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Today's Top Stories
1.
Forest CEO goes mano-a-mano with Carl Icahn
2.
Novartis plant snafu sends desperate Excedrin users to eBay
3.
Amid Krystexxa woes, Savient plots layoffs and taps new CEO
4.
Ranbaxy lines up plans for U.S. growth
5.
FDA plan requires opioid makers to fund anti-abuse CME
Editor's Corner:
An FDA warning letter often means a tipping point has been reached
Also Noted: Pegasystems and Cognizant
Spotlight On...
Top 20 licensing deals show shrinking dollar amounts
Investor sues Dendreon over Provenge sales info; Bristol-Myers launches offer for Amylin;
and much more...
More Fierce Life Sciences News:
1.
J&J offers up to $300M for each diabetes drug in Evotec/Harvard portfolio
2.
Spanish API maker has problems with tests, pests and water
3.
Abbott Labs strikes drug pact with Russian R&D group
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An FDA warning letter often means a tipping point has been reached
Every week there is some news, recall or event that reminds us that the give and take with the FDA over manufacturing often means poor GMPs give companies major headaches and take a lot of time and money to resolve.
A week ago, it was Johnson & Johnson ($JNJ) recalling nearly 70,000 packages of its K-Y Liquibeads Vaginal Moisturizer. This week it is an item on how Extra Strength Excedrin will cost you up to $100 a bottle on eBay. Extra Strength Excedrin is one of Novartis' ($NVS) many OTC products that are in short supply since closing a plant in Lincoln, NE, for remediation.
The thing is, when companies get to the point of a warning letter from the FDA, problems often have reached a tipping point, a place that takes an incredible amount of resources to rebalance. The examples you will find in our 2012 FDA Red Flags Report are not all tipping point examples but many are.
The report serves as a kind of warning itself on why companies just don't want to get to the place where they are receiving FDA warning letters. I can't imagine there isn't a company in this report that doesn't wish now that it had taken a different tack along the way and spent the time and money earlier to steer a different course. Of course hindsight is always 20/20. Read and see what you think. Click here to view the full report >> -- Eric Palmer (email | Twitter)
Read more about: K-Y Liquibeads Vaginal Moisturizer
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Today's Top News
1.
Forest CEO goes mano-a-mano with Carl Icahn
This time, Carl Icahn may have chosen a biopharma adversary as stubborn as himself. And that's saying something. Forest Laboratories ($FRX) CEO Howard Solomon shows no sign of backing down in his defense of the company's current regime. And he's perfectly willing to fight eye-to-eye with the activist investor. No shying away from a public argument here.
In fact, as Reuters reports, Icahn offered to compromise with Forest. Before launching his second proxy fight for four seats on the drugmaker's board, he offered to accept two seats on an enlarged board instead. It's a strategy that worked before with other drugmakers; Biogen Idec ($BIIB), for instance, gave Icahn one board seat to get his backing for two of its own nominees.
Solomon and his team would have none of it. The 84-year-old CEO disputes Icahn's criticisms--including charges that he's mismanaging Forest's response to the Lexapro patent expiration--and his board is backing him up. "[Solomon] just said, 'The board doesn't want you on.' And that was the end of it," Icahn told Reuters.
Instead, Solomon chose to go the distance. Not without reason; Forest shareholders nixed all of Icahn's nominees last year. And now that Icahn has started poking at Solomon's son David, the Forest chief has personal motivation.
Icahn took aim at the company's succession plan--or alleged lack thereof--suggesting that Solomon wanted his son to take the job. Now, Forest has hired an executive search firm to help. But that's as far as Solomon's sympathy goes. Want to critique my son's resume? What about your son's?
"I did not anticipate that my son David would be publicly disparaged and caricatured by someone utterly ignorant of even the slightest information about his qualifications or performance," Solomon wrote, going on to remind Icahn that he himself has appointed his son to the boards of public companies. "The qualifications of our sons should speak for themselves," Solomon added. And for the record, he said, David Solomon will be "neither favored nor handicapped" for promotion at the company "because of his relationship with me."
