Yesterday, North Carolina-based Pozen gave a detailed Investor Update, focused

English: Dollar General variety shop at 800 Br...

Tomorrow’s Pharmacy?

on PA32540, a “Coordinated-Delivery Tablet Containing Enteric-Coated Aspirin and Immediate-RElease Omeprazole.”

Information on the company’s pipeline is available here, while the investor presentation (lengthy PDF) is here.

At Lacerta Bio, we follow the drug delivery/reformulation space quite closely. We happen to have a lot of experience in this space. Plus, we believe that there can be a lot of therapeutic value gained from these approaches, especially if this therapeutic value can be achieved using an efficient development plan and reasonable drug pricing.

So with PA32540, it appears that Pozen has really latched onto this second point (reasonable drug pricing). But first, a little background…

There is no question that aspirin is a valuable agent to prevent cardiovascular and cerebrovascular events. However, as Pozen points out, nearly 70% of patients who should be on aspirin therapy are actually taking it. So even though aspirin is very cheap, the side effects make long-term aspirin therapy prohibitive for many patients.

In fact, Pozen’s clinical data support this. They demonstrated that nearly 12% of their subjects on enteric coated aspirin experiences gastric and/or duodenal ulcers. Further, over 11% of subjects discontinued enteric-coated aspirin due to any adverse event.

Now that’s not to say aht PA32540 is perfectly safe either. For example, Pozen’s own data demonstrate a 17.5% incidence of gastritis, versus 16% for enteric coated aspirin.

Nevertheless, the safety data, coupled with the well-established efficacy data supporting aspirin in this population, make PA32540 a compelling product.

But what about cost?

As one would suspect, Payers responded with little enthusiasm when initially presented with the PA32540 profile.

What changed their minds?

$1

Pozen correctly noted that pricing is the key component to having a successful reformulation product.

Pozen Payer Market Research Findings

Pozen Payer Market Research Findings

Specifically, at $1 a day, this makes PA32540 cost neutral to the Payers. Even better, the product will likely be on Tier 2 on the formularies, instead of Tier III.

Brilliant.

In fact, since Tier II copays are around $30 a month anyway, a contracting approach will likely not be required.

Now stop and think about this for a second. Let’s suppose you currently sell a branded product in a category where there are generic alternatives (statins, for example). With a generic available, the brand would have to have compelling clinical evidence of superiority to have Tier II pricing, and even that will be a challenge.

The way many companies handle this is through bundling a basket of products, offering different prices on the products in a basket in order to make that branded Tier III product more compelling for the Payers.

So while a Pfizer or an AstraZeneca can do this, a small company without a substantial portfolio of products cannot.

This is critically important from a business development perspective (and hence another reason why we’re so interested). Time and time again we see plans and business models which do not have substantive payer research supporting the model. There is a real danger that products can be approved, yet fail miserably in the marketplace, partly due to unreasonable pricing and revenue expectations.

The “Affordable Medicine” concept Pozen is supporting can really resonate with a number of Payers. Importantly, if a developer can execute on a plan while maintaining an Affordable Medicine mindset, and not the Wall Street/Investor-driven blockbuster mindset, then we may see more approved products on the market, with broader usage for each product.

Further, by moving aspirin from OTC to Rx, we will now have a much better tracking system for aspirin prescribing, usage, adverse events, etc. Again, this is another way the entire system benefits from their approach.

We can’t say whether or not Pozen (or their commercial partner) will hit their Revenue targets. We dont’ even know if Pozen will successfully out-license this asset to strong commercial partners. However, given some of the plans we’ve seen recently, we have to commend Pozen for their pricing and commercial strategy.

 

Consider the following situation:

English: "Wilshire Room," company in...

Where is everybody over there?

…and you are met by a complete lack of response from your best leads.

Sound familiar?

After all, you have a desirable asset, and the initial meetings were enthusiastic, with promises of follow-up calls, exchange of confidentiality agreements, etc., etc.

Why are you being met with silence? With a lack of responsiveness?

Where was the enthusiasm that you felt during that 30 minute meeting in the grey numbered cubicle?

