Private Equity firms snap up 50% of Rattapharm – 15 May 12

http://www.fiercepharma.com/story/private-equity-firms-snap-50-rottapharm/2012-05-15

Italy’s Rovati family has found its new partners, Bloomberg sources say. Two private equity firms will buy a 50% stake in the family’s drug maker Rottapharm, in a deal that values the company at about €1.7 billion ($2.2 billion). Under the agreement, Avista Capital Partners and Clessidra Capital Partners will each own a 25% stake in the company, leaving the Rovatis majority control. The family had been hunting for minority investors since last year. At a $2.2 billion valuation, this deal falls short of the family’s asking price; the Rovatis had valued their company at around $2.6 billion. Its 2011 revenues are estimated to be about €600 million ($770 million).

Merck KgaA reveals $385M in cuts – 15 May 12

http://www.fiercepharma.com/story/merck-kgaa-reveals-385m-cuts-geneva-protests-continue/2012-05-15

Merck Serono employees in Geneva may have won a battle, but do they have any hope of winning the war? Looking at the cost-cutting numbers Merck KGaA laid out today could be disheartening. After reporting a 48% decline in first-quarter profits (skewed by a one-time gain last year), the German company said it’s aiming for €300 million ($385 million) in pharma-related savings by 2014–and €120 million of that comes from shuttering Serono’s Geneva site. The now-unionized workers at Merck Serono’s Swiss headquarters are fighting that shutdown, which they say endangers 1,250 staffers and 250-odd longtime contractors. They’ve been protesting, petitioning and appealing to Geneva officials for backup. By threatening to strike, the employee group persuaded company officials to extend a required “consultation period” to June 4–giving the union more time to propose alternatives.

Big Pharma looks at Amylin’s books – 15 May 12

http://www.fiercepharma.com/story/big-name-pharmas-peer-amylins-books-prep-bids/2012-05-15

A who’s who of drug makers are eyeing Amylin Pharmaceuticals for a possible buyout. As Bloomberg reports, the world’s biggest drug makers have lined up to take a look at Amylin’s books as the U.S.-based company prepares to entertain a first round of bids. Among the Amylin shoppers are 6 of the Big Pharmas: Pfizer, AstraZeneca, Sanofi, Merck, Roche and Bristol-Myers Squibb. Japan’s Takeda Pharmaceutical is also checking the company’s stats, sources tell Bloomberg.

GSK buys Cellzome for $98M – 15 May 12

http://www.fiercebiotech.com/story/gsk-snags-proteomics-platform-tech-98m-cellzome-buyout/2012-05-15

Four years after it first clambered aboard Cellzome’s drug discovery platform, GlaxoSmithKline ($GSK) has opted to buy out the company for $98 million, snagging full rights to a pair of early-stage inflammation programs and a proteomics technology that it plans to use to screen drug candidates. In the deal GSK will cherry-pick the assets it likes, leaving room for a spinoff company to take shape with the unclaimed portion of work being carried out in labs in Cambridge, U.K. and Heidelberg, Germany

Glaxo goes hostile in its quest to buy Human Genome Sciences – 9 May 12

http://www.fiercepharma.com/story/glaxo-goes-hostile-hgs-26b-bid/2012-05-09

Prepare yourself for a drawn-out buyout battle–and lots of debate about the lupus treatment Benlysta. GlaxoSmithKline plans to launch a hostile bid for Benlysta partner Human Genome Sciences, without hiking its $2.6 billion offering price. HGS stiff-armed Glaxo’s friendly offer of $13 per share last month. The U.S.-based company said the price undervalued a., Benlysta’s sales potential, and b., the promise of two in-development drugs it’s working on with Glaxo. HGS then brought in the investment bankers for advice on its quote-unquote strategic alternatives.