- read the letter from Solomon - see the Reuters news - get more, also from Reuters - check out The Wall Street Journal story
Related Articles Icahn looks askance at Forest CEO's stock trading Icahn confederate could profit off a seat on Forest board Forest urges investors to reject Icahn's board nominees
Read more about: Howard Solomon
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2.
Novartis plant snafu sends desperate Excedrin users to eBay
Johnson & Johnson ($JNJ) isn't the only drugmaker struggling to get recalled over-the-counter products back on store shelves. Novartis ($NVS) hasn't yet restocked brands pulled back in January, and consumers are fretting, particularly those who suffer from migraines.
Some patients swear by the Novartis pain reliever Excedrin Migraine, and it's simply not available these days. As ABC News reports, some have even turned to eBay for relief, paying more than $1 per tablet. "I went into panic mode after I found out about the recall," migraine patient Susan Scranton, who bought $500 worth on eBay, told ABC.
Novartis Consumer Health pulled Excedrin, along with No-Doz, Gas-X and Bufferin, after broken and mixed-up pills were found in packages. The drugs were among those made at a troubled plant in Lincoln, NE. Since then, the company has been working on fixes at the plant, but production hasn't gone back to normal. Besides Excedrin, products, including Maalox and pet drugs, are still running short.
The recalls have been giving investors headaches too, as Morningstar analyst Damien Conover recently told WNYC News, "It's not giant, but it's meaningful. It's weighing on the company stock." Unfortunately for users of the consumer meds, Conover expects inventory to be lower than normal till next year.
- read the ABC News story
Special Report: Fierce's 2012 Top 10 FDA Red Flags
Related Articles:
FDA report shows deep problems at closed Novartis Consumer Health plant
Novartis plant closure contributes to Maalox shortage in Canada
Novartis names new leader for its troubled OTC operations
Read more about: Novartis, Johnson & Johnson
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3.
Amid Krystexxa woes, Savient plots layoffs and taps new CEO
Savient Pharmaceuticals ($SVNT) had high hopes for Krystexxa, the gout drug it launched in 2010. But when it comes to drug sales, hope doesn't spring eternal. After $102 million in 2011 losses, and first-quarter Krystexxa revenues of just $3.1 million, the U.S. drugmaker plans to cut 35% of its workforce and trim costs to save $56 million annually.
Savient's cutbacks--about 60 jobs, including current vacancies--will leave the company with about 35 sales reps and three regional managers, Dow Jones reports. That's not much of a field force, but Krystexxa has proven to be more of a specialty drug for severe gout than a standard-issue treatment for the painful disorder.
Interim chief David Norton is also a casualty: He'll remain on the board, but will give up CEO duties to Louis Ferrari, who has been running Savient's North American commercial operations. Ferrari has worked at the company since February 2011, soon after Krystexxa won FDA approval. Norton had been filling in since February 2012, when ex-chief John Johnson jumped ship. Johnson is now CEO at Dendreon, which makes the cancer treatment Provenge (also with its own sales disappointments, but that's another story).
Actually, Savient never meant to field a sales force at all. The company wanted to win FDA approval for Krystexxa and then sell itself to a bigger company that could support its launch. But those hopes never came to fruition, either. So, as the Star-Ledger reminds us, the company added 62 to its sales roster last year to back up the Krystexxa launch. And now, it's on to Plan C.
- see the release from Savient
- read the Dow Jones coverage (sub. req.)
- get more from the Star-Ledger
Related Articles:
Hedge fund claims Savient's bankrupt after failed Krystexxa launch
Struggling Chelsea jettisons staffers, plots survival strategy
What will Dendreon's new chief do about Provenge?
Read more about: dendreon, Savient
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4.
Ranbaxy lines up plans for U.S. growth
You can't fault Ranbaxy Laboratories for lack of ambition. Or for lack of faith. The Indian generics company, majority owned by Japan's Daiichi Sankyo, refuses to let regulatory snafus dampen its desire to grow in the United States.