In our experience, there are three general reasons why your desirable asset is met with enthusiasm, then silence. In this post, we discuss these three reasons, but there may be others! Please feel free to offer alternatives.

Wrong Audience – This is one reason why so many company executives argue against the use of networking conferences. Namely, that the person you met is simply the wrong person for that meeting.

Now what do we mean by wrong person? It could be that the person on the other side of the table:

Moved On – We recently ran into a situation where our key contact on the other side of the table suddenly became unavailable for an extended period of time due to a death in his immediate family. In another case, a key contact went on an extended maternity leave without notifying us. When situations like this happen, it can be weeks to months before a company responds, especially if the person who has moved on has not communicated the situation internally.

Wrong Asset – It’s entirely possible that the asset presented was simply not a fit, but the meeting was held for any number of reasons, such as:

So what can you do to reduce the amount of BD&L radio silence? Here are a few tips:

1. Pay very close attention to the exact person(s) you are meeting. Where possible, try to schedule a meeting directly with an individual, not a company.

2. Be choosy when deciding which companies you want to meet. Blanket conference coverage will likely result in a lower percentage of quality leads.

3. Keep your presentation very short, and leave a lot of time to ask questions about their internal process. For example, will the person you are speaking with lead the process internally? If not, who is that internal champion? What are the key criteria or questions that can be addressed immediately?

4. In select cases, if the meeting goes very well, you can schedule a follow-up meeting right on the spot. Suggest picking a date 2 weeks after the conference for a follow up. After all, isn’t that what smartphones are for?

5. Send a LinkedIn invitation soon after that initial meeting.

6. Mail a hand-written thank you note, along with a hard (bound) copy of the slides. Trust us. You will likely be the only person mailing a paper copy! For a greater impact, use overnight delivery.

These are but a few techniques we have used to overcome the “radio silence” problem sometimes seen in business development.

What techniques have you used in the past? What has worked for you?

 

At Lacerta Bio, we’re in the middle of several international out-licensing projects. This process is enabling us to re-connect with many companies around the world. In addition, we’re making new contacts in other companies, especially in Central/South America, Korea, China, and Japan.

The benefits for you are:

If you have a late-stage asset and are looking for help out-licensing your asset, let us know…we can help.

So said Shams Ruston from Labopharm at last week’s Interphex conference in New York.

We happen to agree.

In fact, there are two ways to look at this.

From the branded side, drug delivery can help extend the patent life of existing assets…a far less risky and less costly approach than trying to in-license the next blockbuster. A reformulation approach buys the innovator time to reap the fruits of earlier investments, or make the necessary ones in the near term to sustain growth. The underlying challenge may be an organizational one, as companies fixated on acquiring safe, effecting Phase II+ assets for a pittance continue to struggle to execute in-licensing deals. Broadening the in-licensing mandate (or the in-licensing mindset) would help companies tremendously.

From the other side, generic companies are competing on price, service, and distribution, and not the actual asset. Drug delivery & reformulation approaches enable generic companies to develop a branded product line. However, we recognize that reformulations require a clinical benefit in order to garner acceptable reimbursement levels.

As we’ve talked about before, drug delivery is far from dead. If anything, the current patent cliff can result in innovative ideas for companies willing to look for them.

 

As FiercePharma correctly points out, GSK’s Q II report reflects the overall industry trends quite accurately:

The rest of Glaxo’s report, like the rest of Big Pharma’s Q2 results so far, reflect current industry trends; sales in U.S. and Europe are on the wane, thanks in part to pricing pressures from cash-strapped governments. Cost-cutting helped deliver bottom-line improvements, and that drive will continue. The company has already identified another £300 million worth of cuts to annual spending, bringing the restructuring savings to £2.5 billion a year. Plus, GSK is eyeing more cost reductions, some of which mimic Novartis’ efficiency efforts, namely supply-chain and procurement efficiencies, and cash-conversion improvements.

The full GSK report (PDF) is here (link). Reports from Reuters, WSJ, and Fierce are also out there.

