The company issued a press release noting that it has received conditional marketing authorization from the European Commission for Pixuvri®.  This pertains to the company’s controversial pixantrone as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. The company further noted that Pixuvri is the first approved treatment in the European Union in this patient setting.

Cell Therapeutics will get to market Pixuvri in the 27 Member States of the European Union but it will also get to market in Iceland, Liechtenstein and Norway.  The company also plans to make Pixuvri immediately available through a named patient program and the marketing and commercialization of Pixuvri will start with CTI’s own sales force in the EU starting in the second half of 2012.

Conditional approval is not an open-ended and endless approval.  On this front the company noted, “conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.”

Shares closed up almost 15% at $1.16 on more than 8 million shares today and the 52-week trading range of $0.95 to $2.40.  Even after the pop, this stock has a market value of $236 million.

JON C. OGG

In addition, ViroPharma has received a notification that the Federal Trade Commission is conducting an investigation into whether the company has engaged in unfair methods of competition with respect to Vancocin.

Vancocin is indicated for the treatment of C. difficile-associated diarrhea and is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including MRSA).  Vancocin is contraindicated in patients who have experienced a hypersensitivity to vancomycin.

ViroPharma also noted that the FDA informed the company that the recent supplemental new drug application  for Vancocin which was approved back on December 14, 2011 would not qualify for three additional years of exclusivity.  The ruling was based on the agency’s assertion that in order for an sNDA for an old antibiotic such as Vancocin to be eligible for a grant of exclusivity, it must be a significant new use or indication.  Furthermore, the FDA indicated that it is approving three abbreviated new drug applications for generic versions of vancomycin capsules.

The company is going to try to fight it out and noted that it intends to file a complaint in the United States District Court for the District of Columbia.  In the complaint the company will seek an injunction to set aside the FDA’s approval of ANDA’s for generic versions of Vancocin.  The courts had previously dismissed ViroPharma’s lawsuit on the procedural basis of standing, but ViroPharma is claiming that the substance of the company’s bioequivalence arguments and the arguments regarding Vancocin’s eligibility for exclusivity have not been litigated before the Court.

Investors are shooting first and asking questions later.  Shares closed at $28.61 against a 52-week range of $14.62 to $33.17, but shares are down over 19% around $23.00 in active pre-market trading.

JON C. OGG

The FDA has now decided to delay its approval decision date by three months (out to July 17) on VIVUS’ obesity pill called Qnexa.  VIVUS had submitted the FDA’s requested data on the company’s risk evaluation and mitigation strategy.  The new plan was based upon discussions that VIVUS had with the agency after FDA panel advisers voted in favor of Qnexa in late-February.  That move sent shares through the roof even though the panel did raise some concerns that Qnexa may potentially contribute to birth defects in pregnant women and due to some heart risks.

As a reminder, VIVUS is in a race with Arena Pharmaceuticals Inc. (NASDAQ: ARNA) and also with Orexigen Therapeutics Inc. (NASDAQ: OREX) to win the first FDA approval for an obesity pill in more than a decade.  The weight loss pill market has been riddled with side effects and the history has been less than pleasant.  Now the hope is that the obesity epidemic has reached such a large size and has created such a high cost that the FDA will weigh the benefits over the risks.

VIVUS shares were down about 8% around $21.10 on last look on Monday evening after the FDA delay was announced and shares are indicated around $21.15 in early bird trading on Tuesday morning with well over 2 hours until the market opens.

JON C. OGG

Thoratec issued a statement commenting about the recall on a recent voluntary medical device correction notification related to the bend relief component for the sealed outflow graft of the HeartMate II® Left Ventricular Assist System.  Here is what matters today: “The company initiated the voluntary Notification to clinicians on February 23, 2012.”

The company noted, “Following the company’s voluntary Notification to clinicians on February 23, 2012, the FDA posted information regarding the action on its website during the week of March 19th.  Today, this same information appeared in the news section of the FDA website.  However, today’s posting was only a reference to the previous communication, and there was no new information provided.“

Thoratec has also contacted all hospitals where the HeartMate II sealed outflow grafts had been distributed.  It noted, “The company’s voluntary Notification was intended to provide information to clinicians, including a clarification of the instructions for use, and did not involve the return of any product.  Subsequently, the company received acknowledgment forms from surgeons at all such U.S. hospitals, verifying that clinicians have reviewed the Notification and understand the information provided.”

This was a situation where the news seemed more like re-news.  It has happened before and it will happen again in the future.  After having been down as much as 10% earlier, Thoratec shares are down just under 4.5% at $32.81.  It is probably safe to assume that analysts who rate Thoratec as “Buy” and “Outperform” will be defending this one Thursday morning.

JON C. OGG

Back on March 19 the FDA recall site noted, “The reported incidence of the defect, disconnected outflow graft bend relief, is 0.91% (29/3,200). Of these 29 incidents, 24 were observed in x-ray images or during surgical procedures, and were thus unlikely to be related to patient symptoms. However, in at least one reported case, it is noted that the disconnected bend relief may have contributed to the need for reoperation. The bend relief is designed to prevent kinking of the outflow conduit that connects the HeartMate II pump to the ascending aorta.”