The company's tangle with the FDA is a familiar story: Back in 2008, soon after Daiichi swooped in to buy its stake, the agency barred 30 products from the country and confiscated shipments at the border. Plants in India had flopped FDA inspections, and the agency accused Ranbaxy managers of falsifying records. Ranbaxy labored for almost three years to settle its differences with FDA, and now it's operating under a consent decree with the agency.
The ongoing wrangle threatened to interfere with one of Ranbaxy's biggest drug launches ever: The exclusive rollout of an independently made Lipitor generic. Because it was first to ask FDA for approval of a Lipitor copycat, Ranbaxy had 6-month exclusivity to sell its version. If it hadn't worked out FDA approval at the last minute, it wouldn't have reaped the big benefits of that first-to-file monopoly.
And Ranbaxy CEO Arun Sawhney is well aware of the importance of first-to-file status. As he tells the Associated Press, gaining 180-day exclusivity is a linchpin of his plans for expanding in the U.S. Already, Ranbaxy is making headway, thanks in part to its Lipitor copy; the company's strong U.S. sales fueled 55% revenue hike worldwide in the first quarter, AP notes.
Two other strategies, as reported by the AP: Brand-name sales--the company just rolled out its first branded product, the malaria treatment Synriam--and new delivery methods for existing drugs. "The US, as a total business, will remain the most important to us," Sawhney told the news service.
- read the story from the AP
Related Articles:
Lipitor copy powers a surge in Ranbaxy sales, profits
Ranbaxy shipping generic Lipitor from new Indian plant
Ranbaxy CEO to ride out transformation under DOJ oversight
$500M charge eats away at Ranbaxy's Q4 sales hike
Read more about: Daiichi Sankyo, Ranbaxy
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5.
FDA plan requires opioid makers to fund anti-abuse CME
Making strong painkillers now comes with extra responsibility. The FDA has unveiled new measures aimed at nipping opioid abuse in the bud. They require drugmakers to fund educational courses for doctors and deliver more safety information to patients, hoping that better-informed prescribers and users can help.
"The problem of prescription drug abuse and misuse is very real," said Dr. Margaret Hamburg, the head of the FDA. "Educating healthcare professionals on how to safely prescribe (the medicines) is essential to address this critical public health issue."
But, as The Wall Street Journal points out, FDA can't require healthcare providers to take the classes. It can only mandate that the drugmakers--and there are more than 20 companies that make these powerful painkillers--provide grants for independently produced continuing medical education courses. The expectation is that at least 60% of prescribers will take the classes by 2016.
Who's most likely to sign up for the new CME? Well-intentioned doctors and other prescribers, the WSJ notes. "The people who are going to take those courses are the prescribers who are already diligent," the Center for Lawful Access and Abuse Deterrence's Michael C. Barnes told the newspaper. "What we need to do is get to those prescribers who aren't already diligent."
- see the WSJ piece
- get more from Reuters
Related Articles:
FDA to look again at reclassifying hydrocodone combos
Painkiller inquiry could aid Zogenix
Purdue aims to extend OxyContin monopoly with test in kids
Read more about: FDA
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Also Noted
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Webinar: Managing Aggregate Spend Compliance and Transparency for Life Sciences Organizations across the Enterprise Tuesday, July 24, 11am ET / 8am PT
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SPOTLIGHT ON...
