Showing posts with label King Pharmaceuticals. Show all posts
Showing posts with label King Pharmaceuticals. Show all posts

Sunday, February 12, 2012

Revealed - UK NHS tests for Transfusion related vCJD. US California new cases.


In More Bad news for purveyors of Bovine derived products and transfusion supporters, thousands of NHS patients could be secretly monitored by the Government for symptoms of the human form of mad cow disease amid concerns that there could be another wave of infections.

Experts advising the Department of Health believe patients who have received more than 80 blood transfusions are most at risk of developing the fatal brain disease because it can be passed on through infected blood.

They say monitoring these patients could give vital clues about the way the disease develops and is transmitted from person to person and could help work out whether there are likely to be further deaths. 
Thousands of NHS patients could be secretly monitored by the Government for symptoms of the human form of mad cow disease amid concerns that there could be another wave of infections
Thousands of NHS patients could be secretly monitored by the Government for symptoms of the human form of mad cow disease amid concerns that there could be another wave of infections
It could also inform officials whether the risk from blood donations needs to be treated more seriously.

But they are considering conducting their surveillance secretly because they fear that informing patients they are at risk and are being monitored will cause unnecessary alarm.

The proposals have been discussed by a powerful panel of leading scientists and doctors, which advises the Government on the disease, known as variant CJD.

The panel's report, published online, suggests conducting 'covert health surveillance' of around 30,000 patients known to have received a high number of blood transfusions.
Experts would expect to see at least 150 cases of vCJD in this group of patients, based on scientific evidence that between one in 4,000 and one in 20,000 of the population may be infected.

Experts advising the Department of Health believe patients who have received more than 80 blood transfusions are most at risk of developing the fatal brain disease as it can be passed on through infected blood
Experts believe patients who have received more than 80 blood transfusions are most at risk of developing the fatal brain disease as it can be passed on through infected blood
But this has so far not been seen and may either mean the risk is lower than previously thought, or that it is taking longer for cases to develop.

The 'highly transfused' group includes people suffering life-threatening illnesses including acute leukaemia, aplastic anaemia and the blood disorder thalassemia - as well as those with multiple injuries due to road accidents, or heavy blood loss from aneurysms. 

The report acknowledges that following patients without their consent is 'ethically problematic'.

But the panel, a subcommittee of the Advisory Committee on Dangerous Pathogens, has asked the Health Protection Agency to set out the various options for monitoring these patients based on seeking their consent or not. 

Chris James, chief executive of the Haemophilia Society, said: 'We are shocked to learn there was ever any suggestion of non-consensual monitoring. 
'Given the history of contaminated blood in the 1970s and 1980s, the maintenance of medical ethics is especially important to the haemophilia community.

'Any proposed framework must be reviewed by an ethics committee and open to challenge from individuals and organisations such as ourselves through a formal consultation process.' 

Latest official figures show seven NHS patients have died from vCJD after having blood transfusions.

Four are known to have been given blood from people who were infected with fatal vCJD, and the other three had previously had transfusions although it is not known whether the blood was contaminated.  
Since the first vCJD cases emerged in the mid-1990s, 175 people in Britain have died from the brain wasting disease, which is linked to eating beef infected with BSE.

Experts predicted that hundreds more could die after receiving blood infected with the disease. But they now admit they are baffled as to why these cases have failed to emerge. 

One theory is that some people have a genetic advantage and may only carry the disease without developing symptoms. However, they can still infect others if they give blood.

In one case, a patient is known to have been exposed to vCJD in a blood transfusion and is still alive 24 years later. 
A memorial plaque to victims of Human BSE on the Riverside Walk near Westminster Bridge
A memorial plaque to victims of Human BSE on the Riverside Walk near Westminster Bridge, London

At the moment, patients are only informed that they are at increased risk of developing vCJD if they have been exposed to blood from more than 80 donors and if they are about to have brain, spinal or complex eye surgery.

But this threshold may now be raised to only inform patients if they are exposed to 300 or more blood donors because the lack of vCJD cases so far may indicate that the risk of catching vCJD in blood may be lower than previously suspected. 

Judy Kenny, of the CJD Support Network, whose husband Deryck died aged 69 in 2003 after being given contaminated blood, said: 'If the authorities are going to do any monitoring, patients should be aware of it. 
'There is no grey area - if they are thinking about unconsented monitoring, then it is wrong.'
CJD occurs when nerve-tissue proteins called prions (illustration above) turn 'bad' and gradually destroy the brain
CJD occurs when nerve-tissue proteins called prions (illustration above) turn 'bad' and gradually destroy the brain


Professor Chris Bunce, science director of charity Leukaemia and Lymphoma Research, said: 'The extent of the risk [of vCJD] to patients who receive regular blood transfusions as part of their treatment is as yet uncertain. 

