patents

UK court slaps down HGS patent

Maureen Martino — Fri, 01 Aug 2008 10:59:09 -0400

Human Genome Sciences--and other biotechs that made claims to parts of the human genetic sequence--have been dealt a blow by the U.K. The High Court yesterday ruled on the first case to question the patentability of discoveries made through the use of bioinformatics. Back in the 1990s, as scientists came to better understand the human genome, biotech companies rushed to patent genes, proteins and human cells for future research work. HGS grabbed one such patent on a disease-linked protein known as neutrokine-alpha. But now the High Court has revoked that patent, saying that "the company had failed to identify any practical use at the time its application had been filed," according to the Financial Times.

That's bad news for HGS, which is working with GlaxoSmithKline to develop a neutrokine-alpha antibody drug called lymphostat. It's a boon for Eli Lilly, however, which is developing its own neutrokine-alpha antibody drug.

- read the Financial Times summary

'Pharma postman' Langer wins €800,000 tech prize

John Carroll — Thu, 12 Jun 2008 11:19:59 -0400

The prolific Harvard/MIT scientist Robert Langer, whose ideas have spawned a string of biotech start-ups, has won the €800,000 Millennium Technology Prize. Langer has been credited with creating new "smart pills" that can hit a precise disease target with a precise dose. That work has earned him the nickname of biotech's "pharmaceutical postman." He holds more than 600 patents.

Langer says he's now working on "using ultrasound to open the nano pores of the skin so that drugs can pass in non-invasively. It's like Star Trek but if you had the choice between being injected or not injected, you know which one you would choose".

- read the report in the India Times

Related Article:
VC/researcher team create biotech start-ups

GSK outlines plans to become more ‘biotech-like’

John Carroll — Tue, 10 Jun 2008 11:53:09 -0400

Biotech is in. At least, that's the message from GlaxoSmithKline's Patrick Vallance, the pharma giant's head of drug discovery. In a speech in London on Monday Vallance made clear that Glaxo intends to become more "biotech-like" in advancing new therapies. That calls for smaller discovery teams which would be incentivized for creating value and ‘disincentivized' for value destruction.

Glaxo has been one of the most aggressive pharma companies in the industry when it comes to in-licensing new biotech therapies in development. The company has been setting up Centres of Excellence in Drug Discovery and is funding outside research through the Centre of Excellence in External Drug Discovery. But Glaxo has been talking up an entrepreneurial atmosphere for eight years even as pressure has built to advance new drugs to take the place of blockbusters losing patent protection.

That trend, no doubt, will make those ‘disincentives' ever more painful.

- read the report from the Financial Times

Bayer, J&J tout rivaroxaban data

Fri, 30 May 2008 06:59:58 -0400

In a head-to-head study against Sanofi's Lovenox, Bayer and J&J's oral anti-clotting drug rivaroxaban proved superior in preventing venous blood clots in patients who underwent total knee replacement surgery. Lovenox, which is the current standard of care, is given twice daily. "Only 6.9 percent of patients treated with Rivaroxaban experienced thomboembolisms, compared with 10.1 percent for the comparison group...This reflects a 31 percent decrease in relative risk," noted Dow Jones. This was the third trial to demonstrate the drug's superiority over Lovenox. An NDA is planned for the third quarter of this year. The drug is also being developed for stroke prevention in atrial fibrillation and VTE treatment.

- see the rivaroxaban release
- here's the Dow Jones brief

India eyes R&D opportunities

Thu, 17 Apr 2008 06:59:55 -0400

India-based drugs have made a name for themselves as makers of copycat drugs. When a developer's lucrative drug goes off-patent, Indian companies are guaranteed to swoop in and make a less-expensive knock-off of the therapy. It's a strategy that's definitly paid off for the developers.

But now some of these companies are shifting gears and developing their own drugs from scratch. Why now? Mainly because the talent pool in India has improved to the point where drugmakers have the resources to do their own R&D. "In the past, anyone interested in fundamental research had to go to the West, but the talent is here and now the barrier is broken," says Ian Cliffe, a senior executive at Ranbaxy. Another factor is India's new patent protection laws, which were a condition of its acceptance into the World Trade Organization.

Ranbaxy recently announced plans to spin off its R&D unit. Sun Pharma, Orchid Research, Wockhardt, Glenmark Pharmaceuticals and Nicholas Piramal all have plans to do the same. India is betting its lower costs and talent pool will give it a leg up in the global pharmaceutical market in the coming years.