Top 20 licensing deals show shrinking dollar amounts
Most biotech analysts have been concentrating heavily on the weakened flow of venture dollars into the industry. But if you look at the licensing side of the business, you'll also find some solid reasons for concern. For more, check out our list of the Top 20 biotech licensing deals this year. Report
@FiercePharma: Can a new CEO turn Savient around? Regrouping after weak Krystexxa sales, Savient to lay off 35% of workforce. News | Follow @FiercePharma
> Dendreon ($DNDN) was sued by an investor claiming that the company withheld information about sales of its cancer treatment Provenge that, when released, triggered a big drop in share price. Report
> Bristol-Myers Squibb ($BMY) officially launched its $31-per-share tender offer to buy diabetes drug specialist Amylin Pharmaceuticals ($AMLN), part of a two-stage deal that also expands a partnerhsip with AstraZeneca ($AZN). Article
> Eisai said its breast cancer drug Halaven failed a study in women with locally advanced or metastatic breast cancer who were previously treated with certain drugs. Report
> Contract manufacturer Siegfried plans to build a new active pharmaceutical ingredients plant in China. News
> FDA warned drugmakers to keep an eye on their supply chain for glycerin made from a plant used in biodiesel. Report
> Australian regulators declined to pull the Sanofi ($SNY) sleep drug Stilnox and its generics from the market despite worries about side effects, especially sleep walking and sleep driving. Report
> Sinclair IS Pharma expects fiscal year revenue to leap 56% on strong sales of its key skin product Kelo-cote. Story
Biotech News
@FierceBiotech: Analysis: Top 20 ?#biotech? licensing deals in H1 2012 - a buyer's market dominates the deal scene. Special Report | Follow @FierceBiotech
@JohnCFierce: J&J licensing a portfolio of diabetes products from Evotec. $8M up, up to $300M down per product in milestones. Release | Follow @JohnCFierce
@RyanMFierce: Ipsen (France) and Inspiration Biopharma (Cambridge, MA) halt late-stage hemophilia drug trials, program in question. Story | Follow @RyanMFierce
> Ipsen shares slide after FDA orders hold on PhIII hemophilia drug trials. Article
> Struggling Chelsea jettisons staffers, plots survival strategy. Story
> Regulatory setback raises fresh questions about Sanofi R&D comeback. News
Medical Device News
@FierceMedDev: Devicemaker Avinger pulled in $33M in fundraising to develop catheters. Item | Follow @FierceMedDev
@MarkHFierce: We have extended the nomination deadline for the 15 fiercest medical device developers to July 13. Spread the word. Survey | Follow @MarkHFierce
@DamianFierce: Abbott nabbed a CE mark for a new diabetes diagnostic the company says bests glucose monitors. Article | Follow @DamianFierce
> Obama signs FDA user fee extension. Story
> FDA sticks Class I label on Maquet's anesthesia device recall. News
> Avinger snags $33M to develop PAD catheters. Item
> St. Jude smacked with breach-of-contract suit over valve tech royalty payments. Article
Pharma Manufacturing News
@EricPFierce: FDA? warning letters , 483 reports can suggest a tipping point has been reached by a drug company. How about yours? Special Report | Follow @EricPFierce
> Ireland campus becomes Eli Lilly's launch pad. Story
> Abemarle again expands Michigan API plant. News
> AEI suggests booting WHO drugmakers that don't meet the grade. More
Biotech Research News
> Key molecule spotted as possible lung cancer weapon. Story
> Mouse model connects specific gene to liver cancer advance. Item
> Acadia's Parkinson's drug shows promise in treating Alzheimer's psychosis. More
> Nanomedicine busts deadly clots in promising mouse study. Article
And Finally... Finally, a video game that really is good for the brain. Report
> Managing Aggregate Spend Compliance and Transparency for Life Sciences Organizations across the Enterprise - Tuesday, July 24, 11am ET / 8am PT
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> EBook: Waiting for Guidelines, Will FDA take the reins of laboratory-developed tests? Read more: eBook: Waiting for Guidelines Should
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> Research: Special Report: Cancer Immunotherapy Production: Overcoming Obstacles to Profitability
Preventative vaccines have changed the face of infectious disease, even leading to the near eradication of polio. Now therapeutic vaccines are looking to change the treatment of cancer and other diseases. The science is exciting and the results are positive. But the challenges of manufacturing cancer vaccines could risk making this an impractical solution to an already complex problem. Download the report today.