Novartis buys Fougera to become #1 in skin drugs – 5 May 12

http://www.fiercepharma.com/story/novartis-now-top-dog-skin-drugs-15b-fougera-buy/2012-05-03

Another day, another deal. Novartis has snapped up Fougera Pharmaceuticals, a U.S.-based maker of generic skin treatments, for $1.5 billion. The buyout will make the Swiss company’s generics unit, Sandoz, the dominant player in dermatology knockoffs–and will add to Novartis’ top line at a crucial time. Novartis’ top drug, Diovan, loses market exclusivity later this year, putting the company in line for a billion-dollar hit to sales. New drugs such as the multiple sclerosis treatment Gilenya can help somewhat, but M&A is another key part of the strategy for pumping up revenue. “Certainly generic pharmaceuticals is a very good way, in these cost-conscious times, to make up revenue

Thermo Fisher Scientific acquires Doe & Ingalls – 1 May 12

http://www.doeingalls.com/Thermo-Fisher-Scientific-has-acquired-Doe-and-Ingalls

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that it has acquired Doe & Ingalls Management, LLC, a premium provider of specialty production chemicals and customized supply-chain services to the life sciences and microelectronics industries, for approximately $175 million in cash. Based in Durham, North Carolina, Doe & Ingalls operates service centers in key biopharma and microelectronics hubs in North America. The business generated 2011 revenue of approximately $110 million. “Doe & Ingalls’ comprehensive line of production chemicals and related services is highly complementary to our industry-leading channel capabilities, and will enhance the growth opportunities across both portfolios,” said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. “Doe & Ingalls will strengthen our value proposition by adding products and services that address the production market within our extensive customer base, which we have historically served primarily from a research perspective.”

Watson unveils $5.6B offer for Actavis – 26 Apr 12

http://www.fiercepharma.com/story/watson-formally-unveils-its-56b-plus-deal-actavis/2012-04-26

The ink has dried, and now it’s official: Watson Pharmaceuticals ($WPI) has agreed to buy its Swiss-based rival Actavis. The price–€4.25 billion ($5.6 billion) up front, plus a potential €250 million worth of stock in milestone payments–was about what the gossips expected, a total of $5.9 billion. There are plenty of reasons to applaud the combo: It will give Watson additional heft in the margin-shaving generics market, plus send it deeper into international markets, both in Western Europe and in emerging markets such as Eastern Europe and Russia.

Amgen jumps into generics with $700 deal to buy MN Pharma – 25 Apr 12

http://www.fiercepharma.com/story/amgen-joins-big-pharmas-branded-generics-club-700m-deal/2012-04-25

Big Pharma has been moving into emerging markets and shoring up sales with generics for some time. Now, the biggest of Big Biotech is joining in. In a twofer deal, Amgen has agreed to pay $700 million for Turkey’s Mustafa Nevzat Pharma, which makes injectable generics for sale in its home country and the surrounding region.

Life Technologies expands GIBCO manufacturing – 24 Apr 12

http://www.fiercepharmamanufacturing.com/story/life-technologies-expands-manufacturing-scotland/2012-04-24

The use of genetic sequencing in drug development is expanding and Life Technologies is lining up its pieces to get more of that market with a manufacturing plant expansion in Scotland. The company says that Scottish economic development agencies are providing some help so that it can invest $20 million in its operations in Inchinnan. The expansion will increase production of its GIBCO cell culture products. The company said it expects the site up and running next year and actually shipping products in 2014. It will serve markets in Europe, the Middle East and Africa. There are currently 500 employees working at its facility at Inchinnan.

 Pfizer divest Nutrition unit to Nestle – 23 Apr 12

http://www.fiercepharma.com/story/pfizer-gets-1185b-nutrition-sale-nestl/2012-04-23

As expected, Nestlé has prevailed in the steeplechase for Pfizer’s nutrition unit. The price, however, was better than expected: $11.85 billion, rather than the $10 billion estimated by analysts. All the more cash for Pfizer to share with investors and invest in its core pharma business. The nutrition-unit sale comes as Pfizer is readying a spinoff of its animal health business. The drugmaker announced its plans to shed both units last summer as part of a restructuring designed to streamline the company and focus attention on its branded-drug nucleus.

Roche walks away from effort to buy Illumina – 18 Apr 12

http://www.fiercepharma.com/story/roche-decides-fold-its-tent-when-illumina-offer-expires/2012-04-18

Roche said it wouldn’t extend its $51-per-share bid for Illumina, after voting tallies indicated that shareholders backed the gene-sequencing company’s incumbent board candidates, rather than Roche’s slate

Valeant Pharma continues buying spree – 18 Apr 12

http://www.fiercepharma.com/story/another-day-another-deal-valeants-pearson/2012-04-18

Valeant Pharmaceuticals made the M&A news again today: This time, the Canadian drugmaker scored some assets from Atlantis Pharma, a Mexican branded-generics company, for $71 million. The small deal, which gives Valeant a boost in the Mexican market, also adds one more piece to the puzzle CEO J. Michael Pearson is assembling, one deal at a time.

