Rituxan

ALSO NOTED: Analysts predict trouble for second-gen Rituxan; Sucampo earns $50M on FDA approval;and much more...

Wed, 30 Apr 2008 06:59:50 -0400

> Jim Reddoch, a biotech analyst with Friedman, Billings & Ramsey, is raising some interesting questions about Genentech's second-generation anti-CD20 antibody that is in development as a more benign version of Rituxan. Given the recent trial failure in lupus, Reddoch tells Pharmalot that he's more skeptical about its chances when the more potent Rituxan fails to hit endpoints in a trial. And that could eliminate a potential "growth area" for the biotech giant. Report

> Sucampo has won a $50 million milestone payment on the FDA's approval of a new indication for Amitiza. Report

> A JDRF collaboration between Johns Hopkins researchers and Genentech has shown that a drug for the treatment of diabetic eye disease--ranibizumab--has performed better in clinical trials than the current standard treatment using laser surgery. Release

> Metabasis Therapeutics announced Monday that its experimental therapy for type 2 diabetes hit its endpoints in a Phase IIa trial. Release

> What's bad for Merck is good for Abbott Labs. When the FDA said "no" to Merck's niacin-based cholesterol treatment Cordaptive, it raised the prospects for Abbott's extended-release form of niacin, Niaspan, and its regular niacin drug Simcor. Abbott report

> The FDA finally put its mouth where the money is. During congressional hearings yesterday, CDER chief Janet Woodcock said the agency would need $225 million to $250 million in additional funding to inspect foreign plants as frequently as it does in the U.S. FDA report

> Consider this scenario from Fred Hassan's nightmares: The $800 million Clarinex, ostensibly under patent till 2020, falls early victim to generic competition. Clarinex report

> Last fall AstraZeneca EVP David Smith said the company was looking to outsource most of it manufacturing, but then backpedaled after the ensuing outcry. Now the company has affirmed a big chunk of those outsourcing plans. Outsourcing report

> Management consultant Dr. David A. Shaywitz has joined with Dr. Dennis A. Ausiello, the physician-in-chief of Massachusetts General Hospital and a director at Pfizer, to deliver a rebuttal to a small group of research scientists who have sworn off any industry-financed drug research work. Report

> Pfizer is providing $14.4 million to fund a research consortium involving four universities and Entelos, a company that does computer modeling for drug research work, in a drive to create a new class of diabetes drugs. Report

And Finally...
Two new human trials of a gene therapy for inherited blindness have demonstrated that injecting replacement genes under the retinas of the blind can spur at least partial sight in some volunteers. Report

Rituxan fails (again) in late-stage lupus trial

Tue, 29 Apr 2008 06:59:55 -0400

Genentech and Biogen Idec were taking it on the chin this morning after researchers announced that Rituxan had failed in a later-stage trial as a therapy for lupus. The failure won't harm the blockbuster's penetration of the markets for non-Hodgkin's lymphoma and rheumatoid arthritis. But the companies had high hopes for the drug's ability to treat a condition with few therapeutic options to pick from. Analyst estimated potential sales in that one category at more than a billion dollars.

Rituxan block B cells, which play a role in inflammation, and has already been put into use for lupus on an off-label basis. Rituxan also recently failed a late-stage trial for MS.

- here's the Rituxan release
- read the story in the Wall Street Journal

On a spree, Roche lands $175M deal for Piramed

Tue, 15 Apr 2008 06:59:58 -0400

Roche snapped up the UK's Piramed today in a $175 million deal that includes a $15 million milestone payment--the latest in a series of new acquisitions. Roche gets Piramed's programs involving PI3-K inhibitors for cancer and immune inflammatory diseases like arthritis. The milestone payment is for starting the mid-stage trial for cancer. Piramed's work on treating immune inflammatory diseases is in the preclinical phase.

Roche has been busily snapping up biotechs to beef up its pipeline work. And this deal marks the first buyout by new Roche CEO Severin Schwan (photo), who engineered a series of deals as head of the company's diagnostics unit. The news of the buyout came as Roche announced that Rituxan had failed in a trial for multiple sclerosis.

"The acquisition of Piramed is a positive step and allows Roche to access a PI3-K inhibitor program, which has become an important emerging target for the treatment of cancers and auto-immune diseases," said Vontobel analyst Karl Heinz Koch.