'One way to ascertain the risk would be to monitor the distribution of the pathogen among people in this group. 
'But with that comes the moral question of whether patients should be informed or not, and this is the dilemma of the Health Protection Agency.'

A Department of Health spokesman said: 'No decisions have been taken on any unconsented follow-up of highly transfused patients.
'No unconsented follow-up has taken place and none would without appropriate ethical approval and on the basis of legal advice.


Meanwhile Stateside...
(Sacramento, CA) 
Friday, February 10, 2012

The Marin County Public Health Officer, Dr. Craig Lindquist, says one person who was diagnosed with a brain disorder similar to Mad Cow Disease has passed away, but that the person did not contract the disease from contaminated beef.  That makes it the classic form of the disease and not the varient form.   
There is another resident still living with Creutzfeldt Jacob Disease or CJD.  Lindquist says there is no evidence it is of the varient variety either. 
CJD is very rare, but always fatal.  It attacks the memory, hand eye coordination and vision before killing the victim within a year. 
The Mad Cow variant of the disease can be spread only by contact with the brain tissue or nervous system tissue of someone or something that is afflicted.  Twenty five years ago, nearly 170 people died of the variant form of the disease in Europe.
Doctor Richard Breitmeyer runs the lab at UC Davis that  tests  Mad Cow disease in sheep and cattle.  
BREITMEYER:  "The current science believes in the United Kingdom that was the cause of Varient CJD in people in that they had consumed meat products that were contaminated with the bovine form."
Breitmeyer's lab is one of six in the nation.
Cattle fed with bovine bone meal was found to be a significant cause of the spread of the disease in Europe.  Of the 40,000 animals tested each year in the United States since, only two tested positive.
In humans, 85 percent of those afflicted with classic CJD had no known risk factors.  Five to ten percent had a genetic history of the disease.

Tuesday, November 8, 2011

Vascular Solutions Q3 2011

Net sales of hemostat products (primarily consisting of the D-Stat Dry, D-Stat Flowable and D-Stat Radial products) were $5.7 million in the third quarter, a decrease of 6% from the third quarter of 2010 and a decrease of 4% from the second quarter of 2011. "The hemostatic patch market has become even more price competitive. At the very end of the second quarter we launched our new Silver versions of the D-Stat Dry and Thrombix(R) products, which add an antimicrobial ingredient to the patches while leaving our pricing unchanged. We continue to expect these Silver versions to allow us to at least maintain our market-leading position in the hemostat patch market into 2012," Mr. Root said.
As previously disclosed, King Pharmaceuticals, Inc. notified Vascular Solutions on July 6, 2011, that it was electing to not proceed further with efforts to obtain a surgical use indication from the FDA for the company's Thrombi-Gel products and to not complete development of the company's Thrombi-Paste products. As a result, Vascular Solutions recognized an additional $2.6 million of license revenue during the third quarter of 2011 as the remaining deferred license revenue originally allocated to the Thrombi-Paste products and the surgical use indication of the Thrombi-Gel products as part of the agreements entered into with King in 2007. Starting in the fourth quarter of 2011, amortization of deferred revenue is expected to be $87,000 per quarter.


Hemostat Products: It appears that revenues will continue to be flat or declining in Vascular Solution’s hemostat product lines. Management cited competitive pricing pressure for Vascular Solution’s D-Stat Dry product. However, the company could see upside if Marine Polymer’s injunction against competitor HemCon is enforced. Marine Polymer was awarded an injunction in September but Hemcon was subsequently given a stay. The injunction would prevent HemCon from selling such products as the HemCon Bandage and the Chitoflex and Dental Dressings. Vascular Solutions management did say that launches of Silver versions of the D-Stat Dry and Thrombix products, which include a new antimicrobial ingredient, would enable the company to maintain hemostat market share.

