The Big Red Biotech Blog

Gotta Love Derek on Open Source Discovery in Pharma

Derek Lowe writes the very very good and very highly read In the Pipeline blog.  Derek has a way of getting right to the point with a nice blend of bluntness and sardonic humor without being mean spirited.  Sometimes his posts just make me smile.  Here's one such post from today on the topic of Open Source discovery.

I'm actually a backer of the concept and think that companies really should try to explore its potential  -- by testing and operationalizing it. However, Derek makes a good point in his blog.  Too often proponents on the topic - provide a lot of talk but don't seem to be able to deliver the concrete actions or proof of concepts. 

Maybe this post hit home a bit more as I received the following note from a colleague commenting on a current discussion on "open innovation" in one of the innovation groups that I participate in. My colleague wrote:

To me it's unbelievable how little capability to analyze things have most of the people who are posting comments on that discussion group!!! They got "stuck" into that Soft skills topics they can read in books of Change management, Leadership, etc, but when it comes to Hard skills and concrete innovation they do bla-bla-bla...

Presumably it is hard to articulate the "hard innovation ideas" as they are hidden in the ball of fuzz that Derek refers to in his post.  Maybe we need to contact Rush to help us find the answer as he seems to know a lot about Fuzzballs.

Posted by  Bruce Lehr July 29th 2010.

Genzyme Rumor Update

Read latest from Fierce Biotech here.  

And the latest from WSJ Health blog here.

Bottom line is Sanofi is making formal offer to acquire Genzyme reportedly around $75 per share.

Posted by Bruce Lehr July 29th 2010.

FDA Panel: Brilinta 7 Aspirin 1

An FDA advisory panel voted today 7-1 to recommend that AZ's potential blockbuster blood thinner, Brilinta, be approved by the agency in September.

FDA Panel OKs AstraZeneca’s Brilinta Blood Thinner // Pharmalot.

Brilinta will become a direct competitor for Sanofi-Aventis' and BMS' Plavix - the world's second leading selling drug at more than $9 B annually.  Brilinta, if approved in September, is expected to easily top $1 B by 2014. 

Panel members issued their approval even as they struggled to explain why the 1400+ patients, out of the more than 18,000 patients tested worldwide, did not respond markedly different than US patients on aspirin.  Higher average aspirin doses in the US were posited as one possible explanation but certainly this was  not conclusive.

On balance, the panel recommended approval based on the sterling results seen in the rest of the world when comparing Brilinta to Plavix where heart attack, stroke or cardiovascular-related death dropped to a rate of 9.8 percent as compared to 11.7 percent after one year.

We await the news of the FDA in September.

Posted by Bruce Lehr July 28th 2010.

Astellas and Regeneron Partner Up for $295 M

As reported in GEN and Fierce Biotech today, Astellas has torn up its old agreement with Regeneron and negotiated a new deal for the latter's VelocImmune monoclonal antibody platform.  In the new deal, Astellas agreed to pay Regeneron $165 M upfront with up to another $130 M in milestone payments due in 2018. Regeneron can also reportedly share in mid-single digit royalties on sale of final products when they go commercial.

"VelocImmune will continue to be the indispensible technology for our antibody drug development program," said Shinichi Tsukamoto, svp of drug discovery research.

 

 

Posted by Bruce Lehr July 28th 2010.

Why Give FDA Monopoly on New Drug Approvals?

As reported in Fierce Biotech, a think tank known as the Pacific Research Institute (PRI) has recommended that the US FDA should also accept drug approvals from the EU's EMA.  The group notes that the EU and FDA have approved a combined 39 drugs in the past two years.  However, the 11 of these are exclusively approved in the EU, and the EU is averaging more than 3 months faster than its US counterpart in spitting out approvals.

The PRI says the FDA's monopoly regulatory position for US approvals is creating inefficiency and is blocking access to new drugs for Americans. Like most conservative groups, they'd prefer (or so they say) to see some healthy regulatory competition to speed the process - which they claim would likely save lives as well.

What that says about safety and efficacy criteria, I'm not sure, but I wouldn't hold my breath for lawmakers or the FDA to relinguish any regulatory control anytime soon.

 

Posted by Bruce Lehr July 28th 2010.

