The Big Red Biotech Blog

VC Funding Down in Qtr 1 a Problem?

An analysis of venture capital funding for biotechs in Qtr 1 showed it dropped by 43%.   PricewaterhouseCoopers did further work to show that companies who received their first round of funding dropped by 53% and dollars invested in deals dropped 38%.

This has been taken by some as an indication that the biotech arena is starving for cash to support the growth of new companies.  Of course, the movement of VCs out of this area has also been a hot topic the past few years. 

However, Bruce Booth of Atlas Venture is less worried. And......he actually makes his living in VC.  Booth says that one shouldn't get too upset over quarter to quarter variations in investments.  He notes that Qtr 1 2012 is still within 10% of Qtr 1 2011 -- which turned out to be a good VC year in life sciences.  Finally, he says that VC investing in biotech as a percentage of total VC capital has remained pretty stable over the last decade at approximately 25%. See Fierce Biotech. Not to worry.

 

 

 

 

 

Posted by Bruce Lehr May 10th 2012

FDA Tilts Positively Toward Accelerated Approval of "Breakthrough" Drugs

From Fierce Biotech (via Reuters), a new law is expected this year to allow the FDA to approve breakthrough drugs more quickly by allowing applicants to conduct speedier trials with fewer patients. The system would be modeled on the speedy approval process used for HIV treatments decades ago.

The FDA has approved several drugs recently in accelerated fashion, including Vertex' Kalydeco for CF, Pfizer's Xalkori and Roche's Zelboraf for skin cancer. Dr. Woodcock, the FDA's director, has been vocal in her advocacy for giving the agency the latitude to make fast approvals for drugs that show breakthrough promise in the clinic -- particularly for serious diseases with few treatment options.  The drugs, of course, would have to pass safety muster as well.

Posted by Bruce Lehr May 9th 2012.

 

Indian minister rails against anti-generics smear campaign

The Indian government says multinational companies are running "a concerted campaign" against its generics industry!

Indian minister rails against anti-generics smear campaign.

"A concerted campaign against Indian pharma industry has been launched by MNC's whose interests are getting adversely impacted due to increasing global presence of Indian pharma companies", said Shri Anand Sharma, Indian Minister of of Industry and Commerce.

India is now billing itself as the "Pharmacy for the World" in response.  A central theme in this campaign is to show generic drugs produced in India meet the quality standards of drugs produced in Western countries or by Western competitors.

India is not going to take it anymore.

 

 Posted by Bruce Lehr May 9th 2012.

Biosimilars Not Only Threat Facing Biopharma

As this piece from BioProcess Blog points out, biosimilar competition is only one hazard faced by biopharma producers of the world's top bio drugs. In addition to increased price competition, there are the unscrupulous drug counterfeiters (see recent Avastin issues).  There is also the possibility of compulsory licenses being invoked in places like India (see recent Nexavar case). 

Biosimilar Competition is Only One of Several Threats Facing Biopharma Blockbuster Drugs.

These type of developments led PhRMA President and CEO John Castellani recently to comment, "If countries begin to routinely use complusory licenses, we could see a 'race to the bottom' in which governments in the developing world walk awayfrom their responsibility to support research and innovation in public health. In the absence of investment made by our members, and the resulting research and development, there would be no generic medicines for the world's patients."

As we say in Oz, "Biosimilars, Counterfeits and Compulsory Licenses, Oh My!"

 

Posted by Bruce Lehr May 8th 2012.

Bayer Challenges Compulsory License In India

To no one's surprise Bayer has gone back to court to challenge the India Patents Office decision to award a compulsory license to the generic manufacturer Natco to make Bayer's patented anti cancer drug Nexavar.  The IPO invoked compulsory license rules citing Bayer's high selling price ($5500 per patient/month) as preventing most India patients from using the drug. Natco will sell its version for $175 or a 97% decrease.

Bayer Challenges Compulsory License In India // Pharmalot.

“We will rigorously continue to defend our intellectual property rights which are a prerequisite for bringing innovative medicines to patients,” a Bayer spokesman writes us. “The challenges faced by the Indian healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India’s essential drug list are not patented.  Rather, the order of the Patent Controller of India damages the international patent system and endangers pharmaceutical research."

“This is the trivial argument Big Pharma has been making for years to cover the impact of its monopoly pricing policies,” writes Brook Baker, a professor in the Program on Human Rights and the Global Economy at the Northeastern University School of Law, and a member of Health Gap, Global Access Project. “Of course, there are other barriers to access, but does Bayer want to seriously argue that medicine priced 60 times more than the newly announced Cipla price doesn’t adversely impact access?"

Bayer unmoved, appears ready for an all out legal fight, you could say "they are going to the Madras" on this one.

 

Posted by Bruce Lehr May 7th 2012