Nycomed sees 60% of sales in emerging markets by 2015

Nycomed has posted a 1.8% dip in turnover for 2010 to 3.17 billion euros, a reasonable result given the effects of generic competition to its gastrointestinal drug pantoprazole.


The Swiss privately-held drugmaker’s adjusted earnings before interest, taxes, depreciation and amortisation reached 850.5 million euros, down 20.9%. Pantoprazole sales fell 27.8% to 908.0 million euros, due principally to the loss of its patent in key European markets, Australia and Switzerland.
Sales of the drug in the USA, where it is sold as Protonix by partner Pfizer, are also falling as a result of 'at risk' launches by Teva and Sun in 2007; US exclusivity did not expire until last month. A lengthy legal battle is ongoing but recent judgments have sided with Nycomed which could pocket damages of up to $2 billion, some analysts have argued.
Much of Nycomed's future success is dependent on its recently-launched chronic obstructive pulmonary disease treatment Daxas (roflumilast). The drug, which hit the market in Denmark, Germany and the UK in September and is now available in several other European Union countries, brought in 3.8 million euros and earlier this week partner Forest Laboratories bagged US approval for the treatment, which will be sold as Daliresp.
Chief executive Hakan Bjorklund noted that a number of other products performed well, particularly from the bovine blood derivative Actovegin,  the haemostatic agent TachoSil (fibrinogen/thrombin), the nasal spray Instanyl (fentanyl) for breakthrough cancer pain and Alvesco (ciclesonide) for asthma. He is particularly pleased with the Zurich-headquartered group's performance in emerging markets where it showed above industry average growth in 2010.
Mr Bjorklund noted that Russia/CIS is Nycomed's largest market and Brazil has moved into second. Emerging markets accounted for 39% of turnover in 2010 and by 2015, "we expect them to make up around 60% of our sales".
He concluded by saying that 2011 results will be impacted by "continuing strong marketing and sales efforts around launches of Daxas and focus on our operations in the emerging markets". 

Tachosil - IFU and FDA info

Horse tendons for production of Collagen Sponge are collected from slaughterhouses. ---(b)(4)-- (horse–(b)(4)) slaughterhouses are certified by authorities of the European Union. -----(b)(4)---- slaughterhouses possess an approval of the EU veterinary authorities and are listed on the FSIS (USDA) list as certified facilities. All slaughterhouses are regularly inspected and approved by the national veterinary authorities and are audited by Nycomed. Each batch of horse tendons supplied to Nycomed is accompanied by a veterinary certificate and by a QA certificate issued by a quality responsible person at the slaughterhouse.

Transmissible Spongiform Encephalopathy

TachoSil has an acceptable safety profile with regard to prions. TachoSil does not contain any bovine ingredients. According to current knowledge, horses do not develop prion disease. Measures to avoid cross contamination of the equine tendons are in place at the slaughterhouses. For the Active Substances - Human Fibrinogen and Human Thrombin - strict plasma donor selection criteria are employed by the manufacturer.........Full FDA document with IFU available below.....

Tachosil - Report Fails to Impress

A new product — a sponge-like patch — is now on the market to help decrease bleeding during cardiovascular surgery.
The sealing patch, called TachoSil, helps prevent bleeding and — better yet — never needs to be removed. It simply dissolves within the body over time.
“TachoSil is the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels when standard surgical techniques are ineffective or impractical,” said Dr. Michelle Yeboah.
The new product received approval in April from the Center for Biologics Evaluation and Research, the part of the Food and Drug Administration that regulates biological products for human use.
The absorbable fibrin sealant patch is unique. It is the first product of its kind available in the United States, said Laura Jacobs, corporate communications official with Baxter Pharmaceuticals.
Officially, the patch is considered an adjunctive hemostatic agent, used to control bleeding during surgery, Jacobs said.
TachoSil is a sponge-like material made up of naturally occurring proteins found in mammals. The product is covered with two proteins: fibrinogen and thrombin.
Together they cause chemical reactions that produce fibrin, which is a protein that brings about blood clots.
This sealant patch is biodegradable, which means that it breaks down within the body in less than six months.
TachoSil does not require preparation and can be applied directly to the bleeding area during both open and minimally invasive surgeries.
“In the presence of saline, blood or other bodily fluids, the coagulation factors in TachoSil dissolve to form a mechanical fibrin clot, which adheres the patch to the bleeding surface and achieves hemostatis,” Jacobs said.
It can be used in cardiovascular surgery when bleeding cannot be controlled by standard surgical techniques such as suture, ligature or cautery. It is not a replacement but rather an additional tool to what is currently available to surgeons.
The patch comes in various sizes. The surgeon can use scissors to cut the patch to a specific size or can overlap patches if the patch is not large enough.
In instances of heavy bleeding, excess blood is to be wiped away before TachoSil is applied.
One side of the patch is yellow, and that is the side that should cover the wound. It is dyed with riboflavin to indicate that the side contains active ingredients.
It is critical to apply pressure on the patch for three minutes.
After the surgery, imaging scans such as X-rays, ultrasounds and CT scans will show evidence that TachoSil was used. The clarity of the image depends on the specific site of application.
No product comes without risk, however.
It is not common, but some patients experience hypersensitivity or allergic reactions. In rare cases, it could turn into severe hypersensitive reaction. Those who are prone to having a systemic reaction to horse proteins or human blood products are not good candidates for use of TachoSil.
TachoSil comes in double packaging which makes it extra sterile. This allows someone to assist during surgery and open one layer of the package while leaving the inner package on the table with the other instruments ready for use.
The sealant patch is a significant advance for cardiologists and represents another tool surgeons can use to address the many types of bleeding challenges in cardiovascular surgery, Jacobs said.
TachoSil has more than 15 years of documented clinical experience and a strong safety record, Jacobs said.
The product, manufactured by Nycomed Austria, is available in more than 50 markets, in addition to the United States.

