The Big Red Biotech Blog

Why is CEO of Onyx smiling?

There is news today that Bayer's new colorectal cancer drug, regorafenib (aka "son of Nexavar') will be submitted to the FDA for approval in 2012. Not only is this a potential blockbuster for Bayer, but this is likely to inspire some smiles at Onyx too. The biotech landed a $160 million payday and won a 20% royalty stake in the drug last fall after prevailing in a bitter dispute over the rights to regorafenib, which bears a close resemblance to the jointly-owned Nexavar. Onyx had accused Bayer researchers of secretly developing analogs of Nexavar before the two partners finally managed to reach an agreement on ownership.

Winning in court and then in the clinic is likely to inspire smiles -- especially for a $160 M plus payday -- and if the analysts are right about the drugs' billion dollar potential the 20% royalty will be worth A LOT.

As Onyx CEO Tony Coles put it, “we are in position to go from one product for two tumors (Nexavar) to potentially three products with strong data or [an FDA clearance] for seven different cancers by the end of this year,” Coles says. The other drug besides Nexavar and regorafenib is known as carfilzomib, which is being reviewed by the FDA as a new treatment for multiple myeloma.

“When you see that kind of momentum in the business in such a short period of time, it’s unrivaled,” Coles says. “We think the future is very bright.”

Say Cheese Tony.

See Fierce Biotech and Xconomy articles.

Posted by Bruce Lehr Jan 18th 2012.

 

GE Enters Turnkey Bioplant Partnership for Emerging Nations

GE and engineering firm, M+W Group, announced that they will team up on a complete biomanufacturing plant development service to serve the growing global demand in the emerging markets. The partnership will provide a single point of contact for customers, primarily governments, including IP access, financing, plant start-up, construction, and staff training. 

GE wont say if turnkey bioplant partnership will cut prices for emerging nations.

The partnership's goal is (to make money) to aid emerging nations in satisfying their unmet needs for the biological products that are predicted to have major positive health impacts. The regional focus of the partnership will highlight the Middle East, Central and Latin America, and SouthEast Asia. They will also sell to Big Pharma looking to upgrade vaccine manufacturing capabilities in emerging nations.

Posted by Bruce Lehr Dec 19th 2011.

 

Brazil & USP Ink Deals to Raise Quality Standards

In another example that recognizes the increasingly global nature of the pharmaceutical business, USP made several new agreements with entitites in Brazil to promote higher quality and increase the degree of regulatory harmonization.

Brazil & USP ink deals to up quality, harmonise standards.

The USP signed agreements with ANVISA, a Brazilian regulatory group, and with Sindusfarma, an industry group representing drug manufacturers that account for 85% of the country's sales.  Under their agreement, ANVISA and USP will develop joint education programs for drug formulators.

"In helping to ensure a high-quality supply of pharmaceutical products and ingredients in Brazil and throughout the world, Sindusfarma looks forward to a continued and strengthened working relatonship with USP," said Sindusfarma's executive vie president, Lauro Moretto.

And pharmaceutical industry globalization continues to march on.

 

 

 

 

Posted by Bruce Lehr Aug 23rd 2011.

Biotech Emerging Markets: Perspectives from Brazil, India, Argentina, and South Africa

At BIO's Partnering for Global Healthcare Forum - panel representatives from the emerging markets of Brazil, India, Argentina and Sout Africa addressed trends in healthcare.

PharmTech Talk » Biotech and Emerging Markets: Perspectives from Brazil, India, Argentina, and South Africa.

They noted that goverment's in these regions all had a goal of getting more people into the healthcare system and providing "healthcare for all".  Targeted goverment investment is up in healthcare in areas like diangostics and biosimilars.

Aging populations and an evolving middle class are among demographic features driving some of this. Speakers from Argentia and South Amercia also talked about their countries as serving as potential regional gateways to other countries/markets in their regions. There is also an expectation that healthcare will shift from a focus of treating acute illness to one focused on chronic care and prevention - as ailments like diabetes, hypertension and cancer grow in developing nations.

Posted by Bruce Lehr June 29th 2011.  

 

Aim It on Rio!

Amgen is acquiring Bergamo, a privately held Brazialian pharamaceutical company, for $215 million and also has a tentative agreement to regain product rights held by Hypermarcas. Hypermarcas currently holds rights to Amgen's cancer therapeutic Vectibix and the hyperparathyroidism medication Mimpara.  Amgen says the transactions will provide it with a significant presence in Brazil, one of the fastest growing pharmaceutical markets in the world.

Brazil is in the top ten world pharmaceutical markets and has been growing at an annual rate of 12 percent.  It is expected to be the world's fifth largest pharmaceutical market by 2015. Amgen says its renewed efforts in Brazil are part of a wider international expansion strategy. See Seeking Alpha.

 

Posted by Bruce Lehr April 10th 2011.

Brazil Pharmerging Market is new Darling of Big Pharma

Brazil is becoming a hot market for big pharma again.  After nearly 30 years since Big Pharm exited en masse due to high inflation, tough price controls and very weak intellectual property rights, Brazil has become popular again.  Patent rules and regulatory requirements for generic drugs have become stricter. Brazil has a rising middle class that is  rapidly growing and also an increasing number of pharmacies to meet demand. Thanks to the rising middle class, the country is now the eighth largest drug market by sales in the world.

Novo Nordisk, Sanofi-Aventis and Pfizer have all either wholly purchased or purchased very large stakes in Brazilian pharma companies in the last few years. AstraZeneca and GSK have also returned to Brazil with segmented pricing strategies to allow them to compete in generic and in more innovative drug categories targeting the middle class.

Nilton Paletta, president for Latin America of IMS, said:

Brazil is becoming one of the largest and most attractive pharmaceutical markets. It’s the second-biggest emerging market after China, with double-digit growth that will continue for the next few years.

No wonder then that the big global pharmaceutical companies believe it to be a market they can’t afford to ignore.  See Seeking Alpha.

 

 

 

Posted by Bruce Lehr November 21st 2010.