The Big Red Biotech Blog

Put Myriad vs AMP to Bed

I've been away awhile and haven't been posting as regularly as in the past.  Hence, I wasn't writing on the day the Supreme court issued its ruling in the AMP vs Myriad.  Of course, by now you know they said that "a naturally occuring DNA segment is a product of nature and not patent eligible merely because it was isolated".  This of course was in disagreement with what have been done with about 4000 genes over the prior 30 years.

However, the court also ruled that "cDNA is patent eligible because it is not naturally occuring" - at least in the usual case where the introns have been removed. If the original gene or DNA segment happened to have no introns then that cDNA might have some patent eligibility issues too. Not to worry.

By now, few if any gene patents are being filed anymore -- especially after the genome was sequenced and published. The court said you couldn't patent native DNA anymore, but you can patent most cDNA and you may be able to patent method claims related to novel discovered DNA sequences, and you could potentially patent new applications based on knowledge of novel genes. And you might also be able to patent DNA sequences where the natural sequence has been altered.

So no doom and gloom.  Those who wanted it recognized that native DNA sequences are products of nature and should not be patent eligible got their way.  And those who derive information and applications from these sequences have a way to protect their commercial value.  On balance, the world will continue to move on and all the doomsayers can stop now.  Plus the cost of BRCA tests look like they will drop slightly for those who found the previous price to be an impediment.

See here, here, here, here, here, and here for more blog posts on this topic. 

SAFC is Out and About

SAFC announced today that it will be presenting at several major investor conferences in June 2013. See attached for the whole scoop.  Download June Conferences 2013  

 

Posted by Bruce Lehr May 29th 2013.

J&J Coming to Grips

I saw this today in Pharmalot.  Apparently, J&J, after a seeming unending stream of gaffes, manufacuring problems and ethical slip ups, is asking its employees do some "soul searching" and examine the 70+ year old corporate credo. 

The health care giant is asking employees to take time to  "reflect, reaffirm, question, challenge and share" their thoughts credo and then take a survey for the purpose of “identifying opportunities for improvement and action.”

Wow! Who'd thunk?  It's like all the physician's in the world sitting down to "think about the Hippocratic Oath".  When I was in business school in the late 80's, J&J was the poster child of ethical behaviour.  In the wake of the Tylenol tragedy (if you are old enough to recall), its management team was held in complete esteem for its safety first, profits second (or third) approach to pulling products off the shelf to protect consumers. It was THE CASE study used in business ethics classes.

Would you ever think you'd see a blog post reflecting the activities that are going on in J&J now?  Neither would I.

Posted by Bruce Lehr May 29th 2013.

Lonza Reaffirms Its Biosimilar Path

Lonza clarified its reported position, inPharma Technologist, with regard to its joint venture with Teva.  A recent interview with Lonza's CEO had led writers to imply that Lonza was rethinking its position on biosimilars -- and presumably its JV with Teva to produce biosimilar drugs.  This was largely caused (according to these articles) by FDAs less than clear guidance on a biosimilar pathway, and the resultant uncertainty to the biosimilar economic models that had been developed circa 2009.

Lonza moved o quash this notion today by reaffirming its intent to produce biosimilars as stated previously thorugh the Teva connection. Lonza will however review its assumptions around the economic models for biosimilars -- particularly in the US market.

"Biosimilars remain an attractive market opportunity and both parties stay fully committed to the TL collaboration," said a Lonza spokesman.

Posted by Bruce Lehr Apr 3rd 2013.

Myriad Flubs "Its Day in Court" with the Supremes

They did if you concur with the opinion of Kevin Noonan, author of the Patent Docs Blog.  According to him, their response in AMP v. Myriad Genetics will not stir the Supremes passions. 

He opines that Myriad should have made a point of "Emphasizing the negative consequences on progress and innovation of a decision in the ACLU's favor would have provided the Court with greater motivation to pause before taking a broad, sweeping and unnecessary position on where the balance should be struck on patenting isolated human DNA.  Myriad's brief gives the Court no basis for doing so."

And their lukewarm brief is likely to go down in defeat. The consequences may not be so good for those pursuing (or holding) gene patents.

Posted by Bruce Lehe Mar 12th 2013.

 

 

Should FDA Panel Review A Bird Flu Vaccine Again?

In short, of course it should.  Science should be guided by data.  If you have new compelling data to examine, you should do it. Decisions can change if there is new data to support the change.  That should be self-evident to scientists and policy makers to my mind.

Should FDA Panel Review A Bird Flu Vaccine Again? // Pharmalot.