WSJ Reports Sanofi Making Formal Bid for Genzyme

This report just in from the WSJ.  It reports that Sanofi will send a "bear hug" letter to Genzyme directors to get the process moving.  The deal is expected to be in the range of $20-21 B.

Posted by Bruce Lehr July 28th 2010.

Merck Signs Deal with Sinopharm for China

The BioJobBlog reports that Merck and Sinopharm have reached an agreement for the distribution of Merck's cervical cancer vaccine - Gardasil in China. The move is Merck's first into a distribution partnership in China and is likely a harbinger of more activity here and in other developing markets worldwide.

China is projected to have high pharmaceutical growth rates in the next decade with the emergence of its middle class, and has high cervical cancer rates in particular.  The HPV vaccine distribution agreement seems like a logical start for Merck and one of China's largest biopharm companies.

Posted by Bruce Lehr July 28th 2010.

UK to create £50 million cancer drugs fund

Andrew Lansley, the UK's Health Secretary, announced that a new 50 million pound fund would be created beginning in October to improve access of NHS patients to new cancer drugs.

Lansley to create £50 million cancer drugs fund | InPharm.

The announcement was made following the issuance of a new report that shows the UK lags behind other European nations in the uptake of new cancer medications.

Posted by Bruce Lehr July 28th 2010.

Biosimilars are Here to Stay - Deal with It!

The WSJ Health blog published on a report yesterday recently released by the Generic Pharma Association (GPhA) touting the savings the US healthcare system is deriving from using generic drugs in the stead of their branded counterpart.

According to the report, every 2% uptake in generic utlization results in $1 B in Medicaid annual savings.  A billion here and a billion there and pretty soon you'e talking about real money. What's more? Utilization of generics within the Medicaid program is about 10% below that of the general population -- meaning there is much more savings to be had.  In total, the GPhA claims that IMS figures support a realized savings of more than $139.6 B due to generics usage in 2009 -- a 15% increase from prior year.

What does this mean?  It means that economica favor the substitution of generics whereever possible - certainly from the 3rd part payer persepective.  Even though the savings are not be projected as high with biosimilars compared to their branded counterparts, there are still ample savings to be realized. One can hardly expect Medicaid adminsitrators to ignore this.

This week the FDA approved a generic biologic from Momenta Pharmaceuticals that will compete with Sanofi's Lovenox branded drug. The drums are already beating that this signals a more assertive stance by the agency toward approving additional biologics and biosimilars.  Teva's Copaxone has been identified by several analysts as perhaps the next branded biologic to be challenged.

Novartis' Jeffrey George, global head of Sandoz generic drug unit, says that starting in 2015 and 2016 many biotech product will begin to come off patent. "Biologic medicine is a $100 B industry.  There is a lot of savings to be had."  Epogen and Neupogen might be the first targets on this list.

Bottom line: the FDA has let the genie out of the bottle with its approval of Momenta's generic and there's no going back.

Posted by Bruce Lehr July 27th 2010.  

Biotech on a Shoestring? There's a Better Way

Follow in the footsteps of other industries like automobiles or electronics.  Cut costs to reduce waste and to add value for the customers. Repeat over and over again with a customer focus in mind.

Biotech on a Shoestring? There's a Better Way.

Seems like simple advice that others have employed successfully.  Now it's well past time that Biotech follow suit. Waste not. Profit more.

Posted by Bruce Lehr July 27th 2010.

Sanofi-Aventis Strikes Back!

News from the Pharmalot blog this morning that Sanofi-Aventis has filed suit  against the FDA over its licensing a generic version of Lovenox. 

Sanofi-Aventis Sues The FDA Over Generic Lovenox // Pharmalot.

Sanofi says the FDA has exceeded its authority and acted arbitrarily and capriciously in granting Momenta the right to market its version of the blood thinner.

Lovenox, of course, is Sanofi's best selling pharmaceutical with sales of more than $4.5 B annually.  A generic competitor could cut deeply into those sales and market share.

In a statement, Sanofi said ".....The company believes that this case poses a number of significant questions regarding the FDA review process for complex pharmaceutical products which are important to pursue"

Translated - We don't like the decision when a generic biologic is being approved to compete against us. And everyone out there thought licensing of biologics and biosimilars was going to be easy.

Posted by Bruce Lehr July 27th 2010.