Source: Reporter News

Baxter International Inc. Q1 2010

Sales in the regenerative medicine business which includes our bio surgery products totaled $119 million and increased 20%. Sales excluding foreign currency grew 14% and continue to reflect robust growth of Floseal, Coseal and Tisseel....... we expect the regenerative medicine to have sales growth exceeding 25% reflecting the ApaTech acquisition and continued double digit growth in the base business.........

Besides the existing growth vehicles of hemophilia and bio surgery and the various product categories of medication delivery like [hemostasia] and nutritionals, if you just look at kind of near-term new product launches in the various businesses, not to get off of IVIG. Let’s start with that. We have a 30 gram IVIG product we hope to get approved this year and hopefully launch in the U.S. by the end of this year. We have a 10% sub-q product without Enhance, without the Hylenex technology that we will be submitting shortly and hope to have on the market in 2011. Then of course HYQ which incorporates the Hylenex technology we are very excited about. Then new indications like MMN and the whole Alzheimer’s thing which we don’t need to get into.

So even within the antibody therapy area we have a very nice lineup of near-term and longer term things that can really I think change the game. The rest of bio science of course we just got approval for TachoSil in our bio surgery business which we will be launching. We continue to make good progress with our seasonal influenza vaccine targeting EU approval this year and hopefully approval and launch in the U.S. before too long.

I guess where we are completing a trial right now for a broader hemostasis claim which could be very helpful for the growth of that product. I mentioned in renal but Enterprise which is the next generation PD cycler we will be launching hopefully by sometime in early 2011. Our hemo next generation infusion pump platform. Then in the short-term a number of market expansion opportunities with existing products. ADVATE launches in big markets this year like Brazil and then next year Russia. Following year China. Supreme launch in Japan. I will stop there. I am getting pretty granular. We have a fairly nice array and continuous array in all of our businesses of new product launches both near-term and obviously some bigger things longer term. In addition to the existing growth platforms whether it is hemophilia or recombinant and bio surgery and so on. I covered a lot.

Comparison between TachoComb and TachoSil

TachoComb has frequently been used for the treatment of both venous and arterial bleeding. However, anaphylactic reactions have been reported after repeated use of hemostatic agents containing aprotinin such as TachoComb. Because aprotinin is also associated with risk of renal failure, manufacturing of a new product--TachoSil--which lacks aprotinin seems a logic evolvement. Furthermore, thrombin on the TachoSil material has been changed from bovine in TachoComb to human origin. These changes in the biochemical composition could lead to changes in the hemostatic performance. Therefore, we aimed to disclose any difference in hemostatic efficacy of the two products. METHODS: Twelve 70-kg pigs had controlled insults to the thoracic aorta with and without heparin administration. The iatrogenic lesion was randomly covered with either TachoComb or TachoSil and the time to hemostasis was measured. RESULTS: Time to hemostasis when using TachoSil compared with TachoComb was increased 14% (-13% to 48%) with heparin and 10% (-26% to 66%) without heparin (mean +/- 95% confidence interval; p > 0.05 in both). Time to hemostasis with heparin administration increased significantly in both treatments: TachoComb 80% (26%-156%) (p = 0.001) and TachoSil 75% (18%-158%) (p = 0.005). CONCLUSION: We found neither statistical nor clinical evidence that TachoComb should have better hemostatic properties than does TachoSil in arterial bleeding. Both TachoSil and TachoComb can be used with heparin administration, but significant prolongation of the time to hemostasis is to be expected for both products. TachoSil should be preferred to TachoComb due to the potential lower risk of side effects when using the former.