Luke Timmerman at Xconomy wrote a provocative piece today entitled The Missing Ingredient in Today’s Biotech: Guts. His thesis is that the industry is so paralyzed by fear and insecurity that it lacks the collective fortitude to take risks, even if they seem delusional. To quote:

If the industry–VCs, scientists, entrepreneurs, everybody—can’t get the mojo back, then we could be sitting around with a lot of scientific insights in the lab that nobody really knows how to turn into products for human health. Everybody will be fixated on the 100 reasons why something won’t work, and failing to see the one reason why it might.

It’s interesting to think about this. Who lacks the guts? Is it the academic scientist who doesn’t want to pursue a potential dead end in the lab, but instead wants to pursue more low-risk projects to get publications and tenure? Is it the VCs, feeling the pressure from the LPs, who want to take fewer scientific and clinical risks? Are the entrepreneurs (especially the ones merely thinking about taking the leap into entrepreneurship) feeling insecure about being paycheck-less for awhile? Is it management, fearing to take risks for fear of losing their jobs or next round of financing?

Is it all of the above?

The answer might lie in Seth Godin’s post today on waiting for fear to subside:

By the time the fear subsides, it will be too late. By the time you’re not afraid of what you were planning to start/say/do, someone else will have already done it, it will already be said or it will be irrelevant. The reason you’re afraid is that there’s leverage here, something might happen. Which is exactly the signal you’re looking for.

 

 

 

We previously posted our comments on BIO 2011. However, one aspect of the conference that really stood out was the use of social media. Attendees were encouraged to provide links to our LinkedIn, FaceBook, Twitter, and other accounts for the myBio web site. The velocity of tweets from the convention was astounding (and continues). And, of course, an informal tweetup was held at a local pub on Monday night.

There is already a lot of banter on the web on how pharma/biotech companies should/should not use social media tools. But what about employees and professionals affiliated with the industry?

BIO demonstrated that private, personal, and professional lives will continue to blur. As we share more personal information on Facebook/Google Plus, professional information will begin to creep into our personal profiles. Conversely, we already see LinkedIn (the “professional” site) encourage users to include personal information, hobbies, interests, etc.

As more of us become more comfortable exposing ourselves online, more of us will be more readily found and accessible. We concede that this is not always a good thing, and some things should definitely be off limits. But, those who are increasingly active and easy to find will likely have access to opportunities that “off line” folks will never see through traditional channels.

This doesn’t mark the end of traditional networking. Far from it. An increasingly noisy blogosphere/twitterverse will make traditional networking functions like BIO increasingly important, especially to build long-term relationships.

In other words, business networking will become more social, and social media will involve business/professional contact points even more. As BIO 2011 demonstrated, a balance of digital and face-to-face approaches will have to be managed (and encouraged) over time.

 

 

The Lacerta Bio team attended the annual BIO Convention in Washington, DC last week. BIO has become one of the key conventions for pharma/biotech business development, and is a “must attend” event for many of us in business development.

Our observations are somewhat limited, as we spent the bulk of our time in one-on-one partnering meetings. For broader coverage of the event, we recommend the official BIO press release, report by LES, and one by Popper and Co.

Generally speaking, the conference was well-attended and well-organized. The cavernous Convention Center never felt crowded, especially since the Exhibition and the Partnering areas were so far apart. Attendance “felt” reduced compared to previous meetings in Chicago and Atlanta, but this may have been due to the size of the convention center itself. But even in the partnering sessions, we noticed more companies were sending one delegate instead of two or three. This is not necessarily a bad thing, as there were plenty of decision makers at meetings. The speed of the follow up which is taking place this week is a testament to the enthusiasm of the folks we met with.

Demand for clinical and/or commercial assets appeared strong, with many companies seeking assets in areas such as CNS and pain. Niche areas such as parenteral hospital products appeared to be of interest. Our impression is that if a product is ~1 year or less from the market, then it will garner interest, irrespective of therapeutic area. In other words, companies seem to be more willing to shift their strategy and organization in order to embrace a near-term revenue opportunity, even a small one.

BIO usually attracts a strong ex-US contingent, and this year was no different. Over 70% of our meetings were with companies based outside the US. If you exclude Canada and Mexico, 64% of our meetings were with companies from Europe, Asia, and South America. We’re curious if the major European conferences attract such a large US contingency.