How Much Should Genzyme be Worth?

The Xconomy post below notes that Genzyme may now be the target of several Big Pharma companies eager to add its biological drugs (and $4.5 B in sales) for rare diseases to their portfolios.

Xconomy: How much would you pay for Genzyme?

The post also notes all the troubles that Genzyme has experienced in the past year with various and sundry manufacturing mishaps - particularly at its Alston, MA plant.  It failed to meet demand for its two highest sellers throughout 2009 and isn't expected to fully recover in 2010 either.

It's stock price rose to $67.07 on Friday's run up following acquisition rumors by Sanofi-Aventis.  Over the weekend, both GSK and J&J's names were added to the list of potential suitors.  Thus, the possibility of a small bidding war perhaps.

Ryan Mcbride of Xconomy is asking its readers to put forth their price ideas.  Analysts have weighed in between low 60's and high 70's price per share range.  Where do you believe the price should land?  And, who will be the winning suitor?

Posted by Bruce Lehr July 26th 2010.

Breaking News: Genzyme rebuffs Sanofi bid - PharmaGossip

According to a report from 'Reuters via PharmaGossip, Genzyme has rejected Sanofi's initial bid to buy the company.

PharmaGossip: Genzyme rebuffs Sanofi bid: report | Reuters.

Does that leave GSK or J&J to make their pitch next?

Posted by Bruce Lehr July 26th 2010.

Momenta's Euphoria Teva's Worry?

On Friday, the FDA approved Momenta Pharmaceutical's generic biologic alternative to Sanofi-Aventis' Lovenox.  Many have hailed this as a sign that the FDA is now more willing to consider "generic competitors" in the biologics space. 

Teva is looking to compete in the biosimilar space as well - so why the worry?  This analysis in Seeking Alpha explains. First off, the FDA decision may signal that the agency is willing to consider approval of a competitor to Teva's multiple scelrosis drug, Copaxone.  Copaxone is a major cog in Teva's growth as the drug's sales totaled more than $2.8 B in 2009 out of the company's $13.9 B in sales.  Copaxone represents about 30% market share of the global MS market.

A market challenger to a drug that represents 20% of Teva's revenues is serious. The remainder of Teva's portfolio is made up mainly of revenues from generics.  Teva maximizes these products' profits by using a first mover strategy to gain 6 months exclusivity in marketing the generic form of the drug.

However, if the generic and biosimilar market is going to grow at a time when many ethical drug producers are facing the patent cliff - one could expect more of these producers to enter with their own generics taking profit out of this segment of the market. And this movement could occur at precisely the time Teva's Copaxone could be challenged with competition.  

As of October 2009, Teva had 210 product applications at the FDA, including 40 tentative approvals.  Branded products covered by these applications totaled $113 B in US sales. Among the 210, Teva filed 136 challenges to branded patents.  It was the first to file on 83 of the 136 applications.  Products associated with these applications had US sales of $54 B. 

If the Teva business strategy is threatened by changing market conditions, then one can see the rationale for investor fears that led to an 8% drop in the Teva stock price based on the Momenta news on Friday. It remains to be seen whether this will occur or not and whether this will present a serious challenge to the Teva business model of "first mover".  Never a dull moment.

Posted by Bruce Lehr July 26th 2010.

EU majors reported to be looking at Genzyme

 
  

EU majors reported to be looking at Genzyme.

European drugmakers Sanofi-Aventis and GlaxoSmithKline (GSK) are rumored to be looking at a possible acquisition of US biotechnology group Genzyme. 

Reportedly Sanofi had made an offer for Genzyme at about the time it was reported publicly that they were in the market to make a US biotech acquisition in the $15-20 B range. 

GSK has reported to have been much more circumspect in their advances. Reportedly, their CEO, Andrew Witty, has merely asked Genzyme to keep him informed if they decide to put themselves on the block. Witty has since denied having any interest in making a major acquisition.

Some analysts have also mentioned J&J as a possibly interested party to an acquisition but company spokemen have declined to comment.

The waiting game commences. It is likely that Genzyme's celebrated manufacturing issues in the past couple of years have opened it up as an acquisition target.  Genzyme id report an earnings drop last week although its stock price rose by more than 17% on Friday based on these takeover rumors.