FULL ARTICLE

FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery

Blood-clotting patch is absorbed by the body

SILVER SPRING, Md., April 5 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved TachoSil, the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels, when standard surgical techniques are ineffective or impractical. TachoSil is a ready-to-use surgical patch composed of a dry collagen sponge made from horse tendons, and coated with fibrinogen and thrombin. At the site of a wound, the two proteins, through a series of chemical reactions, produce fibrin, a stringy, white, insoluble protein that allows a clot to form. The TachoSil patch is biodegradable and breaks down inside the body within four to six months. TachoSil is not intended for use within blood vessels.
"This approval provides an additional tool for surgeons to help control mild and moderate bleeding from blood vessels during cardiovascular surgery when standard surgical techniques are ineffective or impractical," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.
The plasma used to manufacture TachoSil is collected from U.S. donors who have been screened and tested for diseases transmitted by blood. The fibrinogen and thrombin used in the surgical patch undergo additional manufacturing processes to remove impurities, including bloodborne viruses. The collagen taken from horse tendons undergoes a separate step to remove impurities, including equine viruses.
The effectiveness of TachoSil manufactured by Nycomed Austria GmbH of Linz, Austria was evaluated in a study of 119 cardiovascular surgery patients. Nearly three-quarters (74.6 percent) of those who received TachoSil, stopped bleeding within three minutes compared with 33.3 percent in the control group.
Hypersensitivity to product components or allergic reactions may occur with TachoSil. The adverse reaction rates were not statistically different between the study and control groups.

Frost & Sullivan Commends Nycomed for Excellence in Product Differentiation Innovation

LONDON, March 23 /PRNewswire/ -- The "2008 European Tissue Sealants & Topical Hemostats Product Differentiation Innovation Award" is conferred on Nycomed in recognition of its revolutionary product - TachoSil. The innovative surgical patch, TachoSil is poised to be the future of the European tissue sealants and topical hemostats markets. At present, Nycomed, with TachoSil, is the sole company in the market with a ready-to-use dual action patch. TachoSil is unique: it does not fit into any of the standard market segments and constitutes a separate category on its own. "This pioneering product has both haemostatic and sealing properties and can be used to stop bleeding as well seal tissue," explains Frost & Sullivan Research Analyst Divya Belle. "TachoSil combines the bioactive mechanism of action of human coagulation factors fibrinogen and thrombin with a collagen patch for mechanical support."

Nycomed's Tachosil receives expanded indication

•Surgical patch TachoSil® – first and only dual action patch for general tissue sealing
ZURICH, Switzerland, Feb. 17, 2009--Today Nycomed received an expanded indication for TachoSil®, its innovative surgical patch, from the European Medicines Agency (EMEA). To date, TachoSil was approved for haemostasis (control of bleeding) in surgery. With the new expanded indication, it becomes the first and only dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.
TachoSil is the key product in Nycomed’s tissue management portfolio and effectively fulfils the market need for a ready-to-use surgical patch, developed to assist surgeons in achieving fast and reliable bleeding control. Now, with the new expanded indication, Nycomed can offer a dual action patch approved for haemostasis, tissue sealing as well as for suture support in vascular surgery.
“With the expansion of TachoSil’s indication, Nycomed will bring the benefits of this unique product to surgical teams and those patients undergoing lung or other types of surgery requiring rapid air or body fluid sealing,” said Lone Nørgaard Andersson, International Brand Manager at Nycomed.
The new indication was filed with the EMEA in 2008, based on international clinical trial results on lung and cardiovascular surgery. TachoSil is currently available in Europe and Russia/CIS. In the United States, the product will be marketed by Baxter International Inc., while Nycomed will manufacture it and be responsible for the US regulatory filing.

Committee For Medicinal Products For Human Use Post-Authorisation Summary Of Positive Opinion For Tachosil

LONDON, Dec. 18, 2008-On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing authorisation for the medicinal product TachoSil. The Marketing Authorisation Holder for this medicinal product is Nycomed Austria Gmbh.
The CHMP adopted new indications as follows: “to promote tissue sealing and for suture support in vascular surgery”.
Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indication for TachoSil will be as follows***: TachoSil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient (see SPC section 5.1)”.

* Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 44 days (Type II variations) and 67 days (Annex II applications) from adoption of the Opinion.

** Marketing Authorisation Holders may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.

Archive - Baxter gets rights to TachoSil

DEERFIELD, Ill., January 7, 2008 — Baxter Healthcare Corporation today announced an agreement with Nycomed that grants Baxter exclusive rights to market and distribute the company’s TachoSil® patch in the United States. TachoSil is a patented Nycomed product, which is currently available in more than 50 markets outside of the United States including Europe and Japan. The product is a fixed combination of a collagen patch coated with human thrombin and fibrinogen. It is used in a variety of surgical procedures to seal tissue and control bleeding, requires little preparation and can be stored at room temperature. The currently approved indication in Europe is “for supportive treatment in surgery for improvement of hemostasis where standard techniques are insufficient.” TachoSil is not yet an approved product in the United States.

TachoSil® is a ready-to-use surgical patch that allows haemostasis to be achieved quickly and easily. TachoSil® is the only ready-to-use fixed combination of a collagen sponge coated with a dry layer of the human coagulation factors fibrinogen and thrombin. TachoSil® achieves haemostasis in 3-5 minutes and has several distinct advantages compared with current supportive techniques.