In this case, you are talking about purported new data that shows an elevated rate of narcolepsy being associated with persons who received the bird flu vaccine that contains a new adjuvant, AS03.  Supporters and detractors of review both rightly point out that the vaccine was approved as it battles a flu that to date has shown a 59% mortality rate in the 566 confirmed cases. The number of infected is small but the mortality is EXTREMELY high.  So I don't think we should focus too much on the original decision to approve -- it seems merited and was not capricious.

However, there is also new data developing that suggests an association with narcolepsy that is 14 times higher than what would be expected.  Couple that with the fact that narcoplepsy is considered to be an autoimmune disease manifestation, and there is also some suggestion that there might be elevated rates of rheumatoid arthritis (also autoimmune) in this vaccinated population.  It would seem prudent to check it out whether the adjuvant might be affecting this.

This seems to me to potentially be yet another very unfortunate fallout of the falisfied study linking autism to vacccination.  In that case, healthy children were placed at risk by parents choosing against vaccination against very common childhood diseases because of falsified data linking the vaccinations to autism. Scandalous really and extraordinarily damaging from a public health perspective, not to mention some unvaccinated individuals and other exposed naive populations. 

But let's don't overcompensate the other way and not look at new data coming in with regard to narcolepsy.  One fraud doesn't necessarily mean another is being perpetrated.  In this case, let's not go to sleep at the wheel without looking at the facts, and acting then on the merits of the case.

Posted by Bruce Lehr Mar 11th 2013.

Sometimes "Greed....Is Not Good."

The latest on the egregious troubles from the New England Compoundng Center are posted today in Pharmalot.  It seems employees are now giving interviews to the effect that "we got greedy" and that resulted in blowing up their scale of work beyond their capabilities, becoming overwhelmed, and producing shoddy-product on a National scale. Spread the wealth, right?

New England Compounding Center ‘Got Greedy’ // Pharmalot.

This will all be laid out on 60 Minutes this weekend.  And Gordon Gecko's bromide is decidely disproven in this instance.

Posted by Bruce Lehr Mar 8th 2013.

One Little Indian

Late last year, GSK said it would release (anonymous) patient level information from clinical trials to allow researchers more access to provide independent analytics.  It is sticking to its guns by endorsing the AllTrials movement to do just that.  GSK also says that it is working on its web porthole that will provide researchers the promised open -- yet secure -- access to trial data.

Glaxo Clashes With PhRMA Over Data Disclosure // Pharmalot.

PhRMA -- which GSK belongs to -- and the Association for British Pharmaceutical Industry however both demur, saying it is a bad idea.  PhRMA claims that this level of disclosure will inhibit trial participants from signing up and also will promote second guessing of regulatory decisions -- both ideas being BAD in their view.

I guess they wouldn't be in favor of instant replay in baseball either?  Oh wait, I got them confused with Bud Selig.

Posted by Bruce Lehr Feb 5th 2013.

 

Maybe It's Just Me

When looking at all the fines that Big Pharma is absorbing -- primarily for violations of selling and marketing regulations around the world -- did you ever find yourself saying "ho-hum" business as usual.  Especially when the fines involved are much less than $1 B!  I do.

Just this week Pharmalot reported fines for Lilly ($29 M), Sanofi ($109 M) and Amgen ($762 M).  The Amgen is big enough for me to take more notice but the others -- "ho-hum".  That's kind of sad.

These pale next to some of the multi-billion dollar settlements we've seen in the past two years as well.

Posted by Bruce Lehr Dec 20th 2012.

Sigma-Aldrich is re-aligning its business segments

St. Louis life science company Sigma-Aldrich announced today that it is restructuring into three market-focused business units: Applied Markets, Research Markets and SAFC Commercial Markets.

Sigma-Aldrich is re-aligning its business segments and SAFC will be reamed the SAFC Commercial Markets Business Unit.

Gilles Cottier will continue to lead the SAFC business. This business will be renamed the SAFC Commercial Markets Business Unit and will continue to serve customers in the life science and electronic markets.

Company officials intend to provide more information about the structure, sales and growth prospects of each of the three business units early in 2013, according to a statement.

Posted by Bruce Lehr Nov 20th 2012.

It's a Bug, It's a Bird, It's a Mouse......My Drugs Come from Where?

It's a Bug. It's a Bird. It's a Mouse. No, not bug nor bird nor even mouse, it's just compounder Ameridose.

Bugs, Birds & Ignored Complaints At A Compounder // Pharmalot.

Just when you thought the compounding scandal at the New England Compounding Center (NECC) couldn't get any worse, it does.   It seems that another compounder sharing the NECC owner's also has been cited by the FDA with serious breeches in its quality systems.