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> Director, Reagent Manufacturing & Operations - San Francisco, CA - Fluidigm
Directly reporting to the VP of Manufacturing, the Director will be responsible for managing and directing Fluidigm's Reagents and Assays Manufacturing operations. This includes formulating manufacturing operations strategies in support of business goals and objectives, developing and mentoring manufacturing employees and driving continuous improvements to achieve optimal operational efficiency. He or she will set up the systems and tools to deliver quality products and services that will meet customers' expectations in the most cost-effective manner. The Director will also lead and manage the supply chain operations in South San Francisco which includes but is not limited to: purchasing, inventory management, supplier management... Learn more.
> Director of Operations at Pharm-Olam International
Opportunity for Director of Operations, with a dynamic and growing international Contract Research Organization ("CRO"), based at our global headquarters in Houston, TX. Director will assist the executive team in developing strategic and operational initiatives and their implementation. The successful candidate will provide leadership and direction to multiple departments in various countries to continue improving efficiency, improving processes and achieving corporate goals. Must have the energy and desire to help develop the best company in its field. Learn more here.
> Diabetes Educator - Roanoke, VA, US – Novo Nordisk
The field based Diabetes Educator is responsible for assessing, implementing and evaluating Diabetes Education based on ADA Standards of care. Educate primary care providers, specialists, Endocrinologists and other medical staff and patients on how to better manage people with diabetes according to national guidelines. A minimum of 3 years relevant experience...Learn more.
> Immunoassay Scientist Job – Pennsburg, PA – Yoh
Yoh has a contract opportunity for an Immunoassay Scientist to join our client in Pennsburg, PA. Responsibilities include Development and optimization of ELISA assays. In addition, write and amend SOPs, technical reports and protocols. MS with eight plus years of experience or PhD with three years of experience required...Learn more.
> Associate Scientist I - SAP-QM Consultant Job – Vacaville, CA – Yoh
Yoh has a contract opportunity for an Associate Scientist I - SAP-QM Consultant to join our client in Vacaville, CA. Responsibilities include to independently schedule and prioritize workload to ensure the work is performed in a timely manner and lead assigned projects. Extensive knowledge and familiarity of SAP systems, including Quality Module (QM) required...Learn more.
> Scientist Job – Emeryville, CA – Yoh
Yoh has a contract opportunity for a Scientist to join our client in Emeryville, CA. Candidates will develop a scale down model of commercial manufacturing processes and prove the model equivalence. Candidate will also use the model for investigations and be responsible for writing the findings in technical reports. Bachelors or Masters of Science degree and eight to ten years of industry experience is required...Learn more.
> Scientist III Job – Danbury, CT – Yoh
Yoh has a contract opportunity for a Scientist III to join our client in Danbury, CT. Job responsibilities include to effectively and independently execute routine analysis of dosing formulations and to troubleshoot effectively and solve scientific problems independently. Incumbent must hold a Master's Degree with three plus of years of experience in related scientific discipline or a Bachelor's Degree with seven plus years in the Pharmaceutical Industry...Learn more.
> Sr. Administrative Assistant, I Job - Summit, NJ, US – Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. Under the direction of the Corporate Counsel/Senior Corporate Counsel, this position will provide general secretarial, clerical and administrative support to several attorneys within the contracts/transactional/securities group of the legal department. Some Paralegal training and/or securities knowledge is a plus...Learn more.
> Director, Lymphoma Marketing Job- Summit, NJ, US – Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. The Director of Lymphoma Marketing is a key member of the REVLIMID® (lenalidomide) brand team responsible for the strategic leadership to successfully position REVLIMID for success in this important future indication. BA/BS required; MBA preferred...Learn more.
> Sr. Director, Shared Services Americas Job - Berkeley Heights, NJ, US - Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. This position is responsible for the design and implementation of the company's shared services strategy and ensuring that it is in alignment with the overall company strategy. 15+ years of Accounting / Finance experience, with at least 5 years managing Shared Services functions required...Learn more.
> Senior Controls Engineer Job - Phoenix, AZ, US – Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. This position will provide engineering (design) and technical support for multiple aseptic production lines and production support functions to ensure the efficient production of a quality product. Requires a Bachelors degree in Engineering or related science from an accredited college or university with a minimum of 5-7 years related experience in a pharmaceutical or engineering environment...Learn more.
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