The Big Red Biotech Blog

Supreme Court Ruling Generally Provides Clarity for Biosimilars

Lost in all the initial misreporting of the Supreme Court decision and even in the correct subsequent reporting was the positive impact the ruling had for Pharma and Biotech companies pursuing biosimilars. There had been fear that if the Court had struck down mandatory purchase of insurance provision portions of the law that the whole house would come tumbling down.  And with the fall of the Patient Protection and Affordable Care Act (PPACA) law, the the Biologics Price Competition and Innovation Act (BPCIA) would go too!

Fortunately for the biotech industry, that did not happen.  We still have a pathway in place to get to biosimilars filed and hopefully someday approved in the US.  Biologic drugs totaled $112.93 billion in worldwide sales in 2011, which constituted a $5 billion, or 4.6 percent, increase over 2010 sales.  Europe, in particular, has had a biosimilar pathway in place for nine years (since 2003), and has approved at least fourteen biosimilar products so far. The US needs to get it in gear.

The European biosimilars market generated is expected to reach almost $4 billion by 2017. Despite these profit incentives, and despite the framework being in force for over two years already, no biosimilars have been approved in the U.S., and most indications are that none are close (as of February, the FDA had yet to receive its first ABLA application).  BIO has been advocating that the new biosims that will compete with branded products should be put through a rigorous clinical trial program, avoiding the onslaught of cheap copycats that has blighted traditional small molecule treatments

The Supreme Court decision erases any hesitation biosimilar producers may have had in using the BPCIA due to the uncertainty of its survival.  Biosimilar producers can now move forward full steam with their biosimilar products without fear of legislative overhaul and potential disruption of their FDA approval progress. Pioneer biosimilar producers such as Sandoz and Hospira are already in Phase III human testing, and they have relied on the BPCIA to provide some clarity as to how biosimilars will be regulated in the U.S. Some of the biggest companies, like Merck, Amgen and BiogenIdec, have also set up biosimilar initiatives too.

The survival of the BPCIA is welcome news for biologics patient consumers as well, who hope to see lower prices in the near future on these important and typically costly drugs.  See Patent Docs blog, In the Pipeline, and Fierce Biotech.

Posted by Bruce Lehr Jun 30th 2012.

BMS and AZ Team up to Buy Amylin at Premium

This one caught me by surprise evn though it was known that Amylin was actively soliciting bids for its own acquisition.  Late Friday, Bristol Myers Squibb announced it was acquiring Amylin for $5.3 B plus paying Eli Lilly about $1.7 B in olbigations to acquire Amylin and its diabetes treatments Byetta and Bydureon. 

Then is was also announced that AstraZeneca will pay BMS $3.5 B to share in the profits of the the two drugs. The deal represented about a 10% premium over Amylin's closing price on Friday.  Some analysts were scratching their heads at the size of this deal for a company like Amylin -- that has had more than its share of trials. 

However, desperate times sometimes call for desperate measures, and there are few companies in Big Pharma land more desperate than AZ for some new products and revenue streams.  Their pipeline and R&D productivity has been characterized as the industry's worst.  At a time when key drugs are coming off patent, they need the shot in the arm so to speak and will get two diabetes drugs from the deal.

The only compnay perhaps looking at a steeper patent cliff than AZ, would be Eli Lilly. They didn't pick up any products in the deal but did get out from being owed a large debt by Amylin and now have $1.7 B more in their pockets to invest. See Xconomy, Pharmalot and PharmaGossip here and here.

Posted by Bruce Lehr Jun 30th 2012.

Biogen Idec and Isis Deal: Antisense Resurgence?

A couple days ago Biogen Idec and Isis announced they woudl be partnering on another deal to apply Isis antisense technology to type 1 myotonic dystrophy. Under the deal, Isis gets a smallish $12 M upfront payment with back loaded milestones of $259 M possible.

Isis scientists are wagering they can fight myotonic dystrophy type 1 now that they have identified a gene that contains three individual DNA bases that repeat extensively, which leads to the production of long, toxic RNA molecules that accumulate in cells and cause the muscle problems. By creating an antisense molecule, Isis and Biogen are hoping to target and get rid of the toxic RNA.  The condition affects about 150,000 patients.

“Myotonic dystrophy has an identifiable genetic cause, the program fits with our mission to bring innovative therapies to patients with serious neurologic diseases, and Isis’ antisense compound has the potential to make a real difference,” said Steve Holtzman, Biogen’s executive vice president of corporate development.

This type of genetically focused drug development program could also be a relatively quick effort.  Dire need for a new treatments in rare conditions can raise the prospect of filing for approval based on proof-of-concept studies. Rare diseases also don't require the big studies with thousands of patients needed to demonstrate safety in a large population. Any treatments for these diseases can also fetch six-figure prices. And that helps explain why a number of Big Pharma companies have been beefing up their work in the rare disease arena.

It's been awhile since antisense therapies have been getting positive press.  Hopefully this deal will work out for both companies and the affected patients. It would also be good to see the technology successfully deployed for at least some conditions. See Xconomy and Fierce Biotech.

Posted by Bruce Lehr Jun 30th 2012

 

FDA Approvals: ‘We Are Back On Track’

The FDA patted itself on the back for meeting its PDUFA review cycle targets (>90%) on New Drug Applications (NDAs) and Biologics License Applications (BLAs) for the past two years.