Among other things found in its sterile processing and packaging areas -- besides the expected drugs -- were bugs, birds, rodents, mold, bacteria, and cracked and corroded walls.  How did they miss bat wings and eye of newt?

Based on the meningitis outbreak caused by NECC preparations shipped to 24 States, Congress is now holding 2 sets of hearings to investigate why FDA does not have more oversight in this area -- or is not exercising more enformcement power that it may already have.  I don't expect this issue to go away.

Unless of course, we find that it is a GMP bird trained to catch mice and bugs.

Posted by Bruce Lehr Nov 13th 2012.

 

 

 

The Biotech Graveyard Report for Halloween

Fierce Biotech just published its 2012 Biotech Graveyard report - the 4th installment in the series chronicling the demise of biotech's for the year. This year's list is shorter than in year's past with only 5 companies that qualified (though several others as explained by Fierce could join them sooner rather than later).  This year's Failed Five (wonder if they all went to Michigan?):

1. Biolex Therapeutics - failed to earn a C (hepatitis that is)
2. Genta - lost its long battle with cancer
3. Halcyon Molecular - yes. the Halcyon Days are over with $100 genome
4. Neurologix - could recover from shaky start (or finish) with Parkinson's
5. Inspiration Biophamraceuticals - failed to inspire with Hemophilia

Let's send them out with a song.

 

Posted by Bruce Lehr Oct. 31st 2012.

Biotech Achieves a Milestone: Abbott's Humira Goes to No. 1

Humira, as noted in a post today in Xconomy, will rise to the number one revenue producing drug in the world in 2012 -- estimated at $9.3 B -- thus supplanting the old champ Lipitor that has reached its patent expiry. This is the first time that a biological drug is in the number one spot and perhaps marks a watershed when bio drugs take over from their small molecule bretheren.

According to Reuters data, Abbott's Humira is not only number one, but J&J's Remicade and Amgen's Enbrel are numbers two and three.  Thus, biological drugs, that are all anti-TNF, hold the top three slots.  And according to Reuters, 8 of the top 10 drugs are now biologicals.  That's an amazing emergence -- Humira is entering its 8th year on the market and was the third drug of its type in its class.  Hurrah!

From here on out, it looks like biologicals will now drive the growth of the world pharmaceutical market, and in addition to the leading Mab drugs we see now, we'll likely see many more non-Mab drugs emerge as the orphan disease classes begin to be better served.

Posted by Bruce Lehr Apr 16th 2012.

New Lipitor Leader in the Clubhouse -- Ranbaxy

Since it is Master's season, I thought I'd go with the golf analogy.  The WSJ Health blog reports that as of last month Ranbaxy's generic version of Lipitor is already outselling Pfizer's original drug. It just goes to show the incredible pace at which generics are now able to overtake the innovator product once it comes off patent.  Presumably this is due to the tremendous cost savings one can get with a generic. 

Incredibly (to me) Ranbaxy only began selling its generic Lipitor (atorvastin) Nov 30th last year and as of the last week in March it sold 17.5 M pills for that week compared to Pfizer's 17.2 M -- at least that is the report according to Wolters Kluer Pharma Solutions.  All I can say is WOW!

Ranbaxy may not have the fabled jacket but they do have the GREEN. 

Posted by Bruce Lehr Apr 6th 2012.

WSJ Reports BMS Still Interested in Amylin

Today's WSJ reports Bristol-Myers Squibb is still interested in acquiring Amylin (mkt cap $3.6 B) -- as one of its larger pearls.  Amylin reportedly turned down and offer from BMS earlier this year of $3.5 B -- which has triggered some furor among its shareholders -- notably one Carl Icahn who owns about 9% of the company's shares.

Amylin's lead drugs Byetta and Bydureon for the treatment of diabetes would help complement the BMS offer that includes drugs like Onglyza (co-marketed with AstraZeneca) and a drug under development called dapagliflozin.  The world wide diabetes market is expected by IMS to reach up to $48 B by 2015 -- making an Amylin acquisition attractive to BMS to replace revenue losses from medicines with expiring drug patents.  In that regard, Amylin would appear to fit neatly into BMS' string of pearls strategy for growth.

Posted by Bruce Lehr Apr 6th 2012.

Icahn Rattles Saber at Amylin Board

Amid market rumors this week that Amylin's board had rejected a $3.5 B takeover bid from BMS, with little or no word of the event, Carl Icahn seized the opportunity to attack.  Icahn (Amylin's third largest shareholder) criticized the Board for failing to discuss the supposed offer publicly and began his saber-rattling to raise a proxy fight to replace the current Board to one more friendly with "the sell the company posture". 