The FDA also noted in mid-March that the disconnection of the bend relief from the outflow graft might cause one or more of the following symptoms:

• low pump flow, hemolysis,
• fluctuations in pump flow,
• speed and/or power,
• or worsening symptoms of heart failure.

The rates of incident were very low, but some fatalities at the time were reported.  Unfortunately, recalling heart devices is no easy measure and the product was said to have been sent to 226 hospitals throughout the United States, Europe, Canada and other countries.

Thoratech shares had been down as much as 10% but the stock is now down “only” 5.6% at $32.42 on about six-times normal trading volume.

Dear Patient, We need to borrow you to get at your heart again….

JON C. OGG

Sadly, this could actually create a one or two year delay and the company was worth only $246 million before the news impact.  Chelsea has said that it still needs to have discussions with the FDA so that it can satisfy the FDA’s request.

The company believes that an ongoing trial might meet the FDA’s criteria but it is not sure if the FDA will require changes to the primary endpoint of Northera.  Unfortunately this is still just unfinished business.

Investors are shooting first and asking questions later.  Shares are down 28% at $2.62 in pre-market trading and the 52-week trading range is $2.18 to $6.06.  The NASDAQ pre-market trading alert has already gone over 800,000 shares and it is worth noting that the most recent short interest was at a yearly high of 7.26 million shares as of the March 15 settlement date.

The company is pre-revenue and it had about $45 million in liquidity at the end of the 2011 year.

JON C. OGG

As a reminder, Amylin agreed to pay $250 million to Lilly as well as milestones of up to $1.2 billion for the molecule that makes up Byetta.  Amylin also confirmed that it will be responsible for the commercialization of Byetta outside of the United States.  Amylin is still working with Lilly during the transition period through 2013.

Amylin shares have not responded so far this morning and the indications have not been matched with any real share volume.  At $15.51, the 52-week range is $8.03 to $18.45.

Amylin currently has a market capitalization rate of $2.27 billion as of now and the company is expected to lose money in 2012 and 2013 even though revenues are expected to be about $681 million and $837 million for 2012 and 2013, respectively.

JON C. OGG

What makes Boniva unique in the osteoporosis market other than that Sally Fields was the ad woman is that it is a once per month tablet marketed to prevent osteoporosis in women after menopause. The osteoporosis drug aims to help increase bone mass to reduce the risks associated with weak bones and spinal fractures in women.

Apotex previously agreed not to sell the drug until the patent rulings were out, so the FDA allowance for generics will allow generics to begin selling.   There is an interesting set of figures.  At least 5 million patients are on one of the drugs under the class called “bisphosphonate therapy” which Boniva is one of several in that class.  Drugs.com noted that the total size of the osteoporosis market is $18 billion in the United States.

Mylan shares are down slightly on the day.  What portion of this generic market it can capture is still an unknown.

JON C. OGG

The European Commission has granted an Orphan Drug Designation for the company’s TH-302, a hypoxia-targeted drug for the treatment of soft tissue sarcoma.  Soft tissue sarcoma is an aggressive form of cancer for which there is a significant unmet medical need.

The company noted that TH-302 was designed “to selectively target hypoxic regions within tumors, which are believed to not be effectively treated with current therapy.”

Keep in mind that Threshold shares were well under $2.00 at the start of 2012. Shares closed on Thursday at $6.73.  This stock has traded in a range of $1.18 to $7.50 over the last year and its market capitalization rate is $330 million.

JON C. OGG

One reason Walmart suddenly has taken the action is First Lady Michelle Obama, the poster child for the new initiative. Walmart went so far as to get a quote from her for its press release about Great for You. She said:

 Today’s announcement by Walmart is yet another step toward ensuring that our kids are given the chance to grow up healthy. Just over a year ago, Walmart committed to save shoppers a billion dollars in their cost of fruits and vegetables and the fact that Walmart exceeded this number is a real accomplishment and a milestone in our efforts to support families eating better. In addition, the healthy seal will be another tool for parents to identify the best products for their kids. Giving parents the information they need to make healthy choices is a key piece of solving childhood obesity.

The quality of Walmart food products probably was never an issue for her and her family. Mrs. Obama did not mention it, but she likely was never a regular patron of Walmart. She almost certainly is not now, either.

The Walmart decision matches ones made by other huge American companies that sell food, either fast food or food that people take home to cook. McDonald’s (NYSE: MCD) is the best example. Last summer, the largest fast-food chain said it would offer low-calorie options for children’s meals. McDonald’s also said it would reduce sodium content in some of its food by 15% by 2015.

Stores and fast-food companies have tried to create the illusion that they have only recently gotten the FDA list of food content by product and studies about which food ingredients undermine healthy eating habits. What actually happened is that pressure from the government and public to cut back on the fatty foods that people love most became overwhelming. Some of the blame for unhealthy foods does fall with the customers. But to turn what should have been done some time ago into a press event masks a lack of actions — ones not taken by these companies for years.

Douglas A. McIntyre