BIO continued to encourage the use of social media such as Twitter both prior and during the convention. The tweetup on Monday evening was well attended, and we were pleased to meet @3NT, @FierceBiotech, @IAmBiotech, @InVivoBlogChris, @ldtimmerman, and others. We believe BIO should continue to push for increased use of social media across our industry as a way to foster dialogue and communication amongst all of our industry stakeholders. Events like the 5K race on Monday were also a good way to stimulate social/informal discussion amongst attendees.

The Exhibition felt rather quiet at times (flash mob excepted). We think this was in part due to the East/West orientation of the hall. Exhibitors along the North wall away from the entrances may have suffered traffic-wise…at least it felt this way as we traversed the floor.

BIO 2012 returns to Boston next year. You can keep up with the action on Twitter by following @BostonBIO2012. See you in Boston!

The June, 2011 issue of Nature Drug Discovery has a interesting short article based on a survey conducted by our good friends at PharmaVentures. The authors surveyed 180 business development executives on their perceptions surrounding deal making.

One of the survey’s findings is that biotech BD executives believe that pharma licensees have greater power in driving deal terms due to their purchasing power. Conversely, pharma licensors believe that the biotechs have the power to drive terms because they are selling a scare asset(s). Another observation was that biotechs generally believed that upfront payments have dropped, while pharma executives believes that upfront payments have risen.

However, data from the PharmaVentures database suggest that these perceptions are not supported by the facts. According to PharmaVentures, the mean upfront deal value from 2006 is very close to the value in 2010.

The authors conclude (correctly, in our opinion) that these data reflect the real tensions existing in today’s market between desperate pharma companies looking to fill pipelines and desperate biotechs looking to monetize assets. While the former may cause bidding wars for highly sought after assets, the latter may cause downward pricing pressure from biotechs looking to remain financially alive (and hence willing to strike deals at lower values).

A singular observation made by the authors was:

We conclude that deal-making is strongly affected by issues other than the recent, persisting pressures in the financial environment – in particular, it is affected by the long standing failure of the research and development model of licensee pharmaceutical companies to produce sufficient late-stage assets, even through deal-making. [Emphasis added]

In other words, the authors note that pharma licensees have been unable to develop assets, irrespective of their source (internal discovery or external discovery). Thus, deal-making, even for “derisked” assets, does not actually increase the probability of successfully completing product development.

But why? Is it because big company bureaucracy interferes with product development? Is is that drug development is simply a remarkably difficult undertaking? Do we not understand pathophysiology well enough? Are the regulatory agencies becoming barriers to innovation?

The truth probably lies somewhere in between all of these factors, and likely others.

Now these results can be influenced by any number of factors, such as respondent experience, NCE versus non-NCE deals, therapeutic area, geographic scope of deals, asset maturity, etc. However, the results clearly point to issues that many of us in business development have noticed over the past few years, namely, that deal-making is more difficult, but not necessarily more rewarding, for either set of parties involved.

Today we learn that Rigel has raised $130 million in financing, in part, to develop candidates in rheumatoid arthritis and other areas. But, as reported by Xconomy, the real gem may be R343 for the treatment of asthma.

Essentially, the Big Pharma partner, as part of its cost-cutting and portfolio review, took a Rigel drug for allergy-induced asthma through early-stage clinical trials, prepared it for Phase 2, then decided to bail out on allergy and respiratory drugs entirely. So Pfizer, after investing its money in critical early stage tests, gave a much more valuable drug, called R343, back to Rigel.

The moral of the story is that a “divorce” from Big Pharma is not necessarily a bad thing, especially when the partner has made value-creating investments in the asset. Whether Rigel decides to invest in R343 or not, Rigel has a much more valuable, de-risked asset in their portfolio. Other prospective partners have undoubtedly started calling Rigel already.

Flowtown has a terrific (and large!) graphic entitled “The New Marketing Trifecta.” The trifecta refers to the three ways companies should (or could) be marketing their products and services. These are eMail, Mobile Devices, and Social Media.