- see the press release
- read the story from Dow Jones

ALSO: Roche spelled out the clinical failure of Rituxan for MS, but says that the company still believes in a "B cell therapy" for MS. Article

Related Articles:
Piramed inks $230M deal with Genentech. Piramed report
Roche invests $387M in biotech. Roche report
Roche to boost R&D spend, reorganize research. Roche report
Roche shakes up R&D, eyes new buyouts. Roche report

Cephalon, investors await FDA Treanda decision

Wed, 19 Mar 2008 07:59:54 -0400

After seeing its stock price shed about a third of its value since last summer, Cephalon is keeping its fingers crossed that tomorrow's scheduled regulatory decision on its cancer drug Treanda can turn things around. At least that's what the analysts are seeing. Some expect a sharp upturn if the agency approves Treanda for chronic lymphocytic leukemia.

"This is the first big step. It will be the foundation for our oncology business," Liz Barrett, vice president of Cephalon's oncology unit, told the Wall Street Journal. Analysts peg its potential in the neighborhood of $250 million a year. But Cephalon is also looking for additional approvals, including using the therapy as an add-on to Rituxan, which could make it a seven-figure market blockbuster.

- here's Cephalon's release
- read the report in the Wall Street Journal

Related Articles:
Cephalon, NitroMed make cuts jobs. Report
Positive Phase III results for Cephalon's Treanda. Report
Cephalon takes heat for off-label narcotic promotion. Report
Cephalon shares tank after Sparlon rejection. Report

Icahn aims for Biogen control

Tue, 29 Jan 2008 06:59:58 -0500

Carl Icahn says that Biogen Idec essentially ran a sham when it put itself up for auction recently, putting in place barriers that warded off serious bidding by Big Pharma companies. "The process was run to placate us and other large shareholders," he wrote in a filing with the SEC. Biogen Idec--which hotly disputed the notion--had a provision in place that prospective bidders couldn't gain access to the company's books unless they agreed in advance not to approach Elan and Genentech, each of which have enormous stakes in Tysabri and Rituxan, two big Biogen drugs. Change of control agreements inked with each of those companies could have prevented a buyer from gaining rights to those drugs. Biogen Idec says that any avid bidder could have opened up talks with Elan and Genentech after a binding offer was on the table and, anyway, could have made any bid contingent on the outcome of subsequent talks.

Icahn, of course, shows no sign of letting Biogen Idec off easily. Analysts say that his bid to place three new directors on Biogen's board is aimed at gaining control of the company--and presumably any subsequent takeover talks. Icahn triggered the brouhaha around a Biogen takeover when he expressed interest in buying out Biogen Idec at $80 a share. Later, after the buyout talk hit the papers, he said that it would be more appropriate for a Big Pharma company to buy the company. Of course, a cynic might suggest he just wanted to stir the pot and get the stock up.

- see this release on Icahn's board nominations
- read the report from The Wall Street Journal
- here's the article from The Guardian

Related Articles:
Biogen CEO: Pharma too wimpy to deal. Report
Biogen shares deflate as it gives up on sale. Report
What's Biogen Idec really worth to Big Pharma? Report
Biogen Idec in play after Icahn makes his move. Report

ALSO NOTED: Rituxan aces RA, leukemia trials; Two die after Gardasil jab; Galapagos earns milestone; and much more...

Fri, 25 Jan 2008 06:59:50 -0500

> Roche's antibody med MabThera (Rituxan) just aced two trials aimed at expanding uses for the drug: one that pitted MabThera against rheumatoid arthritis and another that used it against adult leukemia. Release

> Two young women died suddenly and mysteriously after getting the Gardasil vaccine, European regulators announced yesterday. Did the vaccine precipitate their deaths? No one knows. Report

> Galapagos has achieved a milestone under its alliance agreement in rheumatoid arthritis with Johnson & Johnson's Janssen Pharmaceutica. The milestone triggered a cash payment of €3.4 million to Galapagos. Release

> Lawyers, Congressional reps, and now Senators are circling around Merck and Schering-Plough as the Vytorin brouhaha escalates into a full-blown scandal. Report

> A small clinical trial of a malaria vaccine funded by the National Institute of Allergy and Infectious Diseases has delivered positive data, triggering a move to expand the research into a second trial that enlisted 400 children in Mali. Report

> Health plans are drawing scrutiny for paying physicians to prescribe cheaper generics rather than brand-name drugs. Report

And Finally... American adults are largely ignoring a slate of important new vaccines that can prevent serious illness, according to a new survey from the National Foundation for Infectious Diseases. Report

Genentech's blistering growth starts to cool

Tue, 15 Jan 2008 06:59:54 -0500

For several years now, Genentech has been the belle of the biotech ball. But with sales of Avastin and Rituxan weakening, some of the glow is being lost. Profits were up 32 percent last year, far off the 74 percent pace hit in the previous two years. The analysts are forecasting a more ho-hum profit pace of 15 percent to 20 percent for several years--the kind of growth most companies would die for.