Takeda buys URL Pharma for $800M – 11 Apr 12

http://www.fiercepharma.com/story/takeda-snaps-url-pharma-800m-deal/2012-04-11

Takeda Pharmaceutical has nabbed another drugmaker. This time, the Japanese company is buying Philadelphia-based URL Pharma for $800 million upfront, plus potential follow-up payments. The deal gives Takeda the gout drug Colcrys, which brought in $430 million for URL last year. That hunk of revenue–expected to grow this year as Colcrys further establishes itself in the anti-inflammatory market–will help make up for sales lost to generic versions of stomach-acid fighter Prevacid, The Wall Street Journal reports. In fact, Takeda expects the URL deal to add $550 million to its top line this year

Covidien buys Oridion for $346M – 5 Apr 12

http://www.fiercepharmamanufacturing.com/story/oridion-picked-covidien-still-under-partial-fda-ban/2012-04-05

With the $346 million acquisition of Israeli device maker Oridion Systems that Covidien announced today, it is getting a company still operating under an FDA import restriction tied to GMP concerns. The all-cash deal was announced today, and Dublin-based Covidien, which also makes medical devices, expects the deal to close by June 30

To set up a meeting with an SAFC representative, or for more information regarding SAFC’s nucleic acid solutions, contact us here. We also invite you to fill out this survey to receive a 20% discount code on your attendee registration.

We look forward to seeing you there!

Over the past five years, a great spotlight has been placed on regulatory standards in the Pharma industry. Landmark scandals, such as the heparin scare of 2008, have forced the industry to come together to find innovative ways to source and manufacture safer products, while also increasing speed to market and security of supply chain. It is not an individual company or country issue, but rather a worldwide Pharma industry issue, and often times the lack of standardization of regulations across the industry creates setbacks. End user (patient) health has to remain top of mind and in order to be successful, companies need to be absolutely certain that the ingredients that they source come from reliable and secure places.

While some countries are ahead of the curve in regulations, others are still coming up to speed, and it is important to find ways to level the playing field for global companies. The Bulk Pharmaceutical Task Force (BPTF) recognizes this as an issue and is working with their members, and the greater pharmaceutical and regulatory communities, to find ways to ensure that the US drug supply chain is secure and that patients are protected.

As a member and chair of the Bulk Pharmaceutical Task Force, SAFC’s Director of Quality Assurance, Patty Benson has insight into the mission of group, as well as the future of the API industry. Here, Patty took the time to sit down and discuss a few of these items with SAFC Live.

Thank you for joining us, Patty. Please start by explaining what the Bulk Pharmaceutical Task Force is.

It is an affiliate organization of SOCMA (the US Society of Chemical Manufacturers and Affiliates) and it represents companies who manufacture or sell APIs, excipients and advanced intermediates into the US market. As these are FDA-regulated products, we have a lot of dealings with the US FDA and also the European counterparts. While some of the member companies may have headquarters in Europe, all do business in the US.

What benefits does it offer its members?

Perhaps the most important benefit is that we continuously review the legislation and guidance that comes out of various countries. Most of these legislation and guidance documents have a commenting process where input is requested from the industry and other stakeholders. The documents are often revised to take the industry comments into account. BPTF stays current on the documents and represents its members in providing these comments.

In recent years, for example, we have commented on chapters of the US Pharmacopeia regarding residual solvents and heavy metals. We have also commented on guidance documents, such as the recent European guidance on GMP for API manufacturers. We are able to provide a mechanism for member organizations to combine their thoughts and their comments, and give a single response that, hopefully, will carry more weight.

What about links to the regulators? Do you engage with them on behalf of members?