Icahn has a history of buying into companies when they are weak to force changes. He has successfully infiltrated both Biogen Idec and Genzyme in the recent past. Now, it looks like Amylin should prepare itself for the upcoming battle. See Seeking Alpha, Fierce Biotech, and PharmaGossip.

 

 

 

 

Posted by Bruce Lehr Apr 5th 2012.

There's 143.5 Million Reasons This Man is Smiling!

From the PharmaGossip blog via Bloomberg's, retiring J&J CEO William C. Weldon will receive a retirement package worth $143.5 M -- yes -- that's GREENBACKS.

And that's why this man is smiling today.  That's a long way from the pay he received as a sales rep back in 1971 when he joined the company.  Wow! Just think what he might have earned if J&J had been able to make artificial hips, otc medicines and vaginal mesh products over the past couple years.

Then we might have been talking some real money.

Posted by Bruce Lehr Mar 14th 2012.

 

13 Pharma, WHO & Gates To Tackle Tropical Diseases

The Gates Foundation announced that it is teaming with 13 of the largest pharma companies to find treatments for 10 neglected tropical diseases by the self-imposd deadline of 2020.  The Gates Foundation itself is pledging $363 M of the total $785 M earmarked for the project.  

Pharma, WHO & Gates To Tackle Tropical Diseases // Pharmalot.

Participating companies include, many of the world's heavy weight in drug development, many of whom have had at least some efforts for some time in going after these diseases.

• Bayer - Chagas disease
• Abbott, J&J, Pfizer, Sanofi, GSK, Eisai - lymphatic filariasis
• MSD - river blindness
• Sanofi, Bayer - sleeping sickness
• Gilead - visceral leishmaniasis
• GSK, J&J - soil helminthes
• Novartis - leprosy
• Pfizer - blinding trachoma
• Merck KGaA - schistosomiasis

Additionally, Abbott, AstraZeneca, Bayer, BMS, Eisai, GSK, J&J, MSD, Novartis, Pfizer, and Sanofi are working with the Drugs for Neglected Diseases Initiative (DNDI) to provide access to proprietary compound libraries to develop new drugs.  

"As an industry, we have the capabilies and the know-how and resources that can improve the state of the world, especially the developing world," said Paul Stoffels, worlwdie chair of the J&J pharmaceuticals business. 

Of course, others weren't quite as optimistic. Medecins Sans Frontieres (aka Doctors without Borders) argues that more research is needed and that these companies only spend a pittance on tropical diseases each year at $18.3 M -- compared to their oft cited figure of $1.3 B on a single approved drug.  See Fierce Biotech and the press release.

As Nike would say, "Just Do It".

Posted by Bruce Lehr Jan 30th 2012.

Dendreon Under-promises and Over-delivers in Q4

Temperence sometimes has its rewards. Dendreon suffered through a poor sales year in 2011 of its own making that hammered the company's stock.  But in Q4, Dendreon achieved Provenge sales ($82 M) that were considerably higher than its guidance. As such, their stock price is being rewarded today -- despite a considerable shortfall of $228 M in revenue for 2011 versus its beginning of year forecast of $350-$400 M.

But by giving the market an expectation of $66 M or so in Q4 Provenge revenue but achieving $82 M instead, its price ramped up $1.98 per share to $9.58 or more than 26 percent.  Better to be under-promisers and over-deliverers than the converse when it comes to speaking with the Market -- as the Market has once again affirmed. 

Of course, that doesn't help the 500 workers laid off in September, but it may remind Dendreon CEO Mitch Gold of a valuable lesson.  See Xconomy.

 

Posted by Bruce Lehr Jan 5th 2012.

What Goes Around Comes Around for KV Pharma

You may remember KV Pharma running into trouble earlier this year for pricing its drug Makena (a form of progesterone already on the market) at $1500 per dose versus the $10 to $20 charged by compounding pharmacies.  The resulting uproar caused them to lowe price to the bargain rate of $690 per dose. Too little too late though.

KV Pharma May Not Be A Going Concern Very Long // Pharmalot.

Now in a recent filing with the SEC, KV discloses that "conditions raise substantial doubt about the company's ability to continue as an ongoing concern." Karma strikes again.

Posted by Bruce Lehr Dec 14th 2011.

Samsung and Quintiles' biosimilars JV teams with Biogen Idec

Biogen Idec and Samsung announced that they are teaming up to develop and market biosimilars. The two companies will form a joint venture, based in Korea, which will be funded by $255 million from Samsung and $45 million from Biogen, giving the latter a 15 percent stake in the venture.

