Samsung plans ambitious rollout of biosims at deep discounts

Posted under antibodies, Biogen Idec, Biologics, biosimilars, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Samsung, Startups, Universities, Videos by john

Samsung BioLogics is moving fast with some ambitious plans to start marketing biosmilars at a deep discount while striking more development deals like the one it has with Biogen Idec ($BIIB) and ramping up its own work on novel biologics. And it's betting that its global rep in the electronics market and construction industry will help make the conglomerate a leading contender in the biopharma business.

Samsung, better known for flat screen TV sets than therapeutics, tells the Financial Times that it will put the finishing touches to its manufacturing site outside of Seoul by June, with plans to have global regulatory sanctions in place by the end of this year. That would set the stage for Samsung and its partner Biogen Idec to have a slate of biosimilars ready to market in 2015, and it plans to offer generic antibodies at half the current price they're available.

"Biopharmaceutical companies are good for sales, and biotech companies for innovation, but neither is good for manufacturing," Tae-Han Kim, the president of Samsung BioLogics, tells the Financial Times. "It is in Samsung's DNA to produce products at low prices while meeting legal and industry requirements. The price of monoclonal antibodies is very expensive and not affordable to all patients. That is a heavy burden on governments and [healthcare] payers."

The article doesn't make clear exactly where Samsung will offer deep discounts. But for the U.S. market, analysts have been projecting far more modest discounts of about 10% to 20%. A 50% discount would represent a much greater challenge to drugmakers.

The FT also just drops word of Samsung's plans to develop new therapies at the end of the story, with no explanation of what it plans to focus on.

- here's the article from the Financial Times

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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

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Pfizer faces bumps in road with potential blockbuster RA pill

Posted under Biologics, blockbuster, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Rheumatoid Arthritis, Startups, tofacitinib, Universities, Videos by Ryan McBride

Pfizer ($PFE) has highlighted its experimental rheumatoid arthritis (RA) pill tofacitinib among the standouts in its pipeline, but a new survey shows that some doctors and payers might not share the pharma giant's exuberance about the program. And many rheumatologists have doubts about whether they would prescribe the pill over existing injectable biologics, Pharmalot reports.

If Pfizer gets the green light to sell the RA pill, the company could hit the blockbuster RA market with a price for tofacitinib that trumps those of the injected drugs that companies such as Abbott Laboratories ($ABT) and Amgen ($AMGN) sell. Payers, of course, would likely warm up to a cheaper option than the already pricey injected RA meds.  

Citing a recent survey of docs and payers, Pharmalot's Ed Silverman writes that 55% of rheumatologists surveyed would balk at prescribing tofacitinib over the injected meds, with some of the docs unconvinced that existing safety and efficacy data support the switch. Not surprisingly, 96% of cost-conscious payers weren't willing to make the switch to the oral drug.

Even during the development phase, pharma companies are as aware as ever of the commercial realities ahead for their experimental drugs. In response to resistant insurers and government payers, developers have been talking up the need to conduct trials that provide evidence that their drugs deliver new benefits for patients and, in some cases, come packaged with data that show the meds are better than the old ones.

Pfizer has offered up data showing that the efficacy of its RA pill is on par with the injected remedies. Yet even though the pill would give some patients a more convenient option than injecting drugs against RA, cash-strapped payers have made it clear that the improvements in treating diseases often have to be part of a package to gain reimbursements.

That said, Silverman writes that 60% of payers surveyed and 85% of rheumatologists had an overall positive impression of Pfizer's RA pill. The trick, if regulators stamp approvals on the drug, will be getting the docs to write scripts and the payers to prove reimbursements.  

- read Silverman's article

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Can Sanofi’s Expanding Predictive Modeling Technology Enhance the Productivity of R&D?

Posted under Biologics, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Sanofi Pasteur, Sanofi-Aventis, Startups, Universities, vaccines, Videos by William Looney

As the hurdles to successful commercialization of new medicines continue to mount, the ability to find and exploit cost efficiencies in the development process has become a critical source of competitive advantage.  This is true not only for biologic drugs but also increasingly for vaccines, now a high growth segment of the medicines business, with a more diverse range of therapeutic targets in addition to traditional prophylactics.  This intensifies the pressure in designing vaccines trials to address complex conditions and to provide evidence of safety, immunological superiority and clear clinical differentiation.  Creating the internal capabilities to advance the process and hedge these risk factors can be more important to achieving a timely market entry than the clinical merits of the compound itself.

Who leads in the race to throw a blanket of predictability over that costly, high thread-count passage from bench to bedside?  Sanofi  Pasteur, the company’s vaccine division, has made a strong start against its rivals with a novel imitative, in vitro test and assay technology that can predict the immune response of a human individual or group to a vaccine candidate. 

Sanofi acquired the technology in 2010 with the purchase of VaxDesign, a Florida-based company which invented a predictive modeling tool, Modular IMmune In vitro Construct [MIMIC], that simulates a clinical trial artificially, using human immune cells.  This “virtual” approach lowers the cost and risks associated with relying on live patients or animals, and provides an early indication of how to structure a real trial in a way most likely to produce the tangible results expected by regulators.  The outcome is – hopefully – fewer abandoned late stage trials and a better batting average in bringing promising vaccines forward to market approval.

Next for VaxDesign: Diseases of Age
On Monday, Sanofi’s President of  Global R&D, Dr. Elias Zerhouni, and the Sanofi Pasteur leadership team dedicated a new R&D facility at VaxDesign’s HQ in Orlando, Fla.  In a discussion with Pharm Exec following the ceremony, Zerhouni and colleagues said that the new facility and the 65 scientists hired to staff it was an expression of confidence in the VaxDesign approach, which will now be leveraged by the entire company to support R&D work in areas in addition to vaccines, such as age-related diseases and conditions.  Following the demographic path of US baby boomers, the new facility will look for ways to apply the VaxDesign work to Sanofi’s portfolio on preventive treatments for the old—which may also fill a well of need among tens of millions of aging Chinese.

“This is a practical application of translational research, with the potential to guide development for any compound that triggers an immunological response, Zerhouni said.  “We’ve come very far in science but it is still a complex mystery what the impact a new medicine has when taken by a human being.  VaxDesign helps make sense of that mystery by facilitating a more targeted drug design, at an earlier stage of the development process.”   Olivier Charmeil,  President of Sanofi Pasteur, noted the MIMIC in vitro approach would not only improve prospects for successful trial design but also provide better guidance toward making those “early kills” that avoid huge costs further down the development line, in Phase II (b) and beyond.  He also sees an opportunity for a steep reduction in the use of animals in testing—a sensitive reputational spot.

All in all, another step signifying the value of innovations  in process as well as product.  And the era of the virtual clinical trial? It’s real, not a misnomer—it’s coming.