Yes, we do. A good example of this is the proposed Generic Drug User Fee Act, or GDUFA. It is similar to PDUFA for prescription medicines, and would allow the FDA to collect fees from generic product and API manufacturers to help fund application reviews and inspections. At present, there is a huge backlog of generic applications in the US which is largely due to the time involved for approvals; on average it can take about 30 months for a generic application to be approved. That is way too long. So the FDA approached us, along with the European Fine Chemicals Group in Europe (an organization in Europe that is affiliated with European chemicals trade association Cefic) and the Generic Pharmaceuticals Association (trade organization for generic drug manufacturers), to work together to develop GDUFA which is now in the process of becoming law.

Are there any other big issues that BPTF is concerned about?

One important issue we have become concerned with in recent years is the lack of parity between US, European and Japanese manufacturers, and those from countries like China and India, where regulations are more lax. The US FDA has a regulatory obligation to inspect US manufacturers every two years, yet there is no such regulatory requirement for foreign manufacturers. This presents a very uneven playing field to US manufacturers – especially as foreign manufacturers supply about 80% of all the APIs that are used in the US. We have put forward citizens’ petitions on this, and one of the primary focuses of the GDUFA negotiations was trying to bring inspection parity between foreign manufacturers and those based in the US. We also recognize that other heavily regulated markets like Europe, Japan, Australia and Canada have similar regulatory requirements to those in the US, so we believe that the FDA should focus its limited resources on those countries where the regulatory pathway is not as mature. The whole reason for looking at the quality of ingredients is to minimize patient risk, and there is certainly not as much patient risk from ingredients originating in highly regulated countries as from those where the regulatory system is less mature. Yet there is still a lack of parity with EU manufacturers – if they are inspected by the FDA they will be notified in advance and the duration of the inspection is usually limited; this is true of any foreign country inspection. This is in contrast to the US, where the inspectors arrive unannounced, and the inspection can last much longer. Our ultimate goal is to achieve parity between inspections in the US and those carried out in any foreign country.

What other benefits does it offer SAFC as a company?

In my personal opinion, one of the major benefits is being able to network with other people in the same business. Certainly, we have to work under strict antitrust guidelines, and of course we do not speak about topics such as pricing or customers, but it does allow us to bounce questions off people who have similar experiences, and may have faced a similar issue before. We generally have a very good relationship with the people we meet within BPTF, and use this to develop and share best practices in terms of how to manufacture APIs, excipients and advanced intermediates. I believe this is a real benefit to the patients we are ultimately serving.

Does BPTF do anything else?

In the past it has sponsored courses, particularly GMP courses, to train people within the industry by bringing in regulatory experts, including FDA representatives. This has not been done for a little while, partly due to economic reasons and restricted travel budgets, but we are now looking at what other education tools we can offer, such as webinars. We also have published best practices and guidance for members to reference, such as the quality agreement template that drug product manufacturers can use to help them set up quality agreements with their API manufacturers. It takes into account the regulations, what API manufacturers are expected to do, and the kind of information they have to communicate back to the drug product manufacturers. Then when customers use this template, the API manufacturers do not have to deal with quality agreements in varying formats, which makes managing quality much more straightforward.

Another activity is our work with the International Pharmaceutical Excipients Council, where we have partnered on some of the issues in the heavy metals guidance that ICH is working on. Finally, we also work with Rx-360, the international supply chain consortium, where we have observer status, and SAFC is a board member.

So what issues are in the pipeline for the near future?

The ICH is reworking heavy metals guidance with the expectation that both the US Pharmacopeia and the European Pharmacopeia will follow what ICH develops. That will then get both agencies, plus the various other regulatory agencies, working together on how exactly to implement heavy metals testing.

Another item on the horizon, of course, is GDUFA; these regulations are now working their way through the legislature. Though we do not know exactly what it will look like once Congress is finished with it or how the FDA will implement it, it is something we await with much interest.

Q1 serves as a lead into even greater expectations for SAFC’s continued organic growth throughout 2012 and beyond. Sachdev provided further detail about these expectations, “With 1% organic growth for SAFC in Q1, we continue to expect sales growth to achieve low- to mid-single-digit organic growth in the second quarter as it is impacted by the same tougher comps related to the pre-buy in the SAFC Bioscience business in 2011, a slightly weaker LED market and capacity constraints in Hitech, which will be progressively alleviated beginning in the second quarter as our new Taiwan plant comes online.”