FDA Approvals: ‘We Are Back On Track’ // Pharmalot.

With PDUFA V just waiting to be signed by the President, the agency is supremely confident in its ability to keep the ball rolling.  Through June 18th this year, CDER has approved a higher percentage of NME applications (12/15) - one third of these for rare diseases continuing a strong trend.

The median approval time for NMEs and NBEs reached 9.9 months in 2011 slightly bettering 10 months in 2010 and beating the 13 months seen in 2009 and 2008.  Faster is better.

Posted by Bruce Lehr Jun 28th 2012

Causes of death: 1900 and 2010

Boing Boing via the Pharma Gossip blog lays out how the leading causes of death have changed from 1900 to 2010.  It's interesting.  There is an obvious shift from many deaths due to infectious diseases in 1900 to non-infectious causes in the "modern world".   Thank you antibiotics and vaccines.

Causes of death: 1900 and 2010 - Boing Boing .

As for modern situation, we need better dietary and living habits.  All I can say is "Watch your heart!"

Posted by Bruce Lehr Jun 28th 2012.

 

Abbott Challenges Biosimilar Legality

This from today's Xconomy.  Abbott has filed a citizen's petition with the FDA to protect Humira by challenging the notion that the agency can refer to Abbott's Humira BLA filing.  Their argument (posted here and here before) is that this would violate the "takings clause" in the 5th amendment that prohibits the taking of "private property for public use without just compensation."

Abbott has argued that its BLA contains trade secrets that would be "taken" without compensation should the FDA use the BLA contents to potentially license a new biosimilar.  Since Abbott's Humira sells in neighborhood of $9 B per annum worldwide, "just compensation" would be considerable in this instance.

So we can expect pharma industry participants to line up on both sides of the question with their teams of lawywers?  On one side, the innovators who have no plan to introduce biosimilars will join Abbott. On the other, we should expect innovators who do have plans to introduce biosimilars and companies who plan to focus only on biosimilars.  There is bound to be plenty of action.

We should also have the government and healthcare advocates lining up to argue for biosimilars on its economic merits to reduce costs in the health care system and for patients.  And on the other side, free market forces will argue for the innovators right to protect their IP and earn a return on its investment for their shareholders. Both won't be right or simultaneously get their way.  Let the games begin.

Posted by Bruce Lehr Jun 25th 2012.

 

India launches 'similar biologics' guidelines

The Indian Government launched its biosimilars guidelines at this year's BIO meetings. The guidelines are aimed at providing a "clear" regulatory pathway for manufacturers of biologic similars and will be applied to new filings now.

India launches 'similar biologics' guidelines at BIO2012.

Manufacturers must prove similarity to a reference product -- either an innovator drug in licensed in India or approved elsewhere.  There is also a requirment for 4 years post-market surveillance on safety data.

The motive for India to promote these guidelines is to encourage more domestic and foreign investment in biosimilars in India with an idea to increase product access and to reduce4 goverment spending on drugs.

Dept of Biotechnology secretary, Maharaj Bhan,  said,  "India needs drugs at reasonable prices so we have to worry about the issue of access so we have to spur innovation and manufacturing in India.  We also need to create an environment where International companies will be interested in using India as a place to manufacture drugs."   The latter comment relates directly to the previous blog post on India's need to raise GMP compliance.

Posted by Bruce Lehr Jun 25th 2012.

Indian Drugmakers Need to Bolster GMP Compliance

Both CARE Research and ICRA (India) credit agencies report that more stringent enforcement of GMPs by the FDA represents a significant risk to the revenue growth of Indian pharma companies -- if they do not raise their game. 

Tighter GMPs a significant risk for Indian drugmakers; CARE.

Companies like Ranbaxy and Aurobindo have had quality and compliance issues that are stunting their current revenue growth.  Closing of manufacturing units, delisting products and other woes have stricken these companies.

Indian companies are taking notice and responding by investing more in quality. This may be a short term increase in their costs and decrease in profits, but in the long run will make it easier for them to compete in more regulated Western markets.

The increase in FDA scrutiny is of course also happening in the US and elsewhere, and the India response of more investment in quality is just what the agency wants to see.  Companies that invest in quality will only become more competitive in the future.

Posted by Bruce Lehr Jun 25th 2012.

Pharma Execs Describe The Future Industry

KPMG published a new survey of 107 pharma execs and their expectations as to how various factors will play out for their company and the industry in 2012.  The 107 execs represented the following breakdown - 45% work for companies with annual revenues greater than $10 B, 36% with revenues between $1 B to $10 B, and the remaining 19% were with companies between $100 M and $1 B in sales.

Pharma Execs Say The Future Looks Like This… // Pharmalot.

The biggest concerns expressed by the executives were with increased regulations and increased FDA scrutiny.  The executives also predicted that head counts would stabilize, that merger and acquisition activity would moderate and that capital spending would be decreased. 

Where will new growth come from?  52% believe from their own pipelines, and 36% from alliance partners.  Also, 34% saw growth coming from outside the US market, and 25% said the repeal fothe healthcare reform bill would spur growth. See Pharmalot above for the rest of survey specifics.

Posted by Bruce Lehr June 25th 2012.