"We think Genentech's best growth days are behind it, as sales of its major products are reaching plateaus, especially Avastin, which continues to be viewed among investors as a high-growth product," says Friedman Billings Ramsey analyst Jim Reddoch.

- check out the AP report for more

Related Articles:
Genentech touts pipeline prospects as doubts fester. Report
Genentech fights to keep edge in drug development. Report
Genentech hiring researchers in big R&D push. Report
Genentech shifts its focus to immunology. Report

Sources: Biogen gets bidders, with Pfizer in lead

Thu, 08 Nov 2007 06:59:56 -0500

The Financial Times is reporting some tantalizing details about the bidding for Biogen Idec, the biotech based in Cambridge, MA, that sent stock analysts into an uproar when it put itself up for sale a few weeks ago. Unnamed sources told the London newspaper that the sequence of events leading to that surprise announcement actually began with Pfizer offering $80 per share for the company. Investor Carl Icahn (photo) then made a counter-offer, and the company retained financial advisors to conduct an orderly sale. Even now, Pfizer remains one of the front-runners for Biogen, the sources said, along with Merck and Johnson & Johnson.

Some other buyers have already dropped out of the race, spooked by the "nosebleed prices" expected. Icahn offered $23 billion, so the winning bid is likely to be higher. Are Biogen's assets worth that much? They include the multiple sclerosis drug Tysabri, in partnership with Elan; the lymphoma and arthritis remedy Rituxan, in collaboration with Genentech; and the MS drug Avonex, which is wholly owns. It also has a pipeline of drugs in development, including two promising MS products.

Meanwhile, headhunters are getting calls from Biogen types expecting a sale to lead to the layoff ax. The non-executive staff is anxious, recruiters said, even though the company continues to hire new workers.

- check out the buyout report from the Financial Times
- read about Biogen staff seeking shelter at Inside Recruiting

Related Articles:
Biotech stocks surge as investors anticipate buyouts. Report
Speculation soars over Pfizer's interest in biotech. Report
What's Biogen Idec really worth to Big Pharma? Report
Will Big Pharma buy Biogen Idec? Report
Biogen Idec in play after Icahn makes his move. Report
Who should Pfizer buy? Report

What's Biogen Idec really worth to Big Pharma?

Mon, 29 Oct 2007 07:59:57 -0400

The Wall Street Journal has dug deep into the numbers at Biogen Idec, raising questions about the real value of the company. Biogen Idec is one of the original pioneers in biotechnology and recently came into play after Carl Icahn (photo) made an overture to buy it. After a bout of enthusiasm, observers now are wondering about the impact of near-term competition for its multiple sclerosis business, the company's shrinking profit share on Rituxan and questions regarding the true value of its pipeline therapies. Nevertheless, a hungry Big Pharma company like Pfizer could easily shrug off any doubters and make a big bid for the company, which is reportedly worth around $23 billion.

- read the article from The Wall Street Journal (sub. req.)

Related Articles:
Biogen Idec in play after Icahn makes his move. Report
Will Big Pharma buy Biogen Idec? Report
Biogen Idec sale could have big impact in Boston. Report
Biotech stocks surge as investors anticipate buyouts. Report

Positive Phase III results for Cephalon's Treanda

Wed, 24 Oct 2007 06:59:57 -0400

Cephalon is touting Phase III results of its non-Hodgkin's lymphoma drug Treanda. In the trial, 100 patients who were not responding to Genentech and Biogen Idec's Rituxan were given Treanda. The overall response rate was 75 percent and the median duration of response was 40 weeks (9.2 months). The study met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile.

"We are encouraged that these results replicate those seen in our Phase 2 study, confirming the substantial efficacy in this difficult to treat population," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "Based on these positive results, we are on track to file a New Drug Application in the fourth quarter for Treanda in patients with indolent NHL who have failed treatment with rituximab." Treanda is also being studied as a treatment for chronic lymphocytic leukemia.

- see this release for more

PLUS: Anthera Pharmaceuticals has reported positive results from a Phase II clinical trial of its first compound, A-002, for the treatment of cardiovascular disease. Release

Related Articles:
Cephalon takes heat for off-label narcotic promotion. Report
Cephalon shares tank after Sparlon rejection. Report