Samsung and Quintiles' biosimilars JV teams with Biogen Idec.

Biogen said that it expects biosimilars to constitute “a meaningful revenue stream” and that the company was working on several biosimilar molecules. Biogen emphasized today that the Samsung joint venture would not pursue biosimilar versions of proprietary Biogen drugs. 

Samsung has laid out plans to invest close to $2 billion in the biosimilar business in expectation of developing a new subsidiary that can earn roughly that amount annually in about a decade. "We are taking a significant step toward becoming a major player in the biopharmaceutical industry and investing in an important growth engine for our company," Samsung Biologics CEO Tae-han Kim said in the statement.

Biogen CEO George Scangos made no secret of his own interest in biosimilars. He indicated Samsung could shoulder sales and marketing while Biogen concentrated its efforts on the manufacturing end of the deal.

"The manufacturing facilities have costs to run them, so the more products you run through them, the more efficient they are," Scangos said. "To set ourselves up commercially could be a big distraction. I'd like a partner to take over that."  Looks like we have a match.  See Fierce Biotech and Xconomy.

 

Posted by Bruce Lehr Dec 6th 2011.

Genzyme Stumbles Again. This Time It's Cerezyme

Genzyme is at it again. After last month's letter to Fabry patients alerting them that they would not be able to get ample supplies of Fabrazyme, Genzyme is now forced to tell Gaucher's patients that they will need to ration Cerezyme for the treatment of that disease.

Genzyme Stumbles Again: New Cerezyme Problems // Pharmalot.

This just continues the multi-year saga of being unable to supply ample amounts of either drug consistently due to persistent manufacturing and quality problems -- primarily at its Allston manufacturing facility.  Genezyme now appears to be pinning its hopes on the opening of its new Framingham facility in Qtr 1 2012 -- though up to now the Company has not been too reliable with time estimates.

Analysts report that this may be another opportunity for a competitor to come in and steal share (Shire already encroaches on Fabrazyme with its Replagel).  Protalix BioTherapeutics is going to the FDA with its taliglucerase to compete with Cerezyme -- and all the quality issues may make the former's case for approval that more compelling.

With all the product supply problems - Genzyme is bringing new meaning to the term Orphan and Neglected Diseases.

 

Posted by Bruce Lehr Sep 16th 2011.

Gold says, "Wish I hadn't given that bullish forecast"

Today, Mitch Gold, Dendreon CEO, said that if had to do it all  over again he wished he hadn't given Wall Street a sales estimate of $350 M - $400 M for Provenge in 2011 when he (and others) didn't understand the dynamics of launching it in the market.

The result?  A mere $3.5 B in lost market capitalization and layoffs of 500 employees or about 25% of the company. See Xconomy.

DOH!  

 

 

 

 

Posted by Bruce Lehr Sep 9th 2011

Dendreon Restructures - BIG TIME!

Dendreon announced its restructuring plan today to reduce its burn rate given the slower than expected uptake of the newly approved Provenge for the treatment of prostate cancer.   The plan calls for the company to lay off 500 persons or about 25% of the total work force.  Among the casualties is the Dendreon COO, Hans Bishop. 

Dendreon reassured investors that it still has $600 M in cash and equivalents on hand, and that its run rate would be reduced from $390-$400 M to about $300 M annually.  Dendreon says it can hit cash flow break even with sales of $500 M a year.  Currently, Dendreon has sold $77.6 M in all of 2011 with sales of $22 M in August.  Some analysts question Dendreon, with its reimbursement problems for a $93,000 drug, can hit sales higher than $450 M before 2021.  Dendreon pulled its sales estimate for $350-$400 M in 2011 at its last quarterly conference call and was punished by investors to the tune of losing $3.5 B from its market valuation.

"While the last month has been difficult for our employees, these cost reductions are necessary to ensure the long-term growth of our compnay," said Dendreon CEO Mitch Gold. See Xconomy.

 

Posted by Bruce Lehr Sep 8th 2011.

Novartis, A Gleevec Patent & India

In follow up to the previous post, the Pharmalot blog published an interview with Brook Baker, a professor in the Program on Human Rights and the Global Economy at Northwestern University School of Law, and a member of Health Gap, Global Access Project. Dr. Baker explains sequence of events in the case and why advocates on both sides have latched onto it.

Novartis, A Gleevec Patent & India: Baker Explains // Pharmalot.

The Indian Supreme Court postponed its hearing this week. The case will establish patentability for changes to existing drugs, define "enhanced efficacy", set rules for evergreening and will likely have important implications to generic manufacturers and drug availability and pricing in India.

That's all.

Posted by Bruce Lehr Sep 7th 2011.