For the full Q1 2012 earnings report, please click here.

Patty’s presentation in the “Perspectives From Active Pharmaceutical Ingredient (API) Suppliers” panel is available for reference here: Q3D BPTF 0412.

To learn more about SAFC, please click here.

SAFC Live: Hi Kevin. Perhaps you could start by telling us where the idea for the CHOZN platform system came from?

About three years back, part of our in-house strategic plan involved interviewing around twenty-five customers from various global biopharma companies that make recombinant proteins. I asked them what they think makes for a really good manufacturing process, and consistently a robust supply chain and high productivity were at the top of their list. From there, it became obvious to us that we could and should be looking to build a CHO platform system to meet their needs. We had recently acquired the rights to use ZFNs and thought of the idea to use that technology and combine cell engineering with our media development skills. The goal was to design a CHO cell expression system that closely resembled what our customers were looking for. To do this, we listed all the characteristics they said they wanted, and went back to them for clarification of their definition of items such as ‘higher productivity’. All of the resulting specifications were put into an ISO design control process to start creating the CHOZN system.

SAFC Live: What does the CHOZN platform system include?

It is a cell line, medium and feed supplement system that is completely chemically defined from start to finish; it is also animal component free. From a commercial standpoint, this is the first time that an off-the-shelf platform like this has been available to biopharma companies that did not have their own cell line platform available. It allows them to create and select a stable cell line to maximize production of recombinant proteins quickly and efficiently, increasing speed to market and reducing costs. There are in-house versions at companies like Amgen and Genentech, but they are not available for sale to third parties. We took what these big, sophisticated companies have and tried to make a system that is available to anyone. They might be a little biotech company out of San Francisco, say, with just six people in a lab, but by buying our new platform system they will be capable of producing the sorts of titres that Amgen and others routinely achieve.

SAFC Live: That sounds like a lot of effort!

It was, yes. To put it into perspective, if a biotech company were to try to build it for themselves from scratch, it would take several years, and the outcome would still be uncertain. We have garnered a great deal of expertise over 25 years of media design work and that experience was the real basis that enabled us to create the CHOZN system of cell line, medium and feed. It includes all the procedures that take you from transfection right through to harvest of the material.

During development, we decided to use the CHOZN GS knock-out CHO cell line as the base of the ‘pyramid’, as we felt that this was the strongest system available. It was used as the basis of all our design, and the plan is to trait-stack on top of that in future. It was also built with harmony in mind; cell, media and feeds all were designed together. This is a result of many years of design effort creating custom media formulations for customers’ cell lines that enable them to achieve high productivity levels. When you think of it, it seems like a crazy number, but each customer’s CHO cell is different, and so they require different things from their media. It would not work to make a platform system without having a platform cell line as the basis for it. Unfortunately, there is no such thing as a medium that is universally good for all of the diverse cell lines used in the industry. The CHOZN cell line is in harmony with the medium, the medium is in harmony with the feed, and the procedures have been designed to optimize the whole process. This is the reason why we put it all together as a package.

SAFC Live: So what about the future?

The GS CHO cell system is our first version of the system and will enable smaller organizations to manufacture efficiently in the same way large companies can without having to invest a lot of time and energy. The plan is to trait-stack on top of this to make further improvements to cell culture performance and efficacy. Next year, it is likely we will be able to offer a triple knock-out cell line with the GS, GGTA1 and CMAH genes all knocked out. Viral resistance will also be added in the future, and we will continue to stack traits on top of the system. As our research finds new ways to make better cell lines along the way, we will work to introduce them. Additionally, as we continue to improve our nutritional biochemistry knowledge of CHO, we will also incorporate that into the media and feeds. This will be an ongoing process, and over time we will create a platform that steadily gets more productive and efficient for our customers.

To read the full release, please click here.