Tuesday, February 1, 2011

Pfizer acquisition of King Pharmaceuticals

It will likely be a few more weeks before King Pharmaceuticals employees learn how a pending acquisition by the world's largest drugmaker will affect their jobs.
Pfizer Inc. officials announced Monday the completion of a tender offer to purchase shares of the Bristol-based drug manufacturer and intentions to finish the acquisition by the end of February. Pfizer received federal antitrust approval to proceed with the $3.6 billion deal late last week.
"At this point, it's too early to determine any [job] impacts," Pfizer spokeswoman Joan Campion said in a phone interview with the Bristol Herald Courier. "We don't fully own the company, but we're expecting that to close in the first quarter -- in the next month or so. It's just too early to determine."
King has 435 administrative and manufacturing employees at its 5th Street corporate headquarters and 2,600 companywide. In addition to the Twin City, King operates drug manufacturing facilities in Florida, Illinois, Michigan, Missouri and Wisconsin, a research and development center in North Carolina and a commercial operations center in New Jersey. It also manufactures animal health products at plants in five states and China.
Pfizer employs more than 110,000 worldwide.
"We will conduct an evaluation of our work force and our real-estate holdings and make decisions based on serving our customers best, while still remaining competitive," Campion said.
Bristol, Tenn., City Manager Jeff Broughton said city officials are also awaiting word on what the purchase will mean for the company and the city.
"We have no information as to what will happen with King's manufacturing and office facility," Broughton said. "We've been waiting to try and approach Pfizer and stress to them the importance of that facility in Bristol, but we've only had preliminary conversations because they haven't completed the purchase."
New York-based Pfizer said Monday that about 93 percent -- or 230.7 million -- of King's outstanding shares were validly tendered and not withdrawn prior to a Jan. 28 deadline. Pfizer had offered to purchase the shares for $14.25 each in cash.
After agreeing to buy King in October, Pfizer extended its tender offer twice before last week's deadline.
For its money, Pfizer will acquire a group of branded prescription pharmaceuticals, including neuroscience products Skelaxin, Flector Patch, Avinza and painkiller Embeda; hospital products, including Thrombin-JMI; the EpiPen auto injector devices and nerve gas antidotes; and Remoxyl, an oxycodone capsule designed to be tamper-resistant that is awaiting approval from the Food and Drug Administration.
Pfizer, which is reporting its quarterly results today, said it will complete the deal through a short-form merger without a vote from remaining King shareholders.
In November, a number of King shareholders filed a series of class-action lawsuits attempting to block the merger. Each claims King's board of directors undervalued the company when it agreed to Pfizer's proposed purchase price and violated a fiduciary duty to make sure the company's shareholders got the best price for their stock.
Once the merger is completed, King's common stock will cease to be traded.
After announcing the tender, a share of Pfizer stock rose 7 cents on the New York Stock Exchange Monday, closing at $18.22. King's stock rose 2 cents and closed at $14.24.

Monday, November 8, 2010

King Pharma Disappoints

King Pharma's branded Pharmaceuticals segment declined 43.3% with revenues coming in at $160.8 million. Revenues of almost all key products declined from the year-ago period.
Thrombin-JMI sales declined 25.9% to $32.2 million. We expect Thrombin-JMI sales to continue declining due to tough competition in the form of Bristol-Myers Squibbs’ Recothrom and Johnson & Johnson’s Evithrom.

Tuesday, October 12, 2010

Pfizer will buy King Pharmaceuticals for $3.6B

NEW YORK -- Pfizer Inc., the world's largest pharmaceutical company by revenue, said Tuesday it will buy pain drug makerKing Pharmaceuticals Inc. for $3.6 billion in cash.
Pfizer ( PFE - news - people ) is paying $14.25 per share for King. That's a premium of 40 percent to the stock's Monday closing price of $10.15. In the deal Pfizer gains products including the pain drug Avinza and EpiPen, a pre-filled injection designed to quickly treat serious allergic reactions.
The deal is Pfizer's largest since it bought rival Wyeth ( WYE - news -people ) for $68 billion in 2009. That deal closed last October.
King has struggled in recent years as patents on several of its key drugs have expired or been thrown out. But the Bristol, Tenn., company is heavily involved in developing pain drugs that are intended to be abuse-resistant. Abuse of pain drugs like oxycodone has become a major concern for health officials and regulators in recent years. The drugs are often crushed or dissolved to defeat their time-release mechanisms, allowing users to get high.
King's Embeda is one pain treatment that is designed to resist abuse attempts. King plans to file new applications for two similar drugs in the next few months, filing for approval of Remoxy in the fourth quarter of 2010 and Acurox in the first quarter of 2011. Remoxy and Embeda are extended-release drugs, while Acurox releases its painkilling ingredient immediately.
King's other products include the bleeding control drug Thrombin-JMI and the Flector pain patch.