This trifecta is clearly an approach that pharma/biotech companies will have to use in order to reach physicians with their messages. Indeed, the increasing number of “no-rep” physicians has been well documented elsewhere. So a lower-cost, digital approach makes sense (although whether pharma can be successful is an open question). What we notice from the Flowtown graphic is:

We believe that the use of this trifecta will extend beyond the company-physician relationship. In our field (business development), we already see a number of small innovator companies who are using social media to “promote” their technologies and projects. Their aim, in part, is to establish themselves in the eyes of potential licensing partners and even future acquirers and investors. In fact, we typically advise our clients to develop a social media strategy for the company and their products or services as early as possible. This gets their names into the digital information flow, and can result in inquiries from all over the world at lower cost.

Hat Tip to Karl Schmieder and our friends at Bridge6, who discuss this graphic in their most recent newsletter.

 

 


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Our Latest Article

The Life Sciences in Wyoming – Part Three of Three 
Posted on Dec 11, 2014

Article

In Part One of his series, Dr. Garrett Lindemann discussed some of the challenges facing Wyoming as it grows its life science industry.

In Part Two of this series, Dr. Lindemann highlights some of the life science companies which are already operating in Wyoming.

Now, in the third and final installment, Dr. Lindemann summarizes some of the life science companies already operating in the state of Wyoming.

_________________________

Existing Life Science Companies in Wyoming

The life science industry uses information and materials derived from biology and chemistry to produce products. Any company employing a process that uses cells like yeast or bacteria to produce products such as cheese, raised bread, yogurt or alcohol is a life science company.

With this as a working definition, Wyoming has had life science companies for a long time. Before Wyoming was a territory, life science companies existed. The Egyptians made mead, a fermented alcoholic drink from honey and the Romans made wine while the Germanic tribes made beer. Breads, yogurt, and cheeses made throughout the world are ancient methods to convert and store biological materials through cellular processes.

Therefore, Wyoming has a life science industry using both ancient technologies as well as a life science industry using modern technologies. Ancient life science technologies utilized in Wyoming are the breweries, bakeries as well as the distilleries located within the state. Those companies using modern technology and knowledge are rare.

The modern life science companies fall into four groups: medical devices, pharmaceuticals, bio-services, and agricultural biotechnology.

Medical Devices

Located in Casper, McGinley Innovations LLC, founded by Dr. McGinley MD PhD, a local radiologist has several innovations for treatment of sports related injuries and muscle-skeletal syndromes. The newest device is an innovation designed to prevent orthopedic screws from penetrating through the opposite side of the bone during orthopedic surgery. Currently, the device is at the alpha prototype stage.

Light Speed Biodetection, Inc., a subsidiary of Softray, Inc., of Laramie, is developing an imaging system to identify pathogens in donated platelets faster to increase the usable shelf life of the platelets by decreasing assay time and time to shelf. Based on research from the lab of Dr. Paul Johnson (UW Astronomy Department), the device is ready for commercialization.

Pharmaceuticals

The largest pharmaceutical company in Wyoming is Cody Labs, which extracts active pharmaceutical ingredients (APIs) directly from plants for finished formulation of ingredients for use in the manufacturing of generic medical products. The lab employs 100 people and is expanding the facilities and workforce an additional 23 positions by the end of 2014.

Southwest of Sheridan is the town of Big Horn, home to a virtual pharmaceutical company, FPR Pharma LLC. The company has a portfolio of novel therapeutic and cosmetic peptides. Within the research and patent portfolios resides information for several molecules demonstrating anti-inflammatory activity.

The company has moved the lead molecule far enough down the drug development pathway and is in discussions for a major investment and licensing agreement with a major pharmaceutical.

Bioscience Services

Dr. Don Jarvis’s faculty research laboratory at the University of Wyoming, the University of Wyoming and the Wyoming Technology Business Center (WTBC) has spun out GlycoBac LLC, a company leveraging Dr. Jarvis’s research and patents in the field of mammalian glycosylation.

Proper mammalian glycosylation expressed on manufactured therapeutic proteins improves biological activity and bioavailability of the proteins. Currently, the company is working to improve the existing technology as well as identify strategic partners and clients.