For more information on SAFC’s CHOZN Cell Lines, visit: www.safcglobal.com/chozn

For more information on SAFC’s CompoZr ZFN offer, visit: www.safcglobal.com/zfnkits

For more information on SAFC’s Cell Design Studio (CDS) offer, visit: www.safcglobal.com/cces

St. Louis, Mo. – April 11, 2012 – Sigma-Aldrich Corporation (NASDAQ: SIAL) today announced that its custom manufacturing and services business unit, SAFC® (www.safcglobal.com), is launching the CHOZN® Platform system, a CHO (Chinese Hamster Ovary) cell expression system that allows for faster, simpler selection and scale-up of high-producing clones for the production of recombinant protein drugs. The new platform consists of the cGMP-produced and tested CHOZN® ZFN Modified GS-/- CHO cell line, an optimized set of cGMP-produced, chemically defined media and specially designed feeds to maximize production of r-proteins. The CHOZN® Platform system has been designed and tested to perform from initial cell line engineering process and stable cell line selection, through large-scale growth and production, providing an off-the-shelf production solution for biopharmaceutical developers who do not currently have a cell line platform. Used for the production of biopharmaceuticals, the CHOZN® GS-/- cell line is the first commercially available glutamine synthetase (GS) knockout CHO line proven to shorten bioproduction times in early development, enabling customers to enhance their speed to market and decrease costs. For more information about the CHOZN Platform, visit www.safcglobal.com/choznplatform.

Along with the cells, media and feed, SAFC provides extensive user protocols covering transfection through scale-up to small scale bioreactors, as well as comprehensive cell line safety testing and development history.

“The CHOZN Platform system provides a solid foundation for SAFC’s continued cell and media development program,” says Bruce Lehr, SAFC Director of Cell Sciences and Development. “It has been proven to show a reduction in product development timelines, enabling customers to get their molecules into the clinic faster. Furthermore, it sets the stage for future cell line enhancements to affect characteristics like protein quality, molecule safety and efficacy, as well as improvements to upstream or downstream biopharmaceutical process development.”

The CHOZN Platform follows the 2011 release of the CHOZN GS-/- and CHOZN DHFR-/- CHO lines.

For more information on SAFC’s CHOZN Cell Lines, visit: www.safcglobal.com/chozn

For more information on SAFC’s CompoZr ZFN offer, visit: www.safcglobal.com/zfnkits

For more information on SAFC’s Cell Design Studio (CDS) offer, visit: www.safcglobal.com/cces

To learn more about SAFC’s Cell Design Studio, which includes ZFN technologies and services, please click here.

To directly contact SAFC for more information about products and services, please click here.

To read the full press release, please click below. To learn more about SAFC’s line of PharmaGrade Products, please click here.

Sigma-Aldrich Acquires Research Organics to Strengthen Portfolio of PharmaGrade Raw Materials

April 2, 2012 – St. Louis, Mo. – Sigma-Aldrich Corporation (Nasdaq: SIAL) announced today it has acquired all outstanding shares of Cleveland, Ohio-based, Research Organics, Inc., to expand the Company’s buffer production capacity and to increase its portfolio of PharmaGrade raw materials for the biopharmaceutical and diagnostic markets.  Research Organics is a leading supplier of high purity biochemicals for use in molecular biology, diagnostics, cell culture, pharmaceuticals, biopharmaceuticals, life sciences and biotechnology and will transition into SAFC, the custom manufacturing and services business unit of Sigma-Aldrich.

“Research Organics is an important addition to our pharmaceutical grade portfolio of raw materials for the biopharmaceutical industry,” said Gilles Cottier, Executive Vice President, Sigma-Aldrich, and President, SAFC.  “This acquisition is an outstanding complement to our existing raw materials portfolio and will help us provide more innovative solutions for some of our customers’ toughest supply challenges.  It will also enable us to provide SAFC’s customers with true dual sourcing of buffers from two of the world’s leading manufacturing sites.”

Founded in the 1950’s, Research Organics was a pioneer in manufacturing zwitterionic biological buffers and developing the HEPES buffer as an industry-standard.

“Joining Sigma-Aldrich is positive for Research Organics, our employees, customers and the city of Cleveland,” said Rob Sternfeld, President of Research Organics.  “The acquisition provides the resources to expand the growth of our business, to enhance our product line and to upgrade our facilities to meet ever changing industry requirements.  We will continue to provide our customers with the superior quality and service they deserve and have come to expect.”

Terms of the purchase were not disclosed.  The Company expects this acquisition to be neutral to earnings per share in 2012.