Monday, August 9, 2010

King Pharmaceuticals - Edited

Net sales of THROMBIN-JMI were $37 million, unchanged from the sales level of the first quarter of this year and were below last year’s second quarter sales of $49 million.
...THROMBIN revenues were flat versus the first quarter, we continue to diligently work with the hospital sales force to manage the lifecycle of this highly competitive and commoditized market.

William Tanner – Lazard Capital Markets

Brian, I know you had a couple 483 letters, at least, certainly this year. I wonder if you could give us a rundown on any outstanding issues that there may be at any of your plants or others relevant to King? Just a second question on the Purdue settlement, was there an attempt to encompass the oxycodone NT with that or is that something likely you have to revis in the future?

Brian Markison

Bill, thank you for the question on the Purdue settlement, but we really can’t and will not add much too it than what we’ve already said, but I appreciate the question. With the 483s, I’ll let Joe speak to that.

Joe Squicciarino

As you point out, we had two of our plants underwent inspection earlier this year, one in Rochester, Michigan, where we manufacture Bicillin, and the other is in Middleton, Wisconsin, where Thrombin-JMI is manufactured. So the outcome of the Rochester, Michigan 483s, we had relatively low number of observations. All of the corrective actions pertaining to those observations have been completed. We submitted the final report to the Detroit office of the FDA about a month ago. So nothing earth shattering there and we feel good about that audit and the outcome.

In Middleton Wisconsin, we had slightly higher number of observations; many of them or some of them I should say pertaining to process validation and a couple of other issues. We have addressed about half of the observations in Middleton. So they’re complete and the remaining observations that are yet to be addressed pertain to future production run, so we won’t be able to address those until those future production runs take place, but in both cases we’re in a good shape.

William Tanner – Lazard Capital Markets

Then just nothing else subsequent to those?

Joe Squicciarino

When you say, no, nothing…

William Tanner – Lazard Capital Markets

In terms of the other 43 letters?

Joe Squicciarino

No, no, we have not received any.

Brian Markison

Keep in mind, the Rochester facility is a single purpose plant for Bicillin only, and as Joe mentioned the Middleton facility is a single purpose plant for THROMBIN-JMI. Again, we believe that the Company’s management or the process is going to accept those steps well.

Wednesday, June 16, 2010

Animal Products


Following on from the Bleeding Calf Syndrome posting available HERE and other postings available Here regarding risks of animal sourced products.
I have provided further info above provided by DEFRA. To the best of my knowledge only the UK and Scotland are acting to investigate?

I expect manufacturers will focus efforts on recombinant, plant-based technologies.
While our industry battles achieving financial success in the market with the ideal of creating an agent that is:

  • of minimized risk
  • efficaious
  • cost effective,
  • easily deliverable
  • and applicable to multiple surgeries
The removal of King Pharmaceuticals crown as leader in the multi- $million Thrombin market by Zymogenetics is
a sure indicator as to market preference and acceptance of these benefits. J&J have a human sourced Thrombin following theirpurchase of Omrix.
Certainly reconstituted animal based technologies are facing severe threats currently as the link between zoonotic diseases (animal/human transfer) become more widely known. While BNP (Bleeding Calf Syndrome) transmission is far from clear it should be of concern. The lack of reporting and individual Government action highlight the inadequacies of public protection even with a cursory investigation.
While Bleeding Calf Syndrome may not pose infection risks via medical devices it exemplifies the public vulnerabilities to weak protection measures from their Governments. This is weak response and is exactly the response delivered that saw vCJD, and Prion borne infections escalate. Harvesting Bovine Materials HERE

Monday, May 24, 2010

Hemostasis Blog Valued Resource!

The Medical Hemostat Blog has gained wide geographical and company interest. You are welcome to contact me at hemostatguy@gmail.com. I also have consulted with market research firms such as Frost and Sullivan amongst other research organisations.

While I address a need for comprehensive information regarding hemostasis, I am pleased to announce our top, google analytics identified company visitors:

  1. Johnson & Johnson
  2. CryoLife
  3. Baxter
  4. Trauma Cure
  5. Tyco
  6. Zymogenetics
  7. Medafor
  8. Hemcon
  9. King Pharmaceuticals
  10. Entegrion
  11. St. Jude
  12. Aventis Behring
I would appreciate any contributions readers care to send and am actively seeking projects in this field.
Thank You for following the Blog.
HG

Thursday, May 6, 2010

King Q1 - Thrombin sales continue slide

Thrombin-JMI net sales totaled $37 million during the first quarter of 2010 compared to $47 million in the first quarter of last year. Net sales of Avinza totaled $23 million compared to $39 million in the first quarter of 2009.