- read the Financial Times article for more

Related Articles:
Ranbaxy spins off R&D unit. Ranbaxy report
Ranbaxy touts R&D abilities in new discovery pact. Ranbaxy report
Glenmark to spin off generics business. Glenmark 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

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Eisai plans $105M expansion in NC. Eisai report

Safety, efficacy problems sink Takeda drug

Fri, 28 Mar 2008 07:59:58 -0400

Japan's Takeda has walked away from development of its once-promising cholesterol drug TAK-475. The first sign of trouble came late in October, when the FDA recommended Takeda stop trials using higher doses of TAK-475 after seeing signs of elevated enzymes that indicate possible liver damage. Takeda discontinued TAK-475 development because, according to a release, the drug's profile was not superior to existing marketed drugs from both efficacy and safety standpoints. TAK-475 is a squalene synthase inhibitor which, had it been successful, would have been the first drug of its kind on the market. Takeda badly needs another blockbuster in its pipeline to make up for the loss of Actos patent protection in 2011.

In order to fill the gap, Takeda said it will aim for the "earliest possible launch of SYR-322 and TAK-390MR of which NDAs are now under review by the FDA, and for earliest possible NDA submission of the development projects in the late stage such as Hematide, a treatment for chronic kidney disease related anemia and cancer related anemia, and Lu AA21004, a treatment for mood and anxiety disorders."

- see Takeda's statement

Related Articles:
Safety questions cloud future of Takeda's TAK-475. Report
Takeda expands R&D budget, may look for buyout. Report
Takeda scraps licensing deals, inks $100M pact. Report

Boehringer wins approval in anti-clotting drug race

Thu, 27 Mar 2008 07:59:56 -0400

Boehringer Ingelheim has stolen a march on arch rival Bayer, winning European marketing approval for a new anti-clotting agent--Pradaxa--that is likely to provide Lovenox with considerable competition. Boehringer's pill formulation is likely to be attractive compared to the injection of Lovenox, which earned €2.6 billion for Sanofi-Aventis last year. Bayer, meanwhile, has been advancing Xarelto for this market, which it forecasts will garner more than $2 billion a year. Pradaxa gets its first rollout in Germany and the UK in the next few weeks.

This first license for Pradaxa "marks an important advance and milestone in anticoagulation therapy and the prevention of potentially fatal thrombi," says Boehringer R&D chief Andreas Barner.

- here's the release on the approval
- read the story in PharmaTimes

Related Articles:
Boehringer anti-clotting drug performs in Phase III. Report
Pfizer, BMS report Phase II clotting trial success. Report
Sanofi loses Lovenox patent protection. Report
Lovenox reduces cardio risks but can cause bleeding. Report
Bayer buoyed by success in late-stage clotting trial. Report

Follow-on legislation follows a twisted path in DC

Mon, 17 Mar 2008 07:59:57 -0400

BIO is toasting proposed new legislation that would provide more than 14 years of patent protection on a biologic. Needless to say, the generics crowd is just a tad disappointed by the bill, saying that patients would have to wait decades before they could benefit from any lower prices. "For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option," said the Generic Pharmaceutical Association. BIO feels a lengthy period of patent protection is the only fair option, given the time it takes to move a biologic to regulatory approval.

As the Wall Street Journal's blogsters point out, new legislation providing a regulatory pathway for biologics gets a thumb's up from most everyone--but no one agrees just how lawmakers should do it. One other commonly agreed point: Starting out, the FDA is likely to take it one biologic at a time, deciding when and how for each program.

- read the Generic Pharmaceutical Association statement
- read the report from the Wall Street Journal

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Waiting game continues for biogenerics. Report
Insulin debate spurs push for generic biologics. Report
Teva plans aggressive move into biogenerics. Report
Budget has mandate for biogeneric approvals. Report

Astellas faces delay gaining crucial Advagraf approval

Fri, 14 Mar 2008 07:59:58 -0400

Astellas' hopes for a quick U.S. approval for Advagraf--a follow-up, new and improved version of the kidney transplant drug Prograf--have run into a serious obstacle. The drug company says that the FDA has asked for more information on the drug, a once-daily immunosuppressant drug that the company needs to take a slot in its lineup now filled by Prograf. Prograf loses its patent protection in April. The regulatory demand, though, will delay any approval by at least six months. Regulators want to see more data on efficacy and safety for Advagraf.

This is one request that is likely to get as quick a response as the researchers can muster. Prograf has a big market in the U.S.--used in roughly five out of every six kidney transplants--and accounts for about 10 percent of Astellas' revenue.

- read the article from the Guardian