Posted by Bruce Lehr July 26th 2010.

Provenge Launch Appears On Track: Analyst's Say

This post from the Pharmalot blog indicates that all the perceived negatives that Dendreon's Provenge might be facing do NOT seem to be effecting the drug's initial acceptance.  In a quick survey of 25% of the sites expected to prescribe Provenge - more than half plan to prescribe next month. 

Provenge Launch Appears On Track: Analyst // Pharmalot.

Further, any doubts about reimbursement aren't effecting the prescribing physcians' intention to prescribe to additional patients.  In fact, 8 of the 13 centers have a wait list. A high penetration rate is therefore expected in defiance of naysayers predictions.

Posted by Bruce Lehr July 26th 2010.

Healthcare Social Media B2B Marketing - Just Do It!

This post says it all. Use new social media channels to make industry connections for such things a product licensing, technology collaborations and to secure funding. The media is interactive and ideal for this type of collaboration. 

PharmTech Talk » B2B 2.0.

Pharmaceutical, biotech and medical device firms — as well as university research departments, technology transfer agents, and independent researchers — should not be asking whether to engage in business to business social media, but how to leverage the new technologies and communications platforms to create a competitive advantage.

Used to its fullest potential, social media can change the way companies market to prospects, communicate with customers, and find and interact with the most appropriate potential business partners — all without incurring significant time and expense.

Posted by Bruce Lehr July 24th 2010.

SAFC's - Enhanced Quality Program (EQP)

I've written quite a number of posts on this blog about the increasing need in the bio/pharma industry to have better characterization, control and traceability on raw materials being used in the process of producing drugs.  The regulatory bodies around the world - FDA, EMEA, etc - clearly are placing more and more emphasis on this need.  Quality is paramount in the production of safe and efficacious products.  The very public incidents of quality lapses with major manufacturers only serves to heighten this concern - whether the incident stem from a China, US or EU based manufacturer. 

Several previous posts highlighted SAFC's new raw material characterization program aimed at better characterizing and qualifying materials used in cell culture based manufacturing of biopharmaceuticals. You can review these here, here, here, here and here. (Told you, I've posted about this before).  You can also refer to the popular Raw Material Detective series of posts for some real life examples.

Now, SAFC introduces its Enhanced Quality Program (EQP^SM).  The EQP is designed to transparently show customers the Quality levels associated with the large number of SAFC products that could be used in manufacturing.  This is meant to aid customers in choosing the RIGHT product for their application - as quality needs are application specific in many instances.  EQP levels differ in their degree of quality certification, documentation and change control. EQP products fulfill a range of needs from industrial applications through the more heightened controls of the biopharma and pharma industry.  Premium, Elite and cGMP levels exist within EQP.

EQP is consistent with ISO requirements and meets international standards for multiple industries. One of the significant features of the EQP is the Change Control Notification (CCN) program. Customers may subscribe to this program at www.safcglobal.com/ccn.  On our website, customers can also search on CAS numbers to determine if we have a product that meets your Quality needs.  If not?  Customers may request an upgraded product and our compliance specialists will be able to determine through consultation whether we can accomodate that change.

For more information, refer to the links in this post - and on overview can be found on this attached flyer.

Download MOU_EQP Flyer_LR

 

 

Posted by Bruce Lehr July 24th 2010.

Genzyme in Play with Offer from Sanofi-Aventis

Fierce Biotech and the WSJ both report that Sanofi-Aventis has made a pitch to buy Genzyme - current market cap lies between $13-14 B.  Genzymes shares reacted strongly with a 19% increase on the news.  Sanofi's fell by 5% - although they were also hit with news of the FDA's approval of Momenta's Lovenox generic today. 

Posted by Bruce Lehr July 23rd 2010.

FDA Gives Green Light For Momenta's Generic Biologic Anti-Clotting Drug

Katy bar the door - the FDA has just approved the first biologic generic anti-clotting factor from Momenta Pharmaceuticals (and Novartis).  This is expected to be a spirited competitor to Sanofi-Aventis SA's Lovenox - a $4.57 B drug. 

Momenta Gets FDA Green Light For Generic Anti-Clotting Drug; Shares Boom.

