Growing Novo Nordisk inks $100M tech deal, boasts of blockbuster hopefuls

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Novo Nordisk, Partnering, Pharmaceuticals, Pipeline, Startups, Universities, Videos by john

It's been a busy couple of days for Novo Nordisk. The pharma company ($NVO) has just struck a $100 million licensing deal on new drug delivery technology as its chief scientific officer reviews potential blockbusters in the pipeline with Reuters. And that comes on top of the news that Novo is planning to launch a major expansion of its U.S. workforce as sales jumped 10% in the first quarter.

Novo's new pact is with Caisson Biotech, which boasts of a delivery tech that uses a customizable sugar polymer that is biodegradable inside cells, making it useful for "cloaking, enlarging and/or protecting drug cargo. We can customize heparosan with respect to polymer size and conjugation chemistry thus providing flexibility to enhance a variety of therapeutic proteins, peptides, delivery platforms (e.g., liposomes, viruses or nanoparticles), and small molecules," says Paul DeAngelis, the chief scientist at Caisson.

The terms of the pact, with a total value billed north of $100 million, weren't disclosed.

Novo Nordisk's Mads Krogsgaard Thomsen, the chief scientific officer, tells Reuters that he's hopeful the company's experimental hemophilia drug, Vatreptacog, can go on to earn enough revenue to replace NovoSeven as that $1.48 billion-a-year drug loses sales steam. And then there's the N8-GP program for hemophilia. 

"If one is lucky enough to make a long-acting N8-GP drug which is a bit better than the competing drugs, then you could be on the way to a blockbuster market, but that is too early to predict," Thomsen tells Reuters in an interview. 

- here's the press release on the tech pact
- read the Reuters story on Novo's blockbuster potential
- get the story on the company expansion

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UPDATED: Novo Nordisk hiring R&D, other workers in U.S. recruitment blitz

Posted under Blog, Companies, Diabetes, Diagnostics, Funding, Medical Devices, Medical Supply, Novo Nordisk, Pharmaceuticals, Pipeline, R&D, Startups, Universities, Videos by rmcbride

In a nice change from the drumbeat of pharma layoff news, Novo Nordisk ($NVO) says it plans to boost its U.S. workforce almost 15% this year amid growth in the Danish drugmaker's diabetes business. And a portion of the hires will be made at a new R&D site focused on new treatments for Type 1 diabetes.

This summer Novo, which employed 4,000 workers in the U.S. at the start of 2012, plans to open the R&D facility in Seattle, where it expects to create 20 research jobs, according to a company representative. 

While Big Pharma companies like Pfizer ($PFE) and Merck ($MRK) have been cutting U.S. workers, Novo has been beefing up its workforce at a clip of about 10% annually over the past 5 years, the company said. Its initial hires are expected within weeks as the company recruits for medical liaisons, diabetes educators, sales positions and other commercial posts. At the same time, the company says it continues to seek new scientists in Seattle and staff for its plant in Clayton, NC.

The company appears to be bullish about the future of its business, which includes three products under FDA review and a pipeline of mid-stage and late-stage drug candidates. Diabetes remains one of the hottest areas of drug development, as cases of the metabolic disorder in the U.S. and around the world skyrocket. There are now more than 20 million Americans diagnosed with diabetes, according to the Centers for Disease Control and Prevention, and the ailment has been tied closely to the obesity epidemic in the country.

"This announcement signals the strength of our business model, the increasing demand for our world-class diabetes products, and the steady output of our robust pipeline," Jerzy Gruhn, president of Novo's U.S. affiliate, stated. "Expanding will provide us the opportunity to better support current business as well as the right structure to meet the future needs of our customers."

- here's the release

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Biopharma giants call on FDA to demand tough standards for biosimilars

Posted under Amgen, biosimilars, Blog, Companies, Diagnostics, FDA, Funding, Genentech, Medical Devices, Medical Supply, Novo Nordisk, Pharmaceuticals, Startups, Universities, Videos by john

Some of the biggest biopharma companies in the business have offered some pointed suggestions to the FDA on how it should tighten up its regulations on biosimilar approvals. And some of their greatest concerns reflected some clear anxieties about the eventual arrival of cheaper competition. 

