Indian gov’t probes drug regulator after scathing review

Posted under Bayer, Blog, Central Drugs Standard Control Organization, Companies, Diagnostics, Emerging Markets, Funding, GlaxoSmithKline, india, Medical Devices, Medical Supply, Novartis, Pharmaceuticals, Regulatory, Sanofi, Startups, Universities, Videos by rmcbride

India's drug regulators are ensnared in a scandalous fix. Days after a parliamentary report noted shoddy oversight of approvals, the Indian government has mounted an investigation into the alleged misdeeds. Meanwhile, big names in biopharma have surfaced in the sea of allegations.

As The Wall Street Journal reports, India's ministry said Friday it has created a special group to probe the long list of grievances in the report, with an eye toward repairing the infrastructure in place for approving drugs in the country. If the allegations in the parliamentary review are true, the Indian government believes that laws were broken and drugs arrived in pharmacies without undergoing required clinical studies.

Drugs from several of the largest drug companies--including Bayer, GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY)--were listed among those that were approved without standard clinical evaluation. Many of the drug manufacturers have professed their innocence after the report cited alleged collusion between pharma groups and India's drug regulator, Central Drugs Standard Control Organization.

- read the WSJ's article (sub. req.)
- see Reuters' report

Related Articles:
Indian panel accuses Big Pharma of colluding with regulators
Subpar clinical trials probed in India's review of regulation

Subpar clinical trials probed in India’s review of regulation

Posted under aliskiran, ambrisentan, Blog, Clinical Trials, Companies, Diagnostics, dronedarone, Emerging Markets, Funding, GSK, india, Medical Devices, Medical Supply, Novartis, Pharmaceuticals, Sanofi, Startups, Universities, Videos by rmcbride

Indian lawmakers and patient advocates charge that their regulator rubber-stamped drugs to be sold in the county without required clinical trials. And a parliamentary report heaps blame for poor adherence to trials standards on Big Pharma groups, the national regulator and other stakeholders in a scathing review of approvals in the country.

The investigation probed the approvals of 42 drugs from groups such as the global heavyweights GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY), finding that certain meds were cleared for the market in India after being banned in developed countries or got approvals without being studied in enough patients, Bloomberg reported. For instance, India's Central Drugs Standard Control Organization approved Sanofi's dronedarone and Novartis' aliskiren based on trials with fewer than 50 patients, allegedly allowing the companies to skirt the minimum 100-patient requirement.

"There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," the report said, as quoted by Bloomberg. "Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk."

Novartis and GSK, for starters, reacted quickly to the news. Switzerland-based Novartis stated that the company follows the same ethical standards for all of its studies around the world, and has mounted an investigation of its own into regulatory activity in India. In its own defense, GSK got Indian regulators to waive trial requirements for the London-based drugmaker's niche hypertension drug ambrisentan, the London-based drug giant told Bloomberg.

The report is a clear signal that Indian lawmakers and advocates are pushing for tighter control of drug regulation in the country, which has been a rapidly growing market for drug development and pharma sales.

- see Bloomberg's report
- check out Reuters' story

Related Articles:
Reactions to poor practices, 'Dateline' special on CROs differ in India
Indian government defends country's generics industry
Bayer slams Indian government, Cipla on Nexavar copies

Eleven adds $20M in venture cash as it preps for the clinic

Posted under Blog, Companies, Diagnostics, EBI-005, Eleven Biotherapeutics, Emerging Markets, Flagship Ventures, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Startups, Third Rock Ventures, Universities, Videos by john

Eleven Biotherapeutics has topped up its bank account with a $20 million injection of venture cash as it readies its first protein therapeutic for the clinic. Third Rock Ventures and Flagship Ventures have chipped in their final $10 million tranche to the Series A, while Japan's JAFCO has joined the venture team and added $10 million of their own, bringing the total A round to $45 million.

Yesterday Eleven, a 2010 Fierce 15 company, unveiled a look at the company's lead treatment, EBI-005, a preclinical topical protein therapy for dry eye syndrome. The biotech got started a couple of years ago after the founding venture groups brought some of the top minds in protein engineering to the table. They've been engineering the first protein therapy for ophthalmology--an IL-1 receptor inhibitor--that can be delivered with an eye dropper. And the developer plans to follow up with another ophthalmology candidate that will trail the lead program by about 12 months.

Getting JAFCO to join the venture group made a lot of sense strategically, says CEO Abbie Celniker. Japan has the second largest ophthalmology market in the world, and it makes a lot of sense to align the company more closely in a region where Japanese pharma companies have been keeping a keen eye on new therapies like the ones Eleven is bringing up the pipeline. 

Adding venture cash also marks an "evolution" of the company's original business strategy. Third Rock's Mark Levin had initially expected to hold the line at the original $35 million mark, expecting early-stage partnership dollars to fund the rest of the work. Adding JAFCO's contribution allows Eleven to bring its lead therapy up to the proof-of-concept phase. After the Phase I, which is slated to get under way before the end of the year, Eleven can design further trials, including a pivotal study. 

"We made the decision to take this to a bigger inflection point," says Celniker. "We're developing that molecule ourselves" and then regional partners can step in with non-dilutive funding. Celniker has also been keeping an eye on the M&A side of the industry. 

"It's sort of heated up over just the last quarter," says Celniker. In this ecosystem, biotechs are stepping up as the industry's innovation engine as Big Pharma continues to restructure R&D and pipelines. "I think we're going to see it heat up a little more," she adds. And if the trend continues, it might present interesting options for companies like Eleven.

- read the press release on the venture cash
- here's the release on EBI-005

Special Report: Eleven Biotherapeutics - 2010 Fierce 15

Related Article:
Biotech vet Abbie Celniker takes helm at Eleven Biotherapeutics

Biocon hiring 300 scientists for new R&D complex in India

Posted under Biocon, Biologics, Blog, Companies, Diagnostics, Emerging Markets, Funding, india, Kiran Mazumdar-Shaw, Kurt Wuthrich, Medical Devices, Medical Supply, Pharmaceuticals, R&D, Startups, Universities, Videos by john

India's Biocon cut the ribbon on a new biologics R&D complex that will host a multi-disciplinary group of more than 300 scientists developing a new generation of "affordable" biologics. Nobel Laureate Kurt Wuthrich will helm the center, which is billed as the first of its kind in southeast Asia.

Biocon, which has experienced its own setbacks in drug development, has set its sights on expanding its work on novel therapies. Biocon chief Kiran Mazumdar-Shaw (photo), who built the company from scratch, has championed the country's drug development community. And she's been hiring an international group of investigators expert in molecular biology, biologics process sciences, formulation research and preclinical and clinical development. 

"I am enthralled with Biocon's research capabilities which are at par with international standards. I will keenly watch the outcome of innovation from this centre as I see a lot of promise in scientific talent here," said Wuthrich in a statement.

"We aspire to build a center of research excellence that will pursue an innovation-led effort to develop advanced yet affordable solutions for several debilitating diseases," says Mazumdar-Shaw. "It will epitomize Biocon's efforts to galvanize the best talent available both in India and from across the globe, and offer them an intellectually stimulating environment combined with an enabling ecosystem to conduct pathbreaking research for biopharmaceuticals."

- here's the press release

Special Report: Kiran Mazumdar-Shaw - The 25 most influential people in biopharma today

Related Articles:
Biocon chief outlines go-go biotech expansion plan, chides regulators
India's biotech leaders criticize lack of R&D support