Industry Briefs November 2014

Janssen Teams With CCFA for IBD Campaign

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Janssen Biotech is partnering with the Crohn’s & Colitis Foundation of America (CCFA) on a new educational campaign that provides resources for people living with inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn’s disease. The campaign, Get Your Full Course, features celebrity cook Sunny Anderson, who will not only provide recipes and cooking demonstrations online but will also speak about her own experiences dealing with UC.

“Having lived with UC for more than 20 years, I recognize the importance of talking more openly about the disease and educating people with IBD that we don’t have to shy away from food because of our disease,” Anderson said in a statement. “Food is a big part of my life. I am excited about Get Your Full Course and its focus on helping the IBD community learn about foods we can enjoy that are also rich in the nutrients we sometimes lack due to the way the disease affects the intestines.”

CSL Acquires Novartis’ Flu Vaccines Business

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Novartis has agreed to sell its influenza vaccine business to Australia-based CSL Ltd. for $275 million—approximately a quarter of its book value. This follows the deal that the Swiss drugmaker made in April 2014 to sell its non-influenza vaccines unit to GlaxoSmithKline for $7.1 billion plus royalties. Meanwhile, CSL plans to merge the newly acquired business with its subsidiary bioCSL to create the No. 2 player in the $4 billion global influenza vaccine industry, according to the Wall Street Journal.

“The Novartis influenza vaccine business provides bioCSL with a global leadership position in an attractive sector we understand intimately,” said CSL Chief Executive Paul Perreault in a statement. “It will transform bioCSL by giving it first-class facilities and global scale as well as product and geographic diversity.”

As part of the deal, CSL will acquire Novartis’ facility in Holly Springs, NC: The first FDA approved U.S. facility to produce flu vaccines using cell-culture technology, which makes it easier to quickly scale up production of vaccines during a pandemic, according to Bloomberg BusinessWeek.

BD Acquires Two Companies

BD was busy last month, agreeing to separate deals to acquire CareFusion for $12.2 billion and GenCell Biosystems, a privately held Irish biotech company, for an undisclosed amount. The merger with CareFusion will strengthen BD’s portfolio of medication management and patient safety solutions and enhance BD’s goal of improving the quality of patient care and reducing healthcare costs. Meanwhile, the GenCell Biosystems acquisition will add to BD’s genomics offerings thanks to GenCell’s proprietary technologies that address key biological analysis protocols.

Orexo Makes Zubsolv Available for Free

Orexo US, Inc. launched the Zubsolv Patient Assistance Program to provide in-need patients with the opioid dependence treatment for free. Currently, 1,000 patients will be allowed to participate in the program, if they meet the program eligibility criteria. Eligible patients’ household income must not exceed three times the federal poverty level and they can’t have insurance coverage that reimburses for Zubsolv. The program is being administered with the help of NeedyMeds, a national, registered charitable organization.

AbbVie-Shire Merger Called Off

After agreeing to a deal in July, AbbVie and Shire have called off the potential $55 billion merger. The U.S. Treasury Department’s revised tax rules were the leading reason why AbbVie decided to pull their offer. Previously, companies could get a tax break by moving their headquarters to lower-tax countries, but those deals are now far more difficult and less lucrative. Shire will still receive about $1.64 billion from AbbVie as part of a break-up fee.

“The agreed-upon valuation is no longer supported as a result of the changes to the tax rules, and we did not believe it was in the best interests of our stockholders to proceed,” AbbVie’s Chief Executive Richard Gonzalez said in a statement.

U.S. District Court Shaves 99% off $9 billion Actos Damages

In just April of this year, we reported that Takeda and Eli Lilly and Co. were fined $9 billion dollars in punitive damages after the controversial Actos (ploglitazone) diabetes case in which both companies were accused of hiding the product’s cancer-causing abilities.

Fast forward to Oct 27, 2014. A U.S. District court judge granted a motion from both companies that cut the damages 99%, down to $36.8 million, according to Bloomberg News. Louisiana U.S. District Court Judge Rebecca Doherty ruled that the punitive damages were “excessive” and cut the amount down “to the maximum amount a jury could have properly awarded.” Takeda officials, Bloomberg reports, say the cut was not large enough and plan to appeal.

J&J, GSK and Amgen Up Ebola Vaccine Efforts

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Johnson & Johnson, GlaxoSmithKline and Amgen are all doing their parts to try to deliver an Ebola vaccine as quickly as possible. J&J is working with Bavarian Nordic on a combination vaccine that features components based on AdVac technology from Crucell Holland B.V., which is part of J&J’s subsidiary Janssen, and the MVA-BN technology from Bavarian Nordic. The companies also announced a $200 million commitment to accelerate and expand the production of this potential vaccine, which has shown promising results in preclinical studies. The vaccine is expected to be tested for safety in healthy volunteers in Europe, the U.S. and Africa starting in early January. If successful, Janssen hopes to produce more than one million doses in 2015.

GSK Chief Executive Andrew Witty says that he expects the first doses of GSK’s Ebola vaccine to be ready later this year, according to Reuters. The company is even exploring how it can work with J&J as well as other pharma companies in order to quickly ramp up production.

Meanwhile, Amgen is working with the Bill & Melinda Gates Foundation and other groups to discover alternate production methods for Mapp Biopharmaceutical’s promising experimental drug ZMapp, which is difficult to produce in large quantities because it requires high doses of three different antibodies, according to Bloomberg BusinessWeek. Amgen will dedicate 12 to 14 staff members to research whether the drug can be made in Chinese hamster ovary cells.

Sanofi Removes Viehbacher as CEO

The Board of Directors of France-based Sanofi voted unanimously to remove Christopher Viehbacher as the company’s Chief Executive Officer. Chairman Serge Weinberg, who will serve as the company’s interim CEO as they search for a replacement, told the WSJ that the board was not happy with Viehbacher’s uncommunicative management style.

“On several points, the board had to ask for information that had never been presented during our meetings,” Weinberg said on a conference call with reporters. “There was a lack of trust; the relationship wasn’t close enough.”

According to Bloomberg BusinessWeek, Sanofi had even reached out to AstraZeneca CEO Pascal Soriot earlier this year—before the decision to officially remove Viehbacher—to gauge his interest in the position. However, according to those same sources, Soriot failed to express interest. Weinberg said that Sanofi’s search for a new CEO will involve mostly external candidates.

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