non-approval letter

Fri, 20 Jul 2007 06:59:55 -0400

The FDA has slapped Canada-based Biovail with a Non-Approval letter for BVF-033, a once-daily salt formulation of bupropion. The FDA said the design of the pharmacokinetic studies required to support the NDA was not sufficient. The company said that though it believes the studies were adequate, it will meet with the agency to resolve the problem.

- see the release for more

PLUS: Funding remains crucial for Canada's biotech industry. Release

Biovail shares rebound on reorganization effort

Tue, 05 Dec 2006 19:01:37 -0500

Embattled Biovail saw its fortunes improve somewhat after announcing that it was reorganizing and eliminating its direct sales group in the U.S. The Toronto-based drug developer said that it had tried to make an acquisition in the U.S. but had failed to find one that met its criteria. In addition, CFO Charles Rowland announced that he was leaving his job to take a position with Endo Pharmaceuticals. Kenneth G. Howling will take his place.

"We could no longer justify a U.S.-based sales and marketing infrastructure that was not properly leveraged," said Biovail CEO Douglas Squires. "Accordingly, management believes that the elimination of long-term debt, a focused and robust investment in research and development, and increasing dividends to our shareholders are more fiscally prudent uses of cash."

- read the AP report on Biovail

Biovail loses effort to stop generic Wellbutrin

Wed, 13 Sep 2006 20:01:34 -0400

Biovail has lost a last-ditch attempt to prevent copycat versions of its popular antidepressant Wellbutrin from hitting the market. A federal judge has ruled against a move to gain a temporary restraining order and an injunction against the FDA to prevent it from approving a generic. The ruling clears the path for Anchen to start selling a competing generic.

- here's the AP report on the ruling

ALSO NOTED: Intercell touts Phase III safety study; Icahn joins ImClone board; and much more...

Wed, 23 Aug 2006 20:00:50 -0400

> Austria's Intercell says a Phase III safety study of its Japanese Encephalitis virus vaccine--which is scheduled for a 2007 launch--showed no adverse effects. The vaccine will be marketed by Intercell partner Novartis. Report

> Carl Icahn and three associates will go on the board of ImClone systems as part of a deal to avoid a proxy fight. Report

> Denmark's NeuroSearch has inked a deal to buy Sweden's Carlsson Research for 875M skr. Carlsson has been developing drugs for the central nervous system. Report

> As planned, Canada's Inex Pharmaceuticals has filed to spin out assets into Tekmira Pharmaceuticals. "We are confident that Tekmira will become a company with all the attributes necessary to take INEX's promising oligonucleotide-based products forward into clinical trials, to work with and benefit from the product development achievements of INEX's existing partners and to build significant value for shareholders," said Inex CEO Timothy Ruane. Release

> In another legal gambit to protect itself from a generic version of Wellbutrin XL, Biovail has sued the FDA saying it can't approve a generic without addressing a citizen's petition first. Report

And Finally... One couple's quest to gain insurance coverage for their child's rare genetic disorder included an Internet campaign aimed at Aetna. Article

SPOTLIGHT: Biovail drops spin off plans

Wed, 09 Aug 2006 20:01:33 -0400

Biovail CEO Doug Squires says the company has dropped plans to spin off their legacy, off-patent products to shareholders into a new company. Instead, money will be focused on R&D. Report

DEALS: AstraZeneca, Pozen in $375M licensing deal

Wed, 02 Aug 2006 20:01:32 -0400

DEALS
WHO	WITH	WHAT	SCOOP
AstraZeneca	Pozen	$375M licensing deal	The companies will co-develop remedies for chronic pain utilizing Pozen's technology. Pozen gets $40 million up front and up to $335 million in additional milestone payments.
Amgen	Predix	$307M licensing deal	Amgen will pay an initial $20 million for Predix's autoimmune disease treatment and up to an additional $287.5 million in milestone payments.
Nextar	Affymax	$17.6M licensing agreement	Nektar is providing Affymax with technology to develop Hematide. The deal was previously undisclosed.
YM BioSciences	Daiichi Pharmaceutical	$14.5M licensing deal	YM BioSciences has licensed developing and marketing rights for nimotuzumab for an up-front payment of $14.5 million plus additional milestone payments.
Archemix	Nuvelo	collaboration	Archemix and Nuvelo have expanded their collaboration. Archemix will be responsible for research and Nuvelo will be responsible for development and commercialization.
Enzon	Santaris	collaboration	Enzon will develop and commercialize a series of RNA antagonists based on Santaris technology.
Avalon	ChemDiv	collaboration	The companies are collaborating for the discovery and development of small molecule oncology therapeutics.
Eli Lilly	Alcon	collaboration	The companies signed a long-term agreement to co-promote ruboxistaurin mesylat.
Biovail	Athpharma	partnership	The companies are ending their development partnership for four cardiovascular drugs.
Dainippon Sumitomo	Bristol-Myers K.K.	partnership	Bristol-Myers will license to Dainippon the development rights of irbesartan. Dainippon will grant Bristol-Myers with co-marketing rights of miriplatin hydrate.
Receptor BioLogix	Aphton	acquisition	Receptor BioLogix has acquired the cancer vaccine Insegia and related assets from Aphton in a Chapter 11 sale.
Cambridge Antibody Technology	Enzon	acquisition	Cambridge acquired the license to CAT-5001 from Enzon.
Iconix	Merck KGaA	services agreement	Iconix will compare several of Merck's compounds to similar products to gain insight into the safety of new drug candidates in the early stages of pre-clinical development.

Biovail trading halted on generic court decision

Tue, 01 Aug 2006 20:01:38 -0400

Canada's Biovail got some more unwelcome news today when a judge ruled that Anchen Pharmaceuticals did not violate its patent on Wellbutrin XL with its generic version of the drug. Trading of Biovail shares was halted as the news hit the wires. Biovail makes most of its money from Wellbutrin XL. While analysts had been looking for a mid-2007 entry of generic competitors, this ruling could well open the way to a much faster rollout. Meanwhile, Biovail's chairman has been accused of violating Canada's insider trading regulations, and the SEC is investigating the company's accounting practices. Shares of GlaxoSmithKline, the marketing partner for Wellbutrin XL, had slipped 2 percent on the announcement.

- check out the Globe and Mail report on the decision

ALSO: A number of experts say the case against Biovail founder Eugene Melnyk will be hard to prove. Report