Research from the University of Wyoming Chemical Engineering Department’s laboratory of Professor Maciej Radosz and Graduate student Zachary Tyrrell have developed a novel system using supercritical methods to load increased quantities of drugs into micelles.

Ingredients for the micelles are FDA approved, and modifications to target cancer cells are available, thereby effectively increasing drug delivery through proper targeting and increased quantity of drug delivered.

The effectiveness of the supercritical method to form and load micelles is well researched and documented. The path forward for this young company is to provide devices and services to allow the increased efficiency of delivering approved cancer drugs to cancer cells through high loading of drugs into micelles that specifically target cancer cells.

PlanktOMICS algae bioservices LLC, is a spinout from the Department of Plant Sciences (University of Wyoming) based on the research of Dr. Stephan Herbert and Levi Lowder. A services company for the growing field of algae biotechnology is positioned to assist in the selection and/or genetic modification of algae species for research and commercial applications. Additional services included storage, maintenance and performance analysis of cultivars.

Agricultural Biotechnology

Based on the concepts of two UW graduate students, Bright Agro-Tech LLC, is a company with a novel method for growing agriculturally important crops (except root crops) in a vertical system.

The system is significant for the ability to increase the capacity and yield of crops over the existing norm of horizontal cultivation methods with the added feature of being able to bring fresh produce directly to the customer. Products include systems for backyard gardeners, as well as systems for commercial produce providers and ongoing sales of replacement parts.

Détente Genetics LLC, located in Sheridan, is a DNA barcoding company for livestock and companion animals. The company utilizes existing technology and selected Single Nucleotide Polyphorisms (SNPs) in a panel format to provide unique DNA barcodes for individual animals.

In the case of the meat industry (beef, pork, and lamb/mutton) these unique barcodes allow clients to follow product (carcasses and packaged meat) through the value chain, providing clients a method and process of traceability from farm to fork, linking the cut of meat to the original animal through the entire value chain.

An additional application of the technology is as a tool for making informative decisions based on the linkage of performance data to genetics for selective breeding to improve market traits of the animals from commercial herds as well as establishing full blood and pure breed lines with commercially desirable traits. The system provides a near incorruptible method to identify animals. It is difficult to falsify a genetic sample but it is easy to remove a microchip or obscure a brand or a tattoo as well as dye markings to change the appearance of the animal.

Astec Global is a Sheridan based company focusing on applying coatings to seeds to ensure uniformity of seed size to allow for even spacing of seeds during planting, thus providing better efficiency of planting across the entire field.

Additionally, the company has special applications of the technology including limited germination and fungicide application as well as novel labeling method. The results are pre-germinated seeds of uniform size and marked to prevent counterfeiting.

Future Wyoming Life Science Companies

Wyoming has the building blocks to form life science companies and has several early stage life science companies. The growth and success of these companies is an ongoing struggle as it is for all businesses. However, life science companies will find fertile soil in Wyoming for germination, growth and maturation. The state has junior colleges and the University of Wyoming from which to source talent and patents for the establishment of new life science companies. The business friendly status of Wyoming and the cost of living as well as the quality of life will appeal to the many talented people that needs must be imported for the success of life science companies.


Latest Posts

Mind The Gap: An Interview with David Grainger of Index Ventures 
Posted on Nov 26, 2014

Mind The Gap… We’re late to this party, but a really good interview of David Grainger from Index Ventures was published in July of this year. We encourage you to read the entire interview. In the meantime, here are a few items which caught our eye: Market Backwards Approach – Index Ventures takes a “market backwards” approach

A Billion Here, A Billion There 
Posted on Nov 21, 2014

The new DiMasi estimates for R&D costs were published this week. You can get a PDF of their slides here, while Ed Silverman has a nice summary in the WSJ. According to DiMasi, we’re now looking at $2.6 billion to develop a new drug. Now DiMasi has been performing this analysis and refreshing the data for

Pharma Likes Deals: Is This News? 
Posted on Nov 17, 2014

Earlier this week, The Economist travels over well-trod ground in an article on pharmaceutical industry M&A: It used to be all about achieving sheer scale, and building a broad portfolio of potential treatments for a range of illnesses. Now it is increasingly about drug companies concentrating on what they do best, and getting out of

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