Momenta's shares soared 70% on the news and Sanofi-A'ventis' stock took a 5% hit.  This approval might be seen as a harbinger that the FDA is going to be willing to assertively approve new biologics.  While Momenta's drug is not genetically engineered, it is a complex biologic and this approval may signal how the FDA may view recombinant biologics when judging equuivalency.

Teva's Copaxone may be next on the list to be challenged by a biologic generic.

Posted by Bruce Lehr July 23rd 2010.

Brand-Name Drugmakers Fight Generics

This from Ed Silverman's Pharmalot blog on how the Big Pharma groups are coping with generic competitors.  The top strategies are outlined below: 

How Brand-Name Drugmakers Fight Generics // Pharmalot.

• Patent challenges pursued by 60% of companies
• Defensive pricing strategies by 57%
• New formulations by 50%
• New indications pursued by 45%
• ONLY 29% tried to produce their own generic

In the next 3 years, even more emphasis will be placed on new formulations (63%) and new indications (56%). 

Survey participants were brand and product managers from Merck, Pfizer, Novartis, Eli Lilly, AZ, Boehringer Indgelheim, Gilead Sciences and Roche.

I think it is interesting that the strategies that are outlined are largely those decried by the Indian Pharmaceutical Alliance (IPA) when challenging whether changes to drugs represent true innovation under Indian Patent law or are really incremental innovations.  I've written about that previously here, here and here. Kind of interesting to see that this is the preferred strategy of the industry at present.

Posted by Bruce Lehr July 23rd 2010.

China's Domestic Pharma Companies Inspire Fear?

Here's a good post from Patricia Arnum in the PharmTech Talk blog.

PharmTech Talk » China’s Pharma Market: Friend or Foe?.

It notes the large amount of funding that the domestic Chinese pharma companies have been able to raise through IPOs in the past 10 months - more than $5 B.  This compares quite favorably to the $1.7 B in IPO funding the US pharma companies have raised in the past 18 months. 

The gist of the post is that with this type of funding engine building, the Western pharma companies shouldn't underestimate the degree of competition they may receive in the Chinese domestic market.  The projected 23-26% growth figure that is tossed out by IMS Health estimates may not be there for the plucking solely by Western companies. 

Competitors could be in for a Long March.

Posted by Bruce Lehr July 21st 2010.

Ireland Invests Pot O'Gold in Biotech Research Center

As reported in Fierce Biotech yesterday, Irish interests are considering building a $6 B pharmaceutical "center of excellence" in Tralee that could provide 4800 new jobs in R&D and manufacturing plus a slew of other jobs in management and academic positions.

The current plan calls for 30 campuses and creation of one of the world's largest R&D sites.  Work at the site could begin as early as 2012.  A final announcement as to whether this plan will be activated or not is expected within 3 months.

Posted by Bruce Lehr July 21st 2010.

Score ONE for Raw Material Detectives!

 In the last installment of the Raw Materials Detectives - The Case of the Fouled Filters - I described a medium filtration problem. 

In this investigation, it was determined that PVA was causing the filtration issue and that the problem was related to variation in the degree of hydrolysis seen with the raw PVA. 

Subsequent discussions (our data in hand) with the manufacturer eventually convinced them there was a change in the product performance resulting from the hydrolysis effect.  It was then determined that an equipment change might be related to this observation. 

The manufacturer went back to the old equipment and produced a lot of PVA for SAFC's Raw Material Detectives to test.  Lo and behold!  The material resulting from the old equipment was more soluble and showed much better filterability.  We now have agreements in place to secure only material produced in this manner & thus can make media again with PVA that filters well.

Score ONE for the Raw Material Detectives.

Posted by Bruce Lehr July 21st 2010.

More on J&J Costs from WSJ - Reputation and Revenue

Yesterday's WSJ health blog had more on the costs J&J is absorbing to its revenue column and to its reputation related to all the OTC recalls. The series of manufacturing issues at its Fort Washington plant,  and now expanding to other plants (Puerto Rico & Lancaster, PA), is expected to cost the company more than $600 M in 2010 revenues. Ouch!

Analysts asked CEO Dominic Caruso if the troubles would have spill over effects on the reputation of other J&J products.  He answered "it was too early to comment on that".  A further probe as to whether J&J would make management changes was met with No Comment.

You can hear the heads rolling about now.

Posted by Bruce Lehr July 21st 2010.