Marc Goodman – UBS....And then can you talk about THROMBIN a little bit. It just – our understanding is that pricing had stabilized a little bit and share had stabilized but it just seems like this product just keeps going down, I mean you can give us the flavor of how should we think about it. Thanks.

Joe Squicciarino.......THROMBIN, yes so yes we had seen price settle down in the marketplace. The comparison that we’re now making now of course is first quarter of this year versus the first quarter of last year, where price is still a factor. The decline versus last year’s first quarter, once again is split evenly between price and volume, but fortunately we’ve seen price stabilize and hopefully it’ll stay that way.

Source:Seekingalpha

Wednesday, May 5, 2010

Zymogenetics Q1 2010 - "Soft" Hemostat Market in January

On the RECOTHROM front net sales for the quarter was $9 million. This is doubling of Q1 sales for 2009. January in particular was a very weak month across the hemostat segment and RECOTHROM was no exception. That said, for the quarter actual hospital demand that it's units moving from the wholesaler inventory to hospital end user increased by 14% compared to the fourth quarter of 2009.

RECOTHROM market share in dollars continued to increase in Q1 to approximately 19% versus 17% in the prior quarter. Jim will discuss the factors that influence our reported net sales for the March 31st quarter, but demand in market share continued to grow and based on momentum we see in the market place, we are comfortable with our full year guidance of $48 million to $54 million of net sales............

Net sales of RECOTHROM were $9 million for the quarter, doubling from $4.5 million a year ago. Net sales were approximately the same as the fourth quarter of 2009 even though we had positive trends in units sold to hospitals and market share as Doug described earlier.

There are two primary reasons for this, both of which were related to differences between the timing of hospital purchases and when we record revenue based on sales to wholesalers. First, decreases in wholesaler inventory levels had a significant impact. We estimated there were about 2.4 weeks of sales in the channel at March 31st, compared to about 3.2 weeks at the beginning of the quarter.

Second, the way that the weeks fell in the calendar had a significant impact, in that there was about one week fewer sales included in the three months ended March 31st compared to the three months ended December 31st. Together these two factors caused our reported net sales to be lower than one would expect based on underlying hospital sales trends.............

Brian Abrahams - Oppenheimer and Company

Great. Can you remind us how was [RECOTHROM] reimbursed and what impact the healthcare reforms would you expect?

Stephen Zaruby

Well, as three reimbursement was captured in the cost of any surgery we don’t see there will be any impact on the reform side at all in terms of our pricing and how we capture. So my guess, we are fortunate in that one of the few maybe who are not affected by that..........

David Miller - Biotech Stock Research

Now switching to RECOTHROM for a moment, can we expect the kind of continued slow grind we have seen for RECOTHROM sales on a quarter-over-quarter basis? Going forward, is there some kind of invents that we can look forward to that might provide an inflection or you would be replacing more of the JMI sales out there?

Stephen Zaruby

This is Stephen Zaruby. I think as Doug said we are encouraged by the momentum that we have seen, but moving forward obviously we are very active in the marketplace at all kinds and different touch points and levels be it through our sales force or national accounts people dealing with GPOs and so on and so forth and as Doug said we remain confident in our annual guidance and so it depends how you might forecast or sort of allocate our sales quarter-by-quarter, but we expect to see continued growth and the growth certainly comes largely or entirely at the expense of Thrombin-JMI........

Paul Latta - McAdams Wright Ragen

One another question on the RECOTHROM, you mentioned that the hemostat market was a little soft in January, any thought as to why?

Doug Williams

It's hard to say. I think it was sort of an observation we made looking at the totality of the markets. If you recall Paul we saw similar situation with our fourth quarter to first quarter situation last year, but I don’t know how much of it is sort of seasonally related, but I think beyond the metrics that Jim sketched out in terms of one less week and drawing down the wholesaler inventory levels. Those are really the sort of firm facts we can throw out and beyond that I think we just beat speculation as to what was happening in the market there, but quite clearly January for everyone in the hemostat area was a soft month.

Paul Latta - McAdams Wright Ragen

Is their [year-end] budget plus possibility too?

Doug Williams

Again it's hard to say. I think you could relate it to everything from bad weather on the East Coast to general economic conditions, but I think fundamentally we don't really have a clear-cut answer for you as to why January was soft.

Source: Seekingalpha