For Novo Nordisk ($NVO), big in the diabetes arena, the prospect of having different delivery systems for biosimilars creates safety issues that the agency needs to guard against, according to in-PharmaTechnologist. And Novo outlined its call for more "robust" data than the FDA has spelled out in the proposed rules governing the field.

Amgen ($AMGN), which is the most vulnerable to looming competition, wants a clear and unambiguous demand for convincing clinical data in the biosimilar process. The FDA needs to "make clear that clinical studies will be necessary for the foreseeable future due to the complexity and diversity of human biology and the limits of scientific knowledge today," according to a report in PharmaTimes. And Amgen called for "class-specific guidance that discusses the approval standards and other key implementation issues for particular product classes" and "require all biological products to have a distinguishable nonproprietary name in order to facilitate accurate attribution of adverse events."

"There can be no grey area when it comes to patient safety," declared Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines, which includes Amgen, Genentech and BIO as members. "Unwanted immunogenicity is the preeminent safety challenge associated with biological therapeutics and can result in unexpected or sometimes severe adverse effects. The predictive value of animal studies is often insufficient to characterize immunogenicity in humans. Clinical studies, in addition to analytical methods, are necessary to weed out ineffective and unsafe drugs--innovator biologics and biosimilars--before they are ever a risk to patients."

- get the press release from the Alliance
- here's the report from in-PharmaTechnologist
- read the story from PharmaTimes

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Lars Rebien Sørensen – The 25 most influential people in biopharma today

Posted under Blog, China, Companies, Diabetes, Diagnostics, Funding, insulin, Lars Rebien Sørensen, Medical Devices, Medical Supply, Novo Nordisk, obesity, Pharmaceuticals, Startups, Universities, Videos by Suzanne Elvidge

Making moves in China

Lars Rebien Sørensen
President and CEO
Novo Nordisk AS

Lars Rebien Sørensen, president and CEO of Novo Nordisk ($NVO) since 2000, joined the company in 1982 in marketing, and so genuinely knows the company from bottom to top. He is at the helm of a company that is weathering the financial storms rather well, and with its focus on metabolic disorders in a world where diabetes is increasing, both in the developed and the developing worlds, Novo Nordisk looks set to continue comfortably under his leadership, and be a role model for the industry.

China is exciting for the biopharma industry--long seen just as a place for low-cost manufacturing, it is increasingly emerging as a biopharma market. This is driven by the improving incomes and quality of life increasing access to (and desire for) healthcare. However, this rising income is a double-edged sword--as people embrace a more Western-style lifestyle they also take on the Western-style diseases of obesity, diabetes, lipid disorders and cancer. China also has a huge aging population, with all the associated diseases of old age.

Sørensen is grasping this opportunity, not by the established route of buying up domestic Chinese generics companies but by creating a brand-new R&D center in China to develop innovative drugs for the local and international market and so contributing to the local community. Something else that Novo Nordisk is doing that should be an example to the industry is educating local physicians directly and through the Chinese government and Chinese academic institutions. Diabetes is also climbing in Qatar and Novo Nordisk is part of an educational partnership there.

Under Sørensen, Novo Nordisk has changed its approach to people with diabetes (and their physicians)--rather than encouraging people to switch, it's aiming to catch people as soon as they are diagnosed. It might only seem like a small change, but it could drive the company toward a much larger bite of the market, because once people get established on a form of insulin, they tend to be loyal. Also in diabetes, Novo Nordisk is using a "me-slightly-better" rather than a "me-too" approach to insulin development in an already crowded market. These are approaches that could work across the industry, and not just in diabetes--why develop a "me-too" when you could make something that's actually better?

Since Sørensen joined Novo Nordisk, he has been a distinctive voice in the access to medicines debate. Under him, the company has maintained its ethical stance while still making a profit, and this is a strand that runs through many of its projects, including the investment of $100 million to create the World Diabetes Foundation, and the commitment to provide insulin at 20% of its standard price to people in the developing world.

Health for Sorensen isn't just a market, it's a personal commitment--he is a keen cyclist and was one of a group of CEOs at Davos who introduced the Workplace Wellness Alliance to promote health and fitness to employees. Workplace health programs, as well as being socially responsible, also have an ROI of $4 per $1 spent-a pragmatic move that deserves to move out across the industry, both for the sake of the employees and for the bottom line.